Biotech, Food and Drug Legal Analysis

The food we eat and the medicine we put into our bodies are highly regulated by a variety of government agencies. In the United States by the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) regulate the processes by which food makes its way to the grocery store and medicine is approved for consumer use. As the science grows more complex behind the pharmaceutical and food industry, interpretation of the regulations in place is becoming more nuanced. Overseas, these industries are regulated by a variety of agencies; for example, the Minister of Agriculture in Canada, Centre for Food Safety in Hong Kong, and the Committee of Environmental, Public Health and Food Safety (EU), are among the many governing-bodies which regulate biotechnology, food, and drugs throughout the world.

The National Law Review is your free online resource to agency news, emerging topics in food and drug, and the latest in biotechnology updates. From nanotechnologies being used in research, to regulations of imported foods coming into the US from overseas or the development of medical devices and drugs, readers can find expert legal analysis of the developments in the industry, as well as reports on changes within the agencies that regulate these industries. The National Law Review also covers topics related to licensing, Food Safety and Inspection Services (FSIS), food and beverage regulation in the US and worldwide, nutrition labeling, and country of origin labeling guidelines.

With recent legislation being passed throughout the US in relation to marijuana use, both for recreational and medicinal purposes, readers will also find up-to-date information, litigation, and news coming from this area of interest as well. Regulations in California for labeling and proper sales of marijuana, to use in different states, or internationally, as well as rules for promoting and advertising marijuana are also covered on the site. Additionally, the development and changing landscape of tobacco use to include vaping, and how e-cigarettes and vaping are regulated, is also covered by NLR authors.

Readers who are interested in food safety, inspection, imports into the US, and regulations, these topics are covered regularly on The National Law Review as well. New legislation from the FDA, USDA, Department of Agriculture, and international bodies, are covered on the site. If you are looking for details on new nutrition-labeling regulations or health risks of consuming certain imported foods, you will find these topics, and many more, on The National Law Review.

For hourly updates on the latest news about biotech, food & drug, and cannabis laws, regulations, and legislation, be sure to follow our Cannabis Twitter feed, and sign up for complimentary e-news bulletins.

Date	Title	Organization
5 Feb	Kerry Inc. Pleads Guilty and Agrees to Pay $19.228 Million in Connection with Insanitary Plant Conditions Linked to 2018 Salmonella Poisoning Outbreak	The U.S. Department of Justice
3 Feb	Bankruptcy Court Finds Cannabis Employee Not Entitled to Chapter 13 Protection	Mintz
3 Feb	FDA Announces Qualified Health Claim for Cocoa Flavanols in High Flavanol Cocoa Powder and Reduced Risk of Cardiovascular Disease	Keller and Heckman LLP
3 Feb	Revamping of Cosmetics Regulation and Safety	Squire Patton Boggs (US) LLP
2 Feb	Food and Chemicals Unpacked: Extended Producer Responsibility: EPR You Ready? [PODCAST]	Keller and Heckman LLP
2 Feb	340B Covered Entities May See Access Changes to Contrast Media, Radiopharmaceuticals and Other Products	McDermott Will & Emery
2 Feb	EU Tightens Checks on Vanilla Extract from US	Keller and Heckman LLP
1 Feb	Not so FAST – AB 257 on Hold Pending Voter Referendum in 2024	Jackson Lewis P.C.
1 Feb	If at First You Don’t Succeed: Updated Medical Cannabis Bill Filed in South Carolina	Bradley Arant Boult Cummings LLP
1 Feb	Unpacking Averages: Using NLP to Assess FDA’s Compliance with Notice and Comment in Guidance Development	Epstein Becker & Green, P.C.
