Agency begins its promised rewrite after a massive grassroots letter-writing campaign.
Last week ANH-USA, together with a number of supplement industry trade associations, met with the US Food and Drug Administration to discuss their promised revision of the FDA’s draft guidance for New Dietary Ingredients (NDIs) which, in ordinary English, means dietary supplements developed since 1994.
As you know, the guidance was originally released in July of 2011, and immediately faced a firestorm of criticism from consumers, natural health advocates, the supplement industry, and Congress. FDA took what was supposed to be a notification process for new supplements and turned it into a de facto pre-market approval system with so many absurd restrictions and arbitrary rules that it would have forced a large number of products off the market, denying you access. It would also have resulted in over $1 billion of lost industry revenue, and cost over 100,000 Americans their jobs now—and far more jobs in the future.
In June, after a massive grassroots letter-writing campaign, congressional leaders persuaded FDA to withdraw the guidance and start over—a startling reversal from the agency’s previous intransigence on the subject. Last Tuesday’s meeting was constructive—and significant in that it was the first time a group representing natural health and consumer activists had been invited to be at the table.
One main focus of the meeting was how the FDA would distinguish between old dietary ingredients (ODIs) and new ones. At issue is whether the FDA will agree with the supplement industry and the natural health community that many of the supplements used by consumers today should be considered ODIs and thus not subject to the new onerous regulations (currently being re-written) that threaten access to supplements.
This is a concern for consumers for many reasons. To take just one example, when a supplement is considered an NDI, drug companies, under some circumstances, are able to develop synthetic version of natural ingredients and then petition the FDA to remove the nutritional supplement versions of the ingredient from the market. This is what happened with pyridoxamine, one of the most bioavailable and best natural forms of vitamin B6—the supplement industry thought it was a grandfathered ODI and didn’t file an NDI notification, but the FDA ruled that it was an NDI. Now the natural supplement form of pyridoxamine is no longer available.
A second issue discussed was the creation of an official list of grandfathered ingredients, which currently does not exist. Should such a list be created? The concern is that FDA may determine that the list is static and any ingredient not on the list is by default an NDI. We don’t want the list to be used as a hammer by the FDA to go after industry and ultimately deny consumers access to safe supplements.
Then there’s the “chemically altered” question. Supplements that have been chemically altered, even if they were originally marketed before DSHEA was passed, become NDIs. But FDA’s definition of “chemically altered” is very broad. It may include a change in the manufacturing process—and there have been many such changes in the past eighteen years!
Many of these manufacturing processes do not chemically alter a supplement, just make it safer and better by taking advantage of new technologies. Since the purpose of the NDI notification process is to ensure safety, FDA shouldn’t freeze-frame the technology to 1994, but should instead allow for improvements—all the more so since the FDA is issuing guidance eighteen years after it was required by Congress.
Our meeting did not decide any of these issues. But as the consumer representative at the meeting, we were able to represent you and express these points strongly. With your help and that of Congress, especially the appropriations committee that controls FDA’s purse strings, we will finally win this battle, no matter how long it takes.