naturopathydigest.com -- Is More Regulation Better?

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Is More Regulation Better?

Speculation abounds regarding the intent behind and potential consequences of the Food and Drug Administration's proposed regulation of CAM products.

By Tina Beychok, Associate Editor

The comment period for a set of U.S. Food and Drug Administration (FDA) draft guidelines to regulate complementary and alternative medicine comes to an end on May 29, 2007. The final version is intended to serve as a guideline for whether CAM products are subject to regulation under the Federal Food, Drug and Cosmetic Act (the "Act") or the Public Health Service Act ("PHS Act"). This issue has become even more important with the exponential rise of CAM use among Americans.
As currently written, the guidelines consist of two fundamental points:
"First, depending on the CAM therapy or practice, a product used in a CAM therapy or practice may be subject to regulation as a biological product, cosmetic, drug, device, or food (including food additives and dietary supplements) under the Act or the PHS Act. ... Second, neither the Act nor the PHS Act exempts CAM products from regulation."
The heart of the controversy over the guidelines stems from what could be considered the intended use of the product in question. For example:
"[A] botanical product intended for use in treating a disease would generally be regulated as a drug; a botanical product taken by mouth, labeled as a dietary supplement, and intended for use to affect the structure or function of the body would generally be regulated as a dietary supplement; a raw or dried botanical intended for use as an ingredient to flavor food would generally be regulated as a food or as a food additive, depending on whether the botanical was generally recognized as safe for its intended use in food; and a lotion containing botanical ingredients and intended for use in moisturizing the skin would generally be regulated as a cosmetic."
To put it in simpler terms: If a vegetable juice is marketed to promote "general health and wellness," it would be subject to FDA regulations that apply to food. However, if it is marketed as part of a treatment regimen for a specific disease (such as colon cancer), it then becomes subject to FDA regulations that apply to drugs.
FDA regulations for drugs become particularly problematic in regard to CAM products such as herbs, because the product could be considered subject to "new drug" regulations "unless it is generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. ‘New drug' status triggers the Act's requirements for premarket review and approval by FDA."
As expected, the proposed regulations have caused considerable dialogue within the health care community. Karen Howard, executive director of the American Association of Naturopathic Physicians, stated the following in a memo to members, dated April 17, 2007:
Considerable confusion and speculation has swirled around the FDA's release of these proposed guidelines. Explanations range from conspiracy theorists that it is an inside play by Big Pharma companies to more mundane descriptions by industry insiders that it is a good sign that the agency is (finally) beginning to codify the results of the many discussions that have taken place over the past ten years. Regardless of the impetus behind this, something of its kind is clearly needed.

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. Nonetheless, we recognize that this document will serve to anchor key concepts and definitions, and be a reference for upcoming policy discussions. So, 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. 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.

Regardless of whether these new regulations represent a foot in the door for naturopathic medicine to gain true legitimacy, or a crackdown on the profession and the entire non-allopathic health care industry, there is little that can be done until the FDA sifts through all of the comments and issues a final guideline. More to come.
References

Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration. Draft Guidance issued by the U.S. Department of Health and Human Services, Food and Drug Administration, December 2006.
Memorandum to the Naturopathic Community. American Association of Naturopathic Physicians, April 17, 2007.