Bearded and hairy-legged devotees of complementary and alternative medicine are quaking in their Birkenstocks over concerns that big government and big pharma are out to get them - and you. They would have you believe:

* Herbs and natural supplements are safer alternatives to conventional medicine (especially medicine made by huge evil pharmaceutical companies) and help increase the efficacy of other drugs.

* The FDA has an organized campaign to keep valuable information from you regarding the miracles some herbal supplements can perform in the prevention of serious illness.

* Strong-armed tactics by a vicious FDA are effectively wiping gentle, natural remedies off the shelves.

Is the panic justified? Will you soon have to say bye-bye to bilberry and sayonara to selenium? Nah - of course not. The natural herb and supplement industry is safe, because the FDA can barely keep a handle on it. But the real question is, are the products?

What's in your capsules?
In 1994, Congress passed the Dietary Supplements Health and Education Act (DSHEA) which gave supplement manufacturers the freedom to market a wider variety of products as dietary supplements, and allowed manufacturers to make claims about how their products affect the "structure and function" of the body. Rather than hinder the sale of natural supplements, the Act expanded the types of products that could be marketed as "supplements." I would think the most logical definition of "dietary supplement" would be something that supplies one or more essential nutrients missing from your diet, right?

Actually the DSHEA went far beyond this to include vitamins, minerals, herbs or other botanicals, amino acids or other dietary substances. Although many such products (particularly herbs) are marketed for their alleged preventive or therapeutic effects, the 1994 law made it difficult or impossible for the FDA to regulate them as drugs. Since its passage, even hormones, such as DHEA and melatonin, are being hawked as supplements.

"I think it's ironic and political that the supplement manufacturers accuse the FDA of heavy-handedness," says Susan Burke, spokesperson for the Florida Dietetic Association, "because without the FDA we'd be back to manufacturers putting the "oat bran" label on potato chips and beer! The FDA is supposed to protect consumers, and because the dietary supplement industry lobby is so strong, today we see all types of claims on packaged foods and supplements that aren't supported by research."

Forget about efficacy, what about safety? Supplement manufacturers aren't required to submit any safety information before marketing. Unlike drugs, which must go through years and years of expensive clinical trials on thousands of participants, dietary supplements have no such requirements. The FDA has to rely on negative reports, product sampling, information in scientific literature, or other sources of evidence of danger to act. And since the FDA is unable to monitor and regulate thousands of individual products, the burden of proof falls on you.

Standards, Shmandards
There are simply no official standards for quality in dietary supplements. "Good Manufacturing Practices" were promised in 1994, when the DSHEA passed, but have never been developed or issued by the FDA for supplements as there are for food.

You can be fairly certain your paper pack of Gold Medal contains a pound of fine-milled, bleached flour rather than talcum powder. But because there are no FDA standards for dietary supplements, there's no way to know if Joe Schmo-brand ginkgo biloba capsules contain any more biloba than my elbow. And that's a fairly "safe" ingredient.

In June 2000, the New England Journal of Medicine published a report regarding an outbreak of urinary tract cancers in Belgium among users of a Chinese herbal product that contained aristolochic acid-a known carcinogen found in an herb called Aristolochia fangi. In an accompanying editorial, Former FDA Commissioner David A. Kessler, MD. JD, noted that herbal products containing A. fangi had been banned in several European countries but were available in the United States.

Commenting on the DSHEA, Kessler said, "The FDA does not scrutinize a dietary supplement before it enters the marketplace. The agency is permitted to restrict a substance if it poses a "significant and unreasonable risk" under the conditions of use on the label or as commonly consumed.

He continued, "The safety standard may sound as if the FDA has all the authority it needs to protect the public. The problem is that the burden of proof lies with the FDA. Even when the agency is able to act, how is it supposed to know which products contain aristolochic acid, and who sells them? What is the agency supposed to tell people who may have consumed these herbs? Congress has put the FDA in the position of being able to act only after the fact and after substantial harm has already occurred."

"A. Fangi" isn't the first dietary supplement to cause potentially serious harm. Among other well-documented examples of adverse reactions, are the association of germander with acute hepatitis, of comfrey with hepatic veno-occlusive disease, of yohimbe with seizures and renal failure, and of ephedra with death from cardiovascular causes.

In his 2000 comments, Kessler added one final, ominous note, "It took a tragedy-poisoning caused by the use of an elixir of sulfanilamide-to prompt Congress to pass the Food, Drug, and Cosmetic Act of 1938, and it took reports of birth defects among the children of women who took thalidomide during pregnancy to secure passage of the Kefauver-Harris Amendments to that act in 1962. Congress has shown little interest in protecting consumers from the hazards of dietary supplements, let alone from the fraudulent claims that are made, since its members apparently believe that few of these products place people in real danger. Nor does the public understand how potentially dangerous these products can be." Yikes.

Dangerous Cocktails
And if all that weren't enough to make you nervous, there's the problem of supplement-drug interactions. Some combinations can be dangerous.

According to the American Council on Science and Health, drugs and supplements may interact in a variety of ways. They may have similar actions in the body, which means taking both at the same time can cause an excessively strong effect. Or a supplement may counteract the effect of a drug. Some dietary supplements may affect the absorption of a drug from the digestive tract into the bloodstream, or affect the way the body breaks it down, thereby reducing its efficacy.

The bottom line is, if you're taking any prescription or over-the-counter medicine (which is like, everybody) make sure you consult your doctor before taking any dietary supplement.

Will the madness end?
Browse past the virtual shelves of supplements online, or walk in a store and you'll see living proof that the FDA is not working very hard on investigating products or claims. You can still buy "Staminol Steel-Libido" (which, by the way, includes yohimbe) or "GroBust" (gee, what really turned my A's into C's? Was it the "blessed thistle" or the "Dong Quai?").

Even the industry leaders would welcome a bit more stringent regulation. Steven Nelson, a spokesman for GNC, "We have supported the additional regulation of dietary supplements over the years to increase consumer confidence in dietary supplements in the form of the proposed Good Manufacturing Practices for dietary supplements and the recently passed Dietary Supplement and Nonprescription Drug Consumer Protection Act which requires the reporting of serious adverse event reports associated with a dietary supplement to the FDA."
Regarding stricter regulations, David Morrison, Vice President of Scientific and Regulatory Affairs for the 300- store Vitamin Shoppe chain, was a bit more succinct: "It would clear out a lot of the dregs in our industry."

According to Morrison, the FDA and the Federal Trade Commission (FTC) have full authority to go after these modern-day snake-oil hucksters, but for the most part, the FDA chooses not to. "They simply don't have the money, time or willpower to regulate dietary supplements, " he says.

Rather than the FDA, it's the FTC that has taken more aggressive action, levying hefty fines against some supplements making preposterous claims. But for a few unscrupulous companies, it may simply be the cost of doing business. Indeed, the FTC fined TrimSpa $1.5 million in January of this year, and Anna Nicole notwithstanding, the company is still going strong.

There's no doubt that some natural supplements have tangible - and proven - health benefits. Why, I'm simply delighted that red wine and dark chocolate are now "good" for me. But with so many things these days, the best advice is, 1. Don't believe everything you read, and 2. Buyer beware. Oh, and one more: if something seems too good to be true, it generally is.

Michele Hickford is a freelance writer with an opinion on almost everything. Her first book, "Do I Need To Slap You?" is available on Amazon.