Sunscreen Label Rules Deadlines Extended by FDA

Next weekend marks the unofficial start of the summer season, and readers will be heading out to the lake or beach, picnics and barbecues.  All the while taking time to reflect on the brave men and women who gave their lives for our freedom serving in the United States armed forces.  (Memorial Day was originally known as Decoration Day, a day to put flowers and flags on the graves of fallen Civil War soldiers.)

Those summer activities may call for sunscreen. On that topic, we note that the FDA recently announced a six-month delay on implementing new labeling rules for sunscreen.  The rules call for additional testing regarding ultraviolet A and ultraviolet B ray protection, and restrict use of certain "waterproof," "sweat-proof" and "sunblock" claims, also regulating claims for ‘‘instant
protection’’ or protection immediately upon application, or claims for ‘‘all-day’’ protection or extended wear claims.

The new rules were set to go into effect June 18, but industry groups like the Personal Care Products Council and the Consumer Healthcare Products Association noted the need for more time. FDA agreed that allowing adequate time for the 2011 final rule requirements to be
fully implemented is in the interest of public health.  Complex label redesign issues and the required broad spectrum testing just is going to take more time.

For example, sunscreens that pass the FDA's new broad-spectrum test procedure can be labeled as "Broad Spectrum" on the front label. And such products will be extremely valuable to consumers concerned about skin cancer risks. If the timeline for implementation discourages manufacturers from conducting broad spectrum testing, and instead prompts them to apply the labeling that the final rule establishes for products that have not been established to offer broad spectrum  protection, a major public health goal of the rule will be undermined.

FDA still encouraged manufacturers to introduce individual products bearing the new labeling as it becomes available, even in advance of the revised compliance date, which ranges from December 2012 to December 2013 depending on the product.

Readers, enjoy your holiday weekend.

 
 

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