By James Gormley, Senior Policy Advisor
The U.S. Food and Drug Administration (FDA) recently issued a Guidance for Industry on “Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration.”
Due to an error in the deadline posted on their website that resulted in confusion among consumers, the FDA extended the deadline for public (and industry) comments to May 29th (Docket No. 2006D-0480, e-mail: fdadockets@oc.fda.gov or fax: 301-827-6870).
According to the FDA in a preamble to the guidance, as the practice of complementary and alternative medicine (CAM) has grown in the U.S., the agency “has seen increased confusion as to whether certain products used in CAM […] are subject to regulation under the Federal Food, Drug and Cosmetic Act […] or the Public Health Service Act.” The FDA claims that it is providing guidance as to when a CAM product is a supplement, a drug or a medical therapy/device.
After reviewing the document, there are many FDA statements of regulatory opinion that, depending on how they are used on Capitol Hill, could open the door to Congressional re-examination of how the agency regulates dietary supplements (including botanicals) and other health products.
The guidance, for instance, offers “raw vegetable juice” as an example. If it is sold as a food, it is a food. However if it is “intended for use” as anything else, such as a treatment regimen, then it would also be subject to regulation as a drug.
How can an agency regulate intent?
Further, the guidance also states that one CAM therapeutic domain is “biologically-based practices.” What is of concern is that the FDA says that this domain “includes, but is not limited to, botanicals, animal-derived extracts, vitamins, minerals, fatty acids, proteins, prebiotics and probiotics, whole diets and ‘functional foods.’ ” Interestingly, this covers the entire supplement category.
Other examples of statements that could be of concern, depending on how they are applied:
• “a botanical product intended for use in treating a disease would generally be regulated as a drug”;
• “probiotics may be regulated as […] drugs […] depending on the product’s intended use”;
• “’functional foods’ may be subject to regulation as […] drugs”; and
• “the bacteria used in a probiotic product could make the product a biologic product subject to the PHS [Public Health Service] Act.”
Although, since 1990 the agency has already well outlined the differences between structure-function claims and treatment claims, the whole focus on intended use and the inappropriate linking of CAM treatment, medical devices and DSHEA-regulated products is both confusing and disturbing.
Consumer health groups, along with some industry observers, are very concerned about the following:
-
The FDA has created a state of regulatory confusion by lumping together different laws, statutes and areas of control regarding foods, dietary supplements, cosmetics, medical devices and CAM therapies;
-
The agency’s opinion as to the scope of its authority is not the same as its actual authority.
-
The FDA should have never issued a guidance encompassing such complex issues without first—not after the fact—soliciting comments from consumers, industry and CAM practitioners.
-
Since the agency did this process backwards and proposed a flawed document, the FDA should withdraw the guidance until it holds proper hearings on all the issues involved.
FDA attorney, Mitchell Weitzman, acting as an FDA spokesperson (who was detailed to the FDA Press Office), called me to discuss the guidance document. He said: “This is a draft guidance—this is not going to change anything. This is not a prelude. This is an explanation of policies that are here today. It doesn’t contain or propose any regulations or requirements. It’s a guidance document, not a law.”
Fine. However, it would be foolish for us to believe that because this is only a guidance that it could not “change anything.” Although this document cannot undo law (i.e., DSHEA), a government agency’s interpretations of policy and law could (1) pave the way for Congress to reconsider DSHEA and (2) allow the FDA to use side doors from the PHS Act and other statutory instruments to decrease free-and-open access to (and information about) efficacious dietary supplements.
