COLUMN ONE : The Potent Politics of Vitamins : The industry has launched a controversial campaign against FDA regulation. It’s had surprising impact.

Edward Handcock is a faithful patron of Mrs. Gooch’s natural food emporium in Redondo Beach, a true believer in the restorative powers of fish oil--and a foot soldier in the “vitamin wars” of the 1990s.

The 82-year-old Torrance resident is a willing recruit in the army of consumers who have gone to bat for the $4-billion-a-year dietary supplement industry in its battle with the federal government over regulation of everything from beta carotene to shark cartilage.

“We have to fight for our freedom,” declared Handcock, who swears by the daily regimen he began after a heart attack 42 years ago: fish oils to keep his arteries unclogged, borage oil to aid his digestion and a smorgasbord of vitamins A, B, D, E and F, as well as calcium and magnesium, to keep him fit and vigorous.

The retired engineer is convinced that federal regulators are waging an assault on his well-being. He has sent numerous letters to members of Congress, urging them to protect his right to buy any product he likes. Legions of Americans like him have made the supplement uprising a movement that some compare to gun control or abortion in its emotional intensity.

In the last year, Capitol Hill has been flooded by correspondence urging Congress to keep the government’s hands off vitamins and related health products. The grass-roots campaign has been stoked by supplement manufacturers and distributors.

The effort has reached millions of supplement users through a nationwide network of mail-order flyers, fax bulletins, TV spots, form letters, petitions, videos, books and other materials distributed through “legislative action tables” at health food stores. The target is the Food and Drug Administration, which is implementing a law restricting health claims for supplements.

There is potent evidence the industry is gaining ground. Not necessarily the high ground, however.

Critics decry the campaign as downright deceptive. Even some mainstream members of the vitamin industry regard some of the rhetoric as overblown and the tactics excessive. Movement activists have tried to jam FDA phone lines, and have compared the agency to the Gestapo. In any case, the supplement showdown demonstrates the increasing sophistication of lobbying campaigns undertaken by special interests who use marketing savvy, public relations skills and technological expertise to create a temporary frenzy on Capitol Hill.

The issue also focuses attention on a small but lucrative industry that occupies a unique niche within the giant health care sector: the purveyors of nutrients and nostrums that the FDA says are generally benign but in some cases potentially dangerous.

The FDA and its congressional allies say they do not intend to restrict access to supplements that are safe and that do not make false or misleading assertions about health benefits. For instance, a supplement cannot be touted as curing cancer or AIDS, or halting the aging process, unless there is substantial scientific evidence.

But the FDA said last year it was considering regulating some amino acids and herbs as drugs or as food additives, which would invoke tougher safety standards. The agency also cited a need to develop new guidelines for vitamins and minerals that “are safe when consumed at low levels but may have adverse effects when consumed daily at higher levels.”

Such talk fueled an already-high level of distrust in the industry and consumers. Vocal activists--some of whom make the kind of exotic products that could face problems from increased regulation--suggested the FDA’s pronouncements proved the government planned to restrict access to all supplements, if not to ban them outright.

“Write to Congress today or kiss your supplements goodby!” warned a brochure widely distributed to consumers through a network of health food stores and mail-order houses by the Nutritional Health Alliance, a coalition of industry groups. In a television ad, a SWAT team crashes into actor Mel Gibson’s house and seizes his vitamins.

Vitamin makers and merchants have told millions of customers that the FDA wants to either require a doctor’s prescription to obtain their products, drive up prices, or pull them off the shelves altogether. It is a potent appeal, because some consumers view access to supplements as nothing less than a matter of life and death.

Moreover, activists have used the issue not only to fight additional safety regulations, but to try to weaken a 1990 nutrition-labeling law requiring supplement makers to support health claims with “significant scientific agreement among qualified experts”--just as most food manufacturers must do.

Whatever its veracity, the high-powered campaign is having considerable impact.

Sen. Barbara Boxer (D-Calif.) received 35,000 letters on supplements last year--nearly as many as on the economy and twice as many as on education. Boxer is one of 65 senators co-sponsoring an industry-backed measure introduced by Sen. Orrin G. Hatch (R-Utah) that would place the burden of proof on the FDA to show a product is unsafe, rather than making the manufacturer prove its safety.

It also would preempt the FDA’s authority to treat any supplement as a drug or food additive and make it far easier for manufacturers to support health claims than it is under regulations that took effect Friday.

In a recent showdown over the Hatch bill and alternative legislation by Senate Labor and Human Resources Committee Chairman Edward M. Kennedy (D-Mass.) that would be tougher on the industry, Kennedy was twice soundly defeated by pro-supplement lawmakers. It was the first time in memory that Kennedy had lost a vote before his own panel.

