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andersunmenschlich · 1 month ago

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Trump and Food Safety (a brief history)

TL;DR The Heritage Foundation said, "Gut food safety regulations"—and Trump did. Now a lot of our food is unsafe.

"A fact sheet issued by Donald Trump's campaign on Thursday said he would roll back food safety regulations if the billionaire businessman is elected president, arguing they are burdensome to farmers and 'overkill.'

"The campaign later deleted the fact sheet from its website and issued a new release that did not include the food safety language."

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"The language in the Trump campaign fact sheet mirrors, almost word for word, parts of a May report from The Heritage Foundation that criticizes increased regulation under President Barack Obama." —AP News, Sept. 2016

"Trump's Deregulation Push Is Setting the Stage for Major National Disasters" … "The lessons of history are clear: deregulation is driven by corporate greed, dangerous for American families and potentially disastrous for our economy." —Public Citizen, Sept. 2017

"Trump's Latest Regulatory Overhaul Raises Food Safety Fears

"The Trump administration unveiled a new plan on Friday to overhaul USDA rules for meat inspection at pork processing plants, proposing changes that have drawn praise from industry leaders and criticism from advocates who fear they will harm workers and increase food-borne illness."

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"[C]onsumer and worker-safety advocates say the proposed changes will harm those already working in a dangerous industry and make food contamination more likely.

"'Every worker will be processing more hogs per hour, because everything will go faster. For workers, it will definitely increase the number of serious injuries they already face,' said Debbie Berkowitz of the National Employment Law Project, a Washington-based research and advocacy group.

"Berkowitz, a former Labor Department official under Obama, said the plan will also reduce federal oversight that is critical to protecting public health, leaving the industry to police itself. 'There will just be fewer inspections going on, and there are serious concerns regarding food safety because of that,' she said." —NBC News, Jan. 2018

"Enforcement of food and drug safety regulations nosedives under Trump administration

"The US regulator of food and drug safety has seen steep declines in several markers of enforcement under the Trump administration, according to a new analysis in the journal Science.

"The Food and Drug Administration (FDA) sends 'warning letters' for tainted food, improperly advertised dietary supplements or even violations of human subjects' protections in clinical trials.

"The number of letters issued has fallen by 33% under Donald Trump, compared with the most recent equivalent period under the Obama administration." … "The number of warning letters also fell significantly between Trump's first and second years. … "The FDA argues that it has other ways of enforcing food and drug safety, but experts interviewed by Piller were alarmed at the rate of decline in the warning letters and other measures." —The Guardian, July 2019

"It was more than a century ago that Upton Sinclair went undercover in Chicago's stockyards, resulting in his reported novel The Jungle. A blood-splattered portrait of the American meatpacking industry, it documented the misery and filth of the city’s slaughterhouses, where miserable workers churned out cuts of rotten meat in treacherous, rat-infested conditions. 'The air would be full of steam, from the hot water and the hot blood, so that you could not see five feet before you,' Sinclair wrote. 'And then, with men rushing about at the speed they kept up on the killing-beds, and all with butcher-knives, like razors, in their hands well, it was to be counted as a wonder that there were not more men slaughtered than cattle…'

"We have The Jungle to thank for certain food-safety regulations today. Protections for meat-industry workers, though, would come later—and President Trump has been trying to undo even that modest progress. His administration last year authorized faster 'line speeds' (the number of animals killed per minute) for poultry plants, and began looking into doing the same for beef. New U.S. Department of Agriculture (USDA) regulations that take effect in December will allow the same at pork plants, while also cutting 40 percent of government inspectors and delegating inspections to employees, who may not have undergone any kind of training in food safety." —The New Republic, Oct. 2019

"For the fifth consecutive year, Food Safety Magazine has compiled a list of food safety recalls announced by the U.S. Food and Drug Administration (FDA) as well as the U.S. Department of Agriculture Food Safety and Inspection Service (USDA FSIS).

"While it's always possible that some recalls may fall through the cracks, our tally confirms 337 recalls issued in 2019—212 by FDA and 125 by USDA FSIS.

"Much like 2018, last year seemed to experience a heightened number of food recalls—so much so that there seems to be some level of fatigue."

…

"…a new outbreak of Escherichia coli O157:H7 likely linked to romaine lettuce… undeclared allergens… Milk… Tree nuts… Eggs… Soy… Sulfites… wheat and peanuts… Listeria, Salmonella, and E. coli… Foreign Material Contamination…"

…

"According to CDC's official list, 17 multistate foodborne outbreak investigations occurred in 2019. While these outbreaks were tied to everything from fresh produce to raw ground beef—and even one Listeria outbreak with no known source more than 2.5 years after the first confirmed illness was reported—last year's list doesn’t top 2018, which had 24 outbreak investigations—the highest of any year since CDC’s tracking which dates back to 2006." —Food Safety Magazine, March 2020

"In fewer than five months, ever since the Covid-19 outbreak was declared a pandemic, the Trump administration has taken a number of significant steps to deregulate the food system. Citing unprecedented disruptions, federal agencies have rolled restrictions back on various segments of food production—from labor protections for meatpacking workers to food labeling requirements for manufacturers."

…

"President Trump himself has repeatedly invoked the coronavirus pandemic as his rationale for loosening the rules governing food production and distribution. However, his administration made its deregulatory ethos clear far earlier: In January of 2017, Trump directed his agencies to repeal two rules for every new one they introduced—a mandate that dovetails neatly with our current reality."

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"Whether for the time being or for good, here are seven notable ways that the Trump administration has cut red tape in the food system.

1. Faster chicken, with a side of tumors … 2. OSHA no longer tracking the spread of workplace illnesses … 3. EPA lets polluters police themselves … 4. Food labels can have some inaccuracies, as a treat … 5. Cutting the net on fishing regulations … 6. Truckers can drive longer into the night … 7. Employers don't have to come clean when they bust unions" —The Counter, July 2020

"Federal agencies under Trump have slowed down food safety enforcement across the board. In the first two-and-a-half years of the administration, the number of warning letters sent by the Food and Drug Administration (FDA) to companies dropped by about a third compared to the previous administration. Warning letters are one key tool used to prevent tainted items from entering the food supply. The number of letters sent from the FDA's Food Safety & Applied Nutrition division dropped 37 percent.

"In 2017, the FDA denied a petition filed by environmental groups to ban perchlorate, a chemical that can be dangerous for children and developing fetuses, in food packaging, and it dismissed concerns from outside scientists about levels of toxic chemicals known as PFAS in food.

"In early 2020, industry groups celebrated when the administration installed Mindy Brashears as the top food safety official. Brashears' past research was funded by the National Cattlemen's Association and the National Pork Board, and she holds several patents related to food contamination, which watchdog groups say means she could profit off of her position.

"During the pandemic, the FDA suspended routine inspections of both foreign and domestic food processing facilities, dairy farms, and animal feed processors. Meanwhile, the USDA indicated it would move to permanently raise poultry line-speed limits, a controversial move that poses potential dangers for workers as well as food-safety hazards. The USDA is also finalizing a rule that will privatize meat inspections for swine." —Civil Eats, Nov. 2020

"Trump has launched an all-out attack on the FDA. Will its scientific integrity survive? … "In the past two weeks alone, the Trump administration has installed a right-wing journalist best known for her gun-rights advocacy as the FDA's top spokeswoman — empowering her to aggressively reshape the FDA's typically nonpolitical, straight-laced public messaging. On Saturday, Trump, with no evidence, accused the FDA of taking part in a 'deep state' political conspiracy to harm his reelection campaign. And two key White House aides, including Trump's chief of staff, have taken the rare step of criticizing the agency publicly, with one reportedly advocating for the approval of an unproven plant extract as a Covid-19 cure."

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"The most striking change at the agency is the appointment of ultra-political conservatives — an emerging pattern that some FDA insiders see as the start of a takeover of an otherwise largely apolitical agency.

"The appointment of Emily Miller, a right-wing activist who has ping-ponged between government and conservative journalism for the past two decades, has particularly dispirited FDA staff, senior agency officials said, speaking on the condition of anonymity."

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"Another hiring earlier in 2020 has similarly troubled FDA insiders: that of David Gortler, a former policy adviser at the Heartland Institute, a conservative think tank. Gortler has extensive experience in drug regulation and has served at the FDA previously, but is also a known agency critic: In a 2016 STAT op-ed, he advocated for 'a good personnel sweep,' calling a number of FDA colleagues 'petty people who have personal agendas' and who 'abuse' small drug companies."

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"FDA staff have been equally alarmed by overt attempts from Trump and other administration officials to influence decisions about emergency authorizations for medical products that would otherwise be based solely on safety and evidence. Heightening that alarm: Trump's baseless new assertion that the agency is part of a 'deep state' plot intent on hurting his reelection odds by intentionally slowing down medical product approvals." … "Trump, reportedly, has expressed his wish that the FDA issue a similar authorization for oleandrin, a plant extract, be approved for use as a Covid-19 treatment. There is no scientific backing for his interest: Instead, Axios reported, Trump’s interest stems from the recommendation of Mike Lindell, a major Trump backer who works as the CEO of MyPillow.Com and recently acquired a stake in a company developing the experimental dietary supplement." —Stat News, Aug. 2020

"During his four years as President of the United States, Donald Trump was remarkably active and often successful in sabotaging the health and safety of the nation’s workers.

"Trump, as the AFL-CIO noted, targeted Medicare and Medicaid for $1 trillion in funding cuts, eroded the Affordable Care Act (thereby increasing the number of Americans lacking health insurance coverage by 7 million), and 'made workplaces more dangerous by rolling back critical federal safety regulations.'

"Trump's administration not only refused to publicly disclose fatality and injury data reported to the U.S. Occupational Safety and Health Administration (OSHA), but slashed the number of federal workplace safety inspectors and inspections to the lowest level in that agency’s 48-year history. According to one estimate, with these depleted numbers, it would take 165 years to inspect every worksite in the United States.

