The U.S. Food and Drug Administration (FDA) has extended the compliance dates for the Final Rule for Over-the-Counter (OTC) Sunscreen Drug Products [1]. In practice, operators will enjoy a six months delay for relabeling their products.
The extension follows requests from the Personal Care Products Council (PCPC) and the Consumer Healthcare Products Association (CHPA). The two trade associations described the process for testing and relabeling products, and expressed concerns regarding a potential shortage of sunscreens on the market.
Both the dates for large and small volume manufacturers have been extended. The new deadlines are:
– December 17, 2012 (from original date June 18, 2012) for OTC sunscreen products with annual sales of US$25,000 or more,
– December 17, 2013 (instead of June 17, 2013) for OTC sunscreen products with annual sales of less than US$25,000
“We had concerns about a possible shortage of sunscreens on the market. Thus, in the hopes that FDA would allow for an additional 6 months for implementation, we worked hard to educate the Agency on the operational timeline for bringing the industry into compliance with the final rule,” said Farah Ahmed, Chair of the PCPC’s Sunscreen Task Force.
Full text of the new rule “Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the- Counter Human Use; Delay of Compliance Dates” (21 CFR Parts 201 and 310) are available on line or may be downloaded here below:
