What the NDI Guidance Means to the Supplement Industry

by Duffy MacKay, N.D.

The curtain has been lifted, and the dietary supplement industry has been given a window into FDAs perspective regarding the highly anticipated New Dietary Ingredient (NDI) Notifications: Draft Guidance for Industry. The dialogue initiated after the release of the Draft Guidance has been dominated by more questions than answers. Specifically: Are commonplace dietary ingredients currently on the market that require manufacturers to file a retro-active NDI notification? Does every dietary supplement that contains an NDI necessitate its own separate NDI notification? There is even the possibility dietary ingredients already consumed widely with no evidence of a safety risk may now not meet the definition of a dietary ingredient at all.

While this Draft Guidance is something the industry has been requesting for the purposes of clarity, prior to its release, the large unknown was how far-reaching the guidance would be and whether FDA would be consistent with Congress original intent when passing the Dietary Supplement Health and Education Act of 1994 (DSHEA). Some industry veterans have voiced their concern that DSHEAs NDI safety provision is now being used to narrow the scope of ingredients that can be considered dietary ingredients, even before assessing their safety. While it is clear Congress intended the NDI provision to enable FDA to review the safety of dietary ingredients that had not been on the market previously, it is debatable if the intent was to narrow the scope of what can legally be defined as a dietary ingredient permissible for inclusion into a dietary supplement.

FDAs draft guidance calls for a separate NDI notification requirement every time a new ingredient is usedin a new product, by a new company and even for some ingredients thought to have been grandfathered. If the dietary supplement industry embraces this Draft Guidance and invests its resources to submitting all of the suggested notifications, will FDA have the ability to review all of these notifications within a 75-day period? All stakeholders (including FDA) will expend significant resources resubmitting or reevaluating previously reviewed information, which will be burdensome for smaller companies, FDA and industry as a whole. This scenario may result in duplicative NDI notifications that may not increase consumer safety and create a bottleneck at FDA that could take away from other areas where the agencys resources are sorely needed.

DSHEA was incomplete without the availability of the NDI Draft Guidance, and FDA should be applauded for meeting its deadline. All stakeholders likely agree with the principles underpinning the NDI safety provision, which can be summarized in the following statement from the Draft Guidance: information showing that a steroid hormone present in nanogram amounts in a serving of milk or beeffoods with a long history of safe usewould not support the safety of a highly concentrated bovine extract that contains the steroid hormone in milligram amounts. However, it is now time to clarify how these principles can realistically and appropriately be turned into meaningful actions that truly benefit consumers. This is especially important at a time when FDA has to grapple with limited resourcesfinancially and personnel-wisethat are needed to address bigger issues such as the implementation of the Food Safety Modernization Act (FSMA), cGMP (current good manufacturing practice) inspections and weeding out criminals who intentionally adulterate dietary supplements with illegal ingredients.  

Duffy MacKay, N.D., is the vice president, scientific and regulatory affairs, at the Council for Responsible Nutrition (CRN), Washington. CRN and VIRGO are hosting a webinar on the NDI Draft Guidance on Sept. 14; the webinar will include a panel of experts examining FDAs thinking on the guidance, providing a legal perspective and detailing tips and best practices for NDI notifications. Get more information or register at NaturalProductsINSIDER.com/Webinars .