The stakes are high. At issue is the way the safety of vitamins, amino acids, herbs and other widely used products will be determined and the standards used to screen health claims for them.

Some 100 million Americans take supplements to bolster diets, enhance well-being or combat illness. Many consumers--who range from anti-government libertarians to health-conscious yuppies to New Age adherents--bring a certain zealotry to the cause.

“In 15 years in this town, I’ve never dealt with anything as emotional as this issue,” said Donna V. Porter, a life science specialist for the Congressional Research Service. “It’s as volatile as abortion, gun control and prayer in schools. People are irrational on this whole subject. They don’t hear what they don’t want to hear. They really believe FDA is out to get them.”

Pitched battles over dietary supplements are not new. The FDA has long maintained that Americans can meet their nutritional needs by eating a well-balanced diet. In 1976, faced with consumer backlash, Congress passed legislation limiting the agency’s authority to regulate the composition of supplements. The FDA then backed off further regulatory efforts.

The climate began to change in 1989 when 1,500 cases of a painful muscle and blood disorder, including 38 deaths, were associated with L-tryptophan, an amino acid used by some to treat insomnia, depression and premenstrual syndrome. The product was taken off the market.

The FDA says that, while most of the ingredients in supplements “present few safety concerns,” there is evidence that a small number can cause liver and kidney damage, seizures, and even death. Manufacturers deny that their products pose such dangers.

In 1990, Congress passed the Nutrition Labeling and Education Act, which established requirements for allowing nutrient and health claims for foods, and authorized the FDA to determine whether it should create a separate system for approving claims for dietary supplements.

“When consumers see a health claim for a dietary supplement, they assume it will provide the benefit it touts,” FDA Commissioner David A. Kessler said. “In fact, the marketplace is awash in unsubstantiated claims,” some of which are fraudulent and harmful.

Congress instructed the FDA to consider four specific health claims for supplements. The agency initially approved a claim that calcium helps prevent osteoporosis. It subsequently approved a second claim that folic acid taken by pregnant women lowers the risk of severe neurological birth defects.

The second key step occurred in 1991 when Kessler, seeking a more comprehensive approach, named an internal task force to examine alternatives for regulating supplements.

A year later, he said the task force had concluded “safety should be the overriding concern” in any FDA regulation and that “its recommendations should recognize a role for dietary supplements in ensuring a balanced diet and, with safety as an underlying principle, freedom of choice for these products should be allowed as much as possible.”

In mid-1993, the FDA took a step that unwittingly gave supplement advocates new ammunition. At the same time it published regulations to implement the labeling law, it announced plans to propose regulations on broader safety issues and requested industry input.

That signal became the basis of the industry’s claims that the FDA intended to treat amino-acid and herbal products as drugs or food additives and to sharply limit the dosage of vitamins. One advocacy group said the FDA aspired to “over-regulate, restrict and eliminate the dietary supplement industry.”

FDA officials insist that the intent and significance of the notice were grossly overstated.

“The agency has absolutely no plans to pursue any of the regulatory options laid out” last year, said Mitch Zeller, a special assistant for FDA policy. “We need a lot more data to even begin to make an informed inquiry into what our regulatory options are.”

But a Democratic congressional aide sympathetic to the FDA’s position faulted agency officials for failing to anticipate the reaction of supplement makers and users.

“This was like putting red meat in front of a wild cat,” the aide said. “They never understood the politics of the movement because their mind-set has been: ‘This is how science operates.’ But science doesn’t operate in a vacuum. Particularly in this country, in terms of scientific regulation, it operates in a political environment.”

Backed by the industry, Hatch and Rep. Bill Richardson (D-N.M.) introduced bills to address the issues of claims and safety. Each lawmaker represents a region with high concentrations of supplement suppliers and consumers. About 250 House members have signed on.

The measures reflect the industry’s desire to adopt a standard for health claims that would recognize all available scientific evidence, rather than significant scientific agreement among experts as required by the 1990 act. Critics say this approach would allow claims to be made based on studies that are preliminary, applicable only to animals or unconfirmed.

Using a network of 10,000 health food stores nationwide as well as mail-order houses, advocates sent flyers urging consumers to oppose implementation of the labeling law and to back the Hatch-Richardson bill to “protect consumers’ access to dietary supplements.”

Displays were set up at health food stores with copies of letters to be sent to members of Congress. Some stores offered discounts to participants. Others provided free phone lines to call lawmakers.

