Thomas (Tommy) Tobin Counsel

The FDA recently launched an updated dietary supplement ingredient directory titled "Information on Select Dietary Supplement Ingredients and Other Substances," replacing FDA’s "Dietary Supplement Ingredient Directory," released March 2023.

The U.S. Food & Drug Administration recently published revisions to its multichapter draft guidance for industry on Hazard Analysis and Risk-Based Preventive Controls for Human Food. More specifically, FDA revised the draft Introduction, as well as draft Appendix 1, to address stakeholder comments submitted on prior drafts made available in 2016.

Perkins Coie is pleased to announce the launch of our eighth annual Food & Consumer Packaged Goods Litigation Year in Review.

The U.S. Food and Drug Administration recently released an updated list of guidance documents that the agency plans to publish in draft or final form throughout 2024.

Perkins Coie is pleased to publish its Q4 Food and CPG Legal Trends Report.

Brian Sylvester and Tommy Tobin authored a Food Safety Magazine article titled "Cultivated Meat: How FDA and USDA are Addressing Food Safety" detailing what cultivated meat is, who is in charge of regulating it, the current landscape of the industry, and key takeaways for food safety professionals.

On November 30, 2023, FDA announced the availability of new resources for stakeholders to facilitate compliance with the Food Traceability Rule.

On November 1, 2023, the U.S. Food and Drug Administration (FDA) published a proposed rule to amend Prior Notice requirements for imported human and animal food.

The U.S. Courts of Appeal for the Second and Ninth Circuits recently issued rulings reinforcing the reasonable consumer standard. In doing so, these cases refine prior precedent and strengthen a court’s ability to properly dismiss cases over labeling claims where no reasonable consumer could plausibly be misled.

Perkins Coie is pleased to publish its Q3 Food and CPG Legal Trends Report.

In the beauty, cosmetics, and personal care world, companies are preparing to comply with upcoming Modernization of Cosmetics Regulation Act provisions of the Federal Food, Drug and Cosmetic Act, which is going into effect on December 29, 2023.

Federal Rule of Evidence 702, which governs expert testimony in federal court, is getting a facelift. The amended FRE 702 goes into effect later this year. In this Update, we review what has changed, as well as takeaways for litigants looking to introduce expert testimony in federal courts.

On September 26, 2023, the U.S. Food & Drug Administration added two new chapters to the agency’s draft guidance: Chapter 11: Food Allergen Program and Chapter 16: Acidified Foods.

Perkins Coie is pleased to announce the launch of our first midyear Food and Consumer Packaged Goods (CPG) Legal Trends Report.

The U.S. Food and Drug Administration (FDA) issued guidance on August 7, 2023, clarifying new requirements for cosmetic facility registrations and product listings under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

Andrew Kline and Tommy Tobin wrote an article published in Law360 on the what the U.S. Supreme Court ruling in National Pork Producers Council v. Ross means for interstate commerce in regards to cannabis.

The fashion industry, known for its dynamic and ever-evolving nature, is embracing environmental, social and governance principles like never before.

In June 2023, the U.S. Department of Agriculture Food Safety and Inspection Service (USDA-FSIS) issued new Directives and a Notice regarding the regulation of cell cultured food products derived from cell lines of USDA-amenable species.

On July 12, 2023, the U.S. Food and Drug Administration released a public inventory of certain food ingredients that the agency has determined are unsafe because they are unapproved food additives that are not Generally Recognized as Safe when used as intended. Concurrently, FDA also released lists of select chemicals in the food supply—including food ingredients, food contact substances, and contaminants under agency review.

Oregon is the first state in the country to offer controlled use of psilocybin to the public. As we detailed in a prior update, the state had finalized regulations. Now, the state has licensed its first psilocybin service centers.

Cell-cultured meat and poultry products have crossed an important milestone on their way to the market. The U.S. Department of Agriculture’s Food Safety and Inspection Service has issued new directives designed to implement the 2019 Formal Agreement between USDA-FSIS and FDA regulating cell-cultured meat.

Andrew Kline and Tommy Tobin share potential outcomes from the Food and Drug Administration’s ongoing review of marijuana regulations.

In recent years, the apparel, fashion, and luxury goods industries have seen an increased focus on environmental, social, and governance (ESG) initiatives.

Governor Jay Inslee signed Washington state’s Toxic-Free Cosmetic Act into law on May 15, 2023. The Act sets stringent standards for companies operating within the state, aiming to eliminate the use of toxic ingredients in cosmetics and personal care products.

The American Bar Association's 2023 Antitrust Spring Meeting, held in Washington, D.C., placed heavy emphasis on employees, contractors, and talent. Government officials, judges, academics, and the private bar debated cutting-edge competition issues affecting workers and labor markets, including criminal enforcement, amicus efforts, public engagement, and rulemaking. Prosecutors sent a clear message that they view no-solicitation, no-poach, and wage-fixing agreements as criminal violations, even in the face of several jury trial setbacks.

