New political landscape could shake industry

The great paradox of the natural foods and dietary supplements industries is that they were founded and embraced by liberal consumers, yet the greatest looming threat comes from their political representatives, the Democrats.

So the November elections, which saw the Democratic Party win both houses of Congress from the free-market Republicans, has many industry observers fretting over the impending regulatory climate — not the least of which is the supplements market's great liberator, the 1994 Dietary Supplements Health and Education Act (DSHEA).

In particular, in the US House of Representatives, long-time industry critics John Dingell of Michigan and Henry Waxman of California will ascend to committee chairs, which set the agenda for the coming two years.

Rep Dingell, for instance, had this saucy quote after the election victory: "There are questions relative to food and drug safety. But also food supplements, where people are being killed."

"These are very sharp words," said industry veteran Loren Israelsen, president of LDI Group consultancy. "But they are consistent with Congressman Dingell's prior public comments about the supplements industry."

Michael McGuffin, president of the American Herbal Products Association (AHPA), said the inflammatory language does not mean immediate action. "Dingell mentioned 23 subjects about which he had an interest. This was 17th on the list," McGuffin told FF&N. "Not that they're not going to come around to it, nor will it not be aggressive."

The adverse events bill was the final order of business for the lame-duck Congress
Most observers were surprised that one of the final actions of the lame-duck Congress was to pass the adverse events reporting bill (S. 3546). "Ultimately such a system will highlight the strong safety record of dietary supplements," said Steven Mister, President and CEO of the Council for Responsible Nutrition.

There was great concern that, absent federal rules, individual states would step in.

"Instead of going to one system that we've been very attentive to assuring details are properly written, are we going to have to file numerous adverse events?" asked McGuffin. "If a manufacturer is in California and a retailer is in Florida and an Internet-site customer is in New York, does the consumer have to file three reports? That's the promise of letting this turn into state-by-state regulations — duplication, additional effort, lack of clarity, different rules."

Rep Waxman, meanwhile, is no friend of the industry. Regulatory expert Marc Ullman, in a blog posted at, said Rep Waxman "has regularly accused the supplements industry of being irresponsible, has called on the FDA to investigate 'safety issues'."

The adverse events reporting bill is hoped to stave off some of that effort. The law would require a phone number listed on labels, and for companies to report calls to FDA within 15 days.

Commented Israelsen, "Let us hope that with regard to our own industry issues we will rise to the moment and move toward a higher level of public confidence and credibility in our products. Great effort will now be spent working with both the majority and minority parties to move on a range of dietary-supplements issues that have stalled, such as GMP regulation, AER legislation and more aggressive but sensible regulation of the DSHEA. Time will tell how well we do."

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