The trade association is the latest to join public discourse on FDA's draft "Guidance for industry on complementary and alternative medicine products and their regulation by the food and drug administration". In February, FDA opened a comment period and announced the availability of the guidance, asserting it is just a point of reference and not in fact regulation.

But the dietary supplement industry has voiced its fear that the document will engender confusion about which products apply, and who in fact regulates them.

"…the draft guidance creates the misinterpretation that certain CAM products that are properly regulated as dietary supplements should be regulated as drugs," wrote Andrew Shao, CRN vice-president of scientific and regulatory affairs, in the comment addressed to FDA.

In the draft guidance, FDA uses the NCCAM (National Center for Complementary and Alternative Medicine) definition for CAM: "a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine."

Of primary concern to CRN is the omission of qualifying language relating to how dietary supplements are excluded from being a "drug" as defined in the Federal Food, Drug, and Cosmetic Act (FD&CA).

For instance, says CRN, the guidance's definition of a drug excludes section 403 (r) of the Act, which outlines how a food or dietary supplement with an FDA-approved health or structure/function claim is not a drug.

In addition, CRN urges that the draft guidance include information on FDA-approved health claims and qualified health claims in its discussion of dietary supplements. Health claims are playing an increasingly crucial role for dietary supplement marketing and research.

Under FD&CA, use of claims implies a product is a drug. However, the Nutrition Labeling and Education Act (NLEA) made labeling of packaged foods compulsory in 1993 and paved the way for label claims that relating certain foods to disease risk reduction.

CRN also finds fault with FDA's supposition that bacteria in a probiotic product could run it into the category of a 'biologic product' subject to the Public Health Service Act. The trade association asserts probiotics are food components subject to FD&CA.

The American Herbal Products Association (AHPA) recently called on FDA to withdraw the CAM draft guidance - stating it will only cause misunderstandings in the industry.

"The effect that the guidance has had on industry to date is to cause significant confusion," AHPA president Michael McGuffin told NutraIngredients-USA recently. "Unless FDA either withdraws it or corrects it and identifies the failure that it is attempting to address, it will continue to have that effect."

AHPA said there is great potential for confusion surrounding what the guidance is for, what products it refers to, and cited it as an example of federal resources badly spent.