Compromise Is a
Prescription for Failure

Y ou’ve heard it before: “With friends like this, who needs enemies?” That’s our response to the defense marshaled on behalf of the supplement industry against the FDA’s draconian New Dietary Ingredient Guidance proposal (NDIG) by the industry’s principal “protectors.” These protectors, the so-called “big five” trade organizations, consist of: The Natural Products Association (NPA), the Council for Responsible Nutrition (CRN), the United Natural Products Alliance (UNPA), the American Herbal Products Association (AHPA), and the Consumer Healthcare Products Association (CHPA). Their approach, individually and collectively, is pretty much the same. It’s about what you would expect from lobbyists, long on wind and short on principal.

In response to NDIG, these organizations sent a joint letter to the FDA requesting that the submission deadline be extended until November 17, 2011. In effect, what the letter said was that the draft guidance is “… thorough and complex, thus requiring an in-depth review by stakeholders. [Emphasis added]” Also, that “[w]e applaud the FDA for the release of this document and welcome the opportunity to provide comments with respect to the draft guidance.” Yes, master! The FDA is trying to destroy the supplement industry, and this is what we get from its so-called leaders.

On behalf of these organizations and their high-heeled members, the letter was signed by Cara Welch, Ph.D. (NPA); Douglas Mackay, N.D. (CRN); Harry B. Rice, Ph.D. (UNPA); Marcia D. Howard, Ph.D. (CHPA); and Michael McGuffin, (AHPA).

More recently, the FDA extended the comment period for NDIG by 60 days to Dec. 2, 2011, one month after the big five industry trade organizations requested FDA to extend the comment period by 45 days.

Said Cara Welch, “The Natural Products Association (NPA) believes these answers [from NDIG] will have a chilling effect on the dietary supplement market …” That’s right! Then she said, “It is important for the industry to use these additional 60 days prudently and continue to prepare comments that reflect the gravity this document holds for the industry, but also work toward a solution where all are satisfied. [Emphasis added]” Furthermore, “Both FDA and industry want to find that common ground where the law is upheld and this industry can continue to thrive. [Emphasis added]” The FDA is the ultimate arbiter of “law” in the process of rule-making.

Then there is Douglas Mackay, of CRN, who wrote, “In FDA’s response to industry comments published in the August 19, 2011 Federal Register, the Agency appears to have mistaken industry’s estimates to include the time necessary to generate the data (e.g. performing required safety and toxicology studies). If this were the case, the time and resource burden would be significantly higher than 100–350 hours.” But he didn’t go on to say, “If upheld, this would bankrupt the industry.”

To take the cake, “UNPA is grateful for the extension,“ said Dr. Harry B. Rice. “This should be considered a win-win for those of us preparing comments as well as those receiving them. For us, at the end of the day, the goal is to find common ground that is in line with the intent of DSHEA. [Emphasis added]” The trouble is, there is no common ground. Essentially, what the FDA has proposed amounts to is a plan to hijack the entire supplement industry, and force it to comply with a non-existent approval process that was never a part of DSHEA, and that was never the intention of Congress. How the “big five” are responding, who most certainly know the issues, is dismal and doomed to fail, for all but those at the very top.

The dietary supplements industry may have a new trade association, as Jarrow Rogovin, founder and president of Jarrow Formulas has proposed the creation of a new trade organization, the Dietary Supplements Manufacturers and Marketers Association. Citing the threat posed by NDIG, and the perceived failings of the existing big five trade associations, this may be an idea whose time has come. As well, challenging the assumptions and interpretations in NDIG, Rogovin recently sent the FDA a 128-item Freedom of Information Request (FOIA). These requests are material in every respect, and proportionate to the massive scope and scale of NDIG as drafted. Charge!

Returning to the big five, it has been said that a compromise is the acceptance of a lesser evil in lieu of a greater one. This we suggest is not a good idea, as the FDA continues to hack away at the supplement industry, the tree of liberty, and the health of the nation. There can be no compromise with the FDA on this one. There should be only one response to the NDI proposal, and that is to kill it.

NB: As in our past two editorials (in September and October), this madness must come to an end, or the end will be dire for the health of the nation. Some time may still remain. If you have not done so already, please send your message to Congress through the Action Alerts at the Alliance for Natural Health Website ( www.anh-usa.org) in opposition to NDIG, the FDA’s NDI Guidance proposal.

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