On February 26 2019, the United States Food and Drug Administration (FDA) proposed a rule that would alter the regulations associated with the manufacturing and selling of sunscreen, as well as other sun-care related products. Since the closing of the comment period on May 28th, 2019, FDA has received over one thousand comments from industry players voicing their concern over various aspects of the proposed measures.

The proposed rule was issued as part of the regulatory proceeding to put into effect a final monograph for nonprescription, OTC sunscreen drug products under the OTC Drug Review. An OTC monograph establishes conditions under which certain OTC drugs may be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE) and not misbranded. The proposed rule classifies active ingredients and other conditions as:

  • Category I (proposed to be GRASE and not misbranded),
  • Category II (proposed to be not GRASE or to be misbranded), or
  • Category III (additional data needed).

The proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded. Due to the changed conditions in the nearly 20 years since publication of the final rule ‘‘Sunscreen Drug Products for Over the Counter Human Use’’ (64 FR 27666, May 21, 1999) (nowstayed) (Stayed 1999 Final Monograph) have meant that additional safety data are now needed to establish that certain of the active ingredients listed in the Stayed 1999 Final Monograph are GRASE for use in sunscreen products. FDA generally intends to follow the current enforcement approach.

We can anticipate news or issuance of a final OTC sunscreen monograph by November 26, 2019 as the SIA calls for FDA to issue a final OTC sunscreen monograph to be effective within 5 years of enactment of the SIA, or by November 26, 2019 (section 586E(a) of the FD&C Act).

FDA is addressing multiple conditions of use applicable to sunscreen monograph products, including both the effectiveness of various SPF values and all marketed sunscreen dosage forms (and intends to do so in the final rule as well).

Below outline the 7 major provisions of the proposed rule:

  1. Proposed GRASE Status of Active Ingredients Listed in the Stayed 1999 Final Monograph
  • FDA’s approach to the clinical safety evaluation of OTC sunscreen active ingredients is based on FDA’s current scientific understanding regarding the safety evaluation of topical drug products for chronic use and involve topical safety studies (irritation, sensitization, and photo safety); bioavailability (absorption); and valuation of adverse events observed in clinical studies).
  • FDA’s approach to the nonclinical safety evaluation reflected in the proposed rule is largely focused on potential long-term adverse effects or effects not otherwise readily detected from human use (i.e., carcinogenicity and reproductive toxicity).
  • Results of Current evaluation for ingredients listed in the Stayed 1999 Final Monograph:
    • Category I: Sufficient safety data on both zinc oxide and titanium dioxide to support a proposal that sunscreen products containing these ingredients (at concentrations of up to 25 percent) would be GRASE, FDA is proposing that these ingredients are Category I.
    • Category II: Safety data for aminobenzoic acid (PABA) and trolamine salicylate, however, has caused FDA to conclude that the risks associated with use of these active ingredients in sunscreen products outweigh their benefits. In the case of trolamine salicylate, these risks include the potential for serious detrimental health effects (including bleeding) caused by the anti-coagulation effects of salicylic acid and increased risk of salicylate toxicity when this ingredient is used in sunscreens. For PABA, the risks include significant rates of allergic and photoallergic skin reactions, as well as cross-sensitization with structurally similar compounds. Accordingly, FDA is proposing that these two ingredients are Category II.
    • Category III: Because the public record does not currently contain sufficient data to support positive GRASE determinations for cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, or avobenzone, FDA is proposing that these ingredients are Category III.
      • The significant systemic availability of oxybenzone, coupled with a lack of data evaluating the full extent of its absorption potential, is a concern to FDA, among other reasons, because of questions raised in the published literature regarding the potential for endocrine activity in connection with systemic oxybenzone exposure. Nearly all of these sunscreen active ingredients also have limited or no data characterizing their absorption.
  1. Proposed Requirements Related to Dosage Forms

 FDA is proposing the following dosage forms as:

  • Category I: Oils, lotions, creams, gels, butters, pastes, ointments, and sticks. As well as spray sunscreens, subject to testing necessary to minimize potential risks from unintended inhalation (particle size restrictions) and flammability (flammability and drying time testing), together with related labeling requirements.
  • Category III: sunscreen powders – subject to particle size restrictions if found to be GRASE will be included in the final monograph.
  • FDA is proposing that sunscreens in all other dosage forms—including wipes, towelettes, body washes, and shampoos—are new drugs because FDA did not receive data showing that they were marketed prior to 1972, as required for inclusion in the monograph.
  1. Proposed Maximum Sun Protection Factor and Broad Spectrum Requirements