1 Feb	FDA Announces Proposed Redesign to Create Human Foods Program	Keller and Heckman LLP
31 Jan	Bankruptcy Court Doors Swing Open For Cannabis Companies, But Just Slightly	Squire Patton Boggs (US) LLP
31 Jan	The FDA Gets Blunt: “New Regulatory Pathway for CBD is Needed”	Dinsmore & Shohl LLP
31 Jan	Old North State Report – Jan. 30, 2023	Nelson Mullins
31 Jan	FDA Issues Final and Draft Guidance Documents Regarding Food Allergen Labeling	Epstein Becker & Green, P.C.
31 Jan	FDA Issues Procedural Notice on Front-of-Package Labeling Research	Keller and Heckman LLP
31 Jan	Are Medical Diagnostic Methods Patent Ineligible by Convention?: CareDx, Inc. v. Natera, Inc. and Eurofins Viracor, Inc.	K&L Gates
31 Jan	This Week in 340B: January 24 – 30, 2023	McDermott Will & Emery
30 Jan	FDA Announces Important Shift in CBD Products Regulation	Bradley Arant Boult Cummings LLP
30 Jan	FDA Finalizes Guidance to Prevent Unsafe Contamination of Animal Feed from Drug Carryover	Keller and Heckman LLP
29 Jan	Beltway Buzz, January 27, 2023	Ogletree, Deakins, Nash, Smoak & Stewart, P.C.
27 Jan	FDA Concludes that New Regulatory Frameworks for Foods and Supplements Containing Cannabidiol are Needed, Will Work with Congress	Keller and Heckman LLP
26 Jan	FDA Passes New Cannabis Guidance for Clinical Research	Beveridge & Diamond PC
26 Jan	2023 Federal Forecast – Agriculture	ArentFox Schiff LLP
26 Jan	Do the Products You Sell Contain PFAS?	Hunton Andrews Kurth
26 Jan	Cannabis: Goin’ to Carolina in My Mind	Bradley Arant Boult Cummings LLP
25 Jan	Further Restrictions on Food and Drink Labeling	OLIVARES
25 Jan	Modernization of Cosmetics Regulation Act of 2022: What You Need to Know	Foley & Lardner LLP
25 Jan	FDA Finalizes Cannabis Guidance Focusing on Clinical Research and Quality Considerations	Nelson Mullins
25 Jan	Costco’s Motion to Dismiss Misleading “Dolphin-Safe” Canned Tuna Class Action Denied	Keller and Heckman LLP
24 Jan	Take a Bite out of Crime: There’s More than One Way to Stem the Flow of Counterfeit Medications	Womble Bond Dickinson (US) LLP
24 Jan	Heavy Metal Updates: FDA Releases Draft Guidance with Action Levels for Lead and Another Heavy Metal Lawsuit Dismissed	Keller and Heckman LLP
24 Jan	Removing the Green Tax: Congress Can Bring Cannabis Tax Policy in Line with Cannabis Enforcement Policy	Bradley Arant Boult Cummings LLP
23 Jan	High Stakes: What to do Now That Your New Jersey Cannabis Business Application Has Been Approved by the CRC	Stark & Stark
23 Jan	What Can the Agriculture Sector Expect from Rep. Andy Harris on Agriculture and BioTech Appropriations	ArentFox Schiff LLP
23 Jan	USDA Finalizes the Strengthening Organic Enforcement Rule	Keller and Heckman LLP
20 Jan	Where In the World Did My Food Come From: FDA’s Food Traceability Rule Takes Effect	ArentFox Schiff LLP
20 Jan	French NGO Claims Certain Everyday Products Contain Unlabeled Nanomaterials	Bergeson & Campbell, P.C.
20 Jan	FDA Approval Mifepristone REMS Program Modification Expands Patient Access to Abortion Care	Sheppard, Mullin, Richter & Hampton LLP
20 Jan	USDA Expands Generic Label Approval for Meat, Poultry, and Egg Products	Keller and Heckman LLP
19 Jan	Preparing a Cannabis Application: Five Things I Learned	Bradley Arant Boult Cummings LLP
18 Jan	Congress Enacts Modernization of Cosmetics Regulation Act of 2022, Significantly Strengthening Regulation of Cosmetics	Bergeson & Campbell, P.C.
18 Jan	What’s Old Is New Again: Reviving “Fairness” With Renewed FTC Price Discrimination Enforcement And What That Means For Companies	Polsinelli PC
18 Jan	Recent Federal Developments in Chemical Law January 2023	Bergeson & Campbell, P.C.
18 Jan	First Major Overhaul of Cosmetics Regulation Since FDR Administration	Nelson Mullins
18 Jan	Plaintiffs Allege Failure to Declare Presence of Additives on Sparkling Water Label is Misleading	Keller and Heckman LLP
