BeautyBroken LawsPolitics

Myth Busting: Are Beauty Products Regulated for Safety in the U.S.?

Contrary to what you may have heard on social media or elsewhere in online beauty chatter about how cosmetics are regulated, the hoops that companies selling beauty products have to jump through to get their products to market are…well, they’re barely hoops at all and the jumping is almost nonexistent.

While there are some government regulations in place, they are barely sufficient. Ingredients used in the beauty industry are virtually unregulated and there hasn’t been a major update to cosmetic safety legislation since 1938. Instead of looking to companies to tell you whether or not their products are safe, it should be up to the U.S.Food and Drug Administration (FDA) to tell Americans exactly what the regulatory oversight is—and put better rules into place.

So What Are Current Beauty Regulations? (Hint: Not Much)

The U.S. Food and Drug Administration is the government agency who has oversight on the $80 billion domestic beauty industry, but there’s one little problem: they have very little authority to actually make sure beauty and personal care products are safe prior to entering the market. In other words, this problem isn’t actually the FDA’s fault, but rather Congress needs to pass laws that empower the FDA to act. So let’s break it down.

Cosmetic companies do not need to get FDA approval for the use of cosmetic ingredients before using them. Under the 1938 Food Drug & Cosmetics Act, cosmetic products and ingredients (with the exception of color additives) are not subject to FDA premarket approval or premarket notification to FDA. This might not be a bad thing if all the ingredients used in beauty products were safe, but peer-reviewed research tells a different story. 

While beauty brands are responsible for the “safety of their products and ingredients”, they are not required to provide any safety information to the agency, even if requested by FDA during an inspection. It’s a trust us, type situation.

In general, except for color additives and those ingredients that are prohibited or restricted from use in cosmetics by regulation, a manufacturer may use any ingredient in a cosmetic, provided that the ingredient does not adulterate the finished cosmetic and the finished cosmetic is properly labeled. 

Translation: that means that even something as seemingly (and hopefully!) benign as, say, a baby lotion requires no testing, oversight, or regulation before you, the consumer, slather it on your baby.

Plain and simple, our laws regulating cosmetics and personal care products are limited, weak, ineffective, and are failing to protect our health from certain harmful chemicals. What’s more, the laws that do exist fail to protect vulnerable and overexposed populations like pregnant women, children, and women of color.

For Beauty Products to be Sold in the U.S. They Must :

  • Colorants must come from the FDA’s approved list.
  • Products cannot be misbranded or cannot have microbial growth. (Real talk: this is not widely enforced and it’s also why using safer preservatives is essential. Run if you see something marketed as “preservative-free”.)
  • Products sold at retail must list their ingredients (with the exception of ingredients used in fragrances, a major loophole). Products sold online and professional salon products do not need to list their ingredients. 
  • Over-the-counter products like sunscreens have additional regulatory requirements to ensure SPF claims and accuracy.

What Beauty Regulations Are Sorely Needed (Hint: A Lot)

  • The FDA needs the authority and funding to establish a program to review and deem ingredients used in beauty products safe or unsafe prior to being used in products.
  • There needs to be a comprehensive approach to reviewing ingredient safety, analyzing cumulative and aggregate exposures wherever possible—with a better understanding of safety for vulnerable populations. Why? Ingredients like asbestos have been found in children’s play makeup, hair straightening treatments have been linked to cancer, and ingredients like formaldehyde and PFAS are still intentionally and unintentionally being used in makeup formulations. 
  • They need to close the loophole that allows fragrance ingredients to be kept secret from consumers.
  • The FDA needs the ability to provide mandatory recalls on egregiously harmful products (currently the recalls are only voluntary and they are rarely complied with by companies).
  • Professional salon products and products sold only online should also be required to list their ingredients. (I was proud to be part of the team who passed a law in California giving salon professionals transparency around ingredients for the first time, but this needs to happen at the national level.)
  • The supply chain for ingredients should become more transparent— ranging from reporting of country of origin, ingredient purity, and contaminant testing. Often it’s hard for brands who are seeking to create clean formulations to have the control over treatments used along the supply chain, which is currently a black box. 

As outlined in the testimony below from Dr. Susan Mayne the director of the FDA’s cosmetic safety program in 2019, cosmetic companies do not need to get FDA approval for the use of cosmetic ingredients before using them. (Bold below added by me for emphasis)

Under the FD&C Act, cosmetic products and ingredients (with the exception of color additives) are not subject to FDA premarket approval or premarket notification to FDA. Cosmetics firms are responsible for the safety of their products and ingredients. However, they are not required to provide any safety information to the Agency, even if requested by FDA during an inspection. In general, except for color additives and those ingredients that are prohibited or restricted from use in cosmetics by regulation, a manufacturer may use any ingredient in a cosmetic, provided that the ingredient does not adulterate the finished cosmetic and the finished cosmetic is properly labeled.

– Dr. Susan Mayne, FDA

In the same hearing, Chairwoman Eshoo has a poignant exchange with Dr. Mayne from the FDA. I’ll leave this transcript here as a final closing to the gaps in our current regulatory system.

Rep. Eshoo: Can the FDA require a review of the safety of baby lotion before it goes to market?

Dr. Mayne: No.

Rep Eshoo: Can the FDA tell the company not to use a toxic ingredient, for example formaldehyde, in its baby lotion?

Dr. Mayne: No.

Rep. Eshoo: Is the manufacturer required to register with the FDA prior to selling the baby lotion?

Dr. Mayne: No.

Rep. Eshoo: Once it comes to market, can the FDA require safety information about the baby lotion?

Dr. Mayne: No.

Rep. Eshoo: If the lotion caused bad reactions, in the babies, can the FDA require a recall?

Dr. Mayne: No.

Rep. Eshoo: If the manufacture is aware of the babies bad reactions, would the manufacturer be required to report that to the FDA?

Dr. Mayne: No.

Exchange between Congresswoman Eshoo and Dr. Susan Mayne before the Energy & Commerce Committee, December 2019

Plain and simple, our limited laws regulating cosmetics and personal care products are weak, ineffective and are failing to protect our health from certain harmful chemicals. Furthermore, the laws that do exist fail to protect vulnerable and overexposed populations like pregnant women, children, and women of color.

So are beauty products regulated? Barely.

Do we need to pass new laws to better protect our health from certain toxic chemicals? Yes.

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