July 30, 2012 — Two Congressmen are calling on the dietary supplement industry to improve manufacturing standards. Senators Dick Durbin (D-Ill) and Richard Blumenthall (D-Conn) have sent letters to three of the largest supplement industry trade groups.
The letters were prompted by an investigation from the Chicago Tribune, which found that inspectors from the U.S. Food and Drug Administration (FDA) found violations of Good Manufacturing Practices (GMP) standards in half of the 450 facilities they investigated.
The organizations that received letters from the senators are the National Products Association, the American Herbal Products Association, and the Council for Responsible Nutrition. The senators’ letter stated, “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.”
Although many consumers believe that dietary supplements are held to the same standards as pharmaceutical drugs in medicines, in reality, companies that manufacture supplements do not need to prove that their products are safe or effective before they can be sold on store shelves. Furthermore, GMP standards are enforced much less strictly.
The Tribune found that as of June 2012, inspectors had found GMP violations in two-thirds of more than 200 dietary supplement manufacturing facilities. There were also 70 citations that had the agency’s worst rating. The investigators found that one facility was infested with rodents — including rodent feces, urine, and dismembered body parts. After the FDA sent the company a warning letter, the managers agreed to halt production, but instead transferred production to another facility. The managers are now facing criminal sentences and prison time, but have appealed the enforcement.
Other investigations found that companies had no master recipes, did not test the amount of ingredients in their products, and had inadequate quality control practices to ensure they were selling safe products.
Investigators were concerned that poor manufacturing practices could cause a widespread public health catastrophe.
As an example, in 2008 in Panama, at least 200 people died after consuming a dietary supplement that contained diethylene glycol (a poison) instead of glycerin (a sweetener). The manufacturers failed to verify the identity of the ingredient they purchased from distributors in China.
In 2009 in the United States, toxic heavy metals were found in a zinc supplement that was mostly given to children. The contamination was discovered when one customer’s private physician found abnormal levels of antimony, a toxic heavy metal, in the child. The supplement manufacturer recalled 15,000 bottles and now tests their product more stringently. It is unknown what long-term effect antimony has on a person’s health.
The FDA prohibits supplement manufacturers from claiming their product can treat, cure, or prevent a specific health condition. Even so, the practice is widespread. The FDA has the authority to issue warning letters and forcibly seize products, though such enforcement actions are rare.
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