AHPA: NDI guidance should be withdrawn, rewritten

The American Herbal Products Association (AHPA) called for FDA to withdraw the New Dietary Ingredient (NDI) Draft Guidance and issue a  new guidance that it is consistent with the Dietary Supplement Health and Education Act of 1994 (DSHEA).

In comment filed with the agency, APHA wrote, "Instead of providing guidance regarding DSHEA's NDI notification provision, as directed by section 113(b) of the Food Safety Modernization Act (FSMA), the draft guidance seeks to erect extra-legal barriers to market entry, impose food additive- and pharmaceutical-type evaluative criteria, require multiple NDI notifications for dietary supplements beyond those required by law, and transform the legal requirements for marketing of dietary supplements that contain NDIs from the notification process described under law to an FDA approval process."

Michael McGuffin, president, AHPA, noted, "Let me be clear; AHPA has called for FDA to remove the guidance. Nonetheless, we believe there would be a benefit for FDA to offer guidance that doesn't rewrite the law and that companies that do have NDIs would find useful."

 AHPA said that instead of facilitating compliance with the NDI provision of DSHEA, the Draft Guidance would, if implemented as written, change the rules that have been in place for the last 17 years and significantly increase the burden on the supplement industry far beyond the intent of Congress with no concomitant benefit for consumers.

 AHPA's top concerns, as listed in its comments, include:

Multiple NDI filings for the same dietary ingredient

AHPA said it believes separate notifications are not required, per DSHEA, when the initial NDI notification (NDIN) provides a description of a dietary supplement or a range of dietary supplements that would include the NDI. "FDA's actual practice has been to file without objection premarket notifications that describe the NDI specifically, but that only generally describe dietary supplements that will contain the dietary ingredient," the association wrote.

Old dietary ingredient proof

AHPA said FDA is incorrect when it said manufacturers must establish the "pedigrees" of all old dietary ingredients (ODIs) they use and submit NDINs for each supplement containing NDIs. "The Draft Guidance would require these notifications to be supported by safety documentation meeting food additive petition requirements, the very requirements DSHEA struck out of the dietary supplement paradigm," AHPA wrote in its comments. Further, AHAP said the DSHEA places the burden on FDA to prove ingredients are NDIs, but the Draft Guidance places the burden on manufacturers to show an ingredient is an ODI.

AHPA also takes issue with the Draft Guidance requiring ingredients to be marketed in dietary supplement form in the United States to be considered ODIs. The organization said per DSHEA,ODIs are that ingredients marketed in any form prior to DSHEA. If the ingredient was sold in a truck stop sandwich in 1993, it's not a NDI, according to AHPA.

"Component" and "constituent" definitions

AHPA said the Draft Guidance, while it defines both "component" and "constituent," uses both terms inconsistently.

"Chemically altered" definition

AHPA said it does not agree with FDAs view that any change in the chemical composition of an ingredient means the ingredient has been chemically altered,  and thus requires an NDIN. Instead, AHPA said a supplement that uses a  traditional food preparation process should not create an NDI. Further, AHPA said even some non-traditional food preparation methods (such as supercritical carbon dioxide) no not chemically change an ingredient and should not require an NDIN.  AHPA also said Congress' list of processes that would not trigger an NDI ("minor loss of volatile components, dehydration, lyophlization [sic], milling, tincture or solution in water, slurry, powder, or solid in suspension") was not an exhaustive list as the Draft Guidance stated.

McGuffin said AHPA intends to submit subsequent comments to the Draft Guidance at a later date to offer extensive and specific comments on the section of the draft related to safety research. "AHPA's view is that this section goes far beyond the intent of the law and is wholly unnecessary and inappropriate in many cases to establish a reasonable expectation of safety," McGuffin said.