In comments filed with FDA, the American Herbal Products Association (AHPA), Silver Spring, MD, called for the agency to withdraw what it called the “hugely flawed” New Dietary Ingredient Notifications Guidance.

In submitting the comments, AHPA also called on the agency to issue new guidance, ensuring that it is consistent with the Dietary Supplement Health and Education Act (DSHEA or the Act) by incorporating revisions to conform to DSHEA and the intent of Congress with regard to new dietary ingredients (NDIs).

“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DSHEA’s NDI notification provision, as directed by section 113(b) of the Food Safety Modernization Act (FSMA), the draft guidance seeks to erect extra-legal barriers to market entry, impose food additive- and pharmaceutical-type evaluative criteria, require multiple NDI notifications for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,” AHPA wrote.

AHPA noted that instead of facilitating compliance with the NDI provision of the law, the draft guidance would, if implemented as written with the flaws identified, change the rules that have been in place for the last 17 years and significantly increase the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.

A key area of concern in the draft guidance is FDA’s call for multiple NDI filings of the same dietary ingredient, AHPA noted in its comments.

“AHPA believes that separate notifications are not required when the initial notification filed for the NDI provides a description of a dietary supplement or a range of dietary supplements that would include the NDI,” the association said.

“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.”

Also of concern in the guidance, “FDA proposes that manufacturers must establish the pedigrees of all old dietary ingredients they use and submit NDI notifications where required for each supplement containing new dietary ingredients,” the organization said. “The draft guidance would require these notifications to be supported by safety documentation meeting food additive petition requirements, the very requirements DSHEA struck out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.”

Michael McGuffin, AHPA president, said that 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.

“One of the key features of AHPA’s comments is that it includes proposed solutions that specifically recommend revisions to the draft guidance,” Mr. McGuffin added. “AHPA has provided FDA with a thoughtful, thorough-and most importantly, lawful-starting point for revised guidance.

“Let me be clear, AHPA has called for FDA to remove the guidance,” he continued. “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.”