Dietary Supplement Claims at POS: Roles & Responsibilities

by Duffy MacKay, N.D.

The mainstream media coverage of the May Senate Hearing on Capitol Hill gave the incorrect impression no rules exists when it comes to marketing dietary supplements. But in fact, as with all industries, dietary supplement advertising claims are required by law to be truthful, not misleading and substantiated with adequate evidence. Further, the Dietary Supplement Health and Education Act (DSHEA) established general boundaries on permissible claims for supplements. Claims to treat, prevent or cure a disease are not permitted, and under the law, such claims render the product an unapproved drug, subject to various civil and criminal penalties.

The Government Accountability Office (GAO) presented a report at this Senate Hearing, accompanied by secret shopper audiotapes, to highlight examples of sales personnel demonstrating a lack of either awareness or understanding in abiding by the regulatory framework for supplement claims. While these examples are not the norm, they reinforce the need for the industry to be cognizant of overlapping responsibilities between manufacturers and retailers.

So what happens when a dietary supplement seller engages in deceptive or questionable marketing practices? What if an unlicensed sales rep provides a consumer with what amounts to medical advice? Questions abound about who should be held responsible for claims being made about dietary supplements at the point of sale (POS). But the law dictates a sellers statements about a dietary supplement could result in the product becoming misbranded or deemed an unapproved new drug. In addition, a seller who gives advice about treating a disease is practicing medicine without a license and is thus subject to prosecution under many states laws. A word of caution: even when a manufacturer does its due diligence to ensure a dietary supplement label and the associated marketing materials are fully compliant with all government regulations, there is still the risk that its product becomes misbranded at the POS if retailers are not mindful of the law.

Determining who is responsible for bogus sales claims is not crystal clear. Previous dietary supplement cases raise some intriguing questions about risk and responsibility. A 2007 National Advertising Division (NAD) case (#4725, Irwin Naturals Green Tea Fat Burner) concluded, When an advertiser receives notice that inaccurate and unsubstantiated claims about its product are being made by third parties (e.g., vendors or distributors), the advertiser has an obligation to notify them of the errors and take steps to ensure that the claims are modified or discontinued.  FTC has also levied fines on national pharmacy chains and their suppliers of more than $6 million for deceptive dietary supplement marketing claims that simply mimicked the claims made by a national brand. The FTC concluded in one case, involving the supplier of Rite Aids product, This settlement is one cold remedy that works.

Dietary supplements are an integral part of more than 150 million Americans healthy habits. Misleading or deceptive marketing practices from a very small minority damage the reputation of the responsible industry. In order for the dietary supplement industry to thrive, it is imperative that all supplement stakeholders, including manufacturers and sellers, do their part to comply with the extensive regulatory framework governing dietary supplements. Fortunately, many retailers, direct sellers and manufacturers have comprehensive internal training and education programs to assure compliance among sales associates. However, the findings of the recent GAO investigation suggest the industry needs to step up its efforts. It does not matter where in the supply chain misleading claims are originated, it just matters that they end.

Duffy MacKay, N.D., is the vice president, scientific and regulatory affairs, at the Council for Responsible Nutrition (CRN).