17 Jan	CMS Proposed Rule for Refunding Overpayments Would Align With False Claims Act “Knowledge” Standard	Mintz
17 Jan	Is Texas Getting Ready to Expand Its Compassionate Use Program?	Bradley Arant Boult Cummings LLP
17 Jan	Court Rules that “Brown Bread” is Not Misleading	Keller and Heckman LLP
17 Jan	Prop 65 Roundup - January 2023	ArentFox Schiff LLP
17 Jan	EPA’s Fall 2022 Unified Agenda Includes Proposed and Final TSCA and TRI Rules	Bergeson & Campbell, P.C.
16 Jan	Cannabis Lounges Coming to New Jersey	Norris McLaughlin P.A.
13 Jan	SweNanoSafe Publishes Notes from Fifth Annual Research Network Workshop	Bergeson & Campbell, P.C.
13 Jan	After Almost 25 Years, FTC Issues New Health Products Compliance Guidance	McDermott Will & Emery
13 Jan	Lead in your Spice Rack?	Womble Bond Dickinson (US) LLP
13 Jan	DEA Chopping Block: DATA-Waiver Requirement	Foley & Lardner LLP
13 Jan	FDA’s Center for Food Safety and Applied Nutrition Continues Evaluation of Heavy Metals in Food and Child Development	Keller and Heckman LLP
13 Jan	Higher Prices in Pennsylvania and Liquor Law Reform in New Jersey	Norris McLaughlin P.A.
12 Jan	USDA Releases Report on State Animal Welfare Policies	Keller and Heckman LLP
11 Jan	California Will Soon Protect Employees’ Off-Duty Cannabis Use	Greenberg Traurig, LLP
11 Jan	FDA Finalizes FSVP Guidance for Importers of Human and Animal Food	Keller and Heckman LLP
10 Jan	Cosmetics Regulations Get a Makeover: Congress Enacts New Requirements	Keller and Heckman LLP
10 Jan	Class Action Targets “No Artificial Sweeteners Claim”	Keller and Heckman LLP
10 Jan	FDA’s Holiday Present from Congress: Bipartisan Reforms to the Accelerated Approval Framework, Long-Awaited Cosmetic Modernization, and Expansion of Certain Existing Programs	Mintz
10 Jan	Get Your Restaurant Business Fit to Transact in 2023	Greenberg Traurig, LLP
10 Jan	10 Steps to Import Your Dream Horse and Minimize Risk Along the Neigh	Greenberg Traurig, LLP
10 Jan	BETO Announces New Notice of Intent for Improving Bioenergy Feedstocks and Optimizing Production of Biofuels and Biochemicals	Bergeson & Campbell, P.C.
10 Jan	GT Legal Food Talk Episode 18: Regulatory Review – Looking Back and Forward [PODCAST]	Greenberg Traurig, LLP
10 Jan	Cannabis Growers and Processors Must Be Aware of Applicable Environmental Laws	Varnum LLP
9 Jan	2023 Labor and Employment Outlook for Manufacturers	Robinson & Cole LLP
9 Jan	The Commission has Issued a Long-Awaited Proposal to Amend the CLP Regulation	Keller and Heckman LLP
9 Jan	FDA Removes L. monocytogenes From Protocol for the Development and EPA Registration of Treatments for Preharvest Agricultural Water	Keller and Heckman LLP
9 Jan	Highest French Administrative Court Lifts the Ban on CBD Flowers and Leaves	Squire Patton Boggs (US) LLP
8 Jan	Multinational Corporation and Several Individuals Charged with Multimillion-Dollar Organic Grain Fraud Scheme	The U.S. Department of Justice
7 Jan	Medical Device Company Zyno Medical LLC Agrees To Pay Nearly $500,000 To Resolve False Claims Act Allegations Relating to Defective Medical Device	The U.S. Department of Justice
7 Jan	CBP Officers at the San Ysidro Port of Entry Seize Over $2 Million Worth of Cocaine	U.S. Customs and Border Protection
6 Jan	Perrigo Co. v. Abbvie Inc. - Third Circuit Holds Mutual Release Bars Generic Drug Company’s Antitrust Claim Alleging That “Sham” Patent Infringement Litigation Delayed Generic Drug Launch	K&L Gates
6 Jan	District of Columbia Medical Cannabis Amendment Act Makes Sweeping Changes to Local Cannabis Laws	ArentFox Schiff LLP
6 Jan	FDA Issues Uniform Compliance Date for Final Food Labeling Regulations in 2023-24	Keller and Heckman LLP
6 Jan	TTB Industry Circular 3: Calculating Tax Rates and Tax Credits on Imported Distilled Spirits	McDermott Will & Emery
6 Jan	2022 TTB Industry Circular 2: Social Media Advertising	McDermott Will & Emery
6 Jan	2022 TTB Industry Circular 1: Consignment Sales	McDermott Will & Emery
6 Jan	Sweet (But Not Too Sugary) Victory: Court Dismisses Lawsuit Over Sprout Foods Baby Food Labeling	Proskauer Rose LLP
5 Jan	Breakthrough FDA Decision: Agency Completes Its First Pre-Market Consultation for Human Food Made from Cultured Animal Cells	K&L Gates
5 Jan	Biden Administration Publishes Unified Agenda, Revealing FDA’s Planned Regulatory Actions for 2023	Nelson Mullins
5 Jan	Foods Produced from Animal Cells: What’s in a Name?	Keller and Heckman LLP
5 Jan	Sesame Listed as Major Food Allergen	Keller and Heckman LLP
5 Jan	ANDA Filing Alone Insufficient for Induced Infringement of Method Patent	McDermott Will & Emery
5 Jan	If You Don’t Believe, You Won’t Receive: Predicting Three Cannabis Reforms in the Coming Year	Bradley Arant Boult Cummings LLP
4 Jan	Petition Filed to Add Polyphenylene Sulfide to List of Chemical Substances Subject to Superfund Excise Tax	Bergeson & Campbell, P.C.
