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USDA and DEA interim final rules on hemp – Major issues remaining to be resolved

While the hemp industry eagerly awaits FDA’s Cannabidiol (CBD) Enforcement Policy draft guidance, both the United States Department of Agriculture (USDA) and Drug Enforcement Agency (DEA) have active comment periods ongoing...more

California update: OEHHA extends comment period

California’s Office of Environmental Health Hazard Assessment (OEHHA) is extending the public comment period for its proposal that lays out what constitutes a Proposition 65 exposure that would require warnings for listed...more

NOP issues proposed rule amending organic requirements to strengthen organic enforcement

The United States Department of Agriculture (USDA) Agricultural Marketing Service’s (AMS) National Organic Program (NOP) issued a proposed rule in early August that would amend the organic regulations to strengthen oversight...more

California’s OEHHA releases draft report questioning the safety of FDA approved certified colors

On August 28, California’s Office of Environmental Health Hazard Assessment (OEHHA), the lead state agency for the assessment of health risks posed by chemical substances, released a draft report concluding its review of the...more

FDA Will Take Its Time on CBD – But Industry Does Not Have to Wait to Get Ready

Tell me if you’ve heard this one before – the regulatory issues surrounding CBD will be completely resolved after a certain “legislative fix” is passed.  Remember all of the articles in December 2018 declaring CBD legal after...more

Proposed Regulation would Significantly Change the Warning Requirements for Acrylamide and Other Chemicals Formed During the...

On August 4, 2020, the Office of Environmental Health Hazard Assessment (OEHHA), the lead agency that implements California’s Proposition 65 (Prop 65), proposed to adopt a new regulation that would significantly change the...more

AMS Requests Comments on Updates to List of Bioengineered Foods for National Bioengineered Food Disclosure Standard

The U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) is seeking comments on recommendations to update the List of Bioengineered Foods (List) under the National Bioengineered Food Disclosure...more

Proposition 65 Updates: Permanent Injunction Against Glyphosate, Proposed Naturally-Occurring Lead Levels in Certain Candies, and...

We would like to bring to your attention three recent developments related to California’s Proposition 65. On July 8, the Office of Environmental Health Hazard Assessment (OEHHA) adopted three safe harbor levels or maximum...more

AMS Issues Final Guidance on Detectability Testing and Validation of Refining Processes Under the National Bioengineered Food...

The U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) issued two final guidance documents providing industry stakeholders with instructions on how to implement certain requirements of the National...more

Council for Responsible Nutrition Submits Citizen Petition Requesting FDA Rulemaking to Allow CBD and other Hemp-Derived...

The Council for Responsible Nutrition (CRN) submitted a citizen petition to the Food and Drug Administration (FDA) requesting that FDA: FDA exercise its statutory authority to establish a regulation under which...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

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

COVID-19 update: FDA issues updated guidance for food industry

As the novel coronavirus (COVID-19) crisis continues to present new questions and challenges, the U.S. Food and Drug Administration (FDA) continues to update its website to provide additional information and guidance to the...more

COVID-19 Update: Supplemental Update on Essential Critical Infrastructure Workers

In our memo of March 19, we summarized federal government policy identifying the Food and Agriculture and Transportation industries as two of the nation’s 16 Critical Infrastructure Sectors. In The President’s Coronavirus...more

COVID-19 Update: Food and Agriculture Critical Infrastructure Sector Classification and State and Local Restrictions and Curfews

As the novel coronavirus crisis continues to escalate, state and local governments have begun implementing increasingly aggressive measures, including restrictions on when and which businesses may operate, quarantines,...more

COVID-19 Update: FDA and USDA Issue Guidance for Industry and Inspectors

As the novel coronavirus (COVID-19) crisis has continued to escalate, both the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) have taken additional action to provide industry, the...more

COVID-19 Preparedness Considerations for the Food Industry

As you likely know, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are closely monitoring the spread of the novel coronavirus (COVID-19), a respiratory disease that has...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

FDA Announces Form of Enforcement Discretion for First Six Months After New Nutrition Labeling Rule Compliance Date

Today, the U.S. Food and Drug Administration (FDA) updated its “Industry Resources on the Changes to the Nutrition Facts Label” webpage questions and answers, stating that the agency does not intend to take enforcement...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

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

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