A man has pleaded guilty to selling misbranded drugs in interstate commerce, a charge which carries a maximum penalty of 10 years in prison.
An Illinois man has pleaded guilty to selling capsules marketed as herbal dietary supplements that in fact contained the prescription erectile dysfunction drug sildenafil.
William Goldsmith, 48, of Glen Carbon, Illinois, pleaded guilty in federal court in East St. Louis on Thursday, Aug. 24, to a charge of introducing misbranded drugs into interstate commerce.
The charge carries a potential penalty of up to a 10-year prison sentence and/or a fine of up to $250,000. Goldsmith’s sentencing hearing is scheduled for Dec. 5, 2023.
Sildenafil is the generic name for the branded pharmaceutical Viagra. Health authorities warn that consuming the drug unknowingly can pose greater risks of heart attack or stroke for patients using blood thinners or some heart medications.
Sildenafil citrate alleged to have come from China, India
Prosecutors alleged Goldsmith had imported sildenafil citrate from China and India and loaded it into capsules, which he then sold online. Goldsmith sold the capsules via an online store called Malosi Herbs under the brand names “Ma’Kava,” “Ma’Kava Private Stock” and “Night Cap X.”
The ingredient list claimed “natural” constituents such as horny goat weed, black maca, kavalactone, tongkat ali, panax ginseng, ginkgo biloba and sea cucumber extract. Sildenafil was not mentioned on the labels.
The FDA press statement announcing the guilty plea did not specify whether any of these constituents were present in the capsules along with the sildenafil, merely saying the drug was part of a “mixture.”
Prosecutors said Goldsmith sold the products from 2016 into 2019. He is alleged to have taken in more than $250,000 in gross proceeds.
“Protecting consumers is critical to a healthy business environment, and entrepreneurs who use deceitful tactics to sell misbranded products place profits above people,” said U.S. Attorney Rachelle Aud Crowe.
“Misbranded prescription drugs that are smuggled from overseas can present a serious health risk to those who buy and use them. The drugs can contain unknown ingredients and can be made under unknown conditions,” said Special Agent in Charge Ronne G. Malham, Food and Drug Administration Office of Criminal Investigations Chicago Field Office.
Tainted products keep cropping up
While Malham said, “We will continue to investigate and bring to justice those who traffic in misbranded prescription drugs,” the presence of undeclared sildenafil and/or tadalafil (branded as Cialis) in products marketed for sexual function has been an issue for many years.
FDA’s page warning consumers about the problem contains links to 418 separate notations of the presence of the drugs in products marketed for sexual performance that the agency tested or which were voluntarily recalled by the companies involved. The warnings go back to May 2012.
FDA posted 19 such notifications in 2022 and 31 so far in 2023.
Goldsmith’s lawyer did not respond to a request for comment in time for publication of this article.
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