#FDA regulations on cosmetics

[thebeautyscientist]

Heavy Metals in Cosmetics: Background to Regulations, Risks, and Testing

  Heavy Metals in Cosmetics? Heavy metals, such as lead, arsenic, cadmium, mercury, and others, are naturally occurring elements that can be found in the environment. They can make their way into cosmetics through contaminated raw materials or during the manufacturing process. These metals are not intentionally added to cosmetics but can be present as impurities. The presence of heavy metals in…

[cinematic-literature]

Legally Blonde 2: Red, White & Blonde (2003) by Charles Herman-Wurmfeld

Book title

Animal Liberation (1975) by Peter Singer

Living in Harmony with Animals (2000) by Carla Bennett

Constitution, Jefferson’s Manual, and the Rules of the House of Representatives

Food Drug and Cosmetic Act: A Practical Guide to Law & Regulation

Animal Testing Question: Alternatives & Analyses

History of the FDA 

[johnwilson88]

Stay ahead in the dynamic world of cosmetics with our comprehensive guide to FDA Cosmetic Regulations for 2023. Discover the latest updates, compliance requirements, and essential insights to ensure your products meet the highest safety and quality standards. From ingredient labeling to manufacturing practices, empower your brand with the knowledge needed to thrive in the competitive beauty industry while prioritizing consumer safety and confidence.

[darkmaga-returns]

The FDA may finally be banning artificial red dye from foods in the US, despite the fact they are already outlawed for use in cosmetics, and the EPA has recently called for full safety reviews for all PFAS, signaling a new era for federal health regulators. Could the anticipation of RFK Jr.’s sweeping regulatory changes be causing the agency to act?

AIRDATE: December 12, 2024

[arodata]

Small PSA that you should probably be checking the ingredients in your personal lubricants, and looking up any chemicals you don't recognize, because I recently discovered that the astroglide brand water based lubricant I had been using contains quaternium-15, a preservative that slowly releases formaldehyde. From wikipedia:

"Quaternium-15 has been banned in the EU since 2017 and a bill was introduced in the US in 2017 to require the FDA to investigate its safety.[4][5]"

"Quaternium-15 is an allergen, and can cause dermatitis.[6] Many of those with an allergy to quaternium-15 are also allergic to formaldehyde."

"Although quaternium-15 releases low amounts of formaldehyde.[10] Even so, Johnson & Johnson announced plans to phase out its use of quaternium-15 in cosmetic products by 2015 in response to consumer pressure.[11][12]"

I'm sure you're more likely to have an adverse reaction to this if you have sensitivities to chemicals, but this cannot possibly be good for anyone to be putting in their bodies, especially long-term. I don't know which other brands use this, but astroglide is popular and cheap, so I felt the need to say something about that. This isn't common knowledge! I only checked what that chemical name meant because I was having recurring genital rashes and trying to rule out possible allergens

Sexual products *desperately* need to be better regulated than they are, but until then the best we can do is warn each other about this type of shit

[kingdrawcse]

Tragic Lessons: The Elixir Sulfanilamide Incident and the Birth of Drug Safety Regulation

In 1937, the US-based Massengil pharmaceutical company's chemists developed a new sulfonamide oral preparation named "Elixir Sulfanilamide." At that time, there was no requirement for safety review before launching new drugs. Consequently, this untested drug went on sale in September of that year. In October, the American Medical Association received reports of fatalities caused by the medication.

In November, the US Food and Drug Administration (FDA) intervened, recalling the drug. The investigation found that "ethylene glycol," used as a solvent in the drug, was the main culprit of poisoning. Ethylene glycol is highly toxic to mammals, with a minimum lethal dose (LD₅₀) of 786 mg/kg in humans. This issue, easily detectable through a simple animal experiment, resulted in over 100 deaths that fall, with 30% being children.

The following year, under immense public pressure, the US Congress passed the landmark "Federal Food, Drug, and Cosmetic Act" (FFDCA), mandating safety reviews for all new drugs before market approval and granting the FDA regulatory oversight authority.

