by Cara Welch
The Draft Guidance for Industry: New Dietary Ingredient (NDI) Notifications and Related Issues was published by FDA on its website July 1, 2011successfully making its congressional deadline of July 5, 2011. The Draft Guidance answers many of the questions industry has been asking during the past 16 years. The Natural Products Association (NPA) believes these answers will have a chilling effect on the dietary supplement market, but what is more disturbing is how FDA will handle the resulting increase in resources needed to handle the wave of retroactive notifications this Draft Guidance suggests are needed.
NPA also believes FDAs current thinking on what documentation is required for establishing pre-DSHEA ingredients is much more stringent than Congress intended when it wrote the Dietary Supplement Health and Education Act of 1994 (DSHEA). Congress wasnt looking to make this provision so hard to meet that it essentially becomes unattainable. Additionally, the safety testing FDA believes is necessary for an NDI notification is on par with the food-additive petition process, but this is another example of FDA seemingly disregarding the intent of DSHEA. Congress clearly differentiated an NDI notification requirement from a food-additive petition by using different language.
Industry members who have been listening to FDA for the last few years could see the direction this Draft Guidance would take in several of the highlighted situations. Additionally, we are all aware this document is only draft guidance and does not establish legally enforceable responsibilities, but we also are aware that this reflects the current thinking of FDA, which can (and often does) enforce along similar lines to its guidance documents. It would be wise for each manufacturer to read this guidance document closely and determine how it affects current and future business practicesI think it will, in some way, affect everyone.
This Draft Guidance begins with a slight admonishment to industry. FDA believes there are approximately 55,600 dietary supplement products on the market and about 1,000 new products are added each year. The agency, though, has only received approximately 700 NDI notifications since the process began 16 years ago. This number identifies some of the serious problems industry has regarding when a premarket safety notification is necessary. The fact that only 150 or so were acknowledged by FDA with a no objection reflects the difficulty industry has with adequately preparing an NDI notification.
FDA starts this document with a comprehensive list of questions for when an NDI notification is necessary. Among the highlights, NDI notifications are required for: components and ingredients of food marketed prior to 1994, dietary ingredients marketed outside the United States prior to 1994, a change in solvent when processing an ingredient and each supplement containing an NDI. These last two areas, in particular, cast a wide net as to which manufacturers are impacted by this Draft Guidance. Outside of manufacturers producing innovative products with NDIs, manufacturers that choose to optimize the manufacturing process of a particular ingredient will then be required to prepare a wave of NDI notifications for every product that contains this newly formed NDI. Additionally, the agency has clarified that synthetic versions of dietary ingredients require an NDI notificationnot too surprisingwith an important exception of synthetic botanical constituents that FDA has declared do not fit the definition of a dietary ingredient, effectively removing such ingredients from the market completely.
Another subject that would reach far and wide is the documentation needed to prove an ingredient has grandfather (or pre-DSHEA) status. Appropriate examples of such documentation includes, written business records, promotional materials or press reports with a contemporaneous date prior to October 15, 1994, and should include the identity (e.g., chemical or botanical name) and form (e.g., ground herb, water extract, oil) of the marketed ingredient, and whether the ingredient was marketed as a dietary ingredient or for some other purpose. This information is much more detailed than most manufacturers have saved for the past 17 yearsespecially when working under the assumption that less detailed documents would suffice. Unfortunately, I believe this response from the agency will lead to a pathetically small number of ingredients that can be proven to be grandfathered. This was most definitely not the intent of Congress when DSHEA was written.
After clarifying when an NDI notification is necessary, the agency then covers what it expects a complete notification to contain. Reading through the requests of FDA regarding safety testing data, the agency is trending strongly toward what is required in the food-additive petition process. Again, this appears to be an example of FDA overstepping its bounds as declared by Congress in DSHEA. The similarity of an NDI notification to a food-additive petition is uncanny, but according to the Federal Food, Drug and Cosmetic Act, this should not be so. Congress was clearly differentiating when it stated a dietary supplement containing a NDI, will reasonably be expected to be safe as described in the premarket safety notification section of the act, while a food additive needs to provide a reasonable certainty of safety; the latter, of course, as the clearly stronger statement.
These are just some of the areas NPA believes will have significant effect on the industry, affecting manufacturers in producing new and better products for the market as well as retailers in providing these products to the U.S. consumer who wants and needs them for a healthier lifestyle. As this is FDAs Draft Guidance to industry, and it specifically requests comments be submitted before the agency begins work on the final version. NPA will be submitting comments on this document and urges the dietary supplement industry to do so as well.
Cara Welch serves as the vice president of scientific and regulatory affairs at the Natural Products Association (NPA). Welch assists natural product industry members to implement policies in response to government initiatives in the regulatory and policy arena, and works with members of Congress and their staff, FDA officials and other agencies whose actions have direct impact on the natural products industry. Additionally, she is responsible for advising association members on regulatory, safety, nutrition and health issues.