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Executive Summary

CAFFEINE IS ONLY INGREDIENT ALLOWED UNDER STIMULANT FINAL MONOGRAPH, published by FDA in the Feb. 29 Federal Register. "The agency has determined that the only ingredient that meets monograph conditions is caffeine," FDA stated. "All other ingredients considered in this rulemaking, i.e., ammonium chloride ginseng, and vitamins (especially vitamin E), have been determined to be nonmonograph conditions." According to the final rule, the only ingredient other than caffeine addressed by comments on the Tentative Final Monograph (TMF) for stimulants, published in June 1978, was ammonium chloride, classified as Category II. The comment requested that a combination of ammonium chloride and caffeine be addressed in the Miscellaneous Internal Drug Products rulemaking, noting that the ammonium chloride component is intended to act as a diuretic, not a stimulant, for relief of premenstrual symptoms. Thompson Medical markets a premenstrual relief product, Aqua-Ban, containing 325 mg ammonium chloride and 100 mg caffeine. Responding, FDA said it "accepts the comment's explanation that ammonium chloride was not intended for use as a stimulant drug ingredient, but rather as a diuretic, and therefore finds no need to classify ammonium chloride in Category II for use as a stimulant." The agency said it "will state its position on the combination of ammonium chloride and caffeine for relief of premenstrual symptoms in the TFM for OTC Menstrual Drug Products, to be published in a future issue of the Federal Register." Overall, the final monograph contains few substantive changes from the TFM. The rule revises the wording of warning statements and adds the term "alertness aid" as an allowable statement of identity. Under the final rule, two warnings that had been proposed are combined to read: "The recommended dose of this product [100 to 200 mg] contains about as much caffeine as a cup of coffee. Limit use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat." Language in the proposed rule had warned of "disturbances in heart rate and rhythm called palpitations." FDA said it was changing the statement to "rapid heart beat" because "the agency believes this language is more readily understandable and potentially less disturbing to consumers." An additional warning required by the rule reads: "For occasional use only. Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or continues to recur, consult a [doctor or physician]." As proposed, the warning would have instructed consumers to consult a physician if symptoms persisted continuously for more than two weeks. FDA said it "finds no basis for specifying a time period of more than two weeks in this instance and concludes that it is more helpful to advise consumers to consult a doctor if fatigue or drowsiness persists or continues to recur." Under the monograph, "stimulant" or "alertness aid" products may carry the indication: "Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness." OTC caffeine products on the market include: Bristol-Myers' Nodoz (100 mg), Thompson Medical's Caffedrine (200 mg timed release) and Quick-Pep (150 mg), Jeffrey Martin's Wakoz (200 mg), Norcliff Thayer's Tirend (100 mg) and Beecham's Vivarin (200 mg), which also contains 150 mg dextrose.

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