INSIDE COMPLIANCE – Page 20 – Loyola University Chicago School of Law

Got (Plant-Based) Milk? New FDA Guidance for Plant-Based Milk

March 9, 2023Uncategorized

Plant-based milks have been on the rise congruently with the movement towards living a plant-based diet and lifestyle. The FDA calls these products Plant-Based Milk Alternatives (PBMA). There are many different PBMA’s on the market, because there are a wide array of sources that can be used to produce PBMA’s and methods for processing. Some of the most popular examples of PBMA’s include oat milk, almond milk, and soy milk, but there are many PBMA’s made from other nuts, seeds, and alternative sources. PBMA’s are currently in the news because the FDA has just released draft labeling guidance (guidance) and recommendations for nutrition fact labeling. This draft guidance applies to any PBMA that uses “milk” in its name. The FDA’s draft labeling guidance will likely help educate more consumers on PBMA’s and their nutrition facts, hopefully leading to generally more informed consumers and labeling transparency.

FDARegulation

Regulatory Scrutiny of Crypto Exchange “Binance” May Cause it to Leave the U.S.

March 8, 2023Finance & Banking

State and federal regulators are opposing a billion-dollar deal between the cryptocurrency exchange Binance.US and the bankrupt cryptocurrency lender Voyager. The regulatory intervention is part of an ongoing struggle between Binance, the ultra-dominant cryptocurrency exchange, and U.S. regulators. Tensions between the two appear to be nearing a boiling point. The dispute also highlights an American regulatory environment that is increasingly hostile toward the cryptocurrency industry writ large, particularly in the wake of the FTX cryptocurrency exchange collapse.

Bankman-FriedBinanceBinance.USChangpeng ZhaocompliancecryptoCrypto-exchangeCryptocurrencycryptocurrency regulationDepartment of JusticefinanceFTXLetitia Jamesnew yorkNew York Attorney GeneralNYNY AG OfficeSam Bankman-FriedSECU.S.

Major Question Doctrine Stirs Controversy over Biden’s Debt Relief Plan

March 8, 2023Uncategorized

Last week, the Supreme Court began hearing oral arguments regarding President Biden’s $400 billion debt relief program. Two cases will be up before the Court that challenge President Biden’s Federal regulatory authority. The program aims to forgive $10,000 in student debt for borrowers earning less than $125,000 per year, while Pell grant recipients will be entitled to an additional $10,000 in debt forgiveness.

Biden AdministrationLitigationStudent Loan Debt ForgivenessSupreme Court

Healthcare Bribery Whistleblower Receives the Highest SEC Award in 2022

March 3, 2023Whistleblower Protections

The United States Securities and Exchange Commission (SEC) has announced that they have awarded upwards of $37 million to one whistleblower in 2022. This individual gave important information to the SEC that led to a successful enforcement action against a large European healthcare company. This award took the cake for being the highest payout to a whistleblower in 2022. What does a whistleblower program look like from the regulator’s point of view and why is it important?

enforcementhealthcarehealthcare compliance programsJournal of Regulatory ComplianceSECwhistleblower

The U.S. Department of Treasury Steps in to Patrol Petroleum

March 3, 2023Uncategorized

The US Treasury’s Office of Foreign Assets Control (OFAC) has sanctioned nine entities involved in the production, sale, and shipment of Iranian petrochemicals and petroleum to buyers in Asia, in violation of US sanctions. Six Iran-based petrochemical manufacturers and three firms in Malaysia and Singapore have been targeted for facilitating the sale and shipment of petroleum and petrochemicals on behalf of Triliance Petrochemical Co. Ltd., which OFAC previously designated for facilitating the sale of Iranian petroleum products. The sanctions are aimed at targeting Tehran’s sources of illicit revenue, and all property and interests in property of the targeted entities must be blocked and reported to OFAC.

