Amtrak OIG-supported investigation leads to charges against New Jersey couple charged for allegedly selling misbranded drugs

NEWARK, N.J. – An Amtrak employee and his wife were indicted July 8, 2019, for allegedly marketing and distributing misbranded drugs and unapproved new drugs, as well as manufacturing drugs in an unregistered facility, the U.S. Attorney for the District of New Jersey announced.

Keith Kovaleski, 55, and Sylvia Kovaleski, 41, of South Amboy, New Jersey, each were charged with one count of conspiring to distribute and cause the receipt and delivery of misbranded drugs and unapproved new drugs, and to impede the functions of the U.S. Food and Drug Administration and U.S. Department of Health and Human Services, 10 counts of introducing misbranded drugs into interstate commerce, four counts of introducing unapproved new drugs into interstate commerce, and one count of manufacturing drugs without registering with the secretary of HHS. In January 2019, Keith Kovaleski was charged in a federal complaint with conspiracy and was released on bail. Both defendants will be arraigned at a future date.

According to court documents, the Kovaleskis owned and operated AA Peptide LLC, aka All American Peptide. AAP allegedly 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, through AAP, allegedly sold products including prescription drugs, such as tadalafil, the active ingredient in Cialis; SARMS, used by body-builders as an alternative to steroids; peptides, also used as performance-enhancing substances; and other drugs that had not been approved for human use by the FDA. The Kovaleskis allegedly failed to provide adequate directions for use of these products.

Additionally, the Kovaleskis allegedly used their basement as a manufacturing facility to make and label AAP products, including homemade capsules containing baking soda and tadalafil. The Kovaleskis earned more than $2.5 million through the sale of misbranded and unapproved new drugs.

In addition to the Amtrak Office of Inspector General, the case was investigated by the FDA Office of Criminal Investigations and the U.S Postal Inspection Service. The government is represented by Assistant U.S. Attorneys Karen D. Stringer and Cari Fais of the Special Prosecutions Division.

More information is available in the U.S. Attorney’s Office press release: https://go.usa.gov/xyeVH