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05 2013

Regulation of herbal dietary supplements in the United States

The Food and Drug Administration (FDA) and its predecessor agencies have had jurisdiction over herbal products marketed in the United States for over 100 years. During this time herbs that have been included in conventional foods, such as peppermint tea or vanilla extract, havebeen regulated as foods, while herbs like digitalis and belladonna, which are recognized as drugs, have been regulated as such. Many other herbs that have long been used for therapeutic purposes or to maintain or promote health have also been broadly sold, but for many years there was no clearly defined regulatory category for these products.


Attempts were made to fill this regulatory gap at the beginning of the 1990s. FDA proposed at that time that herbal “dietary supplements” should be regulated in the same manner as food additives, which is to say with the same rules that apply to added ingredients like aspartame. But this did not seem like alogical approach for herbs such as chamomile, echinacea, ginseng, and the host of other herbs that have long been used in cultures around the world. Instead, in 1994 the U.S. Congress passed the Dietary Supplement Health and Education Act(DSHEA) that amended the Federal Food, Drug & Cosmetic Act (FFDCA), to clarify the way in which vitamins, minerals, herbs and specialty supplements are regulated by the federal government. Almost all such products are now marketed in the U.S. as dietary supplements.


The law clarifies that herbal and other dietary supplements should be regulated in many of the same ways as foods. FDA has jurisdiction over how these products are made and labeled, and may seize and detain herbal and supplement products that are adulterated or misbranded. FDA may also forbid the sale of any dietary supplement or ingredient any time that the agency determines that it represents a sig-nificant or unreasonable risk. And the law requires that FDA be notified of any “new” dietary ingredients intended for use in supplements.


Federal law also defines the responsibilities of manufacturers and marketers of dietary supplements. Dietary supplements are required to identify every dietary ingredient in the product and to state the quantity of each ingredient or proprietary blend. Claims that are made on a product’s label or labeling are strictly controlled, must be substantiated, and must not claim to diagnose, treat, cure, or prevent any disease (even if there is evidence to support such a “drug claim”). Facilities in which herbal and other dietary supplements are manufactured are held to the high standards of FDA’s Good Manufacturing Practice (GMP) regulation for dietary supplements.  Additionally, supplement companies are required by law to tell FDA about any reports of serious adverse events they receive from consumers.


Another important benefit of the Federal law is that it explicitly allows consumers to be provided with balanced scientific information about herbs and other supplement ingredients. Prior to the passage of this law, FDA considered such information to be illegal if it contained any reference to cure, treatment, or prevention of diseases. But the Congress decided that the government “should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers,” and established rules to allow dissemination of truthful and non-misleading publications about ingredients found in dietary supplements.

The discussion presented above addresses only the regulation of herbs and other supplements by FDA. As with any other industry, however, companies that make and sell supplements must conform with the regulations of many other federal agencies, as well as state and local jurisdictions. For example, the Federal Trade Commission enforces the laws that govern advertising of all consumer goods, and companies in the herbal business must comply with these. Marketers of organic herbal products must be familiar with rules maintained by the U.S. Department of Agriculture, and manufacturers of herbal extracts need to be in compliance with the legal guidelines set by the Tax and Trade Bureau. The list goes on and on—the Department of Transportation rules apply to all interstate shipments; U.S. Customs and Border Protection governs imports; the Occupational Safety and Health Administration protects workers in all trades; etc.


In conclusion, manufacturers and marketers of herbal supplements are subject to extensive federal laws and regulations. Each of these federal agencies is responsible for enforcing their rules so that the needs of consumers are properly met, and so that companies that do not follow the rules do not gain an advantage over those that do. The laws that are currently in place in the U.S. were designed to ensure that safe and beneficial dietary supplements, including herbal products, are available to well-informed consumers for use when making their own self-care choices. Responsible manufacturers and marketers will continue to provide these products and the citizens of the United States will continue to enjoy the health freedom which they demand and deserve.