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. Every two weeks, we will be sending you an email that gives a brief synopsis of 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.
Here is the first list of recent enforcement actions taken against non-compliant dietary supplement companies:
FDA
On June 17, FDA sent a warning letter to Desert Stream, Inc., a supplement firm based in Utah, for a variety of missteps. One product’s name—apparently, Arthritis Discomforts—promotes the product for conditions that cause it to be a drug. Further, the firm was cited for a number of cGMP violations, in addition to inadequate responses to FDA’s Form 483, which detailed FDA’s inspectional observations. Finally, the products are misbranded because of undeclared ingredients in the products, an inadequate statement of identity on the products, and incorrect serving sizes declared on the labels.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm452294.htm
On July 10, the Department of Justice, on behalf of FDA, filed a civil complaint against Iowa Select Herbs LLC to prevent the firm’s distribution of adulterated and misbranded dietary supplements. The company, which received an FDA warning letter for the violations last year, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm394259.htm, violated cGMPs, failed to adequately list the ingredients and nutritional information on the label, and advertised its products for conditions that cause them to be drugs. For example, the company claimed that its products could treat or cure cancer, diabetes, bronchitis, and a host of other illnesses.
Senator’s Inquiry
U.S. Senator McCaskill of Missouri, a Democrat on the Senate Special Committee on Aging, is leading a charge against anti-aging supplements. She recently sent out letters to major retailers requesting information on their dietary supplement marketing policies and asking how the retailers remove products “determined to be adulterated, improperly labeled, or fraudulently marketed.” It will be interesting to see where this inquiry leads.
http://www.mccaskill.senate.gov/imo/media/doc/CombinedRetailerLetters.pdf
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.