# Food and Drug Administration FDA

[my-autism-adhd-blog]

Why is everything getting recalled lately? My favorite drink isn’t even safe!

According to the article I found:

Snapchill has initiated a voluntary recall of hundreds of its products after they were found to potentially be harboring grounds for the toxin botulinum, which can cause botulism, a sometimes fatal form of food poisoning.

According to the recall notice posted on the website of the Food and Drug Administration (FDA), the manufacturing process used for the products led to low acid levels in the canned foods. Low acid conditions can lead to the growth and production of botulinum.

I’ll leave the full article below in case anyone wants to read it:

Link to Article

[battleangel]

⛔️FDA BANS HAIR RELAXERS⛔️

[justinspoliticalcorner]

Chris Geidner at Law Dork:

The future of mifepristone access is up in the air on multiple fronts right now — just five months after the U.S. Supreme Court rejected a challenge to the U.S. Food and Drug Administration’s treatment of the medication abortion drug.

In June, a unanimous Supreme Court held that the private plaintiffs challenging the FDA’s rules surrounding mifepristone access lacked standing to bring their claims. At that point, the challenges had already been whittled down. They were not to the original approval of mifepristone itself but to the 2016-and-since changes to access of the drug, including allowing the mailing of the drug by ending the in-person dispensing requirement and increasing the gestational limits on when mifepristone can be used. Now, though, Donald Trump has won election to the presidency — and questions about what his new administration will do to federal policy surrounding the drug are front and center. Additionally, moves in recent weeks in existing litigation suggest that neither backers of the drug’s availability nor those seeking to restrict its access are willing to sit back and wait for the Trump administration to act. The result could be a flurry of litigation in the coming months, some all but forcing the Trump administration to quickly weigh in on the matter and, potentially, sending one or more questions back to the Supreme Court sooner rather than later.

Relevant to the mifepristone litigation, Trump has announced that former Florida Attorney General Pam Bondi is his nominee for attorney general, Robert F. Kennedy Jr. is his nominee to run the Department of Health and Human Services, and Marty Makary is his nominee to run the FDA. Since the election, anti-abortion groups and activists have been “emboldened,” as The Washington Post reported, despite abortion protections passing almost everywhere they were on the ballot. There will be efforts to push the administration to adopt anti-abortion positions, but, beyond that, those same groups will be going to court regardless of what the new administration does. Although far-right groups like Project 2025 were advocating for a Trump administration to resurrect and use the 1873 Comstock Act to prevent mailing of mifepristone (and, potentially, any other “article or thing” used in an abortion, under reasoning I described in this article), neither Trump nor any of these key nominees have backed such a step. Although Bondi certainly identifies as “pro-life,” the primary case cited from her time as Florida attorney general is her 2016 defense of a Florida law requiring a 24-hour waiting period before a woman or other pregnant person could get an abortion. It is important to remember that she left office more than three years before Roe v. Wade was overturned. As such, limits in her arguments in the case don’t tell us — in either direction — what her views would be today.

[...]

Missouri, Kansas, and Idaho — the trio of states — filed a motion on Oct. 11 to amend their complaint in the case, basically, to add to it in light of new information and in the wake of the Supreme Court’s standing ruling. On Nov. 1, however, the Justice Department filed a motion to dismiss the case, as well as a memorandum of law supporting that and opposing the states’ request to amend their complaint because, the lawyers wrote, “Once Plaintiffs’ Complaint is dismissed, the separate Complaint filed by the three Intervenor States—the States of Missouri, Idaho, and Kansas (“the States”)—must likewise be dismissed. The Fifth Circuit has squarely held that intervention requires a jurisdictionally proper suit. Because this Court never had jurisdiction over Plaintiffs’ claims, it could not obtain jurisdiction over the States’ claims.“ Danco Laboratories, the maker of Mifiprex, filed a similar motion and argument.

[...]

