Research · 6 min read
What Federal Law Forbids When a Drug Is Sold
One section of the food and drug law lists the acts that are prohibited. Three others say what happens next: a criminal penalty, a court order, or the seizure of the goods themselves.
Key takeaways
- Section 331 is a list of prohibited acts, and the penalty, injunction and seizure sections all work by referring back to it.
- The core prohibitions turn on an article being adulterated, misbranded or introduced in violation of the approval requirement — not on proof of harm.
- Refusing to permit an authorized inspection is its own prohibited act, separate from whatever an inspection might reveal.
- The baseline criminal penalty is up to one year or $1,000; intent to defraud or mislead, or a prior final conviction, raises it to three years or $10,000; the prescription drug marketing offenses reach 10 years or $250,000.
- A good-faith defense exists for a middleman, but it is conditioned on furnishing the supplier's name and address and the delivery documents on request.
- Condemned goods may be destroyed, sold as the court directs, or released on bond to be brought into compliance under supervision at the owner's expense.
Answer first: one list, and everything else points back at it
The federal food and drug law is built around a list. Section 331 of Title 21 opens with a single sentence — "The following acts and the causing thereof are prohibited" — and then runs through lettered paragraphs. Almost every enforcement provision in the act works by referring back to that list.
The first four paragraphs cover the core. Paragraph (a) prohibits "The introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded." Paragraph (b) prohibits adulterating or misbranding such an article in interstate commerce. Paragraph (c) prohibits "The receipt in interstate commerce" of an adulterated or misbranded article "and the delivery or proffered delivery thereof for pay or otherwise." Paragraph (d) prohibits introducing into interstate commerce "any article in violation of section 344, 350d, 355," and other named sections — section 355 being the new drug approval requirement.
Note what those four paragraphs have in common. None of them requires that anyone be harmed. Each turns on the status of the article — adulterated, misbranded, or introduced in violation of the approval requirement — and on a commercial act.
The paragraphs people meet without knowing the letter
Further down the list are provisions that describe conduct rather than product status, and several of them explain enforcement actions that otherwise look arbitrary.
Paragraph (e) reaches records: it prohibits refusing access to or copying of required records, and failing to establish or maintain a record or make a report required by the named sections. Paragraph (f) is one sentence long: "The refusal to permit entry or inspection as authorized by section 374 of this title." Refusing an inspection is itself a prohibited act, separate from anything the inspection might have found.
Paragraph (k) covers what happens to an article after it is shipped: "The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, tobacco product, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded." The phrase held for sale, whether or not the first sale, is what extends the act's reach past the factory gate.
Paragraph (i) covers forging, counterfeiting and simulating identifying marks. Paragraph (t) gathers the prescription drug marketing rules — importation in violation of section 381(d)(1), trading in a drug or drug sample in violation of section 353(c), coupon offenses, distribution of samples in violation of section 353(d), and distribution of drugs in violation of section 353(e).
Reading the list is a quicker way to understand the act than reading commentary about it, because the list is what every other enforcement section refers to.
The criminal penalty, and how much it can escalate
Section 333 sets the consequence. Its baseline is modest: "Any person who violates a provision of section 331 of this title shall be imprisoned for not more than one year or fined not more than $1,000, or both."
It escalates in two circumstances that are written into the next paragraph. If a person commits such a violation after a conviction under the section has become final, or "commits such a violation with the intent to defraud or mislead, such person shall be imprisoned for not more than three years or fined not more than $10,000, or both."
For the prescription drug marketing offenses in paragraph (t) of the prohibited-acts list, the numbers change by an order of magnitude. A person who knowingly imports a drug in violation of section 381(d)(1), knowingly trades or offers to trade in a drug or drug sample in violation of section 353(c)(1), knowingly trades in or counterfeits a coupon, or knowingly distributes drugs in violation of section 353(e)(1) "shall be imprisoned for not more than 10 years or fined not more than $250,000, or both."
The same section also writes down defenses. Under section 333(c), a person is not subject to the baseline penalty for having received an article in interstate commerce and delivered or proffered it, "if such delivery or proffer was made in good faith," unless the person refuses to furnish, on request of a designated officer, "the name and address of the person from whom he purchased or received such article and copies of all documents, if any there be, pertaining to the delivery of the article to him." A second defense covers a person who establishes a written guaranty, signed by and naming the United States person the article was received from in good faith, to the effect that the article is not adulterated or misbranded. Giving a false guaranty of that kind is itself prohibited under paragraph (h) of the list.
The structure is worth noticing: the good-faith defense for a middleman is conditioned on naming the supplier and producing the paperwork.
Two remedies that do not need a conviction
Criminal penalties are not the usual instrument, and the act supplies two others.
The first is an injunction. Section 332 is short: the district courts "shall have jurisdiction, for cause shown" ... "to restrain violations of section 331 of this title, except paragraphs (h), (i), and (j)." (A footnote marker sits between those two phrases in the printed text.) That is a civil action to stop conduct, and its subject matter is again the prohibited-acts list. The section adds that where an injunction is violated in a way that also violates the act, "trial shall be by the court, or, upon demand of the accused, by a jury."
The second is directed at the goods. Section 334 provides that an article of food, drug or cosmetic "that is adulterated or misbranded when introduced into or while in interstate commerce or while held for sale (whether or not the first sale) after shipment in interstate commerce," or which may not be introduced into interstate commerce under section 344 or 355, "shall be liable to be proceeded against while in interstate commerce, or at any time thereafter, on libel of information and condemned in any district court of the United States" within whose jurisdiction the article is found. Counterfeit drugs are separately liable to condemnation at any time.
