It’s outrageous! The FDA can’t recall harmful supplements

Consumer Reports News: May 17, 2010 02:37 PM

The FDA warned against the dietary supplement Vita Breath on May 1st because of high lead levels, but why hasn’t the supplement been recalled? Because the FDA doesn’t have the authority to pull dietary supplements from the market, even when public health is in danger.

The world of vitamin and dietary supplements is not well regulated, and the FDA has less authority over supplements than over drugs and medical devices.

Under the Federal Food, Drug and Cosmetic Act the FDA regulates lead in cosmetics, food, and food wrappers. For example, in 2005 the FDA put out “guidelines,” that limited  lead levels in candy to 0.1 parts per million. Vita Breath was reported to have contained about 10 times that amount at 1100ppm, which is 12 times the limit allowed for lead in paint. The supplement would not have to adhere to the FDA’s candy guidelines.

If lead were found in a product that people do not consume in large amounts, like spices, the FDA makes regulatory determinations on a case-by-case basis, according to FDA spokesperson Patricia El-Hinnawy. Vita Breath would seem to fall into this case-by-case category. 

The FDA explains that for situations where the presence of extremely small amounts of lead in food may be unavoidable -e.g. its presence as a natural contaminant in some foods- the agency may set limits to ensure the lowest practicable levels exist.

Our take: Clearly this product should not be ingested, but while the FDA does its own tests on Vita Breath, bottles of the pills can still be bought online for $65 a pop, which is outrageous given that its apparent lead content can cause lead poisoning.

-Maggie Shader   

Marc Perton

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