The U.S. Food and Drug Administration today sent a 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.

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 http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm188361.htm

FDA Drug Safety Initiative http://www.fda.gov/cder/drugSafety.htm

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For Immediate Release: Oct. 30, 2009 Media Inquiries: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA

Earnings beat analyst estimates, even as sales were down 6 percent to $19.8 billion.

P&G said it is seeing signs of a rebound and hiked its growth outlook for the 2010 fiscal year to 2 to 4 percent.

Also this morning, consumer products competitor Colgate-Palmolive posted earnings that beat expectations.

Colgate earned $590 million, or $1.12 per share, as compared to $500 million, or 94 cents per share, in the same quarter last year.

Sales were up by about one quarter of one percent, to $4 billion.

Colgate said it is looking for another year of double-digit earnings growth in 2010.

The preceeding is a transcript of the MarketNewsVideo.com video published at: http://www.marketnewsvideo.com/?id=200910-ProctorGamble102909&mv=1.

http://www.marketnewsvideo.com/

Bob McDonald, president and CEO of Procter & Gamble, said: "Our September quarter results give us encouragement we are making the right choices to grow market share profitably. We are investing in innovation, expanding our portfolio and improving consumer value to serve more consumers, in more parts of the world, more completely.

"We are driving simplification and improving execution while leveraging scale to create cost efficiencies that help fund these investments and accelerate growth."

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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 http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm188361.htm

FDA Drug Safety Initiative http://www.fda.gov/cder/drugSafety.htm

Media Inquiries: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

http://www.fda.gov/