Pharmaceutical Innovations has agreed to pay a $250,000 civil penalty following allegations by the U.S. Environmental Protection Agency that the New Jersey company made unsubstantiated claims in marketing and packaging two antibacterial products.
The EPA alleged the company violated the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) by making unproven assertions about controlling bacteria, killing viruses and overall safety and efficacy regarding its PI Spray and PI Spray 2 products utilized in cleaning specialized imaging equipment at health care facilities, an EPA release said.
Pharmaceutical Innovations also has voluntarily recalled both brand-name items from retail shelves, the release said.
EPA said in the release the products’ labels made the unproven assertions and also omitted inert ingredient information.
“These products were marketed to health care facilities and their patients, which of course relied on the claims that they kill micro-organisms, but in this case those claims were not properly substantiated through the EPA registration process,” EPA regional Administrator Pete Lopez said in the release. “When the EPA registers products, EPA requires that companies demonstrate that products do what they claim and that they don’t present unacceptable risk if used properly.”
FIFRA is intended to ensure the proper use of pesticides and minimize human and environmental health risks.
“The settlement will help ensure that sellers and distributors of antimicrobial products do not make claims about pesticides without first registering their products with EPA,” the release said.