FDA's Proposed Rule

• FDA's proposed rule, if adopted as proposed, would establish new standards or "current good manufacturing practices" (CGMPs) to help reduce risks associated with adulterated or misbranded dietary supplement products.
• The proposed rule would establish industry-wide standards necessary to ensure that dietary supplements are manufactured consistently as to identify, purity, quality, strength, and composition.
• The minimum standards include requirements on the design and construction of physical plants that facilitate maintenance, cleaning, and proper manufacturing operations, for quality control procedures, for testing final product or incoming and inprocess materials, for handling consumer complaints, and for maintaining records.
• Examples of product quality problems the CGMPs will help prevent are: superpotent, subpotent, wrong ingredient, drug contaminant, other contaminant (e.g., bacteria, pesticide, glass, lead), color variation, tablet size or size variation, under-filled containers, foreign material in a dietary supplement container, improper packaging, and mislabeling.
• The proposed CGMPs would apply to all firms that manufacture, package, or hold dietary ingredients or dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distributing them. The proposed regulations also would apply to both domestic firms and foreign firms that manufacture, package, or hold dietary ingredients and dietary supplements for distribution into the U.S.
• FDA is soliciting comments from the public and industry on this proposal. Written comments will be received until 90 days after the date of publication in the Federal Register.

Consumer Benefits

• Consumers should have access to dietary supplements that meet quality standards and that are free from contamination and are accurately labeled.
• The proposed rule would not limit consumers' access to dietary supplements. The proposed rule, if it becomes final as proposed, would give consumers greater confidence that the dietary supplement they use will have the identity, purity, quality, strength, and composition that is claimed on the label.
• 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.
• 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.
• This proposed regulation follows FDA's consumer initiative announced last December intended to improve FDA's policies on providing information about health consequences of food and dietary supplements and to increase enforcement efforts to prevent misleading health claims made by certain dietary supplement manufacturers.

Manufacturers

• Under DSHEA, manufacturers have an essential responsibility to substantiate the safety and efficacy of the dietary ingredients they use in manufacturing a product.
• 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.
• The CGMPs will assist manufacturers in producing unadulterated and properly labeled dietary supplements and will provide a basis for consumers to have confidence that the dietary supplement products they purchase contain the identity, purity, quality, strength, and composition that the label claims.
• 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.
• Under the CGMP proposed rule, manufacturers would be required to:
  
  
  • Employ qualified employees and supervisors;
  • Design and construct their physical plant in a manner to protect dietary ingredients and dietary supplements from becoming adulterated during manufacturing, packaging, and holding;
  • Use equipment and utensils that are of appropriate design, construction, and workmanship for the intended use;
  • Establish and use a quality control unit and master manufacturing and batch production records;
  • Hold and distribute materials used to manufacture, package, and label dietary ingredients, dietary supplements, and finished products under appropriate conditions of temperature, humidity, light, and sanitation so that their quality is not affected.
  • Keep a written record of each consumer product quality complaint related to CGMPs; and
  • Retain records for 3 years beyond the date of manufacture of the last batch of dietary ingredients or dietary supplements.
    
    
• 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
    
    
• 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.

Background

• FDA has found that manufacturing problems have been associated with dietary supplements. Products have been recalled because of microbiological, pesticide, and heavy metal contamination and because they do not contain the dietary ingredients they are represented to contain or they contain more or less than the amount of the dietary ingredient claimed on the label.
• In recent years, several private sector laboratories analyses found that a substantial number of dietary supplement products analyzed did not contain the amount of dietary ingredients claimed in their product labels.
• The Dietary Supplement Health and Education Act of 1994 provide the Secretary of Health and Human Services, and the FDA by delegation, the express authority to issue regulations on dietary supplement CGMPs.

FDA Proposed Standards

FDA Press Release

FDA Overview

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