What’s the Potential Impact of the 2016 FDA New Dietary Ingredients Draft Guidance?
By Dr. Skye Lininger, CEO, Healthnotes, Inc.
The newly published FDA New Dietary Ingredient Draft Guidance could significantly alter the way the industry does business. The data presented in this article show the potential number of products affected and the consequent economic impact could be substantial.
The dietary supplement industry is extremely complex and wide-ranging. Products are sold through multiple channels (specialty, FDMC, doctor’s offices, multi-level, and direct-to-consumer), there are over 2,500 different brands, and (according to both Healthnotes and the Office of Dietary Supplements) an estimated 80,000+ SKUs.
For the development of Vitature®, Healthnotes cloud-based product development software platform, we have collected and analyzed almost 54,000 SKUs of dietary supplements. Initial analysis reveals there are approximately 15,000 dietary ingredients (DIs) listed on the labels of products currently in the US market.
The Data Break Down
Of those 15,000 DIs, 4,000 are inactive ingredients (e.g. excipients and binders) and 11,000 are active ingredients. Of the 11,000 actives, half are herbal parts and preparation methods (e.g. root or root powder), the other half (5,400) are the herbs themselves and all other DIs.
The FDA has recently stated the “pre-DSHEA” lists the industry has been relying on (NPA/NNFA, CRN, and Herbs of Commerce) should not be considered authoritative. Even if those lists will ultimately be supported there are still huge potential gaps since those lists only include 3,500 “grandfathered” or “pre-DSHEA” DIs, leaving all others currently in use as potential NDIs. The gap becomes greater if plant parts and preparation methods are eventually ruled to be NDIs.
Depending on whether you use the 11,000 number or the 5,400 number, between 40% and 68% of all active DIs are not on any list. The open question is how many of these “ambiguous” DIs will be considered by the FDA to be NDIs that have not yet had any filings?
Total number of DIs 15,000
Inactive ingredients 4,000
Active ingredients 11,000 (includes plant parts and prep)
Active ingredients 5,400 (excludes plant parts and prep)
On a pre-DSHEA list 3,500 (NPA/NNFA, CRN, HOC, NDI, GRAS)
The Example of Echinacea
To illustrate the scope of the potential problem, we took a closer look at Echinacea and how it is represented in products.
- Of the 55 ways Echinacea is listed on currently labels, only 8 are included on pre-DSHEA lists, NDI filings or GRAS statements.
- That means 47 Echinacea ingredients as described on labels are not on any pre-DSHEA list—but are still currently in products.
- Looking specifically at Echinacea angustifolia, only two of 13 ingredients listed on product labels are on any pre-DSHEA list. And, there are inconsistencies—e.g. root powder is listed but not root extract.
- Echinacea also contains a number of chemical markers/features that are sometimes included on labels. Most of these actives are not on any pre-DSHEA list nor do they have GRAS or NDI notifications.
The Potential Exponential Impact of the NDI Guidance
Additional analysis of the product labels shows that between 50% and 60% of all supplement products on the market today include at least one “ambiguous” DI. That is, at least one DI in those products are not on any pre-DSHEA list, no NDI filing from any company, and no published GRAS notice. For most companies, just the cost and complexity of undertaking an in-depth label analysis would be very time-consuming and expensive.
Industry is just beginning to appreciate the scope and potential impact of the new draft guidance. As we learn more, Healthnotes will continue to analyze and provide data to help companies understand and navigate these complex issues.
About Skye Lininger – Skye Lininger, DC, is CEO of Healthnotes Inc., the data and software company behind Vitature, the platform of data and tools for companies to manage compliance efficiently and get to market faster.