Most important to all of this is what happens if Kacsmaryk rejects DOJ’s request or does not rule by Jan. 20. At that point, although Danco’s position isn’t likely to change, it is possible that DOJ and the FDA’s position in the case could change. If not dismissed by Jan. 20, then, it is very possible that this case could force the new Trump administration to very quickly weigh in on these questions about mifepristone access. Remarkably, that is not all. In a less closely watched case, a group of Democratic-led states sued the FDA in Washington to protect — and, in fact, expand — access to mifepristone. The case had been in a holding pattern while some Republican-led states unsuccessfully sought to intervene in the case, but it recently got going again. The Democratic-led states filed their motion for summary judgment in October, arguing that mifepristone should not be subject to “special restrictions” when “[i]t is even safer than such well-known drugs as Tylenol, Viagra, and insulin” that have no such restrictions.

[...] Most important to all of this is what happens if Kacsmaryk rejects DOJ’s request or does not rule by Jan. 20. At that point, although Danco’s position isn’t likely to change, it is possible that DOJ and the FDA’s position in the case could change. If not dismissed by Jan. 20, then, it is very possible that this case could force the new Trump administration to very quickly weigh in on these questions about mifepristone access. Remarkably, that is not all. In a less closely watched case, a group of Democratic-led states sued the FDA in Washington to protect — and, in fact, expand — access to mifepristone. The case had been in a holding pattern while some Republican-led states unsuccessfully sought to intervene in the case, but it recently got going again. The Democratic-led states filed their motion for summary judgment in October, arguing that mifepristone should not be subject to “special restrictions” when “[i]t is even safer than such well-known drugs as Tylenol, Viagra, and insulin” that have no such restrictions.

With Trump's win, the future of mifepristone could be more decisively settled this SCOTUS term or the next one.

[reasonsforhope]

“A new U.S. law has eliminated the requirement that drugs in development must undergo testing in animals before being given to participants in human trials.

Animal rights advocates have long pushed for such a move, and some in the pharmaceutical industry have argued that animal testing can be ineffective and expensive...

Signed by President Biden in December as part of a larger spending package, the law doesn't ban the testing of new drugs on animals outright.

Instead it simply lifts the requirement that pharmaceutical companies use animals to test new drugs before human trials. Companies can still test drugs on animals if they choose to.

There are a slew of other methods that drugmakers employ to assess new medications and treatments, such as computer modeling and "organs on a chip," thumb-sized microchips that can mimic how organs' function are affected by pharmaceuticals.

But Aliasger Salem, a professor at the University of Iowa's College of Pharmacy, told NPR that companies opting to use these alternative testing methods as a replacement for animal testing must be aware of the methods' limits to ensure their drugs are safe.

"The companies need to be aware of the limitations of those technologies and their ability to identify or not identify potential toxicities," Salem said.

"You don't want to shift to systems that might not capture all of the types of toxicities that have been seen in the past without ensuring that the methods that you have will capture that."

An FDA spokesperson told NPR that it will "implement all applicable provisions in the omnibus and continue to work with stakeholders to encourage the development of alternative testing methods."

This year's federal budget also includes $5 million for a new FDA program aimed at reducing animal testing by helping to develop and encourage industry to adopt new product testing methods, the spokesperson said.”

-via NPR, 1/12/23

[xtruss]

We're Having A COVID Summer Surge. Should You Get The Updated Vaccines Now?

The FDA Just Approved an Updated Vaccines, and Officials Say Paxlovid is Still Effective in Preventing Severe Cases.

— By Sanjay Mishra | August 22, 2024

A Colorized Ccanning Electron Micrograph of a Cell (Blue) Infected with the Omicron Strain of the SARS-CoV-2 virus (Yellow). Micrograph By National Institute of Allergy and Infectious Diseases (NIAID)/National Institutes Of Health/Science Photo Library

The summer of 2024—the fifth since the COVID-19 pandemic began—is projected to be the biggest summer wave of COVID infections to date.

Since early May, COVID infections have steadily increased in the United States, Europe, Singapore, New Zealand, and Australia. The U.S. Centers for Disease Control and Prevention estimates that COVID-19 infections are currently increasing in 25 states based on data from emergency department visits. However, hospitalizations and deaths from COVID remain at their lowest levels.

Now, the U.S. Food and Drug Administration has approved updated vaccines to protect against current variants of the virus.

This recent surge has been driven mainly by a new group of closely related Covid subvariants, known collectively as "FLiRT."

