The proposed rule would restrict the use of sunlamp products to individuals aged 18 years and over and require all prospective users to read and sign a risk acknowledgement certification before use (unless the prospective user has previously signed the form within the preceding 6 months).

The social benefits from this proposed rule stem from a potential reduction in the incidence of skin cancer. The social costs of the proposed rule are associated with the value of time spent by users and tanning facility operators on the risk acknowledgement certifications and verifying proof of age, as well as other compliance costs.

Regulatory Impact Analysis

General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products (Proposed Rule) (PDF - 640KB)

Federal Register: 80 FR 79493, December 22, 2015

Docket:  FDA-2015-N-1765