According to a 2002 study from the National Institutes of Health (NIH), more than one-third of Americans have sought out some form of alternative medicine. In the medical aesthetics arena, some patients are using bioidentical hormones, human growth hormones, dietary supplements and intravenous infusions—among other nontraditional approaches—in an effort to reverse the aging process.
Offering alternative therapies in your aesthetic practice or medspa may provide your patients with options to avoid surgical procedures and enhance their appearances. However, providing these treatments can expose your practice to increased scrutiny from both state and federal agencies.
The biggest problem facing physicians who offer alternative therapies is the Federal Trade Commission (FTC), which frequently prosecutes claims relating to drugs and devices that are not approved pursuant to the Federal Food, Drug and Cosmetic Act (FD&C Act). In the U.S., product manufacturers who want to claim health benefits for their products—e.g., it makes hair grow, it cures cancer, it will lower your cholesterol—must work with the U.S. Food and Drug Administration (FDA) to complete clinical trials to prove the efficacy of their products. If efficacy is not proven—or the manufacturer opts not to go through testing—the company cannot make health claims. If they do, it is considered consumer fraud. This is where things get tricky for physicians who offer and promote alternative therapies.
According to the FDA, a health product is fraudulent if it is deceptively promoted as being effective against a disease or health condition but has not been scientifically proven safe and effective for that purpose. The FTC, which is an enforcement agency for the FDA, has gone so far as to issue “scam alerts” on its website warning consumers to avoid natural hormones and bioidentical hormones, because the FDA argues that “there is no credible scientific evidence to support the claims, safety or effectiveness of these products.”
The FTC also warns that “antiaging” hormone therapies aimed at both men and women have no scientific support and cites specific examples of therapies that, it claims, are not proven to have any influence on the aging process. These include human growth hormone (HGH), melatonin, dehydroepiandrosterone (DHEA) and testosterone. Furthermore, the FTC cautions patients that use of these therapies may carry significant risks.
Another target of the FTC is weight loss products and dietary supplements. This is based on the FDA’s ruling that it is “not legal to market a dietary supplement product as a treatment or cure for a specific disease, or to alleviate the symptoms of a disease.”
While the FTC and the FDA typically focus on pharmaceutical companies and manufacturers, they also monitor the actions of physicians through online searches and consumer complaints. If a medical practice is advertising a treatment—such as vitamin infusions, HGH or bioidentical hormones—and promoting physical health benefits, the FTC can act.
For instance, a doctor in Washington was sanctioned for infusing patients with hydrogen peroxide and micronutrients as a treatment for heavy metal toxicity, since there was no proof that such a combination was effective. Another doctor received a warning letter from the FDA after the FDA and the FTC reviewed his website and determined that he was promoting a product, “Immune Support Formula,” that violated the FD&C Act.
More generally, the FTC has cautioned that “it is against the law to make or exaggerate health claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims.”
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