AsiacomplianceInternational AffairsIranJournal of Regulatory ComplianceOFACPetroleumRegulationSanctions

Crypto Platforms Under Scrutiny by Various U.S. Agencies

March 2, 2023Uncategorized

Since the beginning of 2023, the cryptocurrency market has faced legal action from multiple U.S. agencies in efforts to control a sector that, until recently, mostly operated beyond the bounds of conventional financial regulation. As a result of the executive order issued by the Biden Administration in March 2022, various federal agencies examined the risk and benefits of cryptocurrencies and have issued official reports. These reports have led to coordinated action against the crypto market. The administration aims to “ensure that cryptocurrencies cannot undermine financial stability, to protect investors, and to hold bad actors accountable.” In their attempts to promote regulation, the Securities and Exchange Commission (SEC), the Department of Justice (DOJ), and the Financial Crimes Enforcement Network (FinCEN), a bureau of the U.S. Department of Treasury, have acted against the crypto market on several fronts, frightening off bank allies, suing crypto firms for violating investor protection laws, and targeting exchanges connected to money laundering.

CongresscryptoDepartment of JusticeDOJFinCENJournal of Regulatory Compliancemoney launderingSEC

The FTC’s Enforcement Action: GoodRx’s Failure to Protect Its Customers’ Personal Health Information

March 1, 2023Healthcare Compliance

On February 1, 2023, the Federal Trade Commission (FTC) brought an enforcement action against GoodRx, a provider of telehealth and prescription drug services at discounted rates. In a first-of-its-kind action, the FTC alleged that GoodRx violated the Health Breach Notification Rule (HBNR) by sharing their consumers’ confidential health information with several advertising companies. While GoodRx is already facing a $1.5 million penalty for the violation, the FTC has also proposed an order that will require GoodRx to remedy the situation and make several changes to protect confidential health information in the future.

breachenforcement actionFTCpersonal health records

Federal Safeguards Against Drug Shortages

March 1, 2023Drugs & Devices, Food and Drug Law, The Marketplace

From October 2022 to January 2023, there was a nationwide Adderall shortage. This recent shortage is no surprise since the Food and Drug Administration (FDA) has announced several Adderall shortages since 2019. Although the recent shortage has ended, researchers fear there will be more Adderall shortages in the coming year as prescribing rates continue to rise. More importantly, the recent shortage has made patients worried about future shortages and concerned about why the federal government has not done more to prevent drug shortages.

DrugsFDARegulation

The Rise of AI: Why Congress Must Regulate Artificial Intelligence Before it is too Late

February 26, 2023Compliance Spotlight

In November of last year, Open AI launched ChatGPT, an AI chatbot that engages users with dialogue to answer questions, write responses to prompts, and interacts with the user. Google quickly responded to the technological advancement by creating their own version of a chatbot called Bard that Google claims will draw “on information from the web to provide fresh, high-quality response.” AI has quickly embedded itself into most everyday activities. Additionally, in light of recent mass layoffs, experts predict that AI could displace tens of millions of jobs in the United States in the coming years. And with new chatbots run by AI, AIs have gone from simply replacing people to assisting people with tasks. As with all emerging technology, the general public may worry about regulating something that can be so intrusive and yet powerful and helpful to society. With the unsurmountable amount of knowledge provided by AI in seconds, it is necessary that Congress catch up to the emerging technology and create regulations for AI that can respect intellectual property and copyright laws and eradicate how AI adds to racial and gender disparities in the United States.

AIartificial intelligenceChapGPT

The Southwest Airline Debacle: What Role Should Regulators Play?

February 24, 2023Fraud & Abuse

To anyone who travelled by plane this last holiday season or tuned into the news, you’re well versed in the Southwest Airlines (Southwest) issues that plagued December 2022. Southwest ended up cancelling over 15,000 flights over the Christmas season, forcing thousands of stranded passengers to sleep at the airport and miss time with loved ones. With the disruptions leading to an estimated $825 million loss for the company, federal regulators have scrutinized Southwest to ensure compliance with its customer service plan and to take mitigating steps to prevent another catastrophe. This failure presents an opportunity beyond mere investigation for the Department of Transportation (DOT) to take important regulatory steps to ensure infrastructure and technology is aligned with the modern expectations of travel.

Journal of Regulatory ComplianceTransportation