FDA Proposes Manufacturing and Labeling Standards for all Dietary Supplements
March 7, 2003

TODAY'S ACTION:

The Food and Drug Administration (FDA) today took action to help Americans get accurately labeled and properly manufactured dietary supplements, through its Proposed Rule for Dietary Supplement Current Good Manufacturing Practices (CGMPs). FDA is submitting this proposed rule as part of the agency’s ongoing effort to help Americans take more control over their own health.

FDA’s Proposed Rule for Dietary Supplement Labeling and Manufacturing Standards

This proposed rule would establish the standards necessary to ensure that dietary supplements and dietary ingredients are not adulterated with contaminants or impurities and are labeled to accurately reflect the active ingredients and other ingredients in the product.

Specifically this proposal would:

• Require the use of new industry-wide standards in the manufacturing, packing, and holding of dietary supplements, thus reducing risks associated with dietary supplements that are contaminated with harmful or undesirable substances such as pesticides, heavy metals, or other impurities or are not properly labeled to accurately describe what they contain.



• Ensure that the identity, purity, quality, strength, and composition of dietary supplements are accurately reflected on the product label, which would be a significant step in assuring consumers they are purchasing the type and amount of ingredients declared.

Science-Based Consumer Protection

Previously, dietary supplements have not been subject to mandatory standards for manufacturing or labeling. Congress gave FDA the authority to develop and implement CGMPs as part of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

The proposed rule addresses the quality of manufacturing processes for dietary supplements, and the accurate listing of supplement ingredients. It does not limit consumers' access to dietary supplements, or address the safety of their ingredients, or their effects on health when proper manufacturing techniques are used. Rather, the proposed rule creates a level playing field for the industry by ensuring that every firm uses high-quality manufacturing procedures and uses the same rules for describing their ingredients.

In December, FDA issued a report on its new policies for taking legal action against dietary supplements that make misleading health claims. Last week, to address concerns about the safety of ephedra, FDA announced a proposed warning label, issued warning letters on certain ephedra marketing practices, and announced a public comment period regarding potential further restrictions on ephedra products.

Background

Under DSHEA, dietary supplement manufacturers have an essential responsibility to substantiate the safety of the dietary ingredients they use in manufacturing a product. Manufacturers are also responsible for determining that any representations or claims made about their products are substantiated by adequate evidence to show that they are not false or misleading. With this proposed rule, FDA will have the authority to determine standards that firms should apply in production and labeling.

• The proposed CGMPs provide much-needed requirements in these areas:



• Design and construction of physical plants,
• Quality control procedures,
• Testing of final product or incoming and in-process materials
• Handling consumer complaints, and
• Maintaining records to demonstrate compliance with these regulations.


• Since 1993, FDA has received about 7000 dietary supplement-related voluntary adverse event reports. Below is a breakout of adverse event reports over the past four years:



• Year 2002: 1,214 adverse event reports
• Year 2001: 553 adverse event reports
• Year 2000: 500 adverse event reports
• Year 1999: 528 adverse event reports


• Many of these adverse events may be related to misbranding or adulteration. In recent years, analyses of dietary supplements by a private sector laboratory suggest that a substantial number of dietary supplement products analyzed may not contain the amounts of dietary ingredients as reflected on the products’ labeling.



• In addition, dietary supplements have been recalled because of microbiological, pesticide, and heavy metal contamination – adulteration that might be prevented through a uniform set of manufacturing requirements.



• Examples of product quality problems that the proposed rule would help prevent are:



• dietary supplements that contain much more than listed on the label and may be harmful
• dietary supplements that contain less ingredients than listed on the label
• wrong ingredient,
• drug contaminant,
• other contaminant (e.g., bacteria, pesticide, glass, lead),
• foreign material in a dietary supplement container,
• improper packaging, and
• mislabeled

Additional materials:

• Press Release
• Proposed Rule (PDF 551 KB)
• Fact Sheet

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