Vitamin Showdown: Who Should Control Dietary Supplements?

By Gannon, Kathi | Drug Topics, January 24, 1994 | Go to article overview

Vitamin Showdown: Who Should Control Dietary Supplements?


Gannon, Kathi, Drug Topics


It all started with a simple act of Congress: In 1990, Congress passed the Nutrition Labeling & Education Act (NLEA), authorizing the Food & Drug Administration to regulate health claims for foods, initially, and, later, for dietary supplements. Sound simple enough? Well, enter the dietary supplement industry, and vitamin products--long a staple in drugstores-- become the center of a heated controversy between the FDA and Capitol Hill.

NLEA initially stated that claims on food products must be backed by "sound scientific data." A later amendment placed dietary supplements under the same standards. NLEA also mandated that the nutritional information found on food labels must also be included on dietary supplement labels.

That never happened. Bowing to pressure from consumer groups and the supplement industry, Congress turned around and--through the 1992 Dietary Supplement Act spearheaded by Sen. Orrin G. Hatch (R, Utah)--blocked the FDA from taking control over dietary supplements for one year (ended Dec. 15, 1993). Now, the 1993 Dietary Supplement Health & Education Act--jointly sponsored by Hatch and Rep. Bill Richardson (D., N.M)--threatens to close the FDA out of the loop altogether. If enacted, the bill would permanently restrict the FDA from regulating dietary supplements under NLEA; manufacturers would be able to make claims without FDA scrutiny. Prior to the expiration of the moratorium, two further bills that would have extended it were issued, but both died before reaching the Senate floor.

The first bill, sponsored by Hatch (R, Utah) and Sen. Edward Kennedy (D, Mass.), would have extended the moratorium for another four months. Kennedy had questioned some aspects of the Hatch-Richardson bill, and the new bill represented a "compromise" between the two senators. The second bill, proposed by Rep. Henry A. Waxman (D, Calif.), would have extended the moratorium for another six months.

With the expiration of the moratorium, the FDA published, in the Dec. 30, 1993 Federal Register, final rules toward implementation of NLEA. These rules stated:

*Health claims can be made that show that folic acid is effective against neural tube birth defects. (Previously, the FDA had approved a calcium/osteoporosis claim.)

*Nutrients in supplements must be listed in a contents panel on the label, just as with foods, by July 1995.

*Recommended daily intakes of seven nutrients previously not recognized on labels must be established. These nutrients are vitamin K, selenium, chloride, manganese, fluoride, chromium, and molybdenum.

Unless they are blocked, the final rules will take effect in July, excluding the nutrient contents portion, which will be put into practice a year later.

REVENUE BOOSTERS: As the hoopla continues, vitamins, minerals, and supplements continue to thrive as revenue-producers on OTC shelves. Drug Topics recently reported on a study prepared by New York City-based Packaged Facts Inc., which revealed that sales in the dietary supplement market hit $3.5 billion in 1992, a 7.4% upswing over the preceding year (Drug Topics, Sept. 6, 1993).

New figures just released by Northbrook, Ill.-based Nielsen Marketing Research show that sales for vitamins alone in drugstores, food stores, food/drug combos, and mass-merchandisers reached $969 million in 1993, up from $862 million in 1992, a 12% gain. In drugstores alone, sales rose 11%, from $426 million to $474 million, during that time span (see table on page 41 for complete breakdown). (Table omitted)

Michael Perlmutter, senior consultant with Fairfield, N.J.-based Kline & Co., a market research firm, doesn't think the fight for control in Washington, D.C., will have any ultimate effect on sales in this booming market, regardless of the outcome. "The way we look at the market, sales won't be affected," Perlmutter said. "The big companies, which generate most of the revenues, meet the FDA guidelines. …

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