FDA

The Food and Drug Administration’s (FDA) final Deeming Rule requires manufacturers of deemed tobacco products to submit their products to the agency for approval before those products can be introduced into the market. On September 25,…

On September 21, 2020, the U.S. Food and Drug Administration (FDA) announced a proposed rule to establish additional traceability recordkeeping requirements for certain foods. The FDA also published a draft “Food…

By Charles Jeane, Assistant Chief Counsel On August 19, 2020, the United States District Court for the District of Columbia issued a Memorandum Opinion and Order enjoining the Food and Drug Administration (FDA) from enforcing its…

On July 22, 2020, The Food and Drug Administration (FDA) issued a guidance that outlines FDA's current thinking on several topics relevant to the development of cannabis and cannabis-derived products: The source of cannabis and…

On November 27, 2019, the Office of Advocacy submitted comments to the Food and Drug Administration (FDA) asserting that the agency improperly certified the Tobacco Product Applications and Recordkeeping Requirements Proposed Rule. The…

On November 26, 2019, the Food and Drug Administration (FDA) published the proposed rule Premarket Tobacco Product Applications and Recordkeeping Requirements; Reopening of the Comment Period. The FDA has reopened the comment period for…

On September 25, 2019, the Food and Drug Administration (FDA) published the proposed rule “Premarket Tobacco Product Applications and Recordkeeping Requirements.” The proposed rule establishes the requirements for the content and form of…

The U.S. Small Business Administration Office of Advocacy will hold a roundtable to discuss the regulation of premium cigars beginning at 10:00 a.m. on Thursday, September 12, 2019. The roundtable will be held in Washington, D.C., at the…

On April 3, 2019, the Food and Drug Administration (FDA) published a request for comments for scientific data and information about products containing cannabis or cannabis-derived compounds (84 Fed. Reg. 12969). The Agriculture…

On April 2, 2019, the Food and Drug Administration (FDA) published the proposed rule “Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence (SE) Reports.” The proposed rule…