A Middlesex County husband and wife have 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 Sellinger said.
Sylvia Kovaleski, 43, of South Amboy pleaded guilty On March 22 by videoconference before U.S. District Judge Susan 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.
The Kovaleskis owned and operated All American Peptide. From 2014 to January 2019, the company 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 couple sold prescription drugs such as tadalafil, the active ingredient in Cialis. They also sold SARMS, which is used by bodybuilders as an alternative to steroids, and peptides that are used as performance-enhancing substances. They sold 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.
Law enforcement officials said the couple used their South Amboy basement as a manufacturing facility to make and label 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 is scheduled for July 26.