FDA has issues a final order to reclassify sun lamp products —tanning beds or tanning booths— as Class II device in an effort to help protect consumers and inform them about the risks of indoor tanning. The regulation affects sunlamp products and UV lamps intended for use in sunlamp products. The move strengthens the oversight of these devices, and requires that sunlamp products carry a visible, black-box warning stating that they should not be used on people under the age of 18.
The effects of UV radiation are cumulative and children and teenagers who are exposed to indoor UV radiation are at greater risk for skin and eye damage, according to the FDA.
“There is increasing evidence that tanning in childhood to early adult life increases the risk of skin cancer, including melanoma,” says FDA dermatologist Markham Luke, MD, PhD.
The use of sunlamp products—tanning beds or tanning booths— increases the risk of skin damage, skin cancer (including melanoma and eye injury).
Indoor tanning heightens the risk of developing melanoma by 59% and the risk goes up with each use, according to the American Academy of Dermatology and the World Health Organization. Yet despite these risks, many Americans still indoor tan.
More Educated Consumers
Manufacturers of sunlamp products (including tanning beds and booths) must comply with applicable FDA regulations for both medical devices and radiation-emitting products. Based in part on risk information and recommendations from experts at an earlier FDA Medical Device Advisory Committee meeting, the agency is reclassifying these devices from Class I (low risk) to Class II (moderate risk). Previously, indoor tanning devices were Class I — the category for items that have minimal potential to cause harm to individuals, such as adhesive bandages and tongue depressors.
FDA has more regulatory control with a Class II device. Under the new reclassification, sunlamp products are required to go through a premarket FDA review and comply with requirements relating to performance testing, software validation and biocompatibility.
Another change is that FDA will require certain user instructions and promotional materials for sunlamp products and UV lamps intended for use in sunlamp products include warnings and contraindications, such as:
• the product is contraindicated for use on persons under the age of 18 years;
• the product must not be used if skin lesions or open wounds are present;
• the product should not be used on people who have had skin cancer or a family history of skin cancer; and
• people repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.
The American Academy of Dermatology Association (AADA) commended the FDA’s action to finalized stricter regulations of indoor tanning devices, including a strong recommendation against the use of tanning beds by minors under the age of 18.
“Restricting teens’ access to indoor tanning is critical to preventing skin cancer,” says Brett M. Coldiron, MD, FAAD, president of the AAD. He notes that AAD will continue to communicate to the FDA the need for stricter regulations on the use and sale of indoor tanning devices for minors under the age of 18.
In 2010, the FDA convened an Advisory Panel hearing to examine the current classification and regulations of tanning beds. Representatives from the AAD, leading dermatologists, researchers and patients testified before the panel highlighting the risks associated with indoor tanning and the need to protect the public from these dangers. Following the hearing, the AAD has been working closely with the FDA, and both state and federal legislatures to protect minors from the dangers of indoor tanning.
“The AAD has been working aggressively with the FDA, congressional leaders and policy makers to help make today’s reclassification of indoor tanning devices and the placement of additional restrictions on indoor tanning possible. We applaud the FDA for taking this important first step,” says Dr. Coldiron. “However, we recognize that there is still more work to be done to protect the public from these dangerous devices.”
Under the final changes, manufacturers will be required to provide updated labeling for all products on the market within 450 days of June 2, 2014.
FDA has issues a final order to reclassify sun lamp products —tanning beds or tanning booths— as Class II device in an effort to help protect consumers and inform them about the risks of indoor tanning. The regulation affects sunlamp products and UV lamps intended for use in sunlamp products. The move strengthens the oversight of these devices, and requires that sunlamp products carry a visible, black-box warning stating that they should not be used on people under the age of 18.
The effects of UV radiation are cumulative and children and teenagers who are exposed to indoor UV radiation are at greater risk for skin and eye damage, according to the FDA.
“There is increasing evidence that tanning in childhood to early adult life increases the risk of skin cancer, including melanoma,” says FDA dermatologist Markham Luke, MD, PhD.
The use of sunlamp products—tanning beds or tanning booths— increases the risk of skin damage, skin cancer (including melanoma and eye injury).
Indoor tanning heightens the risk of developing melanoma by 59% and the risk goes up with each use, according to the American Academy of Dermatology and the World Health Organization. Yet despite these risks, many Americans still indoor tan.
More Educated Consumers
Manufacturers of sunlamp products (including tanning beds and booths) must comply with applicable FDA regulations for both medical devices and radiation-emitting products. Based in part on risk information and recommendations from experts at an earlier FDA Medical Device Advisory Committee meeting, the agency is reclassifying these devices from Class I (low risk) to Class II (moderate risk). Previously, indoor tanning devices were Class I — the category for items that have minimal potential to cause harm to individuals, such as adhesive bandages and tongue depressors.
FDA has more regulatory control with a Class II device. Under the new reclassification, sunlamp products are required to go through a premarket FDA review and comply with requirements relating to performance testing, software validation and biocompatibility.
