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"ANTIFLATULENT" AND "ANTIGAS" ARE SYNONYMS IN FDA's VIEW

Executive Summary

"ANTIFLATULENT" AND "ANTIGAS" ARE SYNONYMS IN FDA's VIEW for OTC product identity statements. After almost 12 years, FDA is acknowledging arguments that an alternative term to antiflatulent would be more comprehensible to consumers. In a proposed amendment to the OTC Antiflatulent Monograph in the Jan. 29 Federal Register, FDA states that "the agency believes that the term 'antigas' is an appropriate alternative statement of identity to the term 'antiflatulent' provided that there are no statements elsewhere in the labeling implying that the symptoms are caused by the presence of excess gas." The agency pointed out that describing an OTC product as an "antigas" agent would be unacceptable if the labeling also carried other statements such as "antigas formulation relieves gas trapped in the intestine" or "for gas pain." The agency is, however, proposing to broaden officially the language for approved indications for OTC antiflatulent agents to include relief or alleviation of "bloating," "pressure," "fullness" and "stuffed feeling." The proposed alternatives are part of an amendment to the 1974 OTC Antiflatulent Monograph. FDA's choice to limit the labeling language for antigas products early during the OTC Review was probably a blessing for the OTC industry. It provided one of the most obvious and telling arguments for the OTC industry against restrictive label indications and FTC's proposal to tie ad claims to FDA labeling.
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