NDIs and Warning Letters: What Happens Next?NDIs and Warning Letters: What Happens Next?
The 10 warning letters FDA sent to DMAA marketers shows FDA is sticking to its viewpoint that synthetic botanicals are not dietary ingredients and that NDI notifications are required for each new supplement.
June 18, 2012
Its been more than six months since the industry filed more than 146,000 pages of comments with FDA regarding its New Dietary Ingredient (NDI) Draft Guidance. Someone asked me recently if I was surprised the agency hasnt answered these comments yet. Given the glacial pace at which FDA typically moves, I would be more surprised if we had received a formal response from the agency by nowwhich may provide some insight into why the Council for Responsible Nutrition (CRN) pressed FDA to formally withdraw the Draft Guidance while we wait for a new one to be issued in its place. But I digress.
At the end of April, however, FDA released 10 warning letters to several companies marketing products containing dimethylamylamine (DMAA), asserting they had failed to file NDI notifications as required by law and alleging safety issues with that particular ingredient. By my count, this marked only the second time in 17 years FDA issued a warning letter for failing to file an NDI notification. Immediately, some in the industry cried foul" that FDA was attempting to enforce its interpretations expressed in the Draft Guidance without properly considering the industrys views as articulated in all those comments.
But not so fast. Even while some of our Congressional champions have urged FDA to refrain from taking any enforcement action based solely on the positions articulated in the Draft Guidance that are not unequivocally grounded in the law, we should recognize the underlying NDI requirements are products of the statute itself, not the creation of FDAs guidance. The Dietary Supplement Health and Education Act of 1994 (DSHEA) has undeniably required for the past 17 years that the introduction of an NDI requires the manufacturer to file a notification with FDA 75 days before it comes to market. And industry has criticized the agency repeatedly over the years for not fully implementing DSHEA and using the ample enforcement authority that the statute conferred on the agency.
What will be more interesting is how FDA executes its were enforcing the statute, but not the guidance" routine. Given that this is a presidential election year, and particularly because we have a sitting President running for re-election, it becomes increasingly unlikely FDA will deal with the NDI Guidance in any comprehensive way as we get closer to Election Day. Administrations of both parties are known for sending quiet edicts to their executive agencies not to rock the ship of state before an election with controversial rulemaking actions that could cost votes. If FDA is indeed going into election year lockdown," one is left to decipher the contents of the warning letters to determine whether the allegations in them are rooted solely in the clear meaning of the statute or, instead, an attempt to impose FDAs controversial interpretations of the law that were revealed in the guidance.
The first issue FDA raised is whether DMAA is indeed a dietary ingredient. One may recall in the Draft Guidance, FDA indicated it would not consider a synthetic ingredient, even if bio-identical to a botanical constituent, to be a dietary ingredient. Period. CRN, among others, argued strongly that there was no such prohibition in DSHEA, and even if FDA did not consider a synthetic to be a botanical, synthetic versions of plant-based materials could still be dietary substances for use by man to supplement the diet by increasing the total dietary intake" of the ingredient. In other words, even if one prong of the dietary ingredient" definition is not available, others are. In those April warning letters, FDA appeared to acknowledge these other alternatives, so the mere fact that FDA is looking beyond the botanical language is, perhaps, an indication that the industrys position is getting through to FDA.
Unfortunately, that victory may be short-lived, because in the next sentence, FDA offered that because DMAA is not commonly used as human food or drink," it cant be a dietary substance. Whoa, whoa, whoa. When did the provision for increasing total dietary intake" translate into commonly being used as food or drink? Many dietary substances appear only in minute amounts in fruits or vegetables and are concentrated for use in supplements. Even though humans ingest these substances whenever they consume fruits and vegetables, they are hardly ingesting the ingredient itself as a food or drink. Those nutrients are just along for the ride. This viewpoint did not appear in the Draft Guidance because FDA never got that far in the analysis, but it should be just as troubling to the industry.
Also troubling is FDAs statement in the warning letters that the NDI notification requirement applies to all dietary supplements that contain new dietary ingredients" The agency is apparently still insisting that the NDI provision applies to every finished product containing an NDI. CRN has arguedeven demonstrated to FDA using the rules of grammarthat the NDI requirements apply to ingredients, not to finished products, unless the product uses the ingredient in ways clearly not contemplated by the original ingredient filing. But FDAs choice of wording here belies that it may indeed be implementing that interpretation first seen in the draft guidanceover the wishes of many members of Congress.
Finally, FDA questioned the safety of the ingredient. Assuming that the adjudication of DMAA even gets to this stage, industry must watch closely to see what level of science the companies are prepared to present, and how much FDA demands. CRN has pointed out that the reasonable expectation of safety" standard for NDIs is not the same as The Redbook requirements for food additives. How many studies, conducted for how long and on how many subjects will the FDA demand? How much is enough? This is an issue raised by the guidance, but not clear from the face of the warning letters.
In the weeks and months ahead, the industrys best indication of whether the 7,000 comments filed with FDA are making an impact on the agency will likely be more evident from the agencys actions in this warning letter context. We are not likely to see the agency issue a formal revision of the guidance this year, but FDAs next move in the DMAA skirmish may be just as instructive. Regrettably, the rush to judgment is on. FDA is under pressure from the U.S. Anti-Doping Agency (USADA) to crack down on this ingredient because it already appears on USADAs banned substances list. The Department of Defense has its own examination of DMAA underway, and Health Canada has applied its own law to declare DMAA a drug in Canada. Some members of the U.S. supplement industry seem to have DMAA in their crosshairs, even before all the data is reviewed. When regulators rush to get an expedient outcome, good precedent and good policy can suffer. Hopefully, what happens next will signal that FDA has listened to the constructive concerns of the industry with respect to the NDI guidance, and that the roadmap the agency sets out for DMAA will be one that provides clarity for the rest of the industry as well.
Steve Mister is the president and CEO of the Council for Responsible Nutrition (CRN).
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