"Furthermore, the administration repealed rules requiring employers to keep and report accurate injury records, proposed eliminating the U.S. Chemical Safety Board, and cut workplace safety research and training programs. The Trump administration also proposed revoking child labor protections, weakened the Mine Safety and Health Administration’s enforcement of mine safety, and reversed a ban on chlorpyrifos, a toxic pesticide that causes acute reactions among farmworkers and neurological damage to children.

"In April 2019, the Trump Department of Agriculture's Food Safety and Inspection Service put into place a rule to allow an unlimited increase in the line speeds for hog slaughter. In an industry already notorious for endangering workers — with more than 4,700 occupational injuries and more than 2,700 occupational illnesses per year — this was a sure-fire recipe for undercutting worker safety. Even so, the Trump administration completely ignored the impact on workers' safety and health before issuing the rule.

"Downplaying workplace hazards, the administration scrapped new rules on styrene, combustible dust, infectious diseases, and silica dust, a mineral that can cause silicosis, an incurable and often fatal lung disease carrying an increased risk of lung cancer. Eager to reduce business expenditures, it also canceled a requirement for training shipyard and construction workers to avoid exposure to beryllium, a known carcinogen. In addition, the administration delayed and proposed a rollback of the Environmental Protection Agency's chemical risk management rule, thus increasing health dangers for workers, the public, and first responders.

"The Trump administration's callous disregard for the health and safety of workers became particularly apparent during 2020, as the coronavirus pandemic swept through American workplaces. Trump refused to issue binding rules requiring businesses to institute safety measures to protect nurses, bus drivers, meatpacking and poultry workers, and other particularly vulnerable workers. Quite the contrary, in April 2020 Trump issued an executive order to require the nation's meat production plants to stay open. This fact, plus an April 2020 authorization by Trump’s Department of Agriculture for 15 large poultry plants to increase their line speed, led by September to the sickness of more than 40,000 meat and poultry workers and to the deaths of hundreds." —Camas-Washougal Post-Record, Aug. 2024

"Following massive recalls and outbreaks, Americans are losing confidence in food safety regulations." —Salon, Sept. 2024

#US politics #food safety #Heritage Foundation #Trump #actions speak louder than words #our food safety regulations have been gutted #of course we're not super confident in them anymore #they need to be built back up

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hopeful-infj · 1 month ago

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I'll stand on this soapbox once, and only once, since the election is soon.

If you love war, crime, chaos, and poverty -- vote Harris!

If you love your fellow Americans and want a more free, more peaceful, more prosperous world -- vote Trump!

Donald Trump will...

Lower prices

Lower taxes

Negotiate an end to bloody (and preventable) wars

Fight rising crime

Seal the border and deport violent rapists, murderers, and sex/drug traffickers

Provide pathways to citizenship for people who want to contribute positively to the country

Bring back American energy independence

Cut useless bureaucracy and regulations

Strengthen the economy by saving manufacturing jobs and funding innovation

Provide school choice for all students (so that they aren't trapped in horrible public schools)

Address unethical farming & food manufacturing practices making American's sick

Create opportunities to support American greatness on the world stage.

Like it or not, Trump's voter block IS the unity party this time around.

Kamala Harris will...

Lead the world into more violence and hyper-inflation

Will weaken the productivity and self-sufficiency of our nation to protect itself

Her ambitions will destroy any chance at hope for prosperous conditions in this country

She will degrade and violate free speech and the second amendment rights of Americans (who need to defend themselves in high-crime areas and isolated areas)

She will steal more money (much more) from every working person's wages and every small business's income, killing jobs and hurting middle class families

Her administration will weaken our safety and defenses even more than they have been.

Her stated policies display spite, condescension, and blatant disregard for our culture, our constitution, our history, our economy, our children, our law enforcement, our sovereignty as a nation, rule of law, American minorities (yes, in many ways), and much more.

Furthermore, SHE SAID SHE WOULD DO NOTHING DIFFERENTLY THAN BIDEN. TWICE.

Kamala hates half the country; she's not good at hiding it. Trump does not. She lacks confidence, and all formidable enemies of freedom would use her as a doormat, as they have Biden. For better or worse, the world listens when Trump talks, and he's good at deterring bad actors from making big moves.

For all his faults, Trump loves the USA deeply (all of it except perhaps the hacks and liars in fake news media, lol) and he is competent to protect us from impending wars and economic ruin. By extension, the entire planet is better off. That's just the way it works. The world wouldn't have lost millions of souls to violence if the United States had been awake at the negotiation table -- untold numbers of Palestinians, Israelis, Ukrainians, and Russians are dead or permanently wounded because of the dereliction of the Biden Admin and, I repeat, Kamala says she'd do nothing differently (including surrendering the people of Afghanistan back to Taliban rule in a sudden and humiliating act of cowardice and incompetence.)

If you're a single-issue voter on abortion, Trump is not going to interfere with it. He merely released the issue from federal control. It is now a state-by-state issue and you can vote accordingly where you live. Most red states today have more liberal abortion laws than any nation in Europe (sad, but true).

If you hate my guts for posting this--even if you wish death on me--I wish you nothing but peace and blessings. I too held radical left beliefs at one time.

Don't be tricked like I was! Consider why those on the radical left can't tolerate a simple difference of opinion, and reevaluate whether everything they've told you about Trump and the right is true. Look into it for yourself. The left is not the side of love and light and progress and inclusivity that it pretends to be. It's the opposite, in fact. Its radicals represent a cult that loves death, hatred, division, chaos, lies, segregation, and tyrannical authority. It discards you if you deviate in any way from the party line.

Needless to say, I am proudly casting my vote for TRUMP 2024!!! And for the protection of your future and my children's future, I am humbly inviting you to do the same, just this once, even if you're a democrat.

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weightlosschoice · 11 months ago

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LeanBiome: Unleashing Your Body's Natural Lean Potential

For many, the pursuit of a healthy weight can feel like an uphill battle. Restrictive diets, grueling workouts, and discouraging plateaus often leave us wondering if there's a better way. Enter LeanBiome, a revolutionary weight management supplement that's making waves for its unique approach to unlocking our body's natural potential for healthy weight.

LeanBiome isn't your typical diet pill or calorie burner. It takes a targeted approach, focusing on the gut microbiome – the vibrant ecosystem of trillions of microorganisms that play a crucial role in our overall health, including weight management. Scientific research increasingly reveals the link between an imbalanced gut microbiome and weight gain. LeanBiome bridges this gap by introducing a powerful blend of nine clinically-backed probiotic strains and a revolutionary prebiotic called Greenselect Phytosome.

The Science Behind the Slim:

These carefully chosen ingredients work synergistically to address imbalances in the gut, promoting a "lean microbiome" environment. LeanBiome probiotics boost diversity and abundance of beneficial bacteria, while Greenselect Phytosome enhances their absorption and effectiveness. This potent combination leads to a cascade of positive effects:

Enhanced Metabolism: LeanBiome helps your body extract more energy from your food, boosting calorie burning and fat oxidation.

Appetite Control: By regulating gut hormones like leptin and ghrelin, LeanBiome reduces cravings and keeps you feeling fuller for longer, supporting healthier eating habits.

Improved Digestion: Balanced gut flora translates to smoother digestion, reduced bloating, and better nutrient absorption, all contributing to overall well-being.

Increased Energy: Efficient metabolism and improved gut health result in a natural energy boost, allowing you to tackle your day with more zest.

More Than Just Numbers:

The benefits of LeanBiome extend far beyond the scale. Many users report improvements in overall health, including better sleep, clearer skin, sharper focus, and a strengthened immune system. By nurturing a thriving gut microbiome, LeanBiome empowers you to feel your best from the inside out.

A Proven Approach:

LeanBiome is built on solid scientific research and is manufactured in a GMP-certified facility, ensuring the highest quality and safety standards. Clinical studies have shown its effectiveness in promoting weight loss, managing appetite, and improving gut health. Additionally, LeanBiome offers a generous 180-day money-back guarantee, demonstrating their confidence in their product and commitment to customer satisfaction.

Learn more here: https://bit.ly/3XZPprw

Unlocking Your Inner Lean:

LeanBiome is a unique and exciting addition to the weight management landscape. By addressing the root cause of weight gain, it empowers you to achieve your weight goals and experience a newfound sense of vitality, all while supporting your overall health. If you're ready to ditch the diet struggle and embrace a natural approach to a healthier, leaner you, LeanBiome might just be the key you've been looking for.

Disclaimer: Before starting any new supplement, it's important to consult with your healthcare provider, if you have any underlying medical conditions.

#weight loss

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foodandbeverages · 1 year ago

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Insect Feed Market 2023-2033: Analysed By Business Growth, Development Factors, Applications, And Future Prospects

According to our projections, the worldwide demand for insect feeds can be pegged at roughly US$ 1,561 million for 2023. Furthermore, the sales of insect feeds are projected to rise globally at a pace of 17.9% per year from 2023 to 2033. Ultimately, the global insect feed market’s net value will reach almost US$ 8,124 million by 2033.

Get PDF Sample Report: https://www.futuremarketinsights.com/reports/sample/rep-gb-11604

As many animals ingest the insects naturally, it makes sense to think about using insect proteins as a potential source of commercial feed additionally, because insects include bioactive components, they are increasingly being used as innovative feed additions to promote the gut health of pet animals.

Sales of animal feed additives are also expected to be constrained by the strict laws and regulations related to introducing new insect feed. For example, the Bovine Spongiform Encephalopathy problem poses a crucial threat to consumer health and safety, impacting the overall approach of using insects as feed in Europe. Another main roadblock to adopting insects as feed in many places is the lack of clear laws and standards governing their usage as food.

“Prominent industries producing animal feed have started investing in research to produce cutting-edge insect feed products to expand consumer base in the international market. Besides, some insect feed suppliers are working with other producers to include their goods in preparation of the final product for livestock.” – Nandini Roy Choudhury (Client Partner for Food & Beverages at Future Market Insights, Inc.).

Key Takeaways from the Global Insect Feed Market Study Report by FMI

The United States captured most of the global market and is predicted to contribute US$ 491.7 million in 2023.

Germany is the leading supplier of insect feeds in Europe and it may contribute to nearly 5.8% of the global market share in 2023.

