The American Herbal Products Association (AHPA) on Sept. 14 submitted comments to the Food and Drug Administration (FDA) regarding proposed amendments to its "Draft Guidance for Industry: Necessity of the Use of Food Categories in Registration of Food Facilities and Updates to Food Categories, as Authorized by the FDA Food Safety Modernization Act."
The draft guidance, issued on Aug. 14, identifies numerous additional human food categories that the agency believes "are appropriate for food facility registration ... as mandatory fields in the food facility registration form." The new food categories identified by FDA include "Dietary Supplement Categories: Proteins, Amino Acids, Fats and Lipid Substances; Animal By-Products and Extracts; Herbals and Botanicals."
AHPA's comments ask FDA to amend its proposed dietary supplement categories by utilizing the already-existing categories that are defined in the Federal Food, Drug, and Cosmetic Act (FFDCA).
AHPA notes that a dietary supplement is defined in the FFDCA as a product that bears or contains one or more of the following dietary ingredients: a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any ingredient described above.
"The dietary supplement industry already has ready familiarity with these categories, and companies in this business can be assumed to currently think of their products as fitting into one or more of these statutory ingredient groups," said Michael McGuffin, AHPA president, in AHPA's comments. "In addition, use of the existing statutory language will ensure that every dietary ingredient that is allowed in a supplement is addressed in the facility registration."
In its comments, AHPA also proposes that FDA revise its facility registration form to ensure that ingredient suppliers are sure to be differentiated from the downstream companies that manufacture or process dietary supplements with their ingredients.
AHPA expressed concern that, unless clarified, the current language may inadvertently and inaccurately indicate to an FDA inspector, for example, that an ingredient supplier is engaged in a dietary supplement operation and would therefore cause the supplier to be wrongly subjected to inspection under 21 CFR § 111.
FDA's draft guidance also recommends additional categories of foods for animal consumption for mandatory disclosure in facility registrations that requires a company that sells a vitamin supplement for pets to check both pet supplement and vitamin categories for one product. While AHPA has no opposition to the addition of these new categories, it noted that this may not be the most efficient way to record a facility's food categories.