Daily Rules, Proposed Rules, and Notices of the Federal Government
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To ensure more timely processing of comments, we are no longer accepting
In November 2007, we received a TEA (Ref. 1) requesting that SSOS be eligible for review under our OTC dandruff, seborrheic dermatitis, and psoriasis monograph (21 CFR part 358 subpart H). In February 2008, we received a supplement to the TEA, which included data and information clarifying some points in the TEA (Ref. 2). After reviewing the TEA and its supplement, we believe that it includes adequate data demonstrating that SSOS has been marketed for a material time and to a material extent as required by § 330.14 (21 CFR 330.14) (Ref. 3). SSOS-containing products have been marketed directly to consumers for over 5 continuous years in 26 countries, with an estimated 21 million dosage units marketed in 34 countries.
The applicant requested that SSOS be indicated for use to treat dandruff and psoriasis, in rinse-off and leave-on formulations. However, nearly all of the submitted marketing data concerns SSOS in rinse-off formulations for dandruff treatment. More marketing experience of SSOS in leave-on formulations for dandruff treatment would be necessary to find SSOS eligible in leave-on formulations. SSOS in leave-on formulations does not meet the “material extent” requirement of § 330.14(b)(2) and section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321). Only 2 to 4 million dosage units of SSOS in leave-on formulations have been sold, which is inadequate compared to the number of dosage units sold for other conditions found eligible for inclusion in the OTC drug monograph system via the TEA process (tens of millions). Therefore, we conclude that SSOS, 0.5 to 2.0 percent in rinse-off formulations for dandruff treatment, is eligible for inclusion in the OTC dandruff, seborrheic dermatitis, and psoriasis monograph.
We invite all interested persons to submit data and information on the safety and effectiveness of SSOS in order for us to determine whether it is GRASE and not misbranded under recommended conditions of OTC use (see § 330.14(f)). The data submitted should include animal and human studies that meet current scientific standards. The TEA does not include an official or proposed United States Pharmacopeia-National Formulary (USP-NF) drug monograph. According to § 330.14(i), an official or proposed USP-NF monograph for each ingredient must also be included as part of the safety and effectiveness data for this ingredient.
Under § 330.14(h), any product containing SSOS may not be marketed as an OTC drug in the United States at this time unless it is the subject of an approved new drug application or abbreviated new drug application.
The following references are on display in the Division of Dockets Management (see
1. TEA for Sodium Shale Oil Sulfonate (SSOS) Submitted by DOW Pharmaceutical Sciences, Inc., dated November 30, 2007.
2. Supplement to the SSOS TEA Submitted by DOW Pharmaceutical Sciences, Inc., dated February 1, 2008.
3. FDA's evaluation of the TEA for SSOS.