FDA Warning Letters: Acetaminophen in Supplements Makes the Product a Drug 28465FDA Warning Letters: Acetaminophen in Supplements Makes the Product a Drug

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

WASHINGTON--Two dietary supplement companies received warningletters from the Food and Drug Administration (FDA) about mislabeling problemswith their products. Both companies were informed by FDA that notwithstandingyour 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 InholtraJoint Pain Caplets and Inholtra Joint Pain Plus Caplets. According to the FDAwarning letter, the products include acetaminophen, glucosamine sulfate andchondroitin sulfate, and were marketed to provide quick pain relief andlong-term joint support. Calls to Omni Nutraceuticals were not returned by presstime.

B.F. Ascher & Co., headquartered in Lenexa, Kan., marketed Melagesic PMCaplets, combining acetaminophen and melatonin, among other ingredients. DickWelch, director of scientific and legal affairs for B.F. Ascher, told Reutersmedia that company lawyers were reviewing the letter.

In both cases, the agency noted that when a drug and dietary ingredient arecombined, the entire product is a drug, and the dietary ingredients, if notsubject of a New Drug Application, violate federal regulations for drugcontents.

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