by Myra Irizarry, PBA Director of  Government Affairs

Manufacturers be on alert. Following the 2012 outbreak of meningitis caused by spinal injections of a contaminated steroid, resulting in the deaths of dozens of people, Congress is looking to the FDA to exercise its granted authority to take a more proactive approach to regulation. In this more aggressive role of enforcement, we have seen an increase of FDA warning letters to cosmetic companies over the past several months regarding advertising and labeling claims.

Advertising of cosmetic claims have ranged from new cell rejuvenation, to curing skin ailments. Some claims can be proven, however, by doing so, the product in question will move out from under the cosmetic category and instead be viewed as a drug, which places it under the subjection of FDA drug requirements.

Currently the FDA administers the Voluntary Cosmetic Registration Program (VCRP). This free voluntary program applies to cosmetic products and is an opportunity for manufacturers, packers, and distributors to assist the FDA by sharing information which is also useful to the Cosmetic Ingredient Review (CIR). The CIR panel of experts reviews the safety of ingredients used in cosmetic products.

The FDA has different requirements for drugs. The requirements are mandatory unlike the voluntary program offered for cosmetic products. Some manufacturers may find their products are a mix of both a cosmetic and a drug. To help define the answer to this question, the FDA has a document on their website called “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?).

Although the FDA does not offer any type of approval process or testing for cosmetics, it does monitor how and what claims are being made by cosmetic manufacturers. No company wants to receive a letter from the FDA stating they have an adulterated or misbranded product. But, labeling and advertising claims have recently landed several major companies in the hot seat.

According to the FDA’s website, a cosmetic can be deemed misbranded if:

  • its labeling is false or misleading
  • its label fails to provide required information
  • its required label information is not properly displayed
  • its labeling violates requirements of the Poison Prevention Packaging Act of 1970 [FD&C Act, sec. 602; 21 U.S.C. 362

If you have questions regarding labeling or the categorization of any of your product ingredients, you are urged to proactively investigate these concerns by contacting the FDA directly or consulting your attorneys. Get more resources and information at