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Massage Today
May, 2003, Vol. 03, Issue 05

FDA Proposes New Standards for Dietary Supplements

By Editorial Staff

The regulation of dietary supplements falls under the auspices of the Dietary Supplement and Health and Education Act (DSHEA), passed by Congress in 1994. Under DSHEA, makers of dietary supplements have an "essential responsibility" to substantiate the safety of the ingredients used in manufacturing a product, and are responsible for determining whether any claims made about their products are substantiated by adequate evidence to show that such claims are not false or misleading.

However, supplement makers are not subject to mandatory standards for manufacturing or labeling, and if a product already on the market is found to be harmful, the Food and Drug Administration (FDA) bears the burden of proving it's hazardous, not the manufacturer.

On March 7, the FDA announced new guidelines for dietary supplement regulation in the U.S. The proposed guidelines would implement new, industry-wide standards in the manufacturing, packaging and holding of supplements, and ensure that they are labeled accurately and do not contain impurities or other contaminants.

"Americans must have confidence that the dietary supplements they purchase are not contaminated and that they contain the dietary ingredients and the amounts claimed on the labels, said Secretary of Health and Human Services Tommy Thompson in a news release. "Millions of Americans use dietary supplements, and we owe it to them to ensure that they are getting the products they're paying for."

The new rules do not address product safety or effectiveness of supplements; instead, they focus on quality control, and require manufacturers to follow new Good Manufacturing Practices (GMPs) to help increase the purity and quality of supplements. Specifically, manufacturers would be required to:

  • employ qualified employees and supervisors;
  • design and construct their physical plant in a manner that protects dietary supplements (and their ingredients) from becoming contaminated 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 supplements, ingredients and finished products under appropriate temperature, humidity, light and sanitation conditions so that their quality is not affected;
  • keep a written record of each consumer complaint related to product quality or good manufacturing practices; and
  • retain written records for three years beyond the date of manufacture of the last batch of dietary ingredients or supplements.

In addition, manufacturers would be legally obligated to evaluate the purity; identity; quality; strength; and composition of the ingredients contained in supplements, and to display accurate information on the product label.

The FDA would have the power to oversee the construction of manufacturers' plants, establish quality control procedures, and send inspectors into plants to test raw ingredients and finished products. It would also have the authority to remove products that are contaminated, contain the wrong substances, or have too much (or too little) of an ingredient.

The proposed GMPs would apply to all firms that manufacture, package, or hold dietary supplements or ingredients, including firms that test, label, distribute or oversee the quality of supplements. These regulations would apply to both foreign and domestic firms.

A company's size would determine how soon it must meet with the FDA's standards. According to the administration, there are approximately 1,000 dietary supplement makers in the U.S. Large supplement manufacturers would have to comply with the rules as soon as they go into effect, but smaller companies could have up to three years to implement the guidelines.

The FDA's announcement was welcomed by many consumer groups and members of the dietary supplement industry.

"The responsible manufacturers are happy to comply," remarked John Hathcock, an executive with the Council for Responsible Nutrition, which represents approximately 80 supplement makers that already follow voluntary quality standards. He added that some manufacturers "cloud our whole industry, and we're glad to see federal action to force them to ... get in line or get out of business."

"We think this will provide consumers with a lot more confidence in the products they are taking," added Donna Edenhart, a spokesperson for the Consumer Healthcare Products Association.

References

  1. Warner J. Standards proposed for labeling, manufacturing of dietary supplements. WebMD Medical News, March 7, 2003.
  2. FDA proposes supplement standards. Guidelines will ensure dietary aids are accurately labeled. Associated Press, March 7, 2003.
  3. Ault A. FDA to demand supplement makers vouch for contents. Reuters, March 7, 2003.
  4. McNeil DG, Day S. FDA to put new rules on dietary supplements. New York Times March 8, 2003.

 

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