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The FDA has warned US-based consumer-goods manufacturer Procter and Gamble over making unlawful claims about one of its products.
The agency says the marketing and usage directions for P&G’s Vicks Early Defense Foaming Hand Sanitizer render it an unapproved new drug under the US Federal Food, Drug, and Cosmetic Act.
Specifically, the FDA believes the firm is promoting the product for use by schoolchildren to prevent colds and to provide antimicrobial activity for up to three hours.
The agency has not heard of any significant health risks associated with the product, but is stepping in because the product has not been approved as safe and effective in terms of the claims made by P&G.
A P&G spokesman said the company did comply with FDA regulations, but would work with the regulator to clear up any confusion.
Dr Steven Galson, director of the FDA’s Center for Drug Evaluation and Research, said: “FDA is concerned with the marketing of this over-the-counter drug for use by schoolchildren and others.
“Over-the-counter drugs are often widely used without supervision by a doctor or other healthcare professional, so it is essential that manufacturers obtain FDA approval or fully comply with OTC monographs and agency policies.”
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