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FDA completes first pre-market consultation for human food made with animal cell culture technology

The U.S. Food and Drug Administration (FDA) recently completed its first pre-market consultation for a human food made from cultured animal cells and issued a letter stating it had no further questions regarding the...more

California’s OEHHA proposed modified regulation on warnings for chemicals formed during cooking

On Friday, 16 April 2021, California’s Office of Environmental Health Hazard Assessment (OEHHA), the lead agency that implements California’s Proposition 65, proposed modified language for its new regulation on the warning...more

FDA issues Final Guidance on use of “Potassium Salt” as an alternate name for Potassium Chloride

Last week the Food and Drug Administration (FDA) issued a Final Guidance document regarding the use of an alternate name for potassium chloride in food labeling....more

HHS proposes to sunset regulations Issued by FDA, CMS, and other regulatory agencies

Our team wanted to highlight a proposed rule issued by the U.S. Department of Health and Human Services (HHS) on 4 November 2020 - with only a 30-day comment period - that would establish sunset (expiration) dates for...more

AMS Releases Draft Instructions on Testing Methods for the National Bioengineered Food Disclosure Standard

The U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) has released Draft Instructions on Testing Methods (Draft Instructions) for use in compliance with the National Bioengineered Food Disclosure...more

AMS Releases Draft Instructions on Validating a Refining Process for National Bioengineered Food Disclosure Standard

The U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) is seeking public comment on draft instructions to validate a refining process under the National Bioengineered Food Disclosure Standard...more

USDA Publishes Interim Final Rule on Hemp: Key Takeaways

On October 31, 2019, the United States Department of Agriculture (USDA) published an interim final rule (IFR) on domestic hemp production. This rule establishes a regulatory framework for USDA oversight of domestic hemp...more

California Chamber of Commerce Challenges the Proposition 65 Acrylamide Warning for Foods

A lawsuit filed yesterday by the California Chamber of Commerce challenges the legality of Proposition 65 warnings on foods that contain acrylamide. The Complaint, which named the Attorney General of the State of California...more

FDA Issues Final Guidance on Added Sugars Labeling for Honey, Maple Syrup, Other Single-Ingredient Sugars and Syrups, and Certain...

On June 18, the Food and Drug Administration (FDA) issued its final guidance document on added sugars labeling for (1) honey, maple syrup, and other single-ingredient sugars and syrups; and (2) certain cranberry products. In...more

The Use of an Alternate Name for Potassium Chloride in Food Labeling: Guidance for Industry

Last week the Food and Drug Administration (FDA) issued draft guidance announcing that the agency intends to exercise enforcement discretion to allow the use of “potassium chloride salt” as an alternative common or usual name...more

FDA Issues Two Guidance Documents on New Nutrition Labeling Requirements

The U.S. Food and Drug Administration (FDA) recently issued two guidance documents – one final and one draft – related to the new nutrition labeling requirements. The final guidance is an update to the previous draft guidance...more

FDA Deauthorizes Seven Synthetic Flavorings and Adjuvants as Food Additives

On October 9, 2018, the U.S. Food and Drug Administration (FDA) issued a final rule revoking authorization for seven synthetic flavorings and adjuvants as food additives. Notably, FDA’s rigorous scientific analysis determined...more

USDA Sends National Bioengineered Food Disclosure Standard to OMB While Facing Lawsuit for Failing to Meet Statutory Deadline

On August 1, 2018, two consumer groups sued the U.S. Department of Agriculture (USDA), USDA Secretary Sonny Perdue, and Agricultural Marketing Service (AMS) Administrator Bruce Summers for failing to meet the statutory...more

FDA Issues Guidance Recognizing Eight Ingredients as Meeting the Dietary Fiber Definition

The Food and Drug Administration (FDA) has issued a guidance document that identifies eight ingredients that the agency has determined meet the regulatory definition of “dietary fiber.” Specifically, FDA has recognized the...more

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