[skaianbruja]

TIL that the use of "hypoallergenic" in cosmetics and skincare is not regulated by the FDA and is essentially a completely meaningless label

[thelooniemoonie]

Love how cosmetics are under FDA regulation and they're required to list their ingredients so there's technically not much stopping me from just taking that list and making that shit at home

[religion-is-a-mental-illness]

Published: Jun 27, 2023

Homeopathic drugs have an unusual status in the United States. On the one hand, they are incorporated into the Federal Food, Drug, and Cosmetic Act (FD&C Act) within the definition of “drug,” which specifically includes articles recognized in the official Homoeopathic Pharmacopoeia of the United States (a historical perspective can be found in this ScienceInsider article from 2015, when government scrutiny was beginning to increase). But on the other hand, there is growing consensus that the effectiveness of such products is not supported by scientific evidence and that they are, in many cases, mere placebos that do not actually treat the patient’s medical conditions; in the worst cases, they contain harmful ingredients that may cause serious injury.

This extraordinary dichotomy has led to both the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) in recent years issuing modernized enforcement policies related to homeopathic drugs. An FTC enforcement policy statement from late 2016 requires homeopathic products to be marketed with clear disclosures stating that, among other things, there is no scientific evidence that the products work (see our prior post on the FTC policy here). Then in 2019 FDA took action to withdraw a long-standing compliance policy guidance for homeopathic drugs and to simultaneously issue a significant number of Warning Letters to companies marketing such products in violation of the FD&C Act (our prior posts on those activities are here and here).

Most recently, FDA finalized its draft guidance on homeopathic drugs – first issued in draft form in 2017 and then revised in 2019 – to lay out for industry the agency’s approach to “prioritizing regulatory actions for homeopathic products posing the greatest risk to patients.” The final guidance document issued in December 2022 can be found here. FDA also appears to be moving aggressively on the enforcement priorities as five letters relating to violative homeopathic drug products have been posted to the agency’s public Warning letter database since the beginning of calendar year 2023, as compared to four for the entire previous year. The FTC also included homeopathic drug manufacturers and distributors in the list of advertisers that received notices in April 2023 that their advertising claims need to be backed up with appropriate and reliable forms of scientific evidence (see here). Taken together, it’s clear that the homeopathy industry remains under major scrutiny by federal regulators seeking to enforce their fundamental public safety mandates, whether they fall under the FD&C Act or the prohibition on deceptive advertising contained in the Federal Trade Commission Act. 

Perhaps more noteworthy and concerning for the homeopathy industry, however, is a Fall 2022 decision by the District of Columbia Court of Appeals to allow civil cases to proceed against two retail pharmacies under a plaintiff’s novel application of D.C.’s Consumer Protection Procedures Act. The plaintiff in both lawsuits is the Center for Inquiry (CFI), a nonprofit that states it is “dedicated to defending science and critical thinking in examining religion. CFI’s vision is a world in which evidence, science, and compassion – rather than superstition, pseudoscience, or prejudice – guide public policy.” As part of this mission, and among several other lawsuits it has initiated in the homeopathy space, CFI sued two retail pharmacies in the District of Columbia on the grounds that they were violating the local deceptive trade practice statute. The complaint alleged these violations arose through the pharmacies’ indirect representations that homeopathic drug products labeled as cough, cold, and flu treatments have the same characteristics and benefits as over-the-counter drug products formulated with traditional active ingredients. In particular, although the pharmacies didn’t make express promotional statements comparing the different product types, the plaintiff argued that they placed homeopathic products adjacent to their traditional counterparts on physical shelves and in online shopping results, thereby creating the misleading impression that the different products had comparable efficacy.

