FDA EXTENDS COMMENT TIME ON SUPPLEMENT LABELING RULES

MINA WILLIAMS

WASHINGTON (FNS) -- The Food and Drug Administration here has extended the public comment period for its proposed dietary-supplement labeling regulations to Sept. 28. Originally, the comment period was to have closed Aug. 27.

"There is no special meaning to this extension," said Ruth Welch, FDA press officer. "There are often extensions given for public comment periods."

The regulations will define the types of statements that can be made about the effect of a dietary supplement on the body.

If passed, these regulations would have a profound effect on the natural and whole-food nutritional-supplement and nutriceutical industry, and would affect vitamins, minerals and dietary supplements. In the proposed regulations the FDA has redefined acceptable labeling statements, industry insiders said.

Retailers, particularly those involved in natural food merchandising, again have found themselves launching campaigns against a federal agency. Last spring these retailers banded together to urge consumers and vendors to comment on the U.S. Department of Agriculture's organic standards. More than 165,000 comments were received before the close of that public comment period.

"As a responsible and conservative retailer, we feel the FDA is out of line," said Phil Nabors, owner of Mustard Seed, Akron, Ohio. "People are seeking natural health solutions and taking their wellness into their own hands. It's insulting."

Reportedly, the FDA already has received 20,000 comments, and industry analysts expect the volume of public comments on the proposed dietary supplement labeling regulations will slightly top responses the up to 40,000 comments received in previous comment periods.

"At Wild Oats [Community Markets], we believe our shoppers have the right to make informed choices about their health," said Karen Lewis, purchasing director of Natural Living nonfood departments at the chain, based in Boulder, Colo. "The FDA's proposed regulations threaten the amount of information and scientific research that consumers can access. We want our shoppers to understand the serious implications that these standards have on consumers' ability to decide what's best for their health."

To educate customers, Wild Oats distributes leaflets about the regulations at its 57 locations. Shoppers are encouraged to sign poster-sized petitions and complete comment cards. This effort is being mounted in hopes that public outcry about the proposed standards will persuade the FDA to rewrite the rules, said Lewis.

Mustard Seed customers are also signing postcards. "In the natural products industry, we have to be activists," said Nabors. "We now know how to put on that hat. We want to sell what people want to buy."

Whole Food Markets, in Austin, Texas, is garnering public comment via preprinted postcards, available for customer signatures at the front end. The cards were made available by Citizens For Health, a Boulder consumer group. Citizens For Health has also distributed placards along with the postcards to retailers.

"We have not had one customer refuse to sign a card," said Pat Toomey, owner of Toomey's a Milford, Ohio, retailer. "Our customers are familiar with dietary supplement legislation since the 1994 DSHEA [Dietary Supplement Health and Education Act] passage. The average consumer in this industry tends to read and take issues to heart. They have an investment in this legislation and see it as a freedom-of-choice issue."

Under the current regulations, outlined by the DSHEA, consumers have access to information about supplements by reading the package or seeking help from trained personnel. If the FDA is successful in amending this act, manufacturers will not be allowed to make claims about products' effectiveness or what scientific research supports its claims.

"We did not expect such substantive rules," said Michael Ford of the National Nutritional Foods Association. "We were very surprised when the proposed rules came out. We were dismayed."

Industry leaders also are concerned that language included in FDA's proposal redefines what disease is. The proposed definition of disease would be any deviation of the body from a "natural" state.

Such a redefinition, consumer activists say, would limit consumers' access to information about vitamins, minerals and herbs that help prevent disease or promote wellness, used to alleviate the symptoms of aging, pregnancy, menopause, headaches and even brittle fingernails. The rule, retailers say, would threaten the availability of popular supplements, including St. John's Wort.

"The FDA has created a Catch-22 with regulations," said Ford. "There can no longer be a discussion about disease."