The American Bar Association's 2023 antitrust spring meeting, held in Washington, D.C. in March, had a heavy emphasis on upstream markets affecting employees and talent.

Can states restrict ownership of licensed businesses to state residents only? The answer to this question would generally be a straightforward no — states cannot attempt to provide undue, preferential treatment to their own citizens over those from other states.

Two recent developments at the federal level are intended to encourage more food donations. First, President Biden signed the Food Donation Improvement Act, which expands Good Samaritan liability protections. Second, the U.S. Food and Drug Administration announced its 2022 Food Code.

Cannabis companies can find themselves in financial distress but are generally locked out of the federal bankruptcy courts.

Perkins Coie is pleased to announce the launch of our seventh annual Food & Consumer Packaged Goods Litigation Year in Review. Accompanying the 2022 report are infographics that highlight key litigation outcomes, filing data, and industry trends.

In late December 2022, the White House Office of National Drug Control Policy, or ONDCP, released its annual drug enforcement report to Congress, focusing in part on high-intensity drug trafficking areas.

Chapter 11 bankruptcy has historically been inaccessible to cannabis and cannabis adjacent businesses. But a Los Angeles bankruptcy court recently denied a motion to dismiss the case of a debtor in the business of wholesale manufacturing and packaging of cannabis products. The decision gives hope that bankruptcy could be a viable path for companies that seek to eliminate risk of future violations of the Controlled Substances Act.

The U.S. Department of Agriculture announced that it has issued a new final rule entitled Strengthening Organic Enforcement. This Update discusses the new regulation and its implications for enforcement. 

The year ahead has much in store for the cannabis industry. Below, we outline some areas to watch at both the state and federal levels.

Oregon became the first state to offer controlled use of psilocybin to the public on January 1, 2023. This Update provides an overview of the new Oregon Health Authority regulations to implement the state’s first-in-the-nation psilocybin program.

The U.S. Food and Drug Administration recently updated its FDA Food Code, requiring new obligations for disclosing major food allergens.

Buried within the thousands of pages of the Consolidated Appropriations Act of 2023 is the most significant statutory expansion over cosmetics to the U.S. Food and Drug Administration’s authority since 1938. Among the spending bill’s many provisions is the Modernization of Cosmetics Regulation Act of 2022, which will have lasting effects on the cosmetics industry. Among other measures, MOCRA will provide FDA authority to conduct mandatory cosmetics recalls, create adverse event reporting and recordkeeping requirements, and establish good manufacturing practices.

The statute of limitations for an action for misappropriation of trade secrets is three years from the time that the misappropriation is discovered, or by exercise of reasonable diligence should have been discovered.

In a rapid shake-up of the antitrust lawsuit filed against the PGA Tour Inc., professional golfers Carlos Ortiz, Abraham Ancer, Pat Perez, and Jason Kokrak have withdrawn from the case.

In a rapid shake-up of the antitrust lawsuit filed against the PGA Tour Inc., professional golfers Carlos Ortiz, Abraham Ancer, Pat Perez and Jason Kokrak have withdrawn from the case.

On July 21, the Cannabis Administration and Opportunity Act was introduced by sponsoring Sen. Cory Booker, D-N.J., and co-sponsors Senate Majority Leader Chuck Schumer, D-N.Y., and Sens. Ron Wyden, D-Ore., Patty Murray, D-Wash., and Gary Peters, D-Mich.

A group of 11 professional golfers launched an antitrust suit in the U.S. District Court for the Northern District of California against the PGA Tour, Inc.

More than 20 state attorneys general (AGs) authored an open letter to congressional leaders calling for legislation that would regulate tetrahydrocannabinol (THC) edibles that mimic the packaging and names of popular products.

On May 4, the U.S. Food and Drug Administration issued new warning letters to five companies selling products containing Delta-8 THC, an intoxicating cannabinoid derived from hemp according to the Law360 article. In announcing the warning letters, the agency advised that "Delta-8 THC has psychoactive and intoxicating effects and may be dangerous to consumers."

This practice note provides practical insight regarding the Dormant Commerce Clause as it applies to the cannabis industry.

Almost all junior associates are introduced to internal investigations on the job. Given how important interviews with corporate employees can be to the investigational process, junior associates new to this tricky subject will want to understand the basics of the process. This article includes five critical tips for tangling with internal investigation work.

Perkins Coie is pleased to announce the launch of our sixth annual Food Litigation Year in Review. In recognition of the firm’s practice expansion, this year-in-review report has been broadened to the Food & Consumer Packaged Goods Litigation Year in Review.

