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Executive Summary

FDA SODIUM LABELING REQUIREMENTS FOR PRESCRIPTION DRUGS RECOMMENDED by FDA Division of Anti-Infective Drugs staffers in July 23 comments on the agency's proposed rulemaking on sodium labeling for OTC drugs. "We feel that the sodium content information should be readily available to the prescribing physician when prescription medications are used as well as to the consumer selecting an over-the-counter medication," the letter states. The FDAers pointed out that "physicians treating patients on sodium-restricted diets need to be cognizant of the amounts of sodium in prescribing medications, especially when it is deemed necessary to increase the daily dose of a medication and when patients are receiving more than one drug concomitantly." The proposed rule, published in the April 25 Federal Register, would require that "the sodium content of all orally administered OTC drug products . . . be included in labeling when the product contains 5 mg or more sodium per a single recommended dose" ("The Pink Sheet" April 29, T&G-1). The rule also calls for oral OTC drugs having more than 140 mg sodium in the maximum daily dose to be labeled with a warning that individuals who are on a sodium- restricted diet should not take the product unless directed by a doctor. The staffers noted that sodium salts are components of brandname and generic drugs, but "the sources for sodium content information that physicians rely upon are incomplete." They added that brandname and generic drugs "may contain different amounts of sodium." Information on sodium content should include "the total sodium in mEq (milliequivalents) and mg per dosage unit, average daily intake, and maximum daily intake recommended, if applicable, and it should include the sodium content from both active and inactive ingredients and from all recommended diluents," the comments say. "Manufacturers should be encouraged to voluntarily produce drug products with lower sodium content." In July 24 comments on the proposed rule, the Nonprescription Drug Manufacturers Association said its members "agree in principle" to identify the quantity of sodium in labeling of "certain" OTC drug products. However, the association suggested that the "scope of covered products should be limited to OTC drugs intended for ingestion, rather than 'orally administered' OTCs." NDMA noted that "orally administered" drugs, if read literally would include "dentifrices and mouthwashes, which are expectorated and not intended for ingestion." The association maintained that the "accidental absorption of residual sodium from use of dentifrices and mouthwashes is miniscule." In addition, NDMA is against FDA's proposal to require a warning for OTC drugs containing more than 140 mg sodium in the maximum recommended daily dose. "FDA presents no evidence that drugs which are not now subject to sodium warnings or proposed warnings in the OTC Drug Review (i.e., antacids, laxatives, and antipyretics) constitute a safety problem that demands an immediate, across-the-board warning rule." The association added that "where sodium exposure is identified as a possible concern in a particular category, the appropriate course is for the agency to conduct rulemaking on the need for a warning for the affected drug product." NDMA proposed that FDA remove the warning requirement and "consider warnings on an as needed basis within the OTC review category system." Several companies, including Colgate-Palmolive and Procter & Gamble, agree with NDMA's suggestions. In July 23 comments, Colgate requested that the labeling requirements "be limited to 'OTC drug products intended for ingestion' and that this language be substituted for the phrase 'orally administered over-the- counter (OTC) drug products.'" Commenting on the warning, the company said: "To preserve the effectiveness of such warnings, they should be considered on a case-by-case basis within the OTC review monographs." In a July 23 letter, Procter & Gamble suggested that FDA consider the appropriateness of sodium warning "on a category-by- category basis, with consideration given to the pharmacological class of drug, the use patterns of the product category in question, and in conjunction with the currently required labeling of the particular active ingredients, and/or pharmacological class."

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