Tag Archives: FDA

FDA Approves New Source of Omega-6 Fatty Acids for Dog Food

The Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) announced the approval of a variety of bioengineered safflower as a source of omega-6 fatty acids in dry adult dog food. The final rule amends Title 21 Code of Federal Regulations (C.F.R.) Part 573 (“Food Additives Permitted in Food and Drinking Water of Animals”) … Continue Reading

FDA Delays Preventive Controls Inspections for Large Animal Food Facilities

The second major compliance dates are coming up for the Preventive Controls for Animal Food Rule under FDA’s Food Safety Modernization Act (FSMA). On September 18, 2017, larger animal food facilities must comply with preventive controls requirements mandated by FSMA. These facilities had to meet Current Good Manufacturing Practice (CGMP) requirements by September 2016. As … Continue Reading

FDA Will Exercise Enforcement Discretion for the Use and Labeling of “Ultrafiltered Milk” in Certain Cheeses and Cheese Products

Mechanical filtration technologies available for milk processing include ultrafiltration.  Ultrafiltered milk (UF Milk) is milk that is mechanically filtered via semipermeable membranes to partially remove water, lactose, minerals, and water-soluble vitamins without altering the “casein to whey protein” ratio of the milk and resulting in a liquid product. FDA’s regulations specify the standards of identity … Continue Reading

FDA Issues Guidances on Exemptions from FSMA Rules

As previously reported on this blog, the U.S. Food and Drug Administration issued final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions under the FDA Food Safety Modernization Act (FSMA) on September 10, 2015. Prior to issuing the FSMA regulations, FDA established: A Seafood Hazard Analysis and Critical Control Point (HACCP) … Continue Reading

House Committee Advances Changes to Menu Labeling Law

Over the past several years, FDA has been in the process of implementing menu labeling provisions added to the Federal Food, Drug, and Cosmetic Act by the Affordable Care Act. Under the new requirements, restaurants or similar retail food establishments (in chains of 20 or more locations doing business under the same name and selling substantially similar … Continue Reading

USDA Nutrition Facts Rule Placed on “Inactive” List

On January 19, 2017, USDA’s Food Safety & Inspection Service (FSIS) released a proposed rule to revise its nutrition labeling requirements for meat and poultry products to reflect current scientific research and dietary recommendations. FSIS indicates that the changes parallel FDA’s recently revised nutrition labeling requirements (see our previous blog coverage regarding FDA’s revised nutrition facts requirements here).  … Continue Reading

GE Salmon Labeling Mandate Included in Senate Appropriations Bill

As previously reported on this blog, Senate Bill 764, which requires the labeling of genetically modified (GM) foods and food ingredients, was signed into law on July 29, 2016. The National Bioengineered Food Disclosure Law directs the U.S. Department of Agriculture (USDA) to develop regulations and standards to create mandatory disclosure requirements for bio-engineered foods by July 2018. Under the … Continue Reading

FDA Authorizes Qualified Health Claim for Macadamia Nuts

A health claim characterizes the relationship between a substance and its ability to reduce the risk of a disease or health-related condition (see 21 CFR 101.14).  A health claim must contain the elements of a substance and a disease or health-related condition.  In addition, health claims are limited to claims about disease risk reduction, and … Continue Reading

FSMA Funds 2017: More Green for Greens

FDA announces FSMA funds to support states’ continued implementation of the produce safety rule. The Food Safety Modernization Act (FSMA) was designed to update and strengthen FDA’s risk-based approach to the oversight of food safety.  The produce safety rule – which establishes science-based minimum standards for the safe growing, harvesting, packing and holding of fruits … Continue Reading

Industry Groups Sue NYC to Block Menu Labeling Enforcement

In 2008, New York City passed the first calorie disclosure rule for restaurants and in 2015, the city amended the rule to match federal requirements (for more information on the federal requirements, see the KHlaw.com article, FDA Issues Final Rules on Menu and Vending Machine Nutrition Labeling Requirements.) As we reported on this blog, FDA … Continue Reading

CFIA Launches New Online Consultation to Streamline Regs Between Canada and U.S.

