Contributed by Isabella C. Lacayo
Cosmetics, despite certain labeling requirement (ingredients, warnings, manufacturer information, etc.), are largely unregulated. Indeed, participation in the FDA’s Voluntary Cosmetic Registration Program is – as the name makes abundantly clear – voluntary. But in the fall, the FDA was busy admonishing makers of cosmetic skin care products over claims made on websites and product labels. The problem: a blurred line between “cosmetics” and “drugs.” The FDA issued six warning letters in September and October 2012 identifying manufacturers’ statements and claims that can only be made in connection with products classified as drugs, not cosmetics.
Under the Federal Food, Drug, and Cosmetic Act (the “Act”), any product that is intended to diagnose, mitigate, treat or prevent disease, or to affect the structure or function of the body is classified as a drug. Any product classified as a drug must either be generally recognized as safe and effective when used as labeled (such as a common over the counter drug) or must go through the FDA’s new drug application and approval process. Cosmetics, on the other hand, do not require any FDA approval prior to going to market. If a product is classified as both a cosmetic and drug (e.g. anti-dandruff shampoo, makeup with SPF), it must comply with the Act’s requirements for both cosmetics and drugs. Thus, because the requisite application and approval process for drugs was bypassed, the marketing of cosmetics with statements indicating that a product is intended to affect the structure or a function of the human body (e.g. skin) is a violation of the Act.
So what kind of statements can get a cosmetic product into hot water with the FDA? Here are some examples of claims made in connection with beauty creams and serums that caught the FDA’s eye:
- “the at-home answer to wrinkle-filling injections”
- “help tighten the connections between skin’s layers”
- “formulated to fortify damaged tissue with new collagen”
- “helping to repair structural damage to deeper layers of the skin”
- “provides all the muscle-relaxing properties of BOTOX®”
- “improves skin’s immune system”
- “fuel the rebuilding of skin structure and elasticity”
- “repairs sun damaged tissues at the cellular level”
- “inhibits microbiological activity of dangerous, pathogenic skin bacteria, including acne”
- “can extend the results of a Botox injection”
- “repairs existing skin damage, prevents future skin damage”
- “promotes collagen synthesis”
- “boosts the activity of genes and stimulates the production of youth proteins”
In addition to these types of statements, the FDA took issue with numerous testimonials on websites where customers make statements about the use and efficacy of the cosmetic product. With high consumer demand for cosmetics that provide drug-like benefits and cosmetics companies investing more in anti-aging product lines, the FDA is likely to have more to say in 2013. And, not surprisingly, plaintiffs have taken note and already filed putative class actions against some of the manufacturers that had been targeted with warning letters. These lawsuits include various claims such as false advertising, unjust enrichment, breach of warranty, and consumer fraud violations.
Now is a good time for cosmetic product makers to take inventory of all of their marketing materials and labels to help avoid being a target in the inevitable next wave of FDA warning letters. Studying FDA warning letters and constantly monitoring all marketing materials is a relatively small burden compared to litigating class action lawsuits.