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June 17, 2011

FDA Takes Action to Update Sunscreen Testing and Labeling and States Nanoscale Ingredients Are Not Absorbed

The ACTA Group

On June 14, 2011, the U.S. Food and Drug Administration (FDA) took long-awaited action to update regulations for testing and labeling over-the-counter (OTC) sunscreen products. The Agency emphasized that the primary intent of its initiative was to establish a consistent standard for testing and labeling sunscreen products to reduce consumer confusion and encourage proper use of these products to enhance their protective function. The most significant elements of FDA’s action include changes in product testing and labeling to clarify use of a “broad spectrum” claim and a call for additional safety and effectiveness data on different sunscreen dosage forms, especially of aerosol formulations.

Notably, FDA’s actions did not include a response to a Citizen Petition submitted to the Agency in May 2008 by consumer and environmental groups concerned about the safety of nanoscale active ingredients use in sunscreens. As discussed further below, an FDA official mentioned in the press briefing announcing the sunscreen actions that the Agency had conducted its own animal studies and found nanoscale sunscreen ingredients were not absorbed through the epidermis.

New Sunscreen Regulations and Call for Data

On June 17, 2011, FDA issued five separate regulatory notices addressing sunscreen products:

Final Rule on Sunscreen Testing and Labeling: Establishes standards for testing ultraviolet A (UVA) and ultraviolet B (UVB) protection, requirements for proper labeling of a product’s sun protection factor (SPF) and use of the claim “broad spectrum,” prohibits use of the claims “sunblock,” “waterproof,” and “sweatproof,” and mandates use of the Drug Facts labeling format. 76 Fed. Reg. 35620. The final rule will become effective June 18, 2012. The compliance date for all products subject to the final rule with annual sales less than $25,000 is June 17, 2013. The compliance date for all other products subject to the final rule is June 18, 2012.

Proposed Rule to Limit SPF Claims: Proposes an upper limit of SPF 50+ in the absence of data demonstrating the effectiveness of a higher SPF. 76 Fed. Reg. 35672. Comments on the proposed rule are due by September 15, 2011. Comments on information collection issues under the Paperwork Reduction Act of 1995 (PRA) must be submitted by July 18, 2011.

Advance Notice of Proposed Rulemaking (ANPR) on Sunscreen Dosage Forms: Solicits public comment and data on the safety and effectiveness of different dosage forms of sunscreen (e.g., gels, sticks, aerosols, wipes, etc.). 76 Fed. Reg. 35669. FDA has indicated a particular interest in receiving data on demonstrating the effectiveness of spray formulations and on the safety of inhaled aerosolized sunscreen ingredients. Data and information must be submitted by September 15, 2011.

Proposed Information Collection Request on SPF Labeling and Testing Requirements and Drug Facts Labeling for OTC Sunscreen Drug Products: Announces an opportunity for public comment on the proposed collection of certain information. 76 Fed. Reg. 35678. FDA requests comments on information collection requests concerning SPF labeling and testing requirements for OTC sunscreen products containing specified ingredients and marketed without approved applications, and on compliance with Drug Facts labeling requirements for all OTC sunscreen products. Comments are due August 16, 2011.

Draft Guidance for Industry: The Draft Guidance, entitled “Enforcement Policy — OTC Sunscreen Drug Products Marketed Without an Approved Application,” outlines FDA’s enforcement policy regarding sunscreen products in light of the Agency’s new final rule on testing and labeling and the tentative final monograph for sunscreen products. 76 Fed. Reg. 35665. Significantly, FDA will allow labeling of specific SPF values above 50 until the proposed rule limiting such claims is prepared in final as long as the claims are supported by data in accord with the current monograph standards. The Draft Guidance also notes that FDA intends to NOT include spray formulations in any final monograph proposal unless sufficient data are submitted in response to the ANPR request. Combination sunscreen-insect repellant products will continue to enjoy enforcement discretion as long as the products contain sunscreen ingredients listed in the current monograph and an insect repellant registered with the U.S. Environmental Protection Agency (EPA). The Draft Guidance is available online. Comments on the Draft Guidance are due by August 16, 2011. Written comments on the proposed collection of information are due by August 16, 2011.

Comments on Nanoscale Sunscreen Ingredients

A significant scientific and regulatory issue regarding sunscreen products is the incorporation of nanoscale materials such as titanium dioxide and zinc oxide into the formulas. In May 2008, eight consumer and environmental groups filed a Citizen Petition alleging that FDA had failed to develop health and safety tests to examine the fundamentally different properties that nanoscale titanium dioxide and zinc oxide had from their bulk counterparts. The groups submitted information purporting to show that nanomaterials had been found to penetrate cells and trigger inflammatory and immune responses.

The Agency has yet formally to respond to the petition, despite addressing the issue obliquely in the myriad of materials released on sunscreen products. The only mention of the nanomaterial issue came in the form of statements made by Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER), during a Webcast announcing the several FDA actions relating to sunscreens. After stating that some critics had suggested that the nanoparticles could penetrate the skin and cause health problems, Dr. Woodcock mentioned that FDA had recently performed animal testing and found that nanoparticles do not penetrate the skin. She is quoted as saying that the findings agree with studies published in the literature and that there is currently no evidence to suggest that other chemicals commonly used in sunscreens are dangerous. In follow-up questions, Dr. Woodcock emphasized that FDA would continue to review data and make decisions based on individual ingredients. She noted, however, that FDA lacked data to make a determination about the safety of aerosolized sunscreen ingredients, including sprays utilizing nanoscale active ingredients. These statements are consistent with the policy expressed by the Agency in its recently issued Draft Guidance on Nanomaterials.

On the same day that FDA held the Webcast, WebMD held an online panel discussion featuring FDA officials and Dr. Henry Lim, Chair of Dermatology at the Henry Ford Hospital and Chair of the Science and Research Council of the American Academy of Dermatology. When asked whether manufacturers would ever introduce non-toxic sunscreens, Dr. Lim discussed a number of ingredients and ended with a few words about nanoparticles and the concern that they would pass through the skin into the bloodstream. Dr. Lim indicated that a very significant amount of information exists to demonstrate that nanoscale sunscreen ingredients are quite safe. When used on intact skin, nanoscale sunscreen ingredients do not penetrate the epidermis.

The comments of Drs. Woodcock and Lim in conjunction with FDA’s action on sunscreens were the sum total of the discussion on the use of nanomaterials in these products. Undoubtedly, the discussion will have to be expanded. Dr. Woodcock did not offer citations to the research that FDA had done, or elaborate on it in any way. Scientists and others will be eager to review that work and determine how it fits with the body of literature that some suggests offers a different conclusion. For example, Dr. Lim limited his characterization of nanoscale sunscreen safety to use only on intact skin, while Dr. Woodcock did not offer such a caveat in her statement on the subject. The limits and parameters of this issue will have to be explored.

In fairness to the FDA, the Agency did not purport to deal with the issue of nanoparticles in the several rules and proposals it issued. Nonetheless, given the Center Director’s statements and the concerns about aerosolized sunscreens expressed in the press statements and in the ANPR’s call for data, the subject is likely to become part of the discussion as the regulatory process unfolds. In the meantime, the Agency’s comments should not be viewed as dispositive of the nanoparticle issue in sunscreen products.