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Are cosmetics unregulated? Episode 16

Is it true that cosmetics are unregulated and that companies can put anything they want in beauty products? Find out as Perry and I talk about the laws that govern the cosmetics industry. We also discuss a news story about the placebo effect in drugs and cosmetics. Super Special Bonus: Perry uncovers cosmetic chemists in comic books and movies!

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Beauty Science News:  “Half Of A Drug’s Power Comes From Thinking It Will Work”

This report involves a pain medication study and the author says: “Basically we show that words can actually double the effect of a drug. That’s pretty impressive.” Here’s what they tested and what they found:

  • No treatment: 15 percent increase in pain.
  • Known placebo: 26 percent decrease.
  • Placebo labeled Maxalt: 25 percent decrease.
  • Maxalt labeled as placebo: 36 percent decrease.
  • Mystery pill (Maxalt or placebo): 40 percent decrease.
  • Known Maxalt: 40 percent decrease.

The “mind over matter” effect of placebos is similar to what we call the “halo effect” in cosmetics.

Listener question: Sarah wants to know about regulation in the cosmetic industry

The idea that the cosmetic industry is unregulated and that “anyone can put anything in any product” is a myth. In fact, there are 3 levels of regulation to which the industry is subjected: federal, state, self-regulation.

Federal level

The Food, Drug & Cosmetic Act 

  • Prohibits “poisonous or deleterious substances”
  • Restricts particular ingredients
  • Mandates claim substantiation
  • Regulates color additives
  • Requires warning label for coal tar based hair dyes

Important point that causes confusion: The FDC act does NOT require companies must test their products for safety prior to marketing. If the FDA determines that the safety of a product has NOT been substantiated, the product is misbranded (illegal).

What can the FDA do?

  • Prosecution – Criminal charge against the company.
  • Seizure – Federal marshals takes possession of all products.
  • Injunction – Civil action that requires you stop making and distributing the product.
  • Recall – Companies have to pull products off the shelf.

The Fair Packaging and Labeling Act 
Mandates that labels must include the following:

  • Product identity
  • Net contents (also includes provisions against under-filling.)
  • Name and location of manufacturer.
  • List of ingredients.
  • Warning statements (when needed)

The FDA’s Over the Counter Drug review
This is another way the FDA has jurisdiction over cosmetics (at least for cosmetic-drugs)

Other laws which grant additional oversight but not JUST to cosmetics:

Toxic Substances Control Act
Under the jurisdiction of the EPA
Controls single ingredients, not finished products.
No direct authority over cosmetics but if the EPA rules that an ingredient is dangerous, you can expect the FDA will look at it as well and likely consider it to cause the product to be adulterated and therefore it would fall under their jurisdiction under the FDC act.

Federal Trade Commission
Regulates advertising. They prohibit “unfair or deceptive acts or practices affecting commerce.” That’s pretty broad.

The NAD is a second source of advertising regulation They are more likely to challenge cosmetic ads but they don’t really have any authority to take action. Instead what they do is turn the issue over to the FTC.

Consumer Product Safety Commission 
The CPSC has authority over:

  • Soap
  • Hazards presented by cosmetic containers – glass packaging which is breakable, or packages with small parts that could endanger children.
  • Special packaging standards under the Poison Control Act (e.g. child proof caps.)

State regulations
In addition to these federal controls, states are free to pass whatever laws related to cosmetics that they want as long as their laws don’t conflict with federal mandates.

Every state has regulations that apply to soap and cosmetics. Most of them follow the FDA regulations pretty closely, but some have more extensive requirements.  For example:

  • California pioneered legislation which restricts VOCs is determined.
  • Florida requires a “cosmetic manufacturer permit” for any person that manufactures or repackages cosmetics in Florida.
  • Maryland outlawed specific phthalates in cosmetics.

Self-regulation of cosmetics

Finally, on top of all these federal and state restrictions, the cosmetic industry polices itself through the following voluntary registration programs:

  • Registration of manufacturing facilities
  • Registration of cosmetic raw material composition and ingredient statements
  • Filing of adverse product experiences

These all help the government get access to information it needs to ensure safety.

The bottom line
Contrary to what misinformed people may tell you, cosmetics are regulated on three levels: Federal, state, and industry self regulation. You may disagree with the level of regulation or how they are enforced but you can’t honestly claim there are NO regulations. 

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Comments on this entry are closed.

  • Grace February 4, 2014, 10:40 am

    Promo for the book: bought the first one, gave to a friend after reading. bought the second (kindle version) and have lent it out! Good work. Everyone should purchase.

    • Randy Schueller February 4, 2014, 11:31 am

      Thanks Grace! But I’d thank you even more if your friends bought their own copies. 🙂

      • Eileen February 4, 2014, 2:46 pm

        OK, so I just bought the Kindle version and skimmed through it during lunch. You guys are funny, informative, and down to earth kind of like TV’s Myth Busters. It was the best $2.99 I’ve spent in quite awhile. And, unlike a couple other well-known blogs that are thinly disguised promotional sites for selling their own products, you guys really know how to keep it real. Thanks for not being shills and for approaching your topics with reason and good humor.

        • Randy Schueller February 4, 2014, 4:44 pm

          @Eileen:-You’ve passed the interview; you’re hired.

          Just kidding! Seriously, thanks for the unsolicited testimonial!

          PS Actually we think that TV’s Myth Busters are like us. (Just kidding again!)

  • Sarah F. February 4, 2014, 10:13 pm

    I thought the caller’s question was really astute;). I am also enjoying the book on kindle.

  • Reitha Weeks February 6, 2014, 10:57 am

    I am interested in your list of actions that FDA can take regarding harmful or mislabeled cosmetics: prosecution, seizure, injunction and recall. Based on the Food Drug and Cosmetic Act, I thought that FDA had to get a court ruling BEFORE they can institute seizures, injunctions and recalls. If that is true, your column doesn’t make that distinction clear.

    If I have my information wrong, please direct me to the laws that I should read. Thanks – I really do like reading your posts!


    • Randy Schueller February 6, 2014, 11:22 am

      Our info was taken from the text book “The Cosmetic Industry: Scientific and Regulatory Foundation.” Per the chapter penned by John A. Wenninger, of the FDA:

      -Prosecution is “a criminal action filed by the FDA against a company.”
      -Seizure is initiated by the FDA “by filing a complaint with the U.S. District Court.”
      -Injunction by definition involves the court system and is a “civil action filed by the FDA.”
      -Recall is voluntary for companies and is “an alternative to FDA-initiated court action.”

      I hope this helps.

  • Audrey May 31, 2016, 1:25 am

    I’ve read that more chemicals have been banned in Europe for cosmetic products that are still used in cosmetic products in the U.S. What is the reason for this difference in regulation?

    • Randy Schueller May 31, 2016, 6:50 am

      When you look at the EU laws that govern cosmetics you’ll see that the list of 1000+ ingredients include chemicals that are not used in cosmetics AT ALL (such as the picric acid, which is explosive, and radioactive substances.) These ingredients would never be used in cosmetics in the US because they are not safe, so even though they are not banned they are not legal in the US. Many of the banned ingredients in Europe are only banned if they contain contaminants. As long as the ingredient is purified, it’s allowed to be used (just like in the US.)

      You can learn more here: https://thebeautybrains.com/2014/10/does-europe-ban-more-cosmetic-ingredients-than-the-us-the-beauty-brains-show-episode-53/

  • Coco August 31, 2016, 2:43 pm

    Long time listener, first time commenter..would be interested in your take on this article from Scientific American: http://www.scientificamerican.com/article/us-government-has-little-authority-to-stop-unsafe-cosmetics/

    Michael DiBartolomeis, chief of the safe cosmetics program at the California Department of Public Health, said in this article, “Cosmetic products that contain known human carcinogens or chemicals that impair human reproduction or development are marketed and sold without adequate safety tests because the existing law allows it.”

    Thanks, guys!

    • Randy Schueller August 31, 2016, 2:45 pm

      Actually the existing law doesn’t permit the sale of unsafe products so technically he’s not correct. Perhaps what he’s missing is that you have to consider that the dose makes the poison. We’re exposed to ALL KINDS of dangerous chemicals all throughout our life but as long as the exposure is low the risk is very low.

      • Mark April 11, 2017, 2:25 am

        First time listener and commenter here. I really enjoyed the show but I’m confused by your replies, Randy. The Scientific American article linked to above is worth reading in full — presumably you were pressed for time and replied simply to the quoted passage, but you made false assumptions about DiBartolomeis’s statement and the rest of the article. Here is the continuation of the passage quoted above:

        “In Brazilian Blowout, he said, ‘the levels of formaldehyde exceeded levels that would be of concern for causing cancers and short-term effects’ such as burning nose and throat, hair loss, asthma attacks and skin blisters.

        ” ‘Although the sale of Brazilian Blowout in California violated five separate state health, environmental and consumer laws and resulted in numerous acute injuries, we have not been able to get it off the market,’ DiBartolomeis said.”

        This story also touches on Heide’s comment, which I don’t believe you adequately addressed by simply saying “NOT correct” and linking to the page she posted it on. I listened to episode 16, which was very informative, and yet the case of Brazilian Blowout suggests that Heide is incorrect only because her statement — a “product can be made and sold until it actually causes problems and is specifically reported in large enough numbers” — assumes that such a product will stop being made and sold after it causes problems reported in large numbers. How else are we to understand that a product, which is blamed by numerous stylists for serious adverse reactions, which triggers OSHA to issue a worker hazard alert and to fine salons “for exposing workers to excessive levels of formaldehyde from Brazilian Blowout,” whose manufacturer is cited by the FDA for “adulteration” and “misbranding” and settles a separate class-action suit about Brazilian Blowout for $4.5 million, and which products are deemed “unsafe” by an FDA-supported panel of health experts established by the cosmetics industry — their “unsafe” assessment supported by the American Chemistry Council and by representatives of the Personal Care Products Council (and similar safety questions acknowledged by “Left Brain” on The Beauty Brains: https://thebeautybrains.com/2009/12/is-brazilian-keratin-straightening-safe/ ) — that this product remains today on the market?

        I admit I haven’t looked into this case extensively, so I may be missing something, but on first read the claims made in the Scientific American article are quite impressive and would seem to deserve an informed response.

        • Randy Schueller April 11, 2017, 7:54 am

          Mark, you raised some really good points, thanks. I have to admit I’m puzzled how the Brazilian Blow out product can still be on the market. My understanding of the law is that the FDA has full authority to act if a product is unsafe, as seems to be the case here. According to the Scientific American article…

          “Saying the product could cause eye, respiratory tract and nervous system disorders, FDA officials told GIB to ensure the product was safe or they would pursue an injunction in federal court and seize the product. However, a year later, the agency has taken no further action against the company, although there is no evidence that the formulation is safe. FDA spokeswoman Tamara Ward said the agency is still investigating Brazilian Blowout but she couldn’t comment because it is “an open case under review.”

          Apparently the process is incredibly slow!

  • Heide April 1, 2017, 8:26 am

    I have always known that there are general regulations regarding cosmetic ingredients. Am I correct in saying: Unless and until a cosmetic product causes harm and/or a reaction, that is specifically reported to the FDA, they won’t take action?

    Effectively the product can be made and sold until it actually causes problems and is specifically reported in large enough numbers. Is that correct? Or is that over simplified?