After years of study, the Food and Drug Administration (FDA) will require that manufacturers of dietary supplements, including vitamins and herbs, test all of the ingredients and abide by a code of good practices. The measure is intended to ensure that the supplements are safe and that they actually contain the substances they advertise. But critics said the measure was much too little and much too late.
"Even with these new manufacturing practices, there will be no assurance that dietary supplements work or are safe," said Sidney Wolfe, MD, Director of the Health Research Group at Public Citizen. Wolfe said the law was 13 years too late. "Congress mandated in 1994 that the agency issue a rule governing the manufacturing practices of dietary supplements.
It is baffling that the FDA has taken until 2007 to finalize it," he said. Wolfe noted that, because of the same 1994 law, the FDA still has no authority to require testing for safety or efficacy of any dietary supplement. "We saw with the ephedra-related deaths the dangers that dietary supplements pose.
Congress should address this enormous deficiency in the law," he said. Last year, the FDA found that some supplements contained undeclared active ingredients in supplements promoted to relieve erectile dysfunction. In other incidents, regulators found supplements that didn't contain the levels of Vitamin C or Vitamin A that were claimed.
“This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label,” said Commissioner of Food and Drugs Andrew C. “In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year, industry will be required to report all serious dietary supplement related adverse events to FDA,” he said. If the FDA finds that supplements do not contain the ingredients they claim, it will be able to ask the manufacturer to remove an ingredient or revise its label.
In more serious cases, it could seize the product, file a lawsuit or seek criminal charges. Dietary supplements are a $22 billion business in the United States and the industry has for years used its considerable lobbying power to block tougher regulations. "This is a long-awaited and welcome development,” said Mark Blumenthal, Founder and Executive Director of the American Botanical Council, a trade group based in Austin, Texas.
“This is a significant day for consumers and health professionals who use these natural products for their health. It will result in their having more confidence in these products and their potential benefits,” he said. The new rules will take up to three years to go into effect, depending on the size of the company.
Large companies (more than 500 employees) will have to comply with the rules within one year (June 2008), while medium-sized companies (less than 500 employees) will have two years (June 2009), and small companies (less than 20 employees) will have up to three years (June 2010) to meet the new requirement. If you've had a bad experience with a consumer product or service, we'd like to hear about it. All complaints are reviewed by class action attorneys and are considered for publication on our site.
Knowledge is power! Help spread the word. After years of study, the Food and Drug Administration (FDA) will require that manufacturers of dietary supplements, including vitamins and herbs, test all of the ingredients and abide by a code of good practices.
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