#fda cosmetic regulations

[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.

[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

[jacksoldsideblog]

trying to imagine the toxicity of Paper Street Soap Company soap,

points of consideration:

-the pipes at paper street house are almost certainly corroded. hello lead

-do you suppose they're on city water or a private well? with the second, there's definitely potential groundwater contamination with solvents and heavy metals from the paper mill

-the fat of an animal is where most non-polar contaminants are accumulated — all your chlorinated pesticides, your dioxins and furans, all the POPs (persistent organic pollutants). regardless of the bougieness of the visitors of the liposuction clinic, there's probably some accumulated organic contaminants. however, the process of making tallow may completely remove them — i can't find a good answer, and my gut says it would either completely remove them or hyperconcentrate them

-once they get a garden going, they're actually bioextracting any heavy metals in the soil (of which there are certainly many due to the nearby paper mill. cadmium, arsenic... probably some POPs too but they may break down due to the actions of the plant, bioremediation isn't my speciality) and i believe there's a high likelyhood this would get into the soap, especially if they were adding shredded bits for artsy texture... like with tallow, making essential oils may clear or concentrate these things

-microplastics almost certainly

overall i'd give it a pretty strong: maybe don't rub your hands in it several times a day for an indefinite period of time

plus, if the soap is marketed as moisturizing or deodorizing or "making you smell nice" then it's considered a cosmetic, and as the FDA helpfully says:

"Neither the product nor its ingredients need approval by FDA, except for any color additives it contains. It is your responsibility to make sure your product is safe for consumers when it is used as intended, and to make sure it is properly labeled. You don’t need to register your company or file your product formulations with FDA"

this means if you say your soap is moisturizing or nice smelling, you can avoid it being regulated by the CPSC and having to do lead testing if it will be used by children!

cosmetics (which are often applied to very sensitive skin and right near mucosal membranes) have been shown more and more to have heavy metals, microplastics, and organic contaminants in them, and companies are incentivized to ensure their product is classified as such since it reduces regulation (cost).

so yeah — Tyler Durden's soap is probably bad for you. but just remember, the same rules that would allow him to sell soap made from people and filled with pollutants are those that apply to the very large companies we are forced to implicitly trust our safety with :)

[mariedemedicis]

fda needs to start regulating vitamins, supplements, cosmetics, lotions, etc. like yesterday

[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

[dontmeantobepoliticalbut]

Food does not contain aborted fetuses, but the total lack of existence of such a product hasn’t stopped one Texas Republican from trying to regulate it.

Ahead of the opening of the Texas state legislature last week, Republican state Sen. Bob Hall introduced a bill to mandate that food containing “human fetal tissue” be “clearly and conspicuously labeled.” If passed, this bill would also apply to food that is “manufactured using human fetal tissue,” or “derived from research using human fetal tissue.” Medical and cosmetic products that have links to fetal tissue would also be subject to these requirements. 

Fetal tissue, according to the bill, is “tissue, cells, or organs obtained from an aborted unborn child.”

To be clear, food with fetal tissue in it? Not a thing. It doesn’t exist.

“There are no conditions under which the FDA would consider human fetal tissue to be safe or legal for human or animal consumption,” an FDA spokesperson told VICE News in a statement. Eating food with fetal tissue would also likely constitute cannibalism, which is typically frowned upon.

Cannibalism has found its way into the news quite a bit lately. Prominent conspiracy theory movements like QAnon hold (falsely) that elite Democrats are running a cannibalistic, Satan-worshiping, child sex-trafficking ring. QAnon’s beliefs are linked to antisemitic and anti-LGBTQ tropes that hold that Jewish and LGBTQ people are trying to hurt children, and even drink their blood. These conspiracies, which have flourished partly through lockdown isolationism and election denialism, have radicalized a stunning number of Americans and torn families apart.

