FDA identifies ingredients to be considered non-GRASE

ROCKVILLE, Md. The Food and Drug Administration last week identified a host of ingredients and indications that will be considered not generally recognizable as safe and effective as part of a proposed rule.

Industry will have 60 days to comment on the proposed rule. According to the agency, FDA first requested data on these ingredients/indications in December 2003 as part of its ongoing review of OTC drug products.

The following ingredients and indications will be identified as non-GRASE if the rule is ratified:

• 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—bed-wetting deterrent; blemish remedy (other than topical acne drug products); bunion remedy; drawing salve (for drawing or removing splinters, slivers or similar items), except ichthammol; 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; impotency cure; medicated bath preparation; nonantimicrobial skin wound cleanse; topical products for treatment or prevention of male urethral problems; treatment or prevention of prickly heat; urinary acidifier or urinary alkalinizer; weight control drug products with ingredients formulated as an impregnated body wrap; and wound wash saline.