FDA Announces Delay in Compliance Deadlines for New Sunscreen Regulations
On May 11, 2012, the U.S. Food & Drug Administration (“FDA”) announced that it has delayed the compliance deadlines for the final rule for over-the-counter (“OTC”) sunscreen drug products that was published in the Federal Register on June 17, 2011. See 76 Fed. Reg. 35620 (June 17, 2011). Previously, the compliance deadlines were set to take effect on June 18, 2012 for OTC sunscreen products with annual sales of $25,000 and June 18, 2013 for those OTC products with less than $25,000 in annual sales. However, manufacturers now have an additional six months for compliance, meaning the rules will become mandatory December 18, 2012 and December 18, 2013 respectively. A copy of the FDAs announcement which was published in the Federal Register can be read here.
As we previously reported, in June of 2011, the FDA announced changes to the requirements for OTC sunscreen products as part of its ongoing efforts to ensure that sunscreens meet modern-day standards for safety and effectiveness. The final rule established labeling and effectiveness testing for certain OTC sunscreen products containing specified active ingredients and marketed without approved applications.
More specifically, under the new rule, sunscreens will no longer be allowed to be labeled as “waterproof” or “sweatproof” because the FDA believes these claims are misleading and overstate the effectiveness of the products. Instead, the new rules require manufacturers to indicate on the front label whether the sunscreen product is effective for either 40 minutes or 80 minutes while swimming or sweating, or if the product is not water resistant, to direct consumers to use a water resistant sunscreen if swimming or sweating. In addition, the new rule allows products to claim they offer “broad spectrum” protection only if they pass specific FDA tests for blocking both Ultraviolent A rays (“UVA”) and Ultraviolet B rays (“UVB”), and if they have an SPF of at least 15. The new rules provide that if a sunscreen do not protect against UVA, or has an SPF of less than 15, then the product must carry a warning which states that the product does not protect against skin cancer.
The delay in compliance deadlines was prompted by two interrelated concerns of the FDA: 1) manufacturers were simply not ready to be fully compliant; and 2) because manufacturers would not be able to be fully compliant by the June 18, 2012 deadline, a summer shortage of sunscreen could have resulted if manufacturers were prohibited from shipping products with old labels. As explained by the FDA:
One of our primary objectives in the 2011 final rule is to provide labeling that will enable consumers to identify and select sunscreen products that provide broad spectrum protection as well as a minimum SPF of 15. These sunscreens are particularly important for public health because, in addition to helping prevent sunburn, sunscreens with a broad spectrum SPF value of 15 or higher, if used as directed with other sun protection measures, decrease the risk of skin cancer and early skin aging caused by the sun. 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 will be undermined.
77 Fed. Reg. 27592 (May 11, 2012). Thus, the FDA determined that “allowing adequate time for the 2011 final rule requirements to be fully implemented is in the interest of public health.” Id.
Fuerst Ittleman will continue to monitor the FDAs rules for labeling and effectiveness testing of sunscreen products and other products or devices related to UVA or UVB exposure. For more information, please contact us at firstname.lastname@example.org.