CINCINNATI Procter & Gamble recently combined the multi-symptom relief of its DayQuil and NyQuil brands with more than 150 percent of the recommended value of vitamin C in DayQuil Plus Vitamin C and NyQuil Plus Vitamin C respectively.
The idea is that while consumers are seeking cold symptom relief, they can take something to help boost their immune system in one remedy. Last cough/cold season, Bayer Healthcare followed a similar line of thinking with its introduction of Alka-Seltzer Plus Immunity Complex, effervescent get-better tablets that contain all supplements, however, as opposed to a supplement and OTC combo.
Bayer did however recently launch a supplement/OTC combination product, Bayer With Heart Advantage, which contains 81 mg of aspirin and 400 mg of phytosterols. That product generated a warning letter from the Food and Drug Administration on Oct. 28, in which the agency suggested that supplement/OTC combinations may run afoul of regulations. “The FDA considers these products new drugs and thus they must undergo the FDA’s drug approval process,” Mike Chappell, the FDA’s acting associate commissioner for regulatory affairs, said. Speaking to the Bayer products, FDA noted that the solution is labeled as being a combination of a drug and a dietary supplement, but when a drug and a dietary supplement are combined in a single tablet, the product is regulated by FDA as a drug.
That’s not to suggest that P&G is marketing a product without FDA approval. Under its OTC drug monograph system, FDA allows some drugs to be marketed without first obtaining agency approval, the agency noted. These drugs must comply with applicable monographs as well as the indications for which the drugs can be marketed.