FDA Rules & Proposed Rules

FDA Amends Animal Drug Approval and Withdrawal Rules

The Food and Drug Administration (FDA) has amended regulations concerning the approval and withdrawal of new animal drug applications. These changes are effective February 6, 2026, and impact the procedures for drug sponsors and the handling of drug approvals.

FDA Allows Spirulina Extract as Color Additive in Human Foods

The Food and Drug Administration (FDA) has issued a final rule allowing spirulina extract to be used as a color additive in human foods. This rule amends the list of color additives exempt from certification. The comment period for this rule closes on March 9, 2026.

FDA Amends Food Coloring Regulations for Beetroot Red

The Food and Drug Administration (FDA) has amended regulations concerning the use of beetroot red as a food coloring additive. This rule finalizes changes to the listing of color additives exempt from certification, specifically impacting beetroot red.

FDA Revokes Mutual Recognition of EU Pharma and Device Reports

The Food and Drug Administration (FDA) is revoking regulations that allowed for the mutual recognition of pharmaceutical Good Manufacturing Practice (GMP) reports and medical device quality system audit reports with the European Community. This action will impact the oversight and inspection processes for products traded between the US and the EU.

FDA Revokes Methods of Analysis Regulation

The Food and Drug Administration (FDA) is revoking its regulation concerning methods of analysis. This rule, published in the Federal Register, will be effective March 23, 2026. The revocation impacts how certain analytical methods are regulated.