Policy on Warning Label Required on Sunlamp Products

Published: 1985-06-25

Status: Final Type: Guidance Document Category: Radiation / Imaging Docket: FDA-2020-D-0957

Official Source

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-warning-label-required-sunlamp-products PDF: https://www.fda.gov/media/73620/download

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Official Full Text

Public Health Service

Food and Drug Adm~n~stration 8757 Georgia Avenue Silver Spring MD 2091 0 TO: ALL MANUFACTURERS, IMPORTERS AND POTESJTIAL MANUFACTURERS OF SUNLAMP PRODUCTS. SUBJECT: POLICY ON WARNING LABEL REQUIRED ON SUNLAMP PRODUCTS. BACKGROUND: The Center for Devices and Radiological Health has f o b d numerous inported and dcmestic sunlamp products labeled i n such a way a s t o render the label illegible and/or inaccessible to view by the consumer under normal conditions of purchase and use. Sunlamp products are electronic products a s defined by Section 355(2) [42 U.S,C 263c(2)1 of the Radiation Control f o r Health and Safety A c t of 1968 (RCHSA) and medical devices a s defined by Section 201(h)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C) [21 U.S.C.321(h)(3)1. The performance standard for sunlamp products (21 CFR 1040.20) promulgated under authority of Section 358 of the RCHSA, requires that labels containing specific information be permanently affixed o r inscribed on an exterior surface of the product s o as to be legible and readily accessible t o view when the product is fully assembled f o r use. The general labeling provisions for medical devices under 21 CFR 801.5 require adequate directions for use be provided t o the user and 21 CFR 801.15 defines the praninence of the required label statements for devices. POLICY: The intended purpose of the warning label required on sunlanp products is t o provide that information necessary f o r the consumer to make an informed decision regarding the risks of using sunlamp products and t o provide adequate directions for skin tanning. Therefore, the label must be legible and conspicuously placed on the product so a s to render it likely to be read by the user under nonnal conditions of purchase and use. The Agency w i l l consider sunlarnp products t o be nonccanpliant with the performance standard under Section 358(a)(1) of the RCHSA and misbranded under Section 502(c) of the FD&C A c t i f the required product label is not legible and accessible to view for the following reasons:

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1. The label required under 21 CFR 1040.20(d)(l) does not appear on a praminent part or panel which is presented o r displayed under normal conditions of purchase and/or use.
2. Adequate space is not provided for the required label o r the label is not prminently displayed on the device.
3. The normal individual can not read the label from a distance of one meter because of inadequate lettering size and background contrast. Lettering of ten (10) millimeters (height) for the word "I;\ANGERW and five (5) millimeters f o r the rest of the label information is recamended t o meet the v i s i b i l i t y requirements. rcl&& Wa ter Gundaker. Director Off ice of compliance Center for &vices and Radiological Health