First Posted: May 29, 2014 09:02 PM EDT
The United States Food and Drug Administration has turned up the regulatory heat on sunlamps and tanning beds.
The agency has reclassified sunlamp products and ultraviolet (UV) lights intended for use in sunlamp products from low-risk (class I) to moderate-risk (class II) devices, an agency news release explained.
The new status requires visible, black-box warnings be affixed to the devices in question and stating sunlamp products should not be used on those under 18 years of age.
The warnings must state: "Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer."
As well, certain marketing materials for sunlamp products and UV lamps must also include specific statements warning against using the products and explaining why.
Sunlamp products, including tanning beds and tanning booths, emit UV radiation that can cause skin cancer, the USFDA said.
People exposed to UV radiation from indoor tanning methods suffer a 59 percent increase in the risk of melanoma, the most lethal form of skin cancer, according to the American Academy of Dermatology, and the risk increases each time they use a sunlamp product.
As part of the reclassification decision, manufacturers will now have to submit a premarket notification to and obtain clearance from the USFDA prior to marketing their devices - which had been exempt from such reviews.
The added governmental scrutiny means sunlamp product manufacturers - aside from placing the warning labels on their wares - will now have to demonstrate their products meet set performance testing requirements and address certain product design characteristics.
In addition to a warning placed on the sunlamp product advising that the product not be used on children under 18, certain marketing materials promoting sunlamp products and UV lamps must carry additional warnings and contraindications, including "Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer."
The USFDA's final order for the reclassification of sunlamp products and UV lamps follows the recommendations issued four years from a panel of outside experts, followed by a public comment period after the release of the proposed order in May 2013.
© 2014 Latin Post. All rights reserved. Do not reproduce without permission.
The United States Food and Drug Administration has turned up the regulatory heat on sunlamps and tanning beds.
The agency has reclassified sunlamp products and ultraviolet (UV) lights intended for use in sunlamp products from low-risk (class I) to moderate-risk (class II) devices, an agency news release explained.
The new status requires visible, black-box warnings be affixed to the devices in question and stating sunlamp products should not be used on those under 18 years of age.
The warnings must state: "Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer."
As well, certain marketing materials for sunlamp products and UV lamps must also include specific statements warning against using the products and explaining why.
Sunlamp products, including tanning beds and tanning booths, emit UV radiation that can cause skin cancer, the USFDA said.
People exposed to UV radiation from indoor tanning methods suffer a 59 percent increase in the risk of melanoma, the most lethal form of skin cancer, according to the American Academy of Dermatology, and the risk increases each time they use a sunlamp product.
As part of the reclassification decision, manufacturers will now have to submit a premarket notification to and obtain clearance from the USFDA prior to marketing their devices - which had been exempt from such reviews.
The added governmental scrutiny means sunlamp product manufacturers - aside from placing the warning labels on their wares - will now have to demonstrate their products meet set performance testing requirements and address certain product design characteristics.
In addition to a warning placed on the sunlamp product advising that the product not be used on children under 18, certain marketing materials promoting sunlamp products and UV lamps must carry additional warnings and contraindications, including "Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer."
The USFDA's final order for the reclassification of sunlamp products and UV lamps follows the recommendations issued four years from a panel of outside experts, followed by a public comment period after the release of the proposed order in May 2013.
© 2014 Latin Post. All rights reserved. Do not reproduce without permission.
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