The latest top stories for the sports nutrition / dietary supplement industry:
FDA Organizational Change
On December 21, FDA announced the creation of the Office of Dietary Supplement Programs (ODSP), elevating FDA’s supplement program from a division within the Office of Nutrition Labeling and Dietary Supplements. The dietary supplement program’s elevation to an office “will raise the profile of dietary supplements within the agency, and will enhance the effectiveness of dietary supplement regulation by allowing ODSP to better compete for government resources and capabilities to regulate this rapidly expanding industry.” FDA writes that it will use the ODSP to continue to enforce against non-compliant supplement marketers. Be advised: this means that the industry can expect even more action from FDA in the coming years!
http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm478303.htm
FDA Enforcement
On December 2, FDA warned Nature’s Health, LLC for a number of alleged serious violations of the Food, Drug, and Cosmetic Act. FDA writes that many of Nature’s Health’s product and ingredient claims cause its products to be misbranded and unapproved new drugs. These claims include: “may lower blood cholesterol, low-density lipoprotein (LDL or bad cholesterol) levels”; “effective against type 1 and type 2 diabetes”; “significantly decrease blood glucose levels and urinary protein levels, preventing damage to the kidneys”; “treat gallbladder disease, gallstones, liver disease, depression . . . high cholesterol levels, and skin diseases such as psoriasis and eczema”; and “known to relieve symptoms of . . . acute and chronic hepatitis, cirrhosis, fatty liver and damage.” Moreover, FDA warns that the products are adulterated because they were not manufactured in accordance with current Good Manufacturing Practices (GMPs). This warning letter highlights the importance of having experienced dietary supplement attorneys assist in responding to FDA’s inspectional observations. While Nature’s Health informed FDA that it complies with many GMP requirements, FDA was “unable to determine the adequacy of [its] response” because it “did not provide documentation to support [its] response (e.g. copies of written specifications).” Note that a more robust response to FDA’s Form 483 may have staved off a warning letter!
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm476988.htm
On December 10, FDA warned Miracle in the Green for promoting its product for conditions that cause it to be a misbranded and unapproved new drug. Aside from the claims themselves (including “Antibacterial, Antifungal, Antitoxins, Antitumors”), this warning letter differs from others because FDA cited the company’s website, along with posts on its Facebook Timeline and “promotional material for [its] product at the 2015 Natural Products Expo East trade show that was held on September 17-19, 2015 at the Baltimore Convention Center.” FDA monitors all marketing outlets to determine whether products have “intended uses” that cause them to be drugs.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm476763.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 giving a brief synopsis of the latest enforcement actions in the dietary supplement space (we never share our subscription list, and you can opt out at any time at the bottom of each email). Staying apprised of enforcement trends in the industry, from FDA warning letters to FTC false advertising allegations, can help you to stay above the fray and off of the regulatory radar. Learning from others’ mistakes is cheaper than learning firsthand what kinds of practices and violations lead to enforcement.
If you have a dietary supplement 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.
Happy holidays!