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FDA Allows Allulose to be Excluded From Sugar Declarations

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On April 18, 2019, FDA released a draft guidance for industry entitled, “The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels.” The guidance announces FDA’s intent to exercise enforcement discretion for the exclusion of allulose from the amount of “Total Sugars” and “Added Sugars” declared on the label and the … Continue Reading

FDA Announces New Tool to Alert the Public of Unlawful Ingredients in Dietary Supplements

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As our readers may remember, earlier this year the FDA announced a plan for modernizing and strengthening dietary supplement regulation and oversight. Under the plan, the FDA stated their intent to preserve consumers’ access to lawful supplements, while also upholding the Agency’s obligation to protect the public from unsafe and unlawful products. And as part … Continue Reading

Despite Gottlieb’s Exit, FDA’s Nutrition Innovation Strategy Marches Forward

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As previously reported on this blog, FDA’s Nutrition Innovation Strategy (NIS) is intended to improve public health via education regarding, and encouraging innovation in, the use of nutrition to promote health. The NIS was initiated under the leadership of FDA Commissioner Scott Gottlieb. Areas of emphasis are modernizing the approach to label claims, modernizing standards … Continue Reading

Proposed Legislation Would Lock-In USDA’s Oversight of Cell-Based Meat

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As we previously reported, the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) have issued a “Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species” (the press release can be … Continue Reading

USDA Pushes Back Against Washington Post Over New Swine Slaughter Inspection System

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On February 1, 2018, FSIS put forward a proposed rule to establish a voluntary, opt-in inspection system for market hog slaughter establishments, called the New Swine Slaughter Inspection System (NSIS). Under the proposed rule, hog slaughter plants may voluntarily join a new inspection system whereby establishment personnel would be responsible for sorting and removing unfit … Continue Reading

FDA Announces Citizen Petition to Grant Fiber Status to IMO

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As our readers are aware, in May 2016, FDA issued final rules to implement changes to the nutrition labeling and serving size regulation. The final rules regarding nutrition labeling established a definition for the term “dietary fiber.” In March 2018, FDA published final guidance on dietary fiber that communicated the Agency’s revised standard of review … Continue Reading

Latest FDA Data Show Foodborne Pathogens in Fresh Herbs, Guacamole, and Processed Avocado; The Source of a New Multistate E. coli O103 Outbreak Remains a Mystery

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  In 2014, the Food and Drug Administration (FDA) began random sampling and testing of a variety of commodities from domestic and foreign sources to learn more about the prevalence of disease-causing bacteria.  The first commodities sampled were sprouts, whole fresh avocados, and raw milk cheese (aged 60 days), followed by cucumbers and hot peppers.  … Continue Reading

FDA Releases Heavy Metal Test Results in Kratom

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In November 2018, FDA announced that it had tested 26 kratom products with “disturbingly” high heavy metal levels.  Also known as Mitragyna speciose, kratom grows naturally in Southeast Asia and has opioid-like properties.  The Daily Intake blogged on the topic here. Besides concerns regarding kratom’s opioid-like properties, FDA also has taken action and issued its … Continue Reading

FDA Encourages Participation in Voluntary Plant Biotechnology Consultation Program and Revises Guidance on Voluntary Labeling of Foods Derived Plant Biotechnology

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Given the increased prevalence of plant biotechnology to develop innovative foods, FDA is reminding industry of its voluntary consultation program to ensure the safety of and public confidence in plant biotechnology-derived foods.  FDA describes “plant biotechnology” as “certain methods scientists can use to introduce new traits or characteristics to a plant.” FDA has assisted in … Continue Reading

FDA Announces New Steps to Advance Regulatory Framework for CBD Products

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Interest in products derived from cannabis (Cannabis sativa L.) and its components, including cannabidiol (CBD) has been high for the past couple of years and only increased when Congress passed the 2018 Farm Bill in December 2018.  Among other things, the law established a category for “hemp,” defined as cannabis (Cannabis sativa L.), and derivatives of cannabis (e.g., … Continue Reading

New Arkansas Law Defines Rice, Beef, Pork, and Meat

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Arkansas recently joined the states that prohibit marketing a product as “meat” if it is not derived from livestock or poultry. Arkansas Governor Asa Hutchinson signed HB 1407, titled, “To Require Truth in Labeling of Agriculture Product Are Edible by Humans,” into law (Act 501) last month. Significantly, Arkansas Act 501, also bans manufacturers from … Continue Reading

