Drug-Supplement Combinations Draw FDA Warning Letters

Reuters Medical News

Two pharmaceutical companies have received warning letters from the Food and Drug Administration for marketing products that combine dietary supplements with over-the-counter drugs. According to FDA standards, the presence of pain-relief agents in these products designates them as unapproved drugs, and therefore ineligible for public use. Both companies were also reprimanded for using insufficient product information on their packaging. BF Ascher & Co. of Lenexa, Kansas was targeted for marketing MelagesicÃ’ PM, a pain relief/sleep aid product containing acetaminophen, an analgesic, and melatonin, a dietary supplement. According to the FDA, this combination makes the product an unapproved new drug, ineligible for marketing. InholtraÃ’ Joint Pain and Joint Pain Plus caplets, a product of Omni Nutraceuticals in Los Angeles, contain a similar combination of acetaminophen with the dietary supplement glucosamine sulfate; the Joint Pain Plus also contains the dietary supplement chondroitin. Because these products claim to bring arthritis pain relief, they, too, are considered to be unapproved new drugs and therefore ineligible for marketing. In both cases, the FDA notes, an individual dietary supplement, when presented in combination with an over-the-counter drug, also becomes "an active drug ingredient" and is therefore considered an unapproved new drug. Return to Top