Herbal Drugs: Legal consequences

Last modified: Sunday, 31. May 2009 - 4:05 pm

Legal history

For decades, the FDA and the herbal products industry have engaged in disputes over the proper way to regulate herbal drugs. The FDA has tried to protect consumers from ineffective or unsafe products. The herbal manufacturers, who have grown more influential as their products have increased in popularity, have argued that consumers should have access to information about herbal drugs and be allowed to make their own choices. Following are some of the important laws passed in the United States affecting herbal drugs that highlight the history of this conflict.
The 1938 Federal Food, Drug, and Cosmetic Act mandated that all new drugs, including herbals, be proved safe before they could be sold. This legislation was prompted when a sulfa drug containing an unsafe additive killed more than 100 people in 1937. However, this law said that it was up to the FDA to prove a drug was unsafe. Drug manufacturers did not have to explicitly prove their products were safe.
The Kefauver-Harris Drug Amendments of 1962 shifted the burden of proof to drug manufacturers. For the first time, drug manufacturers had to prove their products were safe and effective before they could be sold. The tragedy in Europe of birth defects caused by the sedative thalidomide spurred U.S. public concern about drug safety and public support for this legislation. (It should be noted that the FDA did not allow thalidomide in the United States because of safety concerns.) In response to this new legislation, many manufacturers of herbal drugs began marketing them as “dietary supplements.” This shift allowed them to bypass the new law, but they could no longer make any therapeutic claims about their products.
Congress passed the 1976 Proxmire Amendments to stop the FDA from regulating vitamin and mineral supplements as drugs based on their potency. This legislation also prohibited the FDA from regulating the potency of vitamin and mineral supplements. Although the language of this law did not expressly state that herbal products were also protected from regulation as drugs, it was assumed that herbals were covered as well.
The 1990 Nutrition Labeling and Education Act permitted manufacturers to make some health claims for foods, including dietary supplements, if the claims were approved by the FDA. This law stipulated stringent requirements for claims made on behalf of herbal and dietary supplements. The law also required standardized nutrition labels for all packaged foods.

Federal guidelines, regulations, and penalties

The 1994 Dietary Supplement Health and Education Act expressly defines a dietary supplement as a vitamin, a mineral, an herb or other botanical, an amino acid, or any other “dietary substance.” This law prohibits claims that herbs can treat diseases or disorders, but it allows more general health claims about the effect of herbs on the “structure or function” of the body or about the “well-being” they induce. Under this law, the FDA bears the burden of having to prove an herbal is unsafe before restricting its use. This law also established the Office of Dietary Supplements within the National Institutes of Health to promote and compile research on dietary supplements.

The poison squad of 1903

To determine the safety of additives and preservatives in foods and medicines, the U.S. government established a “poison squad” in 1903. This group of young men volunteered to eat foods treated with chemicals such as borax, formaldehyde, and benzoic acid. The principles of the federal laws that arose from this experiment still govern herbal dietary supplements in 2002.
Although establishing the “poison squad” might seem a drastic measure, at the time the U.S. food and drug industry operated virtually without control. Although many manufacturers provided wholesome products, many others used chemical preservatives and toxic coloring agents in foods, and did so with very little regulation or oversight. The government desperately needed knowledge about these additives in order to properly regulate them.
In addition, the purveyors of thousands of patent medicines — containing drugs such as opium, morphine, heroin, and cocaine — sold them without restriction. The makers of these medicines, who regularly made false claims about their therapeutic value, did not even list ingredients or warnings on the labels.
The poison squad was established by Dr. Harvey W. Wiley, head of the U.S. Bureau of Chemistry, the precursor to the FDA. Wiley campaigned for more stringent food and drug laws, sharing his findings with the public through speaking at women’s clubs and civic and business organizations.
Patent medicine firms and whiskey distilleries opposed Wiley’s campaign, believing new federal regulations would put them out of business. But Wiley’s efforts were instrumental in influencing Congress to pass the Food and Drug Act of 1906, which prohibited interstate commerce in misbranded or adulterated foods and drugs. In 1912, Congress passed the Sherley Amendment, which prohibited manufacturers from making fraudulent therapeutic claims when labeling their medicines.

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