No ODI List Biggest NDI Issue for ABC

AUSTIN, TexasIn its comments to FDA regarding the New Dietary Ingredient (NDI) Draft Guidance, the American Botanical Council (ABC) called for the agency to recognize a consolidated list of Old Dietary Ingredients (ODIs) created by industry trade organizations.

ODIs are dietary ingredients sold in the United States market prior to the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), and do not require NDI notifications (NDINs) to be filed with FDA. In the Draft Guidance, FDA said no list of ODIs was available to industry. However, ABC noted lists were developed by the American Herbal Products Association (AHPA), Council for Responsible Nutrition (CRN) and the National Nutritional Foods Association (now the Natural Products Association, NPA). Then, the Utah Natural Products Alliance (now known as the United Natural Products Alliance, UNPA) combined the various association lists to create one that should be considered the official list, according to ABC.

ABC noted this official list of ODIs is dynamic, not static, and also subject to revision with added ingredients, as appropriate. ABC also emphasized the existence of such a list should not be misinterpreted as a legal burden on industry members to prove that ingredients in dietary supplements are ODIs; the council said there is currently no such legal requirement for industry to do so.

ABC suggested the list compiled by UNPA could be reviewed by a special expert advisory committee of representatives from the various herb and dietary supplement trade associations (AHPA, CHPA, CRN, NPA and UNPA) as well as independent nonprofit research, education, and/or standard-setting organizations. The panel would evaluate any ambiguous entries.

Other issues ABC raised regarding the Draft Guidance include:

Premarket approvalABC said the document as a whole makes is appear FDA is trying to create a non-statutory pre-market approval system for dietary supplements, which is not required per DSHEA.

Supplement vs. ingredient notificationABC said its understanding of DSHEA is that NDINs are required for new ingredients, not each new supplement with an NDI as it outlined in the Draft Guidance. Further, ABC said combining ODIs does not create a NDI, and should not require a notification.

SolventsThe Draft Guidance lists several solvents (water and ethanol) that would not trigger NDIs, but ABC said the list was too limited.  "ABC believes the emphasis for the matter of determining whether an NDI notification should be made should focus on the safety (which implicates chemical profile) of the resulting extract, not the process by which it is made nor the solvent(s) that is/are used in the extraction process," according to the submitted comments. ABC added various solvents not noted in the Draft Guidance were marketed before the passage of DSHEA, and therefore should not need NDINs.

Further, ABC said the expert committee created to review the ODI list would also review the issue of chemically altered" to determine if pre-DSHEA data supports the use of a specific solvents in the production of a botanical extract or other dietary ingredient.

Synthetic botanicalsThe Draft Guidance said a synthetic copy of a botanical constituent is not a dietary ingredient. ABC said in principle, it believes botanical extracts should be naturally derived, but some instances require for nature-identical synthetic materials, and these should be allowed in dietary supplements.  "Again, the focus should be about the safety of the ingredient, with less emphasis given to the process by which it is produced," the comments said.