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Executive Summary

The alcohol content of over-the-counter systemic medications should not exceed 5%-10% for individuals over 12 years of age, FDA's OTC Drugs Advisory Committee concluded at its Dec. 17 meeting in Bethesda, Md. For children between six and 12 years of age, the advisory committee recommended that alcohol content in OTC medications should range from .5% to 5%. For children under six, the committee recommended that OTC products be "alcohol free" (.5% or less). The advisory body emphasized that for all age groups, OTC firms should attempt to formulate their products so that alcohol content falls at the lower end of the recommended range. Although no formal vote was taken, there was a consensus among the committee members on the alcohol limits. The committee also agreed that a statement indicating that an OTC medication contains alcohol should be displayed "on the front of the [package] where it's easily seen by the consumer, boldly a type and contrast that makes it clearly identifiable," committee member Joseph Veltri, Intermountain Regional Poison Control Center, Salt Lake City, said. At the request of FDA, the second day of the advisory committee's Dec. 16-17 inaugural meeting was exclusively devoted to discussing whether limits should be placed on the amount of alcohol in OTC systemic drugs. After deliberation on the issue, the advisory committee came to alcohol content recommendations similar to those proposed by the Nonprescription Drug Manufacturers Association earlier at the Dec. 17 session. NDMA Senior VP and Director of Science & Technology William Soller, PhD, noted that in response to FDA concerns about alcohol content in OTC drugs, the association has instituted a voluntary program for its members that establishes "age-related alcohol content limits for OTC medications intended for oral ingestion." Under the NDMA program, alcohol content in OTC-monographed drugs would be limited to "up to and including 10% alcohol" for individuals 12 years old and over, "except in cases where, for known formulation reasons, higher concentrations of alcohol must be used" such as in drugs derived from plant extracts, an NDMA position paper states. OTC-monographed products intended for oral ingestion by children ages six to 12 may contain up to 5% alcohol, NDMA said, and OTCs intended for use by children under six should be "alcohol free" (less than .5% alcohol). Companies with affected products intend to make these changes "as soon as practicable," NDMA noted, with the goal for voluntary compliance with the alcohol limits slated for November 1993. The NDMA voluntary program also maps out warning statements for alcohol-containing product labeling. For example, "directions for use of adult OTC monographed products containing greater than 5% alcohol and not more than 10% alcohol should convey that physician supervision is recommended for children less than 12 years of age," NDMA suggested. For pediatric OTC-monographed products with greater than .5% alcohol, directions for use should state that physician supervision is recommended for children less than six years of age. The goal for implementing the segment of the program involving voluntary warning labels is December 1994, NDMA said. Soller repeated a long-standing NDMA position that alcohol is a well-recognized pharmaceutical excipient with "a long history of safe use" as a solvent, preservative and organoleptic agent. He added that review of consumer experience with alcohol-containing, orally-ingested OTCs supports the safety of the products and the continued availability of alcohol as an OTC excipient. Although the committee's ultimate recommendations on alcohol content limits assimilated the NDMA position, the group initially considered more stringent alcohol ceilings of 5% for adults and .5% for children under 12. However, the group's industry liaison, Edward Marlowe, PhD, VP-research at Clairol, convinced committee members that up to 10% alcohol content "gives the industry some flexibility to design some excellent formulations with high compliance by consumers." Marlowe explained that there are many factors that cause certain products to require higher alcohol levels. For example, he noted that some firms do not have "very sophisticated water- treatment programs" and therefore "have to build in more preservative capacity in [their OTC drug] formulation" through the use of alcohol. OTC drug formulators also use alcohol to "assure that the product maintains its stability over the shelf life, including the microbiological integrity of the product," and "to ensure that the flavor system is stable over that period of time," Marlowe explained. Maintaining the flavor of the medication is crucial to consumer compliance with product labeling, he asserted, especially in pediatric and geriatric populations. Marlowe's suggestions met with resistance from committee member Alan Sinaiko, MD, University of Minnesota Medical School. Sinaiko, a professor of pediatrics who supported the idea of .5% alcohol levels for all age groups, asked NDMA's Soller "whether you would be willing as an organization to get" data on the effects of alcohol-containing OTC medications in children under 12, an area where Sinaiko said "there really are no data." In response to Soller's remark that there are "concerns as to which [institutional review board] would approve the use of alcohol on children of that age," Sinaiko complained of the "reluctance to deal with studies" of pediatric populations due to an "unjustified fear of liability and IRBs." He added that "we're not talking here about giving children alcohol," but rather "setting up studies where you use the over-the-counter preparations currently on the market." Sinaiko then asked the committee to "put off this decision" on limiting alcohol levels in OTC drugs "for a year or eight months" until data on pediatric populations can be gathered. Striking a compromise, Elizabeth Connell, MD, Emory University School of Medicine, declared that "we ought to vote today" on alcohol content limits, but "at the same time concede to the fact that we don't know very much" on the effects of alcohol-containing OTCs on children. FDA or industry should be asked to "formulate a protocol to evaluate the questions that were raised" on pediatric populations "and get back to us about the feasibility" of conducting such studies, Connell said. She also officially suggested changing the original proposal of a 5% alcohol content ceiling for adult formulations to 5%-10% alcohol. Marcus Reidenberg, MD, New York Hospital-Cornell Medical Center, agreed with Connell, pointing out that "if we were to recommend [alcohol content limits] today rather than putting it off, perhaps that would accelerate the process of implementing" alcohol limits. The advisory group decided to discuss at a future meeting a potential warning about the concurrent use of acetaminophen and alcohol. Michael Weintraub, MD, an FDA consultant and director-apparent of FDA's Office of OTC Drug Evaluation, said the agency is "in the process now of rewriting the rulings about acetaminophen...and alcohol toxicity." In 1989, Whitehall Labs proposed a label warning that liver damage may result from the use of acetaminophen and heavy alcohol consumption ("The Pink Sheet" Dec. 4, 1989, T&G- 15). Weintraub noted that a "large-scale...epidemiologic survey," which "we will have information on in the very near future," will "add to our rulemaking" on acetaminophen and alcohol. FDA will "probably end up bringing that [issue] back to the committee," he said. (ITEM 150)[EDITOR's NOTE: A videotape recording of the two-day OTC Drugs Advisory Committee meeting is available from F-D-C Reports. Contact Amy Burd at (301) 657-9830, ext. 263.]

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