Both of the over-the-counter (OTC) 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.
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. 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.
(Editor’s note: The warning letter sent to Procter & Gamble today concerns the same products as the letter mistakenly posted on the FDA Web site on Oct. 14, 2009, due to a computer error.)
For more information
FDA Warning Letter to Procter & Gamble
FDA Drug Safety Initiative
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