Early last month, the U.S. Food and Drug Administration (FDA) issued a warning to the Procter & Gamble Company regarding how the drug maker marketed some of its Vick’s brand cold medications. The letter was immediately retracted, with the FDA saying there was a computer problem that inappropriately released the letter.
Now, reports the Associated Press (AP), the agency sent another warning letter to Procter & Gamble stating that the drug maker was illegally marketing two of its over-the-counter (OTC) Vicks cold and flu medications that contain vitamin C. The single-dose versions of Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C are not legally marketable since they were never “proven safe and effective,” said the AP.
The FDA said it sent its warning letter to Procter & Gamble notifying the company that its Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C are illegally marketed combinations of drug ingredients and a dietary ingredient.
Also, said the AP, the FDA has determined that there does not exist sufficient information to prove the vitamin’s safety and efficacy in either preventing or treating colds. Both of the OTC Vick’s medicines, which contain vitamin C in addition to several drug ingredients, are marketed as treatments for cold and flu symptoms.
The FDA took the action against the Cincinnati-based company: To clarify that these single dosage form combinations of drug ingredients and dietary ingredients legally cannot be marketed because they have not been proven safe and effective, and because the agency previously determined that there are insufficient data to show that vitamin C is safe and effective in preventing or treating the common cold.
The earlier agency letter was retracted, according to FDA spokesman Christopher Kelly, because it was “issued prematurely—it had not completed our internal clearance process,” quoted the AP.
Under its OTC monograph system, the FDA allows some OTC drugs to be marketed without agency approval. Such drugs must comply with applicable monographs, which are regulations that set requirements for the drugs’ labeling, formulations, and indications, said the FDA. According to the FDA. the two Vicks products do not comply with the applicable FDA monograph and must first be evaluated and approved under the FDA’s new drug approval process to be legally marketed.
The FDA’s position on the regulatory status of OTC drug products that combine drug ingredients with dietary ingredients in a single dosage form has been described in previous warning letters issued in 2001 and 2008. The agency’s position on the marketing of vitamin C for preventing or treating the common cold also has been stated in a number of previous warning letters, said the FDA.
The FDA’s Warning Letter to Procter & Gamble can be accessed at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm188361.htm Also, the FDA’s Drug Safety Initiative can be accessed at: http://www.fda.gov/cder/drugSafety.htm.
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