As the summer winds down, students across the U.S. will return to school. Traditionally, this also coincides with the season of respiratory viruses, such as flu, RSV, and increasingly COVID.

"Not sure what will happen this fall and winter," says Kei Sato, a virologist at the University of Tokyo. While the FLiRT variants are likely to keep evolving after summer, entirely new subvariants cannot be ruled out. "An Omicron-like event” seems to have occurred every year in the fall since 2021, says Sato.

Here's what you need to know about the new variants and the new vaccines.

What Are FLiRT Variants?

The "FLiRT" variant family includes the majority of currently circulating variants, identified with the letters KP, JN, and the variant LB.1.

The unofficial name "FLiRT" is an acronym for a set of mutations on the spike protein of SARS-CoV-2, the virus that causes COVID-19. The virus uses spike protein to bind with ACE2 receptors in our nose and lung cells to cause infection.

All proteins are made up of amino acids that string together like beads. Mutations can change one amino acid to another, thereby altering the behavior of the protein and making the virus more or less infectious, or able to dodge immunity.

The FLiRT subvariant family members are descended from the JN.1 variant that was dominant in the U.S. in early 2024. JN.1 itself was highly unusual because it acquired 41 mutations that differentiated it from Omicron XBB.1.5, which is the variant upon which the current bivalent COVID booster is based.

Should You Get The New Vaccines?

The two updated mRNA vaccines, manufactured by Pfizer-BioNTech and Moderna, target a FLiRT variant called KP.2. Anyone over the age of 12 can get the new shots, as long as they haven't received a booster in the last two months.

“Vaccination continues to be the cornerstone of COVID-19 prevention,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research said in a statement.

Another vaccine targeting the variant JN.1 and manufactured by Novovax is also under review and could be approved soon.

Previous research also showed that older vaccines based on XBB.1.5, an earlier subvariant of Omicron, were still effective in preventing severe COVID-19. While this vaccine produces antibodies that still target the FLiRT variants, the efficiency is notably reduced. A recent infection from the JN.1 variant also seems to provide strong protection against all the FLiRT variants.

That said, the CDC recommends that everyone six months and older get a COVID vaccine. Those at high risk for serious COVID-19 should get vaccinated with the most recent versions available.

How Alarming Are FLiRT Variants?

Coronaviruses, such as SARS-CoV-2, frequently mutate to avoid recognition by antibodies. The two FLiRT mutations remove the sites on the virus where antibodies bind the SARS-CoV-2 virus.

Additional mutations on the FLiRT variants can either help the virus bind more efficiently to ACE2 receptors making it more infectious, help it evade previous immunity, or both, says Adrian Esterman, an epidemiologist at the University of South Australia, Allied Health & Human Performance in Adelaide, Australia

Early studies show that all existing FLiRT subvariants are very good at dodging previous immunity acquired through multiple COVID vaccinations—including the most recent COVID bivalent booster—or a breakthrough infection from a previous strain of Omicron.

But the good news is that by escaping the antibodies, the FLiRT variants have also seem to lost some ability to infect their target because the virus needed the original antibody-binding sites to bind the ACE2 receptor and enter cells.

"These variants are not yet particularly concerning, even with the new mutations that affect certain aspects of the virus's biology," says Shan-Lu Liu, a virologist at the Ohio State University.

It is common for viruses to acquire mutations that help them dodge immunity, which can affect their ability to infect cells, says Liu. "The viruses can quickly evolve new mutations to restore their infectivity."

But in the meantime, Sato thinks that waning immunity from previous vaccinations and infections, coupled with the FLiRT variant's ability to dodge remaining immunity, are probably the main reason for the recent surge in infections.

Liu also agrees that the currently rising numbers of COVID infections are mostly due to low booster uptake and increased summer travel.

Are COVID Medicines Still Effective?

Emergency department visits, hospitalizations, and deaths have all spiked during this summer but are still much lower compared to earlier waves of the pandemic.

There is no indication that these new FLiRT variants are more dangerous than other Omicron strains.

A study shows that Paxlovid is still effective against FLiRT variants. Other antiviral drugs such as molnupiravir and remdesivir are also expected to work since their mechanism of action is not affected by mutations in the spike protein.

