Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: SUNDAY, July 3, 1994 TAG: 9407030021
SECTION: NATL/INTL PAGE: A6 EDITION: METRO
SOURCE: Los Angeles Times
DATELINE: WASHINGTON LENGTH: Long
The 82-year-old Torrance, Calif., 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.
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 good-bye!" 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 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 pre-empt 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 under regulations that took effect Friday.
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 and New Age adherents - bring a certain zealotry to the cause.
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.
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 Mitch Zeller, a special assistant for FDA policy. "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."
by CNB