U.S. DOJ Alleges That New Jersey Company Was Selling Misbranded And Unapproved Drugs

My Central Jersey reported on the arrest of a man and a woman for allegedly participating in a scheme to market and distribute misbranded and unapproved new drugs. The U.S. Department of Justice (DOJ) filed a charge of conspiring to distribute and cause the receipt and delivery of misbranded new drugs against both Keith Kovaleski of South Amboy and Inew Maltez of Sayreville. According to a court document, between 2014 and January 2019, Kovaleski was the principal of AA Peptide LLC (AAP).

During this timeframe, AAP used its website to market and distribute products used by bodybuilders and those engaged in weight training to either enhance performance or to mitigate side effects of performance-enhancing substances. There was even a fake disclaimer on AAP’s website that stated that substances for sale on its website were research chemicals and neither food nor drugs. On five occasions between April 2018 and December 2018, an undercover law enforcement agent purchased misbranded and unapproved drugs from AAP’s website.

Two of the purchases included pills that contained tadalafil, the active ingredient in Cialis. The dosages of these pills were significantly higher than the maximum recommended dosage of 20-milligrams. Laboratory testing showed that the pills in a bottle purchased on May 9, 2018 contained 130-milligrams of tadalafil. The second batch of pills purchased on December 4, 2018 contained approximately 108-milligrams of the active pharmaceutical ingredient.

Customer reviews on AAP’s website make it hard for the company to argue that the things they sold were strictly for research purposes. On April 10, 2018, an AAP email account responded to customer complaint about the tadalafil pills purchased on the company’s website containing baking soda with the following: “This is the owner. I’ve been making: Cialis, Viagra, and [other performance-enhancing pills] for 4 years now, have sold probably 10,000 pack with THEE (sic) BEST reviews on the internet, and GUESS WHAT? I’ve always cut it with baking soda!!! In closing, ENJOY.”

Kovaleski and Maltez initially appeared before U.S. Magistrate Judge Michael A. Hammer and were both released on $100,000 unsecured bond. In to a DOJ press release, U.S. Attorney Craig Carpenito credited the work of special agents with the U.S. Food and Drug Administration (FDA), the FDA’s Office of Criminal Investigations, U.S. Postal Inspection Service, and AMTRAK Office of Inspector General for conducting the investigation that led to these charges. Assistant U.S. Attorneys Karen Stringer and Caril Fais of the Special Prosecutions Division will represent the government at trial.