FDA Proposes to Designate Certain Active Ingredients in OTC Drug Products, Etc. as Generally Not Safe and Effective

Once the final rule is issued, such products would be considered misbranded in the absence of an approved new drug application (NDA).

(FDA is issuing this proposed rule because it did not receive any data and information on the subject drug products in response to its December 31, 2003 call for data and therefore has nothing to review to determine if any of the products are GRASE and not misbranded for OTC use.)

Comments are due September 17, 2008.

Rule Would Add to List of Not-GRASE Drug Products

The proposed rule would classify the following drug products containing certain listed active ingredients, that are offered OTC for certain uses, for which FDA did not receive any safety and effectiveness data and information, as not GRASE¹:

Any external analgesic drug products containing aloe vera or urea;

Any topical antimicrobial drug products containing aloe vera;

Any drug products containing urea for any labeled claims;

Ammonia as a reflex stimulant;

All skin protectant blister guard drug products;

Any skin protectant drug products labeled with claims or directions for use as a nipple protectant (previously referred to as breast creams for use when nursing), except lanolin;

Any drug products formulated as a wet dressing other than skin protectant and astringent drug products formulated and labeled in accordance with 21 CFR Part 347;

Any drug products labeled with claims or directions for the following uses:

o Bed-wetting deterrent

o Blemish remedy other than topical acne drug products formulated and labeled in accordance with 21 CFR part 333, subpart D

o Bunion remedy

o Drawing salve (for drawing or removing splinters, slivers, or similar items), except ichthammol

o Foot balm, bath, or other topical dosage forms for any ''foot'' claims (including relieving foot muscle strains and soreness from working out), other than topical antifungal drug products formulated and labeled in accordance with 21 CFR Part 333, Subpart C and certain external analgesic drug products

o Impotency cure

o Medicated bath preparation

o Nonantimicrobial skin wound cleanser (previously listed as ''detergents'' in call-for-data notices

o Topical products for treatment or prevention of male urethral problems

o Treatment or prevention of prickly heat

o Urinary acidifier

o Urinary alkalinizer

o Weight control drug products with ingredients formulated as an impregnated body wrap

o Wound wash saline

Noncompliant Products Would Require Approved NDA

Any OTC drug product that is not in compliance with 21 CFR 310.545 would be subject to regulatory action if without an approved NDA and initially introduced or initially delivered for introduction into interstate commerce after dates specified in 21 CFR 310.545 (d)(1) through (d)(52).

Proposed Rule Will Help Those Who Missed 2003 Call for Data

According to the ITC, when no data is received after a Federal Register request, it often indicates that manufacturers have little or no interest in those ingredients, have phased out or are in the process of phasing out those ingredients, or in some cases are removing the drug claims at issue from the product label. However, ITC sources state that this proposed rule will "flush out" anyone who missed the 2003 call for data.

Products for Which FDA Did Receive Information Will be Discussed in Future

The FDA will discuss in a future issue of the Federal Register the following product categories, for which data was submitted in response to the December 2003 call for data: lubricants and vaginal moisturizers, nasal moisturizers, urinary analgesics/antiseptics, wrinkle removers, lanolin as a nipple protectant, and ichthammol as a drawing salve.

¹i.e. nonmonograph

FDA contact - William E. Gilbertson (301) 796-2090

FDA proposed rule (D/N FDA-2008-N-0297, FR Pub 06/19/07) available at http://edocket.access.gpo.gov/2008/pdf/E8-13826.pdf