Health Law Daily Wrap Up, MEDICAL DEVICES—PROPOSED RULES: Restricted sale, distribution, and use of sunlamp products proposal withdrawn, (Mar 18, 2026)

By WK Editorial Staff

The withdrawal of the proposed rule does not preclude the FDA from reinstituting rulemaking concerning the issues addressed in the proposal.

The FDA announced the withdrawal of the proposed rule titled “General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products,” which published in the Federal Register of December 22, 2015. The FDA is taking this action because it no longer intends to finalize the proposed rule. The FDA received more than 8,100 comments on the Proposed Rule from entities including industry associations, medical and healthcare professional associations, law firms, cancer advocacy groups, and other interested parties, including individuals. In general, the comments discussed the dangers of UV radiation from sunlamp products; scientific aspects of the Proposed Rule; vulnerability of young people to the risks of sunlamp products; support for personal choice and parental decision-making; availability and relative safety of sunlamp product alternatives; and compliance burdens on small businesses. (Notice, 91 Fed. Reg. 12524 (Mar. 16, 2026)).

Dates. The proposed rule published on December 22, 2015 (80 FR 79493) is withdrawn as of March 16, 2026.

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