The FDA regulates herbal supplements by different standards from foods, OTC drugs, and prescription drugs. Herbal supplements are not subject to the same standards of testing, production, and labeling that drugs are. This is because herbal supplements are not subject to clinical trials, nor are they subject to the same manufacturing standards as prescribed or mainstream OTC medications. Also, since herbal supplements are subject to different regulations, manufacturers are allowed to make claims on their products that are not allowed with prescription drugs.
It is important to keep in mind that herbal supplements are not subject to FDA regulations, and thus, they are not tested in an FDA clinical trial to demonstrate effectiveness for treating or managing health conditions. Therefore, herbal supplements are usually proven to be unsafe only after causing harm to a consumer, while prescription drugs need to be proven to be safe before being put into a consumers hands. Dietary supplements are subject to stricter manufacturing and quality-control regulations than foods, and therefore, they must be manufactured at CGM-compliant manufacturing facilities approved to manufacture dietary supplements. Current laws, including the Dietary Supplement Health and Education Act, designate dietary supplements as a specific subset of foods (but not, actually, foods, and therefore subject to more lax regulations than those applied to conventional foods and medicines).
The act places dietary supplements under the special subcategory under the umbrella of foods, but products falling within its drug definition are regulated as drugs. It should be noted that nutritional supplements were exempted before the 2005 repeal of exemptions in South Dakota. Texas does not typically impose sales taxes on vitamins and supplements. Nonprescription or over-the-counter drugs and medications may also be purchased without sales tax.
Other medical products used by humans, either internally or externally, to maintain health, as well as products (other than foods) intended to affect the structure or function of the human body, are also exempt. Many prescription drugs and over-the-counter medications are also made with botanical products, but those products only contain refined ingredients and are regulated by the FDA. Artemisinin has been available as an herbal supplement without a prescription in the U.S. for at least 10 years; these supplements are sold for general health and to treat pestilence and cancer. Although it is commonly used in the herbal supplements produced by American manufacturers, artemisinins were until recently unavailable in the U.S. for medical use, with the exception of by CDC through the Investigational New Drug Protocol.
FDAs Center for Food Safety and Applied Nutrition has more reports of adverse events related to artemisinin-containing food additive products, which were not included in this review ( FDA, unpublished data, 2009 ). Health-care providers should be aware that patients may take herbal supplements that contain artemisinin and should consider asking about use of these products among patients evaluated for hepatitis with no apparent etiology. Although Federal Drug Administration regulations on herbal supplements are less strict than those affecting foods or medications, if a person has been injured by a herbalism supplement, a consumer might have a right to sue the manufacturer and other liable parties for product defects.
The FDA regulates safety, manufacture, and labeling for food additives, whereas the Federal Trade Commission has primary responsibility to regulate advertising for such products. The scope of this organization has been expanded to cover all FDA centers and products that are regulated, including the Office of Nutritional Products, Labeling, and Dietary Supplements at the CFSAN. For that reason, FDA will continue to strive to supplement these measures with industry and consumer education efforts, and continue to provide assistance to the dietary supplement industry through rulemakings and guidance documents that address dietary supplement manufacturing, labeling, and sales.
At the heart of FDAs enforcement efforts is our commitment to strengthening the lawful manufacture, sale, and use of dietary supplements, while protecting consumers from unsafe products, fraudulent label claims, and other unlawful practices. To further support public health goals under the Dietary Supplement Health and Education Act (DSHEA), FDA also issues guidance documents that provide nonbinding recommendations to assist industry in understanding and implementing all regulations and laws. The Federal Drug Administration requires manufacturers, including those who manufacture herbal products, to comply with specific manufacturing practices in order to prevent ingredient cross-contamination and adulteration of products. There are a number of concerns associated with using herbal medicines, as, unlike traditional medicines, they are not regulated by the U.S. Food and Drug Administration, and manufacturers are not required to demonstrate safety and effectiveness of herbal medicines before making them available to the public.
This includes both prescription and non-prescription medicines, as well as medications recognized by the US Pharmacopeia, US Homeopathic Pharmacopeia, or National Formulary. USP Documentation standards for food additives are supported by chemical reference standards, which are highly characterized samples of food ingredients, impurities, and degrading products, as well as by compendium-level USP reagents and performance calibrators, which are specified for use in conducting official USP-NF tests and analyses. USP documentary standards for dietary supplements are supported by chemical Reference Standards, which are highly characterized specimens of dietary ingredients, impurities, and degradation products, as well as USP compendial reagents and performance calibrators that are specified for use when conducting official USP-NF tests and assays. This scenario may potentially provide an incentive to manufacturers to state that their food ingredients or supplements conform to public-quality standards, such as those contained in USP-NF, since products may be considered to have been falsely labeled when they actually fail to meet the public-quality standards. Under US law, a dietary supplement shall be deemed violative if it is represented (eg, on the products labeling) as conforming to a standard in the USP-NF but fails to so conform.5 This situation potentially creates a disincentive for manufacturers to claim that their dietary ingredient or supplement meets a public quality standard, such as one contained in the USP-NF, because the product could be deemed misbranded if it does not actually conform to a public quality standard. These increases in the number of products and consumer use highlight the importance for physicians of understanding the potential quality concerns of products presented as dietary supplements, given the fact that the U.S. Food and Drug Administration (FDA) does not have as stringent regulation as drugs.