4 Jan	IDR Payment Disputes are Far Outpacing Projections, Creating Backlogs	Squire Patton Boggs (US) LLP
4 Jan	California Judge Temporarily Enjoins Implementation of FAST Recovery Act	Ogletree, Deakins, Nash, Smoak & Stewart, P.C.
4 Jan	Target’s Fruit Punch Water Enhancer Class Action Permanently Dismissed	Keller and Heckman LLP
3 Jan	Cosmetic Regulatory Reform Finally Becomes Law	Mintz
3 Jan	2022, Who Were You? A Recap of Hot Issues in 2022.	Bradley Arant Boult Cummings LLP
3 Jan	FDA Releases 2022 Edition of the Food Code	Keller and Heckman LLP
3 Jan	A Way Too Early Prediction: Alabama Cannabis 2.0	Bradley Arant Boult Cummings LLP
31 Dec	China to Remove Infringing Pharmaceuticals from Procurement Platforms	Schwegman, Lundberg & Woessner, P.A.
30 Dec	Potential Litigation Impacts of the Modernization of Cosmetics Regulation Act of 2022	Greenberg Traurig, LLP
30 Dec	Companies Gear Up For Mass Production of Cultured Meat	Womble Bond Dickinson (US) LLP
30 Dec	New Cosmetic Regulatory Requirements: What Cosmetic Manufacturers Need to Know	Greenberg Traurig, LLP
29 Dec	Mississippi Medical Cannabis, Charles Dickens Style	Bradley Arant Boult Cummings LLP
29 Dec	Welcome (but Last Minute) Relief for Prescription Drug Reporting Originally Due December 27	McDermott Will & Emery
29 Dec	Petition Filed to Add Polyoxymethylene to List of Chemical Substances Subject to Superfund Excise Tax	Bergeson & Campbell, P.C.
29 Dec	Doctor-Patient Relationships and Medical Marijuana: Where Are We Now?	McDermott Will & Emery
28 Dec	EPA Finds Carbon Tetrachloride, as a Whole Chemical Substance, Poses an Unreasonable Risk to Human Health	Bergeson & Campbell, P.C.
28 Dec	Consolidated Appropriations Act, 2023 Contains Significant Provisions for Cosmetic Products	ArentFox Schiff LLP
28 Dec	RxDC Reporting Relief for Plans, Issuers, and Plan Service Providers	Foley & Lardner LLP
28 Dec	Federal Regulators Offer Employer Health Plans Last-Minute Relief on Prescription Drug Reporting	Ogletree, Deakins, Nash, Smoak & Stewart, P.C.
27 Dec	EPA Announces Removal of PFAS Chemicals from Approved Inert Ingredient List for Pesticide Products	Bergeson & Campbell, P.C.
27 Dec	FDA Expands Inspection Guidance to Apply to Device Manufacturers	Sheppard, Mullin, Richter & Hampton LLP
24 Dec	Back to the Drawing Board: CMS Proposes Changing the Overpayment Rule’s “Identified” Definition	McDermott Will & Emery
24 Dec	The Greatest Gift of All…Tri-Agencies Issue Welcome Relief on Prescription Drug Reporting	Proskauer Rose LLP
23 Dec	OECD Accepting Comment on Draft Study Report on Applicability of the key event based TG 442D for in vitro skin sensitisation testing of nano-materials	Bergeson & Campbell, P.C.
