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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Last week the Food and Drug Administration (FDA) issued draft guidance announcing that the agency intends to exercise enforcement discretion to allow the use of “potassium chloride salt” as an alternative common or usual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 Final Guidance on FCN Requirements for FCS in Contact with Infant Formula and Human Milk

We are writing this memo to bring to your attention that the Food and Drug Administration (FDA) recently published a new final guidance titled: “Preparation of Food Contact Notifications for Food Contact Substances in Contact...more

Consumer Horizons: CBD in foods, dietary supplements, and cosmetics: Navigating the global Wild West

Increasing consumer interest in cannabis-derived ingredients has led to an explosion of the use of the non-intoxicating cannabinoid, cannabidiol (CBD) in a wide variety of products, including drugs, foods, dietary...more

CBD at TTB: TTB Issues New Industry Circular on Hemp-Derived Ingredients in Alcohol Beverages

Many food and beverage companies are assessing the use of hemp-derived ingredients in their products in light of the 2018 Farm Bill provisions excluding “hemp” from the definition of marijuana under the federal Controlled...more

FDA Releases Draft Guidance regarding the Low Calorie Sweetener – Allulose

Last week, the FDA released a draft guidance regarding the low calorie sweetener, allulose, and stated the agency will not treat this ingredient as contributing to total or added sugars content in the nutrition information....more

Dietary Supplement Regulation Update: FDA Announces Public Meeting on Responsible Dietary Supplement Innovation; FDA Launches...

As a part of the Food and Drug Administration’s (FDA’s) initiative to modernize and reform dietary supplement oversight, FDA announced it will hold a public meeting on responsible innovation in dietary supplement...more

Cannabis Regulation Update: FDA Announces Public Meeting on Cannabis; FDA and FTC Issue Warning Letters to Manufacturers of CBD...

This post summarizes several regulatory developments related to cannabis and cannabis derivatives, including cannabidiol (CBD). The Food and Drug Administration (FDA) recently announced it will hold a public meeting on May...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

FDA Announces Plans for Modernizing and Reforming Dietary Supplement Oversight and Issues Batch of Warning Letters Over Unlawful...

The Food and Drug Administration (FDA) recently announced a plan for “policy advancements with the goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25...more

Doing business in the United States – U.S. Consumer sector 2019

The United States has the most well-developed consumer economy in the world, with approximately US$13.2 trillion in annual consumer spending, the world’s highest per-household spending, and retail space per capita that is...more

USDA’s AMS Issues Final Rule on National Bioengineered Food Disclosure Standard

Yesterday the U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) released its final rule implementing the National Bioengineered Food Disclosure Standard (NBFDS) passed by Congress in July 2016. In...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

OEHHA Proposes Significant Amendment on Determining the Daily Intake of Listed Chemicals as Causing Reproductive Toxicity

Last week, the California Office of Environmental Health Hazard Assessment (OEHHA), the lead agency that implements California’s Proposition 65, proposed an amendment to the existing regulation requiring: (1) the average...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

Updated Chinese Tariffs Impact Food Products

Last Friday, China announced a second round of American products that could be subject to retaliatory tariffs between 10 to 25 percent. 1/ The proposed list would target $60 billion worth of additional United States...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

California Appeals Court Reverses Decision Requiring Proposition 65 Warnings on Cereals for Acrylamide

A California appeals court has reversed a trial court decision that would require businesses to post Proposition 65 cancer warnings on certain breakfast cereals for acrylamide. The court ruled that a Proposition 65 warning...more

Ninth Circuit Issues Ruling on “Made in the USA” Claims in California

The U.S. Appeals Court for the 9th Circuit issued a favorable decision earlier this year interpreting the California “made in the USA” statute. In a March 2018 unpublished opinion, the court affirmed the dismissal of lawsuits...more

Impact of China’s Proposed Retaliatory Tariffs on Food Products

On June 15, 2018, the Office of the United States Trade Representative (USTR) released a list of products imported from China that will be subject to additional tariffs as part of the United States response to China’s alleged...more

Proposed OEHHA Regulation Declares No Significant Risk of Listed Proposition 65 Chemicals in Coffee

On Friday, June 15th, the California Office of Environmental Health Hazard Assessment (OEHHA) announced a proposed regulation clarifying that exposures to Proposition 65 chemicals in coffee do not pose a significant cancer...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

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

USDA’s AMS Issues Proposed Rule on National Bioengineered Food Disclosure Standard

On May 3, the U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) issued its proposed rule implementing the National Bioengineered Food Disclosure Standard (NBFDS) passed by Congress in July 2016....more

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