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World of the FDA

If we were in the business of selling garlic, the following sentence could land Viable Herbal Solutions in a heap of trouble: "Garlic reduces cholesterol."
The statement is true!  But no Company that sells garlic is allowed to tout its proven health benefits.
Welcome to the Alice-in-Wonderland world of the Food and Drug Administration (FDA), a topsy-turvy realm where the agency responsible for protecting the nation's health winds up threatening it. "The FDA knows little, if anything, about medicinal herbs," explains Varro Tyler, Ph.D., the Lilly Distinguished Professor of Pharmacognosy (natural product pharmacy) at Purdue University. "As far as the public health is concerned, FDA regulations governing medicinal herbs do more harm than good."
The above claim is not a lie: Garlic does reduce cholesterol. Earlier this year, the Journal of the Royal College of Physicians of London, a prestigious medical journal, analyzed 16 studies to conclude that, compared with people who took placebos, garlic users showed an average cholesterol reduction of 12 percent. A similar review of other studies last year in the Annals of Internal Medicine showed that eating just one clove of garlic a day reduced cholesterol levels an average of 9 percent.
Few Americans understand garlic's value, but they should. A high cholesterol level is a significant risk factor for heart attack, the nation's leading killer. Heart attacks now hit 1.5 million Americans a year. Studies suggest that garlic might help prevent up to 360,000 of them - or 30,000 a month - an astonishing benefit for any present day therapy.
And garlic costs only pennies per clove. It requires no prescription, adds zing to low-fat diets, and causes no side effects (unless you're offended by garlic breath, in which case, another medicinal herb, parsley, can minimize it).
Doctors increasingly recommend a low-fat diet for cholesterol control. But instead of garlic, physicians promote prescription drugs like Cholestyramine (Questran). Cholestyramine is effective, but it costs $1 to $2 a day, requires regular professional monitoring that adds to its cost, and may cause side effects, notably constipation, vomiting, loss of appetite, bleeding, and vitamin deficiencies. In addition, animal research hints that Cholestyramine might accelerate tumor growth.
What we have here is a public-health no-brainer. Some people with super-elevated cholesterol levels might still need a synthetic drug like Cholestyramine, but everyone with high cholesterol should be encouraged to eat at least one clove of garlic a day.
Unfortunately, if growers or marketers attached this information to bags of their aromatic bulbs, the FDA could confiscate their garlic. Ditto if they reprinted it in a pamphlet and mailed it to consumers or supermarket produce buyers.
Why? Because under FDA regulations, using garlic to reduce cholesterol makes the culinary herb a "drug." To the FDA, the assertion that "garlic reduces cholesterol" constitutes a "new drug claim." The FDA has never approved this claim, and it is a violation of FDA regulations to make un-approved claims on drug labels or promotional materials.
U.S. drug regulations made their first modern appearance in 1906, when "The Jungle," Upton Sinclair's indictment of the meat-packing industry, convinced a grossed-out Congress to pass the Food and Drug Act. The law created what is now the FDA, but it gave the agency no enforcement authority. The Food, Drug, and Cosmetic Act of 1938 rectified that, giving the FDA the authority to set, and enforce, drug safety standards.
The FDA remained pretty laid-back until 1961, when about 8,000 babies worldwide were born with malformed arms and legs. Investigators quickly found the cause - a thalidomide, an over-the-counter sedative sold in several European countries. The thalidomide scandal spurred the U.S. Congress in 1962 to direct the FDA to require safety and effectiveness testing for new drugs.
Those standards were so rigid that they threatened not only herbs, but also hundreds of over-the-counter (OTC) pharmaceuticals. To address this issue, the FDA appointed panels of physicians, pharmacists, and pharmacologists to write monographs determining if drugs already on shelves were safe and effective. The OTC Review Panels mainly examined data submitted by manufacturers and other concerned citizens. The OTC monographs, which are being finalized now, incorporated hundreds of drugs, and some medicinal herbs, including the active ingredients in many OTC laxatives (senna, psyllium seed, and cascara sagrada) and a few decongestants (peppermint oil and eucalyptus oil). But the approved herbs represented only a tiny fraction of the hundreds of botanical medicines with extensive historical and clinical evidence of safety and efficacy.
Despite America's long history of using herbs, herbalism had almost died between the 1930s and the 1960s, the victim of antibiotics' miraculous effectiveness. Only since the mid-1970s have Americans become skeptical enough of high-tech pharmacology to fuel today's modest Herbal Renaissance.
At the time of the OTC review, however, the resurrection of herbal medicine had barely begun. The herb companies that did exist in the 1970s and early 1980s, when the review panels did most of their work, were run by mom-and-pop herbalists who sold medicinal teas at local health food stores. While these people knew the review was taking place, for the most part they lacked either the money or the political 'will' to participate.
When they did organize, it was already too late. "We would have tried to submit data to several OTC Review Panels," says Lynda Sadler, president of Traditional Medicinals, an herb company in Sebastopol, Calif. "But the public comment period was already over, and that was that."
