FDA Plans New Rules on Food Standards Petitions, HCT/P Inspections
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FDA has added three new proposed rules to its regulatory agenda for this year focused on food standards petitions, requirements for entities that manufacture human cell and tissue products, and regulations regarding the list of drugs that cannot be compounded because they have been withdrawn or removed from the market. The agency included the new proposed rules on its unified agenda unveiled Jan. 4.
The first new proposal, “Food Standards; General Principles and Food Standards Modernization,” is slated for release in October.
The proposal would amend FDA’s and the Food Safety and Inspection Service’s regulations to create principles for preparing food standards petitions. The principles established under the proposed rule also would apply to FDA and FSIS when they’re considering whether to implement, revise or eliminate food standards, either based on a petition or on the agencies’ own initiative.
The proposed rule aims to support flexibility along with production and nutrition advances in food production and promote harmonization in international food standards where appropriate.
“The proposed rule would simplify and modernize food standards and continue to ensure that food standards will protect the public as well as promote honesty and fair dealing in the interest of consumers,” FDA says in its regulatory agenda.
