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Posted September 2, 2016

Maker of Prescription Multi to Pay $15.5 Million to Settle Lawsuit Over Ingredient Claim

Endo Health Solutions Inc. has reportedly agreed to pay $15.5 million to settle a class action lawsuit which alleged its Qualitest Multi-Vitamin with Fluoride Chewable Tablets contained just 44% of the fluoride claimed on the label.

The tablets can be prescribed to children who do not live in areas which provide adequately fluorinated water.

The plaintiff contended that the Qualitest "bottle label and insert were deliberately misleading because they were intended to convey falsely that the Tablets provided the dosage of fluoride ion recommended by the ADA [American Dental Association] and the AAP [American Academy of Pediatrics]."

ADA-APP guidelines recommend children in communities that do not provide a minimum amount of fluoride in drinking water be prescribed a daily 1.0 mg fluoride supplement tablet. According to the lawsuit, the Nutrition Facts section of the Qualitest label lists the ingredient as "Fluoride ...1 mg," indicating that each tablet provides 1 mg of fluoride. However, the tablets contain 1 mg of the compound sodium fluoride — of which, less than half is fluoride ion. (Sodium fluoride is listed elsewhere on the label as the "active ingredient.")

( has noted that some supplement labels can be misleading when the amount of an entire mineral compound is listed - in addition to, or instead of, the amount of the actual, or elemental mineral - and provides more information about this issue in its Magnesium Supplements Review).

According to court documents, Qualitest "admitted that the Tablets were sub-potent and did not deliver the dosage of fluoride ion indicated on the labels. The defendants allegedly knew that the master formula for the Tablets differed from the fluoride concentration listed on the labels and package inserts."

The judge noted that "Nothing in the label or the insert explained that the Tablets do not contain the recommended dosages of fluoride ion that are discussed on the insert itself or that sodium fluoride contains only 45% of the recommended amount of fluoride ion. Thus, although the labels indicate that the active ingredient was sodium fluoride, the complaint contains strong circumstantial evidence of the defendants' fraudulent intent."

To read the judge's full opinion and order, use the link below.