NOV-DEC 2016

MedEsthetics—business education for medical practitioners—provides the latest noninvasive cosmetic procedures, treatment trends, product and equipment reviews, legal issues and medical aesthetics industry news.

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LEGAL ISSUES | By Allyson Avila RATMANER © GETTY IMAGES 14 NOVEMBER/DECEMBER 2016 | Med Esthetics 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 medi- cal aesthetics arena, some patients are using bioidentical hormones, human growth hormones, dietary supplements and intravenous infusions—among other nontraditional ap- proaches—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. How- ever, providing these treatments can expose your practice to increased scrutiny from both state and federal agencies. The biggest problem facing physicians who offer alterna- tive 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 benefi ts 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 effi cacy of their products. If effi cacy is not proven—or the manufacturer opts not to go through test- ing—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 scientifi cally 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 scientifi c evidence to support the claims, safety or effectiveness of these products." The FTC also warns that "antiaging" hormone therapies Alternative erapy Hazards Some medical boards are working to protect physicians who offer alternative therapies from federal scrutiny, but risks remain.

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