The latest top stories for the sports nutrition / dietary supplement industry:
FDA Updates Nutrition and Supplement Facts Panels
On May 20, FDA finalized its rule updating Nutrition and Supplement Facts Panels. This is FDA’s first major overhaul of food labels in over 20 years. FDA intends the updated label to reflect new scientific information concerning the link between diet and chronic diseases, like heart disease and obesity. The changes include updates to the panel’s design, serving sizes that track how much food consumers actually eat, and changes to the nutrients that are required to be listed. Perhaps the most notable change to the panel is the inclusion of “added sugars.” Most marketers must implement the changes by July 26, 2018, but marketers with less than $10 million in annual food sales will have an additional year to comply. Please call us with any questions on these proposed changes—2018 will sneak up on us before we know it!
Cosmetics Claims Under Increasing Scrutiny
Cosmetics claims should be geared toward “cleansing, beautifying, promoting attractiveness, or altering the appearance.” Unlike dietary supplements, cosmetics may not be promoted as affecting the structure or function of the human body—for example, reducing wrinkles. Under FDA’s regulatory scheme, if “cosmetics” bear structure/function claims, they will generally be considered “unapproved new drugs.” Cosmetic companies claiming their products will “reduce[] the depth of wrinkles…by attenuating muscle contraction,” “improve[] the firmness and elasticity of skin, remove[] crow’s feet,” or “help increase fatty tissue volume to…plum up [skin]” should not be surprised when they receive an FDA warning letter. The line between proper cosmetics claims and improper structure/function claims is often narrow and winding. Legal advisors experienced in this area, like the attorneys at CGMB, are crucial in helping keep cosmetics companies from crossing that line.
See, e.g., http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm497702.htm; http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm500684.htm
FDA Warns Ultimate Weight Loss Co. for Selling Unapproved and Misbranded New Drugs
On April 14, 2016, FDA warned Ultimate Weight Loss Co. for selling products it claimed contained undeclared sibutramine and phenolphthalein. “Sibutramine is the active pharmaceutical ingredient in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the United States market on December 21, 2010 after clinical data indicated sibutramine poses an increased risk of heart attack and stroke. Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States.” If FDA’s allegations are true, these products, masquerading as dietary supplements, are in fact unapproved and misbranded new drugs.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm504533.htm
In today’s regulatory climate, where FDA, FTC, state attorneys general, industry self-regulatory organizations, class action lawyers, and even individual U.S. Senators are leading a patchwork of crusades against dietary supplement companies, it is vital to keep up to date with the latest enforcement efforts and trends. We regularly send out emails summarizing the latest enforcement actions (opt in; we never share our subscription list, and you can opt out at any time). Please share them! Learning from others’ mistakes is cheaper than learning firsthand what kinds of practices and violations lead to enforcement.
If you have a dietary supplement or cosmetics company and have any questions about your responsibilities under the law, including label claims, labeling requirements, advertising review, Good Manufacturing Practices, or anything else, give us a call anytime at 516-294-0300.