On February 26, 2019, the FDA published yet another additional proposed rule in the proceedings to finalize the OTC Sunscreen Monograph.
Comments on the proposed rule may be filed with the FDA within 90 days from the Federal Register publication date.
The proposed rule does the following:
- Reclassifies most of the ingredients classified in 1999 as Category I ingredients, or generally recognized as safe and effective (GRASE), as Category III ingredients, ingredients that require additional information/data to establish safety. The FDA based its determination on the significant increase in use of these sunscreen ingredients which the FDA characterized as chronic use ingredients that require additional data beyond clinical data to support safety.
- The ingredients to be reclassified are: cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, or avobenzone. The nonclinical safety testing proposed for these ingredients is largely focused on potential long-term adverse effects (such as carcinogenicity and reproductive toxicity).
- Ingredients found unsafe based on available data were aminobenzoic acid (PABA) and trolamine salicylate, which resulted in a conclusion that the risk of these ingredients outweighs their benefits. Accordingly, these ingredients will not be permitted for use in sunscreens.
- Zinc oxide and titanium dioxide were found GRASE, Category I – ingredients that are safe and effective in concentrations of up to 25 percent.
Dosage form approvals:
- The FDA found the following dosage forms to be GRASE, Category I:
- Oils, lotions, creams, gels, butters, pastes, ointments and sticks.
- Sprays – 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 will be considered Category I or GRASE.
- Powders – the FDA is proposing to make these GRASE eligible dosage forms subject to particle size restrictions.
- The FDA continues to contend that sunscreens in all other dosage forms – including wipes, towelettes, body washes and shampoos – are new drugs that require New Drug Approval before they can be marketed.
Maximum SPF and Broad Spectrum requirements:
- The FDA is proposing to increase the Maximum SPF to 60+ because evidence shows meaningful clinical benefit associated with broad spectrum sunscreen products with an SPF of 60+. Given the lack of data showing clinical significance above 60+, SPF’s over 60 cannot be claimed, but the FDA is willing to permit products with SPF values above 80. The FDA noted several concerns with high SPF products that do not pass the broad spectrum test or provide inconsistent UVA protection – the concern is excessive large dosages of UVA with no or limited A protection. The FDA is proposing:
- to require that all sunscreen products with an SPF of 15 or above label their lowest tested number;
- to satisfy the broad spectrum requirements for all products with an SPF of 15; and
- 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.
- The FDA is proposing that the Principal display panel list the active ingredients in the product.
- For products that are not Broad spectrum, there is a required label disclosure.
New Safety testing requirements to establish GRASE
The agency identified data gaps in clinical safety testing for all of the chemical screens that the agency moved from Category I to Category III status in this notice. The agency’s noted concerns were chronic use of these ingredients and lack of information on systemic absorption as there is no control over the final formulations for these sunscreen products. In addition to requiring the testing listed below, the FDA proposes to require oversight over final formulations and is requesting comments and information on final formulation.
The types of tests the agency proposes are those required for NDA’s for topical drug products: photosafety, phototoxicity and photoalleregnicity; human absorption studies; maximal usage trials, pediatric studies; carcinogenicity studies (which will require animal testing), developmental reproductive toxicity studies, and toxicokinetics studies. Some of this testing could be eliminated if absorption levels are less than the threshold value of 0.5 ng/mL. The agency described in detail the data gaps for each of the chemical screens it proposes to move to Category III, as well as the data that supported Category I status for zinc and titanium dioxide and the basis for moving trolamine salicylate and Paba to Category II.
Proposed Requirements Related to Final Formulation Testing and Recordkeeping
The FDA says data issues with some of the final formula testing confirm the requirements and notes that the party whose name is on the product label will ultimately be responsible, although some of these obligations may be delegated, with the exception of record keeping. Certain record keeping responsibilities will fall on other parties as well, including the party responsible for final product testing and certain other parties responsible for labeling.
Review of the position on combination sunscreen and bug repellent products
In the notice the FDA outlined its issues with these combination products and again called for data and comments.
The proposed effective/compliance date is November 26, 2019. Separately, the FDA will consider requests to defer further rulemaking with respect to specific sunscreen active ingredients to allow the submission of new safety and or effectiveness data if such requests are submitted to the docket within the initial 90-day comment period.