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In Brief: FDA responds to Nasacort suit, acts on acetaminophen and continues medical food enforcement

This article was originally published in The Tan Sheet

Executive Summary

FDA responds to Nasacort Allergy suit; FDA will act on lower acetaminophen dose; FDA warns consumers about wart removers; FDA continues medical food enforcement; Supplements must include declared ingredients; CHPA applauds DXM-related legislation; and USP opens Shanghai facility.

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The Consumer Healthcare Products Association’s No. 1 legislative priority in 2014 is restoring OTC coverage by flexible spending and health savings accounts, followed by a “close No. 2” goal of establishing an age requirement to buy DXM products. Other goals include protecting access to PSE products and blocking take-back programs.

Sanofi Sues FDA To Stop Publication Of Nasacort Labeling Before Launch

After FDA denied Sanofi three years of market exclusivity for OTC Nasacort, the firm filed suit against the agency not to publish the product’s labeling prior to the launch. If successful, the firm could postpone the launch of generic competition.

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Ingredient safety, new dietary ingredient notifications, adverse event reporting, claims substantiation and disease claims are all drawing FDA attention in the supplement space, Daniel Fabricant says. Compliance for good manufacturing practices still heads the priorities for enforcement, he says.

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