US Code 337, officially known as 21 U.S. Code 337, primarily defines the nature of legal proceedings related to the enforcement or restraint of violations within Chapter 9 of Title 21 of the United States Code. This chapter specifically deals with the Federal Food, Drug, and Cosmetic Act (FFDCA).
Key Provisions of 21 U.S. Code 337
This section of the US Code dictates that, with certain exceptions, all legal actions aimed at enforcing or preventing violations of the Federal Food, Drug, and Cosmetic Act must be conducted **by and in the name of the United States**.Here's a breakdown of its core aspects:
- Proceedings in the Name of the United States: The most significant provision is that enforcement actions—whether for compliance or to halt illegal activities—are not brought by individuals or private entities but by the federal government itself. This underscores the public interest nature of regulating food, drugs, and cosmetics.
- Scope of Application: This section applies broadly to "this chapter," which refers to Chapter 9 of Title 21. This chapter encompasses a wide range of regulations under the Federal Food, Drug, and Cosmetic Act, covering everything from the safety and efficacy of drugs to the labeling of food products.
- Exceptions: The statute includes a clause "Except as provided in subsection (b)." This indicates that there are specific circumstances outlined in subsection (b) where proceedings may not necessarily be solely in the name of the United States or where other procedural rules might apply. These exceptions often relate to certain types of subpoenas or specific enforcement scenarios.
- Provision as to Subpoenas: The full title of the code section also mentions "provision as to subpoenas," suggesting that subsection (b) or other parts of the law may detail procedures or limitations regarding the issuance and enforcement of subpoenas in these types of governmental actions.
Understanding the Implication
The requirement for proceedings to be "in the name of the United States" is crucial for several reasons:- Governmental Authority: It signifies that these actions are official government endeavors, backed by the full authority and resources of the United States.
- Public Interest: Enforcement under the Federal Food, Drug, and Cosmetic Act is deemed to be in the public interest, aiming to protect the health and safety of consumers. By making it a federal government responsibility, the law ensures a consistent and comprehensive approach to regulation.
- Prevention of Private Litigation: In many cases, this provision means that private citizens or companies cannot directly sue to enforce the FFDCA under this specific section; instead, they must rely on the relevant federal agencies (like the FDA) to initiate proceedings.
To delve deeper into the specific text of this law, you can refer to the official source:
- 21 U.S. Code 337 - Proceedings in name of United States; provision as to subpoenas: https://www.law.cornell.edu/uscode/text/21/337
Summary of 21 U.S. Code 337
| Aspect | Description |
|---|---|
| Code Section | 21 U.S. Code 337 |
| Official Title | Proceedings in name of United States; provision as to subpoenas |
| Core Principle | All proceedings for the enforcement or restraint of violations of the Federal Food, Drug, and Cosmetic Act are conducted by and in the name of the United States. |
| Scope | Applies to Chapter 9 of Title 21 of the US Code, which is the Federal Food, Drug, and Cosmetic Act. |
| Key Exception | "Except as provided in subsection (b)," indicating specific procedural or enforcement nuances may apply under certain conditions outlined elsewhere in the statute. |
