EPA and Newark pharmaceutical company reach agreement

NEWARK, NJ — The U.S. Environmental Protection Agency recently announced that it has reached an agreement with Pharmaceutical Innovations of Newark, resolving alleged violations of the Federal Insecticide, Fungicide and Rodenticide Act. The EPA had alleged that Pharmaceutical Innovations sold and distributed the unregistered and misbranded antimicrobial pesticides “PI Spray” and “PI Spray 2.”

The unregistered and misbranded pesticides were used to clean ultrasound and mammography equipment and other surfaces in health care facilities. As a result of the settlement, Pharmaceutical Innovations stopped producing and selling their unregistered and misbranded products called “PI Spray” and “PI Spray 2” and did a voluntary recall of both products.

“These products were marketed to health care facilities and their patients, which of course relied on the claims that they kill microorganisms, but in this case those claims were not properly substantiated through the EPA registration process,” EPA regional administrator Pete Lopez said in a press 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.”

The product labels, product inserts and promotional material for both products reportedly made unsubstantiated claims to control bacteria and kill viruses; made unsubstantiated claims as to the efficacy and safety of the product; and did not list the inert ingredients or bear the name and percentage by weight of each active and inert ingredient.

In the settlement, Pharmaceutical Innovations agreed to pay a civil penalty of $250,000 and certified that it has come into compliance with FIFRA.

The sale and distribution of unregistered and misbranded antimicrobial pesticides pose a danger to people’s health. Without the company’s submission of efficacy and safety data and product labels to EPA for review and approval, as required by law, health care facilities and their patients may use the product inappropriately and are deprived of important health and safety information.

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. It will also help ensure that antimicrobial products are not mislabeled with unsubstantiated claims or without important information for use.

The goal of FIFRA is to promote the appropriate use of pesticides and to minimize the risks to the public, pesticide applicators and the environment from their use. FIFRA requires that pesticides sold in the United States be registered with EPA to ensure they are effective for their intended use and distributed with labels bearing approved claims and all required information. Facilities that produce pesticides must also be registered with EPA and are required to submit annual production reports.