## Facts

- In 1996, the Food and Drug Administration (FDA) issued regulations addressing cigarettes and smokeless tobacco, including limits aimed at youth-oriented marketing and advertising.
- The FDA asserted authority under the Federal Food, Drug, and Cosmetic Act (FDCA) by treating tobacco products as “devices” (and as drug-device products in the broader tobacco rulemaking context) and relying on the FDCA’s device provisions.
- The statutory language the FDA relied on included 21 U.S.C. § 360j(e), which allows certain devices to “be restricted to sale, distribution, or use.”
- The FDA argued that the ability to “restrict[] … sale” of a device implied power to impose advertising-related limits because advertising affects how a product is sold.
- Coyne Beahm, Inc., a business affected by tobacco advertising rules, filed suit seeking declaratory and injunctive relief, contending the FDCA did not give the FDA authority to regulate tobacco advertising.
- The case came before the United States District Court for the Middle District of North Carolina on summary judgment briefing focused on the scope of the FDA’s statutory authority to regulate tobacco advertising through the FDCA’s device provisions.

## Issues

1. Whether the FDCA’s device provision authorizing a device to “be restricted to sale, distribution, or use” permits the FDA to impose restrictions on tobacco advertising as part of restricting “sale.”
2. Under Chevron, whether the FDA’s interpretation of its device authority to reach tobacco advertising is consistent with the statute and the broader federal scheme governing tobacco advertising.

## Decision

- The court held that the FDA lacked statutory authority under the FDCA’s device provisions, including § 360j(e), to regulate tobacco advertising in the manner attempted by the challenged portions of the 1996 tobacco regulations.
- The court granted summary judgment for Coyne Beahm, Inc. as to the advertising-related provisions at issue and denied the FDA’s attempt to sustain those provisions.

## Legal Principles

- An agency must point to statutory authority for the regulatory power it claims; it cannot create major new regulatory authority from broad or general language.
- Under Chevron, a court first asks whether Congress has spoken to the specific question presented; if Congress’s intent is clear, the agency must follow it.
- Statutory terms authorizing restrictions on a product’s “sale, distribution, or use” generally address conditions of transaction or access to the product, not a general power to regulate advertising content and placement.
- When Congress has enacted specific tobacco advertising and labeling statutes and allocated enforcement roles to other institutions (including the Federal Trade Commission in advertising contexts), courts are reluctant to infer overlapping authority for a different agency from a separate, general statute.
- Reading a single phrase (such as “restricted to sale”) to authorize broad advertising controls is disfavored where doing so would expand the agency’s role beyond what the FDCA’s structure and related legislation indicate Congress intended.

## Conclusion

Coyne Beahm, Inc. v. United States Food & Drug Administration held that the FDCA’s device authority to restrict a device’s “sale, distribution, or use” did not give the FDA power to impose wide-ranging tobacco advertising rules; the court therefore ruled for the plaintiff and invalidated the challenged advertising-related provisions as beyond the FDA’s statutory authority.


Coyne Beahm, Inc. v. United States Food & Drug Administration, 966 F. Supp. 1374 (1997)