CFI’s complaints were dismissed at the trial court level for failure to state a claim upon which relief could be granted. The two cases were then consolidated for purposes of the plaintiff’s appeal to the D.C. Court of Appeals. On the question of whether a cognizable claim had been asserted (this post won’t discuss the separate question that the appellate court reviewed, which was whether CFI had standing to sue the defendants), a three-judge panel ruled on September 29, 2022 that “whether the complained-of practices have a tendency to mislead reasonable consumers is a jury question” – thereby reinstating the complaints and remanding the cases for factual development. In reaching its decision, the court determined that a defendant did not need to make verbal statements in order for a “representation” to exist and that actions could also fall within the scope of the deceptive trade practices statute. Therefore the various factual allegations in CFI’s complaints – for example that the pharmacies displayed homeopathic products next to “science-based” drug products and that signage in the stores indicated that the entire section contained products for “Cold, Cough & Flu Relief” – were sufficient at the pleading stage to survive a motion to dismiss. As of June 2023, the dockets for both of these CFI lawsuits are active and discovery appears to be ongoing, so they continue to bear watching for future resolution on the merits. 

This recent ruling from the D.C. Court of Appeals foreshadows the possibility that retailers may opt to stop carrying homeopathic products in their stores (both physical and online) if the risk of liability to their own businesses becomes too great. Between the tightening of FDA’s and FTC’s rules for the industry and the increasingly creative use of existing consumer protection statutes by legal advocates, we could be witnessing a slow-motion demise of direct-to-consumer-based homeopathic product marketing. Only time will tell how the industry evolves in response to these numerous and formidable headwinds.

[lucysweatslove]

Number asks: 10, 20, 30, 40, and 50!

Someone I think is funny:

She has long dark brown hair, wears giant glasses, has a sort of dry and sardonic sense of humor some of the time but also goofy and punny with more wordplay. (It's me. I am describing myself, because I think I am hilarious lmao).

My favorite movie:

It's about a boy. Well, two of them, actually. Once is a rich dude who is kinda self-centered and jerk-ish who pretends to be a single dad in a support group in order to get with single mums who have low self-esteem. By doing this, one of the kids of the moms at the group realizes he doesn't have a kid and blackmails him into letting him spend time with him. They develop a sort of "big brother" type relationship and both grow as people. (The name of the movie is, in fact, About a Boy)

My best birthday:

Is it bad that I don't really know? Nothing is coming to mind. I have a worst birthday (can't get much worse than the only person still friendly with you dying), but I honestly struggle with a best one since I don't have memories before that and since then, my birthday reminds me of harder times. We usually have low-key birthdays now. I guess maybe my 26th birthday, as that was around the time that I found out I was accepted into my master's program and my dream of medicine could still live on.

My favorite animal:

Domestic: squat little body and short stubby lil legs with a curly tail, smooshed face, and flippy floppy ears. Can fit 200 lbs of love in a 20 lb body. (Pugs, obvi)

Non-domestic land animal: Giant pachyderm with human-level attachment and tbh probably smarter than a lot of us too. People are evil and ride them when they shouldn't, putting too much stress on their backs. Have visited non-riding sanctuaries and wish I could again (eles)

Technically an animal and can be kept as pets but not really a pet: Beautiful aquatic animals (of my favorite phylum, cnidaria) that just kinda float and swim along slowly, looking all pretty and serene, but some could actually kill you. (Jellyfish. Of all types)

Anything! Make up your own:

Look I'm not a creative person, like the color green. But because it's my special interest AND it's skin cancer awareness month: my favorite sunscreen of all time is Purito Daily Go-To because it has great protection and is super cosmetically elegant in every situation i've needed it and isn't freakin expensive. Also US FDA sunscreen regulations are laughable at best. They're talking about banning every organic UV filter which would literally leave us with only zinc and titanium formulations which actually suck and are super inelegant in comparison. People are going to stop using sunscreen all together which will result in rising rates of preventable skin cancers which already costs us a significant amount to treat. It may also impact other domains of health, as some people may opt to spend less time outdoors and exercising due to the hassle of preventing sunburns. (I have a lot to say about this but I'll shut up now because I know most people check out around this point)

Thank you!