Vaguely recalled by practicing attorneys, the Dormant Commerce Clause (DCC) is often the bane of first-year students’ Constitutional Law courses.

Offers attorneys of all stripes an introduction to how different areas of law and legal practice intersect with food. Ranging from intellectual property to food policy and food regulation, this guide aims to whet the appetite for individuals looking to engage with the unique needs of clients in the food and beverage industry.

Starting this October, millions of American households on food stamps will see their benefits increase significantly.

The pandemic has exacerbated issues of food insecurity across the country, with millions of Americans struggling to regularly afford food for their households.

From investors and shareholders to customers and employees, key stakeholders are increasingly demanding both corporate action and broad-based public disclosure of environmental, social, and governance (ESG) issues. As corporations take action and report on their ESG challenges and achievements, they will be well served to take steps to mitigate the risks of both regulatory enforcement and private litigation. 

In 2019 and 2020 alone, there were over 100 class action cases filed against cannabis companies, with many focused on issues regarding cannabis labeling, marketing, and disclosures. This article outlines recent cannabis class action trends from across the country.

Cannabis business faces a dizzying array of federal and state laws presenting significant challenges for companies attempting to comply with this increasingly complex patchwork of rules.

Families in New York are still struggling to secure adequate food during the pandemic. The unemployment rate statewide this February was 8.9%, more than double the rate a year ago.

As the economic consequences of the COVID-19 pandemic continue to reverberate across the country, the U.S. Department of Agriculture has taken steps to expand food stamp eligibility for those most at risk of hunger. 

On March 19, 2021, California’s Office of Environmental Health Hazard Assessment (OEHHA) announced proposed regulations that would significantly affect the warning requirements for products that cause exposure to cannabis smoke and/or delta-9-tetrahydrocannabinol (THC).

Last week, the House of Representatives passed the George Floyd Justice in Policing Act (H.R. 1280). Among other things, the bill would eliminate local law enforcement officers’ ability to use the doctrine of qualified immunity to shield themselves from liability for misconduct. Read the full article on The Hill.

In November 2020, California voters approved a new data privacy law. Unfortunately, the law contains a provision that may threaten the future of digital content for underrepresented communities.

The passage of the California Privacy Rights Act more closely aligns the consumer privacy standards of one of the United States’ most economically important jurisdictions with those of the European Union.

On January 8, 2021, California’s Office of Environmental Health Hazard Assessment (OEHHA) announced proposed regulations that would significantly affect how businesses may use short-form Proposition 65 warnings.

It often is more favorable for a defendant to litigate a case in federal court rather than state court. Federal courts, however, are courts of limited jurisdiction. A mechanism called “snap removal” may allow defendants to litigate cases in federal court when removals ordinarily would not be permitted.

Proposition 65 warning requirements announced last year are set to be enforced starting January 3, 2021; if your business is selling cannabis products in California, now is the time to ensure that your labeling complies with state requirements. 

As the dust clears from the 2020 general election, four more states have legalized recreational marijuana, bringing the total up to 15 states and the District of Columbia.

The global pandemic related to the novel coronavirus has altered daily life for food producers and consumers. These changes have affected not only how individuals work but also the way producers supply food, how consumers shop, and how regulators approach the food system during the pandemic. Months into the public health emergency, the story is still being written.

The cannabis industry’s rapid growth presents companies with the need to protect their brands from trademark infringement, and to avoid infringing on the trademarks of others.

Amid anti-racism protests nationwide and police-reform efforts, there is no time like the present to take a close look at “qualified immunity”—a legal doctrine that can restrict citizens’ ability to recover damages for civil rights violations by shielding government officials from lawsuits and civil liability.

The cannabidiol (CBD) industry has seen a new wave of consumer class actions. The industry is poised to see further cases, especially as the market for CBD-containing products grows.

Marijuana businesses, especially those in the medical marijuana industry, often have access to sensitive consumer information.

On July 15, 2020, a California state court made an important ruling upholding the validity and application of regulations exempting coffee from Proposition 65 warnings.

The forum defendant rule, which is codified at Title 21 of the U.S Code, Section 1441(b)(2), might stir up vague memories of civil procedure courses long ago. Litigators should shake off the cobwebs, as federal courts are increasingly reevaluating the application of this rule when an in-state defendant has not yet been served.

The U.S. Food and Drug Administration (FDA) submitted a report to Congress on July 8, 2020, providing an analysis of the cannabidiol (CBD) marketplace.

Amid the COVID-19 pandemic, cosmetic companies continue to see growing numbers of class action litigation cases targeting the industry.

CBD companies facing class action lawsuits regarding product labeling during this time of regulatory uncertainty have a reasonable chance of succeeding in a motion to stay on primary jurisdiction grounds, say Perkins Coie attorneys. But, they must be sure to tie anticipated agency rulemaking to the claims at issue before the court.