Insect feed demand is rising in China and South Korea, which is expected to lead to strong growth in the Asia Pacific. In 2023, the two countries are estimated to contribute nearly 15.8% and 2.8% of the global revenue share respectively.

Australia is another emerging market for insect feeds in the Asia Pacific with an estimated global market share of 1.9% in 2023.

With an overall market share of nearly 43% in 2023, the aquaculture segment is expected to lead the market among end users.

Competitive Landscape

To increase their product offerings and introduce cutting-edge items, leading insect feed manufacturers spend highly on research and development. For instance, Nutrition Technologies Company declared in June 2022 to create bacteriophages to replace antibiotics in the protein found in black army flies.

Recent Developments

Protenga Incorporate obtained nearly US$ 1.6 million in July 2020 with Roslin Technologies, a British agri-tech startup. The investment has been made to discover the black soldier fly’s new, effective genetic strains for use in aquaculture, livestock, and pet feed.

Nutrition Technologies and Evonik partnered in March 2022 to do research and development on poultry insect feed. The partnership concentrated on the amino acid needs of Southeast Asian BSF to achieve sustainable results in livestock production by optimizing BSF diets.

In May 2022, Pet World Nutrition Technologies, SPCA Selangor, and Nutrition Technologies introduced a sustainable commercial dog food containing protein from black soldier fly larvae.

Information Source: https://www.futuremarketinsights.com/reports/insect-feed-market

#Insect Feed Market

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farzanatradingcompany · 1 year ago

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The Health Advantages of Consuming Dairy Products in your Diet

Few food collections are as adaptable and nutrient-dense in the world of nutrition as dairy products. Dairy products have long been an integral component in human diets, from creamy milk to delicious cheese and yogurt. We will examine the multiple health benefits of consuming dairy products in this blog post, with a focus on the premium goods provided by Farzana Foodstuff Trading company UAE

Ways to Include Dairy in Your Diet:

Let's now explore how we can easily incorporate these healthy treats into our diet after talking about the benefits of dairy for our health and the goods offered by Farzana.

Breakfast boost : Start the day off right with a cup of yogurt topped with fresh fruit and some honey. This not only satisfies your taste buds but also provides a dose of probiotics, vitamins, and minerals to get your day going.

Delicious Creations: Some of our meals must contain cheese. Whether you're making salads, sandwiches, or pasta dishes, cheese adds flavour and nutrients to your culinary creations.

Food Sensation: Grab a yoghurt mix or a glass of milk for a quick and satisfying snack. These foods will keep you energised in between meals because they include both protein and carbohydrates.

The Booster of Protein

Protein is abundant in dairy products and is essential for growth, repair, and overall health. High-quality protein sources like milk, cheese, and yoghurt supply the body with all eight needed amino acids. So, if you want to build and retain muscle mass, boost your immune system, and regulate your hormones, a dairy is a perfect choice.

Minerals and Vitamins in Abundance: Additionally, dairy products are of high in vitamins and minerals that are good for your general health. Vitamin D, popularly known as the "sunshine vitamin," is crucial for calcium absorption and strong bones. Many dairy products, including those sold by Farzana Foodstuff Trading Company UAE , are fortified with vitamin D, making them a simple way to ensure that you're obtaining your required daily supply.

Furthermore, dairy products contain B vitamins including riboflavin, vitamin B12, and pantothenic acid, which are essential for the production of red blood cells, the health of the nervous system, and the metabolism of energy. These nutrients work together to sustain your energy and concentration.

Developing Your Dairy Experience with Perfection and Quality:

Farzana is a dependable and excellent source when it comes to consuming dairy products as part of a balanced diet. To satisfy all tastes and nutritional requirements, our company, which is dedicated to quality and health, offers a variety of dairy delicacies. Every product we sell receives a high level of value from us. Our dairy products are constantly inspected for quality and adhere to the highest requirements for food safety. By selecting our products, you support a company that cares about and supports your health.

In conclusion, dairy products have established themselves as a nutritional powerhouse in our diets, offering a range of health benefits from gut health to bone strength. You may count on Farzana Trading LLC commitment to excellence. Enjoy the path to a healthy life.

#Fresh Vegetables Suppliers Dubai #Foodstuff Trading Company UAE #Foodstuff Trading Company Dubai #HoReCa supplier in UAE

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bethanyhamiltonsstuff · 1 year ago

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Can Hamsters Eat Apples? 8 Fascinating Facts

Can Hamsters Consume Apples? You're wondering if hamsters can eat apples. Discover the answer in our article! Here are the best tips for your furry friend!

Apple's Mysteries

Apples, with their crisp texture and juicy sweetness, have long been a human favorite. But what about our little hamster pals? In this detailed blog post, we'll answer the question "Can hamsters eat apples?" and look at the benefits and drawbacks of including this fruit in their diet.

What Is the Composition of Apples?

Apples, nature's gift, are made up of delectable flesh encased in a thin skin. Apples, which are members of the Rosaceae family, come in a wide range of colors, flavors, and varieties. What matters most is whether they are appropriate and safe for your hamster.

Apple Nutritional Composition

While apples are not a primary food source for hamsters, they do contain essential nutrients that can benefit their health:

Fiber: Helps with digestion and gut function.

Vitamins: These include vitamin C and a variety of B vitamins.

Minerals include potassium and trace amounts of calcium.

Why Are Apples Safe for Hamsters?

Because of their natural sweetness and fiber content, apples make an excellent hamster treat. The fiber in apples aids digestion, and the vitamins and minerals improve overall health. However, keep in mind that apples should only be a minor and infrequent part of your hamster's diet.

The Advantages of Feeding Apples to Hamsters

Uncovering the Benefits Incorporating apples into your hamster's diet in moderation may provide several benefits:

Digestive Health: The fiber in apples aids in the maintenance of a healthy digestive system and the prevention of constipation.

Vitamins and antioxidants: Apples contain vitamins that help your hamster's immune system and overall health.

Enrichment: Introducing new foods, such as apples, can provide your hamster with mental stimulation.

Exemplifying Health Advantages

The vitamin C in apples can help your hamster's immune system, while the fiber helps regulate digestion, lowering the risk of gastrointestinal issues.

Apples Contain Nutrients

Apples contain a variety of nutrients that can benefit your hamster's health, including vitamin C, vitamin A, potassium, and dietary fiber. These nutrients work together to improve your hamster's vitality and overall health.

The Dangers of Feeding Apples to Hamsters

Taking Precaution Though apples are generally safe for hamsters, there are a few risks to be aware of:

Pesticides: If apples aren't organic, their skin may contain toxic pesticides. To keep your pet safe, always choose organic apples.

Natural sugars in apples can cause weight gain and blood sugar fluctuations if consumed in excess.

Compositions to Avoid

Apple seeds contain trace amounts of cyanide, which can be dangerous in large quantities. Always remove the seeds and core from apples before giving them to your hamster for safety.

Overconsumption's Consequences

Excessive apple consumption in your hamster can result in health issues. Too much sugar from apples can cause weight gain, dental problems, and digestive problems.

Recognizing Apple Poisoning Symptoms in Hamsters

Possible Indicators If your hamster eats a lot of apples, keep an eye out for the following symptoms:

Diarrhea, bloating, or changes in stool consistency are all symptoms of digestive distress.

Lethargy: Your hamster may appear drowsy or less active than usual.

Cases of Apple Poisoning In rare cases, hamsters may suffer from digestive upset or diarrhea after consuming an excessive amount of apple flesh. Observing your hamster's reaction to apples will allow you to adjust portion sizes as needed.

Choosing an Appropriate Number of Apples

Moderation is essential.

Moderation is essential when it comes to apples. As an occasional treat, serve a small slice or cube. Limit apple treats to 1 to 2 times per week, and keep them to no more than 10% of your hamster's overall diet.

Dietary Guidelines for a Healthy Lifestyle

A well-balanced hamster diet includes a variety of fresh vegetables, high-quality hamster pellets, occasional fruits such as apples, and appropriate treats. This method ensures that your hamster receives a wide variety of nutrients.

Investigating Alternatives and Supplemental Foods

Dietary Variety Hamsters can eat a variety of foods in addition to apples, including:

Leafy greens such as spinach, kale, and parsley are high in vitamins and minerals.

Blueberries, pears, and strawberries are high in natural sugars and antioxidants.

Carrots, bell peppers, and cucumber are all crunchy and nutritious vegetables.

Famous Hamster Foods

Aside from fruits and vegetables, hamsters thrive on commercially available hamster pellets that contain essential nutrients. On occasion, treats like pumpkin seeds and small portions of unseasoned cooked meat can be included.

#hamster food

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veritywarner90 · 1 year ago

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When considering substantial changes to how society functions (the VOICE Referendum) its wise to look at other country’s experiences.

Canada has passed similar legislation:

https://justice.gc.ca/eng/declaration/index.html

Below is an email I have obtained from a Canadian farmer… see how it sits with you.

FROM A CANADIAN FARMER:

I have received a text concerning a meeting in Peace River on June 8 th concerning a proposal put forward to support native people coming on to privately owned land at will and without permission.

My husband and I are beef farmers in the xxxxx Valley of B.C. and we appose this idea vehemently. I will outline some of the reasons for our opinion on this matter.

First of all it’s privately owned farm land that we purchased, pay taxes on, and maintain and protect at great cost to us. This land was bought fairly and according to the law of the land. We cleared it via bull dozer, and excavator over a fifteen year period. We have cleared timber, picked sticks, and spent at least two hundred thousand in clearing the land and developing it into productive farm land that feeds Canadian citizens. This does not include the cost of the building of our home and out buildings which we built with the timber from the land and erected ourselves. Also extensive fencing and forestry maintenance.

We have a herd of Black Angus Beef cows that we nurture and keep safe with in the confines of our completely fenced in farm. If people were to come upon our farm either through the fencing or through the gate system without notification they are putting themselves in danger as well as our horses and cows. Encountering an angry charging bull or calving cow is best avoided for safety reasons.

