Pharmaceutical companies maneuver to gain patents on natural herbs and supplements, threatening consumers' health freedom.
Scientifically reviewed by: Dr. Gary Gonzalez, MD, in October 2024.
Written by: Life Extension Editorial Staff.
Passage of the Consumer Health Free Speech Act (HR 2868), which would enact into law the principle that "foods are not drugs," would be the simplest and best way of protecting health freedom in the United States. In the 1990s, thousands of scientific studies have demonstrated the value of vitamins, minerals, herbs and botanical extracts in preventing and fighting diseases. This has become so persuasive that the medical establishment is reeling from the impact.
After decades of largely ignoring nutritional supplements, pharmaceutical companies (and their supporters in government, medicine and the media) are scrambling to try to gain control over nutritional medicine. Their goals are to transform nutrient supplements into patented, Food and Drug Administration-regulated pharmaceuticals no longer freely available by mail, in health food stores, or on the Internet.
If they succeed, many small vitamin and herb companies are likely to fail, the cost of nutrient supplements will soar, and these supplements will be under strict government control.
Among the steps being taken to curtail health freedom in this country are the following:
Regulating herbs and botanicals as over-the-counter drugs. The Commission on Dietary Supplement Labels has recommended to Congress that the FDA establish a review board to facilitate the making of OTC drug claims on herbs. This proposal is being supported by compromised vitamin trade associations, fake grass-roots industry front groups and a shadowy organization called the European-American Phytomedicines Coalition. It threatens to create an unlevel playing field. Smaller manufacturers might not be able to clear the regulatory hurdles involved with OTC drug manufacturing, and might be driven out of business. Consumers would then be forced to pay much higher prices.
The FDA's new definition of health fraud as "the promotion of unproven claims." This policy abolishes the rights of health food store owners, mail-order and Internet supplement companies, and food companies to inform their customers about the benefits of dietary supplements. Although this Draconian policy is not yet being widely enforced, it threatens us all.
The FDA's anticipated new good manufacturing practices standards. These standards, which will be unleashed on the industry this spring, will likely create enough red tape to favor the large companies over the smaller ones, according to attorney Jonathan Emord, in comments submitted to the FDA.
The U.S. Patent Office's granting of use-patents for popular dietary supplements. This policy is leading to potential monopolies over some of our most beneficial nutrient supplements. Recently, companies have tried to obtain use-patents or FDA-approval for such popular herbal supplements as saw palmetto, St. John's wort, green tea, ginkgo, garlic, bilberry, milk thistle, echinacea, valerian, ginger, black cohosh, agnus castus and mistletoe.
The goal: to convert the $12.6 billion worldwide market for herbals into a pharmaceutical market. If approved, the cost of these supplements could soar. For example, in Europe, where saw palmetto is sold as a "drug," it costs $45 for the identical saw palmetto extract that Americans can obtain as a freely available dietary supplement for less than $19.
Misinformation has accompanied this campaign. Following the publication in the Journal of the American Medical Association last fall of a positive study about ginkgo, doctors interviewed on the ABC News program Nightline told the public not to buy the ginkgo found in health food stores, claiming that health food store ginkgo is not the same as the ginkgo used in the study.
This is untrue. One of the largest raw material suppliers of ginkgo extracts to supplement makers in the United States is a company called Indena, and most of the gingko sold in stores and by mail is the identical ginkgo extract used in the study published in JAMA.
The FDA's plans to harmonize its regulations to international standards. This is according to an Advanced Notice of Proposed Rulemaking, in the July 7, 1997, Federal Register, Vol. 62, #129, pp. 36,243-36,248. It could lead to government control over supplements similar to that in European countries such as Germany, where vitamins are sold strictly in pharmacies, and England, where you may soon need a doctor's prescription for more than 10 mg of vitamin B6.
If consumers, health food stores, alternative medical practitioners and vitamin companies don't stand firm on the principle that foods are not drugs, and further, if we don't work hard to pass HR 2868, market forces will inevitably usher in pharmaceutical domination of the industry.
Help pass the Consumer Health Free Speech Act (HR 2868) by urging members of Congress to support it. The form letter that follows will help you voice your concerns to your senators and representatives. For more details, see the International Advocates for Health Freedom web site, at www.pnc.com.au/~cafmr/ hammell/index.html.