 FDA is now proposing

    • To raise the maximum labeled SPF value to SPF 60+. Given the lack of data showing that sunscreens with SPF values above 60 provide additional meaningful clinical benefit, FDA is proposing not to allow labeled SPF values higher than 60+.
    • To permit the marketing of sunscreen products formulated with SPF values up to 80.
    • Not to allow the marketing (without an approved NDA) of sunscreen products with SPF values above SPF 80.
    • Require that all sunscreen products with SPF values of 15 and above satisfy broad spectrum requirements.
    • To add to the current broad spectrum test a requirement that broad spectrum products meet a UVA I/UV ratio of 0.7 or higher.
    • Sunscreens with SPF 2 to 14 are not required to pass the revised broad spectrum test.
    • To require that sunscreen products with SPF values of 15 or above be labeled with an SPF number corresponding to the lowest number in a range of tested SPF results. For example, sunscreens testing at SPF 15–19 would be labeled ‘‘SPF 15’’; those testing at 40–49 would be labeled ‘‘SPF 40.’’
    • That sunscreens testing at SPF 30 or more be labeled in increments of 10 (i.e., SPF 30, SPF 40, SPF 50, with a proposed maximum of SPF 60+), that sunscreens testing at SPF 15 to 29 be labeled in increments of 5 (i.e., SPF 15, SPF 20, SPF 25), and that the requirement that labeled SPF values correspond to ranges (rather than precise numerical values) is not necessary below SPF 15.
  1. Proposed PDP Labeling Requirement
  • FDA proposing to partially revise the current requirements for information that must appear on the principal display panel (PDP) of sunscreen products.
    • The PDP is the part of a product label that is most likely to be viewed or examined when the product is displayed for retail sale.
  • A major feature of the PDP is the statement of identity (SOI). FDA is proposing that the SOI consist of an alphabetical listing of the sunscreen active ingredients in the product, followed by ‘‘Sunscreen’’ and the product’s dosage form (such as lotion or spray).
    • This information would supplement other important elements of the PDP (e.g., SPF, broad spectrum, and water resistance information).
    • FDA believes/ argues that permitting consumers to more readily compare products and either select or avoid a given product accordingly. For sunscreen products that have not been shown to help prevent skin cancer or early skin aging caused by the sun, the SPF statement would be followed by an asterisk (*) directing consumers to see the ‘‘Skin Cancer/Skin Aging alert’’ elsewhere we are revising the
    • FDA is also revising the format requirements for the SPF, broad spectrum, and water resistance statements on the PDP.
  1. Proposed Requirements Related to Final Formulation Testing Processes and Recordkeeping
  • To ensure that FDA can assess compliance with our regulations, FDA is proposing to require records of required final formulation testing of sunscreen products to be maintained for 1 year after the product expiration date, or, if the product is exempt from expiration dating (as most sunscreens are), for 3 years after distribution of the last lot labeled in reliance on that testing.
  • In addition, FDA is proposing to require responsible persons to keep records of sunscreen formulation testing, and clarifying that required records would be subject to FDA inspection.
  • FDA is also proposing a number of revisions to our labeling and testing regulations designed to clarify FDA expectations about clinical final formulation testing processes and to ensure that the testing of marketed sunscreen products is conducted in a manner that both protects human subjects and produces reliable results.
  1. Proposed Status of Sunscreen-Insect Repellent Combination Products
  • The proposed rule also addresses sunscreen-insect repellent products, which are jointly regulated by FDA as sunscreen drugs and by the Environmental Protection Agency (EPA) as pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).
  • FDA is proposing to classify these products as Category II as DEET may increase absorption of components. 
  1. Proposed Actions to Effectuate Lifting of Stay and Harmonize Impacted Regulations
  • FDA is proposing to lift the stay on the 1999 Final Monograph and have proposed revisions to applicable regulations necessary to effectuate the lifting of the stay and to harmonize any impacted regulations.

 DTL assists clients in complying with FDA regulations. Contact us today to for a label review and to explain in detail the proposed changes! Our Customs and International Trade Law attorneys are available at 305-456-3830 or info@diaztradelaw.com.