A farm that is actively in production of vegetables, hay or livestock is not a place to just wonder around in without permission or notification. Trespassers can easily damage crops either unknowingly or purposely with out guidance from the owners who husband that farm. Hunting on a farm, especially without permission is exceptionally dangerous to both the livestock and human inhabitants due to stray bullets that could possibly hit cows or horses or possibly go through walls of buildings. Gut piles left behind can attract predators further endanger livestock and family members due to attracting large unwanted predators to the area, and there is no guarantee that messes from hunted undulates would be cleaned and removed from our farm.

Trespassers can unknowingly bring diseases into farms that can result in great financial loss or destruction of crops or animals. The stress on livestock can be very detrimental especially during calving season and if disease is brought in to any livestock operation via trespassers it can possibly impact consumers.

There are laws developed by provincial and federal authorities that hold farmers accountable to properly protect their animals with standards used to guide farm animal care in Canada that were developed by the National Farm Animal Care Council . Therefore trespassing makes it impossible for farmers to meet the outlined standards implemented by the National Farm Animal Care Council. The regulations require animals that are used for food must be handled in a way to avoid stress or pain. Having unwanted trespassers entering a farm would make meeting this criteria impossible. It simply must not be allowed.

Clearly, allowing any group of people on private property with out permission is a dangerous and rudely invasive endeavour. It promotes conflict by removing the established rules, guidelines, and laws that have been put in place to keep the peace, and create good relations among Canadian citizens of all creeds and backgrounds. Raising one group above the other and condoning willful trespassing because of historical differences is detrimental to maintaining civil order and good relations as well as placing farmers in a very precarious position of being unable to meet health and safety standards for their animals on secured pasture.

Read more articles at:

https://veritywarner90.wordpress.com

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healthylifesupplement · 1 year ago

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World of Dietary Supplements: Uses, Benefits, Usage Guide, and Finding the Right Ones

Dietary supplements have gained significant popularity in recent years as people strive to enhance their overall health and well-being. Available in various forms such as capsules, tablets, powders, and liquids, these supplements are designed to provide essential nutrients or other beneficial substances that may be lacking in our diets. In this comprehensive article, we will delve into the world of dietary supplements, exploring their uses, benefits, proper usage, and how to find the right ones for your specific needs.

I. Understanding Dietary Supplements:

A. What are Dietary Supplements? Dietary supplements encompass products that contain vitamins, minerals, herbs, botanicals, amino acids, enzymes, or other dietary substances. Their purpose is to supplement the diet and provide additional nutrients that may be lacking.

B. Types of Dietary Supplements:

Multivitamins: These supplements combine essential vitamins and minerals to support overall health.

Herbal and Botanical Supplements: Derived from plants, these supplements may offer specific health benefits.

Omega-3 Fatty Acids: These supplements provide essential fats that support heart health and brain function.

Probiotics: Live bacteria and yeasts that promote gut health and digestion.

Protein Powders: Often used by athletes and fitness enthusiasts to support muscle growth and recovery.

II. Benefits and Uses of Dietary Supplements:

A. Meeting Nutritional Needs: Dietary supplements play a crucial role in bridging nutritional gaps, particularly for individuals with specific dietary restrictions, limited food choices, or increased nutrient requirements.

B. Supporting General Health: Supplements can help maintain overall health and well-being by providing essential nutrients and supporting various bodily functions.

C. Addressing Specific Health Concerns: Certain supplements have been studied for their potential benefits in managing specific health conditions, such as joint health, cognitive function, or immune support.

D. Athletic Performance and Fitness: Many athletes and fitness enthusiasts use supplements to support performance, enhance muscle growth, improve endurance, and aid in recovery.

To find the right supplement for your needs, visit Healthy Life Supplements: Click Here.

III. How to Use Dietary Supplements Properly:

A. Consultation with a Healthcare Professional: Before starting any new supplement regimen, it is crucial to consult with a healthcare professional to assess your specific needs and ensure compatibility with your current health status.

B. Recommended Dosages: Follow the recommended dosages provided on the supplement packaging or as advised by your healthcare professional.

C. Timing and Administration: Some supplements are best taken with meals, while others are more effective on an empty stomach. Read the instructions or consult your healthcare professional for guidance.

D. Complementary Lifestyle Factors: Supplements are not a substitute for a healthy diet and lifestyle. They should complement a well-balanced diet, regular exercise, and other healthy habits.

IV. Finding the Right Supplements:

A. Research and Education: Conduct thorough research and seek reliable sources of information to understand the specific benefits, potential risks, and recommended usage of various supplements.

B. Quality and Safety: Look for reputable brands that adhere to Good Manufacturing Practices (GMP) and have undergone third-party testing for quality and purity.

C. Reading Labels and Ingredients: Carefully read product labels to understand the active ingredients, concentrations, and any potential allergens or additives.

D. Consumer Reviews and Recommendations: Consider feedback from other users, but be cautious and prioritize scientifically supported information over anecdotal experiences.

V. Understanding Supplement Safety and Regulation:

A. FDA Regulations: The U.S. Food and Drug Administration (FDA) regulates dietary supplements, but unlike drugs, they do not undergo pre-market approval. Instead, manufacturers are responsible for ensuring the safety and labeling compliance of their products.

B. Adverse Effects and Interactions: While supplements are generally safe when used as directed, they may still carry risks, especially when taken in excessive doses or in combination with certain medications. It's important to be aware of potential interactions and any warnings associated with specific supplements.

C. Quality Control and Third-Party Testing: Look for supplements that have been tested by independent third-party laboratories to verify their potency, purity, and quality. This can provide additional reassurance regarding the product's safety.

D. Reporting Adverse Events: If you experience any adverse reactions or unexpected side effects from a dietary supplement, it is crucial to report them to the FDA's MedWatch program or the relevant regulatory body in your country. This helps to monitor the safety of supplements and protect public health.

VI. Personalization and Individual Needs:

A. Bioindividuality: Each person has unique nutritional needs and health considerations. What works for one individual may not work the same for another. It's important to consider factors such as age, gender, existing health conditions, lifestyle, and personal goals when selecting supplements.

B. Genetic Testing and Nutrigenomics: Advances in genetic testing and nutrigenomics can provide insights into how certain individuals may respond to specific nutrients or supplements. This personalized approach can help tailor supplementation based on an individual's genetic profile.

C. Tracking and Monitoring: Regularly assess your overall health and monitor changes in your body's needs. Periodically reevaluate your supplement regimen to ensure it aligns with your evolving health goals.

VII. The Importance of a Balanced Diet:

A. Supplements as Supplements: Dietary supplements should not replace a well-rounded diet. They are meant to complement a healthy eating plan and fill nutritional gaps, rather than serving as a primary source of nutrients.

B. Whole Foods and Nutrient Synergy: Whole foods offer a complex matrix of nutrients, fiber, and phytochemicals that work synergistically to support optimal health. Relying solely on supplements may not provide the same benefits as consuming a diverse range of nutrient-rich foods.

C. Prioritizing Whole Foods: Emphasize a diet rich in fruits, vegetables, whole grains, lean proteins, and healthy fats. These whole food sources should serve as the foundation of your nutritional intake, with supplements used as a targeted and supplementary approach.

Click here to find the right supplement for you

In conclusion, dietary supplements can be valuable tools for supporting health and well-being when used responsibly in conjunction with a balanced diet and lifestyle. By understanding their uses, benefits, proper usage, and how to find the right ones for your needs, you can make informed decisions and optimize the potential benefits of supplements. Remember to prioritize safety, consult healthcare professionals, and maintain a holistic approach to health that encompasses proper nutrition, exercise, and overall well-being.

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robertreich · 3 years ago

Video

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How the Supreme Court Could Make Your Life More Dangerous

Your life could get a lot more dangerous. Republican appointees on the Supreme Court seem poised to strip away basic safety standards for our workplaces, our food, our air and water.

Congress gives federal agencies the authority to enact regulations that protect us in our daily lives. Congress defines the goals, but leaves it up to the health and safety experts in those agencies to craft and enforce regulations.

I know regulations don’t sound very exciting, but they’re how our government keeps us safe.

******

Btw, if you’d like my daily analyses, commentary, and drawings, please subscribe to my free newsletter: robertreich.substack.com

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Remember when lots of romaine lettuce was recalled because it was causing E.coli outbreaks? That was the Food and Drug Administration protecting us from getting sick.

Working in a warehouse? The Occupational Safety and Health Administration sets standards to ensure you don’t breathe in dangerous chemicals like asbestos.

Enjoying the fresh air on a clear, sunny day? Thank the Environmental Protection Agency for limiting the amount of pollution that can go into our air.

These agencies save lives. Since OSHA was established a half-century ago, its workplace safety regulations have saved more than 618,000 workers’ lives.

Republicans have been trying to gut these agencies for decades. Now, with the Supreme Court’s right-wing majority solidly in place, they have their best chance yet.

In January 2022, the Supreme Court blocked OSHA’s vaccine-or-testing mandate from going into effect, which was estimated to prevent a quarter-million hospitalizations.

The Court claimed that Covid isn’t an “occupational hazard” because people can become infected outside of work, and that allowing OSHA to regulate in this manner “would significantly expand” its authority without clear Congressional authorization.

This is absurd on its face. Section 2 of the Occupational Safety and Health Act of 1970 clearly spells out OSHA’s authority to enact and enforce regulations that protect workers from illness, injury, and death in the workplace. Congress doesn’t need to list every specific workplace hazard before OSHA can protect workers.

What this ruling tells us is that the Republican appointees on the Supreme Court are intent on gutting the power of agencies to issue regulations.

This term, the Court will also hear a case regarding the EPA’s authority to enforce the Clean Water Act. If the Court undermines the EPA’s authority, it will put our environment – and our health – at risk. Remember when the Cuyahoga River caught on fire because it was brimming with oil, acid, and factory chemicals? That’s what we may be returning to.

And what’s next? Will they gut the Federal Trade Commission and put us all at risk of being defrauded? Target the Securities and Exchange Commission and deregulate the financial sector, sparking another financial crisis?

