FDA Warning Letters: Acetaminophen in Supplements Makes the Product a Drug

WASHINGTON--Two dietary supplement companies received warning letters from the Food and Drug Administration (FDA), informing the companies of mislabeling problems in their products. Both companies were informed by FDA that "notwithstanding your attempt to market [the products] as a combination drug-dietary supplement, the presence of the acetaminophen, with its intended use to relieve pain, renders the entire product a drug."

Omni Nutraceuticals, based in Los Angeles, marketed the products Inholtra Joint Pain Caplets and Inholtra Joint Pain Plus Caplets. According to the FDA warning letter, the products include acetaminophen, glucosamine sulfate and chondroitin sulfate, and were marketed to provide quick pain relief and long-term joint support. Calls to Omni Nutraceuticals had not yet been returned at press time.

B.F. Ascher & Co., headquartered in Lenexa, Kan., marketed Melagesic PM Caplets, combining acetaminophen and melatonin, among other ingredients. Dick Welch, director of scientific and legal affairs for B.F. Ascher, told Reuters media that company lawyers were reviewing the letter.

In both cases, the agency noted that when a drug and dietary ingredient are combined, the entire product is a drug, and the dietary ingredients, if not subject of a New Drug Application, violate federal regulations for drug contents.

The companies had 15 working days from the Oct. 12 release date of the warning letter to respond to FDA, including what corrective actions will be taken. The warning letters have been posted on the FDA Web site (http://www.fda.gov/cder/warn/warn2001.htm).

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