Herbal Supplements Are Regulated, Says Pharmaceutical Executive
HerbalGram Article Outlines Laws and Regulations that Government Agencies Can Use to Regulate Dietary Supplements
Austin, TX. (September 20, 2000) - Despite erroneous media reports of an "unregulated industry," there are numerous federal laws and regulations that deal with the manufacture, labeling, and marketing of herbs and other dietary supplements, writes an executive with a pharmaceutical and dietary supplement trade association in the current issue of HerbalGram.
R. William Soller, Ph.D., Senior Vice President and Director of Science and Technology of the Consumer Health Product Association, a major trade organization dealing with over-the-counter medications and dietary supplements, says that the idea that herbs are unregulated is a "myth."
Dr. Soller describes four federal laws under which herbs are regulated:
Food, Drug, and Cosmetic Act (FD&C Act), the Nutrition Labeling and
Education Act of 1990 (NLEA), the Dietary Supplement Health and
Education Act of 1994 (DSHEA), and the Food and Drug Administration
Modernization Act (FDAMA).
The HerbalGram article explains the "considerable enforcement authority" that both the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have "to ensure safe, beneficial and quality dietary supplements for health promotion and maintenance and disease risk reduction, as intended by Congress in the passage of DSHEA. This article also demonstrates that in contrast to assertions to the contrary usually made by persons unfamiliar with regulatory issues, the herb and dietary supplement industries are substantially regulated, but these regulations are significantly different from those in the pharmaceutical industry."
In the area of regulations and their enforcement, from 1962 to 1999 FDA published 143 notices, actions, and proposed, interim and final rules in the Federal Register, the official publication of the U.S. government. Also, the FTC has initiated 70 cases against supplement manufacturers challenging or seeking documentation for claims made in product advertising.
The article also quotes FDA Commissioner Jane Henney, M.D., who told a House committee in 1999, "FDA has tools at its disposal to take enforcement actions against dietary supplements found to have safety, labeling, or other violations of the FD&C Act, as amended by DSHEA."
In general, the FDA has numerous powers:
It can stop any company from selling a dietary supplement that
is toxic or unsanitary;
it can stop the sale of a dietary supplement that has false or
it can take action against dietary supplements that pose "a
significant unreasonable risk of illness or injury";
it can stop any company making a claim that a product cures or
treats a disease;
it can stop a new dietary ingredient from being marketed if FDA
does not receive enough safety data in advance.
Further, FDA must require dietary supplements to meet strict manufacturing requirements (Good Manufacturing Practices, GMPs), including potency, cleanliness and stability. Congress mandated FDA to develop new GMPs for dietary supplements in 1994, but FDA has not published final rules in this area.
In the area of the advertising and promotion of herbs and dietary supplements, the FTC has the power to:
enforce laws outlawing "unfair or deceptive acts or practices" to ensure consumers get accurate information about dietary supplements, so they can make informed decisions about them;
challenge and stop advertising that is not adequately substantiated;
investigate complaints or questionable trade practices;
negotiate a consent order or proceed through an FTC adjudication resulting in a cease and desist order, which can be broad in scope;
seek injunctions to stop false advertisements or other violations of the FTC Act;
seek civil penalties for violations of trade regulations or cease and desist orders.
The article appears in the most recent issue of HerbalGram (#49), a peer-reviewed journal on herbs and medicinal plant research published by the American Botanical Council (ABC). The complete text was just released on ABC's website http://www.herbalgram.org/default.asp?c=reg_herb_market
ABC founder and executive director Mark Blumenthal said, "The article strongly suggests that current laws are adequate to deal with these products. The biggest problem is FDA's lack of enforcement of existing regulations and the its delay in publishing new GMPs for herbs."
Founded in 1988 in Austin, Texas, ABC is an independent non-profit research and education organization educating the public on the responsible use of medicinal plants. HerbalGram has been published since 1983 as a reliable and authoritative source of herb and medicinal plant research, regulatory and market issues, medicinal plant conservation and other general interest aspects of herb use. Information can be found on the organization's website www.herbalgram.org.