Industry group calls on FDA to withdraw “hugely flawed” program for new dietary ingredients; Chiropractic organization suggests regulation of NDIs may require legislation to restrain the FDA
The American Herbal Products Association has called on the US Food and Drug Administration to “withdraw” its “hugely flawed” proposal for regulating new dietary ingredients (NDI) used in herbal and other dietary supplements. The FDA posted its plan in July of this year. In a December 5, 2011 release, AHPA took the following position:
“Instead of providing guidance regarding [Dietary Supplement Health and Education Act’s] DSHEA’s NDI notification provision, as directed by section 113(b) of the Food Safety Modernization Act (FSMA), the draft guidance seeks to erect extra-legal barriers to market entry, impose food additive- and pharmaceutical-type evaluative criteria, require multiple NDI notifications for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 executive director Michael McGuffin notes that the organization’s intention is to work with the agency. “One of the key features of AHPA’s comments is that it includes proposed solutions that specifically recommend revisions to the draft guidance,” McGuffin added. “AHPA has provided FDA with a thoughtful, thorough-and most importantly, lawful-starting point for revised guidance.” The full text of AHPA’s comments are here.
Comment: The American Botanical Council (ABC) took a position that focused on clarifying “old dietary ingredients. The 501c3 charitable organization urged that an expert advisory panel be created to develop such a list. The ABC response is here. Late breaking: AHPA sent a release December 6, 2011 noting that the 5 top trade associations are all calling for the FDA to withdraw the NDI document.
In a release entitled “ACA Seeks Preservation of Patient Access to Dietary Supplements”, the American Chiropractic Association notified members that it believes that following a comment period, the FDA plan for new dietary ingredients (NDIs) will be “somewhat improved” over than the original proposal. However:
” … the Association believes it is unrealistic to expect the FDA to satisfactorily address the full range of the industry’s concerns, and that the final FDA requirements will still prove overly burdensome and harmful to the interest of DCs and their patients. If this proves to be the case, then the ACA and the supplement industry will have to turn to Congress in order to seek the enactment of a responsible legislative ‘fix’ to reign in the over-reach of the FDA with respect to the NDI guidance requirements — and the ACA fully anticipates supporting and cooperating with the industry in seeking enactment of the required legislative solution, and engaging the ACA’s grassroots resources in that battle. The ACA is monitoring the NDI issue on an on-going basis and will inform its membership if and when grassroots action is needed.”
A query to the American Association of Naturopathic Physicians (AANP) yielded a response at press-time. Their statement is posted here. The laud aspects of the regulation then note that access to 25% of products on the market may be impacted. Bottom line: “We believe it is in the consumers’ best interest to minimizing the use if overly burdensome regulations that do not impact the issues central to ensuring quality and patient safety.”