Dietary Supplement Regulation FactsJanuary 13, 2012
The Food and Drug Administration
This agency has significant authority to regulate the dietary supplement industry, including (but not limited to) the authority to:
- Stop a company from selling any dietary supplement that is unsanitary or unsafe.
- Stop the sale of any dietary supplement that makes false or non-substantiated claims on its labeling
- Stop the sale of any nutritional supplement that poses “a significant or unreasonable risk of illness or injury”
The Federal Trade Commission
This agency has the authority to regulate the advertising of the supplement industry, including (but not limited to) the authority to:
- Challenge and stop advertising that is not sufficiently substantiated
- Negotiate a consent order for a company to change or fix its promotional marketing or advertising practices
- Seek substantial civil penalties for violations of trade regulation rules or violations of cease and desist orders
Legislation Regulating the Dietary Supplement Industry
1990 Nutrition Labeling and Education Act
The law gives the Food and Drug Administration (FDA) authority to require nutrition labeling of most foods regulated by the Agency; and to require that all nutrient content claims and health claims meet FDA regulations.
Creates a structure for regulation of dietary supplements by making dietary supplements a new category of regulation within the framework of food and apart from drugs, that included labeling requirements, safety provisions, good manufacturing practices, also created the Office of Dietary Supplements at NIH.
Requires registration of facilities with FDA and record-keeping regulations extend to those that transport, distribute, receive, or import foods and dietary supplements.
Requires a manufacturer, packer, or distributor whose name appears on the label of a dietary supplement—known as the “responsible person”—to report a serious adverse event to FDA within 15 days of receipt of the information.
Prohibits the addition of drugs or biologics to food and to authorize the creation of a “reportable food registry” to collect information about articles of food that may pose serious health risks.
Current good manufacturing practices (CGMPs) require that proper controls are in place for dietary supplements so that they are processed in a consistent manner, and meet quality standards.
FDA also regulates dietary supplements under FSMA, a comprehensive food safety statute enacted in 2011. Nearly all the provisions of the FSMA apply to dietary supplements.