22 Dec	Omnibus Bill for Fiscal Year 2023 (H.R. 2617) – Cosmetics Summary	Keller and Heckman LLP
22 Dec	Consumer Reports Evaluates Heavy Metals in Chocolate	Keller and Heckman LLP
22 Dec	Heinz PFAS Consumer Fraud Lawsuit Continues 2022 Trend	CMBG3 Law
21 Dec	PTO Expands the Scope of the Immunotherapy Pilot Program	Schwegman, Lundberg & Woessner, P.A.
21 Dec	ANSES Applies Methodology to Assess Risks of Nanomaterials in Food to Titanium Dioxide	Bergeson & Campbell, P.C.
21 Dec	FTC Revises Longstanding “Dietary Supplement Guide” to Cover all Health Products	Hunton Andrews Kurth
21 Dec	FDA Issues Final Guidance on GRAS Panel Best Practices	Keller and Heckman LLP
20 Dec	Comment Period for “Healthy” Regulations Extended; But Consumer Class Actions Targeting “Health Halos” May Continue	Sheppard, Mullin, Richter & Hampton LLP
20 Dec	OSTP Publishes RFIs on Coordinated Framework for the Regulation of Biotechnology and National Biotechnology and Biomanufacturing Initiative	Bergeson & Campbell, P.C.
20 Dec	Mississippi Department of Health Releases Proposed Modifications to Medical Cannabis Regulations	Bradley Arant Boult Cummings LLP
20 Dec	California Legislative Update Part II: Upcoming Changes for Health Facilities	Mintz
20 Dec	Office of Science and Technology Policy Requests Public Input on Biotechnology Regulation	Keller and Heckman LLP
19 Dec	340B Hospital Reimbursement Update – Underpayments and the Need to Act Now	Polsinelli PC
19 Dec	Proposed Changes to the Canadian Feed Ingredients Table	Keller and Heckman LLP
16 Dec	FTC Starts Long-Awaited Green Guides Review	Keller and Heckman LLP
16 Dec	EUON Announces Results of Desk Study on (Bio)degradation, Persistence, and SbD of Nanomaterials	Bergeson & Campbell, P.C.
15 Dec	Psychedelic Drugs – Easing the Regulatory Hurdles for Development	Foley & Lardner LLP
15 Dec	Economically Motivated Adulteration in Honey	Keller and Heckman LLP
15 Dec	China Announces New Management Measures for Food-Related Products	Keller and Heckman LLP
14 Dec	FDA Published Food Safety Culture Literature Review	Keller and Heckman LLP
13 Dec	California’s Newly Adopted “Safe Harbor” Warning Label for Acrylamide In Foods Turns Up the Heat In Ongoing First Amendment Challenge to Proposition 65	Sheppard, Mullin, Richter & Hampton LLP
13 Dec	FDA Letter States that β-Nicotinamide Mononucleotide is Not Lawful Dietary Supplement	Keller and Heckman LLP
13 Dec	Warning Sign? A New Round of FDA Warning Letters Over CBD Consumer Confusion May Signal a Shift in Government Enforcement	Bradley Arant Boult Cummings LLP
12 Dec	American Hospital Association Urges DEA to Issue Special Registration for Telemedicine Controlled Substances	Foley & Lardner LLP
12 Dec	“Cold-Pressed Juice” Lawsuit Permanently Dismissed	Keller and Heckman LLP
10 Dec	HHS Goes Back to The Drawing Board on the 340B ADR Process	McDermott Will & Emery
8 Dec	FDA Releases Traceability Final Rule	K&L Gates
8 Dec	Like a Steam Locomotive, Rolling Down the Track: Biden Signs Marijuana Research Bill	Bradley Arant Boult Cummings LLP
8 Dec	DOJ Weighs in on SAFE Banking Act, Requests “Minor Changes”	ArentFox Schiff LLP
8 Dec	FSIS and FDA Continue to Investigate Food-Borne Illnesses	Keller and Heckman LLP
8 Dec	USDA Seeks Applications for Grants to Help Rural Businesses Produce and Market Value-Added Products	U.S. Department of Agriculture
7 Dec	Materials Available from EPA’s NAMs Conference and CompTox Chemicals Dashboard Training	Bergeson & Campbell, P.C.
7 Dec	External Evaluation of FDA’s Human Foods Program Published	Keller and Heckman LLP
7 Dec	New Law Eases Federal Restrictions on Medical Marijuana Research and Cultivation	ArentFox Schiff LLP
6 Dec	Don’t Let Drugs Bring You Down: The Importance of an Effective Drug Diversion Program	Sheppard, Mullin, Richter & Hampton LLP
6 Dec	USDA Receives Petition Requesting Amendment to Import for Personal Consumption Regulation	Keller and Heckman LLP