[johnwilson88]

FDA Cosmetic Regulations in 2023: What You Need to Know

Read the latest updates and requirements in FDA cosmetic regulations for 2023. Stay informed about changes in ingredient transparency, labeling standards, and compliance protocols. Learn how these regulations impact your business and explore strategies for ensuring compliance while maintaining product integrity. Stay ahead of the curve in the dynamic landscape of cosmetic regulations with our comprehensive guide to FDA standards in 2023.

[darkmaga-returns]

Consumer groups and 23 members of Congress have called for a ban on red dye No. 3, citing its ban in other regions and the urgency of protecting public health from harmful food additives.

For over 30 years, red dye No. 3 has been debated for its potential cancer-causing effects, with mounting evidence linking it to cancer in rodents, yet the FDA has not banned it.

Recent U.S. Senate hearing saw lawmakers press FDA Deputy Commissioner Jim Jones on the agency's inaction despite clear evidence of the dye's carcinogenic potential.

The FDA's reluctance to ban red dye No. 3 reflects broader regulatory issues, where chemicals remain in the food system without action despite emerging evidence of harm, unlike European regulators who adopt a precautionary principle.

Red dye No. 3 is widely used in popular foods and drinks, with over 2,800 products containing it, and research indicates it can disrupt thyroid function and damage DNA in human liver cells.

For over three decades, the debate over the safety of red dye No. 3, a chemical commonly used in candy, foods and drinks to give them a cherry-red color, has raged on, with mounting evidence linking the synthetic additive to cancer in rodents. Despite this, the Food and Drug Administration (FDA) has yet to take decisive action, leaving consumers to navigate a food supply riddled with potentially harmful chemicals. As the Biden administration draws to a close, consumer advocacy groups and lawmakers are intensifying their calls for a ban on red dye No. 3, a move that would protect millions from the hidden dangers lurking in their favorite foods.

The issue came to a head during a Dec. 5 Senate hearing where FDA Deputy Commissioner for Human Foods Jim Jones faced intense questioning. Senator Tommy Tuberville (R-Ala.) expressed his frustration, stating, "If we know something is deadly for anybody that ingests it, how do we continue to just study that and not say, 'enough is enough'?" His sentiments were echoed by other lawmakers, who pressed Jones on the FDA's inaction despite clear evidence of the dye's carcinogenic potential.

The FDA's reluctance to ban red dye No. 3 is part of a broader pattern of regulatory laxity when it comes to food additives. Thomas Galligan, principal scientist for food additives and supplements at the Center for Science in the Public Interest, highlighted this issue, stating, "Once chemicals are in the food system, they can stay there for as long as [companies] want because the FDA is not taking action when new evidence of harm emerges." This approach stands in stark contrast to the precautionary principle adopted by European regulators, who ban or require warning labels on food additives when there is any question about their safety.

The FDA's inaction is particularly alarming given the widespread use of red dye No. 3 in popular candies, foods, and drinks, as researchers have found that it can disrupt thyroid function and even damage DNA in human liver cells.  The Environmental Working Group (EWG) has identified over 2,800 food products that contain the dye, including childhood favorites like Fruit by the Foot and Dubble Bubble chewing gum. In 2021 alone, food and drug manufacturers used approximately 200,000 pounds of red dye No. 3 in their products. Despite the FDA banning the dye from cosmetics in 1990, it remains approved for food use, with the agency citing species-specific findings in rodents as justification for its continued presence in the food supply.

[moussezi]

FDA Registration Cosmetics Regulation

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of the FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938.

ITB HOLDINGS LLC 390 North Orange Avenue, Suite 2300 Orlando, FL 32801 United States T: +1 855 389 7344 T: +1 855 510 2240 T: +44 800 610 1577 https://www.itbholdingsllc.com/services/cosmetics/

[melivora]

Given that Kinder Eggs aren’t allowed in the US because

This is because of a regulation set out by the Food and Drug Administration (FDA) – which is given its powers by the US Federal Food, Drug and Cosmetics Act of 1938. Essentially, the law dictates that any food with a ‘non-nutritive object embedded’ – including toys embedded inside confectionery items – is not allowed.