[cripp-tid]

living in the USA really just is reading a news headline like "BREAKING: FDA outlaws cancer-causing food coloring" and you click it and its "beta-dextraflubenrabinol #5 (shortened to beta DFR5), is commonly used in the manufacturing of paintballs. it has been around since 1943. today, it is present in 95% of sodas." and u just kinda go "wtf wasn't that already illegal?" and u look MORE into it on google and find some shit like "the FDA allows up to 12% toxicity in all products meant for consumption" and u just kinda stare into the camera like the office

[whoneedssexed]

This abortion pill "safety" lawsuit should TERRIFY you.

“For reference, pregnancy has a mortality rate of about 8.8 in 100,000, which is 15x higher. Penicillin has a mortality rate of 2 in 100,000, which is 4x higher. And interestingly, Viagra has a mortality rate  of 4 in 100,000, which is 8x higher.”

[faggotfungus]

My friend sent me a tiktok that was telling people that all eyedrops have been contaminated with human shit and plastics so they're being recalled.

So, like a sane person, I Googled, "Eyedrop recall." First thing I found was this statement by the FDA. There are only 2 eyedrops being recalled, and the bacterium/fungi they're contaminated with are all sourced from the environment (dirt, water, vegitation).

Please don't believe what people say just because they say it enthusiastically.

[religion-is-a-mental-illness]

By: Bernard Lane

Published: Sep 6, 2023

America’s drug regulator, the FDA, has been asked to take urgent action on the unapproved use of hormone suppression drugs to block the natural but unwanted puberty of transgender-identifying children.

“Although this use has not been approved by the [Food and Drug Administration], the FDA must not turn its back on the potential harm to children,” says a citizen petition filed with the agency.

“Despite the widespread—and rapidly growing—use of these drugs in this population [of children with the distress of gender dysphoria], and despite serious known and potential risks from these drugs, this use has never been evaluated for safety and effectiveness by the FDA.”

The petitioners include child and adolescent psychiatrist Dr Miriam Grossman, paediatric endorcinologist Dr Quentin van Meter and the groups Genspect, Detrans Help, FAIR in Medicine and the Gender Dysphoria Alliance.

The webpage hosting the petition is open to public comment. The FDA acknowledged receipt of the petition on September 5.

“Puberty blockers, or gonadotropin-releasing hormone (GnRH) agonists, are a class of drugs that are FDA-approved for treating certain cancers, endometriosis, and, in pediatric populations, central precocious puberty. Brand name puberty blockers include Lupron Depot-PED, Supprelin LA, Fensolvi, Synarel, and Triptodur. These drugs suppress the release of sex-specific hormones—testosterone in males and estrogen in females. When given to children in the early stages of puberty, they delay sex-related changes normal to adolescent development, such as deepening voice in males and breast development in females.”—citizen’s petition to the FDA, September 2023

The petitioners urge the FDA to—

• commission the National Academies of Sciences, Engineering, and Medicine (NASEM) to undertake a transparent and unbiased systematic review of the evidence for trans puberty blocker drugs • issue requests for long-term registry studies of the children given trans puberty blockers, given that long-term data “is critically important and sorely missing” • create a webpage disclosing the known and potential risks of off-label puberty blockade to “help to counter widespread confusion and misinformation about this use”

“Many in the medical profession and the media continue to represent the off-label use of puberty blockers as ‘well established’ and ‘lifesaving’,” the petition says.

“While the FDA has taken an aggressive stance against medical misinformation in other contexts, it has done nothing to counter these misrepresentations.

“What is most concerning is that, because puberty blockers are not FDA-approved in children with gender dysphoria, there is no demonstrated benefit of the drugs to justify these risks.

“This is why Sweden, Finland, the UK, Norway and other countries have all turned against the use of puberty blockers and other medical interventions as a front-line treatment of gender dysphoria, recognizing this use as experimental.

“The [American] public deserves the truth from its government about the potential harms of these drugs and the lack of established benefit.”

Puberty blockers are used off-label for gender dysphoria internationally, although brand names may vary from country to country.

