FDA is proposing to amend the Over-the-Counter (OTC) Monograph which covers sunscreen drug products for OTC human use. The public has until November 12, 2021 to submit comments on the impact the proposed changes may have on consumers and industry. This blog provides background on why FDA is considering such changes and discusses FDA’s newly deemed final order for OTC sunscreens as well as the changes included in the proposed order for sunscreens. Industry is encouraged to contact Diaz Trade Law to assess the implications of the proposed changes on its products and to assist in drafting and submitting comments to FDA.

Why is FDA Taking New Steps to Enhance Sunscreen Safety?

The 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act reformed and modernized the way FDA regulates certain OTC monograph drugs, including sunscreen.

The CARES Act replaced the rulemaking process for OTC monograph drugs with an administrative order process for issuing, revising, and amending the OTC monographs.  The administrative order process gives FDA new tools to help revise the OTC monographs as science changes, innovation progresses, new data becomes available, or emerging safety signals arise.

For sunscreens specifically, in addition to establishing a deemed final order, the CARES Act requires FDA to issue a proposed order to amend and revise the deemed final order for sunscreens. The FDA believes that most sunscreens on the market will be in compliance with the deemed final order because the provisions are nearly identical to the pre-CARES Act marketing conditions for sunscreens.

As background, an OTC monograph establishes conditions, such as active ingredients, uses (indications), doses, labeling, and testing, under which an OTC drug is “generally recognized as safe and effective” (“GRASE”) and can be marketed without a new drug application and FDA pre-market approval.

FDA’s Newly Deemed Final Order

The deemed final order for sunscreens includes technical amendments to facilitate the combination of 21 CFR part 352 and 21 CFR 201.327 into one order, including updates to headings, numbering, and cross-references, and to use the current established names for active ingredients as set forth in the 1999 final monograph regulation for OTC sunscreen products, which never took effect, and the labeling and effectiveness requirements from a final 2011 labeling and effectiveness testing rule.

The deemed final order largely corresponds to the approach of an FDA sunscreen enforcement policy guidance, which had been in place before the CARES Act because the sunscreen monograph was not in effect.

The final order sets forth the following conditions:

  • M020.1 Scope An over-the-counter (OTC) sunscreen drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this OTC monograph and each general condition established in 21 CFR 330.1.
  • M020.10 Sunscreen active ingredients The active ingredient of the product consists of any of the following, within the concentration specified for each ingredient, and the finished product provides a minimum sun protection factor (SPF) value of not less than 2 as measured by the testing procedures established in § M020.80 (the ingredients in bold are being questioned by FDA in the proposed order – discussed below):

(a) Aminobenzoic acid (PABA) up to 15 percent.

(b) Avobenzone up to 3 percent.

(c) Cinoxate up to 3 percent.

(d) Dioxybenzone up to 3 percent.

(e) Ensulizole8 up to 4 percent.

(f) Homosalate up to 15 percent.

(g) Meradimate9 up to 5 percent.

(h) Octinoxate10 up to 7.5 percent.

(i) Octisalate11 up to 5 percent.

(j) Octocrylene up to 10 percent.

(k) Oxybenzone up to 6 percent.

(l) Padimate O up to 8 percent.

(m) Sulisobenzone up to 10 percent.

(n) Titanium dioxide up to 25 percent.

(o) Trolamine salicylate up to 12 percent.

(p) Zinc oxide up to 25 percent

  • M020.50 Labeling of sunscreen drug products
    • Principal display panel. Must have statement of identity (sunscreen), Effectiveness claim (broad spectrum test), and Water resistance statements.
    • Informational panel. Must have Active Ingredients, Indications (uses), Warnings, Directions, Other information.
    • False and misleading claims. There are claims that would be false and/or misleading on sunscreen products. These claims include but are not limited to the following: “Sunblock,” “sweatproof,” and “waterproof.” These or similar claims will cause the product to be misbranded under section 502 of the FD&C Act.
  • M020.80 Sun Protection Factor (SPF) test procedure
    • Detailed testing procedures are included in the final order.

Importantly, sunscreens in all dosage forms other than oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder currently require an application approved under section 505 of the FD&C Act in order to be marketed. Dosage forms that cannot currently be legally marketed without an approved application (or a final order issued under 505G) include sunscreen wipes, towelettes, body washes, and shampoos.

FDA’s Proposed Order For Sunscreens

The proposed order sets out changes to final 2011 labeling regulation requirements to bring them up to date with the current science. When finalized, the proposed order will fully replace the deemed final order with new requirements for sunscreens. We outlined the changes in our 2019 blog “Here are the Major Changes FDA is Proposing to Make to the Sunscreen Rule!” Since FDA has transitioned from proposed rulings to proposed orders under the CARES Act, FDA is now following the proposed order process – bottom line the 2019 proposed ruling and now the 2021 proposed order have the same substantive changes to the sunscreen monograph.

Difference Between Differences Between the Sunscreen Deemed Final Order and The Proposed Order.

Below are a few key examples and short explanations of the differences.

  • Maximum SPF:
    • The deemed final order does not impose an upper limit on SPF values.
    • The proposed order, in contrast, proposes a maximum labeled SPF of 60+ and proposes a maximum on the formulated SPF value of a sunscreen.
  • Active ingredients:
    • The deemed final order makes sunscreens containing 16 specified sunscreen active ingredients GRASE by incorporating the ingredients from the (not in effect) 1999 sunscreen monograph.
    • However, the proposed order proposes:
      • GRASE status for sunscreens containing: zinc oxide and titanium dioxide
      • NOT GRASE status for sunscreens containing:
        • aminobenzoic acid and trolamine salicylate because of data showing safety issues;
        • cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone because of inadequate data to support a safety finding.
  • Broad spectrum requirements:
    • Consistent with the requirements in the labeling and effectiveness rule for sunscreens issued in 2011, the deemed final order does not require broad spectrum testing, but it creates an optional broad spectrum labeling claim and broad spectrum testing that is required to include this claim on labeling.
    • To address the growing evidence of significant harms associated with UVA exposure, the proposed order proposes a requirement that all sunscreens with SPF values of 15 and above satisfy broad spectrum requirements.

What Should Comments include:

FDA will consider the on-time comments received on the 2019 proposed rule as comments submitted on this proposed order. FDA is asking people not to resubmit the same comments, or rewrites of the same comments, to the proposed order if they submitted those comments timely during the comment period for the 2019 proposed rule. This will make things easier for both the commenters and for FDA and will help keep the process moving quickly. In addition, this proposed order gives the public an opportunity to submit new information that has become available since the comment period closed on the 2019 proposed rule.

Diaz Trade Law attorneys have vast experience in assisting companies in complying with FDA OTC monographs as well as submitting effective comments to federal agencies. Contact us at info@diaztradelaw today to assist in assessing the impacts of the proposed order on your sunscreen products and voicing your concerns to FDA.