The COVID-19 pandemic has caused economic disruption across the country, leading to layoffs comparable not only to those of the Great Recession a decade ago but among the highest rates since World War II. The economic challenges facing American families have led to increased difficulty in accessing affordable and healthful food.

Cannabis companies are facing a slew of class action lawsuits under the Telephone Consumer Protection Act (TCPA), which prohibits unwanted automated calls and text messages.

Retailers hit by the economic downturn are considering bankruptcy protections.

The marijuana industry has not escaped the economic impacts of the coronavirus pandemic, and contract issues are a particular concern. 

In recent days the federal government has taken two significant steps to increase healthcare funding to assist providers in responding to the medical and economic consequences of the novel coronavirus pandemic.

Amid the COVID-19 pandemic, many manufacturers are pivoting their production lines to make personal protective equipment and other much-needed supplies to aid consumers and healthcare professionals in the fight against the disease.

The Families First Coronavirus Response Act created a set of expansions to federal food assistance programs designed to provide relief to families across the nation struggling with the economic disruptions caused by the COVID-19 public health emergency.

About a month ago, the Families First Coronavirus Response Act created a pandemic electronic benefit transfer (P-EBT) program to give low-income families access to nutritious food while schools are closed. That law was enacted on March 18th and required states to submit, and the U.S. Department of Agriculture (USDA) to approve, plans to operate the new P-EBT program.

The Coronavirus Aid, Relief, and Economic Security Act, known as the “CARES Act,” became law on March 27, 2020. The CARES Act implements wide-ranging changes to law and funding designed to ameliorate the coronavirus pandemic’s impact on the American economy and its workers.

The federal Department of Health and Human Services (HHS) on March 13, 2020, invoked its authority under section 1135 of the Social Security Act (the act) to waive certain requirements that providers normally must meet to receive reimbursement for services to Medicare, Medicaid, and Children’s Hospital Insurance Program (CHIP) beneficiaries

By a vote of 363-40 the U.S. House of Representatives passed H.R. 6201, the Families First Coronavirus Response Act, on March 14, 2020. The bill now proceeds to the U.S. Senate, and the White House has voiced its support for the legislation.

The U.S. Department of Justice (DOJ) has reached a settlement with hospice company AseraCare, closing a 12-year-old saga that carries substantial implications for False Claims Act (FCA) enforcement in cases involving a clinician’s medical judgement.

The ever-expanding market for alternative proteins shows no signs of being a mere food fad.

California’s Office of Environmental Health Hazard Assessment (OEHHA) added Δ9‑tetrahydrocannabinol, better known as “THC,” to the list of chemicals requiring specific labeling for retail sale in California. 

In 2019, the White House proposed changes to the food safety net that could drastically affect whether Americans who are at risk of hunger will go without food. Over the coming year, many of these changes will go into effect and will lead to millions of individuals losing eligibility for food assistance.

In his State of the Union address Tuesday night, President Trump declared that “poverty is plummeting” and that over the past three years this has resulted in “7 million Americans” coming off of food stamps.

California’s Office of Environmental Health Hazard Assessment (OEHHA) issued finalized amendments on January 14, 2020 to California’s Safe Drinking Water and Toxic Enforcement Act of 1986.

The absence of clear federal guidance regarding food and beverages that contain cannabidiol (CBD) has led to a patchwork of state-level regulatory actions across the country. Without uniform guidelines, states have adopted varying and often conflicting approaches.

A flurry of recent class action lawsuits against manufacturers of CBD products involving a range of claims—from marketing to stock pricing to CBD content—should put the industry on alert. Perkins Coie attorneys look at the recent spate of class actions, what the FDA is doing, and offer mitigating steps for CBD suppliers and manufacturers.

On the heels of the U.S. Food and Drug Administration’s (FDA) recent declarations regarding the safety of products containing cannabidiol (CBD), several companies have been hit with class action lawsuits alleging that the company’s CBD-containing products are mislabeled and falsely advertised in violation of state law.

On November 25, 2019, the U.S. Food and Drug Administration (FDA) took several significant actions regarding sellers of products containing cannabidiol (CBD).

Food & Consumer Packaged Goods Litigation
The Food Safety Modernization Act (FSMA) ushered in a sea change in the government’s regulation of food safety. Pursuant to FSMA, the FDA has promulgated a series of rules, including a 2015 rule related to the Foreign Supplier Verification Programs (the FSVP Rule).

A practical overview of the Attorney-Client Privilege and the Work Product Doctrine, as well as common challenges to these protections. Common pitfalls facing practitioners and case examples from specific jurisdictions with unique rules regarding these protections.