Dietary supplements and nutraceuticals (Proceedings)


Dietary supplements and nutraceuticals (Proceedings)

Apr 01, 2008

Passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA) dramatically changed the market for both human and pet supplement products. This is because while the Act doesn't legally apply to products intended for animals, the massive influx of new and different products in the human supplement market as a result of DSHEA has not unexpectedly crossed over to products for pets. However, that places many dietary supplement and so-called "nutraceutical" products for pets in a precarious regulatory position.

Effects of DSHEA

Basically, DSHEA added a new term, "dietary supplement," to the regulatory lexicon to describe a product that, while under the umbrella of "foods," was granted leeway in terms of both ingredients and claims not allowed for foods prior to passage of the Act. As passed by Congress, those products containing vitamins, minerals and other essential nutrients, as well as herb and botanicals, "metabolites," and other substances were no longer subject to the requirements for all food ingredients to be GRAS (generally recognized as safe), approved food additives, or otherwise sanctioned for their intended use in food. Historically, the US Food & Drug Administration (FDA) could take action against a product containing an ingredient that did not meet the above requirements as an "adulterated food" by virtue of the presence of an "unapproved food additive." However, DSHEA says that as long as the product meets the statutory definition of a "dietary supplement," and otherwise complies with the Act (e.g., in pill, powder, liquid, bar or other non-conventional food form, represented as a "supplement" and not represented as a meal or diet replacement), that regulatory remedy did not apply. Essentially, it shifted the burden from a manufacturer having to prove an ingredient was safe (e.g., via a Food Additive Petition) before the product could be on the market to FDA having to prove an ingredient was unsafe before it could be removed from the market. To date, only one dietary supplement ingredient has been codified in the regulations as unsafe by FDA, namely ephedra, AKA the Chinese herb ma huang.

The nature and extent of acceptable claims on dietary supplements has also been affected by DSHEA. Historically, any claim that explicitly or implicitly indicated use for the treatment or prevention of disease, or to affect the structure or function of the body beyond traditional nutritional precepts was considered a "drug claim." Further, since the product had not undergone testing and submission of data as required for approval as a drug, it could be subject to enforcement action as an "adulterated drug." This still holds true for dietary supplements that make disease treatment/prevention claims. However, DSHEA allows for statements of "support," wherein claims for an effect not related to traditional nutritive value of the ingredient can be made. For example, an herbal supplement containing saw palmetto may make a claim akin to "helps support healthy prostate function," even though its purported effect does not appear to be through provision of a vitamin, mineral, or other recognized essential nutrient. However, "cures benign prostatic hypertrophy" or "helps urinary flow problems" would not be acceptable. Also, "support" claims must be accompanied by the disclaimer "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.''

These provisions under DSHEA do not apply to human foods in conventional form. Thus, while an herbal product in capsule form containing echinacea may be sold to "help support a healthy immune system" (for the implicit but undeclared effect on the treatment or prevention of colds), a similar statement on a chicken soup product would not be tolerated. In fact, unless the herb was determined to be GRAS or approved as a food additive, its inclusion in the chicken soup product could cause the soup to be subject to enforcement action.