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FDA signals uptick in enforcement with market sweep on depression claims

On 19 February, 2021 the U.S. Food and Drug Administration (FDA) announced warning letters to ten companies for selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health...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

FDA issues draft guidance on voluntary disclosure of sesame when added as flavoring or spice

On 10 November 2020, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance recommending that companies voluntarily declare sesame in the ingredient list when it is used as a “flavor” or...more

FDA announces additional flexibility for new nutrition labeling requirements

The U.S. Food and Drug Administration (FDA) announced in a recent Constituent Update that it is providing additional flexibility to food manufacturers with less than $10 million in annual food sales in complying with FDA’s...more

COVID-19 Update: FDA Issues Guidance on Temporary Flexibility Policy Regarding Certain Labeling Requirements for Foods for Humans...

On May 22, 2020, the U.S. Food and Drug Administration (FDA) announced two policies to provide temporary flexibility with respect to packaged foods formulation and labeling requirements during the COVID-19 pandemic. The...more

COVID-19 Update: FDA Issues Minor Updates to Guidance on Hand Sanitizer Production

In March, the Food and Drug Administration (FDA) issued guidance documents, first revised on March 27, temporarily relaxing certain regulatory requirements for the production of alcohol-based hand sanitizers, to respond to...more

FDA Issues Temporary Policy Regarding Labeling of Shell Eggs Sold by Retail Establishments

The FDA issued a new guidance document that provides retailers with some flexibility from labeling requirements for shell eggs in order to facilitate the distribution of eggs during the COVID-19 pandemic. This guidance...more

COVID-19 Update: FDA and TTB Response to Increased Demand for Alcohol-Based Hand Sanitizer Production

As the novel coronavirus crisis continues to escalate, the demand for hygienic products such as hand sanitizer has dramatically increased. In response, many businesses, such as food and industrial and beverage alcohol...more

FDA Announces Temporary Flexibility Regarding Nutrition Labeling Due to COVID-19 Pandemic

The U.S. Food and Drug Administration (FDA) announced yesterday two policies to provide flexibility with respect to nutrition labeling requirements during the COVID-19 pandemic. First, the agency committed to work...more

FDA Public Meeting: Horizontal Approaches to Food Standards of Identity Modernization

On September 27, 2019 the U.S. Food and Drug Administration (FDA) hosted a public meeting to gather information from stakeholders on changes the agency could make to existing standards of identity (SOIs), particularly changes...more

National Advertising Division Issues Decision on “0 g Added Sugars” Claim for Oatmilk

Oatly, Inc. has chosen to discontinue its “no added sugars” advertising claims after the Campbell Soup Company brought a challenge before the National Advertising Division (NAD). Campbell argued that various claims found on...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

FDA Encourages “Best If Used By” Labeling to Describe Quality Dates

On May 23, the Food and Drug Administration (FDA) issued a letter to the food industry “strongly support[ing]” the use of “Best If Used By” labeling to describe the date when a food will be at its best flavor and quality. FDA...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

National Academies Release Dietary Reference Intakes for Sodium and Potassium

The National Academies of Sciences, Engineering and Medicine (NASEM) recently released updated Dietary Reference Intakes (DRIs) for sodium and potassium. For the adequate intake of sodium, the report reaffirms the existing...more

Nutrition Labeling Implementation Update – FDA Issues Technical Amendments to Final Rule

The Food and Drug Administration (FDA) recently issued technical amendments to the final rule revising the nutrition labeling requirements. These technical amendments restore provisions that were inadvertently omitted when...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 Holds Public Meeting on Nutrition Innovation Strategy

On July 26, 2018, the FDA held a public meeting to discuss issues related to the agency’s comprehensive multi-year Nutrition Innovation Strategy. This public meeting and comment period follows FDA Commissioner Dr. Scott...more

FDA Issues Proposed Rule on Front-of-Pack Calorie Disclosures Used for Vending Machine Labeling Compliance

The Food and Drug Administration (FDA) is proposing to revise the type size requirements for front-of-pack (FOP) calorie declarations that are used to comply with the vending machine calorie labeling requirements. The...more

Developments Related to the Compliance Date for FDA’s Final Determination on the GRAS Status of Partially Hydrogenated Oils

As the June 18, 2018 compliance date for the Food and Drug Administration’s (FDA’s) final determination that partially hydrogenated oils (PHOs) are no longer generally recognized as safe (GRAS) approaches, the food industry...more

FDA Finalizes Extension of Compliance Date for Nutrition Labeling Final Rules

The Food and Drug Administration (FDA) has issued a final rule extending the compliance date for the final rules revising the requirements for the nutrition and supplement facts labels and the declared serving sizes and...more

FDA Commissioner Gottlieb Announces New Nutrition Innovation Strategy

On March 29, 2018, Food and Drug Administration (FDA or the agency) Commissioner Scott Gottlieb, M.D., delivered a nutrition-related policy address. The Commissioner emphasized FDA’s role in helping Americans improve their...more

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