FDA Sends Warning Letter to Skincare Company about Approval Issues


Recently, the U.S. Food and Drug Administration (FDA) issued a warning letter to a skincare company for advertising and selling unapproved new drugs. Whether at Headquarters or at the District Office level, the FDA will take action against products promoted with unsubstantiated claims about what the product contains or does for the consumer. The letter itself is not an unusual one in content, but the enforcement action carries on a growing trend.

An example of the specific enforcement is that the FDA objected to a product that referred to a stem cell renewal treatment. Claims referenced “wrinkles,” “stem cells,” “skin lightening,” “skin healing,” “eliminates age spots,” and “boosts collagen synthesis,” to name a few which caught the agency’s attention. The FDA said the product was not specifically recognized as safe and effective for the purposes promoted and therefore, was an unapproved new drug.

It is recommended by the FDA that the company re-review its website, labels, and labeling to ensure that agency guidelines are being followed. Many cosmetic companies do not utilize an internal review process, such as a Promotional Review Committee, often seen with pharmaceutical and medical device companies. By allowing representatives from commercial, marketing, medical, regulatory, and legal to review product claims to maximize compliance and at the same time, attempting to achieve business goals. Such collective wisdom is seen as valuable input. The company’s own website is an easy place to start and often likely where the FDA will look first.

The FDA rarely issues an enforcement letter based on one term or phrase, although it is possible to do so. More often, a number of claims are made that may merit FDA scrutiny. Aside from plaintiff lawyer’s complaints, companies must also consider examination from other federal and state regulatory bodies for deceptive advertising.