According to the Food and Drug Administration’s (FDA) website, “FDA’s legal authority over cosmetics is different from other products regulated by the agency, such as drugs, biologics, and medical devices. Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives. However, FDA may pursue enforcement action against violative products, or against firms or individuals who violate the law.”
FDA’s website states further, “Cosmetic firms are responsible for substantiating the safety of their products and ingredients before marketing.” The FDA does regulate cosmetic labeling under the authority of the Federal Food, Drug and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act.
But what happens when a cosmetic includes a drug or biologic as the active ingredient? What are the regulations? According to the FDA, such products must comply with the requirements for both cosmetics and drugs.
The FD&C Act defines cosmetics by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” [FD&C Act, sec. 201(i)].
The FD&C Act defines drugs, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)].
Per FDA regulations, a cosmetic is also a drug when it is intended to cleanse, beautify or promote attractiveness as well as treat or prevent disease or otherwise affect the structure or any function of the human body and “articles intended for use in the … cure, mitigation, treatment, or prevention of disease … and … articles … intended to affect the structure or any function of the body …”(Sec. 201(g) and (i), FD&C Act and Sec. 509, FD&C Act).
This definition is applicable to biologics as well since the FDA considers biological products as a subset of drug and as such both are regulated under provisions of the FDC Act. Therefore, a biologic or drug product must be reviewed/approved by the FDA prior to placing on the market in the US.
The FDA is issuing Warning Letters to cosmetic companies that are making drug/biologic claims. Below is a link to the FDA website providing a list of all Warning Letters issued since 2002. Notice the increase in 2012; from 2002 to 2011 there have been thirteen Warning Letters issued spanning nine years whereas, in 2012 eleven letters were issued to companies such as Lancôme and Avon.
To see the Warning Letters associated with drug and biologic claims made for products marketed as cosmetics click here.
Some excerpts from the Warning Letters where the FDA concluded the products are intended to affect the structure or function of the body based on claims include:
- “Formulated to boost shock-absorbing proteins to help strengthen skin’s support layers.”
- “Improve fine & deep wrinkles up to 50%. Immediately plumps out wrinkles and fine lines. Within 48 hours begins boosting collagen production.”
- “[B]oosts the activity of genes and stimulates the production of youth proteins.”
- “A powerful combination of unique ingredients – Reconstruction Complex and Pro-Xylane™, a patented scientific innovation– has been shown to improve the condition around the stem cells and stimulate cell regeneration to reconstruct skin to a denser quality.”
- “Immediate lifting, lasting repositioning. Inspired by eye-lifting surgical techniques . . . helps recreate a younger, lifted look in the delicate eye area.”
- “Blemish Free Skin in Just 3 Days!”
- “Organic Plant Stem Cells … reactivate your body’s own dormant and weak skin stem cells, pushing them to regenerate.”
- “[T]riggers your body’s own skin regeneration activators”
- “[R]epairs sun damaged tissues at the cellular level”
- “Long-term repair – 5% each of two additional peptides with anti-oxidants stimulate production of collagen and elastin… helping to repair structural damage to deeper layers of the skin.
I understand the balance between revenue, risk and compliance faced by corporations. However, when a drug or biologic is added to a cosmetic it makes the threshold of safety that much more critical. We are not talking about a one-time application of a cosmetic; we are talking about decades and decades of application of creams, foundation, lipstick, eyeliner, etc with little to no scientific evidence demonstrating the safety and effectiveness of the active ingredient(s). Not only do consumers deserve to know that the products they are using are safe but they also have the right to know the products they are using actually comply with US laws.
After what appears to be a lull of enforcement activity in 2013, it is uncertain if the FDA will refocus its attention on cosmetic companies en masse or if they will continue to enforce a particular company through website trolling, but either way if your company happens receive a letter in the mail, the negative impact on revenue and company reputation will be felt immediately. That, quite clearly, is the down side of business risk.