MANHATTAN (CN) - Qualitest Pharmaceuticals will pay $39 million to settle fraud charges related to its sale of half-strength fluoride supplements.
The American Dental Association and American Academy of Pediatrics had recommended certain fluoride dosage strengths since at least 1994 to prevent tooth decay.
Per those guidelines, children living in communities without fluoridated water supply should take in up to 1 mg of fluoride ion a day, depending on the child's age and the local water fluoridation level.
Qualitest labeling indicated that its chewable fluoride tablets contained 1 mg, 0.5 mg and 0.25 mg of fluoride, in line with the guidelines, which the labels specifically referenced. The company's products are covered by federal health care programs, including Medicaid.
In early 2013, a doctor named Stephan Porter filed a federal complaint that blew the whistle on the fact that Qualitest's manufacturing processes were not designed to produce tablets that would contain the fluoride ion dosages it boasted.
After the Government began its investigation into the whistle-blower's allegations later that year, Qualitest stopped making and selling their chewable fluoride tablets.
According to a statement last week from the Justice Department, Qualitest eventually admitted that it used less than half the appropriate amount of sodium fluoride between 2007 and July 2013.
Children taking the Qualitest fluoride tablets thus received less than half the recommended amount of fluoride ion, the press release continues.
The settlement requires Qualitest to pay the government $22.44 million, while settling states will take home $16.56 million.
Porter is entitled to $4.71 million from the settlement under the False Claims Act.
Vintage Pharmaceuticals, as Qualitest is also known, is a subsidiary of Endo Pharmaceuticals.
U.S. District Judge Denise Cote approved the settlement on Dec. 16.
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