FDA cracks down on dietary supplements

Jun 25 2007

It's taken a few years but the Food and Drug Administration (FDA) in the U.S. has finally established a set of regulations to ensure good manufacturing practices for dietary supplements.

The final regulations are aimed at the manufacturers of dietary supplements, including vitamins and herbs, and will guarantee that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and carry accurate and comprehensive labels.

The regulations require manufacturers to test all of the ingredients and abide by a code of good practice in order to ensure that the supplements are safe and actually contain the substances stated.

The final rule aims 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.

However many critics are saying the regulations promise too little and come much too late and the new manufacturing practices will offer little assurance that dietary supplements work or are safe.

Dr. Sidney Wolfe, the director of the consumer watchdog group Public Citizen says the rules are too late and it is a mystery why it has taken the FDA 13 years to finalise the mandate by Congress issued in 1994.

Wolfe says the 1994 law does not give the FDA any authority to demand testing for safety or efficacy of any dietary supplement and recent experience suggests that Congress needs to address this deficiency in the law.

Last year, the FDA found that some supplements contained undeclared active ingredients in supplements promoted to relieve erectile dysfunction and in other incidents, regulators found supplements that didn't contain the levels of Vitamin C or Vitamin A that were claimed.

However the FDA Commissioner of Food and Drugs, Dr. Andrew C. von Eschenbach, says the rules will ensure the quality of dietary supplements and by the close of the year recent amendments to the Federal Food, Drug and Cosmetic Act, will mean the industry will be required to report all serious dietary supplement related adverse events to FDA.

Dietary supplements are a billion dollar business in the United States and the industry has managed for years to block tougher regulations.

Dr. Robert E. Brackett, the director of FDA's Center for Food Safety and Applied Nutrition says the final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product, free of contamination, with accurate labeling.

The new rules will take up to three years to go into effect, depending on the size of the company;companies with more than 500 employees will have to comply with the rules within one year (June 2008), while companies with less than 500 employees will have two years (June 2009), and companies with less than 20 employees will have up to three years (June 2010) to meet the new requirements.