Tag Archives: AGENCY POLICY

Important Details Remain Unsettled Following USDA and FDA Announcement of Decision to Jointly Regulate Cell-Cultured Meat

As previously reported on this blog, the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) have both claimed regulatory oversight of cell-cultured meat, a product that some say could be available for marketing in as early as three years.  Federal law grants regulatory authority over meat products, poultry, catfish, and … Continue Reading

FDA Announces New Steps to Protect Youth From Tobacco Harms; National Youth Tobacco Survey Results Released

On November 15, FDA and the Centers for Disease Control (CDC) published the results of the National Youth Tobacco Survey (NYTS).  As summarized in their joint Statement, the “NYTS is a cross-sectional, voluntary, school-based, self-administered, pencil-and-paper survey of U.S. middle and high school students.”  Results of the survey showed a 78 percent increase from 2017 … Continue Reading

FDA Emphasizes Continued Commitment to Develop a Strong Tobacco Product Application Review Process

In an October 22, 2018 press release, FDA Commissioner Scott Gottlieb, M.D., emphasized the agency’s ongoing commitment to significantly reduce tobacco-related disease and death, with particular emphasis on protecting kids from the dangers of nicotine. In order to do so, FDA asserted the critical need to have an efficient regulatory process that puts novel products, … Continue Reading

USDA Secretary Signals USDA Role Over Animal Cell Culture Technology Regulation Ahead of Joint USDA-FDA Meeting

As previously reported on this blog, the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) announced that they will hold a joint meeting on October 23-24, 2018, to discuss the use of cell culture technology to develop products derived from livestock and poultry. The meeting will focus on potential hazards, regulatory … Continue Reading

FDA Collects Thousands of Pages of Documents in Inspection of JUUL Labs

On April 24, 2018, FDA announced its Youth Tobacco Prevention Plan to stop adolescent use of, and access to, vapor products.  FDA followed up on its announcement by issuing 17 warning letters for marketing e-liquids in allegedly misbranded and misleading packaging found  to be appealing to youth.  In September, FDA announced that it has issued … Continue Reading

FDA Issues Policy and Related Draft Guidance on Publicizing List of Retailers in Certain Food Recall Situations

FDA Commissioner Scott Gottlieb announced on September 26, 2018 a new FDA policy on disclosing retail information for products subject to food recalls—particularly in Class I recall situations, where consumption of the food has a reasonable probability of causing serious adverse health consequences or death to humans or animals.  Historically, the agency has not released … Continue Reading

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
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