Although food would not be impacted if Hall’s bill became law, medicine and science could be, since fetal cell lines can be used to develop and test drugs. These lines can be collected from a single miscarriage or abortion, then replicated in labs, over and over again, for decades. (Cell lines derived from aborted fetal tissue can be preferable, both because it’s easier to collect and because fetal tissue derived from a miscarriage may carry whatever genetic or chromosomal problem may have caused the miscarriage in the first place.) Fetal cell lines have led to development of many major vaccines, such as the vaccines against chickenpox and Hepatitis A.

After the outbreak of the coronavirus pandemic, a split erupted in the anti-abortion community over the morality of taking COVID vaccines that may have been developed or tested using fetal cell lines. The Moderna, Pfizer, and Johnson & Johnson vaccines do not include any fetal cells, although fetal cell lines were sometimes used in the development stages.

Hall’s office did not immediately return a VICE News list of questions about the bill. However, his office told HuffPost in a statement, “Unfortunately, many Texans are unknowingly consuming products that either contain human fetal parts or were developed using human fetal parts.”

“While some may not be bothered by this, there are many Texans with religious or moral beliefs that would oppose consumption or use of these products,” the statement continued.

The U.S. Conference of Catholic Bishops has previously said that, although vaccines with links to fetal cell lines can cause “a problem of conscience for some Catholic parents,” they can take them in service of the greater good of public health. In 2020, the conference urged people to get vaccinated against COVID.

“A well-informed consumer can make whatever choice they decide on purchasing a product so long as they have all of the information in hand to make the choice,” Hall told HuffPost.

So far, Hall’s bill has not been assigned to a committee.

[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

[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.

[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!

[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?

[isocertificationinfrance]

GMP Certification in Bangalore: A Comprehensive Guide

Good Manufacturing Practice (GMP) certification is a critical standard for industries, particularly in sectors like pharmaceuticals, food production, and cosmetics. It sets the framework for ensuring that products are consistently produced and controlled according to quality standards. In a city like Bangalore, which is known as a hub for innovation, biotech, and pharmaceutical industries, GMP Certification in Bangalore plays a pivotal role in maintaining high-quality production standards and enhancing global competitiveness. This article explores the meaning, benefits, importance, and process of obtaining GMP certification in Bangalore.

What is GMP Certification?

Good Manufacturing Practice (GMP) certification is a system that ensures products are consistently manufactured and controlled in accordance with quality standards. GMP standards cover all aspects of the manufacturing process, including raw materials, facilities, equipment, and staff hygiene. Compliance with GMP is essential in minimizing risks inherent in production, such as contamination, mix-ups, and errors, ensuring that the final product is safe and of high quality.

GMP guidelines are often enforced by regulatory authorities like the World Health Organization (WHO), the US Food and Drug Administration (FDA), and in India, the Central Drugs Standard Control Organization (CDSCO). For companies in Bangalore looking to sell products in international markets, adherence to GMP standards is essential for meeting global regulatory requirements.

Benefits of GMP Certification

1. Enhanced Product Quality and Safety

GMP Services in Bangalore  ensures that your manufacturing process adheres to stringent guidelines, which helps in maintaining the highest levels of product quality and safety. This is especially important for industries such as pharmaceuticals, where the risk of contamination or incorrect formulation can have serious health consequences.

2. Increased Market Access

With Bangalore being a hub for various industries like pharmaceuticals, food, and cosmetics, companies that obtain GMP certification can expand their market reach both domestically and internationally. Many countries require GMP certification as a prerequisite for importing products, particularly in regulated sectors.

3. Building Consumer Trust

Having GMP certification boosts consumer confidence in the products being manufactured. This is particularly important for businesses in highly regulated sectors such as pharmaceuticals and food, where consumers are highly conscious of the quality and safety of products.

4. Regulatory Compliance

In India, companies operating in industries like pharmaceuticals and food production must comply with GMP regulations enforced by the CDSCO. Non-compliance can lead to severe penalties, including fines, product recalls, or even the suspension of manufacturing licenses. GMP certification helps companies ensure they meet these legal requirements, mitigating potential risks.

