Keith Kovaleski, Pharmaceutical Forgery, New Jersey 2019

NEWARK, N.J. – In a brazen scheme to deceive the public, a Middlesex County couple, Keith Kovaleski, 55, and Sylvia Kovaleski, 41, of South Amboy, New Jersey, have been charged with selling misbranded and unapproved new drugs, and running a drug manufacturing facility in their basement.

The indictment alleges that from May 2014 to January 2019, the Kovaleskis owned and operated AA Peptide LLC, a/k/a All American Peptide (AAP), which 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 AAP website included a bogus legal disclaimer that its products were intended for laboratory research use only, and not as drugs or food. The Kovaleskis employed the bogus “research chemicals” disclaimer to conceal that they and others were distributing misbranded drugs and unapproved new drugs for use by their customers.

The Kovaleskis, through AAP, sold products including: (1) prescription drugs, such as tadalafil, the active ingredient in Cialis; (2) SARMS, used by body-builders as an alternative to steroids; (3) peptides, also used as performance-enhancing substances; and (4) other drugs that were not peptides or SARMS, and had not been approved for human use, for example, clenbuterol, a drug sold in foreign markets but not approved by the FDA.

The Kovaleskis failed to provide adequate directions for use for these products, such as frequency of administration and other dosage information. They even used their South Amboy 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. If convicted, the conspiracy charge carries a maximum potential penalty of up to five years in prison, each count of introduction of misbranded drugs in interstate commerce carries a maximum potential penalty of three years in prison, and each charge also carries a maximum potential fine of up to $250,000 or twice the gross pecuniary gain or loss.

The case was investigated by special agents of the Food and Drug Administration, Office of Criminal Investigations, New York Field Office, under the direction of Special Agent in Charge Jeffrey J. Ebersole, 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, under the direction of Inspector in Charge Michael Waters.

The indictment is merely an accusation and the defendants are presumed innocent until proven guilty.

According to documents filed in this case and statements made in court, the FDA is responsible for enforcing the Federal Food, Drug, and Cosmetic Act (FDCA), a law intended to assure that drugs are safe, effective, and bear accurate labeling containing all required information. The FDA regulates the manufacture, labeling, and distribution of all drugs shipped or received in interstate commerce.

Source: https://www.justice.gov/usao-nj/pr/middlesex-county-couple-charged-selling-misbranded-and-unapproved-new-drugs-and-running