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Rx DRUG "SULFITE FREE" LABEL CLAIM IS OKAY

Executive Summary

Rx DRUG "SULFITE FREE" LABEL CLAIM IS OKAY as long as "the statement is informational and accurate," according to a final rule for sulfite warnings in the Nov. 5 Federal Register. FDA told manufacturers that if they use the "sulfite free" statement they must be sure "that their products do not contain either directly added sulfite or detectable levels of sulfites from indirect sources when tested by current state-of-the-art methods. The presence of sulfites in a product labeled as 'sulfite free' would cause the product to be misbranded." The rule was proposed after reports of adverse reactions to sulfites occurring in certain persons, especially asthmatics. The proposed rule was published in the November 19, 1985 Federal Register ("The Pink Sheet" Nov. 25, 1985, T&G-3). The warning statement for Rx drug labeling will read as follows: "Contains (insert the name of the sulfite, e.g., sodium metabisulfite), a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people." FDA received comments requesting that a sulfite warning be required on OTC drug products. The agency said that some of the comments emphasized that there "appears to be an inconsistency in the agency's rationale in the proposed rule for not including such a warning on OTC products while requiring the warning on all Rx drug products." FDA said "warnings for OTC's are probably not necessary" for people susceptible to sulfite allergic-type reactions since they are aware of the problem, "provided the presence of sulfites is declared in the ingredient statement of the package labeling." The agency noted that the Proprietary Association has adopted a policy of indicating the presence of sulfites on OTC product labels. An alternate warning statement was added for injectable epinephrine. The epinephrine warning will "inform health care professionals that the benefits of using injectable epinephrine that contains sulfite for the treatment of allergic-type reactions as well as other emergency situations outweigh possible disadvantages." The effective date for the labeling change is June 3, 1987. Products "initially introduced or initially delivered for introduction into interstate commerce" at that date will have to meet the labeling requirements. FDA's Center for Drugs & Biologics estimates that there are about 1,000 Rx drug products on the market with added sulfites. FDA calculates that the expenses for label printing and redesign, graphics redesign, and new negative preparation will cost a pharmaceutical manufacturer "approximately $60 per drug product" and the total cost to manufacturers will be $66,000 ($60 X 1,100).
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