07.01.07
Following on the heels of the American Herbal Products Association (AHPA), Silver Spring, MD, The United Natural Products Alliance (UNPA), Salt Lake City, UT, has decided to respond to FDA’s “Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.” One May 29th the organization filed public comments about this guidance, first asking why FDA would issue such a guidance in the first place since there is no regulatory class called “CAM products.” “The term itself, ‘CAM Products,’ connotes a medicinal or therapeutic intent with respect to any foods, dietary supplements, cosmetics or other products used in CAM practice. We are concerned that the agency is, through this Guidance, reinterpreting existing law and in particular key provisions of the Dietary Supplement Health & Education Act (DSHEA),” UNPA said. “Our view is reinforced by FDA’s use of the term ‘biologically based practices’ to include, but not be limited to: botanicals, animal-derived extracts, vitamins, minerals, fatty acids, amino acids, protein, prebiotics, probiotics, whole diets and ‘functional foods’ and that the intended use of such substances is central to their regulation.” In other words, UNPA says FDA now takes the view that the regulatory status of a dietary supplement is likely to be determined by the actual or intended use of a dietary supplement/CAM product by a CAM practitioner. “This, we believe, is beyond the scope of FDA’s jurisdiction.” UNPA also asserts that FDA now seems to believe that sales of lawfully labeled dietary supplements to health professionals infers that such products are biologically based products used primarily to treat, cure, prevent or mitigate disease by virtue of their use by a CAM practitioner. “This view, if intended by FDA,” the organization said, “is both incorrect, inappropriate and in contradiction of current law and industry practice.”
Of equal, if not greater concern to UNPA is the agency’s comments with regard to food additives. In its comments, the organization quoted from page 10 of FDA’s guidance, which said: To illustrate how a CAM product might involve “food additives” under Section 201(s) of the ACT, some CAM practices involve dietary modifications where substances such as botanicals or enzymes are added to foods in the diet. If a manufacturer adds such a substance to a food, the substance may fall within the “food additive” definition at Section 201(s) of the Act. “We are baffled by this statement,” UNPA said. “Does the agency mean that a CAM practitioner is creating an unapproved illegal food additive if they blend up a healthy shake containing botanicals, enzymes or other dietary ingredients for patients in their office or dispensary?”
The UNPA believes this draft Guidance has and will continue to provoke confusion, controversy and uncertainty with respect to the regulation of dietary supplements when used by CAM practitioners. Accordingly, the organization respectfully requested that FDA permanently withdraw this draft Guidance.
Of equal, if not greater concern to UNPA is the agency’s comments with regard to food additives. In its comments, the organization quoted from page 10 of FDA’s guidance, which said: To illustrate how a CAM product might involve “food additives” under Section 201(s) of the ACT, some CAM practices involve dietary modifications where substances such as botanicals or enzymes are added to foods in the diet. If a manufacturer adds such a substance to a food, the substance may fall within the “food additive” definition at Section 201(s) of the Act. “We are baffled by this statement,” UNPA said. “Does the agency mean that a CAM practitioner is creating an unapproved illegal food additive if they blend up a healthy shake containing botanicals, enzymes or other dietary ingredients for patients in their office or dispensary?”
The UNPA believes this draft Guidance has and will continue to provoke confusion, controversy and uncertainty with respect to the regulation of dietary supplements when used by CAM practitioners. Accordingly, the organization respectfully requested that FDA permanently withdraw this draft Guidance.