"Traditional use" and regulatory change in the arena of natural health products.

• Author: Kurata, Vincent
• Position: Canada

Over the last three years, the federal government has been pressured to loosen advertising restrictions on Natural Health Products (NHPs). Such pressure has originated both externally (consumer petitions and the industry lobby) and internally (private member's bills). Government responded to this pressure by proposing new NHP regulations that would see these products exempted from the "health claim prohibition" effected by s. 3 of the Food and Drugs Act (FDA).

The health claim prohibition has functioned, in the past, to prevent NHP manufacturers from advertising their goods as treatments, cures or preventatives for a list of approximately 40 serious diseases / conditions set out in the FDA. With respect to diseases not covered by the health claim prohibition, NHP manufacturers have been allowed to advertise their goods as cures, treatments or preventatives provided that they could prove the safety and efficacy of the product with scientific data. The "traditional use exception" has functioned as a regulatory loophole of sorts, allowing NHP manufacturers to advertise their goods as treatments, cures or preventatives for ailments excepted from the health claim prohibition, provided that they could demonstrate that the NHP has been "traditionally used" as a treatment, cure or preventative for the ailment in question.

The exception has been harshly criticized by groups such as the Centre for Science in the Public Interest because it has allowed NHP manufacturers to make health claims respecting NHPs even when the effectiveness of the product has been disproved scientifically. Moreover, Health Canada has proposed a regulatory amendment that will completely exempt NHPs from the health claim prohibition, thus expanding the scope of application attendant to the traditional use exception.

This presentation discussed the legal nuances of the traditional use exception from a critical perspective, and advanced arguments opposing prospective regulatory changes that would provide NHP manufacturers greater leeway in advertising. These arguments were threefold. First, allowing health claims based only on traditional use is an invitation for charlatanry. Consumers rely on health claims when purchasing NHPs, and leaving them unregulated will result in economic exploitation. David Schardt has highlighted many ridiculous health claims in his article, "Herbal Roulette: Does it work? Is it safe? Don't ask the government." (1) For example, Schardt notes that...