Beware. If Republican appointees on the Supreme Court succeed in gutting regulatory agencies, we all lose. This agenda is anti-worker, anti-consumer, and anti-environment. The only thing it’s good for is corporate profits.

#SCOTUS #Supreme Court #OSHA #EPA #FDA #FTC #SEC #safety #video #videos

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laurelkrugerr · 5 years ago

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Should You Microdose to Treat Depression?

May 8, 2020 7 min read

Opinions expressed by Entrepreneur contributors are their own.

The following article is written by Ben Angel. Author of the book, Unstoppable: A 90-Day Plan to Biohack Your Mind and Body for Success. Buy it now from Amazon | Barnes & Noble | iBooks | IndieBound. And be sure to order The Unstoppable Journal, the only journal of its kind based on neuroscience, psychology and biohacking to help you reach your goals.

If you asked 100 people about psychedelics, you’d most likely get 100 opinions based on their firsthand experience, strong condemnation or stories from their adventures at Woodstock in the ’60s. No matter what people might know or think they know about psychedelics, the 40-year moratorium that closed down related research in the ’70s is now coming to an end. Psychiatrists are beginning to realize that strategic, supervised use of these psychopharmacological drugs is helping people with mental disorders including obsessive-compulsive disorder, post-traumatic stress disorder, alcoholism, depression and cluster headaches. Still, are there enough scientific studies to warrant the use of these drugs in mainstream society?

I’ll admit that talk of psychedelic therapy to treat depression makes me nervous. In researching my book, Unstoppable, I looked at other key triggers that can mimic psychological disorders like depression and anxiety, such as inflammation, nutritional deficiencies, hormonal changes, side effects from medications, gut imbalances and food sensitivities. The reality is, depression is complex. What works for one may not work for another. Any successful treatment must first identify the root cause of one’s depression successfully, which can be a complex process if not done under the right medical care. A psychedelic treatment isn’t suddenly going to fix a nutritional deficiency, for example, but it may help target other symptoms and behaviors that correspond with depression. This is why it was critical to set my own biases aside and speak to an expert.

Related: There Will Be 4 Identity Types in This Recovery. Which One Are You?

Image credit for photo of Dr. Sportelli: Jen Vitale Photography

I was fortunate enough to interview Dr. Domenick J. Sportelli, who is board-certified by the American Board of Neurology and Psychiatry for General Psychiatry and fellowship-trained and Board Certified in Child and Adolescent Psychiatry. He also specializes in human behavior and psychopharmacology. I wanted to get the most current information on the use of psychedelics in treatment for depression, anxiety and PTSD, so I first asked him first to clarify what psychedelics were.

“The term ‘psychedelic substance’ refers to an exogenous substance [derived outside the body] that, when taken into the body in various ways, physiologically, neurologically and psychologically manifest an internal personal experience of altered states of consciousness,” he explains. “This includes perceptual distortions, hallucinations, synesthesia [a mixing of the senses], altered sense of time and space, as well as potentially inducing what researchers call a ‘mystical experience’ — a sense of oneness, of noetic experience and an undefinable but profoundly spiritual quality.”

Is there enough evidence to support psychedelic therapy?

Sportelli wants to make clear that the most researched psychedelics — LSD, psilocybin (mushrooms), peyote, MDMA, DMT and ketamine — have different mechanisms of action and even induce subtle, subjective experiential differences. Although each is grouped under the term “psychedelics,” they are quite disparate.

Dr. Sportelli is cautiously optimistic about the multitudes of large-scale, university-based testing and prior research compiled decades ago, but worries about the abiliity to circumvent bureaucracy and conduct safe, credible and substantial testing today. He does add that recent testing of psilocybin, LSD, ketamine and MDMA in particular has generated cause for optimism, and that they will likely have a place not only in continued, diverse research design and protocol, but eventually in therapeutic use.

What types of depression can psychedelics treat?

If we were to look at the onset of most mental illnesses, the majority start to become evident between the ages of 11 and 24, according to the National Institute of Health. With only 42 percent of people getting treatment, most typically do not seek out assistance until a secondary mental illness occurs several years later.

When asked how broadly psychedelics might be able to help treat people with depression, Sportelli concedes that, “Unfortunately, research hasn’t determined the level of scientific data to specify the type of depression or mood disorder that psychedelic therapy will benefit.” But he does add that research and data are beginning to show statistically significant improvements in mood, reduced anxiety, change in positive personality traits over time, the possibility of reducing addictive behaviors, reduction in suicidal tendencies and increased personal insight.

Do psychedelics treat the symptoms or the cause?

According to Dr. Sportelli, depression stems from a mix of genetic, biological, neurological, psychological and sociological factors. Recent research has demonstrated how the chemical breakdown of psilocybins closely resembles that of serotonin, and indicated the promising interplay of select hormone transmission. Dr. Sportelli stresses the critical role that these drugs might offer in mood disorders is at the forefront of the pharmaceutical quest for treatment.

“We have never seen substances like these that can potentially change the way that we look at our life and change perspective with lasting results,” he says, noting that they might be able to help “supercharge psychotherapy.”

Is this ultimately a recommend reatment, and where does one turn for it?

“At this time, in the U.S., I would only recommend this treatment be a part of, and under the close supervision of, a university-based IRB [Institutional Review Board]-monitored clinical trial,” Sportelli emphasizes. Before any psychiatric treatment, Dr. Sportelli also recommends a full medical and neurological evaluation to rule out any of the multitudes of medical circumstances that can manifest as a primary mood disorder, and reiterates that significant and often profoundly adverse outcomes associated with such powerful, mind-altering chemicals need to be weighed further as well. That’s why, as part of any regulated trial, all the necessary medical workups would be completed before participation.

Is the stigma around psychedelic therapy warranted?

Sportelli acknowledges that there is a safety concern associated with psychedelics, and does not condone their recreational or illict use. But he does believe that regulated clinical trials, judicious and ethical research methodology and the progression for therapeutic intervention should not be overlook based on previous stigma and possible misclassification.

Related: 50,000 Entrepreneurs Tell Us How to Avoid Stress and Anxiety

I’ve never been one to throw the baby out with the bathwater. After interviewing Dr. Sportelli, I hold hope for the future, but also a concern for those who may seek out this kind of treatment without an accurate medical diagnosis. My number-one hesitation remains — that is we simply do not have the studies to show which types of depression psychedelic therapy successfully treats, which may result in people attempting to use a hammer when in fact they need a nail.

Either way, if you are to venture into this arena, find someone who specializes in it. The risk of going it alone could come at too a high price.

Are you ready to become unstoppable?

Visit www.areyouunstoppable.com and take your FREE 60-second online quiz now. By answering a series of simple questions, my software will analyze your results and provide you with a comprehensive report that will indicate your identity type and lead you to the tools and tips you need to close that gap between who you are and who you could become. Take the quiz to get started!

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source http://www.scpie.org/should-you-microdose-to-treat-depression/ source https://scpie1.blogspot.com/2020/05/should-you-microdose-to-treat-depression.html

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vaderssidechick · 6 years ago

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FIC Snippet: A Little Fire (From The Chronicles of House Vader Verse)

A little snippet of total Piett Domestic Kink.

Ship: Pielissa (Piett and OFC Palissa)

Palissa turned the corner to her right. Piett followed her into the long, gleaming galley kitchen of polished durasteel and black granite counters. The smell of the roasted meat in the oven enveloped him as he stepped in. Covered side dishes warmed on heated slabs. His eyes set on a decadent choco and cream dessert on the counter. His mouth watered-- he hadn’t seen food like this in ages. “You cooked all this yourself?”

Palissa set her glass down on the counter. “Mmm hmm.”

“No droid to help you?”

She smirked at him. “You Navy berks, with all your droids and tech.” She grasped a handle hanging from the ceiling, pulling it down. A UV-lit pallet emerged, bursting with green leaves and living vegetables of all colors.

“Hydroponics,” he exhaled. “Well. I’m impressed.”

She picked fresh greens and bulbs out of the decanters. “Don’t you have hydroponics in the officers’ mess?”

“No, not at all. Our meals are all prepackaged, balanced with only the essential proteins, carbohydrates, and k-cals required. Served with a delicious side of chloro-phyto nutrient capsules for dessert.”

Palissa grimaced. “Yuck.”

“It’s not all that terrible. Some of it is rather good. Considering our meals are all prepared by droids, they’re quite palatable. And much better than the grub we got on the anti-pirate ships around Axxila.” He indulged in another sip of champagne.

“No wonder you officers are all so thin,” Palissa quipped as she carried an armful of fresh vegetables over to the counter.

Piett chuckled. “We must maintain regulation body mass. If we ate like this every night, we’d all be the size of Hutts.”

“Can you imagine that? A crew of Hutts?” She snatched a large chef’s blade from a magnetic strip above her head. “Most of their days would be spent just getting from one place to another! Nothing would ever get done!”

“Exactly.” He raised the glass to his lips again. Already, he could feel the champagne’s infamous effects soothing out the ridges in his neck. “However does the Baroness stay so slim eating like this?”

Palissa hiccupped a laugh. “I’ve never seen anyone eat the way Lylla…” she winced a little before she continued, “the Baroness does. I think she could put any Hutt to shame with her appetite.”

Piett cocked his head. “You call her by her first name.”

“In private, yes.”

“Hmm.” He wasn’t sure why he was so surprised by this, as he and Veers were also on a first-name basis in private. Then again, Veers was not the betrothed of the Dark Lord of the Sith. He found himself wondering again about her relationship with the formidable Baroness until he shook it off. “How can I assist you, Lissy?”

“By staying over there and keeping me company while I cut this up.” He watched her set the head of green leaves and assorted colorful bulbs on the counter. Then, with astonishing speed and almost inhuman precision, Palissa shred through the vegetables with the knife. His mouth dropped as she sliced and cut, her hands almost a blur, and flipped the blade over her hand, catching it in the air, then sliced some more, then miraculously bounced the handle off the counter and caught it in her other hand without even looking at it.

“Do that again!” he exclaimed.

She glanced over her shoulder. “Do what again?”

“That, what you just did with the knife.” He indicated it with a nod.