U.S. Supreme Court to Consider Whether Courts Must Defer to an Agency’s Interpretation of its Regulations – a Judicial Policy That Recently Resulted in Dismissal of Litigation Over ‘No Sugar Added’ Claims on 100% Juices

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 Kavanaugh, Roberts In Crossfire of Battle Over ‘Auer’ (subscription to Law360 required) The U.S. Supreme Court heard arguments on March 27, 2019 about whether to overturn the principle of judicial review of federal agency actions that requires a federal court to yield to an agency’s interpretation of an ambiguous regulation that the agency has promulgated.  Under … Continue Reading

FDA Announces Enforcement Discretion for Certain Commodities Related to Produce Safety Rule

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The FSMA final Produce Safety Rule was published on November 27, 2015 (80 FR 74353) and establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce. Our detailed summary of the rule is available here. In a recently released guidance for industry, “Produce Safety Rule: Enforcement Policy for Entities Growing, Harvesting, Packing, … Continue Reading

California Jury Awards $80 Million Verdict in Glyphosate Case

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A California plaintiff, who used Roundup on his 56-acre Santa Rosa property and alleged glyphosate caused his non-Hodgkin lymphoma, has been awarded $80 million by a jury in the U.S. District Court for the Northern District of California.  The docket of the case, Hardeman v. Monsanto Co. et al., is available here (subscription required).  This … Continue Reading

KIND Petitions FDA to Update Nutrient Content Claim Regulations

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On March 12, 2019, snack bar producer, KIND, submitted a Citizen Petition to the FDA asking the agency to update the framework for regulating nutrient content claims (NCCs). In sum, the petition requests that FDA consider the overall quality of the food, rather than just the quantity of a certain nutrient when regulating nutritional claims … Continue Reading

Soda Tax Debate Continues

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The effectiveness of taxing sugar-sweetened beverages to reduce the amount of sugar consumed has been the subject of debate for several years. As we’ve previously reported on this blog, the World Health Organization (WHO) issued a report in 2016 that concluded that taxing sugary drinks (and foods) reduces their consumption. However, an independent panel advising … Continue Reading

Ned Sharpless Named New Acting FDA Commissioner

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As previously reported on this blog, on March 5, FDA Commissioner Scott Gottlieb announced plans to resign from his post as FDA Commissioner beginning in April. Gottlieb was confirmed as FDA Commissioner in May 2017 and drove several significant initiatives from food safety modernization to youth nicotine use. On March 12, 2019, Alex M. Azar III, … Continue Reading

FDA Promotes Programs for Safe Use of Biotechnology

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Drs. Susan Mayne, head of the Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition (CFSAN), and Dennis Keefe (head of CFSAN’s Office of Food Additive Safety) published a post on the FDA Voices blog on March 21 discussing FDA’s  Voluntary Plant Biotechnology Consultation Program (the Consultation Program) and the Plant and … Continue Reading

San Francisco to Propose Banning Sale of E-Cigarettes

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The San Francisco City Attorney, in coordination with the City’s Board of Supervisors, announced on March 20, 2019 that it will introduce legislation to prohibit the sale and delivery of e-cigarettes in the City unless such products have been established as “appropriate for the protection of the public health” through the Food and Drug Administration … Continue Reading

Arizona Legislators Join Cell-Cultured Meat Labeling Debate

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As previously reported on this blog, there has been considerable discussion around the regulation of cell-cultured meat both at the federal and state levels. Earlier this month, USDA and FDA published a formal agreement regarding federal agency oversight of human food produced using cell technology. Under the formal agreement, FDA will oversee cell collection and … Continue Reading

‘Dairy Pride Act’ Introduced Again

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As previously reported on this blog, U.S. Senator Tammy Baldwin’s (D-WI) introduction of the Dairy Pride Act  in 2017 was met with controversy. On March 14, 2019, Sen. Baldwin, along with Sens. Jim Risch (R-ID) and Mike Crapo (R-ID), reintroduced The Defending Against Imitations and Replacements of Yogurt, milk, and cheese to Promote Regular Intake … Continue Reading
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