FDA warns P&G over marketing of a Vicks soap

By Guy Montague-Jones

- Last updated on GMT

Related tags: Fda, Marketing, Procter & gamble

Procter and Gamble today came into conflict with the FDA over what
the agency called the "unlawful" marketing and labeling of a
Vicks branded soap, which the company claims fights germs for
up to three hours after application.

P&G intends to challenge the FDA over the reprimand, which follows a number of similar cases in the food and cosmetics industries where regulators have taken action against companies over unjustified health claims. In a warning letter sent to the personal care giant, the FDA said that Vicks Early Defense Foaming Hand Sanitizer is an unapproved new drug under the Federal Food, Drug, and Cosmetic Act. In the letter, district director Carol Heppe said the FDA is not aware of any evidence that demonstrates the safety of the product or its effectiveness at fighting germs and keeping colds at bay. Furthermore, the agency explained that Early Defense should instruct users to rinse their hands with water after washing because it contains the chemical tricolosan. As the directions for use do not instruct the user to rinse, the FDA considers the product to be unlawfully marketed, she stated. Defending Vicks Early Defense, David Bernens from P&G told CosmeticsDesign.com: "We agree with the FDA that this not a question of safety. When it comes to the product monograph P&G believe that we are within the regulations and we will work with the FDA to clear up any misunderstanding."​The FDA is particularly anxious about these violations in light of the fact that Early Defense appears to be aimed at school children. "FDA is concerned with the marketing of this over-the-counter drug for use by school children and others,"​ said FDA spokesperson Steven Galson. On the Vick's website parents are invited to take the 'germ-defense zone pledge' and enter their child's school into a prize draw to win a 'germ-fighting fest', which features food goodies and Early Defense product samples. Bernens said: "Theproduct is for anyone - it is not specifically marketed at children."​ The spokesman added that the website only features the 'germ-defense zone pledge' to coincide with the start of the school year. The FDA stated in its warning letter that failure to promptly correct the violations may result in legal action without further warning.

Related topics: Market Trends, Color Cosmetics

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