FDA, State, And Local Governments Act To Modernize The Regulation Of Sunscreen Products In The United States

On February 26, 2019, FDA published its long-awaited proposed rule, Sunscreen Products for Over-the-Counter Human Use (Proposed Rule).1 The Proposed Rule is a step towards FDA's full compliance with the mandates of the 2014 Sunscreen Innovation Act (SIA)2 and builds on the stayed 1999 Sunscreen Final Monograph3 by proposing to, among other things, formally classify the safety and effectiveness of certain active ingredients and dosage forms, update sunscreen testing and recordkeeping requirements, and address new uses of sunscreens, including the sale of combination sunscreen-insect repellant products. FDA has proposed a 90-day comment period, and comments must be submitted on or before May 28, 2019.

In addition to updating testing and recordkeeping requirements, FDA proposes to:

classify zinc oxide and titanium dioxide as Category I (Generally Recognized as Safe and Effective - GRASE) sunscreen active ingredients, including certain products made with nanotechnology; designate oil, lotion, cream, gel, butter, paste, ointment, stick, and spray sunscreen dosage forms as GRASE under the monograph (and the powder form potentially GRASE subject to FDA's receipt of additional safety and efficacy data regarding the dosage form); designate all other dosage forms, including wipes, towelettes, body washes, and shampoos as "new drugs" that are ineligible for inclusion in the monograph; establish new labeling and broad spectrum requirements (including a maximum SPF level of SPF 60+); and classify combination insect repellant-sunscreen products as Category II (not GRASE). Below, we provide an overview of the key provisions included in the Proposed Rule as well as other relevant state and city-level measures banning certain sunscreen active ingredients in Hawaii and Key West, FL. Given the increase in use of sunscreen ingredients in topical consumer products, including moisturizers and concealers, these developments are sure to impact any stakeholder in the OTC drug or personal care product industry.

1. Background

   The Proposed Rule is FDA's most recent effort to modernize the regulation of sunscreen products in the US to account for increasing use of sunscreen in consumer products. The Proposed Rule builds on numerous Federal Register notices issued over the past decade4 and attempts to close the loop on the stayed 1999 Sunscreen Final Monograph by meeting the SIA's requirement to issue a final OTC sunscreen monograph by November 29, 2019. The SIA was passed in 2014 and amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to expedite the review of nonprescription sunscreen active ingredients that were not included in the stayed 1999 Sunscreen Final Monograph. While the SIA required issuance of this Proposed Rule (plus certain guidance documents), the sunscreen active ingredients submitted under the procedures established in FDA's Time and Extent Application (TEA) notice that are being considered under processes established by the SIA are not under consideration in the Proposed Rule.5

2. Overview of Proposed Sunscreen Rule

   There are seven key takeaways in the Proposed Rule for stakeholders—(1) how FDA intends to classify 16 sunscreen active ingredients; (2) FDA's position on specific sunscreen dosage forms; (3) FDA's perspective on the use of nanomaterials and nanotechnology in sunscreen products; (4) FDA's proposed maximum labeled SPF values and broad spectrum requirements; (5) recommended labeling changes, including revisions to the products' statement of identity; (6) proposed modifications to sunscreen testing and recordkeeping requirements; and (7) FDA's proposal to classify combination insect-repellant sunscreen products as not GRASE.

   1. Classification of Active Ingredients

      Central to the Proposed Rule is FDA's safety assessment of sixteen sunscreen active ingredients that were originally included in the stayed 1999 Sunscreen Final Monograph. Following a review of publicly available data, including, but not limited to scientific literature, adverse event reports, submissions to the sunscreen monograph docket, FDA Advisory Committee Reports, and FDA and European Medicines Agency approval documents, FDA is proposing to classify the active ingredients as follows:

      Category I (GRASE) Zinc Oxide, Titanium Dioxide Category II (Not GRASE) Para-Aminobenzoic Acid (PABA), Trolamine Salicylate Category III (Insufficient Data Available to Permit Final Classification) Avobenzone, Cinoxate, Dioxybenzone, Ensulizole, Homosalate, Meradimate, Octinoxate, Octisalate, Octocrylene, Oxybenzone, Padimate O, Sulisobenzone Category I - GRASE

      FDA proposes to classify zinc oxide and titanium dioxide as GRASE. For both active ingredients, FDA's determination is based, in no small part, on existing and substantial evidence that these mineral compounds largely do not penetrate the skin (even particles on the nanoscale (1-100 nanometers)), and to the extent that "de minimis" penetration occurs, do not cause adverse health effects.6

      Category II - Not GRASE

      FDA proposes to classify para-aminobenzoic acid (PABA) and trolamine salicylate as not GRASE because the Agency has determined that the risks outweigh the benefits for the use of these active ingredients in sunscreen products. This determination should not affect the marketplace for sunscreen products or manufacturers in any measureable way because to FDA's knowledge, neither active ingredient is...