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NPA clarifies FDA draft guidance on CAM products

Put down the pitchforks. Douse the torches. Don't storm the Bastille—or, in this case, the Food and Drug Administration—over a draft document that addresses the agency's current attitude toward complementary and alternative medicine products.

That's the message coming from at least one major organization that represents the natural products industry. The Natural Production Association issued a statement to reassure its nearly 10,000 members after some raised concerns that the FDA draft guidance document for CAM products would classify all dietary supplements as drugs. Some e-mails and online blogs have gone even further, spinning a conspiracy theory that big business pharmaceuticals are trying to slam the coffin lid on the natural products industry.

"This is untrue and the document in question should not be cause for alarm," according the statement from NPA. "First, a 'guidance' document is by definition not legally binding and does not change or create laws or regulations. [They] are usually issued to help explain how a law or laws are applied. In this case, the guidance clarifies how products used in CAM, such as foods and dietary supplements, are regulated under different provisions or statutes depending on their intended use and claims. Whether finalized or not, the draft guidance will not change current laws and regulations, such as the Dietary Supplement Health and Education Act."

Specifically, the draft guidance (docket no. 2006D-0480) states that it seeks to remove confusion as to when certain products used in CAM are subject to regulation under the Federal Food, Drug and Cosmetic Act or the Public Health Service Act. The document says that the increase in practice of alternative medicine, as well as the growth of imported CAM products, prompted the FDA to publish a notice concerning when a CAM product may be subject to certain regulations.

"It's just a recap of the laws that are already in existence," explained Daniel Fabricant, vice president of scientific affairs at NPA, dismissing theories that the document is a means to undermine the industry. "The issue is just a failure to understand what the guidance is about. If anything, I think there's an overall lack of information in it."

The 14-page FDA draft guidance document, by definition, is nonbinding and does not make any regulatory changes, according to Philip Chao, senior scientific adviser at the FDA's Office of Policy and Planning. "It's just a statement on the thinking of a particular document," he said.

For a pdf of the draft guidance document, click here.
The draft guidance can be found online, and the FDA is taking comments on the document through April 30 (Deadline for public comments has been extended until May 29). In part, the document defines the four categories or domains of CAM therapy—biological-based therapies, energy therapies, manipulative and body-based methods, and mind-body medicine—and provides examples when various regulations might apply. For instance, if a dietary supplement makes claim to treat a specific disease, it would be regulated as a drug.

That's the case now, Fabricant pointed out. "There is nothing new in this guidance. It's their current thinking. It's just a rehashing of that current thinking."

But government watchdog groups like the American Association for Health Freedom, based in Arlington, Va., don't view the draft guidance as entirely innocuous. While the AAHF agrees that "much of the regulation proposed in the document has already been claimed by the FDA," it says it has several major concerns, according to the nonprofit organization's Web site.

The biggest of those concerns involve what is says are the FDA's attempt to broaden the definition of "health claim" and the agency's apparent desire to pre-empt the states in the regulation of health care issues.

Jim Fussell, issues manager for AAHF and its educational arm, the Health Freedom Foundation, said the guidance document makes sweeping statements that the natural products industry should not ignore. For example, Fussell said functional foods, such as certain vegetable and fruit juices, have always made some nutritional and health claims. He said the FDA document indicates these claims would now classify these products as drugs, requiring expensive pre-market applications and research before they could be put on store shelves.

"It seems like the FDA wants to expand their authority into an area that would reduce innovation in one of the most promising areas of natural products," he said. "The FDA is saying that any health claim is going to bring it into their purview, and that's real problematic in our viewpoint."

Fussell agreed that there has been a disproportionate amount of gnashing of teeth over the FDA draft guidance, but said it follows the same political pattern of behavior the FDA has shown over the last six years concerning the natural products industry. "It's one of the larger and more important bricks in the wall of regulation that they're trying to build, but it's not the only one," he said.

Enquiries to Bastyr University, a natural medicine academy in Seattle, for comments on the FDA guidance document were referred to the American Association of Naturopathic Physicians. Karen Howard, executive director of the AANP, issued a statement that said guidance from the FDA of this nature is needed whatever the impetus behind it.

"It is our position that this guidance is designed to serve as an advisory document and constitutes no immediate or direct threat to CAM products of CAM practitioners," Howard wrote. "Nonetheless, we recognize that this document will serve to anchor key concepts and definitions, and be a reference for upcoming policy discussions."

All three organizations indicated they would submit comments to the FDA. Fussell said the AAHF is asking the FDA to extend the comment deadline by 90 days, and is encouraging citizens to contact congressional representatives in addition to submitting comments to the FDA.

Fabricant said the NPA would provide comments to the FDA regarding the guidance document by the April 30 deadline. While it was still drafting its response at the time of this report, the crux of the NPA's message to the federal agency is that the FDA should better define the scope of the regulations. Fabricant said that if the FDA truly wants to remove the growing confusion created by an expanding market, it should be prepared to provide more guidelines.

"If people are confused, they don't need less information, they need more information," he said. "They need a little more handholding. Not in a bad way, but to get clearer on some of these issues. … It's kind of a good sign, and I wish people would take it as such, that more and more Americans are really taking their own health care into their own hands."

Howard also previewed what AANP proposed to say to the FDA regarding the draft document.

"… Our submittal to the FDA will pay particular attention to the precision of their terms, propose additional key concepts, and advocate for more explicit recognition of Naturopathic Medicine," she wrote. "We also see this as an opportunity to deepen our relationship will the FDA, and to embed our position in the ongoing processes that will determine what constitutes CAM research and full implementation of the Dietary Supplement Health and Education Act."

Chao said there is no timeline as to when the FDA will publish a final guidance. Comments were still coming in as the deadline approached. "I know we have several thousand to go through," he said.

Hard copy comments to the draft guidance can be sent to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.1061, Rockville, MD 20852. Comments can also be submitted online at

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