Legally Speaking: The Draft Guidance for NDIs and You

Since the FDA's release of its draft guidance for NDIs, there has been a daily bombardment of opinions expressed from all areas of the supplement industry. Many have expressed disappointment in the perceived failure of FDA to provide the clarity it intended by releasing the draft guidance. Still others have expressed deep concern over what they view as an increased burden placed on supplement companies regarding NDIs.  Even FDA has weighed in, expressing surprise over the controversy raised by the draft guidance, which it says does not contain any information which should surprise industry.

While the various sections of the draft guidance may raise different questions and issues for supplement companies, based on the nature of their respective products and ingredients, the release of the draft guidance raises at least one industry-wide question. Does this draft guidance signify that FDA is going to increase its attention and enforcement focus in the area of NDIs moving forward?   At first blush, it would seem obvious that the answer is yes. This draft guidance on NDI notifications has been in the works for quite some time and has been long anticipated by industry. While it is always important to remember that the draft guidance does not create new laws or regulations, the draft guidance is supposed to give clarity and provide insight as to how FDA is likely to interpret the laws and regulations that are already in place. One would surmise that the only reason to provide the supposed clarity is so that FDA can go about enforcing the provisions and point to the draft guidance as a sort of “we told you this is what we were going to do.”  

However, not every draft guidance signifies an immediate marked increase in FDA action.  FDA issued a draft guidance for Industry titled “Factors that Distinguish Liquid Dietary Supplements from Beverages” in December 2009. The FDA has taken little to no action in this area despite the growing number of products that have blurred the line between beverages and supplements. 

In fact, Senator Durbin’s new proposed bill cites the very issue of the confusion between liquid supplements and beverages as a problem. Perhaps instead of creating additional regulations, these issues may be resolved by FDA following up the regulations and guidance already in place, but that is a different discussion for another day.

While FDA has not followed up on the supplements vs. beverages guidance, all signs in this case do point to a likely increase in action from FDA regarding NDIs.  In an interview with Nutraingredients-usa.com, Daniel Fabricant, Director of the Division of Dietary Supplement Programs, indicated that the supplement industry has not adequately addressed the NDI provision in the law. Fabricant stated that only 700 NDI notifications have been submitted since the passage of DSHEA in 1994, an average of about 50 a year out of the approximately 1,000 new supplements launched each year. 

These statements and this draft guidance seem to indicate that FDA believes this is a situation that needs to be rectified sooner rather than later.