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Picamilon Targeted: FDA Warns Five Companies for Using the Ingredient

Enforcement Report

Here are the recent enforcement actions and claims against purportedly non-compliant dietary supplement companies:

FDA

After months of rumblings about the substance picamilon (see our October 26 Enforcement Report), on November 30 FDA issued five warning letters to dietary supplement companies that sold the ingredient. FDA also created a webpage stating its position on the substance. According to FDA, picamilon does not fit within any of the categories of a “dietary ingredient,” defined by the Food, Drug, and Cosmetic Act as “a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances.” FDA writes that picamilon is therefore not a dietary ingredient, and any supplements declaring the substance as a dietary ingredient are misbranded.

http://www.fda.gov/Food/DietarySupplements/QADietarySupplements/ucm472881.htm

On October 15, FDA warned Seeds of Light Enterprises, Inc. for selling an allegedly unapproved new drug and misbranded drug, in violation of the Food, Drug, and Cosmetic Act. FDA writes that it tested the company’s product and found it contained the pharmaceutical ingredient sibutramine, which was an obesity drug withdrawn from the market in 2010 for safety reasons (an increased risk of heart attack and stroke). According to FDA, products containing sibutramine are excluded from the definition of “dietary supplement.”

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm473779.htm

On November 12, FDA issued a warning letter to Nature’s Mojo, Inc. FDA alleges a number of violations, including disease claims that the company’s products address arthritis, headaches, viruses, fever, blood disorders, depression, psoriasis, and other maladies. Additionally, FDA writes that the products were not made in compliance with Good Manufacturing Practices (GMPs), and notes that while companies can contract out certain manufacturing operations, they cannot contract out their responsibility to ensure that the products they sell are made in accordance with GMPs. Finally, FDA states that the products are misbranded because they don’t bear adequate statements of identity, don’t have supplement facts panels, don’t list serving sizes, and omit several other required label statements.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm473789.htm

DoJ

On December 1, the Department of Justice announced that Toby McAdam pleaded guilty to criminal contempt of court for selling dietary supplements in violation of two court orders. The court sentenced McAdam to four months in prison and ordered him to pay $80,000 in liquidated damages and $4,936.48 in attorney’s fees. In 2010, McAdam entered into a consent decree arising out of his sale of allegedly adulterated and misbranded supplements and drugs. According to court documents, the products bore claims that they could cure cancer and a variety of other diseases. The consent decree barred McAdam from selling supplements and drugs until FDA authorized him to return to business. In 2013, McAdam was held in civil contempt for violating the consent decree by allegedly returning to business without FDA’s authorization. McAdam admitted to continuing to sell both supplements and drugs in violation of the 2010 consent decree and the 2013 order of civil contempt, which resulted in his current prison sentence.

http://www.justice.gov/opa/pr/dietary-supplement-manufacturer-pleads-guilty-criminal-contempt-court

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 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.

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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