In comments submitted to the Food and Drug Administration (FDA), the American Herbal Products Association (AHPA) expressed concern that the latest revision of draft guidance for New Dietary Ingredients (NDIs) is unlikely to achieve FDA's stated goals and is contrary to the intent of the law in numerous areas.
FDA issued on August 12, 2016 a revised draft guidance for industry titled, "Dietary Supplements: New Dietary Ingredient Notifications and Related Issues." This revised draft guidance replaced draft guidance of the same name initially issued by FDA in July 2011. In the 2016 revised draft guidance, FDA identifies two goals: improving the rate of compliance with the NDI notification requirement; and improving the quality of notifications.
"AHPA recognizes some improvements in the revised draft guidance compared to the 2011 draft guidance," said AHPA President Michael McGuffin. "However, AHPA continues to have some of the same concerns about the content of the 2016 revised draft guidance and has additional concerns related to revisions in the 2016 revised draft guidance."
AHPA notes in its comments that the 2016 draft NDI guidance would unnecessarily burden the dietary supplement industry and dietary supplement consumers and is wholly inconsistent with the economic and small business analyses prepared in connection with the NDI notification regulations in 21 CFR § 190.6.
In order to address these issues, better achieve FDA's stated goals and align the guidance with the intent of the law, AHPA recommends FDA revise the draft guidance to:
- Refrain from declaring or implying that each dietary supplement that contains an NDI requires a separate NDI notification and encourage companies selling new dietary ingredients to include in notifications very broad descriptions of the many dietary supplements that are expected to contain the subject NDI;
- Ensure any list of FDA-recognized pre-DSHEA (Dietary Supplement Health and Education Act) dietary ingredients includes all ingredients that are very likely to have been marketed in the U.S. prior to October 15, 1994, as well as traditional preparations of all such ingredients. It shouldn't be limited to the actual ingredients proven to be sold at that time, but should be broadly described;
- Clearly state that manufacturers and distributors of dietary ingredients and dietary supplements are not required to have documentation in their files proving that an old dietary ingredient (ODI) was marketed prior to DSHEA;
- Specify that changes to manufacturing processes or products specification of an existing ingredient do not automatically create an NDI;
- Not require an NDI notification when processing or specification modifications lower impurities;
- Clarify that the "chemical alteration" standard is not limited to conventional foods, but applies to dietary ingredients as well;
- Specify that conventional foods and other ingestible substances marketed within the U.S. prior to DSHEA are not NDIs unless they are chemically altered;
- Acknowledge that changes inherent in traditional food manufacturing processes are not "chemical alteration";
- Acknowledge that supercritical fluid extracts were marketed as food ingredients prior to DSHEA;
- Implement the use of master files as an option;
- Not imply that shelf life dating is required, and not impose impractical or unfeasible requirements with respect to the identification or presence of "degradants" in chemically complex ingredients;
- Not require new dietary ingredients to meet safety standards higher than those that existing foods would meet, when interpreting toxicological data;
- Clarify various definitions and remove a number of inaccurate or inappropriate statements.