FDA warning over Procter & Gamble's hand sanitizer claims
Global giant Procter & Gamble has been warned to take immediate action to remedy unlawful marketing claims made about its Vick Early Defense Foaming Hand Sanitizer.
According to the US Food and Drug Administration (FDA), some marketing statements made about the product are inconsistent with labelling allowed under the FDA’s OTC Drug Review.
The product has been promoted on the Vicks website as a hand sanitizer containing tricolsan – an ingredient used by many anti-microbial sanitiser – that helps to fight germs for up to three hours. Statements on the Vicks website suggest the ingredient need not be rinsed off as its use is recommended when ‘soap and water are not available’.
However, the FDA disagrees. The organisation said: ‘Although the active ingredient in Vicks Early Defense Foaming Hand Sanitizer, ie, triclosan is covered by these ongoing rulemakings for certain topical antimicrobial uses, the claims reference above and the directions to “leave-on” without rinsing with water are not.’
The FDA has also challenged the claim that the product is effective in fighting germs that cause colds, saying that it is not: ‘aware of sufficient evidence to show that the product is generally recognised as a safe and effective in preventing individuals from becoming infected with colds, a condition caused by the viruses.’
Procter & Gamble were issued the letter on 14 September and instructed to respond in writing o the FDA office outlining the specific steps it would be taking to correct the violations.
A spokesperson from the company said Procter & Gamble would be working with the FDA to clear up any misunderstanding.