CAM Guidance Confuses Issue Of FDA Authority, Omits Key Points, Groups Say

Dietary supplement industry trade groups say FDA's draft guidance intended to clarify the agency's regulation of complementary and alternative medicine products in fact confuses the issue further, with one group saying the draft should be withdrawn.

In the draft published Feb. 27 in the Federal Register, FDA's Center for Food Safety and Applied Nutrition said the guidance will explain when a CAM product would be "subject to regulation as a biological product, cosmetic, drug, device, or food (including food additives and dietary supplements)" under the Food, Drug and Cosmetic Act or the Public Health Service Act (¹ 'The Tan Sheet' March 5, 2007, In Brief).

The document - "Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration" - also clarifies that neither the FD&C Act nor the PHS Act exempts CAM products from regulation, CDER said.

In comments submitted April 27, the American Herbal Products Association said, "since publication of the draft guidance, confusion has mounted and continues to grow."

The draft guidance "has had exactly the opposite effect as the agency's expressed intention to address confusion concerning the regulatory status of products used by practitioners of complementary and alternative medicine," AHPA said.

FDA should cease work on the guidance and "simply inform the public" it has been withdrawn, AHPA President Michael McGuffin and General Counsel Anthony L. Young wrote.

However, if FDA continues working on the guidance, AHPA suggested the agency must clarify that how a product is used by a CAM practitioner "does not in any way affect the regulatory status of that same product when it is first manufactured, labeled and distributed."

While other trade groups did not recommend withdrawing the guidance, they also questioned the document's clarity in their comments.

The Council for Responsible Nutrition filed comments questioning the draft's definitions for dietary supplements and drugs.

The draft "creates the misimpression that certain CAM [products] that are properly regulated as dietary supplements should be regulated as drugs," Andrew Shao, Ph.D., CRN's vice president for scientific and regulatory affairs, wrote in May 2 comments.

In comments submitted April 30, the Natural Products Association said the draft marks just the beginning of discussion on FDA's CAM regulation.

"While the draft guidance repeatedly states that additional discussion is outside of the scope of the draft, we believe the additional discussion is exactly what is vital to the guidance, to eliminate further confusion," NPA Vice President for Scientific Affairs, Daniel Fabricant, Ph.D., wrote.

Fabricant said perhaps the "most important" issue the guidance must address is how FDA works with the Federal Trade Commission and the Agriculture Department to regulate CAM products. "These collaborations with FTC and USDA clearly define the regulatory boundaries of the CAM landscape and would be beneficial for industry, regulators and consumers to better understand," he said.

The draft's discussion of FDA's authority over CAM products omits "numerous statutes that are relevant," Fabricant said. As examples, he said the draft's "Drug" and "New Drug" sections omit information on laws concerning good manufacturing practices for drugs, adverse event reporting and when new drug applications or investigational new drug numbers would be applicable to CAM products.

"It would appear much more is needed in the way of detail on the effect of these various statutes," Fabricant wrote.

Additionally, several broader statutes applicable to CAM products are absent from the draft, Fabricant said. The Food Allergen Labeling and Consumer Protection Act of 2004 and Public Health Security and Bioterrorism Preparedness and Response Act of 2002 are applicable and should be included in the guidance, he said.

CRN also pointed out the draft fails to make clear that supplements are not regulated as drugs by omitting portions of the FD&C Act and other laws concerning FDA's regulatory authority.

The draft refers to the FD&C Act to define the term drug, "but does not quote all of the relevant portions of the drug definition that exclude dietary supplements from that term," Shao said.

Similarly, the draft's discussion of dietary supplements does not mention FDA-approved health and qualified health claims, he added. While the FD&C Act says claims that refer to treatment of a disease or condition establish a product as a drug, the Nutrition Education and Food Labeling Act of 1990 allows claims for supplements that refer to disease risk reduction.

Shao added the draft's discussion of probiotic products also creates an impression of supplements being regulated as drugs because FDA says "bacteria used in a probiotic product could make the product a 'biologic product' subject to [the PHS Act]."

However, "due to their presence in conventional foods such as yogurt, probiotics are properly regulated under the [FD&C Act] as a component of food," Shao wrote.

AHPA also recommended adding a specific statement on what industry the guidance addresses. The agency should particularly make clear the guidance is not intended to affect the delivery of health care services, which are regulated by states, AHPA said.

Furthermore, AHPA questioned FDA's use of the term "CAM products" because it "implies that any product used by a CAM practitioner is a 'medicine.'" The term also suggests the agency "is attempting to create both a new legal definition and agency mandate," AHPA said.

In the comments, AHPA reiterated its position that the April 30 deadline was announced in error and May 29 is the actual close of the comment period. AHPA said it "may submit additional comments" by the later date.

Although an FDA spokesperson on May 2 said the agency did not change the deadline from April 30, multiple food and drug law commentators have reported FDA posted an announcement on its Web site indicating the deadline had been changed.

- Malcolm Spicer ([email protected])