“Firmus,” she giggled, suddenly self-conscious.

“Do it again,” he repeated, this time softly. “Please?”

An expression that could almost be described as smug cross her face. “Alright. You might want to step back.” Piett grinned, obviously intrigued, and obliged her. Palissa took the knife again and twirled it through her fingers, constantly keeping the blade in check. She bounced the handle off the counter again, caught it, then actually flipped it behind her back up over her shoulder, caught it again. Piett watched in utter amazement as she twirled it over, around, and through her hands. Her eyes never left the blade as she tossed it about, faster and faster, until she caught it one more time, spun to her side, and threw it. The blade sliced through the air, just centimeters from Piett’s nose, down the long galley until it sank into far wall with a resounding thunk, the handle still wobbling from the impact.

The Captain gawked at the knife, then back to Palissa. “By the Force, Lissy,” he exhaled.

Palissa merely simpered and shrugged. “I told you I was pretty good with a vibroblade.”

“Pretty good? You’re a regular assassin with that thing.” He saw her smile fade and her eyes darken at the remark. He furrowed his brow at her reaction. “Is that who taught you? An assassin?”

“A… friend,” she said quietly as she strode past him to retrieve the knife from the wall.

“Oh.” He watched her wrench the handle out of the wall and come back to finish making the salad. The hesitation in her answer did not escape his notice. “A male friend?”

Palissa stopped for a moment, and her back stiffened. “Yes.” She tapped the sonic hand-cleaner installed over the counter on and ran her hands under it.

“A lover?” he asked, an odd heat rising on his neck.

Again she stilled, pursing her lips, before she scooped the cut greens evenly onto two small plates. She picked the plates up and, when she turned to face him, he saw a quiet anger smolder in her eyes. “Yes Firmus. A male assassin lover friend. If that is any of your business, which it isn’t,” she said, her softness in volume doing nothing to disguise her irritation. “And salad is served.” She brushed past him back into the dining area.

Piett winced. He turned around and followed her. She set the plates down on the table with a bit more force than needed. “Lissy,” he murmured. She straightened, but didn’t turn around. He drew a breath. “You’re right, it’s none of my business. I… don’t know what came over me.”

“I haven’t been a virgin for a while, so I don’t need you judging me--.”

“I never expected you to be, Lissy,” he said, confused.

“I’ve only been with three people my whole life, including you, Firmus--”

“Lissy,” he soothed, stepping toward her, concerned by her heated, almost panicked outburst. “Forgive me. It’s been… a very long time since I’ve been involved with anyone. I got jealous.” He huffed an embarrassed breath as he looked into his glass again. “It’s silly, really.”

“Oh,” she said, very softly. She turned over her shoulder. “I thought you were insinuating…that I was… promiscuous.”

“Stars, no,” he breathed, coming to the table and setting his glass down. He put his hands on her shoulders and turned her to face him. “And even if you were, it’s still no business of mine now, is it?” He sighed. “I am married. I have no right to judge you that way.”

Palissa exhaled, and set her hands on his waist. She drew her lips in. “I see the way they look at me. The men. The officers.” She looked up at him. “If any of them say they’ve been with me, they’re lying, Firmus--”

“I know they are,” he murmured, stroking her cheek, trying to calm her unease and his own rising anger. The men’s indecent attitudes toward her didn’t just anger her. “They frighten you, don’t they?” He felt her hands shaking on his sides, and covered them with his own. “Lissy, they wouldn’t dare touch you. And if anyone is foolish enough to even try, Vader is the LAST person they should fear.”

Palissa looked up at him, surprised by the ferocity in his voice, no matter how quiet it was. “Firmus, you can’t...you mustn't...please, don’t endanger your position because of me--”

“My duty above all others,” Piett murmured, gently cutting her off, “is to ensure the safety of every being aboard this vessel.” He stroked her cheek with the backs of his fingers. “It is my duty to protect you, Lissy.” His gut clenched at his own words. In avoiding or dismissing himself from his fellow officers’ lewd conversations about her, that was the last thing he was doing.

Palissa noticed his jaw work and his eyes darken. “Firmus, what is it?”

“Lissy, do you carry a vibroblade on you?”

“Only when I’m planetside with the Baroness,” she answered.

“Start carrying one on the ship, at all times. Even when you’re with the Baroness. And don’t conceal it. Carry it openly.”

She blinked a few times. “All right.”

“And don’t hesitate to practice in public. Especially in front of the officers.” The intensity in his face cracked a little when he smirked. “Show them what you can do with that thing. Especially where their bullocks are concerned.”

“Firmus!” Palissa exclaimed in an incredulous laugh. “These are your own men you’re talking about!”

“Damn right they are. And it’s about damn time they started conducting themselves like Imperial officers.” He gently pulled her into an embrace, set his chin on her head. And sighed. “That includes me as well.”

Palissa nestled her cheek into his chest. “What do you mean, Firmus?”

“Never mind.” The growl in his stomach led to a welcome change of subject. He planted a kiss atop her head and looked down at her. “May we start?”

NOTE: Yes, I totally cast Juno Temple as Palissa.

#star wars #fanfic #chronicles of house vader verse #piett #domestic kink

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newsupdate-1 · 3 years ago

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Eubiotics Market Size, Growth, Emerging Trends And Forecast

The global eubiotics market is expected to reach more than USD 8.60 billion by 2026 with a CAGR of 5.6% during the forecast period as per a new study released by Polaris Market Research. The report “Eubiotics Market [By Ingredient Type (Prebiotics, Probiotics, Organic Acids, Essential Oil); By Functionality (Yield, Productivity, Immunity, Nutrition & Gut Health); By Application (Poultry, Cattle, Aquaculture, Swine); By Regions]: Market size & Forecast, 2017 – 2026”. provides an extensive analysis of present market dynamics and predicted future trends.

Now-a-days there are many stringent regulations on the usage of antibiotic growth promoters. There has also been a pressure from consumer towards food safety, these two are the main drivers to drive the growth of eubiotics.

Get Sample copy of this report : https://www.polarismarketresearch.com/industry-analysis/eubiotics-market/request-for-sample

The specific organic acid such as essential oil compounds, benzoic acid, probiotics and nucleotides can be used as a single product or can be combined with two or more eubiotics to achieve quality result. Prebiotics can be defined as a specific kind of micro-organism that helps to improve the balance of pathogenic to beneficial bacteria. Prebiotics comes under non-digestible oligosaccharides that serves subtract for probiotics and helps to compete with pathogens which helps to regulate` the gut cell adhesion.

Eubiotics are used for weaning piglets at the time of transition from suckling milk to feeding solid feed. This also helps in preventing bacteria growth and helps to improve digestion of feed ingredients. It is also used in the form of benzoic acid as preservatives. The usage in the food industry has also fueled the growth of eubiotics market.

There are many projects undertaken at the Pig Research Centre of the Danish Agriculture and Food Council on eubiotics. There are numerous tests taken to find the performance of eubiotics on animals. One project was undertaken where it was found that supplementation of 0.5% of benzoic acid is similar to the effect of the usage of1% benzoic acid. Piperin, an essential oil compound helps to stimulate the production of digestive enzymes. The above characteristics have led to the increase in the demand for eubiotics.

Key Findings from the study suggest that the largest share of the eubiotics market in 2017 was of the Europe region. Europe was the first region to put a ban on use of antibiotics as growth promoters. Increasing concerns of animal safety and nutrition that eventually lead to components of processed meat for humans are the major concerns for the region’s ban on antibiotics. This ban created remarkable opportunities for the eubiotics which are the direct substitutes.

Request For Discount : https://www.polarismarketresearch.com/industry-analysis/eubiotics-market/request-for-discount-pricing

About Polaris Market Research

Polaris Market Research is a global market research and consulting company. The company specializes in providing exceptional market intelligence and in-depth business research services for our clientele spread across different enterprises. We at Polaris are obliged to serve our diverse customer base present across the industries of healthcare, technology, semi-conductors and chemicals among various other industries present around the world

Polaris Market Research

Phone: 1-646-568-9980

Email: [email protected]

Web: www.polarismarketresearch.com

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udaycmi · 3 years ago

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Eubiotics Market 2021 Future Growth Analysis and Challenges

Get Sample copy of this report : https://www.polarismarketresearch.com/industry-analysis/eubiotics-market/request-for-sample

Request For Discount : https://www.polarismarketresearch.com/industry-analysis/eubiotics-market/request-for-discount-pricing

About Polaris Market Research

Polaris Market Research

Phone: 1-646-568-9980

Email: [email protected]

Web: www.polarismarketresearch.com

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guthealthglasgow · 3 years ago

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What are the top reasons for SIBO recurrence?

Unfortunately, SIBO recurrence is not uncommon. “Sixty-five percent of all SIBO cases require retreatment,” says Sarah Steinberg, MDPhD , a double-board certified internal medicine and gastroenterology physician at Parsley Health. This number can be lower if you’ve undergone some type of post-treatment maintenance program with the help of a health professional. But still, it’s hard to completely eliminate the chance of recurrence.

As for why SIBO recurs, there are several possibilities. A big one: “I see a lot of people who get SIBO and then just want to go back to their old life—eating late, eating whatever they want, not exercising,” says Dr. Steinberg. Here, we dive into why these habits—and several other factors—can prime you for a SIBO repeat.

1. You were diagnosed with the wrong type of SIBO.

There are actually three different types of SIBO—hydrogen-dominant, methane-dominant, and sulfide-dominant—which refer to the main type of gas produced by the unwelcome bacteria in your small bowel. Specific antibiotics and herbal antimicrobials are used depending on the type of SIBO someone has. “A lot of time I see patients with hydrogen and methane SIBO, but their treatment was just focused on hydrogen, so they probably got inadequate treatment and we need to try again,” says Dr. Steinberg.

There’s also a possibility you didn’t have SIBO at all. When someone receives SIBO treatment several times but makes only minor improvements, Dr. Steinberg explores whether they may actually have small intestinal fungal overgrowth.

