The Feds' New War On Drugs

By Kaz Murphy

On June 15, 1993, the U.S. Food and Drug Administration (FDA) proposed new rules extending the Nutritional Labeling and Education Act of 1990 (NLEA) to include dietary supplements, such as vitamins, minerals, herbs, amino acids and glandular extracts. The pending regulations would set new standards for nutrient content claims and product labeling, and would also require disease-related claims to be scientifically valid.

The agency's plan is to regulate supplements for safety without determining whether they are effective. This fiercely defies the theory behind natural healing. Herbalists and naturopaths agree with the FDA that supplements must be safe, but, at the same time, they want to continue practicing medicine and be free to educate the public on the effective use of all supplements.

As the federal government continues its efforts to regulate dietary supplements, many in the alternative health community are up-in-arms over what they say is a vicious and misguided attempt to clamp down on alternative medicine.

Few consumers, however, are even aware that the issue exists. Of the 100 pr so supplement users contacted for this article, less than a dozen of them knew what I was talking about.

If you use alternative medicine, take heed: these new regulations will not only hit your pocketbook, they could seriously restrict the availability, quality and strength of nutritional supplements.

Your Tax Dollars At Work
The FDA's plan is to categorize supplements as either "drugs" or "food additives" and then make them meet certain regulations. The FDA's main interest is in herbs, amino acids and glandular extracts because little is known about these substances.

"How can so little be known about them when supplements have been used for centuries with not one confirmed death?" asked one employee of Capitol Hill's Central Co-op. "I meant today there are over 100 million consumers."

The FDA's plan would also restrict levels of maximum dosage in vitamins and minerals. For example, it is proposed that vitamin C will have a maximum dosage of 60 milligrams. Most consumers take doses of 500 milligrams.

"Once we set those levels ... anything above those levels would be considered unapproved food additives," says FDA Deputy Commissioner Gary Dykstra. "You couldn't get it by prescription. You would just have to take more pills."

This is typical of the reasoning that has the alternative health community so upset. The FDA already has a proposed list of dietary supplements - including ginseng, echinacea, chaparral, guar gum, germanium and many others - that it wants tested, regulated and possibly removed from the marketplace altogether.

This means dietary supplements will be taken out of the hands of alternative practitioners and put under lock and key by pharmaceutical companies and the American Medical Association, at a healthy profit. New costs for research, manufacturing, labeling and packaging would send prices through the roof.

Plus, because the FDA wants to place limits on maximum dosage, consumers would not get as much for their money.

The labeling issue is blurry because if a supplement is not classified as a drug, it is therefore illegal for a health store clerk or practitioner to claim that it has healing qualities. If there is no label on a product (like with raw herbs), it's the same story: They can sell it to you but they're breaking the law if they tell you how much to take. Keeping the public uninformed about supplements creates a greater possibility of danger. Having supplements tested and labeled might make the public more aware, depending on how it were done. But critics feel that the FDA's present stance does not give supplements due justice.

Standard, modern medicine involves taking drugs in order to control disease symptoms when they appear, while alternative medicine focuses on strengthening the entire body to fight off disease before it happens: totally opposite philosophies.

If the NLEA regulations go into effect, which could happen as early as Dec. 31, 1993, the FDA will have the power to classify certain supplements as drugs, meaning the manufacturer would need a pharmaceutical license to sell them. Forget some supplements, you might even need a prescription from a doctor.

Not surprisingly, many questions are buzzing through the alternative health community:

• Will safe and beneficiary supplements be unfairly restricted and removed from shelves?
  
• Does new labeling mean higher prices?
  
• Will alternative practitioners slowly be forced out of business because of expensive equipment needed to test and regulate?
  
• Will you need a prescription form an M.D. in order to purchase certain supplements?
  
• Will consumers be buying from drug stores instead of licensed herbalists?
  
• Will licensed herbalists need pharmaceutical licenses to sell their products?
  
• And finally, could alternative medicine eventually be squeezed out of the picture in favor of synthetic drugs?

"Alternative healers have spent 20 years educating the public," says Clarissa Smith, the owner of Wyoming Wildcrafters, an herbal manufacturing and mail order business in Jackson Hole.

"We did the hard work of getting the word out and now that the public is aware of alternative medicine, the FDA is going to put us out of business and - whether intentionally or not - hand it over to drug companies.

"I don't think the FDA has a clue about the long history and real use of herbs," says Smith of Wyoming Wildcrafters. "It's frightening to think how easy it will be for drug companies to make less potent supplements and doctors to be unknowingly prescribing them.

"There's got to be another way," she said. "This way seems to be an outright attack on the freedom of choice of U.S. citizens. Alternative medicine won't be alternative anymore."