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Congressmen Calling for Supplement Industry to Improve Standards

July 30, 2012 — Last month, the Chicago Tribune reported that the U.S. Food and Drug Administration (FDA) inspectors had found serious violations of Good Manufacturing Practices (GMP) in half of the 450 facilities they inspected. Many of these facilities have received warning letters, in what is “considered a significant enforcement action.” In response, Senators Dick Durbin (D-Ill) and Richard Blumenthal (D-Conn) sent letters to three major dietary supplement organizations asking them to improve manufacturing standards at their facilities.

The letters were addressed to the Council for Responsible Nutrition, the American Herbal Products Association, and the Natural Products Association. These three trade organizations are some of the most influential in the dietary supplement industry. The senators said, “We are deeply concerned about the poor manufacturing standards that expose consumers to potentially serious health risks. Consumers should have access to dietary supplement that meet fundamental quality controls.”

As of June 2012, the FDA had found violations of good manufacturing practices in two-thirds of the approximately 200 dietary supplement manufacturing facilities. Of these, 70 inspections were given the agency’s worst rating. Some violations in the investigation revealed facilities infested with rodents, rodent feces and urine, or dismembered rodents. Other companies had no master recipes, could not verify the amount of active ingredients in their products, or failed to conduct adequate quality control before selling their products.

In 2008, more than 200 people were seriously injured when they consumed a multivitamin dietary supplement that contained poisonous amounts of selenium. Instead of containing 200 micrograms of selenium, the products contained 40,800 micrograms. Some of the victims have suffered permanent physical and mental disability. Many injured people filed a dietary supplement lawsuit and received a settlement from the company. Other lawsuits are in the midst of settling.

In Panama in 2006, more than 200 people were killed when a dietary supplement company failed to verify the identity of a sweetener (glycerin) they ordered from China. The ingredient was actually a poison, known as diethylene glycol.

In 2009 in the United States, a company that manufactured zinc supplements recalled 15,000 bottles after finding dangerously high levels of antimony, a heavy metal. The contamination was only discovered when a customer’s private physician discovered unusually high levels of antimony. The long-term effects of antimony are unknown.

Companies that sell dietary supplements do not need to prove to the U.S. Food and Drug Administration (FDA) that their products are safe before they are allowed on store shelves. The FDA does prohibit claims that supplements can treat, cure, or prevent a specific disease, and the FDA can enforce this rule by issuing warning letters or forcibly seizing products.

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