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Consumer OTC Drugs

Bristol-Myers Squibb cites own "expert panel" to support caffeine GRAS/E status.

This article was originally published in The Tan Sheet

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Executive Summary

BRISTOL-MYERS CITES OWN "EXPERT PANEL" TO SUPPORT CAFFEINE GRAS/E STATUS in an Aug. 21 letter to FDA submitted by the company's law firm Kleinfeld, Kaplan and Becker. Bristol-Myers Squibb argues in the letter that caffeine should be designated generally recognized as safe and effective for use as an analgesic adjuvant with acetaminophen. FDA announced in April 18 "feedback" letters to analgesic manufacturers, including BMS, that caffeine will be allowed as an analgesic adjuvant with aspirin and aspirin/acetaminophen combinations in the external analgesic final rule adjuvant, but will not be permitted with acetaminophen alone ("The Tan Sheet" May 8, p. 1).

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