Source: https://www.federalregister.gov/documents/2003/05/07/03-11285/ingrown-toenail-relief-drug-products-for-over-the-counter-human-use
Timestamp: 2018-02-25 11:39:33
Document Index: 667682190

Matched Legal Cases: ['art 358', 'art 358', '§\u2009310', 'arts 310', 'art 358', '§\u2009358', '§\u2009330']

A Rule by the Food and Drug Administration on 05/07/2003
II. Comments Received in Response to the Proposal
https://www.federalregister.gov/d/03-11285 https://www.federalregister.gov/d/03-11285
The Food and Drug Administration (FDA) is issuing a final rule establishing conditions under which over-the-counter (OTC) ingrown toenail relief drug products containing sodium sulfide 1 percent in a gel vehicle are generally recognized as safe and effective and not misbranded. This rule also amends the regulation that lists nonmonograph active ingredients in OTC drug products for ingrown toenail relief by removing sodium sulfide from that list. This final rule is part of FDA's ongoing review of OTC drug products.
In the Federal Register of October 4, 2002 (67 FR 62218), after reviewing new data that had been submitted, FDA proposed to establish conditions under which OTC ingrown toenail relief drug products containing sodium sulfide 1 percent in a gel vehicle are generally recognized as safe and effective and not misbranded. The product is used with a retainer ring to keep the product at the area of application. The agency also proposed to amend the regulation (21 CFR 310.538) that lists nonmonograph active ingredients in OTC drug products for ingrown toenail relief by removing sodium sulfide from that list.
In response to the proposal, the agency received two comments, which are on public display in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. One comment, from a drug manufacturer, supported the agency's proposals and requested that the agency's review of the comments and publication of the final rule be completed as expeditiously as possible. The second comment, from a consumer, stated that the use of the product with a “restraining” ring as indicated should have a “green light.” The comment added that there are many people who experience the pain of an ingrown toenail, and that these products will help.
The agency concludes that the data support OTC drug monograph status for 1 percent sodium sulfide in a gel vehicle applied topically for the relief of discomfort (pain) of ingrown toenail. The product is used with a retainer ring to keep the product at the area of application. Accordingly, the agency is proposing a new monograph in part 358, subpart D (21 CFR part 358, subpart D) for ingrown toenail relief drug products that includes 1 percent sodium sulfide gel. The agency is also amending § 310.538 to state that it no longer applies to sodium sulfide.
Mandating warnings in an OTC drug monograph does not require a finding that any or all of the OTC drug products covered by the monograph actually caused an adverse event, and FDA does not so find. Nor does FDA's requirement of warnings repudiate the prior OTC drug monographs and monograph rulemakings under which the affected drug products have been lawfully marketed. Rather, as a consumer protection agency, FDA has determined that warnings are necessary to ensure that these OTC drug products continue to be safe and effective for their labeled indications under ordinary conditions of use as those terms are defined in the Federal Food, Drug, and Cosmetic Act. This judgment balances the benefits of these drug products against their potential risks (see 21 CFR 330.10(a)).
FDA's decision to act in this instance need not meet the standard of proof required to prevail in a private tort action (Glastetter v. Novartis Pharmaceuticals, Corp., 252 F.3d 986, 991 (8th Cir. 2001)). To mandate warnings, or take similar regulatory action, FDA need not show, nor do we allege, actual causation. For an expanded discussion of case law supporting FDA's authority to require such warnings, see Labeling of Diphenhydramine-Containing Drug Products for Over-the-Counter Human Use, Final Rule (67 FR 72555, December 6, 2002).
FDA has examined the impacts of this final rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 et seq.). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Under the Regulatory Flexibility Act, if a rule has a significant economic impact on a substantial number of small entities, an agency must analyze regulatory options that would minimize any significant impact of the rule on small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement of anticipated costs and benefits before proposing any rule that may result in an expenditure in any one year by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million (adjusted annually for inflation).
The agency believes that this final rule is consistent with the principles set out in Executive Order 12866 and in these two statutes. FDA has determined that the final rule is not a significant regulatory action as defined by the Executive order and so is not subject to review under the Executive order. As explained later in this section, FDA concludes that the final rule will not have a significant economic impact on a substantial number of small entities. The Unfunded Mandates Reform Act Start Printed Page 24348does not require FDA to prepare a statement of costs and benefits for this final rule, because the rule is not expected to result in any 1-year expenditure that would exceed $100 million adjusted for inflation. The current inflation adjusted statutory threshold is about $110 million.
The purpose of this final rule is to establish a monograph for ingrown toenail relief drug products for OTC human use and include sodium sulfide 1 percent in a gel vehicle in the monograph. This final rule provides for OTC availability of this type of product.
Manufacturers who wish to market this type of product have the standard costs associated with the introduction of any new product. These include preparation of labeling, stability testing, and implementing manufacturing procedures. Any cost incurred will be voluntary if manufacturers elect to market this type of product. This cost may vary from manufacturer to manufacturer; however, the burden on small manufacturers is not greater than that for large manufacturers. Manufacturers will not incur any costs related to proving safety and effectiveness of the active ingredient for this intended use.
Under the Regulatory Flexibility Act, if a rule has a significant impact on a substantial number of small entities, an agency must analyze regulatory options that would minimize any significant impact of a rule on small entities. This final rule allows manufacturers to market OTC ingrown toenail relief drug products containing sodium sulfide 1 percent in a gel vehicle without having to obtain an approved new drug application, as is currently required, and is beneficial to small entities. Thus, this final rule will not impose a significant economic burden on affected entities. Therefore, under the Regulatory Flexibility Act, the agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities. No further analysis is required.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 310 and 358 are amended as follows:
2. Section 310.538 is amended by removing the ingredient sodium sulfide in paragraph (a) and by adding paragraph (e) to read as follows:
4. Part 358 is amended by adding new subpart D, consisting of §§ 358.301 to 358.350, to read as follows:
Subpart D—Ingrown Toenail Relief Drug Products Sec.
(a) Statement of identity. The labeling of the product contains the established Start Printed Page 24349name of the product, if any, and identifies the product as an “ingrown toenail relief product” or as an “ingrown toenail discomfort reliever.”
(b) Indications. The labeling of the product states, under the heading “Use,” the following: “for temporary relief of” [select one or both of the following: 'pain' or 'discomfort'] “from ingrown toenails”. Other truthful and nonmisleading statements, describing only the use that has been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.
[FR Doc. 03-11285 Filed 5-6-03; 8:45 am]