The Food and Drug Administration regulates dietary supplements in a different manner than drugs and other foodstuff that consumers buy. Regulation by the FDA puts stringent requirements for product labeling and claims about efficacy rather than safety of the ingredients used to make a dietary supplement. Millions of people use dietary supplements to promote weight gain or loss, improve memory function and eyesight or for sexual enhancement. Purity and safety of the available dietary supplements is subject to manufacturing standards rather than governmental regulation.
Dietary Supplement Act
In 1994, the Dietary Supplement Health and Education Act was put into effect to place the burden of dietary supplement safety on the manufacturer of the products. Manufacturers were seen as the responsible party for the truth of the label on products and not to mislead consumers. Manufacturers didn't have to register their dietary supplements with the FDA before making them available to the public. Since October 1994, manufacturers have had to register their products with the FDA. No formal process or protocol is in place for manufacturers to meet minimal guidelines for safety or effectiveness.
Regulation
The FDA took the stance of providing oversight when dietary supplements became dangerous to the health of the public. Dietary supplements sold in the United States prior to Oct. 14, 1994, are not required for review by the FDA because with long-term use by the public, the FDA deemed those dietary supplements and ingredients as safe. For dietary ingredients sold after 1994, the manufacturer has to notify the FDA of its marketing intent of the new ingredient or supplement and how the manufacturer determined safety of the product. The burden of proving safety, purity and testing is placed on the manufacturer, so the FDA is using an honor system for dietary supplement regulation.
Truth in Labeling
Manufacturers cannot mislead the purchasing public with false claims of dietary supplements. A manufacturer cannot put claims on the label of the product if it cannot prove with documentation that the supplement can do what it claims. What manufacturers must supply is the product name; list all ingredients including fillers, sweeteners and coloring agents; and serving size that contains a specific amount of ingredients. Botanical ingredients must be listed by their scientific or common name, including the part of the plant that is used in the making of the botanical ingredient. For supplements that contain a proprietary blend that is unique to the manufacturer, the total weight of the blend, along with the list of ingredients that make the proprietary blend in order of weight, must be included.
Standardization
As of 2007, the FDA issued good manufacturing practices, or GMP, for dietary supplements. This is a set of standards that manufacturers can follow in order to illustrate they are being truthful in the quality and purity standards of their supplements. The FDA demanded GMP for large companies, and in June 2010, smaller companies had to follow suit. The ensures what is listed as ingredients is actually in the product. Manufacturers uses GMP to ensure consistency with creating batches of their products. This doesn't guarantee each serving is consistently providing the same amount of ingredients in each container sold. Currently, there are no standardization regulatory rules set by the FDA for dietary supplements.
Safety and Efficacy
Efficacy and safety of dietary supplements is provided by the manufacturer. Ineffective and unsafe supplements have to be proven by the FDA in order to pull the product off the market. The opposite holds true for manufacturers of drugs, who have to get FDA approval for safety, efficacy and purity before the drug is allowed to enter the marketplace.
Member Comments