Petition Requests Skin Treatment GRASE For Ophthalmic Monograph Ingredient
This article was originally published in The Tan Sheet
Executive Summary
A beauty professional says an eye redness reliever containing tetrahydrozoline hydrochloride – included in FDA’s OTC monograph for ophthalmic drug products – safely and effectively controls redness from acne and other skin ailments. She requests adding the ingredient to the skin protectant drug monograph.
A beauty industry veteran cites her successful “home” experiment in asking FDA to add tetrahydrozoline hydrochloride – a vasoconstrictor currently established as GRASE for relief of eye redness – to the OTC monograph for skin protectant drug products.
In a citizen petition, Christine Oddo requests that FDA permit the ingredient’s use in cosmetic leave-on topical skin gels, creams and lotions for external face and body applications at concentrations of 0.01% to 0.05%, providing “the same relief for topical skin redness from minor irritation just as it is currently allowed for eyes.”
Oddo, doing business as Madison Co. in Redondo Beach, Calif., also asks the agency to issue a notice of enforcement policy allowing the interim marketing of the ingredient prior to the publication of a final rule amending the monograph.
According to the petition FDA received Jan. 22, the move is justified by “the long-standing and extensive use of the ingredient, the immense records of safety and efficacy of the ingredient, efficient rewards utilizing the agency’s resources in contributing to public health and wellness and extensive consumer market demand.”
Oddo identifies herself as an experienced professional in the beauty industry, having held positions in sales and marketing and product development within her own company and a contract manufacturer.
According to her personal testimony, Oddo has experimented with an eye redness reliever, applied directly to her face and mixed with various cosmetic skin care products, to treat adult acne and other skin woes that cause “extreme red bumps [that] were highly professionally and socially embarrassing.”
The experimental remedy effectively kept redness under control and enabled her to use less-drying acne medications, according to Oddo.
“In the approximately 15 years of this home practice I can self-report that there has not been one indication of irritation after use,” she says.
The OTC drug monograph for skin protectant products currently outlines conditions for which colloidal oatmeal, sodium bicarbonate and astringent active ingredient aluminum acetate, among other substances, can be used in formulas marketed in the U.S.
Ophthalmic GRASE Should Count
Tetrahydrozoline hydrochloride currently is listed in FDA’s OTC monograph for ophthalmic drug products.
Oddo suggests as a drug established as GRASE for the eye – “one of the most sensitive parts of the external human body” that “readily absorbs the redness-relieving product” – tetrahydrozoline hydrochloride should be safe and effective for topical skin application.
“It appears consistent that a drug approved and proven safe and effective for the eye would be generally considered safe and effective for topical cosmetic skin application,” she says in the petition.
The petition adds that with FDA’s “extensive knowledge of this drug and current regulations supporting it, translating these same parameters” of 0.01% to 0.05% concentrations from the [ophthalmic] monograph to the skin protectant monograph “would be an efficient utilization of Agency resources for maximum public benefit.”
According to Oddo, labeling requirements specified for the ingredient in the monograph could translate readily for use in marketing OTC skin protectant drug products on an interim basis, in advance of a final rule.
The agency currently is accepting comments on the petition, docket number FDA-2015-P-0233.
FDA acknowledged receipt of the petition in a Jan. 26 letter to Oddo, noting that acceptance of the petition does not indicate the agency will propose the requested change, a process that would start with a notice of public rulemaking.
Adding an ingredient to any OTC monograph, or in some cases finalizing an entire monograph, is a much slower and more complicated process than FDA and drug industry stakeholders expected when the agency launched its OTC Drug Review program in the 1970s for the purpose of evaluating the safety and efficacy of nonprescription drug ingredients.
FDA currently is considering comments submitted on its February 2014 notice to look at overhauling the monograph process (Also see "Without User Fees, OTC Monograph Changes Are Low Priority At FDA" - Pink Sheet, 14 Aug, 2014.).
With monograph products accounting for the majority of OTC drugs available in the U.S., improving the monograph process could affect the OTC drug marketplace more than another ongoing agency initiative looking at allowing Rx-to-OTC switches under conditions of safe use and potentially incorporating uses of technology (Also see "FDA Encourages Novel Switch Ideas, Though NSURE Remains Unsure" - Pink Sheet, 7 Nov, 2013.).