Why are they allowed fortune cookies?

[aravalihoneyindustries]

"How to Choose the Best Natural Honey Supplier for Your Business"

Natural honey is a prized commodity in various industries, from food and beverages to cosmetics and pharmaceuticals. Its versatility and health benefits make it a sought-after product. However, selecting the right natural honey supplier for your business can be challenging, especially with the growing demand for authenticity and quality. Here’s a comprehensive guide to help you choose the best farming honey suppliers.

1. Understand Your Business Requirements

Before you start your search for a supplier, it’s crucial to identify your business needs:

Quantity: Determine how much honey you require monthly or annually.

Type: Are you looking for raw, organic, or processed honey?

Usage: Will the honey be used for retail, manufacturing, or as an ingredient?

Packaging: Do you need bulk packaging or consumer-ready jars?

Understanding these factors will narrow down your options and help you communicate your needs effectively to potential suppliers.

2. Prioritize Quality Standards

The quality of honey can vary significantly. Here’s what to consider:

Purity: Ensure the honey is free from additives, preservatives, and artificial sweeteners.

Certifications: Look for certifications such as organic, non-GMO, or Fair Trade, depending on your target market.

Moisture Content: Quality honey typically has a moisture content below 18%.

Testing: Check if the supplier provides lab test results for each batch, confirming the absence of contaminants like pesticides and heavy metals.

3. Research Supplier Reputation

A supplier’s reputation speaks volumes about their reliability. Here’s how to assess it:

Reviews and Testimonials: Look for reviews from other businesses that have worked with the supplier.

Experience: Established suppliers with a long history in the honey industry are often more dependable.

References: Ask the supplier for references and speak to their current clients.

Memberships: Check if they are members of recognized trade associations or honey producer groups.

4. Verify Authenticity and Traceability

Counterfeit honey is a growing concern in the market. Ensure the supplier provides:

Source Transparency: The supplier should disclose the origin of their honey.

Traceability: They should track their honey’s journey from the hive to your business.

Beekeeping Practices: Inquire about their beekeeping and harvesting methods to ensure ethical and sustainable practices.

5. Evaluate Logistics and Delivery

Efficient logistics are essential for a seamless supply chain. Assess:

Shipping Capabilities: Can the supplier deliver to your location within your required timeframe?

Packaging: Honey must be packaged securely to prevent leaks and contamination.

Storage Conditions: Confirm that the supplier maintains optimal storage conditions to preserve honey quality.

Lead Times: Discuss lead times to avoid supply chain disruptions.

6. Assess Pricing and Payment Terms

Cost is a significant factor, but it shouldn’t compromise quality. Consider:

Pricing Structure: Is the pricing competitive and transparent?

Volume Discounts: Do they offer discounts for bulk purchases?

Payment Terms: Negotiate payment terms that align with your cash flow needs.

Hidden Costs: Ensure there are no hidden costs, such as customs duties or extra shipping charges.

7. Check for Compliance and Certifications

Your supplier should adhere to local and international standards. Verify:

Food Safety Standards: Ensure compliance with regulations like HACCP, ISO 22000, or FDA standards.

Organic Certification: If organic honey is your focus, verify certifications from recognized bodies.

Environmental Practices: Check if the supplier uses eco-friendly practices and supports biodiversity.

8. Request Samples

Before committing, request samples to assess the quality of their honey. Evaluate:

Taste and Aroma: Genuine natural honey has a distinct taste and aroma, depending on its floral source.

Texture and Consistency: High-quality honey has a smooth, viscous texture.

Appearance: Look for natural color variations without cloudiness or impurities.

