Criminal Liability of a Salesclerk Under the Federal Food, Drug, and Cosmetic Act

Pharmacy TimesMay 2018 Skin & Eye Health
Volume 84
Issue 5

Can a salesclerk working in a head shop be convicted of a criminal violation of the Federal Food, Drug, and Cosmetic Act for selling misbranded synthetic drugs?


Can a salesclerk working in a head shop be convicted of a criminal violation of the Federal Food, Drug, and Cosmetic Act for selling misbranded synthetic drugs?


The case arose in a midwestern state when federal charges were filed against the owner of the store, his domestic partner, and his son. The latter 2 worked as clerks in the operation. The shop specialized in paraphernalia related to marijuana and marijuana-associated products.

At the center of the charges was a supply of drugs that had arrived through interstate commerce. Although they were labeled “Not for Human Consumption,” those affiliated with the shop knew that their customers intended to use them, usually by smoking them.

Undercover agents of the federal government purchased 75 synthetic drug products over a 13-month period. The clerk at the center of this report handled 6 of those transactions. One of those packages contained trace amounts of a synthetic cannabinoid that is a controlled substance.

Criminal charges were filed against the owner and the 2 clerks under 3 separate federal statutes: the Controlled Substance Analogue Enforcement Act of 1986; the Controlled Substances Act of 1970; and the Federal Food, Drug, and Cosmetic Act. Specific charges against the owner and the clerks were each tied to their role in the operation.

The clerk in question was charged with aiding and abetting the delivery of misbranded drugs received in interstate commerce and was convicted of 2 federal criminal misdemeanors related to the delivery of misbranded drugs without intent to defraud. The clerk thought that the instructions given to the jury members by the judge for them to use during their deliberations and that led to his conviction were erroneous. The judge had instructed the jury that the clerk could be found guilty of the misbranding offense without there being criminal intent. Most crimes require the presence of 2 elements: the doing of an act and the requisite mental state related to criminal intent.

Because the crimes of which he had been convicted were misdemeanors, the penalties may well be deemed slight: 3 years’ probation, 90 days of home electronic monitoring, and payment of slightly more than $1000.

Basing his argument on the lack of intent and the error by the judge related to that, the clerk appealed his conviction to the relevant federal court of appeals.


The federal court of appeals rejected the arguments advanced by the clerk and upheld his conviction.


The appellate court looked at several cases for legal precedent. In a prior case in that same federal court of appeals, the panel had ruled that “neither knowledge nor intent is required for a misdemeanor violation” of the relevant section of the Federal Food, Drug, and Cosmetic Act. The court also reached back to 1943 for a US Supreme Court decision standing for the proposition that misbranding is a strict liability offense. Strict liability means liability without fault or liability without a negligent act or the requisite mental state of intent to harm. The mere doing of the act results in culpability under the concept of strict liability.

The court also reviewed a more recent case, from 1975, dealing with criminal liability under the Federal Food, Drug, and Cosmetic Act in which the US Supreme Court had ruled that “misdemeanor liability stems not from ‘corporate hierarchy’ but from an individual’s role in the sale of misbranded drugs.” This was directed at the argument of the appellant that he had merely been a salesclerk fulfilling a customer’s order.

The government only had to prove beyond a reasonable doubt that the clerk was “responsible for, aided and abetted in the commission of delivering misbranded drugs after they had been received in interstate commerce,” the court ruled. Although the clerk had very limited responsibilities at the shop in terms of overall operations, credible evidence had been presented that he had a role in delivery of the drugs to the undercover purchasers. That fact led to his conviction, despite the lack of intent or knowledge on his part.

Finding no errors in the proceedings at the trial court level, the court of appeals affirmed the conviction based on strict liability theory.

Something to think about: What if this had been a clerk in a pharmacy completing the sale of, say, an OTC product that had experienced a quality control lapse. Could that clerk have had the same criminal liability as the salesclerk in this case?

Joseph L. Fink III, BSPharm, JD, DSc (Hon), FAPhA, is a professor of pharmacy law and policy and the Kentucky Pharmacists Association Endowed Professor of Leadership at the University of Kentucky College of Pharmacy in Lexington.

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