Tag Archives: FDA

Health Canada Urged to Allow the Term “Potassium Salt” on Food Labels

In a letter to Health Canada and the Canadian Food Inspection Agency (CFIA), a number of health advocacy groups, food manufacturers, and food retailers have urged regulators to allow “potassium salt” to be used as a permitted synonym for potassium chloride on food labels.  As reported by FoodNavigator, the group argued that the addition of … Continue Reading

Food Companies Agree to Phase Out Industrially Produced Trans Fat by 2023

As previously reported on this blog, the World Health Organization (WHO) released a plan in May 2018 aimed at eliminating industrially-produced trans fatty acids from the global food supply. On April 26, 2019, WHO Director-General Dr. Tedros Adhanom Ghebreyesus issued a statement about that plan. He said in the statement, “The elimination of industrially-produced trans … Continue Reading

FDA’s Quiet Reorganization of the Office of Food Additive Safety Begins Today

Before the Food and Drug Administration (FDA) took it down this morning, the website for the Office of Food Additive Safety (OFAS) showed three divisions for (1) Food Additive Petitions (FAPs) and Color Additive Petitions (CAPs), (2) Food Contact Notifications (FCNs), and (3) Biotechnology and Generally Recognized as Safe (GRAS) notifications.  Since the last reorganization of the Center … Continue Reading

Sharpless: ‘No Pause’ Following Gottlieb’s Departure

As previously reported on this blog, Ned Sharpless succeeded Scott Gottlieb as Acting FDA Commissioner in April 2019.  Prior to Sharpless’ tenure, it was unclear whether the agency would continue Gottlieb’s efforts in the area of food and tobacco, including reevaluating certain standards of identity, modernizing the oversight of imported food and product recalls, and … Continue Reading

FDA Announces “New Era of Smarter Food Safety”

On April 30, 2019, Acting FDA Commissioner Ned Sharpless, M.D., and Deputy Commissioner Frank Yiannas announced a “New Era of Smarter Food Safety,” an effort intended to combine the implementation of FSMA with the use of new and emerging technologies. This new approach will start with the development of a “Blueprint for a New Era … Continue Reading

CSPI Calls for National Registry of Gene-Edited Agricultural Crops

Criticizing the US Department of Agriculture (USDA) and Food and Drug Administration (FDA) for lack of oversight over foods produced with gene editing technology (e.g., Zinc Finger Nucleases, TALENS, or CRISPR/Cas 9), the Center for Science in the Public Interest (CSPI) is calling for a federal registry of all gene-edited agricultural crops. CSPI is not … Continue Reading

FDA Issues Initiation of Voluntary Recall Draft Guidance

Today, FDA published a draft guidance on ways to prepare, plan, and work with the FDA to ensure voluntary recalls are initiated properly and timely. The draft guidance, titled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” applies to voluntary recalls of all products subject to FDA’s jurisdiction, including food, drug, and … Continue Reading

FDA Allows Allulose to be Excluded From Sugar Declarations

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

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

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

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

FDA Announces Citizen Petition to Grant Fiber Status to IMO

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

FDA Releases Heavy Metal Test Results in Kratom

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

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

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

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

 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

KIND Petitions FDA to Update Nutrient Content Claim Regulations

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

Ned Sharpless Named New Acting FDA Commissioner

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

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

Arizona Legislators Join Cell-Cultured Meat Labeling Debate

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

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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