What happens after condemnation is spelled out. The article "shall, after entry of the decree, be disposed of by destruction or sale as the court may... direct," with any proceeds paid into the Treasury, and it may not be sold contrary to the act or to local law. Alternatively, on payment of costs and the posting of a bond, the court may order the article delivered to its owner "to be destroyed or brought into compliance with the provisions of this chapter, under the supervision of an officer or employee duly designated by the Secretary," with the owner paying for that supervision.
That last route is why a seizure does not always end in destruction. Bringing goods into compliance is an outcome the statute expressly contemplates, at the owner's expense and under supervision.
How to use this when reading about an enforcement action
Public reporting about drug enforcement tends to compress very different instruments into the same phrase. The statute makes the distinctions available.
A criminal charge under section 333 requires a violation of the prohibited-acts list, and the sentence exposure depends on which paragraph and whether intent to defraud or mislead, or knowledge, is alleged. An injunction under section 332 is a civil order restraining conduct, granted for cause shown, with no conviction involved. A seizure under section 334 is an action against the goods themselves, resolved by a decree that may end in destruction, in a supervised bringing-into-compliance, or, for imported goods in defined circumstances, in export instead of destruction.
The corresponding questions for a reader are: which of these three is being described, which prohibited act is named, and whether the article's status — adulterated, misbranded, or unapproved — is the issue, or the conduct is. Those are answerable from a public document, and they change what the action actually means.
Nothing in this article says whether any company has done any of these things. The list is what the law forbids; whether a given fact pattern falls inside it is a question for the agencies and the courts.
Sources
- 21 U.S.C. 331 — Prohibited actsThe opening sentence of the section; the text of paragraphs (a) through (d) covering introduction, adulteration or misbranding, receipt and delivery, and introduction in violation of section 355 and other named sections; paragraph (e) on records; paragraph (f) on refusal of entry or inspection; paragraph (h) on false guaranties; paragraph (i) on forging and counterfeiting marks; paragraph (k) on acts done to labeling while an article is held for sale after shipment; and paragraph (t) gathering the prescription drug marketing offenses.
- 21 U.S.C. 333 — Penalties (subsections (a), (b) and (c))The baseline penalty of not more than one year or $1,000; the escalation to three years or $10,000 after a final conviction or where the violation is committed with intent to defraud or mislead; the 10-year, $250,000 penalties for the prescription drug marketing offenses; and the good-faith and guaranty defenses in subsection (c), including the requirement to furnish the supplier's name and address and delivery documents on request.
- 21 U.S.C. 334 — Seizure (subsections (a) and (d))The grounds on which an adulterated or misbranded article, or one that may not be introduced into interstate commerce, may be condemned in a district court; the separate liability of counterfeit drugs; and the disposition provisions after a decree, including destruction or sale with proceeds to the Treasury and release on bond for destruction or bringing into compliance under supervision at the owner's expense.
- 21 U.S.C. 332 — Injunction proceedingsThe grant of jurisdiction to the district courts, for cause shown, to restrain violations of section 331 except paragraphs (h), (i) and (j), and the provision for trial by the court or, on demand of the accused, by a jury where an injunction is violated.
Frequently asked questions
What does the prohibited acts section actually list?
It begins by stating that the following acts and the causing thereof are prohibited, then lists them by letter. The first paragraphs cover introducing, delivering or receiving adulterated or misbranded articles in interstate commerce and introducing articles in violation of the approval requirement in section 355. Later paragraphs cover records refusals, refusal of inspection, counterfeiting of marks, acts done to labeling while an article is held for sale, and the prescription drug marketing offenses.
Does someone have to be harmed for a violation to occur?
The listed acts turn on the status of the article and on a commercial or record-keeping act, not on injury. Introducing an adulterated or misbranded article into interstate commerce is prohibited on its own terms, and refusing to permit an authorized inspection is its own separate paragraph.
What are the penalties?
Section 333 sets a baseline of imprisonment for not more than one year or a fine of not more than $1,000, or both. A violation after a final conviction, or one committed with intent to defraud or mislead, carries not more than three years or $10,000, or both. The prescription drug marketing offenses carry not more than 10 years or $250,000, or both.
Is there a defense for a distributor who did not know?
The statute provides two. One protects a person who received an article and delivered it in good faith, but only if the person furnishes, on request of a designated officer, the name and address of the supplier and copies of all documents pertaining to the delivery. The other protects a person who establishes a signed guaranty from a United States supplier that the article is not adulterated or misbranded. Giving a false guaranty of that kind is itself a prohibited act.
What does a seizure do to the goods?
Section 334 allows an adulterated or misbranded article, or one that may not lawfully be introduced into interstate commerce, to be condemned in a district court. After a decree, the article is disposed of by destruction or sale as the court directs, with proceeds paid into the Treasury. On payment of costs and posting of a bond, the court may instead order the article delivered to its owner to be destroyed or brought into compliance under supervision, at the owner's expense.
Can the government act without bringing criminal charges?
Yes. Section 332 gives the district courts jurisdiction, for cause shown, to restrain violations of the prohibited-acts section, with three lettered paragraphs excepted. That is a civil injunction, and section 334's condemnation action proceeds against the goods rather than a person.