Dietary Supplement Regulation Facts

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.

1994 Dietary Supplement Health and Education Act

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.

2002 Public Health Security and Bio-terrorism Preparedness and Response Act

Requires registration of facilities with FDA and record-keeping regulations extend to those that transport, distribute, receive, or import foods and dietary supplements.

2006 Nonprescription Drug Consumer Protection Act

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.

2007 Food and Drug Administration Modernization Act

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.

2007 Dietary Supplement Current Good Manufacturing Practices (CGMPs)

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.

2010 Food Safety Modernization Act

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.