A warning letter was issued by the U.S. Food and Drug Administration (FDA) to a skincare company for promoting and selling unapproved new drugs. Whether at the District Office level or at Headquarters, the FDA will take steps against products promoted with unproven claims about a new product being made available to the public. The letter in content is not unusual, but the enforcement action is the sign of a growing trend.
The FDA cited an example of the special enforcement when the agency objected to a product that referenced a stem cell renewal treatment. Claims referred to “wrinkles,” “stem cells,” “skin lightening,” “skin healing,” “eliminates age spots,” and “boosts collagen synthesis,” to name a few terms that caused the agency’s closer examination. The product in question was not specifically recognized as safe and effective for the purposes promoted and therefore, was an unapproved new drug, according to the FDA.
The FDA recommends that the company re-review its website, labels, and labeling to ensure compliance with agency guidelines. Pharmaceutical and medical device companies often use a Promotional Review Committee, for example, as an internal review process. Many cosmetic companies to not take advantage of this collective wisdom that can be an important factor in the eventual approval of a product. By having representatives from commercial, marketing, medical regulatory, and legal to review product claims, there is additional input to aid in compliance efforts as well as the company’s achieving its business objectives.
It normally takes more than one term or phrase, although not impossible, to cause an enforcement letter to be sent by the FDA. A number of claims are usually made that may merit FDA attention. Along with plaintiff lawyer’s complaints, companies must also consider scrutiny from other federal and state regulatory bodies for false advertising.