Tag Archives: FDA

FDA: Antibiotics Sold and Distributed for Use in Food-Producing Animals Down in 2016

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 Discontinues Food Advisory Committee

The Food Advisory Committee was established on March 6, 1992 (57 FR 8064).  Over the years, the Committee has provided advice to the Commissioner of Food and Drugs and other appropriate officials on emerging food and cosmetic safety, food science, nutrition, and other food-related health issues. Today, the FDA announced in the Federal Register (82 … Continue Reading

FDA Publishes Draft Guidance Concerning “Refusal of Inspection”

Section 807(b) of the Federal Food, Drug, and Cosmetic Act, added by section 306 of the Food Safety Modernization Act (FSMA) authorizes the U.S. Food and Drug Administration (FDA) to refuse imported food from being admitted into the United States if the Agency is not permitted to inspect the foreign establishment that produced the food. … Continue Reading

IFSAC Publishes Paper on How to Categorize Foods Linked to Foodborne Disease Outbreaks

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 Takes New Approach to Produce Safety

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. When the Produce Safety Rule became final in November 2015, FDA began building the Produce Safety … Continue Reading

FSMA For Cotton Ginners?

Are cotton farmers and ginners subject to FDA’s Food Safety Modernization Act (FSMA)?  If you are a cotton ginner that is not a farm the answer is currently yes. FDA is currently exploring the extent to which cotton ginners should be covered by FSMA. Cotton farmers and ginners, of course, produce the fabrics that we use … Continue Reading

USDA Withdraws Biotech Regulation Proposal

As previously covered on this blog, on January 19, 2017, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS)published a proposed rule to update its regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered (GE) organisms in response to advances in genetic engineering and the Agency’s understanding of the plant … Continue Reading

Menu Labeling Update: FDA Releases Supplemental Draft Guidance

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 Study Shows Low Pesticide Levels in Food

Ninety-eight percent of domestic and 90% of imported foods tested in FY 2015 were compliant with federal pesticide residue limits, according to a U.S. Food and Drug Administration (FDA) report issued on November 6, 2017. The testing was done as part of FDA’s ongoing pesticide residue monitoring program, which began in 1987. By way of … Continue Reading

FDA Issues Guidance to Allow “Co-Manufacturers” Additional Time to Implement Certain Supply-Chain Program Requirements

As our readership is well aware, three of the rules created to implement the FDA Food Safety Modernization Act (FSMA) – Preventive Controls for Human Foods, Preventive Controls for Animal Food, and the Foreign Supplier Verification Programs – have requirements for a supply-chain program for certain raw materials and other ingredients. FDA has designed the … Continue Reading

FDA Releases Proposed Rule Seeking to Revoke Health Claim that Soy Protein Reduces Risk of Heart Disease

Since 1990, the U.S. Food and Drug Administration (FDA) has evaluated health claims on packaged foods to ensure that they are adequately substantiated. 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 … Continue Reading

New NARMS Report Shows Mixed Results on Antibiotic Resistance

The National Antimicrobial Resistance Monitoring System (NARMS), established in 1996, is a collaborative program of state and local public health departments and universities, the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the U.S. Department of Agriculture (USDA).  NARMS gathers surveillance data from human clinical samples, slaughter samples … Continue Reading

FSMA Update: FDA Launches Web Page with Compliance Dates

The U.S. Food and Drug Administration (FDA) introduced a new web page that consolidates the compliance dates for the Agency’s Food Safety Modernization Act (FSMA) rules. The rules that include compliance dates, in the order they became final, are: Preventive Controls for Human Food Preventive Controls for Animal Food Produce Safety Foreign Supplier Verification Sanitary … Continue Reading

FDA Commissioner Gottlieb indicates future of FDA’s role in defining claims such as “healthy”

As previously reported on this blog, the Food and Drug Administration (FDA) received a Citizen Petition from KIND in December 2015 requesting that the Agency revisit the definition of “healthy” – which has not changed since 1994 – to take into account present-day scientific understanding about the health benefits of many nutrient-dense foods.  In September … Continue Reading

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
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