The dietary supplement world is awaiting some critical guidance regarding new dietary ingredients from the FDA due to arrive by the end of June 2011. In anticipation of this guidance, chatter in the industry has increased, and this has even made the news. An article published in the Salt Lake Tribune on May 1, 2011 focused on this anticipated communication.
One of the provisions that Congress included in the Dietary Supplement Health and Education Act (DSHEA) addresses the safety of new dietary ingredients. This provision gives the FDA the right and responsibility to review new dietary ingredients for safety prior to their being marketed in dietary supplements. “New” is defined as any dietary supplement ingredient that was not marketed in the United States before October 15, 1994. It is the manufacturer's responsibility to make this determination, and if new, submit a new dietary ingredient (NDI) application to document the safety of the new ingredient. If the FDA does not respond within 75 days after the application is submitted, the manufacturer can introduce the ingredient to the marketplace. It is important to note that a “successful” NDI submission does not mean that FDA has confirmed that the ingredient is safe for its intended use.
Despite the growth in the number of natural products since 1994, Daniel Fabricant, the director of the FDA's Division of Dietary Supplement Programs, reported that the FDA has received only 700 new dietary ingredient applications since 1994, out of an estimated 60,000 dietary ingredients in use. One of the reasons for this is that, in the absence of clear guidelines, the industry has been confused about what to submit. The FDA guidance expected by the end of June should clear up this confusion. And that is where the change is likely to start happening.
The requirements to prove safety may be quite onerous for smaller companies.
Depending on the requirements to demonstrate safety, hundreds to thousands of products may in be jeopardy of discontinued sales until their safety is proven. The requirements will also affect the introduction of new ingredients into the marketplace. This includes both advanced technology ingredients and botanical ingredients from other parts of the world (if not marketed for use prior to 1994). The requirements to prove safety may be quite onerous for smaller companies. A somewhat similar situation has recently taken place in the European Union. In the EU, the 7-year transition period set out in the 2004 Herbal Directive (2004/24/EC) has expired. This means that, as of May 1, 2011, only medicinal products that have been registered or authorized can remain on the shelves. A manufacturer who wishes to register a traditional herbal medicinal product must provide documentation showing that the product is safe for its intended uses. They must also provide evidence that the product has been used safely for at least 30 years, 15 of them in the EU. Although this legislation is different than the NDI requirement in the United States, the intent and approach is quite similar. Smaller herbal manufacturers in the EU are already voicing their concerns about their ability to comply with these requirements. This is, in part due to the scope of the documentation necessary to establish safety. Whether the clarified NDI requirements will present a similar challenge to smaller manufacturers in the United States remains to be seen.
Dietary supplement manufacturers are watchful of events in the EU as they await the NDI guidance. The implications to availability, and potentially cost, of affected dietary ingredients are yet to be determined. If a product is found to contain an NDI that does not have an application filed, that product is considered adulterated and will likely be removed from commerce. It's possible that the FDA could require retailers and healthcare practitioners to pull thousands of products off the shelves as it determines the safety of these new dietary ingredients. This will also trigger remedial action on the part of the manufacturer. Despite the potential implications, most manufacturers are eager for NDI clarification. Ultimately, this guidance is what the industry has been asking for since 1994. Defining these requirements should help manufacturers submit what the FDA requires. This, in turn, will provide greater assurance of safety to dietary supplement users. Getting there may be somewhat painful, but the destination should be worth it.
American Botanical Council. HerbalGram. 2004; 63:70-74. Retrieved from: http://cms.herbalgram.org/herbalgram/issue63/article2716.html.