FDA Revises Draft Guidance on New Dietary Ingredient Notifications

On August 11, 2016 FDA published their long-awaited revised draft guidance on New Dietary Ingredient Notifications.  The guidance contains numerous requirements that will significantly affect the dietary supplement industry and establishes a 60 day comment period if manufacturers wish to affect the final rule.  The draft guidance is written in a question and answer format and about half of the 102 page document provides detailed information on the type of information and format that FDA expects of New Dietary Ingredient Notification.

I will be reading and re-reading the details of the draft guidance in coming weeks and sharing details with you but for now I would like to list a few items that stood out to me on first reading. Let’s begin with some non-surprises:  FDA reiterated the definition of dietary ingredients and noted that there is no authoritative list of dietary ingredients that were marketed in the US prior to October 15, 1994.  Interestingly, FDA did note

“that the present definitions of “dietary supplement” and “dietary ingredient” were not added to the FD&C Act until after October 15, 1994, and that many products now marketed as dietary ingredients for use in dietary supplements were marketed under other product categories, such as foods for special dietary use or food additives. Therefore, we interpret “dietary ingredient” to refer to ingredients that (1) if marketed today, would qualify as “dietary ingredients” under 21 U.S.C. 321(ff)(1); and (2) when marketed before October 15, 1994, were intended for use as or in a product that would now be a “dietary supplement” as defined in 21 U.S.C. 321(ff) and that would not also meet the definition of a drug.”

In general the document reiterated the concept that supporting data for safety must be based on studies using substances that match the new dietary ingredient in chemical form, method of preparation, intended use and level of use, just as is required for substantiation of dietary supplement claims.

One portion of the draft guidance will be of comfort to many manufacturers:

“If I want to market a dietary supplement containing several pre-DSHEA ingredients that haven’t previously been marketed together, do I have to submit an NDI notification?
No. The NDI notification requirement applies only to dietary supplements that contain at least one NDI. If each of the dietary ingredients in a dietary supplement was marketed in the United States before October 15, 1994, marketing these ingredients together for the first time in the same dietary supplement does not create an NDI or trigger the NDI notification requirement.”

 The section of the draft guidance that discusses “chemical alterations” that render a dietary ingredient “new” will greatly trouble a number of dietary supplement manufacturers since it includes the following:

• Changing agricultural or fermentation conditions to alter the chemical or molecular composition or structure of the ingredient. Examples: sprouting garlic or fermenting yeast using a medium containing large amounts of sodium selenite to create large amounts of organic selenium compounds.
• Fermentation using a fermentation medium different from the one used to make conventional foods in the food supply. Example: use of a defined commercial growth medium to produce a microorganism previously made by fermenting milk into dairy products like yogurt or cheese.
• Use of a botanical ingredient that is at a different life stage than the life stage of the botanical ingredient used as a conventional food. Examples: making an extract from unripe instead of ripe apples or using the mycelium instead of the fruiting body of a fungus.”

The processes listed above are used for many dietary ingredients that are common today and will require New Dietary Ingredient Notifications for the products to remain on the market. I encourage every dietary supplement manufacturer and marketer to become acquainted with this document.  Let me know what questions you have and I will do my best to answer them.

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