2. You received inadequate treatment for SIBO the first time.

If you received antibiotics as your sole form of SIBO treatment, it may not have been sufficient. “If we just kill the bacteria and don’t address anything else that got you here, you’re definitely going to increase your risk of recurrence,” says Dr. Steinberg. She, and other clinicians at Parsley Health, like to do a “maintenance phase” after a combined antibiotic and herbal antimicrobial treatment, which involves appropriate probiotics , supplements for gut-healing, and supplements to enhance motility (movement of food through the GI tract).

Fun fact: Anything that slows GI motility causes too much bacteria to remain (and multiply) in the small intestine, which can trigger SIBO recurrence.

3. You have an underlying condition that slows gut motility.

Speaking of gut motility, “some people have impaired small bowel motility due to chronic constipation, or an underlying condition like type I diabetes, celiac disease, Crohn’s disease, or hypothyroidism, which can predispose you to SIBO,” says Dr. Steinberg. So, appropriate management of these conditions, and taking specific steps to improve GI motility, may be necessary to treat SIBO and avoid recurrence.

4. You spend too much time sitting (and snacking).

Remember how Dr. Steinberg said patients who go back to (or never stopped) their old, unhealthy habits after SIBO treatment, often experience a relapse? Well, sitting for long stretches and all-day snacking (which often go hand-in-hand) are two of the big ones. Here’s why:

Sitting reduces blood flow to the digestive tract, which slows GI motility. This allows food to remain in the small intestines longer, which means bacteria can take up residence (and grow in numbers) where it shouldn’t, which is a recipe for SIBO recurrence.

Snacking can impair one of our body’s most important mechanisms for digestion—the migrating motor complex (MMC) . The MMC is a cyclic, recurring wave of movement that clears food out of the small bowel. It occurs every 90 minutes or so when your stomach is empty, but when you’re constantly adding food to your stomach, the MMC is inhibited and can’t sweep the small bowel clean like it should, says Dr. Steinberg.

5. You got food poisoning.

Interestingly, SIBO (and a SIBO recurrence) can be triggered by certain pathogenic bacteria. That’s because “an infectious insult, like a bad traveler’s diarrhea or food poisoning, can cause impairment in small bowel motility,” says Dr. Steinberg. Specifically, the bacteria that cause food poisoning such as E. coli, Campylobacter jejuni, Shigella, and Salmonella produce a substance called cytolethal distending toxin (CDT) , which can damage cells in the intestines and impair the MMC in certain people.

7 simple but effective ways to help prevent a SIBO recurrence

There’s actually a lot you can do to stay healthy and after SIBO treatment and prevent recurrence (as long as you weren’t treated for the wrong type of SIBO to begin with)—and most of that involves making diet and lifestyle changes that support long-term healthy gut function and motility.

1. Incorporate movement throughout your day.

According to Dr. Steinberg, the number one way we can support healthy motility is through movement—but going for one jog or taking one HIIT class and then sitting at your desk the rest of the day is not going to cut it. You need to be moving periodically throughout the day, too. “We all need to be getting up every 20 minutes, and if that’s not possible every 40 minutes to walk around, do a few balance exercises, do a few Sun Salutations, something to get moving,” she says. Some people may also benefit from post-meal walks.

2. Stop eating at least three hours before bedtime.

When it comes to eating, the cardinal rule for improving motility is to stop eating at least three hours before bed. This allows that migrating motor complex (MMC) to clear out the small bowel while you sleep . “If you eat right before bed, you’re inhibiting the MMC and putting your small bowel at a tremendous disadvantage,” says Dr. Steinberg.

3. Stop eating between meals (or try intermittent fasting).

Another way you can help your MMC do its thing: Avoid snacking between meals. “Basically you want to put three to five hours between meals to give your small bowel time to push things through,” says Dr. Steinberg. Certain intermittent fasting protocols may be helpful, as long as you’re not pushing your eating window too close to bedtime.

4. Eat a plant-heavy, nutrient-rich diet.

Specific foods aren’t thought to trigger SIBO directly, but a low-quality, highly processed diet may lead to constipation, which slows motility and increases risk of SIBO relapse. So what should you eat? While many experts recommend a low-FODMAP diet during SIBO treatment and for a short time after, Dr. Steinberg says it’s not a long-haul strategy since it can be restrictive. Over time, you want to gradually re-introduce so you’re eating a varied, plant-heavy, nutrient-rich diet with plenty of fiber and probiotic-rich foods to support gut health and regularity.

5. Manage your stress levels.

When you’re experiencing stress, various hormones are released that down-regulate digestion and trigger contraction of GI sphincter muscles, which can inhibit motility and slow food transit in the stomach and small intestines. Any steps you can take to manage stress—exercise, meditation , deep breathing—can help alleviate stress-induced motility issues, and thus, help reduce risk of SIBO recurrence. “I also really like self-hypnosis for SIBO or IBS in general,” says Dr. Steinberg, adding that some of her members at Parsley Health like the self-hypnosis app Nerva , which is designed to help you retrain the gut-brain connection .

Oh, and if you can do your stress-busting activity outside, that’s even better. Exposure to sunlight helps reset circadian rhythms, which is great, since circadian rhythm disruptions have been tied to digestive issues . And avoid late-night screen time while you’re at it!

6. Consider an intestinal massage.

Sometimes the impaired GI motility that leads to SIBO recurrence is a structural issue that needs manual manipulation. For example, adhesions and scar tissue that remain after certain surgeries can impede the movement of the intestines and their contents. In these cases, a visceral manipulation therapist can be helpful, says Dr. Steinberg. These therapists are trained to help break up this scar tissue and massage the lower abdominal area in such a way that improves motility and does great things for overall digestion.

7. Follow basic food safety guidelines.

Since getting food poisoning can trigger a SIBO relapse, you’ll want to make sure you’re taking some basic food safety precautions when you cook and entertain. That means, heating meat and fish to the appropriate internal temperature, avoiding cross-contamination of utensils and cutting boards, following proper storage guidelines, and more outlined here by the USDA .

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your-dietician · 3 years ago

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Long-Term CRYSVITA® ▼ (burosumab) Treatment Reduces the Burden of Disease in Adults With X-Linked Hypophosphataemia (XLH), a Rare Genetic Metabolic Bone Disease

New Post has been published on https://depression-md.com/long-term-crysvita-%e2%96%bc-burosumab-treatment-reduces-the-burden-of-disease-in-adults-with-x-linked-hypophosphataemia-xlh-a-rare-genetic-metabolic-bone-disease/

Long-Term CRYSVITA® ▼ (burosumab) Treatment Reduces the Burden of Disease in Adults With X-Linked Hypophosphataemia (XLH), a Rare Genetic Metabolic Bone Disease

TOKYO–(BUSINESS WIRE)–Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin) today announced the publication of new data highlighting the sustained benefits of treatment with CRYSVITA® (burosumab) in adults with X-linked hypophosphataemia (XLH), a rare genetic metabolic bone disease. The data show that adults with XLH experience substantial pain, stiffness, fatigue and impairment in physical and ambulatory function. Treatment with CRYSVITA was associated with a significant improvement from baseline after 96 weeks.1

The data are from a randomised, double-blind, placebo-controlled, phase 3 study with an open-label extension to assess the efficacy and safety of CRYSVITA in adults with XLH.2 The study met its primary endpoint, showing a statistically significant effect in increasing serum phosphorus concentrations at 24 weeks, compared to placebo.3 After 24 weeks, all patients were switched to CRYSVITA treatment and data was collected on metabolic and biochemical markers, patient reported outcomes (PROs) and measures of mobility up to 96 weeks. This new publication focuses on the results from the PRO analysis and mobility scores.1

At week 96, the study showed statistically significant improvements in PROs, including the Western Ontario and the McMaster Universities Osteoarthritis Index (WOMAC), Brief Pain Inventory–Short Form (BPI-SF) and Brief Fatigue Inventory (BFI), compared to baseline.1 Statistically significant improvements in ambulatory function, measured by the 6-minute walk test (6MWT), were also seen at 96 weeks compared to baseline.1 Data previously published at 48 weeks also showed improvements in some PROs, including stiffness and pain, as well as fracture healing.3

Lead author Pr Karine Briot, Hôpital Cochin, Paris, France said: “The study highlights the many physical challenges faced by adult patients with XLH, including pain, stiffness, fatigue and difficulty walking or physical function. Burosumab treatment has previously been shown to improve phosphate homeostasis in adult XLH patients, compared to placebo. This new analysis suggests that, despite the long-term complications and physical impairment associated with XLH in adults, treatment with burosumab can also improve the physical function and quality of life of adults with XLH over the longer term.”

Tomohiro Sudo, Executive Officer, Head of Global Product Strategy Department of Kyowa Kirin, said: “Kyowa Kirin is committed to improving the lives of people with XLH and their families. One of our areas of focus is to generate new data that improve our understanding of how best to manage and treat XLH. These important new data highlight the many physical challenges that people living with XLH face every day, how their needs could be better met and how Kyowa Kirin is delivering on its purpose, to make people smile.”

The data were published today in the BMJ journal RMD Open, Rheumatic and Musculoskeletal Diseases.1 CRYSVITA is licensed in Europe for the treatment of XLH in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults.4

▼This medicinal product is subject to additional monitoring.

About X-linked hypophosphataemia

X-linked hypophosphataemia (XLH) is a rare, genetic disease that causes abnormalities in the bones, muscles, and joints.5,6 XLH is not life-threatening, but its burden is life-long and progressive, and it may reduce a person’s quality of life.7

People with XLH have a genetic defect on the X-chromosome, which causes an excessive loss of phosphate through the urine and poor absorption from the gut due to excess of a hormone known as fibroblast growth factor-23 (FGF23), resulting in chronically low levels of phosphate in the blood.4,8 Phosphate is a key mineral needed for maintaining the body’s energy levels, muscle function, and the formation of healthy bones and teeth.9,10 While there is no cure for XLH, therapies aimed at helping to restore and maintain phosphate to normal levels within the body may help to improve the progression of disease symptoms.2

XLH is the most common form of hereditary rickets.11 It can sometimes appear in individuals with no family history of the disease but is usually passed down from a parent who carries the defective gene.12

About CRYSVITA® (burosumab)

CRYSVITA (burosumab) was created and developed by Kyowa Kirin and is a recombinant fully human monoclonal IgG1 antibody against the phosphaturic hormone fibroblast growth factor 23 (FGF23). FGF23 is a hormone that reduces serum levels of phosphate by regulating phosphate excretion and active vitamin D production by the kidney. Phosphate wasting and resulting hypophosphataemia in X-linked hypophosphataemia (XLH) is caused by excess FGF23. CRYSVITA is designed to bind to, and thereby inhibit, the biological activity of FGF23. By blocking excess FGF23 in patients, CRYSVITA is intended to increase phosphate reabsorption from the kidney and increase the production of active vitamin D, which enhances intestinal absorption of phosphate and calcium.

