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Volume 8: No. 4, July 2011
BRIEF |
| Box. Label Requirements and Food and Drug Administration (FDA) Policy Regarding Sunlamp Products |
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FDA promulgated the sunlamp products performance standard, 21 Code of Federal Regulations (CFR) 1040.20, in 1979, 44 Fed. Reg. 65,352 (November 9, 1979), and most recently amended it in 1985, 50 Fed. Reg. 36,548 (September 6, 1985). This regulation requires each sunlamp product to have a label that contains a warning statement with the words:
21 CFR 1040.20(d)(1)(i). The regulation does not specify requirements for the format in which these words must appear, or the exact location on the product that the warning label must appear, as long as it is “permanently affixed or inscribed on an exterior surface of the product when fully assembled for use so as to be legible and readily accessible to view by the person being exposed immediately before the use of the product.” 21 CFR 1040.20(d)(3)(i). FDA also issued a letter dated June 25, 1985, regarding the warning label to sunlamp product manufacturers outlining FDA policy. The policy letter states
Note: The terms “sunlamp products” and “indoor tanning devices” have the same meaning. Source: FDA (8). |
Research on compliance with various indoor tanning regulations is limited, but studies suggest low compliance with posting the regulations (9-11). This noncompliance may impede informed decision making by consumers and pose a threat to public health. This study was conducted to estimate the prevalence of warnings in all of the tanning facilities in New York City.
In this cross-sectional study, we compiled telephone numbers and addresses from Yellow Pages (for Bronx, Brooklyn, Manhattan, Staten Island, and Queens) and 3 online address sites (Google, Yahoo Local, and Switchboard.com) to determine the number of tanning facilities in New York City, which yielded 183 sites. Of these, telephone outreach identified 85 (46%) tanning facilities. The remaining sites had disconnected telephone numbers or were businesses that did not offer tanning (93 [51%]); 3 (2%) sites offered only spray tanning, and 2 (1%) offered only gel tanning. This process was repeated by a second coder who confirmed that there were 183 tanning facilities listed in New York City.
The observer visited each of the 85 facilities and asked to view the machines that were not occupied by customers. The number viewed at each site varied depending on the number of machines present and available in each site. Direct observations were conducted to assess the number of tanning machines and the presence and visibility of a warning sign posted on each machine observed (Table). All tanning machines were considered, regardless of whether they were beds or stand-up models. Spray tanning devices were found at several facilities studied, and those devices were excluded from our study. All data were collected by a single person (C.H.B.) during April and May 2010. Data analysis involved descriptive statistics, including frequencies and percentages. This study was deemed not human subjects research by the Human Subjects Committee at Columbia University Medical Center.
Most tanning facilities were in Manhattan (n = 46), followed by Brooklyn, (n = 18), Queens (n = 12), Staten Island (n = 8), and the Bronx (n = 1). Most of the businesses were freestanding tanning facilities (n = 62), although some tanning machines were available in beauty salons (n = 21) and in a fitness facility (n = 2). A variable number of machines were present in each facility (total, 951; mean, 11; range, 1-42), and a different number was viewed in each facility depending on availability (range, 1-8). Of 951 machines, 224 (24%) were observed. Seventy-eight (35%) machines in 47 (55%) of the 85 facilities had no warning labels. For the remaining 146 machines, the warning labels were barely visible (n = 32); moderately visible (n = 54); clearly visible (n = 57); and completely visible (n = 3).
This study was limited by the cross-sectional design, by having only 1 researcher conducting observations and recording data, and by uncertainty about the representativeness of the machines observed. Generalizability of the findings is restricted to New York City. Nevertheless, the findings begin to fill a gap in knowledge regarding compliance with required warnings on tanning machines. No studies were identified that used systematic direct observations of tanning machines to assess the presence and visibility of warnings. One study, conducted more than a decade ago, assessed warnings and other criteria via observation or query of a clerk but did not specify the number of tanning machines observed to measure the presence of warning signs (12).
This study suggests that compliance with federal regulations is low for warning signs on indoor tanning machines in New York City. Research is needed to verify this finding and to assess generalizability to other localities. Warning signs are not sufficient to change consumer behavior (13) but are necessary to help consumers make informed choices about indoor tanning. Regulations requiring posted warnings on tanning machines will not serve their intended purpose if compliance is low, which was found in this study.
Corresponding Author: Corey H. Brouse, EdD, Postdoctoral Research Scientist, Columbia University, 722 W 168th St, 7th Floor, New York, NY 10032. E-mail: chb24@columbia.edu.
Author Affiliations: Charles E. Basch, Alfred I. Neugut, Columbia University, New York, New York.
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The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
Privacy Policy | Accessibility This page last reviewed March 30, 2012
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