Tag Archives: AGENCY POLICY

FDA Publishes Goals for Supporting Antimicrobial Stewardship in Veterinary Settings for Fiscal Years 2019-2023

On July 31, 2018, FDA announced that it was working on a five-year blueprint to combat antimicrobial resistance in animals.  On September 14, 2018, FDA published Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for Fiscal Years 2019-2023. FDA provides action items to promote three goals; we summarize several major steps for each; Align Antimicrobial Drug … Continue Reading

FDA Announces Increased Enforcement to Curb Youth E-Cigarette Use

In a September 12, 2018 press release, FDA announced its largest coordinated enforcement effort in agency history to address what it described as an “epidemic” of e-cigarette use in minors, based on not-yet-released survey data.  As part of its enforcement since June 2018, FDA has issued 1,300 warning letters and imposed civil penalties on brick-and-mortar … Continue Reading

FDA Releases Q&A for Preventive Controls for Animal Foods

In light of the approaching September 17, 2018 compliance date for small animal food businesses (i.e., those with less than 500 full-time equivalent employees) to comply with Hazard Analysis and Risk-Based Preventive Controls (HARPC) rules, FDA has released a Q&A document concerning what to expect in the near term regarding FDA enforcement and inspections. The … Continue Reading

Groups Petition FSIS to Change “Product of the USA” Policy

The Organization for Competitive Markets (OCM) and American Grassfed Association (AGA) have petitioned the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) to change its standard for making a “Product of the USA” claim on meat and meat products. Currently, FSIS allows the statement “Product of USA” if either (1) the country to which the product is … 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

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

“Healthy” Update: Industry, Others Weigh In on ‘Healthy’ Claims

As previously reported on this blog, 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, and in September 2016, FDA issued a request … Continue Reading

USDA Publishes Proposed Rule to Revamp Its Biotechnology Regulations

For decades, the United States 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 … Continue Reading

The Hullabaloo about Healthy: FDA Formally Seeks to Redefine “Healthy”

FDA requests comments on “healthy” definition and issues guidance regarding the use of the term “healthy” in the labeling of human food products. FDA regulations prescribe qualifying criteria for foods to bear the claim that they are “healthy” (including related terms) (21 CFR 101.65(d)).  Among other factors, a “healthy” food generally must contain 3 grams or less … Continue Reading

Organic Melee: USDA Loses Latest Round in Legal Challenge Over Synthetics in Organic Production

A district court judge has denied USDA’s motion to dismiss a lawsuit alleging that the Agency illegally changed its process for reviewing synthetic substances used in organic production. By way of background, the U.S. Department of Agriculture (USDA) administers the National Organic Program (NOP), which includes standards for “organic” food in the United States.  The … Continue Reading

FVM Futures

FDA releases Foods and Veterinary Medicine (FVM) program’s future plans. FDA’s Foods and Veterinary Medicine (FVM) program encompasses the Office of Foods and Veterinary Medicine (OFVM), the Center for Food Safety and Applied Nutrition (CFSAN), and the Center for Veterinary Medicine (CVM), as well as related activities under the Office of Global Regulatory Operations and … Continue Reading

Recalls Revisited

HHS OIG issues early alert criticizing FDA’s food recall procedures. Under the FDA Food Safety Modernization Act (FSMA), FDA now has mandatory recall authority over conventional foods.  However, FDA has only threatened the use of this authority twice.  In reality, firms continue to work voluntarily with FDA to recall risky foods under the Agency’s recall … Continue Reading

Honing in on “Healthy”

FDA to revisit definition of “healthy” on food labels. FDA regulations prescribe qualifying criteria for foods to bear the claim that they are “healthy” (including related terms) (21 CFR 101.65(d)).  Among other factors, a “healthy” food generally must contain 3 grams or less of total fat per serving and 1 gram or less of saturated fat per … Continue Reading

Pets and Vets: Therapeutic Vet Diet CPG Finalized

FDA finalizes enforcement policy with respect to therapeutic veterinary diets. As a general matter, companies may not make therapeutic or “drug” claims in connection with the marketing of food or feed, including pet food.  However, in reality, therapeutic pet food products have been marketed for years without official drug approvals in accordance with FDA’s longstanding enforcement discretion … Continue Reading

Lunch Lines, Lunch Fines

USDA proposes rule to enhance enforcement of nutrition standards in schools. Enacted in 2010, the Healthy, Hunger-Free Kids Act (HHFKA) set nutrition standards for schools.  First Lady Michelle Obama is a prominent supporter of the law and its underlying goal to improve childhood nutrition and combat obesity. On March 29, USDA’s Food and Nutrition Service … Continue Reading

Ninth Circuit Neutralizers

Ninth Circuit puts food labeling challenge on hold pending FDA action. As food industry stakeholders are well aware, “natural” claims invite the risk of consumer class action challenges in the absence of any formal regulatory definition or regime to govern the use of the term.  Similarly, food companies also have faced challenges related to the use of … Continue Reading

Cheese Controls

FDA revisiting its safety criteria for raw milk cheese. For years, FDA has been warning consumers about the potential health risks associated with consuming raw milk products (i.e., products made from unpasteurized milk).  The Agency also has included raw milk cheese in its systematic surveillance sampling program.  In 2010, FDA published a Compliance Policy Guide (CPG) to … Continue Reading

Ample Samples

FDA targets cucumbers and hot peppers as part of its FY 2016 sampling program. Since 2014, FDA has been developing a robust surveillance sampling program intended to promote food safety.  The Agency’s sampling approach involves the collection of a statistically determined number of samples of targeted foods over a 12- to 18-month period and the testing … Continue Reading

The Nuances of “Natural”

FDA requests comments on “natural” definition. As food industry stakeholders are well aware, the use of the term “natural” in food labeling and advertising is fraught with ambiguity and risk of challenge.  FDA’s informal policy is that “natural” means nothing artificial (including artificial flavors) or synthetic (including all color additives regardless of source) has been included in … Continue Reading

IND Inroads

FDA stays portions of IND guidance and provides greater flexibility to research health benefits of foods. As a general matter, human clinical research studies to evaluate the therapeutic benefits of a substance are subject to FDA’s Investigational New Drug Application (IND) process.  In September 2013, FDA issued a final guidance document regarding how to determine whether and … Continue Reading

Safety Grants

USDA-NIFA provides grants to establish two regional food safety centers. As previously covered on this blog, FDA recently released its FSMA Training Strategy, indicating the Agency’s roadmap for facilitating industry training and thus promoting effective implementation of the FDA Food Safety Modernization Act (FSMA).  As part of its plan FDA is partnering with the U.S. Department … Continue Reading
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