Regulatory Focus™ > News Articles > FDA to Delay Implementation Date for Sunscreen Labeling and Testing Changes

FDA to Delay Implementation Date for Sunscreen Labeling and Testing Changes

Posted 10 May 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) announced 10 May it will delay implementation of a final rule intended to establish labeling and effectiveness testing for over-the-counter (OTC) sunscreen products, marking the latest development in a long struggle over the regulation of sunscreen products.

FDA's final rule establishes new requirements for sunscreen products containing specific active ingredients and marketed without approved applications, "amends labeling claims that are not currently supported by data," and mandates sunscreens containing an active ingredient contain a drug facts label.

For instance, sunscreens containing claims to provide "all-day" protection or hour-specific lengths of protection would now be required to undergo a premarket approval process.

The agency said in a statement it is giving manufacturers an additional six months of time to implement the regulations, which will now go into effect 17 December 2012. Products grossing under $25,000 in sales will receive an additional year to become compliant with the regulations (17 December 2013).

The action marks another development in a long, complicated and often contentious regulatory development process for sunscreen products.

The New York Times reported in April 2012 the agency has frequently clashed with the White House over the implementation strategy for the sunscreen rule.

While the White House had signed off on the rule, FDA wanted more stringent regulations to ban any product containing a sun protection factor (SPF) less than 15 from being called sunscreen "because they do not protect against cancer or skin aging," reported The Times.

"It was all a personal reaction on their part," a top FDA official involved in the discussions said of White House officials to The Times. "They made it clear they used these products and they thought they were fine."

The matter eventually was arbitrated by Cass Sunstein, the Director of the Office of Information and Regulatory Affairs (OIRA).

"In a compromise Mr. Sunstein supported, the F.D.A. decided products with SPFs of 14 or lower could be called sunscreens but must carry warnings," wrote The Times.

In delaying the implementation of those rules on 10 May, FDA said two trade groups-the Personal Care Products Council and the Consumer Healthcare Products Association-had convinced the agency that the cosmetic industry needed more time to implement "complex labeling redesign issues" and "broad spectrum testing."

Read more:

FDA - Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-the-Counter Human Use; Delay of Compliance Dates

Regulatory Focus - Report: Clashes Between White House, FDA Frequent

The New York Times - White House and the F.D.A. Often at Odds

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