CRYSVITA has been available for clinical use since 2018. The first approval came from the European Commission, that granted a conditional marketing authorisation for CRYSVITA for the treatment of XLH with radiographic evidence of bone disease in children one year of age and older and adolescents with growing skeletons. In 2020, this authorisation was subsequently expanded to include older adolescents and adults.2

CRYSVITA is approved by the US Food and Drug Administration (FDA) for patients with XLH aged 6 months and older and by Health Canada for patients with XLH aged one year and older.13,14

In 2019, CRYSVITA received approval from Japan’s Ministry of Health, Labour and Welfare for the treatment of FGF23-related hypophosphataemic rickets and osteomalacia. In 2020, CRYSVITA was reimbursed by National Health Insurance (NHI) in Japan as a self-injection presentation for the treatment of FGF23-related hypophosphataemic rickets and osteomalacia.

In January 2020, Swissmedic approved CRYSVITA for the treatment of adults, adolescents and children (one year of age and older) with XLH.15

In June 2020, the U.S. Food and Drug Administration (FDA) approved CRYSVITA for patients aged two and older with tumour-induced osteomalacia (TIO), a rare disease that is characterised by the development of tumours that cause weakened and softened bones.16

Kyowa Kirin and Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE: Ultragenyx) have been collaborating in the development and commercialisation of CRYSVITA globally, based on the collaboration and licence agreement between Kyowa Kirin and Ultragenyx.

About Kyowa Kirin

Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company with a more than 70-year heritage, the company applies cutting-edge science including an expertise in antibody research and engineering, to address the needs of patients and society across multiple therapeutic areas including Nephrology, Oncology, Immunology/Allergy and Neurology. Across our four regions – Japan, Asia Pacific, North America and EMEA/International – we focus on our purpose, to make people smile, and are united by our shared values of commitment to life, teamwork/Wa, innovation, and integrity. You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com/

Kyowa Kirin International

http://www.international.kyowa-kirin.com / www.kyowakirin.com

Galabank Business Park

Galashiels, TD1 1QH

United Kingdom

References

1 Briot K, Portale AA, Brandi ML, et al. RMD Open 2021;7:e001714. doi: 10.1136/rmdopen-2021-001714.

2 Insogna KL, Rauch F, Kamenický P, et al. Burosumab improved histomorphometric measures of osteomalacia in adults with X-linked hypophosphatemia: a Phase 3, single-arm, international trial. J Bone Miner Res. 2019;34:2183-2191.

3 Portale AA, Carpenter TO, Brandi ML, et al. Calcif Tissue Int 2019;105:271–84.

4 European Medicines Agency. CRYSVITA EPAR product information. Summary of Product Characteristics. Available at: Crysvita, INN-burosumab; (europa.eu). Last updated: June 2021. Last accessed: July 2021.

5 Linglart A, Biosse-Duplan M, Briot K, et al. Therapeutic management of hypophosphatemic rickets from infancy to adulthood. Endocr Connect. 2014;3:R13-30.

6 Haffner D, Emma F, Eastwood DM, et al. Consensus Statement. Evidence-based guideline. Clinical practice recommendations for the diagnosis and management of X-linked hypophosphatemia. Nat Rev Nephrol. 2019;15;435-455.

7 Skrinar A, Dvorak-Ewell M, Evins A, et al. The lifelong impact of X-linked hypophosphatemia: Results from a burden of disease survey. J Endocr Soc. 2019;3:1321-1334.

8 Beck-Nielsen SS, Mughal Z, Haffner D, et al. FGF23 and its role in X-linked hypophosphatemia-related morbidity. Orphanet J Rare Dis. 2019;14:58.

9 Pesta D, Tsirigotis DN, Befroy DE, et al. Hypophosphatemia promotes lower rates of muscle ATP synthesis. The FAESB Journal. 2016;39:3378-3387.

10 Unnanuntana A, Rebolledo BJ, Khair MM, et al. Diseases affecting bone quality: beyond osteoporosis. Clin Orthop Relat Res. 2011;469:2194-2206.

11 Carpenter TO, Imel EA, Holm IA, et al. A clinician’s guide to X-linked hypophosphatemia. J Bone Miner Res. 2011;26:1381-8.

12 National Center for Advancing Translational Sciences. X-linked hypophosphatemia. Available at: https://rarediseases.info.nih.gov/diseases/12943/x-linked-hypophosphatemia. Last updated: February 2018. Last accessed: July 2021.

13 Health Canada. Regulatory Decision Summary – CRYSVITA. Available at: https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.php?linkID=RDS00463. Last updated: April 2020. Last accessed: April 2021.

14 Available at : https://www.kyowakirin.com/media_center/news_releases/2019/e20190930_01.html. Last accessed: July 2021

15 Swissmedic. Crysvita, injektionslösung (burosumabum). Available at: https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/new-medicines/vrysvita-injektionsloesung_burosumabum.html. Last updated: January 2020. Last accessed: July 2021.

16 FDA. Available at: FDA Approves First Therapy for Rare Disease that Causes Low Phosphate Blood Levels, Bone Softening | FDA. Last accessed: July 2021

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olgagarmash · 3 years ago

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The Covid-19 pandemic has spurred the pharmaceutical industry to cast a wide net for potential treatments, ranging from drugs approved for other indications to compounds still in development. Kaleido Biosciences’ test of its experimental gut microbiome therapy as a way to support Covid-19 patients now has the company in regulatory hot water for evaluating the product as a medical food, not as a drug.

Kaleido has been evaluating its microbiome product candidate, KB109, as a way to supplement supportive care of patients with mild-to-moderate Covid-19. KB109 is being tested in patients, but the company did not call the research a formal clinical trial. The company characterized the research as a “non-IND” clinical study, referencing the investigational new drug application (IND) filings that are required for tests of experimental drugs. The company said that the product is “generally recognized as safe,” or GRAS, an FDA designation that means an ingredient is safe according to an expert review.

The FDA isn’t buying it. The agency said that while some of the study goals are safety outcomes, others clearly assess the use of KB109 in combination with supportive care “for the treatment or mitigation of Covid-19.”

The warning letter to Lexington, Massachusetts-based Kaleido was posted to the FDA’s website this week. According to a regulatory filing for the publicly traded company, the correspondence was received on Aug. 27. In that filing, Kaleido noted that none of the FDA’s findings relate to the conduct or the oversight of the studies or the data, adding that the company is “coordinating with the FDA and intends to continue with its plans to submit an IND for KB109 in support of future clinical research.”

Kaleido calls its product candidates microbiome metabolic therapies (MMTs), a descriptor it applies to both drugs and food products, including medical foods. These company says these MMTs are a collection of molecules that affect the microbiome, driving the function and distribution of an organ’s existing microbes.

Before the pandemic, Kaleido was developing KB109 as a way to prevent infections in patients before they undergo hematopoietic stem cell transplants. Last year, the company announced it would broaden KB109’s scope, exploring application of that MMT for use in patients with mild-to-moderate Covid-19. The company framed KB109 as product that Covid-19 patients would be able to take in their homes.

Kaleido tested KB109 in an open-label study enrolling 350 patients; 181 of them received the Kaleido product plus self-supportive care while 169 patients received self-supportive care alone. In March, the company reported positive results showing that the group given KB109 had fewer hospitalizations, emergency room visits, and urgent care visits. Based on those results, the company said at the time that it planned to file an IND—that’s the formal clinical trial paperwork—to evaluate the microbiome product in a pivotal study in mild-to-moderate Covid patients who are at risk of prolonged symptoms.

According to the warning letter, Kaleido contended that its study of KB109 in Covid patients evaluated the product candidate as a medical food. Medical foods are products formulated for the dietary management disease. Developing a product as a medical food can be a faster way to the market, as medical foods don’t need to go through the three phases of clinical testing required of drugs. None of Kaleido’s products have been formally designated medical foods, but the company has been considering it.

“In parallel with our development of MMT product candidates for therapeutic indications, we are exploring the development of some of our product candidates as medical food products,” Kaleido stated in its 2020 annual report. “To date, we have not elected a product candidate to develop and market as a medical food and may never elect to do so.”

The company acknowledges the risk of the medical food route, going on to state in the annual report that the FDA may determine that Kaleido’s product candidates cannot be marketed as medical food, or do not meet medical food requirements. That’s exactly what the regulator did with KB109.

The FDA warning letter, which refers to the Kaleido microbiome product as a drug, was based on the findings of inspections conducted from Feb. 24 to March 3. The investigator found that Kaleido failed to file an investigational new drug application before starting a clinical trial. According to the warning letter, Kaleido intended to argue that the clinical studies evaluated KB109 as a medical food. But the FDA said that argument fails to meet the term’s definition, which states that these products are for the dietary management of a disease with distinctive nutritional requirements. “No such distinctive nutritional requirements have been established for Covid-19,” the FDA said in the letter.

Kaleido has 15 days from the Aug. 27 receipt of the warning letter to respond to the FDA. In the meantime, KB109 isn’t the only product candidate that Kaleido has evaluated in humans without formally submitting a clinical trial application. The test of KB295, which the company is evaluating for use in the inflammatory bowel disorder ulcerative colitis, is another non-IND study. The company said last month that it expects preliminary data from that study will be available by the end of the third quarter of this year.

via Wealth Health

#IFTTT #Wealth Health

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