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Consulting Our Mates Down Under for NDI Guidance

Consulting Our Mates Down Under for NDI Guidance

By Ashish R. Talati and Jennifer M. Adams, Amin Talati & Upadhye


As the dust settles on the release of FDA’s revised new dietary ingredient (NDI) draft guidance, dietary supplement companies, whether multinationals or startups, should be preparing their own comments to file with FDA—or at least be working with one of the trade associations on comments the association will file.

Although, on the surface, the 2016 revised draft guidance has made great progress and includes many positives as compared to FDA’s 2011 first draft of the guidance, there are still areas of concern. In particular, the revised sections on manufacturing changes and chemical alteration have a potential to affect every single company in the dietary supplement space.

As currently written, these sections are overly broad and would result in the need for companies to file NDI notifications due to seemingly benign changes in product manufacturing. The industry needs to provide specific, detailed (read: granular), and science-based comments to FDA that both demonstrate why these sections of the guidance are too broad and advise FDA on how these sections should be changed to ensure the guidance can be applied appropriately throughout the industry.

In general, comments relating to manufacturing changes and chemical alteration should address the following:

·      Not all changes (manufacturing or chemical alterations) should be considered significant

·      Not all significant changes alter an ingredient’s identity from its pre-1994 (pre-DSHEA) identity and therefore should not trigger an NDI notification

·      What type of scientific evidence will FDA accept for measuring baseline ingredient identity and any manufacturing changes that take place thereafter?


Ideally, companies should submit science-based comments indicating which processes do and do not result in a “manufacturing change” or “chemical alteration” and trigger an NDI analysis. Making these comments as detailed as possible would help demonstrate to FDA exactly how far-sweeping the guidance is as presently drafted. Additionally, and perhaps more importantly, such comments would provide FDA with a list of examples and explanations to include in future guidance drafts in terms of what is considered a manufacturing change or chemical alteration, and what is not.

But before hauling out the chemistry textbooks in order to draft their NDI comments, companies should first take a moment to review how other countries handle similar regulations. A particularly applicable example is Australia. The Therapeutic Goods Administration (TGA) in the Australian government’s Department of Health and Ageing is tasked with regulating “Complementary Medicines.” Because there is no dietary supplement category in Australia, ingredients such as botanicals, amino acids, and vitamins and minerals are considered to be Complementary Medicines. All Complementary Medicine products are required to either be listed or registered with the TGA.

In particular, TGA’s “Guidance on Equivalence of Herbal Extracts in Complementary Medicines” provides some key instructions to Australian companies on how they should measure the scope of manufacturing changes made to their ingredients. After publishing a draft guidance in 2007 and soliciting comments from industry, TGA finalized its guidance in February 2011. Importantly, the guidance instructs companies on how to determine when an ingredient is altered and when it is not.

What’s covered in this TGA guidance may serve as a roadmap for NDI comments U.S. companies should consider filing with FDA.


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