On July 1, the U.S. Food and Drug Administration (FDA) made good on its promise to issue a draft guidance on new dietary ingredients (NDIs), as mandated by the Food Safety Modernization Act. FDA stated this is an “important preventive control to ensure that consumers are not exposed to unnecessary public health risks from new ingredients with unknown safety profiles.”
Overall, the document has received mixed reviews from industry. In a web-seminar hosted by the Natural Products Association, Scott Bass, head of the Global Life Sciences Team at Sidley Austin LLP, stated, “The document was excellently written and I think it shows a huge amount of input from toxicologists, immunologists, senior regulatory people, Office of Chief Council, et cetera…it is good for the NDI scheme, but not what the industry needs.” He later stated, “I think everybody has had the reaction that this document elevates NDI submissions to food additives or GRAS levels and there are problems inherent in that.”
The long-awaited draft guidance defines an NDI as “a dietary ingredient that was not marketed in the United States before October 15, 1994.” The document defines the term “marketed,” as well as what documentation is required to prove a supplement was sold before the Dietary Supplement Health and Education Act (DSHEA) of 1994. Of note, it states that an ingredient is considered an NDI if it was sold only in foods before 1994 (i.e., it must have been present in a dietary supplement before DSHEA).
The guidance says supplement makers must alert the agency if they want to use an NDI in their product at least 75 days before it is marketed. Such notifications must include safety data about the ingredient. Some changes in manufacturing processes (like using a new solvent to prepare an extract) could mean an NDI must be filed. Bass also expressed concern during the NPA event that some products already on the market, and presumed legal, are now going to need NDI notification.
This notification process was designed to be a safety net for FDA, said attorney Anthony Young, Esq., during a web-seminar hosted by the American Herbal Products Association (AHPA). He stated, “Given the history of ingredients and the fact that these ingredients have been on the market so long, it’s most likely that if we see a safety issue with respect to dietary ingredients, it will be in something that is new…FDA will be able to say that the law required notification and, most likely, would be able to say that a notification about this particular ingredient was not made. So, FDA broadly is covering itself by assuring that it has asked for notifications on almost any change that’s made.”
One criticism is that FDA is imposing overly burdensome criteria for review. “I’m disappointed in this draft guidance document,” stated Paul Rubin of Patton Boggs LLP during the same web conference. “FDA has proposed a policy that is inconsistent with Congressional intent and also goes far beyond what is legally justified or is necessary…I think the draft guidance is troubling in many respects.”
Rubin zeroed in on FDA’s argument that the marketing of an ingredient in conventional foods before DSHEA doesn’t satisfy the NDI criteria. DSHEA indicates that supplements are a subcategory of foods, so he feels the new FDA stance on NDIs is inappropriate. “If you think about what Congress was intending to do at the time [of DSHEA], I’m quite confident that there was no intent by Congress to exclude ingredients present in conventional foods from being relevant to the NDI determination,” Rubin stated.
Another bone of contention is that NDI notification is product specific, and some argue that the process is time consuming and expensive. The fact that NDIs are product specific strikes some industry members as overkill, especially for single-ingredient products. In essence, FDA could be reviewing hundreds of NDI submissions that are the same, for all intents and purposes.
A third problem raised by Jim Prochnow, Esq., partner at Greenberg Traurig, LLP, during the same session is that synthetic copies of botanicals are not considered dietary ingredients in all cases. FDA offers this example: “Taurine is the end product of the metabolism of the amino acid cysteine. It is thus a metabolite of an amino acid and fits one of the definitions of a dietary ingredient.” On the other hand, resveratrol is an example of a synthesized botanical that requires an NDI notification.
Others fear the probiotics category could be at risk, since FDA stated that bacteria that have never been eaten in food are not dietary ingredients. But, being generally recognized as safe (GRAS) could exempt the bacteria from NDI notification since probiotics are often used in foods.
In fact, one positive of the guidance, according to Ashish R. Talati, J.D., M.S., RAC, another speaker in the AHPA seminar, is the section about GRAS and NDIs. GRAS ingredients are exempt from NDI notifications. “Assuming your ingredient is not chemically altered, you are exempt,” Talati said.
But during the NPA seminar, Bass voiced his concerned that FDA says it could withhold its review of any NDI submission if it isn’t complete. “The way this has worked in other regulated product areas is that ‘not complete’ could mean even a substantive failure to have animal or human tests…if you’re going to have a pre-look at the filing, the only reason that FDA should not accept [the application for review] is if something is missing like an address or a technical feature,” he stated. In other words, FDA could theoretically reject an NDI under the guise that the safety data is not fully included without fully reviewing the filing, resulting in a circular process in which NDIs never are filed.
Experts at both events reiterated how important it is to submit comments to FDA about the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues. Electronic comments can be submitted at www.regulations.gov before October 3, 2011.
Published in WholeFoods Magazine, September 2011 (online 7/20/11)