Heme-Burgers and Hot Dogs: Ninth Circuit Affirms FDA’s Approval of Plant Meat...
A US Court of Appeals for the Ninth Circuit panel recently affirmed a decision by the US Food and Drug Administration (FDA) approving soy leghemoglobin (also known as “heme”), a soy protein ......By:
View ArticleFDA’s Latest Initiatives Seek Input from Industry to Develop Food...
To enhance its food traceability objective through the use of technology that strengthens the food safety system, the US Food and Drug Administration (FDA) unveiled, on May 19, its latest initiative...
View ArticleChocolate Cicadas and Mealworm Mints: Will FDA Spit Out Guidance for Edible...
The month of May was buzzing with good news for the edible insect industry, but this emerging food trend still faces regulatory uncertainty in the United States....By:
View ArticleBipartisan Group of Senators Introduces Bill to Regulate Hemp and...
US Senators Ron Wyden (D-Ore.), Rand Paul (R-Ky.), and Jeff Merkley (D-Ore.) introduced legislation on May 21 to ensure hemp-derived cannabidiol (CBD) is regulated by the US Food and Drug...
View ArticleUSDA’s Proposal to Take Back Regulatory Oversight of GM Animals from FDA...
On December 14, 2020, the US Food and Drug Administration (FDA) approved GalSafe pigs, which are genetically modified (GM) for use in food production and medical products. At the time, the agency noted...
View ArticleFTC and USDA Promote Transparency in ‘Made in USA’ Labeling Claims
The Federal Trade Commission (FTC) recently issued a final rule that marks a major shift in the regulatory landscape for labeling that has already begun to impact other regulatory bodies—namely, the US...
View ArticleProposed Antitrust Legislation Targets Pharmaceutical Industry, Would Grant...
A bipartisan group of lawmakers in the US House of Representatives’ Judiciary Antitrust Subcommittee recently voted three bills out of committee that target the pharmaceutical industry practices of...
View ArticleFood Labeling Modernization Act Reintroduced in Congress
Congress on August 3 introduced the Food Labeling Modernization Act of 2021 (H.R. 4917 or 2021 Bill), a bill that proposes to amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to improve...
View ArticleUSDA Bioengineered Food Disclosure Rule Goes Into Effect on January 1, 2022
The US Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) published a final rule on December 21, 2018, implementing the National Bioengineered Food Disclosure Standard (NBFDS)....
View ArticleFDA Signs Domestic Mutual Reliance Agreements with Four States to Protect...
FDA recently entered into domestic mutual reliance (DMR) agreements with the states of California, Florida, Utah, and Wisconsin to help ensure the safety of domestic food production and distribution...
View ArticleAnti-Spoil(er) Alert: FDA Issues Guidance on Antimicrobial Agents in Food
FDA issued an updated Q&A guidance in September 2021, Microbiological Considerations for Antimicrobial Agents Used in Food Applications: Guidance for Industry (Antimicrobial Agents Guidance), which...
View ArticleNew US Department of Agriculture Initiative to Combat Salmonella in Poultry
The US Department of Agriculture (USDA) recently announced a new initiative that its Food Safety and Inspection Service (FSIS) plans to put in place to limit Salmonella in poultry plants to help reduce...
View ArticleA Pinch of Salt, but No Pepper(ing) This Time: FDA Issues Voluntary Guidance...
FDA issued a Voluntary Sodium Reduction guidance in October 2021, aimed to help Americans reduce average daily sodium intake over the next two and a half years. The guidance suggests voluntary sodium...
View ArticleFDA Grants First E‑Cigarette PMTA Authorization
The US Food and Drug Administration recently issued an order authorizing R.J. Reynolds Vapor Co. to market its Vuse Solo electronic nicotine delivery system and corresponding e-liquid pods. These...
View ArticleMonograph Soup: The ABCs & XYZs for OTCs on Formal Meetings with FDA
The US Food and Drug Administration (FDA) on February 1 issued a draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of OTC Monograph Drugs” (Meeting Guidance), that specifies the...
View ArticleDr. Robert Califf Confirmed to Fill FDA Commissioner Position
The US Senate voted on February 15 to confirm Dr. Robert M. Califf as the next commissioner of the US Food and Drug Administration (FDA), a position that has been filled since April 2021 by acting...
View ArticleFDA Outlines Evaluation Approach to Non-Major Food Allergens in Draft Guidance
Last week, FDA issued a draft guidance that outlines the agency’s proposed approach for evaluating the public health importance of food allergens other than the eight major food allergens identified by...
View ArticleExecutive Order Outlines New Federal Biotechnology/Manufacturing Goals
President Joseph Biden issued an “Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy” (EO) on September 12. Under this...
View ArticleEat Your Greens: FDA Proposes New Definition for ‘Healthy’ Packaged Food Claims
The US Food and Drug Administration issued a proposed rule on September 29 setting forth new criteria for the labeling of food products with the nutrient content claim “healthy” intended to help...
View ArticleFDA Embraces Alternative Tools for Inspecting Facilities
On October 17, 2022, the US Food and Drug Administration (FDA) implemented revisions to two of its compliance policy guides (CPGs). CPGs are intended to advise FDA staff as to the agency's strategy...
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