Each is summarized below. Final Rule: New Testing Methods, New LabelingNearly 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.

er the non-final OTC monograph proceedings for OTC skin bleaching drug products, they now must be removed from the market within 180 days of the enactment of the CARES Act (i.e., by September 23, 2020), unless FDA issues an administrative order directing otherwise. By contrast, the most recently applicable proposed classification issued for benzalkonium chloride, ethyl alcohol, and isopropyl alcohol hand sanitizers was the proposal that such products be classified as Category III (i.e., lacking sufficient data on safety or efficacy to permit classification) in an amended TFM issued in 2016; such products therefore may remain on the market unless and until FDA issues a final administrative order determining that the drug is not GRASE. (With respect to sunscreen drugs, the CARES Act provides that sunscreens will be deemed GRASE if they conform to the final monograph issued in 1999, “except that the applicable requirements governing effectiveness and labeling shall be those specified in” 21 C.F.R. § 201.327.)The statute also outlines a process under which minor changes in the dosage form of an OTC drug can be implemented without having to obtain an administrative order. Under this procedure-for-minor-changes process, the manufacturer must conduct studies showing that the change “will not affect the safety or effectiveness of the drug” and “will not materially affect the extent of absorption or exposure to the active ingredient,” and then provide the information supporting the change to FDA upon request.

Presently existing final monographs and TFMs will be deemed to be final Administrative Orders, as will the current regulation on disallowed OTC ingredients (21 CFR § 310.545). For sunscreen products, the Administrative Order shall implement the existing monograph conditions at 21 CFR part 352 and 21 CFR 201.327. Further details on how the new process will work shall be developed via FDA guidance documents.

Among the particularly interesting issues covered are sunscreen spray dosage forms which have become extremely popular in the past decade. FDA clarifies that it will exercise enforcement discretion for sunscreen spray stating that “pending further rulemaking action on [sunscreen sprays],” it does not intend to object if manufactures include the warnings and directions discussed in the 2011 ANPR, including variations on the labeling regulation at 21 CFR § 201.327(e)(1)(ii). The specific warnings and directions are laid out in the Draft Enforcement Policy.

Whether pediatric studies are required will depend on the characteristic of the ingredient.Efficacy testing on the ingredient should be done in accordance with the procedures described in FDA’s regulation for SPF testing of monograph products, 21 C.F.R. 201.327(i).One novel issue is FDA’s discussion on possible requirement for final formulation testing.

76 Fed. Reg. 35620-21 (Jun. 17, 2011) (Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-the-Counter Human Use). Significantly, these regulations mandate that over-the-counter sunscreen labels state the SPF value resulting from the detailed testing procedure described in the regulation. 21 C.F.R. § 201.327(a)(1) & (I) (describing testing procedure to arrive at appropriate SPF values and providing that labels “shall” state the SPF value). Addressing the plaintiff’s proposal for a label disclaimer about the effectiveness of high SPF sunscreens, the court found that this would “plainly add[ ] to and is not identical with the FDA’s requirements, [and thus] is expressly pre-empted.”