Misinformation

“The FDA can address the misinformation surrounding the off-label use of puberty blockers in children by commissioning a systematic review of existing peer-reviewed studies by NASEM with the goal of developing an authoritative assessment of the evidence,” the petition says.

The citizen’s petition says the gender-affirmative treatment model used in the United States lacks the safeguards imposed by the Amsterdam gender clinic which in the late 1990s pioneered the use of puberty blockers followed by cross-sex hormones and surgery.

��Because of the prevalence of the affirmative model in the US, the number of children with gender dysphoria receiving puberty blockers has also risen sharply, more than doubling between 2017 and 2021,” the petition says.

“These drugs are known to interfere with bone development and fertility (when followed by cross-sex hormones) and serious concerns exist about their effect on long-term bone health and neurocognitive development.

“What is most concerning is that this [poorly understood] safety profile is currently tolerated in drugs prescribed to children for which the benefit is highly uncertain.”

The petition notes the vulnerability of dysphoric children, who have “higher rates of other psychological and developmental conditions, including autism, eating disorders and depression.”

“US District Court judges have been asked to compel the FDA to reveal what it knows about the off-label use of puberty blocker drugs by gender clinicians.”—news report, Gender Clinic News, 16 March 2023

This week’s citizen petition also calls upon the FDA to warn drug companies and health providers of the consequences of unlawful promotion of puberty blockers for children with dysphoria.

“Puberty blockers have been marketed directly to teenagers with promotions that characterize the drugs as a safe way to ‘put puberty on hold,’ without disclosing any of the required risk information,” the petition says.

“For example, a Planned Parenthood ad that first aired in 2022 depicts two cartoon teenagers speaking directly to potential users, stating—

‘[p]uberty blockers are safe and can give you more time to figure out what feels right for you, your body, and your gender identity,’ and ‘[y]our gender identity is real. You should be the one to decide what changes you want to make to your body’

The petition says, “Pharmaceutical companies that promote their drugs for off-label uses have paid multi-million-dollar settlements to avoid civil and criminal judgments.

“But the potential for harm to users doesn’t depend on who runs the ad: off-label promotions by practitioners that oversell the benefits of an off-label use and fail to disclose the risks have the same potential to deceive consumers.”

GCN has contacted the FDA for comment

==

Hopefully sanity will prevail.

[a-typical]

Are parabens really harmful?

Parabens are a class of chemicals that are commonly used as preservatives in cosmetics, personal care products, and some food products. There has been some concern in recent years that parabens may be harmful to human health, particularly in terms of their potential to act as endocrine disruptors, which are chemicals that can interfere with the body's hormonal system.

However, the scientific consensus on the safety of parabens is that they are generally safe for use in cosmetics and personal care products at the concentrations typically used. Regulatory agencies such as the US Food and Drug Administration (FDA) and the European Union's Scientific Committee on Consumer Safety (SCCS) have evaluated the available evidence and determined that parabens, when used as directed, do not pose a significant health risk to consumers.

That being said, some individuals may be sensitive or allergic to parabens, and may experience skin irritation or other adverse effects as a result. In addition, some people may choose to avoid parabens for personal or environmental reasons, as they are not biodegradable and can potentially accumulate in the environment over time.

Overall, while parabens have been the subject of some controversy, the weight of scientific evidence suggests that they are generally safe for use in cosmetics and personal care products, and are an effective means of preventing microbial growth and extending the shelf life of these products.

[nationallawreview]

FDA Issues New Guidance on Cosmetic Product Registration and Listing

On December 11, 2024, the U.S. Food & Drug Administration (FDA) issued updated guidance for industry on the registration and listing of cosmetic product facilities and products. The guidance provides recommendations and instructions to help individuals and companies comply with the Modernization of Cosmetics Regulations Act of 2022 (MoCRA). MoCRA mandates that cosmetic companies report serious…

[justinspoliticalcorner]

Oliver Milman at The Guardian:

A red food dye that is ubiquitous in American drinks, snacks, candies and cereals may finally be banned by the federal government after years of concern that it has adverse health impacts, particularly upon children. The federal Food and Drug Administration (FDA) has said that it could soon act to crack down upon the additive known as red 3, derived from petroleum and used to provide a cherry-red coloring to an array of foods.

