The U.S Federal Drug Administrators warned Proctor & Gamble to discontinue illegal marketing of two of their products, Vicks Nyquil and Vicks Dayquil, both containing vitamin C.
According to federal regulators, a combination of a dietary ingredient (Vitamin C) and drug ingredients is not permitted, implying that adding vitamin C to Vicks cold formulas is not allowed by drug regulations.
Vicks Nyquil and Dayquil are Over-the counter medications that are marketed for relief against cold and flu symptoms. However, there is no sufficient data to prove the efficacy of vitamin C in treating cold and it has not been proven safe to use for this indication. According to the agency, a panel of experts found “no study which demonstrated that vitamin C is unequivocally effective for the prevention or treatment of the common cold.” Contradicting this is P & G’s advertising for Vicks, which says the vitamin can help “blunt the effects of a cold”.
According to FDA’s OTC monograph system, some drugs can be marketed without approval from the agency. Such OTC products must comply with existing monographs, which are nothing but rules that state requirements for categories of non-prescription drugs, such as what ingredients may be used and for what intended use. In this case, the two Vicks products do not meet the terms of the FDA monograph and must be evaluated and approved under the FDA’s new drug approval process before being legally marketed.
FDA only approves drugs and not dietary ingredients. Hence, it dissuades drug companies from packaging drugs with dietary supplements as this creates an impression that both components were evaluated and approved by FDA, when in fact, the agency only regulates drugs.
While calls placed to the Cincinnati based company were not returned immediately, FDA has given P & G fifteen business days to respond with an action plan addressing the violations.
In recent years the FDA has begun cracking down on manufacturers who overstate the benefits of their products, amid increased demand for healthy foods.
Article by Snigdha Taduri for Biomed-Middle East