Sunscreen’s Moment to Shine: FDA Announces a Flurry of New Requirements for OTC Sunscreen Drug Products

June 16, 2011

By Susan J. Matthees

On Tuesday, sunscreen finally stepped out of the shadows at FDA.  After years waiting, FDA announced the availability of a number of new documents related to over-the-counter (“OTC”) sunscreen drug products marketed in the US, including a guidance document on enforcement policy for OTC sunscreen drugs marketed without an approved application, a proposed rule on limiting the maximum labeled SPF value for sunscreen products to “50+,” advance notice of proposed rulemaking (“ANPR”) to address difference dosage forms of sunscreen, and a final rule on labeling and testing methods. 

OTC sunscreen drug products have a lengthy regulatory history at FDA.  In 1978, FDA announced an ANPR for sunscreen drug products.  In 1993, FDA published a proposed rule on generally recognized as safe and effective (“GRASE”) conditions for OTC sunscreen drug products and then proposed amendments to that rule in 1996 and 1998.  In 1999, FDA finalized the OTC drug sunscreen monograph, but just a year later FDA delayed the effective date for the final rule.  In 2001, FDA stayed the effective date of the 1999 monograph, and then in 2007, FDA published another proposed rule on sunscreen drug products.  Unfortunately, Tuesday’s announcement of a final rule does not end the sunscreen regulatory saga; FDA is not finalizing the amendments to 21 C.F.R. Part 352 or lifting the stay on that section, and the final rule is not the final monograph for sunscreen drug products.  FDA states that the stay will be lifted when the Agency reaches its final conclusions on conditions under which sunscreen products are GRASE and not misbranded.  In the mean time, those of us in the OTC drug world will have to be satisfied with the final rule, proposed rule, ANPR, and the draft guidance.  Each is summarized below. 

Final Rule:  New Testing Methods, New Labeling

Nearly 5 years and 2,900 comments after publishing the last proposed rule for sunscreen products, FDA has published a final rule, codified in 21 C.F.R. § 201.327, to establish labeling and testing requirements for OTC sunscreen drug products marketed without an approved application.  Because FDA has still not yet made a decision on the conditions under which sunscreen drug products are GRASE, the final rule applies only to those sunscreen products that contain the ingredients specified in the stayed 1999 monograph. 

The final rule provides new test procedures that manufacturers must follow in order to label their products as “Broad Spectrum SPF” protection.  The final rule also requires labels of sunscreen drug products to bear the familiar “Drug Facts” box found on most OTC drugs and prohibits the claims “waterproof,” “sweatproof,” and “sunblock.”  The claim “water resistant” can be made for a sunscreen if the manufacturer follows the test method set forth in the final rule.  Perhaps the most interesting aspect of the final rule is that it resurrects labeling claims that use of sunscreen can prevent skin cancer and skin aging.  In the 1993 proposed monograph, FDA proposed a “sun alert” claim that explained that use of sunscreen could prevent skin cancer and skin damage.  58 Fed. Reg. 28194, 28298 (May 12, 1993).  The 1999 final monograph adopted the sun alert statement, but in 2007, FDA stated that there was insufficient evidence that sunscreen could prevent skin cancer and therefore the Agency was modifying the sun alert statement such that it would only warn consumers that UV exposure could cause cancer, not that sunscreen would prevent cancer.  72 Fed. Reg. 49070, 49089 and 49114 (Aug. 27, 2007).   Now, under the final rule, Broad Spectrum SPF products may bear the explicit claim “if used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.”  Non-Broad Spectrum products, however, may only claim to prevent sunburn. 

The final rule is effective June 18, 2012.  The compliance date for products with annual sales less than $25,000 is June 17, 2013. 

Proposed Rule:  Claims for SPF 50+

The proposed rule seeks to limit the maximum labeled SPF value for OTC sunscreen products to “50+.”  FDA explained that although the Agency received submissions demonstrating the accuracy and reproducibility of SPF tests at values as high as SPF 80, “the record continues to lack data demonstrating that sunscreen products with SPF values above 50 provide additional clinical benefit compared to SPF 50 products.”  FDA does not rule out the possibility that sunscreen could bear SPF values above 50 in the future, but states that the Agency will need data demonstrating a clinical benefit of the higher SPF values.  FDA recommends that parties interested in conducting such studies first contact FDA.  Alternatively, FDA requests comments on whether the Agency should establish a maximum SPF value for sunscreen formulations marketed under the monograph.  FDA explains that if a maximum SPF were established, a product that tests SPF above that value would no longer be permitted because, if having an SPF above 50 does not confer an additional clinical benefit, the risk benefit-assessment for those products may no longer be favorable. 

Comments to the proposed rule are due 90 days after publication. 

ANPR:  Request for Comments on Novel Dosage Forms

The ANPR seeks data to establish monograph conditions for sunscreen products, including specification of certain dosage forms.  In particular, FDA is seeking additional data or information to support adding spray sunscreen products to the monograph. Spray sunscreens have become popular in the past few years, but FDA is concerned that there is a lack of information on how consumers use spray products, how uniformly the sunscreen is applied, how frequently consumers reapply the product, whether consumers follow product directions, how rubbing the product into the skin changes the effectiveness, and how the SPF values as the product is applied compared to those under laboratory conditions.  FDA also is requesting information on the risks associated with inhaling the active sunscreen ingredients and whether toxicology studies are needed for these products.  FDA also states that it does not consider sunscreen wipes, towelettes, powders, body washes, and shampoos currently eligible for review under the OTC monograph process. 

Comments to the ANPR are due 90 days after the date of publication. 

Draft Guidance:  FDA’s Enforcement Policy

The draft guidance document, “Guidance for Industry:  Enforcement Policy- OTC Sunscreen Drug Products Marketed Without an Approved Application,” is intended to guide manufacturers who market sunscreen products that have not been approved via an NDA.  FDA states that the Agency will continue to exercise enforcement discretion for sunscreen drug products that contain active ingredients that are listed in the stayed monograph, do not make claims addressed in the final rule, comply with the requirements for OTC drugs in 21 C.F.R. Part 201 and 330.1, and follow labeling and testing requirements in the new final sunscreen regulation (21 C.F.R. § 201.327).  FDA notes that combination cosmetic/sunscreen drug products are covered by this enforcement policy. 

By 2 years after the publication date of the final rule, FDA will expect that all OTC sunscreen products marketed after publication of the rule will follow SPF testing procedures set forth in 21 C.F.R. § 201.327(i).  Although the final rule sets forth testing procedures for broad spectrum UV claims, FDA states that as long as a sunscreen product does not bear labeling claims for broad spectrum protection, the Agency will not expect sunscreens to have been tested in accordance with the new 21 C.F.R. § 201.327(j). However, FDA will take enforcement action against OTC sunscreens if the products are labeled with an SPF that was generated by a method other than that included in the 2011 final rule, 1999 final rule, or 2007 proposed rule. 

FDA will permit sunscreens to bear SPF values higher than 50 until FDA decides on the proposed rule to limit claims to “SPF 50+.”  FDA also states that while the ANPR on dosage forms is pending, FDA will permit spray dosage forms to be marketed.  However, FDA may take regulatory action against products such as wipes, towelettes, powders, body washes, and shampoos.