During a nationwide “blackout day,” many stores refused to sell products that were allegedly threatened. To underscore the notion that supplements could face extinction, sponsors made the brontosaurus the event’s symbol.

The lobbying effort hit a nerve with legions of consumers who regard the FDA as an agent of a medical, pharmaceutical and political Establishment that opposes alternative approaches to nutrition and health care, such as homeopathy. Conspiracy theories abound about the motivation of the FDA as well as lawmakers who support supplement regulation.

“What has made the campaign so effective is that you have a zillion consumers who really believe in these products and want to make sure they not only have the right to take them but have the right to get information about them,” said Patricia Knight, Hatch’s health policy adviser.

The grass-roots campaign fused the claims and safety issues as one in the public’s mind. Critics contended that this was a deliberate tactic designed to frighten consumers into believing that they might lose their supplements, mobilizing them behind the industry’s more subtle crusade to ease the standard for making health claims.

“This was the big lie of 1993,” said Bruce Silverglade, director of legal affairs for the Center for Science in the Public Interest, a consumer-advocacy group. “The consumers who wrote Congress had a financial interest in the matter or were duped into believing the FDA was using the new labeling law to ban their favorite vitamins.”

The industry has not relied on public pressure alone. It has spent more than $2 million lobbying Congress to pass the Hatch and Richardson bills, an analysis of public records by the center found.

Industry advocates insist the FDA’s anti-supplement track record gives them reason to suspect the worst. They contend the agency has been reluctant to approve the claims that Congress instructed it to consider. And they say they do not consider the FDA a fair arbiter because it relies on scientists who oppose non-traditional approaches to nutrition and health.

“There needs to be an independent body looking at both ingredients and claims, but not necessarily the government,” said Michael Ford, executive director of the National Nutritional Foods Assn., a coalition of 5,000 retailers, manufacturers and distributors. “FDA is utterly uninterested in input from the affected industry.”

Still, Ford is among various industry mainstays who acknowledged discomfort with elements of the pro-supplement campaign.

“We do not agree with many of their tactics,” said Kenneth M. Rosenberg, chairman of Pharmavite Corp. and head of the government relations committee for the Council for Responsible Nutrition, which represents mainstream manufacturers of vitamins and minerals and supports the Hatch-Richardson legislation. “We do not agree with much of their literature. We absolutely feel they have gone overboard in many instances.”

The campaign led Congress, at the industry’s urging, to postpone initial implementation of the regulations implementing the 1990 labeling act.

On May 11, Kennedy’s panel approved Hatch’s bill on a 12-5 vote after rejecting Kennedy’s alternative. The Hatch measure would preclude the FDA from treating any dietary supplements as drugs or food additives and delay imposition of the new restrictions on health claims for two to three years. It also would give the FDA emergency authority to act against dietary supplements that pose an imminent health hazard.

In a bid to allay some opposition concerns, Hatch incorporated a proposal to create a congressionally appointed commission to conduct a two-year study of how to improve the process for determining the validity of health claims. And he vowed to revise the bill to allow the labeling act to take effect while the commission deliberates.

Rep. Henry A. Waxman (D-Los Angeles), who chairs the House Energy and Commerce subcommittee on health and environment and wrote the 1990 labeling law, said disputes remain over the standard of scientific support for health claims, and a provision of the bill that could allow prescription drugs to be sold as supplements without any safety review.

For its part, the FDA maintains that, no matter what consumers are told, it will continue to allow access to supplements.

“Sell anything you want as long as it’s safe,” said the FDA’s Zeller. “But if you’re going to make a claim to treat or cure or reduce the risk of something like AIDS, cancer or Alzheimer’s disease, you better have the science to back it up. If you don’t have the science, you can sell your product; just don’t make the claim that the science doesn’t support.”

Researcher D’Jamila Salem contributed to this story.

A SAMPLER OF QUESTIONABLE CLAIMS

The Food and Drug Administration cites these examples of unsubstantiated health claims made by makers of vitamins and supplements:

Garlic: Inhibits growth of bacterial and viral infections.

Raw Thymus: Prevents AIDS, cancer and herpes.

Yucca: Helps fight arthritis and gout.

Hawthorne: Relieves high blood pressure and hypertension.

Horsetail: Speeds the healing of fractured bones.

Shark Cartilage: Eradicates cancerous tumors.

Parsley: Removes small kidney and gallstones.

Comfrey*: Fights infection and kidney/bladder ailments.

Vitamin C: Improves the immune system.

* Plants

Source: “Unsubstantiated Claims and Documented Health Hazards in the Dietary Supplement Marketplace,” Food and Drug Administration, July, 1993.