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FDA issues guidelines for dietary supplements
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Dietary supplements are now required to be labeled and manufactured in accordance with stricter regulations issued by the U.S. Food and Drug Administration. The final regulation on current good manufacturing practices “ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities and are accurately labeled,” according to an FDA press release.
To comply with this rule, the FDA said, “Manufacturers are required to evaluate the identity, purity, strength and composition of their dietary supplements.” The rule will control the substances manufacturers put on the market and ensure that consumers know precisely what they are purchasing.
“The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling,” said the FDA in the press release.
Response from Natural Products Association
In a press release, the Natural Products Association, which has been self-regulating since it established many of the same requirements for dietary supplements in 1999, said the regulations are “strong” but “reasonable” in meeting the needs of both the consumers and the industry.
The regulations control such aspects of the manufacturing process as packaging, labeling and storing to guarantee that manufacturers meet standards for quality and purity. Quality control procedures, design and construction of manufacturing plants, testing of ingredients and the finished product, recordkeeping requirements, and handling consumer product complaints are issues contained in the final rule, according to the Natural Products Association release.
David Seckman, executive director and CEO of the Natural Products Association, acknowledged in the press release that the final rule is reasonable for manufacturers and should not interfere with production of dietary supplements. Mr. Seckman said, “It offers a more flexible framework in meeting standards, such as testing and facility design. This will help smaller companies control costs – costs that would have been passed along to the consumer – while still maintaining quality standards.”
Phase-in period for smaller businesses
Small businesses will phase in to the regulations, as companies with fewer than 20 employees do not have to fully comply with the regulations until June 2010. Meanwhile, companies with fewer than 500 employees have until June 2009, and companies with at least 500 employees must comply with the regulations by June 2008, the FDA press release states.
The real benefit of the final rule is for the consumers, who will not have to worry about contaminated or otherwise unsafe or unsatisfactory supplements. “With heightened consumer concern over the safety of food ingredients, particularly those coming from overseas, this new regulation should help increase consumer confidence in the dietary supplement products they buy,” Mr. Seckman said. “Consumers want to be assured that what’s on the label is in the bottle – nothing more, nothing less – and this regulation aims to make sure that is the case.”
For more information:
- The Natural Products Association can be reached at www.naturalproductsassoc.org.
- Information about the final rule can be found on the FDA Web site at www.fda.gov.