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Supplement Counsel Enforcement Report: August 11, 2015

Enforcement Report,FDA

FDA compliance lawyersIn 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. Every two weeks, we will be sending you an email that gives a brief synopsis of enforcement actions in the dietary supplement space (unless you opt out of our mailing list, which you can do at the bottom of this 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 are the recent enforcement actions taken against purportedly non-compliant dietary supplement companies, and the claims made against them:

FDA
 
On July 13, FDA sent a warning letter to Golden Caviar Skin Care for a plethora of disease claims as well as claiming that all of their products were FDA approved in FDA-approved laboratories. The FDA flagged nine products that the manufacturer labelled with such claims as 1) “Reduce hypertension”, 2) “Great for preventing Osteoporosis”, 3) “Anti-depressant capsules”, 4) “A natural antiseptic and antibacterial”, and many more. FDA alleges that such claims made these products drugs and that they therefore needed FDA approval.

On July 29, the Department of Justice, on behalf of FDA, began pursuing criminal contempt sanctions against Toby McAdam for selling dietary supplements and drugs in violation of two court orders. In 2010, the United States and McAdam entered into a consent decree relating to McAdam’s sale of misbranded and adulterated dietary supplements and drugs. The products displayed unsupported claims to cure cancer, ADD/ADHD, epilepsy and intestinal parasites, among other things. McAdam violated the consent decree, and in 2013 the court found McAdam to be in civil contempt. He was ordered to close his business until the FDA authorized him to return to business. Since then, undercover FDA employees say that they purchased more products from McAdam. The government therefore alleges that McAdam has continued to sell both supplements and drugs, and failed to close down his business and online sites. The government’s criminal contempt complaint asks the court to impose a term of imprisonment and a fine.

On July 31, three dietary supplement companies in Wisconsin entered into a consent decree of permanent injunction that requires them to cease all operations until the FDA determines their GMPs have come into compliance with the law. The court approved the consent decree on August 4. The three firms, Atrium Inc., Aspen Group Inc., and Nutri-Pak of Wisconsin Inc. needed to close their doors because of the following alleged GMP violations: 1) failure to establish identity specifications for each component, 2) failure to set product specifications for the identity, purity, strength, and composition of the finished dietary supplement and limits on contaminants, 3) failure to establish the reliability of a supplier’s certificate of analysis (COA) by confirming results of supplier’s tests or examinations, 4) failure to establish or follow written procedures for the responsibilities of the quality control operations, 5) failure to develop and use complete master manufacturing records (MMRs), and 6) failure to examine if packaging and labels conform to the MMR. The Department of Justice’s complaint follows (not quite on the heels of) a 2012 FDA warning letter sent to the companies for the same violations.  
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.

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