South Amboy Couple Indicted For Selling Bodybuilding Drugs

SOUTH AMBOY, NJ — A South Amboy husband and wife were indicted Monday and charged with cooking up homemade bodybuilding drugs in their basement, and selling them online without the FDA's approval.

Keith Kovaleski, 55, and Sylvia Kovaleski, 41, ran a business out of their home in South Amboy that manufactured several different types of pills and supplements for body building. However, U.S. Attorney Craig Carpenito says what they peddled online was not regulated by the U.S. Food and Drug Administration, and that unregulated bodybuilding drugs can cause kidney failure, liver damage, stroke and even death.

From May 2014 to January 2019, the Kovaleskis owned and operated All-American Peptide out of their South Amboy home. On its website — since taken down — All-American Peptide sold supplements primarily used by bodybuilders for performance enhancement.

Peptides are amino acids; they are often used by body builders as well as in the skincare industry because of their ability to both build muscle mass and regenerate skin cells. Peptides are normally taken as a cream on the skin, or injected. The legality of their use in the U.S. is currently a grey area. Peptides function similar to synthetic human growth hormone, and they can make serious changes to the human endocrine system.

But it wasn't just peptides. According to the U.S. attorney, the Kovaleskis also sold products that included prescription drugs, such as tadalafil (the active ingredient in Cialis) and SARMS, used by body-builders as an alternative to steroids. Some of their supplements also included clenbuterol, a drug sold abroad but is not approved by the FDA.

The Kovaleskis' website included a legal disclaimer — which the U.S. Attorney says is bogus — that their products were intended for laboratory research use only, and not as drugs or food. The feds say the entrepreneurial husband-and-wife team used that disclaimer as a cover under which they could sell the drugs.

The Kovaleskis also failed to provide adequate directions for use for these products, such as frequency of administration and other dosage information. Some of their tadalafil (Cialis) capsules contained significantly higher dosages than the FDA allows, Carpentino said.

The Kovaleskis earned more $2.5 million through the business.

The Kovaleskis were each charged with one count of conspiring to sell misbranded and unapproved new drugs. They were also charged with 10 counts of introducing misbranded drugs into interstate commerce (selling them through their website), four counts of introducing unapproved new drugs into interstate commerce, and one count of manufacturing drugs without registering with the secretary of Health & Human Services.

In January 2019, Keith Kovaleski was charged in a federal complaint with conspiracy and was released on bail. At that time, an employee of their company, Ines Maltez, 33, of Sayreville, was also implicated. She was charged with lesser charges, for mailing the drugs and for collecting payment for them.

The husband and wife are each facing up to five years in prison and fines.