Breaking News: FDA issues proposed order for stricter regulations on indoor tanning devices

The U.S. Food and Drug Administration (FDA) today has proposed changes to its regulation of tanning devices, including a strong recommendation against the use of tanning beds by minors under the age of 18. The American Academy of Dermatology Association (AADA) supports the reclassification of indoor tanning devices and placing additional restrictions on indoor tanning, and is pleased that the FDA has taken this important first step.

The FDA announced that it is proposing to raise the classification for sunlamps and tanning beds to a Class II level which institutes stricter regulations to protect public health. Currently, indoor tanning devices are Class I, the category for items that have minimal potential to cause harm to individuals, such as adhesive bandages and tongue depressors.

The AADA recognizes that there is still more work to be done to protect the public from these dangerous devices, and urges the FDA and state legislative and regulatory bodies to prohibit the use and sale of indoor tanning devices for minors under the age of 18.

• FAQs on the FDA’s proposed order on tanning devices.
• Read the AADA’s position statement on indoor tanning.

AADA advocacy on indoor tanning regulation:

• AAD joins with AAP to send a letter to Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiologic Health. The letter reiterates the alarming statistics related to indoor tanning devices and called upon the FDA to eliminate the use of tanning beds for minors.
• View the American Academy of Pediatrics (AAP) policy statement addressing the hazards of ultraviolet radiation on children and adolescents. 
• AADA testifies at FDA hearing on indoor tanning devices (March 25, 2010).
• AADA comments at FDA tanning hearing (March 2, 2010).
• AAD position statement on indoor tanning.
• Dangers of indoor tanning.

Sunscreen monograph: On June 14, 2011, the Food and Drug Administration (FDA) announced new regulations to standardize testing and require revised labels for sunscreens. Academy President Ronald Moy, MD, joined Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in the long-awaited announcement.

• The FDA issued a proposed rule to cap sunscreen’s SPF value to 50+. The AAD submitted a comment letter supporting the FDA’s proposal to increase the cap to 50+ and urge them to consider higher SPF values upon clinical studies and validated SPF assessments.

Drug approvals, warnings, recalls and shortages: The Academy works with the FDA to stay abreast of the latest actions that affect patient safety and access to dermatologic drugs.

• House Energy and Commerce Committee moves prescription drug and medical device legislation forward.
• AADA provides comments to the FDA regarding biosimilars.
• Read the AADA comment letter to members of the Senate Health, Education, Labor and Pensions (HELP) Committee to address prescription drug shortages. (March 29, 2012)
• Read the AADA comment letter to FDA on the iPLEDGE, isotretinoin distribution program.
• AADA and Society for Pediatric Dermatology ask FDA Pediatric Advisory Committee to reconsider black box warning on pimecrolimus and tacrolimus (May 2, 2011).
• FDA panel votes to approve additional Restylane indication: AADA submits letter highlighting 2009 Facial Soft Tissue Fillers Conference and commends Medicis for seeking indication expansion. (April 28, 2011).
• Methoxsalen available in the United States on a limited-supply basis (June 21, 2010).
• About the iPLEDGE isotretinoin risk-management program.
• FDA gives update on botulinum toxin safety warning (Aug. 3, 2009).
• FDA changes safety labeling for isotretinoin capsules (April 12, 2010).
• FDA issues warning letters about drugs promoted in fat-elimination procedure (April 9, 2010).
• Read AADA comments on national drug shortage.

Physicians across the country have expressed concern regarding the ongoing shortage of vital drug products. Unfortunately, drug shortages are affecting every medical specialty, including anesthesia, oncology, emergency medicine and dermatology. The Academy continues to work with FDA officials to resolve drug shortage issues.

• AADA provides comments to FDA regarding drug shortages.
• AADA commends Congress for considering drug shortages.
• FDA works to alleviate drug shortages.
• President Obama issues executive order on drug shortages.

Advertising issues: The FDA’s Bad Ad Program is designed to help physicians recognize and report misleading advertising of prescription drugs.

Agencies and programs:

• Medwatch program
• Food and Drug Administration (FDA)
• FDA current drug shortages index