Tag Archives: FDA

FDA Releases Guidance Documents Concerning Animal Food CGMPs and the FSMA “Solely Engaged” Exemptions

As previously covered on this blog, the Final Rule for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, 80 Fed. Reg. 56170 (Sept. 17, 2015) under the Food Safety Modernization Act (FSMA) became effective on November 16, 2015.  Covered large and small businesses are now required to be in compliance … Continue Reading

San Francisco Ordinance Requires Grocery Chains to Disclose Antibiotic Use in Meat

For years, FDA, USDA, and various industry stakeholders have sought to tackle public health concerns associated with the use of medically important antibiotics to promote growth or feed efficiency in food-producing animals.  In the U.S., FDA is working with industry to gradually phase out the use of medically important antimicrobials in food animals for production … Continue Reading

FDA Announces November 2017 Public Meetings Concerning Its Agricultural Biotechnology Education and Outreach Initiative

On April 18, 2017, as the House Committee on Appropriations marked up the FY 2017 agriculture spending bill, more than 65 agriculture and food industry groups sent a letter to Congress urging Congress to appropriate $3 million to FDA to fund a joint FDA/USDA consumer outreach program to educate consumers about foods produced with genetically … Continue Reading

FDA Warns Bakery to Fix cGMP Violations and Remove the “Love”

On September 22, 2017, following an inspection of the company’s manufacturing facility, the U.S. Food and Drug Administration (FDA) issued a warning letter to Nashoba Brook Bakery regarding significant current Good Manufacturing Practice (cGMP) violations.  cGMPs describe the methods, equipment, facilities, and controls for producing food.  cGMPs prescribe the minimum sanitary and processing requirements for … Continue Reading

IFSAC to Host Webinar on Foodborne Illness Source Attribution Estimates

Created in 2011, the Interagency Food Safety Analytics Collaboration (IFSAC) is a partnership of three federal agencies—the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and the Food Safety and Inspection Service of the United States Department of Agriculture (FSIS). IFSAC aims to enhance the coordination of federal food safety analytic … Continue Reading

FDA Hints at Marijuana Health Claim Crackdown

As many of our readers may know, marijuana is listed as a Schedule I substance under federal law.  However, individual state laws do not always conform to the federal standard.  In eight states, the sale and possession of marijuana is legal for both medical and recreational use, and twenty-three states and the District of Columbia … Continue Reading

FDA Pushes for Sharing Whole Genome Sequencing to Promote Food Safety

Whole genome sequencing (WGS) provides insight into the genetic fingerprint of a pathogen by sequencing the chemical building blocks that make up its DNA and is increasingly being employed in food safety efforts.  Since 2012, the U.S. Food and Drug Administration (FDA) has regularly turned to WGS to better understand foodborne pathogens, including identifying the … Continue Reading

OIG: “Challenges Remain in FDA’s Inspections of Domestic Food Facilities”

A recently released Office of the Inspector General (OIG) report has found that the U.S. Food and Drug Administration (FDA) is making steady progress on its implementation of the Food Safety Modernization Act (FSMA) with specific regard to inspections of domestic food facilities, but challenges remain. In particular, the OIG found, in part, that: Although … Continue Reading

FDA Proposes Rule to Extend Nutrition Labeling Compliance Date 1.5 Years

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 set for July 26, 2018 (or July 26, 2019 for manufacturers with less than $10 million in annual food sales).  As previously covered on this blog, however, FDA announced … Continue Reading

Lawsuit Over FDA Delaying Menu Labeling Rule on Hold for Now

As previously reported on this blog, on June 7, 2017,  two nongovernment organizations (NGOs)—the Center for Science in the Public Interest and the National Consumer League—filed a complaint in U.S. District Court in Washington, D.C. against FDA for delaying implementation of the menu labeling rule. By way of background, the menu labeling provisions were added to the … Continue Reading

Gottlieb Tweets New Nutrition Labeling Compliance Date Extension “Closer to 18 Months”

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 previously covered on this blog, however, FDA announced … Continue Reading

FDA Requests Input on Reducing Regulations

As previously reported on this blog, the White House  issued Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs” on January 30, 2017. A few weeks later, on February 24, 2017, the White House issued Executive Order 13777, which directs each Agency to establish a Regulatory Reform Task Force (RRTF) to evaluate existing regulations and … Continue Reading

FDA Authorizes Qualified Health Claim Linking Early Peanut Introduction and Reduced Risk of Developing Peanut Allergy

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 C.F.R. 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 cannot … Continue Reading

FDA Issues Compliance Guide for Small Businesses under FSMA Produce Safety Rule

FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption.  Our detailed summary of the rule is available here. On September 5, 2017, FDA announced the availability of a Small Entity Compliance Guide (SECG) … Continue Reading

FDA Announces October Meeting on Pre-DSHEA List

Manufacturers or distributors of new dietary ingredients (NDIs) must submit a pre-market notification called a new dietary ingredient notification (NDIN) to FDA at least 75 days before marketing a dietary supplement that contains an NDI (i.e., one not marketed in the U.S. prior to October 15, 1994).  On August 12, 2016, FDA issued a revised Draft Guidance on … Continue Reading

FDA Delays Decision on Plant-Based Milk Labeling Petition

As previously reported on this blog, there is an ongoing debate on whether the use of the term “milk” by manufacturers of plant-based products—such as soy milk and almond milk—is a violation of milk’s standard of identity. On one side of the debate, the dairy industry has called on FDA to crack down on the … Continue Reading

FDA Releases Sixth Chapter of Draft Guidance for the Human HARPC Rule

As our readership is well aware, the Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food was published on September 17, 2015 (80 FR 55907), and compliance dates for some businesses began in September 2016.  The final rule implements hazard analysis and risk-based preventive controls (HARPC) for human food production. To facilitate compliance … Continue Reading

FDA Commissioner Issues Statement Touting Menu Labeling Rule, Announces Additional Guidance is Forthcoming

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

FDA Releases Compliance Guide for Small Businesses under FSMA Intentional Adulteration Rule

On May 27, 2016, FDA published its final rule to implement the intentional adulteration (or “food defense”) provisions of the FDA Food Safety Modernization Act (FSMA).  Click here for a copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule. In short, the final rule establishes various food defense measures that registered facilities are … Continue Reading

FDA Launches Food Safety Plan Builder to Facilitate FSMA Compliance

The Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food was published on September 17, 2015 (80 FR 55907), and compliance dates for some businesses began in September 2016.  The final rule implements hazard analysis and risk-based preventive controls (HARPC) for human food production. The new HARPC requirements implemented by the … Continue Reading

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
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