Increasing Regulatory Scrutiny of Dietary Supplement Manufacturers and Marketers

The Food and Drug Administration (FDA) and Federal Trade Commission (FTC) share jurisdiction over consumer health products such as dietary supplements. In recent actions against dietary supplement marketers and manufacturers both agencies have demonstrated that they intend to employ their enforcement powers. These actions highlight the need for those involved with such products to ensure that the products are manufactured in accordance with current good manufacturing practices, are safe and not adulterated, and that any health claims are properly substantiated.

FDA's "Beware of Fraudulent 'Dietary Supplements'" Alert

The Food and Drug Administration (FDA) recently warned consumers to "beware of fraudulent dietary supplements," as it continues to crackdown on infractions from incorrect labeling, failure to maintain good manufacturing practices ("cGMPs"), and filing of adverse event reports (AER). The FDA warning comes after the agency found that 300 products promoting weight loss, bodybuilding, and sexual enhancement products were found to be tainted with hidden or improperly labeled ingredients. The FDA cautioned that many of these products contained unapproved prescription ingredients that exceeded approved standard quantities. Indeed, the government has brought criminal actions against manufacturers who have been found to have manufactured tainted products.

Challenge To FDA cGMP Regulations Rejected

On April 6, 2011, the United States District Court for the District of Columbia granted summary judgment for the FDA in a case challenging the dietary supplement good manufacturing practice ("GMP") regulations -- Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements. In the decision, Alliance for Natural Health U.S. v. Sebelius, the court rejected plaintiffs' challenges to the FDA's GMP regulations regarding dietary supplements. The court found that the FDA did not exceed its statutory authority to issue the regulations as well as plaintiff's argument that the regulations were unconstitutionally vague. Thus, the court declined to strike the challenged regulations which remain in effect.

Recent FTC Actions

The FTC also continues to be active against dietary supplement marketers. Two recent actions highlight the agency's enforcement priorities. For example, the FTC announced that it had finalized a Consent Order settling charges that NBTY, Inc. and two subsidiaries, NatureSmart LLC and Rexall Sundown, Inc alleging that the companies made false and unsupported claims that their Disney and Marvel Heroes line of children's multivitamins contained a significant amount of DHA (docosahexaenoic acid, an Omega-3 fatty acid) and promoted healthy brain and eye development in children. The settlement: bars NBTY, NatureSmart, and Rexall Sundown from misrepresenting the amount of any ingredient contained in any product; bars them from misrepresenting that any ingredient, including DHA, promotes brain or eye health or provides any other health benefit, unless the claim is true and backed by competent and reliable scientific evidence; specifies that any violations could subject the NBTY, NatureSmart, and Rexall Sundown to civil penalties; and requires defendants to pay $2.1 million in refunds to purchasers of the challenged Disney and Marvel multivitamins.

The FTC also announced that it was proceeding with a contempt action against Daniel Chapter One and its principal, James Feijo, for allegedly violating a prior FTC Order. The civil penalty action also seeks a preliminary injunction to stop the company and Feijo from continuing to make allegedly deceptive claims on the company's daily radio show and website about the purported cancer-fighting properties of its supplements, and to require the company and Feijo to send a notice to purchasers explaining the FTC's findings that the advertisements were unsubstantiated.

The FTC alleged that Daniel Chapter One and Feijo allegedly deceptively advertised that four dietary supplements - BioShark, 7 Herb Formula, GDU, and BioMixx - inhibit tumor formation or growth, eliminate tumors, treat or cure cancer, or heal the effects of radiation or chemotherapy. An administrative trial took place in April 2009, and the Administrative Law Judge found that the defendants were making deceptive claims. The Commission upheld the ALJ's initial decision in December 2009. As part of the FTC Order issued in December 2009, Daniel Chapter One and Feijo were required to stop making the deceptive claims, and to send a notice to purchasers explaining the FTC's findings that advertising claims for the supplements were unsubstantiated, and that consumers should consult with health care providers before using any herbal product, to ensure that all aspects of their medical treatment work together.

In March 2010, DCO and Feijo petitioned the U.S. Court of Appeals for the District of Columbia Circuit to review the FTC ruling that the defendants were making deceptive claims. In December 2010, the appellate court ruled in favor of the FTC. The Court of Appeals found that the Commission did not exceed its authority by requiring a reasonable basis for the defendants' claims, and that the defendants' legal arguments based on First Amendment were "wholly without merit."

Take Away:

As the FDA and FTC continue to crack down on dietary supplement manufacturers and marketers, companies involved in their distribution and marketing must work to ensure that the products are safe, properly manufactured in accordance with cGMPs, and that the claims are reasonably substantiated based on competent and reliable scientific support.

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