“With red 3, we have a petition in front of us to revoke the authorization board, and we’re hopeful that in the next few weeks we’ll be acting on that petition,” Jim Jones, the FDA’s deputy commissioner for human foods, told a US Senate health committee on Thursday. Red 3 is used in nearly 3,000 food products, according to a database by one environmental health group, including Pez, Peeps, Betty Crocker’s products and Dubble Bubble chewing gum. Like other food dyes, it adds nothing of nutritional value and is used instead to add color to foods for marketing purposes. While the FDA said that this food dye, like other such approved additives, is safe to consume if done so correctly, red 3 has been found to be carcinogenic in animals and has been banned for use in cosmetics since 1990. Public health groups have also linked it to behavioral problems in children. Pressure is now building upon the FDA to ban the food dye, along with others that are routinely provided warning labels or are banned in the European Union – yet allowed freely in the US.

The FDA is making a move towards banning Red 3 food dye this is used in many foods.

[ehssafetynewsamerica-blog]

Riverside Natural Foods Inc. Issues Voluntary Recall of Select MadeGood Granola Bar Products Over Potential Presence of a Piece of Metal

Chicago, Illinois, December 9, 2024 – Riverside Natural Foods Inc. is voluntarily recalling certain batches of MadeGood granola bars due to the potential presence of a piece of metal in the product, which, if consumed, may result in a safety hazard. The health and safety of our consumers is our highest priority. This recall is being initiated as a precautionary measure; no injuries have been…

[neosciencehub]

Selection of Dr. Jay Bhattacharya: A Controversial Choice for NIH

Selection of Dr. Jay Bhattacharya: A Controversial Choice for NIH @neosciencehub #sciencenews #NIH #neosciencehub #covid19 #publichealth #FDA #healthcarepolicy

In a move that has ignited discussions across medical and political communities, US President-elect Donald Trump has nominated Dr. Jay Bhattacharya on Tuesday (November 26), to lead the National Institutes of Health (NIH). Dr. Bhattacharya, a physician and economist from Stanford University, is known for his controversial stance on public health measures during the COVID-19 pandemic, particularly…

[news-buzz]

Clonazepam Recall Grows Over Harmful Labelling Error

Endo USA, Inc, has expanded its beforehand introduced recall of clonazepam orally disintegrating tablets resulting from a packaging error that may very well be life-threatening. An ongoing investigation by the corporate has recognized the chance that sure clonazepam product tons comprise cartons printed with the wrong power and Nationwide Drug Code (NDC) code resulting from an error by a…

[head-post]

Coca-Cola recalls over 13,000 cases of “zero sugar” lemonade

Coca-Cola recalled 13,151 cases of Minute Maid Zero Sugar Lemonade after mislabelling on containers, according to the Food and Drug Administration (FDA), The Independent reported.

This came after cans of regular Minute Maid lemonade were put into cases labelled Minute Maid Zero Sugar Lemonade. The two types of lemonade differ greatly in ingredients: one can of Minute Maid Lemonade contains 40 grams of total sugar, 50 mg of sodium and 150 calories, whereas Zero Sugar Lemonade contains zero grams of total sugar, 50 mg of sodium and only five calories.

The recalled product was shipped to retail shops in Indiana, Kentucky and Ohio. However, the FDA clarified that the cases of lemonade were no longer in the shops.

No impacted product remains in the market, and all recall activities in those markets are complete.

To find out if their purchase was recalled, customers could look for the codes FEB1725CNA and FEB1725CNB on the packaging of the lemonade cases.

On 10 October, the recall was classified as a Class II. It is “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

However, there has been an increase in the number of food recalls over the past year. In 2023, the FDA issued 506 recalls, the highest number of reports in five years, according to Sedgwick Brand Protection’s 2024 recall report. From 2022 to 2023, the number of FDA recalls increased 19.6 percent.

Last month, HP Hood LLC, which owned the lactose-free brand, announced a voluntary recall with the FDA over concerns about possible contamination with an almond allergen.

This issue was discovered as a result of routine maintenance programs which revealed the potential for trace amounts of almond.

Read more HERE