New Jersey Husband and Wife Admit Selling Misbranded and Unapproved New Drugs

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FILE PHOTO: Signage is seen at the United States Department of Justice headquarters in Washington, D.C.

NEWARK, N.J. – A Middlesex County husband and wife pleaded guilty in connection with a scheme to market and distribute over $3 million worth of misbranded drugs and unapproved new drugs, U.S. Attorney Philip R. Sellinger announced today.

Sylvia Kovaleski, 43, of South Amboy, New Jersey, pleaded guilty On March 22, 2022, by videoconference before U.S. District Judge Susan D. Wigenton to one count of conspiring to distribute misbranded drugs and unapproved new drugs. Her husband, Keith Kovaleski, 57, pleaded guilty to the same charge on March 21, 2022.     

According to documents filed in this case and statements made in court:

The Kovaleskis owned and operated All American Peptide (AAP). From 2014 to January 2019, AAP used its website to market and distribute substances primarily used by bodybuilders and others engaged in weight training to enhance performance and mitigate the side effects of performance enhancing substances.   

The Kovaleskis, though AAP, sold: prescription drugs, such as tadalafil, the active ingredient in Cialis; SARMS, used by bodybuilders as an alternative to steroids; peptides, also used as performance enhancing substances; and other drugs that had not been approved for human use, for example, clenbuterol, a drug sold in foreign markets but not approved by the U.S. Food and Drug Administration. 

The Kovaleskis used their South Amboy basement as a manufacturing facility to make and label AAP products, including homemade capsules containing significantly higher dosages of tadalafil than the highest recommended dosage. The Kovaleskis failed to provide adequate directions for use for their products, such as frequency of administration, dosage information, or warnings about side effects.     

The conspiracy charge carries a maximum potential penalty of up to five years in prison and a maximum potential fine of up to $250,000 or twice the gross gain or loss, whichever is greatest. As part of their plea agreements, the Kovaleskis must forfeit over $3 million in criminal proceeds. Sentencing for both defendants is scheduled for July 26. 2022. 

U.S. Attorney Philip R. Sellinger credited special agents of the Food and Drug Administration Criminal Investigation’s New York Field Office, under the direction of Acting Special Agent in Charge Michael Felezzola; special agents of the Amtrak Office of Inspector General, under the direction of Special Agent in Charge Michael Waters; and postal inspectors with the U.S. Postal Inspection Service in Newark, under the direction of Inspector in Charge Damon Wood, Philadelphia Division, with the investigation leading to the guilty pleas. 

The government is represented by Assistant U.S. Attorneys Cari Fais, Chief of the Opioid Abuse Prevention and Enforcement Unit, and Barbara Ward of the Asset Forfeiture and Money Laundering Unit.