Data evaluation has held up sunscreen monograph, says FDA

By Katie Bird

- Last updated on GMT

Final regulations on sun protection products in the US are set to be published in May, after significant delays which the FDA says are due to the large amount of information to be evaluated.

The regulatory body published a proposed sunscreen monograph in 2007 with details on the testing and labeling of sunscreen products that protect against both UVA and UVB. (Previous monographs did not include specific regulation to address the protection provided against UVA radiation.)

This proposed rule was then opened up for public comment, but a final ruling is still awaited. The publication of this final monograph is now set for May 2010.

"FDA believes it is important to public health that we issue a final rule for OTC sunscreens as soon as possible," ​said an FDA spokesperson when commenting on the new publication date.

UVA regulation needed

However, according to critics, the publication of this final monograph is seriously overdue and finalised regulation that takes in UVA is sorely needed.

Consumer organization, the Environmental Working Group (EWG), has criticized FDA, calling the delays interminable and indefensible.

In a letter to FDA Commissioner Margaret Hamburg in July 2009, the group claimed that ‘in the absence of formal guidance from FDA, companies continue to make billions of dollars annually by misleading consumers about the protection from the sun their products offer.’

Responding to the letter earlier this month, FDA defended its position and said that the need to investigate new developments in the sector had delayed the operations.

“Although we understand your concern regarding the protracted nature of this process, we trust that you will appreciate the need for us to continue to fully investigate and evaluate new research and development for sunscreen products, permit adequate opportunity for public comment, and weigh all research and development fairly and with full input from FDA subject area experts as well as industry stakeholders and the American public,”​ FDA said in the letter.

In addition, the regulatory body said that it received an extremely large number of comments when it published the 2007 proposed ruling for public comment.

“In response to our request for public comment on the proposed rule we received nearly 3,000 submissions from the public.”

Typically the body receives no more than 100 submissions on a proposed rule. In addition, those relating to the sunscreen monograph contained multiple references to technical data and references that FDA claims takes time to evaluate.

Related topics: Formulation & Science

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