Tag Archives: FDA

Looking Ahead: Proposed Regulatory Actions by FDA and USDA in the Fall 2018 Unified Agenda

The Executive Office of the President recently released the Spring 2019 Unified Agenda. As we described in our post for the release of the Fall 2018 Unified Agenda, twice a year, federal agencies publish this comprehensive report describing regulations currently under development or recently completed. The agenda provides stakeholders with a preview of agencies’ top … Continue Reading

NuTek Withdraws “Potassium Salt” Citizen Petition

NuTek Food Science—the company that filed a 2016 citizen petition to obtain FDA permission to label potassium chloride as “potassium salt”—has withdrawn its citizen petition.  The company made its decision based on FDA’s recent issuance of draft guidance authorizing the term “potassium chloride salt” as an alternative name for “potassium chloride” on food labels. NuTek’s … Continue Reading

FDA Endorses “Best If Used By” Label for Food

Packaged food and beverage products for retail sale contain an array of date labels, such as “Use by,” “Best If Used By,” “Expires On,” etc. Ultimately, with few exceptions, such as labels for infant formula, data labels are not required on packaged foods. While manufacturers are prohibited from placing false or misleading information on a … Continue Reading

FDA Launches Menu Labeling Social Media Toolkit

FDA has launched a social media toolkit to assist with consumer awareness of menu labeling information.  The toolkit features web badges that can be added to an organization’s website, a sample newsletter/blog, and social media messages for sharing on Facebook and Twitter. The new consumer-focused materials refer to FDA’s www.fda.gov/caloriesonthemenu website, which provides consumers with … Continue Reading

FDA Extends Application Deadline for VQIP

The U.S. Food and Drug Administration (FDA) announced that the application period for importers to submit their notice of intent to participate in the Voluntary Qualified Importer Program (VQIP) for the Fiscal Year 2020 benefits period has been extended to July 31, 2019. (In a previous blog, we noted that the VQIP application portal opened … Continue Reading

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
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