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The FDA may be out to take your vitamins

Vitamins, FDA

Vitamins and supplements

Brian Hagiwara

ONE ISSUE OUTSTRIPPED ALL OTHERS IN BOTH THE volume and the intensity of its citizen lobby during the first session of the 103rd Congress. Far beyond the budget or NAFTA or congressional perks, nutritional supplements generated the most heat and the most mail of any issue considered. And it’s not over yet.

Fearing a proposed increase in the regulatory authority of the Food and Drug Administration, the supplement industry has mounted a textbook lobbying campaign to oppose it. The industry has taken advantage of a tremendous grass-roots network of health-food stores, which sell vitamins, herbs, amino acids, minerals and more to a clientele ranging from young bodybuilders to people with AIDS to aging beatniks. Spurred by literature warning consumers to “kiss your vitamins goodbye” if the FDA isn’t collared, supplement users have responded by deluging Congress with mail demanding “Freedom of Choice” in health care.

The source of the industry’s angst is the Nutrition Labeling and Education Act. Though passed in 1990, the act authorized the FDA, starting in December 1993, to prohibit supplement producers from making health claims not endorsed by “significant scientific agreement” — a more specific standard than applied under previous law. The NLEA, backed by the American Heart Association, the American Cancer Society and consumer groups, empowers the FDA to halt unscrupulous or unfounded claims that certain dietary supplements are “cures” for various ailments.

The FDA, for instance, could force a manufacturer to withdraw a claim that its product helps fight the AIDS virus. Presumably, the NLEA will also make commerce a bit more precarious for manufacturers of products such as Memory Booster, Immune Action and Calms Kids. (None of these makes explicit claims, though their brand names clearly imply results.)

The FDA swears it means supplement consumers no harm: It merely wishes to subject products to basic truth-in-labeling regulations. Industry representatives, on the other hand, swear the FDA, in league with pharmaceutical corporations, wants to destroy the supplement business. “I’m aware of the charges, and we’ve been telling anyone who’ll listen that those charges aren’t true,” says FDA spokesman Mitch Zeller.

The industry, however, has succeeded in convincing many consumers that the NLEA is a threat to their way of life. Many letters to Congress warn of dire consequences of FDA regulation. “My husband’s cancer has been held in check since 1987 by massive doses of vitamin C,” one woman wrote. “He will surely die if access to this important vitamin is made difficult” Judging from the long list of co-sponsors on legislation seeking to exempt the industry from the NLEA, the mail barrage is winning converts.

Bubbling just beneath the surface of the battle is the real source of the industry’s enmity. The supplement crowd views the FDA as a pillar of the official medical establishment, which has ridiculed alternative health care for years. But despite the establishment’s best efforts, alternative providers continue to expand. Supplement makers alone now make up an almost $4 billion industry. They fear any increased powers for the FDA — including power to determine what constitutes “significant scientific agreement” about a health claim — will inevitably favor established medicine at their expense.

Despite the industry’s often hysterical propaganda, its list of grievances with the FDA is compelling. Though the FDA approves health claims for fruits, vegetables and grains that provide vitamin C, betacarotene and fiber, it refuses to grant similar claims for supplements that provide the same nutrients.

And the FDA waited long after the Public Health Service and the Centers for Disease Control to acknowledge that folic-acid supplements deter neural tube birth defects, such as spina bifida. “There are literally several hundred children with birth defects that could have been prevented”, says Carl Germano, director of product development at Solgar, a New York supplement manufacturer.

Currently, as the volume of research grows suggesting antioxidants like vitamins C and E may reduce the risk of heart disease and certain cancers, the FDA prohibits supplement makers from advertising the results of such studies. “There’s a load of data on many nutrients they don’t acknowledge,” says Germano. “We’re very concerned about the bad image of our industry that has resulted from a fringe element out there. We welcome the day when the fad products and the fringe are gone. But there’s been a consistent bias against this industry by the FDA.”

Given this perception, it’s somewhat easier to see why even high-quality supplement producers are concerned about the FDA’S requiring “significant scientific agreement” before permitting claims. From the industry’s viewpoint, there was significant scientific agreement about the benefits of folic acid well before the FDA ever got around to accepting it. ” ‘Significant scientific agreement’ — that’s not so far off fromwhat we would accept,” says Germano. “But we don’t know what they mean by ‘significant scientific agreement.’ “

Meanwhile, the industry continues to pull out the stops. In a 60-second public-service announcement produced by supplement maker Trace Minerals Research, a SWAT team bursts from the back of a van and charges toward an immaculately maintained mansion. Once inside, the troopers’ night-vision goggles focus on a grand, sweeping staircase worthy of Norma Desmond. The black boots mount the stairs and lunge into a second-floor kitchen, shouting, “Freeze!”

The culprit, caught in his bathrobe, is actor Mel Gibson, holding a bottle of contraband Vitamin C. “What you saw in the Mel Gibson public-service announcement is only a faint heartbeat away from becoming reality,” warns Bruce Anderson, president of Trace Minerals, in a video complement to the ad.

Though the FDA’S new authority commenced Dec 15, Congress may yet enact pro-industry legislation. The industry’s champion in the House is Democrat Bill Richardson, whose Santa Fe, NJM, district includes a host of New Age constituents who don’t want the feds messing with their minerals. In the Senate, it’s Republican Orrin Hatch of Utah, in whose state a number of supplement makers, including Trace Minerals, are based.

Before the holiday recess, Richardson had signed up more than 200 House co-sponsors, and Hatch had a solid majority of the Senate. How many of these are true believers and how many just want temporary respite from bothersome constituents remains to be seen. Either way, the issue has exposed a remarkable level of public anxiety. If a proposal to regulate vitamin labels can engender so much passion, imagine what’s in store when health-care reform finally gets on the table.


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