News

FDA Delays Sunscreen Rule by 6 Months


 

The Food and Drug Administration announced in May that it was giving sunscreen manufacturers 6 additional months to comply with the final ruling on product labeling and effectiveness testing.

That final rule was published in June 2011; soon after, the Personal Care Products Council (PCPC) and the Consumer Healthcare Products Association (CHPA) sought a 6-month delay in the deadline, saying that manufacturers needed more time.

The agency agreed and has pushed back compliance dates. Now, products that have sales of less than $25,000 will have until Dec. 17, 2013, to comply; all other products must comply by Dec. 17, 2012. However, the agency is encouraging manufacturers to "introduce individual products bearing the new labeling as it becomes available, even in advance of the revised compliance date."

The American Academy of Dermatology also urged sunscreen makers to comply sooner, rather than later, but said in a statement that the extension "allows manufacturers the necessary time to test their products for broad-spectrum protection and properly label them."

The Environmental Working Group, which publishes a database of sunscreen effectiveness, chided the FDA, saying in a statement that it "has caved to industry pressure every step of the way," of getting the rules finalized – a 30-year process. The group estimates that 90% of sunscreens are already in compliance with what it calls the FDA’s "low-bar regulations on efficacy and safety."

Recommended Reading

Prepare Parents to Leave Exam Room
MDedge Family Medicine
Palliative Care Specialists Ponder Public Awareness Campaign
MDedge Family Medicine
Wellness Visits Work for Medicare Patients and the Bottom Line
MDedge Family Medicine
Dark-Skinned Patients Not Getting Skin Cancer Message
MDedge Family Medicine
IOM Urges Collective Action Against Obesity
MDedge Family Medicine
NQCA-Led Group Proposes Adolescent Well-Care Measures
MDedge Family Medicine
Feds Set to Boost Primary Care Medicaid Payments for 2 Years
MDedge Family Medicine
Medicare Overhauls Hospital Rules to Cut Red Tape
MDedge Family Medicine
ACC Urges Shift to Patient-Centered Care
MDedge Family Medicine
Financial Forecast Bleak for Noncompliance With EHR
MDedge Family Medicine