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FDA Offers Draft Guidance on Enforcement Discretion for OTC Sunscreen Drug Products, Bloomberg Law Reports®

Friday, June 17, 2011
Draft Guidance for Industry on Enforcement Policy for Over-the-Counter Sunscreen Drug Products Marketed Without an Approved Application; Notice of Availability, 76 Fed. Reg. 35665 (June 17, 2011) In an effort to address industry concerns about the approach of the Food and Drug Administration (FDA) in regulating over-the-counter (OTC) sunscreen drug products, the FDA announced the availability of draft guidance entitled “Enforcement Policy — OTC Sunscreen Drug Products Marketed Without an Approved Application.” The draft guidance explains the FDA’s thinking on enforcement with respect to OTC sunscreen drug products that contain active ingredients or combinations of active ingredients that were labeled “generally recognized as safe and effective” in a 2004 final rule on sunscreen, and that are marketed without an approved new drug application (NDA).

No Final Monograph

The formulation of rules governing OTC sunscreen products poses complex challenges for both the FDA and the products’ manufacturers. The FDA has been actively considering options for regulating sunscreen drug products since at least 1978, but never finalized a monograph. The FDA included a sunscreen monograph in a final rule published in 1999, but subsequently stayed the effective date of the rule, and the monograph, indefinitely. Without a final monograph, OTC sunscreen drug products for which manufacturers do not have an approved NDA under 21 U.S.C. § 355 (which would otherwise be required due to the presence of certain active ingredients) are marketed under the FDA’s enforcement discretion.

FDA Enforcement Policies

The draft guidance separately addresses the FDA’s enforcement policy for the following categories of OTC sunscreen drug products: (1) products subject to 21 C.F.R. § 327 (see Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use, 76 Fed. Reg. 35620 (June 17, 2011)), which are characterized by their level of broad spectrum SPF protection; (2) products in dosage forms, including sprays; and (3) products containing an insect repellant active ingredient registered by the U.S. Environmental Protection Agency (EPA). The draft guidance also clarifies that, pursuant to 21 C.F.R. § 330.14, some sunscreen drug products are not covered by the enforcement discretion and may not be marketed without an approved NDA.

SPF Protection

With respect to OTC sunscreen drug products that bear an SPF value and are marketed as “Broad Spectrum,” the draft guidance relies on the final regulations at 21 C.F.R. § 201.327, which were published in a final rule simultaneously with the release of the draft guidance. The draft guidance emphasizes that in order to fall under the FDA’s enforcement discretion, a product bearing an SPF value must have been tested and labeled according to the methods and standards set forth in § 201.327. In addition, the draft guidance addresses the use of SPF values higher than 50, which is the subject of a proposed rule that was published concurrently with the final rule and the draft guidance. Under the proposed rule, no numbers higher than 50 may be used; rather, products would have to be labeled as “SPF 50+” or “SPF 50 plus.” The draft guidance states that the FDA will exercise its enforcement discretion for any product that claims to have an SPF value of higher than 50 until the proposed rule is finalized.

Dosage Forms

Manufacturers of OTC sunscreen drug products use various dosage forms for their products, including oils, lotions, creams, gels, butters, pastes, ointments, sticks and sprays. The FDA intends to include all of these dosage forms—except for sprays—in a final monograph and, as such, will exercise its enforcement discretion with respect to products using any of the dosage forms until that time. With regard to sprays, the guidance suggests that there is currently not enough evidence to support a conclusion that they are safe and effective. Accordingly, the FDA has requested comments regarding the use of sprays in OTC sunscreen drug products, but the draft guidance states that, until the publication of a final monograph (which may or may not allow for sprays), the FDA will exercise its enforcement discretion for sprays if the labeling contains additional warnings and directions specified in the draft guidance. Significantly, the FDA warns that dosage forms such as wipes, towelettes, powders, body washers and shampoos “remain liable to regulatory action.” Draft Guidance at 8.

Insect Repellant

The guidance document advises manufacturers of OTC sunscreen drug products that contain insect repellant registered with the EPA to comply with the labeling and other requirements of § 201.327. The FDA will accept comments on the draft guidance until August 16, 2011.

Legal Topics:

Pharmaceuticals, Medical Devices & Biologics FDA Approval

Industry Topics:

Health & Medical Personal Care Products

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