(October 3, 2006, Salt Lake City, Utah) An association of leading companies which manufacture, distribute and assure the quality of dietary supplements is calling on the federal government to take prompt action to assure that illicit street drug “sound-alike” products are not inappropriately marketed as dietary supplements.
Recent media reports have highlighted the marketing of a product called “The Cocaine Energy Drink.” The product contains no narcotics but boasts on its Web site, "Instant Rush. No Crash!"and that drinkers will experience "possible feelings of euphoria".
The United Natural Products Alliance (UNPA) believes that such names and claims are inappropriate and that the federal government has the authority to protect consumers from them. UNPA supports strong enforcement by the FDA of its 2000 guidance which specifically addresses this topic.
In its March 2000 “Guidance for Industry: Street Drug Alternatives,” the Food and Drug Administration (FDA) stated that:
“The Agency has become aware of the proliferation of various products that are being manufactured, marketed, or distributed as alternatives to illicit street drugs (street drug alternatives). FDA is concerned that these products are being abused by individuals, including minors, and pose a potential threat to the public health.
These products are intended to be used for recreational purposes to effect psychological states (e.g., to get high, to promote euphoria, or to induce hallucinations) and have potential for abuse. FDA considers these street drug alternatives to be unapproved new drugs and misbranded drugs under sections 505 and 502 of the Act.
FDA is also aware that some of these street drug alternatives are being marketed as dietary supplements. FDA does not consider street drug alternatives to be dietary supplements. The term dietary supplement as defined in section 201(ff) of the Act means, inter alia, a product "intended to supplement the diet." While the Act does not elaborate on the meaning of this phrase, many congressional findings, set forth in the Dietary Supplement Health and Education Act of 1994, suggest that dietary supplements are intended to be used to augment the diet to promote health and reduce the risk of disease. FDA does not believe that street drug alternatives are intended to be used to augment the diet to promote health or reduce the risk of disease. Moreover, FDA considers the diet to be composed of usual food and drink that may be designed to meet specific nutritional requirements. Illicit street drugs are not food or drink, and neither they, nor alternative street drugs, can be said to supplement the diet. Rather, these products are intended to be used for recreational purposes to effect psychological states (e.g., to get high, to promote euphoria, or to induce hallucinations). Accordingly, street drug alternatives are not intended to supplement the diet and are not dietary supplements. This position is consistent with that set forth at 62 Fed. Reg. 30678, 30699-700 (June 4, 1997).
FDA considers any product that is promoted as a street drug alternative to be an unapproved new drug and a misbranded drug in violation of sections 505 and 502 of the Federal Food, Drug, and Cosmetic Act. Such violations may result in regulatory action, including seizure and injunction.”
The United Natural Products Alliance (UNPA) is an association of leading companies which manufacture, distribute and assure the quality of dietary supplements.