9. Evaluate Communication and Customer Support

Effective communication is vital for a successful partnership. Consider:

Responsiveness: Are they prompt in answering queries?

Transparency: Do they provide clear and honest information?

Flexibility: Can they accommodate special requests or customizations?

After-Sales Support: Ensure they provide support in case of issues like damaged shipments or product complaints.

10. Start with a Trial Order

Instead of committing to large orders initially, start with a trial order. This allows you to:

Test their product quality and consistency.

Evaluate their delivery timelines.

Assess their reliability in handling your requirements.

11. Build a Long-Term Relationship

Once you’ve found a reliable supplier, focus on building a strong partnership. Benefits include:

Consistent Quality: A trusted supplier ensures consistent product quality over time.

Better Pricing: Long-term relationships often lead to better pricing and terms.

Exclusive Offers: Suppliers may prioritize loyal customers for limited-edition products or exclusive deals.

Conclusion

Choosing the best natural honey supplier for your business requires thorough research and due diligence. By prioritizing quality, verifying authenticity, and evaluating logistics, you can find a supplier that aligns with your business goals. Remember, the right supplier is not just a vendor but a partner in your success, contributing to the growth and reputation of your business.

[chitradentaltvm]

Top 5 Whitening Clinics in Trivandrum

A dental procedure called teeth whitening can give you a brilliant, self-assured smile. Numerous dental clinics in Trivandrum provide excellent teeth-whitening services. The top five clinics in Trivandrum that might give you a beautiful smile are described in this blog.

1.Chitra Dental clinic

Chitra Dental Clinics is one of the best places in Trivandrum to get teeth whitening. Among the many cosmetic dentistry procedures they offer are veneers, smile design, teeth whitening, and more. Whether you’d rather use take-home kits or in-office whitening, Chitra Dental Clinics offers a safe and efficient way to get a whiter smile.

Why Select Dental Clinics in Chitra?

Knowledgeable team of dental specialists.

Application of modern whitening technology.

Stressing the comfort and contentment of patients.

The best option if you want to whiten your teeth is Chitra Dental Clinic.

2. Smile Dental Care

Smile Dental Care is yet another great choice in Trivandrum for teeth whitening. The clinic is well-known for its affordable and efficient services and provides whitening solutions customized for a range of dental conditions. Their skilled team guarantees a painless procedure with long-lasting results.

Key Highlights:

Personalized teeth-whitening plans.

Using whitening products that have received FDA approval.

A convenient location and adjustable appointment times are provided.

3. Dental Professionals in Trivandrum

A trustworthy name for comprehensive dental care, including skilled teeth-whitening treatments, is Trivandrum Dental Specialists. Because the clinic places a strong focus on offering top-notch care and producing measurable results, the locals adore it.

Key Highlights:

Advanced whitening procedures.

Staff members are amiable and knowledgeable.

Strict adherence to safety and hygienic regulations.

4. White Pearl Dental Care

Despite providing a variety of cosmetic dentistry services, White Pearl Dental Clinic specializes in teeth whitening. The clinic employs state-of-the-art technology to safely and effectively give patients the whitest shade possible.

Key Highlights:

Focuses on offering services related to cosmetic dentistry.

Modern teeth-whitening technology that is quick and effective.

Comprehensive post-treatment care instructions.

5. The Perfect Smile Dental Clinic

As the name implies, the goal of Perfect Smile Dental Clinic is to provide you with the smile of your dreams. To help patients feel more confident about their smiles, their teeth-whitening procedures aim to get rid of tough stains and discolorations.

Key Highlights:

Affordable teeth-whitening packages.

Ability to effectively care for teeth that are sensitive.

A welcoming and warm environment.

Getting a brilliant smile is now easier than ever thanks to the excellent teeth-whitening services offered by these Trivandrum clinics. Professional care and exceptional results are assured whether you choose Chitra Dental Clinics or any of the other top options.

Are you prepared to have your smile transformed? Schedule a visit with one of these reputable clinics right now!