Supplement Promos To Health Professionals Merit More Flexibility – AHPA

Dietary supplement promotional speech targeted to health care practitioners should be allowed to contain substantiated disease treatment claims, the American Herbal Products Association maintains.

The "nature of the audience for commercial speech (learned intermediaries or consumers) is an important factor to be considered with respect to the nature of the administration record necessary to support a commercial speech regulation," AHPA says in Sept. 13 comments to FDA.

There should be "greater deference paid by FDA as a regulator where commercial information is communicated to 'learned intermediaries' than to consumers," the association asserts.

"Truthful and not misleading communications about the conclusions regarding botanicals in either literature or [foreign] government monographs to learned intermediaries...should be viewed by FDA through the prism of the learned intermediary as opposed to the prism of ordinary consumer," AHPA adds.

Furthermore, although the Dietary Supplement Health & Education Act prohibits disease claims on labeling, it is "nonetheless lawful under the [FD&C Act] to advertise such products for use in the treatment of diseases so long as such advertising is not false or misleading or does not constitute a deceptive act or practice under the Federal Trade Commission Act," AHPA contends.

The group points to supplement ingredients shown to be effective in lowering cholesterol as an example.

Under FDA's implementation of DSHEA, supplements are restricted to claims such as "Helps support healthy cholesterol levels that are already within the normal range." However, AHPA notes a number of ingredients have been demonstrated to lower cholesterol in "adequate and well-controlled clinical trials."

Use of clinical data to support supplement claims in advertising "should not cause FDA to take regulatory action under theories that the advertising falls under some broad interpretation of the definition of labeling or that it evidences an intent by the company making the claim to market the product as a drug," AHPA says.

The trade group submitted its comments in response to FDA's May 16 Federal Register notice asking for feedback on the agency's application of the First Amendment (¹ (Also see "Supplement Claims Rules v. Drugs, Foods: FDA Opens Free Speech Debate" - Pink Sheet, 20 May, 2002.), p. 6).

AHPA also applies a First Amendment argument to its request that FDA allow a moratorium on the relabeling of Siberian ginseng as eleuthero, as required under the Farm Bill (² (Also see "FDA Ginseng Labeling Enforcement Stressed In House Ag Approps Bill" - Pink Sheet, 15 Jul, 2002.), p. 15).

The stay is warranted because the bill "does not give companies a reasonable time to come into compliance," the group argues, adding the legislation "does not pass muster under the Supreme Court's decision in Thompson v. Western States Medical Center."

Additionally, AHPA joins other industry groups in urging FDA to allow structure/function claims on food labeling; in separate comments, the Consumer Healthcare Products Association reiterated its call for equal labeling allowances for supplements and foods that contain the same nutrients (³ (Also see "OTC Drug Review’s Constitutionality Questioned By CHPA" - Pink Sheet, 16 Sep, 2002.), p. 3).

The National Nutritional Foods Association presents a similar position in Sept. 13 comments, saying the "arbitrary restriction on the use of structure/function claims on non-nutritive ingredients in foods stands in the way of the First Amendment goal of communicating truthful non-misleading information to consumers."

"It makes no sense to allow ingredients to be present in dietary supplements with appropriate structure/function claims and not allow the same claims to be used for the same ingredients in foods," NNFA maintains.

NNFA also argues FDA's broad definition of "disease" in its structure/function claims final rule is inconsistent with the "goals of DSHEA, consumer interest or the First Amendment principles of commercial speech."

The reg, published in January 2000, "should be revised to allow...companies to communicate accurate information about prevention and health maintenance to consumers even if this means that dietary supplements mention a condition such as a cold," NNFA says.

Finally, NNFA contends FDA's limitation of nutrient content phrases such as "good source of" and "contain" solely to vitamins and minerals which have Recommended Daily Intake levels is "unduly restrictive."

Since the majority of supplements used by consumers contain non-vitamin/mineral ingredients that do not have RDIs, NNFA maintains these nutrient content claims should be allowed for all ingredients, perhaps with an accompanying disclaimer noting there is "no RDI for the ingredient."