Source: LOHAS Weekly Newsletter
Published: Thursday, October 01, 1998

WASHINGTON—FDA’s public comment period for its proposed supplements labeling regulations ended with a bang on Sept. 28 as a deluge of more than 100,000 comments was received by FDA from consumers opposing the agency’s proposed regulations for structure/function claims on dietary supplements labels. The comment period, which began in late May and was originally scheduled to end Aug. 27, was extended for 30 days by FDA after lobbying and petitions from industry trade groups and pressure from U.S. Sens. Tom Harkin, D-IA, and Orrin Hatch, R-UT. A final count is expected to be available in mid-October, according to Susan Haeger, president and CEO of the Boulder, CO-based consumer advocacy group Citizens For Health (CFH).

Citizens for Health in July launched the consumer “Write to Know” campaign with the goal of generating 100,000 comments opposing the proposed rules. “Unlike the USDA organic standards comment period, after which Agriculture Secretary Dan Glickman publicly acknowledged the negative comments received, we’ve heard nothing regarding FDA’s proposed supplements-labeling regulations except this recent spate of articles saying that this is an unregulated industry,” Haeger says. “I find the timing of these articles quite interesting, and based on the historical activity of FDA, it should be taken somewhat as their response.”

The impact of recent negative press about nutritional supplements—including the androstenedione controversy and a New England Journal of Medicine editorial that was critical of dietary supplements and alternative/complementary medicine—may be to embolden FDA, says John Cordaro, president of the Council for Responsible Nutrition (CRN) in Washington. “It provides a basis for them to take a harder line than they would have otherwise. The dietary supplements industry has to appreciate that DSHEA could be taken away unless we demonstrate that these products are safe. The burden of proof is on us. That’s why CRN has stepped up action on this,” he says.

Haeger agrees that the dietary supplements industry bears responsibility for the safety and quality of the products for which it has sought consumer access.

The natural products industry’s next step is to keep talking with FDA, Cordaro says. “We take seriously the comments that we made regarding this issue, and we will talk to the FDA people quietly to ensure that they understand the meaning of those comments and the positive implications of our position. We think that what we have to say will be listened to.”

CFH’s game plan is similar, Haeger says. “We’ve formally requested a meeting with Lead Deputy Commissioner Dr. Michael Friedman, and we’ve asked U.S. Senators Tom Harkin, D-IA, and Orrin Hatch, R-UT, to assist us in setting up this meeting,” Haeger says. “It is important that Dr. Friedman address the comments and indicate what the agency plans to do about them.” Haeger says that CFH’s next effort will be to ask its membership to write letters to the editors of local newspapers and take other actions to focus grass-roots media attention on the number of consumer comments that FDA has received indicating that its proposed supplements labeling regulations should be changed and on FDA’s responsibility to acknowledge this response.