One of the questions that often comes up at any conference of marketers of prescription drugs is this: why are some non-drug products allowed to make what seem like unregulated health-benefit claims about their products for aging, weight-loss and treating low testosterone, among others?
Good question, but before we offer more of the legal/regulatory response below, let’s give some kudos to the FDA for its action this week against L’Oreal, the world’s largest cosmetics/beauty group. The FDA ordered the Lancome USA unit of L’Oreal “to stop advertising skincare products using language that makes them sound like drugs,” according to a Reuters report.
The FDA said Lancome, in some advertising, has made the claim that certain of its skin creams can “boost the activity of genes” and / or “stimulate cell regeneration,” which then will reduce signs of aging.
“Any product that is intended to affect the structure or function of the human body is classified as a drug, the FDA said, according to a warning letter posted on its website on Tuesday,” Reuters noted. And, as the marketing community is well aware, companies in the United States cannot market or sell “drugs” without first receiving the FDA’s approval and conducting the appropriate scientific research.
We have nothing against L’Oreal, but we do know that marketers of prescription drugs often feel the playing field is tilted in favor of the non-Rx product category. Why? Because their advertising “claims” are not held up to the rigor of FDA approval and oversight. Perhaps this week’s regulatory action is a sign of a more vigilant FDA and, also, FTC, which is really in charge of overseeing advertising for OTC products.
Reuters, as of mid-morning Tuesday, reported that L’Oreal officials had not responded to the FDA letter. This whole regulatory area has been confusing to both marketers and patients, and it certainly could use some tidying up.
“The drug/non-drug claim is nearly impossible for non-lawyers to understand and should be reformed by FDA,” John Kamp, executive director of the Coalition for Healthcare Communication, told BTP Insights this week. “But, meanwhile non-drug companies should not be able to make drug-like claims not based on scientific research. The current system is confusing to consumers and unfair to the companies that make legitimate drugs.”
Among the skin creams cited by FDA – the violation is dated Sept. 7 – were Genifique Repair Youth Activating Night Cream and Absolue Eye Precious Cells Advanced Regenerating and Reconstructing Eye Cream.
Now, as for why the FDA stepped in here. The agency is charged with “overseeing the approval and marketing of prescription drugs,” according to the FDA website. This authority comes, in part, from the Federal Food, Drug, and Cosmetic Act. “Among other areas, this law specifically addresses prescription drug advertising. This law requires that advertisements for prescription drugs be accurate and not misleading,” the FDA notes.
However, it is the FTC that regulates the promotion of over-the-counter products.
Under section 12 of the FTC Act, the commission has jurisdiction over the advertising of food, drugs, devices and cosmetics. The FTC also has concurrent jurisdiction with FDA over the labeling of foods, OTC drugs, devices and cosmetics.