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Indoor tanning beds should carry warnings against their use in people under age 18 years and should advise users to be screened regularly for skin cancer, according to a proposal announced by the Food and Drug Administration on May 6.
The agency seeks to reclassify the ultraviolet lamps used in tanning beds, upgrading them to class II (moderate risk) from class I (low risk) and to rename them "sunlamps." As class I devices, these lamps are currently deemed to be at the same risk level as adhesive bandages and tongue depressors.
Under the proposal, manufacturers would be required to display "a prominent visible label on the tanning bed itself," warning against use in people under age 18 years, Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, Silver Spring, Md., said during a briefing held to announce the proposal. Manufacturers also would have to add labels contraindicating the use of sunlamps in people with certain skin lesions.
Information advising regular skin cancer screenings would be added to materials such as brochures, catalogues, and consumer websites, he added.
"We believe that our proposal will allow for safer, more reliable sunlamps and better arm consumers with the critical information they need," Dr. Shuren said.
In 2010, an FDA advisory panel unanimously recommended that these devices be switched to at least class II.
The proposed reclassification does not prohibit the use of sunlamp products in minors.
Manufacturers are currently not required to submit applications to market these devices, but if they are reclassified as class II devices, a "premarket notification" application will be required and "manufacturers would have to show that their products have met certain performance testing requirements, address certain product design characteristics and provide comprehensive labeling that presents consumers with clear information on the risks of use," according to the FDA statement announcing the proposal.
Clinical trials would not be required, but manufacturers would be required test the performance of timers and alarms and ensure that sunlamps provide the correct amount of energy to prevent burns. Reports of burns associated with these products indicate that this testing is not being done properly now, Dr. Shuren said.
According to the American Academy of Dermatology, the risk of melanoma increases by 75% among people exposed to ultraviolet radiation from indoor tanning products, and the risk increases with increased use.
During the briefing, Dr. Mary Maloney, chair of the academy’s regulatory policy committee, said that an estimated 2.3 million teens use indoor tanning facilities every year, and that melanoma is the most common form of cancer in adults aged 25-29 years and the second most common form of invasive cancer among people aged 15-29 years. In a 2011 youth risk behavior survey, 13% of all high school students said that they had used indoor tanning, and by 12th grade, 32% of girls had reported using a tanning bed, according to the Centers for Disease Control and Prevention.
Dr. Maloney also referred to evidence that young people are given misinformation about the risks of indoor tanning, citing a study by Washington University in St. Louis, which found that 43% of indoor tanning facilities in Missouri denied there were any risks associated with indoor tanning and that two-thirds allowed minors aged 10-12 years to use tanning devices, sometimes without parental consent.
The FDA will accept comments on the proposed order at www.regulations.gov for 90 days from publication in the Federal Register.
Indoor tanning beds should carry warnings against their use in people under age 18 years and should advise users to be screened regularly for skin cancer, according to a proposal announced by the Food and Drug Administration on May 6.
The agency seeks to reclassify the ultraviolet lamps used in tanning beds, upgrading them to class II (moderate risk) from class I (low risk) and to rename them "sunlamps." As class I devices, these lamps are currently deemed to be at the same risk level as adhesive bandages and tongue depressors.
Under the proposal, manufacturers would be required to display "a prominent visible label on the tanning bed itself," warning against use in people under age 18 years, Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, Silver Spring, Md., said during a briefing held to announce the proposal. Manufacturers also would have to add labels contraindicating the use of sunlamps in people with certain skin lesions.
Information advising regular skin cancer screenings would be added to materials such as brochures, catalogues, and consumer websites, he added.
"We believe that our proposal will allow for safer, more reliable sunlamps and better arm consumers with the critical information they need," Dr. Shuren said.
In 2010, an FDA advisory panel unanimously recommended that these devices be switched to at least class II.
The proposed reclassification does not prohibit the use of sunlamp products in minors.
Manufacturers are currently not required to submit applications to market these devices, but if they are reclassified as class II devices, a "premarket notification" application will be required and "manufacturers would have to show that their products have met certain performance testing requirements, address certain product design characteristics and provide comprehensive labeling that presents consumers with clear information on the risks of use," according to the FDA statement announcing the proposal.