Another change is that FDA will require certain user instructions and promotional materials for sunlamp products and UV lamps intended for use in sunlamp products include warnings and contraindications, such as:
• the product is contraindicated for use on persons under the age of 18 years;
• the product must not be used if skin lesions or open wounds are present;
• the product should not be used on people who have had skin cancer or a family history of skin cancer; and
• people repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.
The American Academy of Dermatology Association (AADA) commended the FDA’s action to finalized stricter regulations of indoor tanning devices, including a strong recommendation against the use of tanning beds by minors under the age of 18.
“Restricting teens’ access to indoor tanning is critical to preventing skin cancer,” says Brett M. Coldiron, MD, FAAD, president of the AAD. He notes that AAD will continue to communicate to the FDA the need for stricter regulations on the use and sale of indoor tanning devices for minors under the age of 18.
In 2010, the FDA convened an Advisory Panel hearing to examine the current classification and regulations of tanning beds. Representatives from the AAD, leading dermatologists, researchers and patients testified before the panel highlighting the risks associated with indoor tanning and the need to protect the public from these dangers. Following the hearing, the AAD has been working closely with the FDA, and both state and federal legislatures to protect minors from the dangers of indoor tanning.
“The AAD has been working aggressively with the FDA, congressional leaders and policy makers to help make today’s reclassification of indoor tanning devices and the placement of additional restrictions on indoor tanning possible. We applaud the FDA for taking this important first step,” says Dr. Coldiron. “However, we recognize that there is still more work to be done to protect the public from these dangerous devices.”
Under the final changes, manufacturers will be required to provide updated labeling for all products on the market within 450 days of June 2, 2014.
FDA has issues a final order to reclassify sun lamp products —tanning beds or tanning booths— as Class II device in an effort to help protect consumers and inform them about the risks of indoor tanning. The regulation affects sunlamp products and UV lamps intended for use in sunlamp products. The move strengthens the oversight of these devices, and requires that sunlamp products carry a visible, black-box warning stating that they should not be used on people under the age of 18.
The effects of UV radiation are cumulative and children and teenagers who are exposed to indoor UV radiation are at greater risk for skin and eye damage, according to the FDA.
“There is increasing evidence that tanning in childhood to early adult life increases the risk of skin cancer, including melanoma,” says FDA dermatologist Markham Luke, MD, PhD.
The use of sunlamp products—tanning beds or tanning booths— increases the risk of skin damage, skin cancer (including melanoma and eye injury).
Indoor tanning heightens the risk of developing melanoma by 59% and the risk goes up with each use, according to the American Academy of Dermatology and the World Health Organization. Yet despite these risks, many Americans still indoor tan.
More Educated Consumers
Manufacturers of sunlamp products (including tanning beds and booths) must comply with applicable FDA regulations for both medical devices and radiation-emitting products. Based in part on risk information and recommendations from experts at an earlier FDA Medical Device Advisory Committee meeting, the agency is reclassifying these devices from Class I (low risk) to Class II (moderate risk). Previously, indoor tanning devices were Class I — the category for items that have minimal potential to cause harm to individuals, such as adhesive bandages and tongue depressors.
FDA has more regulatory control with a Class II device. Under the new reclassification, sunlamp products are required to go through a premarket FDA review and comply with requirements relating to performance testing, software validation and biocompatibility.
Another change is that FDA will require certain user instructions and promotional materials for sunlamp products and UV lamps intended for use in sunlamp products include warnings and contraindications, such as:
• the product is contraindicated for use on persons under the age of 18 years;
• the product must not be used if skin lesions or open wounds are present;
• the product should not be used on people who have had skin cancer or a family history of skin cancer; and
• people repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.
The American Academy of Dermatology Association (AADA) commended the FDA’s action to finalized stricter regulations of indoor tanning devices, including a strong recommendation against the use of tanning beds by minors under the age of 18.
“Restricting teens’ access to indoor tanning is critical to preventing skin cancer,” says Brett M. Coldiron, MD, FAAD, president of the AAD. He notes that AAD will continue to communicate to the FDA the need for stricter regulations on the use and sale of indoor tanning devices for minors under the age of 18.
In 2010, the FDA convened an Advisory Panel hearing to examine the current classification and regulations of tanning beds. Representatives from the AAD, leading dermatologists, researchers and patients testified before the panel highlighting the risks associated with indoor tanning and the need to protect the public from these dangers. Following the hearing, the AAD has been working closely with the FDA, and both state and federal legislatures to protect minors from the dangers of indoor tanning.
“The AAD has been working aggressively with the FDA, congressional leaders and policy makers to help make today’s reclassification of indoor tanning devices and the placement of additional restrictions on indoor tanning possible. We applaud the FDA for taking this important first step,” says Dr. Coldiron. “However, we recognize that there is still more work to be done to protect the public from these dangerous devices.”
Under the final changes, manufacturers will be required to provide updated labeling for all products on the market within 450 days of June 2, 2014.
