United States: FDA Releases New Enforcement Policy For OTC Sunscreen Drug Products Marketed Without An Approved Application

Michael Werner is a Partner in Holland & Knight's Washington D.C. office

In May 2018, the Food & Drug Administration (FDA) released a new enforcement policy for over-the-counter (OTC) sunscreen drug products marketed without an approved application. While sunscreens have been commercially available since the 1940s, the FDA did not begin to regulate them until 1978. Since then, the FDA has published a handful of rules governing the marketing of sunscreens. Under the FDA's OTC monograph system, if a drug complies with a final monograph, that drug can be marketed without an FDA approved marketing application. Unfortunately, there is no final monograph for sunscreens. In the interim, the FDA has exercised its discretion when deciding whether to take enforcement action against OTC sunscreen products marketed without approved applications.

This newly released policy, which is a revised and finalized version of the FDA's previously issued 2011 policy, clearly describes the circumstances under which the FDA will exercise enforcement discretion on OTC sunscreen products marketed without approved applications. Manufacturers that market such products can avoid FDA enforcement action by complying with the guidelines in the policy. As is always the case, these guidelines merely represent the FDA's current thinking on the matter. The guidelines are not exclusive—the policy notes that a manufacturer is free to take an alternative approach as long as it satisfies the requirements of all applicable statutes and regulations.

The updated policy begins by describing the history of the FDA's regulation of sunscreens. The FDA first published an Advanced Notice of Proposed Rulemaking (ANPR) in 1978 that included recommendations on the safe and effective use of OTC sunscreen products. In 1993, the FDA published a proposed rule listing active ingredients that the FDA thought were "generally recognized as safe and effective" (GRASE) and proposing a permissible SPF value range of 2 to 30. In 1999, the FDA published a final rule (64 FR 27666) regulating the safe and effective use of sunscreen products. The rule established a sunscreen monograph listing those active ingredients the FDA considered to be GRASE, but did not address broad spectrum protection or insect repellant-sunscreen combination products. Because the FDA wanted to include labeling and testing requirements for broad spectrum protection in the final monograph, it delayed and eventually stayed the effective date of the 1999 rule. The FDA published an ANPR in 2007 requesting information on insect repellant-sunscreen combination products, and another ANPR in 2011 requesting information on what dosage forms should be included in the OTC sunscreen monograph. Also in 2011, the FDA published a new final rule (76 FR 35620) establishing labeling and testing requirements—including requirements for broad spectrum protection—for OTC sunscreen products, and also identified the types of claims that would render a covered product misbranded. Again in 2011, the FDA published a proposed rule (76 FR 35672) seeking to limit the maximum labeled SPF value to "50+."

According to the new enforcement policy, the FDA will not object to the marketing of an OTC sunscreen drug product without an approved application if the product has all of the following characteristics:

  • Contains as sunscreen active ingredients only the following ingredients or combinations of ingredients:
    • Aminobenzoic acid (PABA), 15 percent
    • Avobenzone, 3 percent
    • Cinoxate, 3 percent
    • Dioxybenzone, 3 percent
    • Ensulizole, 4 percent
    • Homosalate, 15 percent
    • Meradimate, 5 percent
    • Octinoxate, 7.5 percent
    • Octisalate, 5 percent
    • Octocrylene, 10 percent
    • Oxybenzone, 6 percent
    • Padimate O, 8 percent
    • Sulisobenzone, 10 percent
    • Titanium dioxide, 25 percent
    • Trolamine salicylate, 12 percent
    • Zinc oxide, 24 percent
  • Does not make any of the following types of claims:
    • Claims in labeling or promotional materials that suggest or imply that the use, alone, of any sunscreen reduces the risk of or prevents skin cancer or early skin aging (§ 201.327(c)(3));
    • False and misleading claims such as "sunblock," "sweatproof," and "waterproof" (§ 201.327(g));
    • Claims for instant protection or protection immediately upon application (310.545(a)(29)(ii)); or
    • Claims for "all-day" protection or extended wear claims citing a specific number of hours of protection that is inconsistent with the directions for application in § 201.327 (§ 310.545(a)(29)(ii));
  • Complies with the following requirements for OTC drugs:
    • Labeling and directions (§ 201);
    • General conditions for recognition as safe, effective and not misbranded (§ 330.1);
    • Requirements for adverse event reporting for OTC drugs (21 U.S.C. § 379aa); and
    • Provisions of the Federal Food, Drug, & Cosmetic Act addressing adulteration;
  • Follows all labeling and testing requirements for OTC sunscreens that are marketed under an approved application (§ 201.327), except as specific recommendations of this guidance address below.

However, the FDA will still object to the marketing of a sunscreen products without approved applications that:

  • Pose a potential health hazard to the consumer;
  • Are formulated in dosage forms that are not eligible for inclusion in the final sunscreen monograph, as further addressed below; or
  • Contain an insect repellent ingredient that is not registered by EPA.

The enforcement policy also provides guidance on broad spectrum testing, SPF testing, labels with SPF values higher than 50, and insect repellant-sunscreen combination products. The FDA acknowledges that some OTC sunscreen products do not provide broad spectrum (both UVA and UVB) protection. Manufacturers do not have to test such products in accordance with § 201.327(j) if those products do not bear any labeling that (1) is only permitted under § 201.327 for products that pass broad spectrum testing or (2) otherwise suggests that the product provides broad spectrum protection or helps decrease the risk of skin cancer or premature skin aging. OTC sunscreen products must bear an SPF value derived from SPF testing according to the method in § 201.327(i). While products may be labeled as "SPF 50+" or "SPF 50 plus," if the product label indicates a specific SPF value higher than 50, the manufacturer must conduct the appropriate tests described in § 201.327. For insect repellant-sunscreen combination products, the FDA advises manufacturers to comply with § 201.327 as closely as possible.

Lastly, the policy states which dosage forms will likely be included in the final monograph for OTC sunscreen products. The FDA's 2011 ANPR listed the dosage forms eligible for inclusion in the OTC sunscreen monograph:

  • Oils
  • Lotions
  • Creams
  • Gels
  • Butters
  • Pastes
  • Ointments
  • Sticks
  • Sprays

The FDA has tentatively concluded that it is safe to include these dosage forms in the future OTC sunscreen final monograph under conditions of labeling and testing included in § 201.327, except that sprays will require additional labeling. The FDA will exercise enforcement discretion for OTC sunscreen products in any of the above dosage forms (except sprays), provided such products comply with the other requirements of the enforcement policy. For sprays, the FDA will exercise enforcement discretion only if the manufacturer includes an additional warning and directions stating:

Warnings:

When using this product keep away from face to avoid breathing it.

Directions:
  • spray liberally [or generously] and spread evenly by hand 15 minutes before sun exposure. (This direction can be provided in lieu of that described in § 201.327(e)(1)(ii).)
  • hold container 4 to 6 inches from the skin to apply.
  • do not spray directly into face. Spray on hands then apply to face.
  • do not apply in windy conditions.
  • use in a well-ventilated area.

The FDA does not consider the following dosage forms eligible for potential inclusion in the OTC sunscreen monograph:

  • Wipes
  • Towelettes
  • Powders
  • Body washes
  • Shampoos

OTC sunscreen products in these dosage forms are not eligible for the enforcement discretion described in these guidelines.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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