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FDA Issues Guidance on Non-Standard Infant Formula Requirements
April 15, 2016 |FDA

The Food and Drug Administration on April 14 posted a guidance document on current good manufacturing practices, quality control procedures, conduct of audits and records and reports for infant formulas exempt from normal requirements (here). Infant formulas are exempt from FDA’s standards if they are labeled for use by an infant with metabolism errors, low birth weight or other unusual medical or dietary problems. Despite the exemption, manufacturers should attempt to follow standards for non-exempt formula “to the extent practicable,” said FDA in the guidance. Comments on the guidance may be submitted at any time, said FDA (here).

FDA to Allow Folic Acid as Additive in Corn Masa Flour
April 14, 2016 |FDA

The Food and Drug Administration is amending its food additive regulations to allow the use of folic acid as an additive in corn masa flour, in a final rule (here). The level of folic acid may not exceed 0.7 milligrams per pound of flour, said FDA. The new regulations take effect April 15, though written objections may be submitted until May 16.

FDA Asks for Input on Drug Supply Chain Pilot
April 14, 2016 |FDA

The Food and Drug Administration is asking for input from industry as it develops its pilot program under the Drug Supply Chain Security Act, it said (here). The agency is interested in “issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying system attributes that are necessary to implement the requirements established” under the 2013 law (see 13121725), it said.

Other Modified FDA Import Alerts for the Week of April 4-10
April 12, 2016 |FDA

During the week of April 4-10, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of: