Samuel Jockel on Food and Drug Administration (FDA)

FDA Seeks to Reform Approach to Regulation of Ingredients Used in Animal Food

With the memorandum of understanding between the Food and Drug Administration (FDA) and the Association of Animal Feed Control Officials (AAFCO) set to expire, the FDA is proposing an alternative path to market for the...more

9/6/2024 / Agribusiness , Agricultural Sector , Animal Food , Food and Drug Administration (FDA) , Memorandum of Understanding , Product Labels , Regulatory Oversight

Feds Continue to Reform Approach to Regulation of Biotech Products

Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more

7/26/2024 / Agribusiness , Biologics , Biotechnology , Environmental Protection Agency (EPA) , Food and Drug Administration (FDA) , Genetically Engineered Animals , Genetically Engineered Seed , Life Sciences , Medical Devices , Pharmaceutical Industry , Regulatory Oversight , Regulatory Reform , Risk Mitigation , USDA

Food & Beverage Digest – Spring 2024: Juicier Than Ever

In the spring edition of the Food & Beverage Digest, our roundup of court cases and litigation trends affecting the food, beverage, agribusiness, and cosmetics industries, we ponder the significance of insignificant, real...more

6/14/2024 / Beverage Manufacturers , Class Action , Dietary Supplements , False Advertising , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Food Marketing , PFAS , Product Labels , Putative Class Actions

New Law Provides Food & Beverage Industry Protection Against Lawsuits Challenging “Healthy” Claims During Ongoing FDA Rulemaking

Our Food & Beverage Team reports good news for the industry: product labels can follow either the Food and Drug Administration’s current version or any new version of a rule defining “healthy.”...more

4/5/2024 / Advertising , Consolidated Appropriations Act (CAA) , Food and Drug Administration (FDA) , Food Labeling , Food Marketing , Product Labels , Regulatory Oversight , Risk Mitigation

FDA Proposes to Overhaul Labeling Requirements for Approved or Conditionally Approved New Animal Drugs

Nearly five decades after the FDA last reorganized animal drug labeling regulations, the agency has released a proposal to revise the requirements for the content and format of labeling for approved or conditionally approved...more

3/22/2024 / Animal Drugs , Animal Health , Biologics , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs , Product Labels , Regulatory Oversight

Cosmetics Update: FDA Publishes Draft Guidance on Cosmetic Product Facility Registration and Listing

Our FDA and Food & Beverage teams outline key requirements of the Modernization of Cosmetics Regulation Act (MoCRA) and provide key takeaways from the Food and Drug Administration’s new draft guidance on facility registration...more

8/10/2023 / Cosmetics , Disclosure Requirements , Distributors , Food and Drug Administration (FDA) , Manufacturers , Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

$19 Million Criminal Penalty Levied Against Food Manufacturer Serves as a Stark Reminder of the Importance of Food Safety...

A salmonella outbreak that sickened hundreds brought the largest criminal penalty ever imposed following a criminal conviction in a food safety case. Our Food & Beverage and White Collar, Government & Internal Investigations...more

2/16/2023 / Beverage Manufacturers , Blue Bell Creameries , CGMP , Criminal Prosecution , Department of Justice (DOJ) , Enforcement Actions , Federal Food Drug and Cosmetic Act (FFDCA) , Food & Drug Regulations , Food and Drug Administration (FDA) , Food Contamination , Food Manufacturers , Food Safety , Food Supply , Government Investigations , Kellogg Company , Popular , Public Health , White Collar Crimes

Food & Beverage Digest – November 2022: Home of Minty Fresh Class Actions

In the November edition of the Food & Beverage Digest, our roundup of court cases and regulations affecting the food, beverage, agribusiness, and cosmetics industries, kombucha creates a buzz, some purported smoked cheese...more

12/1/2022 / Beverage Manufacturers , Class Action , False Advertising , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Food Marketing , Nutrition Facts Labels , Product Labels

FDA’s Proposed Revamp of “Healthy” Claim Requirements: What Industry Should Do Now

Decades after the FDA first issued its initial definition of the claim “healthy,” its proposed new definition of the implied nutrient content claim used in the labeling of human food products is here. Our Food, Beverage &...more

10/3/2022 / Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Nutrition Facts Labels , Product Labels

Food and Drug Amendments of 2022 (PDUFA VII)

Our FDA and Health Care Policy teams discuss how sponsors and manufacturers can prepare for legislative and regulatory changes that could come from the final Food and Drug Amendments (PDUFA VII) and what companies can do...more

6/15/2022 / Food and Drug Administration (FDA) , Inspections , Life Sciences , Manufacturers , Medical Devices , Pharmaceutical Industry , Prescription Drugs , Public Policy , User Fees

FDA Extends Pause on Non-mission-critical Domestic Surveillance inspections to February 4 – Medical Products Supply Chain Week in...

In this week’s issue, OSHA withdrew its emergency temporary standard (ETS), which required a mandatory vaccination policy for large private employers with an exception for employers that adopt a policy requiring mandatory...more

2/1/2022 / Biden Administration , Centers for Disease Control and Prevention (CDC) , Coronavirus/COVID-19 , Cybersecurity , Department of Health and Human Services (HHS) , Executive Orders , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Medical Supplies , Pharmaceutical Industry , Prescription Drugs , Public Health Emergency , Supply Chain , Vaccinations

Bringing Dietary Supplements to Market: Key Requirements and Best Practices

Whether you are looking to enter the market or grow your footprint in the industry, you need to know what regulations are relevant and how to prepare to bring a dietary supplement to market. ...more

1/25/2022 / Dietary Supplements , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Labeling , Manufacturers , Marketing , Product Labels , Regulatory Requirements

FDA Suspends Non-Mission-Critical Domestic and Foreign Inspections – Medical Products Supply Chain Week in Review

Just before the New Year holiday, the FDA announced it that was suspending non-mission-critical domestic and foreign inspection activities. The FDA amended the EUA of the Moderna COVID-19 vaccine booster. The Center for Drug...more

1/18/2022 / Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Medical Supplies , Pharmaceutical Industry , Supply Chain , Vaccinations

FDA Authorizes Booster Dose for Adolescents – Medical Products Supply Chain Week in Review

Over the holidays, the CDC updated its recommendations for post-exposure quarantining and masking. The FDA authorized the Pfizer vaccine booster dose for adolescents 12–15 years of age and for immunocompromised children 5–11...more

1/4/2022 / Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Medical Supplies , Pharmaceutical Industry , Supply Chain , Vaccinations

Food & Beverage Digest – New Year’s 2022

In the New Year’s edition of the Food & Beverage Digest, our roundup of court cases and regulations affecting the food, beverage, agribusiness, and cosmetics industries, the FDA’s cherry pie standard warrants a review, salt...more

1/3/2022 / Advertising , Beverage Manufacturers , Class Action , False Advertising , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Food Marketing , Nutrition Facts Labels

FTC to Probe Supply Chain Issues of Major Companies – Medical Products Supply Chain Week in Review

In the past two weeks, the Federal Trade Commission (FTC) has ordered major U.S. companies to provide information on their supply chain issues and solutions. The FDA issued an emergency use authorization (EUA) for a...more

12/20/2021 / Emergency Use Authorization (EUA) , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Medical Supplies , Office of Foreign Assets Control (OFAC) , Supply Chain , Vaccinations

Pfizer and BioNTech to Request Approval for Vaccine Use in 12-to-15-Year-Olds – Medical Products Supply Chain Week in Review

In the past week, Pfizer and BioNTech announced they will request full approval from the FDA for the use of their COVID-19 vaccine in adolescents 12–15 years of age. They also plan to seek authorization of the booster dose in...more

12/6/2021 / Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Medical Devices , Medical Supplies , Pharmaceutical Industry , Popular , Supply Chain , Vaccinations

Samuel Jockel

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