Clinical trials would not be required, but manufacturers would be required test the performance of timers and alarms and ensure that sunlamps provide the correct amount of energy to prevent burns. Reports of burns associated with these products indicate that this testing is not being done properly now, Dr. Shuren said.
According to the American Academy of Dermatology, the risk of melanoma increases by 75% among people exposed to ultraviolet radiation from indoor tanning products, and the risk increases with increased use.
During the briefing, Dr. Mary Maloney, chair of the academy’s regulatory policy committee, said that an estimated 2.3 million teens use indoor tanning facilities every year, and that melanoma is the most common form of cancer in adults aged 25-29 years and the second most common form of invasive cancer among people aged 15-29 years. In a 2011 youth risk behavior survey, 13% of all high school students said that they had used indoor tanning, and by 12th grade, 32% of girls had reported using a tanning bed, according to the Centers for Disease Control and Prevention.
Dr. Maloney also referred to evidence that young people are given misinformation about the risks of indoor tanning, citing a study by Washington University in St. Louis, which found that 43% of indoor tanning facilities in Missouri denied there were any risks associated with indoor tanning and that two-thirds allowed minors aged 10-12 years to use tanning devices, sometimes without parental consent.
The FDA will accept comments on the proposed order at www.regulations.gov for 90 days from publication in the Federal Register.
Indoor tanning beds should carry warnings against their use in people under age 18 years and should advise users to be screened regularly for skin cancer, according to a proposal announced by the Food and Drug Administration on May 6.
The agency seeks to reclassify the ultraviolet lamps used in tanning beds, upgrading them to class II (moderate risk) from class I (low risk) and to rename them "sunlamps." As class I devices, these lamps are currently deemed to be at the same risk level as adhesive bandages and tongue depressors.
Under the proposal, manufacturers would be required to display "a prominent visible label on the tanning bed itself," warning against use in people under age 18 years, Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, Silver Spring, Md., said during a briefing held to announce the proposal. Manufacturers also would have to add labels contraindicating the use of sunlamps in people with certain skin lesions.
Information advising regular skin cancer screenings would be added to materials such as brochures, catalogues, and consumer websites, he added.
"We believe that our proposal will allow for safer, more reliable sunlamps and better arm consumers with the critical information they need," Dr. Shuren said.
In 2010, an FDA advisory panel unanimously recommended that these devices be switched to at least class II.
The proposed reclassification does not prohibit the use of sunlamp products in minors.
Manufacturers are currently not required to submit applications to market these devices, but if they are reclassified as class II devices, a "premarket notification" application will be required and "manufacturers would have to show that their products have met certain performance testing requirements, address certain product design characteristics and provide comprehensive labeling that presents consumers with clear information on the risks of use," according to the FDA statement announcing the proposal.
Clinical trials would not be required, but manufacturers would be required test the performance of timers and alarms and ensure that sunlamps provide the correct amount of energy to prevent burns. Reports of burns associated with these products indicate that this testing is not being done properly now, Dr. Shuren said.
According to the American Academy of Dermatology, the risk of melanoma increases by 75% among people exposed to ultraviolet radiation from indoor tanning products, and the risk increases with increased use.
During the briefing, Dr. Mary Maloney, chair of the academy’s regulatory policy committee, said that an estimated 2.3 million teens use indoor tanning facilities every year, and that melanoma is the most common form of cancer in adults aged 25-29 years and the second most common form of invasive cancer among people aged 15-29 years. In a 2011 youth risk behavior survey, 13% of all high school students said that they had used indoor tanning, and by 12th grade, 32% of girls had reported using a tanning bed, according to the Centers for Disease Control and Prevention.
Dr. Maloney also referred to evidence that young people are given misinformation about the risks of indoor tanning, citing a study by Washington University in St. Louis, which found that 43% of indoor tanning facilities in Missouri denied there were any risks associated with indoor tanning and that two-thirds allowed minors aged 10-12 years to use tanning devices, sometimes without parental consent.
The FDA will accept comments on the proposed order at www.regulations.gov for 90 days from publication in the Federal Register.
