by Paul A. Holmes
With several health care reform packages on the table and the media desperately trying to make a story out of the President's apparent involvement with a failed savings and loan, it might come as a surprise to Washington insiders and those who cover them that the policy issue that has generated most public interest—measured in terms of correspon­dence with Congress—over the past few months has been new regulation concerning vitamin labeling.
The outpouring of public support for the vitamin and nutritional supplement industry, and the level of concern about the Food & Drug Administration's plan to hold the industry accountable for the health claims it makes in its labeling and promotion, has come as a surprise to almost everyone involved in the issue.
In addition to lobbying by the National Nutritional Foods Association, manufac­turers such as Hoffman LaRoche and Lederle Laboratories, retailers like General Nutrition Centers, and a vast number of consumer groups have formed around the issue, anxious to defend products to which they are clearly very attached.
"These are people Clinton really needs to reach out to and recruit if he is going to get healthcare reform,” says Steve Sims, senior vp at Porter/Novelli in Washington, D.C., which represents the National Nutritional Foods Association and GNC. "They are influentials, middle to upper income people who are very involved in their communities. And they are being turned against the Clinton administration by [FDA commissioner] David Kessler."
In June of 1993, the FDA proposed new rules calling for full disclosure on labels of vitamins and minerals—an industry category worth an estimated $4 billion a year and cov­ering everything from Flintstones vitamins to products made from "ground raw bovine prostate" which claim to enhance male sexual potency.
The Administration also raised questions about herbal remedies used as an alternative to pharmaceuticals, and expressed concern about the nutritional value and safety of the fast-growing amino acids category, which includes products aimed at body builders and dieters. The idea that these products might be re-categorized as drugs requiring a prescription was floated.
"We're not looking to deprive anyone of taking what they want," said Kessler at the time. "But we believe that what's in the bottle should be safe, and claims should not be made that cannot be substantiated."
The FDA's interest in the subject began in the late 1980s, when doctors traced an epidemic of unusual and serious symptoms to an amino acid, L-trytophan, which was later banned. Then, studies showed vast differences in the purity and efficacy of dietary supplements, even from pill to pill within the same bottle.
Experts at Duke University examined several brands of L-carnitine and found that more than half were indigestible by humans.
In 1991, more than 50,000 calls to poison centers around the country were questions about vitamins and minerals. Of 18 deaths reported, most were young children who had taken iron pills prescribed for their par­ents, other children were taken seriously ill after swallowing Jin Bu Huan, a powerful central-nervous-system depressant.
Industry spokespeople say such problems are very much the exception rather than the rule, and that there is virtually no risk asso­ciated with dietary supplements.
"There is a small segment of the industry whose activities need to be curtailed," says J. B. Cordaro of the Council for Responsible Nutrition, which represents more than 60 vitamin and mineral manufac­turers.
The Council recommends that members disclose as much information as possible on labels, including possible side-effects, but says many companies do not comply, because such labeling puts them at a disad­vantage. "If my label lists the chemical names of ingredients and your product doesn't, that gives the impression that your product is natural and mine is not," Cordaro says.
Elsewhere, the reaction of the industry was swift and, to a large extent, overblown. One press release claimed that "if the FDA has its way, you won't be able to buy chamomile tea without a prescription." And a video sent to Congress by a coalition of celebrities shows government storm troop­ers staging a midnight raid, breaking into the kitchen of a bath robed Mel Gibson to confiscate a bottle of vitamin C. The video is also scheduled to air as a television com­mercial.
"To a large extent the industry's response has been to prey on people's fears and to spread as much unnecessary alarm as possi­ble," says one healthcare PR agency head, who asked not to be identified. "It's been wholly irresponsible. Basically, all this activ­ity is to mask the fact that the industry does not see why it should have to tell consumers the truth."
The consumer group Center for Science in the Public Interest, which supports label­ing regulation, has been very vocal in its condemnation of the industry's communica­tions campaign, and particularly the Mel Gibson ad.
"The claim that the FDA is about to ban vitamins, or require consumers to obtain a prescription before purchasing them, is the big lie of 1993," says Bruce Silverglade, director of legal affairs for CSPI. "The industry is using scare tactics and misinfor­mation to persuade Americans to support legislation that will allow supplement com­panies to barrage consumers with hundreds of poorly substantiated health claims."
Despite the exaggerations and scare tac­tics—or perhaps because of them—the issue has succeeded in mobilizing many con­sumers. Most prominent in the fight is Citizens for Health, an advocacy group based in Washington state, but individual consumers have inundated Congress with postcards picked up in retail stores and with ads clipped from holistic health publica­tions.
Meanwhile, Porter/Novelli and Ketchum Conununications, which repre­sents Hoffman-LaRoche and created the Vitamin Nutrition Information Service on its behalf 14 years ago, have been taking a more low key approach. They have been working to ensure that the com­mittees studying these issues on Capitol Hill understand them fully, and to balance some of the excesses of the con sumer activist groups involved with more rational discourse.
"The challenge has been not so much to control these groups as to make sure every­one is working in the same direction," says Porter/Novelli's Steve Sims. "By their nature the people involved in this issue have very firm opinions and they will make their own minds up about how best to challenge these regulations."
In one case, for example, consumers in California have started a recall petition to protest the involvement in labeling regula­tion of Sen. Henry Waxman. "That's not necessarily a course of action we would have recommended," Sims says diplomatically. "But these people know what they want and they are prepared to fight for it."
Sims points out that vitamins differ from pharmaceuticals in that the risks associated with them are very low, while the risks asso­ciated with misusing pharmaceuticals are significant. Ketchum's Mark Scheineson echoes this argument, and adds that labeling requirements for foods are not appropriate for supplements, because many of the key ingredients in supplements cannot be listed under the Nutrition Labeling Education Act.
"There is a clear bias at the FDA against supplements," Scheineson says. "They believe that if you have a balanced daily diet and don't take supplements you will be just fine. In fact, the evidence is that supple­ments, added to the daily diet, can make a significant difference in your health, partic­ularly in terms of preventing problems, and preventive medicine is one area we should be concentrating more on."
Both Sims and Scheineson argue that unlike the much larger pharmaceutical industry, where products are protected by patents, it is not economically feasible for vitamin and supplement makers to invest in the kind of scientific research the FDA requires. Moreover, since the claims of many supplements have to do with pre­venting disease, extremely lengthy tests—perhaps ten or 15 years—would be required to indicate their effectiveness.
Despite all its—efforts to the con­trary, however, the industry has lost the first round of the lobbying battle. In mid-December, a moratorium preventing the FDA from regu­lating vitamins and supplements under the NLEA expired, and the draft proposals the Administration put forward in June became official.
The only health claims currently approved for use are on the relationship between calcium and osteoporosis, sodium and hypertension, fat and cholesterol and coronary heart disease, fiber and cancer and antioxidants in fruits and vegetables and heart disease. The FDA has also indicated that it will allow claims that folic acid in early pregnancy can reduce the threat of certain birth defects.
There are now two bills before Congress, however, which would prevent the FDA from taking action, sponsored by Senator Orrin Hatch of Utah, one of the industry's strongest supporters, whose home state is headquarters to some of the industry's largest players, and Representative Bill Richardson of New Mexico. The industry is now throwing its weight behind those two bills, each of which is designed to curtail the FDA's authority.
The focus of the industry's communica­tions efforts will also change. Says Gerald Kessler (no relation to the FDA administra­tor), executive director of the Nutritional Health Alliance, an industry group: "We are honing in more on censorship of state­ments rather than the lack of availability of products."
The industry will argue that consumers have a right to information; the FDA will argue not if that information is misleading.