The current U.S. approach to the regulation of herbal products is rather complex and generally considered to be unsatisfactory. Until 1994, the FDA classified most herbal remedies as either "food additives" or "drugs," and manufacturers had to meet strict FDA standards before placing their products on the U.S. market. This changed in 1994 when Congress enacted the Dietary Supplement Health and Education Act (DSHEA), which placed herbs together with vitamins and minerals in a category know as "dietary supplements." DSHEA defines a dietary supplement as follows:
a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract or combination of any (of these ingredients).
DHSEA effectively means that manufacturers can now market herbal remedies and other supplements without first obtaining FDA approval of their safety and efficacy. Under DSHEA, manufacturers do not have to demonstrate that their products are effective, or even that they are safe, and they are not required to report side effects. The FDA must also prove that a supplement is harmful before it can be banned.
DHSeA also addresses labeling requirements, specifying that although manufacturers can make claims about how a product affects the body's "structure and function," they cannot claim that it prevents, treats, or cures a disease or medical condition. Manufacturers cannot, therefore, make a therapeutic claim that cranberry juice "can prevent urinary tract infections," but they can say that it "helps maintains a healthy urinary tract."
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