5. Operational Efficiency

Adopting GMP guidelines often results in more efficient operational practices, as the certification process requires companies to streamline their production processes, maintain cleanliness, and ensure the appropriate training of staff. This not only reduces waste but also minimizes errors and downtime, contributing to a more efficient manufacturing process.

Importance of GMP Certification in Bangalore

Bangalore is one of the leading centers for the pharmaceutical, biotechnology, and food processing industries in India. With its growing prominence as a major hub for innovation and manufacturing, especially in high-tech sectors, the need for stringent quality control systems like GMP has never been more vital. Here’s why GMP Implementation in Bangalore is particularly important for businesses in Bangalore:

1. Global Competitiveness

As a significant player in India’s biotech and pharmaceutical landscape, businesses in Bangalore face stiff competition both locally and globally. GMP certification serves as a mark of quality, which can give companies an edge over competitors, particularly when entering international markets. Being GMP-certified makes it easier to comply with international regulations, opening doors to exporting opportunities.

2. Local Consumer Demand

Bangalore’s large, informed, and quality-conscious consumer base makes it essential for businesses to adhere to high standards. GMP certification allows companies to meet this demand by ensuring that their products are safe, reliable, and of consistent quality.

3. Alignment with Industry Trends

As global standards and industry regulations evolve, there is increasing emphasis on quality management and compliance. GMP certification ensures that companies in Bangalore stay ahead of these trends by consistently updating their production processes and facilities to meet new standards.

4. Support from Regulatory Authorities

India’s government has taken steps to encourage businesses to adopt international standards like GMP. Through various initiatives, including grants and subsidies, businesses in Bangalore have access to the resources needed to implement and maintain GMP certification, making it a feasible and attractive option.

Steps to Achieve GMP Certification in Bangalore

Obtaining GMP certification requires adherence to a defined set of guidelines and a rigorous auditing process. Here is a step-by-step guide on how companies in Bangalore can achieve GMP certification:

1. Understand GMP Requirements

The first step is to thoroughly understand the GMP guidelines applicable to your industry. GMP standards may vary depending on the sector—whether pharmaceuticals, food production, or cosmetics. For businesses in Bangalore, working with a local GMP consultant can help in understanding these specific requirements.

2. Gap Analysis

Once the GMP requirements are clear, the next step is conducting a gap analysis. This involves assessing the current state of your manufacturing processes and identifying areas that do not meet GMP standards. The gap analysis helps in understanding what changes need to be made to achieve compliance.

3. Implementation

This step involves making the necessary changes identified during the gap analysis. These changes can include upgrading equipment, modifying facilities, improving staff hygiene, or adjusting production processes. It’s crucial to ensure that all staff members are trained on GMP standards to maintain compliance throughout the production cycle.

4. Internal Audit

Before applying for certification, it’s advisable to conduct an internal GMP Audit in Bangalore to ensure that all processes, systems, and documentation are in place and meet GMP standards. This helps in identifying any last-minute gaps and rectifying them before the formal audit.

5. Application and External Audit

After ensuring that your facility meets GMP standards, you can apply for certification. The certifying body will then conduct an external audit, which typically includes a thorough inspection of your production facility, review of documentation, and assessment of compliance with GMP guidelines.

6. Certification and Maintenance

Once the external audit is completed, and your facility is deemed compliant, you will receive GMP certification. However, maintaining GMP certification is an ongoing process. Regular audits will be conducted to ensure continued compliance, and your team must remain vigilant in upholding GMP standards.

How can I get a consultant forGMP Certification ?A GMP (good manufacturing practice) certification guarantees that goods are manufactured and controlled in accordance with quality standards on a regular basis. It focuses on reducing production hazards that cannot be removed by testing the finished product. B2BCERT offers simplified GMP Consultants in Bangalore  to assist businesses in meeting legal requirements, enhancing product quality, and fostering customer trust. For sectors including food, cosmetics, and pharmaceuticals to guarantee consumer safety and high-quality products, this accreditation is crucial.