Through Enforcement Discretion, FDA Facilitates Market Entry for New Infant Formulas (For Now); President Invokes Defense Production Act
FDA Law Blog
MAY 19, 2022
If FDA concludes otherwise, proceeding to market with the formula could leave the manufacturer vulnerable to regulatory action. The guidance offers an opportunity that could be of special interest to foreign manufacturers who already market infant formula in other countries and have considered entering the U.S.
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