The Canada-United States Regulatory Cooperation Council (RCC) is a joint initiative between Canada and the United States that facilitates regulatory cooperation between the two countries and aims to enhance economic competitiveness. The RCC was created in 2011 to facilitate closer cooperation between Canada and the United States to develop smarter approaches to regulations and to make both economies stronger and more competitive, while … Continue Reading

Update: Industry Urges USDA to Start Over on Proposed Rule to Revamp APHIS Biotech Regs

For decades, the U.S. government has regulated genetically modified organisms (GMOs) under a regulatory framework called the “Coordinated Framework for the Regulation of Biotechnology” (Coordinated Framework).  The Coordinated Framework explains the different roles played by the three major agencies involved in the regulation of GMOs: The Food and Drug Administration (FDA) regulates GMOs under the … Continue Reading

FDA Signs MOU with China Establishing Registration Process for U.S. Food Manufacturers Exporting Goods to China

As background, China’s General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) supervises and regulates the production of food-related products, such as food packaging materials, containers and food processing tools throughout China. AQSIQ also oversees the safety and quality of food imports and exports and collects and analyzes information on the safety of food imports … Continue Reading

FDA Launches Accredited Third-Party Certification Website

As previously covered on this blog, in November 2015, the U.S. Food and Drug Administration (FDA) finalized The Food Safety Modernization Act (FSMA) rule on Accredited Third-Party Certification that established a program for the accreditation of third-party certification bodies to conduct food safety audits and to certify that foreign food facilities and food produced by such … Continue Reading

FDA: No Plans to Reopen Nutrition Facts Label Rule

In May 2016, FDA issued final rules to implement changes to the nutrition labeling and serving size regulations. Mandatory compliance with the new nutrition labeling requirements for food products was initially slated for July 26, 2018 (or July 26, 2019 for manufacturers with less than $10 million in annual food sales).  As covered on this blog last … Continue Reading

FDA to Extend Compliance Dates for Nutrition Facts Label Changes

As previously covered on this blog, in May 2016, FDA issued final rules to implement changes to the nutrition and dietary supplement labeling and serving size regulations. Mandatory compliance with the new nutrition labeling requirements for food products that are initially introduced into interstate commerce is currently slated for July 26, 2018 (or July 26, 2019 for manufacturers … Continue Reading

Consumer Groups Sue FDA for Delaying Menu Labeling Rule

As previously covered on this blog, on May 4, 2017, FDA published an interim final rule that delays the compliance date for menu labeling requirements from May 5, 2017, until May 8, 2018 and invites comments for 60 days on the implementation of the menu labeling requirements. Yesterday, the Center for Science in the Public … Continue Reading

FDA Slated to Extend Compliance Dates for Agricultural Water Standards

Agricultural water can be a major conduit of pathogens that can contaminate produce. FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes agricultural water standards.  In particular, the Produce Safety Rule sets microbial quality standards for agricultural water, including irrigation water that comes into contact with produce.  In March 2017, the … Continue Reading

Kraft Motion to Dismiss ‘All Natural’ Lawsuit

Kraft seeks to end ‘all-natural’ sour cream labeling suit (subscription to Law360 required) Kraft Heinz Foods Co. (Kraft) asked the court (the U.S. District Court for the Eastern District of New York) to dismiss a putative class action over claims the “All Natural” label on its Breakstone’s sour cream is misleading because the sour cream … Continue Reading

More Than 99.5% of ‘Gluten-Free’ Products Tested by FDA in Compliance

As previously reported on this blog, in August 2013, the U.S. Food and Drug Administration (FDA) issued a final rule on “gluten-free” food labeling. After the final compliance date of August 5, 2014, FDA measured the gluten level of more than 250 different products labeled “gluten-free.” More than 99.5% of the food products labeled “gluten-free” … Continue Reading

Questions (and Answers) on FSVP

As previously covered on this blog, the general compliance date for the foreign supplier verification program (FSVP), under the Food Safety Modernization Act (FSMA), is May 30, 2017 (for a summary of which importers are covered by the general compliance date, see here). The U.S. Food and Drug Administration recently issued additional guidance for importers on … Continue Reading

USA Rice Questions Whether Riced Vegetables Can Use Rice In Their Name

USA Rice, in a recent blog post indicated that it is considering asking FDA and other regulatory agencies to “look into” the use of “rice” or “riced” in the name of vegetables that have gone through a ricer.  USA Rice President and CEO Betsy Ward states “Vegetables that have gone through a ricer are still … Continue Reading

CFS and Others Sue FDA Over GRAS Rule

FDA has premarket review authority over food additives; however, substances that are generally recognized as safe (GRAS) are not legally considered “food additives” as that term is defined under the Federal Food, Drug and Cosmetic Act, and therefore are not subject to the premarket clearance requirements that apply to other substances used in or in … Continue Reading