Having missed the review process, herbal missionaries now have to file a New Drug Application (NDA). Today's major drug companies claim that this process costs $230 million per drug approval.
The FDA contests that figure, saying that drug companies add in the cost of testing drugs that fail the approval process. So let's assume that the approval process costs less than half of what the drug companies claim…..say only $100 million. And let's pick “garlic” to push, since persuasive studies already exist showing that garlic reduces cholesterol; therefore we can assume that an herb marketer wouldn't have to finance much, if any, new research. So the NDA process for garlic could conceivably cost as little as 1 percent of the $100 million figure, or $1 million…..an amount that a large herb company or garlic grower might be able to afford.
But here's the catch: When a drug company wins approval for a new drug, it also gets a patent with exclusive rights to market that drug. "But who in their right mind would spend $1 million on a new drug application for garlic?" asks James Duke, Ph.D., a senior botanist at the U.S. Department of Agriculture. "They could never recoup the investment, because they could never hold exclusive rights to an herb that anyone can grow and use themselves."
In 1990, Congress passed the Nutritional Labeling and Education Act (NLEA), allowing foods, including vitamins and herbs, to carry approved health claims. So far, the FDA has allowed claims that fiber helps prevent certain cancers, that calcium prevents osteoporosis, and that folic acid helps prevent spinal birth defects.
The FDA claims to be "very open" to NLEA petitions for medicinal herbs. But Loren Israelsen, a Utah attorney specializing in natural-product regulation, says that the NLEA regulations make it "difficult, if not impossible, for herbal products to win approval."
And, unfortunately, an NLEA petition poses the same sticking point as an NDA: No herb company will pay for the approval when it can't win the exclusive marketing rights that will allow it to recoup its investment.
Germany, on the other hand, has a much different drug-approval process…..one that's considerably more open to herbal medicines. Like the FDA, Germany requires pre-approval testing for all new synthetic pharmaceuticals. But it does not hold herbs to so high a standard.
In 1978, the former West Germany's FDA-equivalent agency began to study the enormous scientific literature on medicinal herbs. Over the last 15 years, the agency has published 285 monographs that Tyler calls "probably the best information available today on [herbs]." Today, an estimated 70 percent of German physicians routinely prescribe herbal medicines, with their cost generally covered by German government health insurance. At a German pharmacy, right next to brands like Sominex and Nytol, you will find OTC herbal sedatives containing valerian.
Canada has a similar process. In Canada, medicinal herbs fall under the regulatory authority of the Health Protection Branch (HPB). In 1986, recognizing the increasing popularity of herbal medicines, the HPB created a new drug category, now officially termed "Traditional Herbal Medicines." They have yet to approve many herbal claims. "But at least," says Mark Blumenthal, executive director of the American Botanical Council, a nonprofit that sponsors herb research, "Canada is moving in the direction of allowing herbal medical claims."
Herbalists wish the United States would adopt a similar system. But mention Germany, and FDA officials cringe: "Most of the thalidomide babies were born in Germany," says FDA Public Affairs Specialist Janet McDonald. "The Germans let drugs on the market with much less pre-approval testing than we insist on. When problems develop, as they often do, they withdraw them."
German drug-approval standards may not be as strict as ours, but the results have been quite similar. In fact, from 1976 through 1985, more than half of the new prescription drugs approved by the FDA (102 of 198) were later found to cause unanticipated reactions serious enough to warrant re-labeling or withdrawal.
The current state of medicinal herb regulations leaves most U.S. consumers confused, and misled, about how herbs might help, or harm, them. In an effort to get information, some consumers turn to medicinal herb guides ("herbals"), but many contain inaccuracies, and few mention possible side effects or discourage use by pregnant women.
Others turn to health food store personnel, who may not know much - at least according to the FDA. Last year, the agency asked staffs at 129 health food stores to recommend natural therapies for a variety of ailments. Employees at 120 of the stores made recommendations the FDA considered improper. But health food store personnel are not responsible for safeguarding the public health; the FDA is. And the main reason that health food store personnel don't know as much as they should is that the FDA prohibits informative labeling of medicinal herbs.
The World Health Organization estimates that 80 percent of the world's population currently uses herbal medicines. More than one-third of Americans now use non-mainstream approaches to meet at least some of their medicinal needs….and that number is growing. American health care costs have soared, and the Clinton administration has identified drug industry profits as a significant part of the problem.
Today seems like a perfect time for the FDA to move forward into our medical past.

It's time to rethink the regulation of herbal medicines…..just as Germany has done, and as Canada is doing. The FDA should create a "traditional herbal medicines" category, and appoint experts to draft monographs on the effectiveness, safety, cautions, and labeling of herbs. Just as they are free to take vitamins and mineral supplements, Americans should also be able to choose what they take for such conditions as motion sickness, indigestion, anxiety, insomnia, immune deficiency, nicotine addiction, and urinary tract infection.
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