INSIDE COMPLIANCE

Infant Formula Shortage: How has the FDA Altered Regulations to Help?

March 21, 2023Amanda ScottFDALeave a comment

Over the past year, the nation has been concerned over an infant formula shortage that has become a crisis for many families in the United States. The Food and Drug Administration (FDA) is responsible for offering support and relief to families affected by this shortage in any way they can. Accordingly, the FDA loosened infant formula regulations. Specifically, the FDA allowed for an increased supply of infant formula by the announcement to infant formula manufacturers of the agency’s intention to temporarily exercise enforcement discretion. Enforcement was on a case-by-case basis, for specific infant formula requirements. This went into effect from May 16, 2022, through November 14, 2022, and was specifically designed to protect infants’ health. Essentially, selective enforcement would allow the FDA to grant permission for formulas despite not meeting all the regulations.

Baby formula shortageFDA

Off the Rails: the Norfolk Southern Train Derailment and its Aftermath

March 17, 2023Zulay Valencia Diazenvironmental regulation, Journal of Regulatory ComplianceLeave a comment

On February 3, 2023, Ohio was suddenly and unexpectedly rocked by an accident whose long-term consequences are still unfolding. A Norfolk Southern-operated freight train carrying toxic chemicals derailed in the village of East Palestine. This accident, which poses severe threats to the environment and safety of the local community, has raised significant concerns about the environmental implications of train accidents and the safety of transporting hazardous materials through residential areas.

chemical spillenvironmental regulationEPAFederal Railroad AdministrationNational Transportation Safety Boardtrain derailment

HIPAA Violations Hurting Americans

March 17, 2023Taelor ThorntonJournal of Regulatory ComplianceLeave a comment

Taelor Thornton Associate Editor Loyola University Chicago School of Law, JD 2024 The Health Information Portability and Accountability Act (HIPAA) complaints and breaches increased from 2017 to 2021, yet the Department of Health and Human Services Office for Civil Rights (HHS OCR) stated that they did not perform any audits due to financial resources in …
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Biden Administration to Knock “Chip” off China’s Shoulders: Proposed Export License Revocation Seeks to Remove Huawei’s Access to the US Market

March 16, 2023Jacob TaylorRegulation, technologyLeave a comment

The Biden administration has considered not only ending all future export licenses between US microchip producers and Huawei, but also revoking existing licenses to sell microchips to the Chinese tech company. This move is just one section of increasing tensions between China and the United States but could have long-reaching consequences for the United States and the global tech market.

big techChinaRegulation

Capitol Attack Aftermath: The 65 Project files Complaint Against Trump-Aligned Attorney

March 16, 2023Jacob ParentisEthics, Fraud & AbuseLeave a comment

Monday, March 6, 2023, marks two-and-one-quarter years since the notorious attack on the U.S. Capitol. Since then, the unprecedented insurrection’s aftermath has thrust Trump-aligned supporters and politicians into the political limelight. As the House of Representatives continues its comprehensive investigation, Cassidy Hutchinson, former White House aide and standout witness of the House’s Jan. 6th committee investigation, recently accused President Trump’s former White House attorney Stefan Passantino of unethical legal maneuvering. On Wednesday February 15, 2023, nearly three months after her allegations were brought, bipartisan U.S. legal advocacy group ‘The 65 Project’ filed an informal ethics complaint against Passantino.

attorney ethicsAttorney Regulationprofessional misconduct

Investors in NFTs find Potential Protection through Real Estate Investment Trusts

March 16, 2023Markael ButlerNFTs, SECLeave a comment

Cryptocurrency’s lack of regulation has been a major focus in the news recently. Furthermore, there is a lack of regulation over non-fungible tokens (NFTs) as well, which is a further concern for consumer safety. Although the first known NFT was established in May of 2014, NFTs didn’t really take-off until 2017. Due to the unique nature of NFTs (being either jpegs, real estate, etc.) the Securities and Exchange Commission (SEC), along with other regulatory authorities, still haven’t clearly laid out if NFTs are securities or what rules/regulations will apply. Unless securities are clearly at issue it is unclear if NFTs will fall under securities laws at this point in time. However, there is a potential way consumers can invest in NFTs related to real estate and still find protection through the SEC.

consumer protectionNFT RegulationREITs

Proposal to Change TULA Late Fee Maximum on Credit Cards: Is it Beneficial or Burdensome?

March 15, 2023Megan AldworthBanking, RegulationLeave a comment

Megan Aldworth Associate Editor Loyola University Chicago School of Law, JD 2023 The Truth in Lending Act (TILA), established 1968, is aimed to protect consumers against unfair credit practices and billing by lenders. Under TILA, lenders must provide consumers (borrowers) with information that allows them to compare loan terms given by various lending institutions. …
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American Banking AssociationCFPBCredit Card FeesTruth in Lending Act

FDA Restrictions, State Action, and Pharmaceutical Responses to the Abortion Pill

March 15, 2023Caroline TaitFDA, Food and Drug LawLeave a comment

As of March 3, 2023, Walgreens, the second-largest pharmacy store in the United States, has announced that it will not offer mifepristone, the abortion pill, in twenty-one states. This decision followed letters written by Republican attorneys generals in the twenty-one states urging Walgreens not to stock the product, and even threatening legal action against Walgreens if they did decide to move forward with stocking mifepristone in those twenty-one states. Rite Aid and other pharmacies have not yet made a decision on whether they will sell mifepristone.

Mifepristonepharmacy regulationWalgreens

Safeguarding Technologies through the Disruptive Technology Strike Force

March 12, 2023Kristen Salas MationgNational SecurityLeave a comment

On February 16, 2023, the Department of Justice (DoJ) and the Department of Commerce (DoC) announced the launch of the Disruptive Technology Strike Force. Under the leadership of Assistant Attorney General Matthew G. Olsen of the Justice Department’s National Security Division and Matthew Axelrod, the Assistant Secretary for Export Enforcement in the Commerce Department’s Bureau of Industry and Security (BIS), the strike force will bring together various agencies throughout the government, including the FBI, Homeland Security Investigations (HSI) and 14 U.S. Attorneys’ Offices, to “target illicit actors, strengthen supply chains and protect critical technological assets from being acquired or used by nation-state adversaries”.

complianceDOJenforcementRegulation

The Future of Telemedicine: Controlled Substance Proposed Rule

March 11, 2023Caren OliverCOVID, DEA, Healthcare ComplianceLeave a comment

On January 31, 2020, the Secretary of the Department of Health and Human Services issued a public health emergency as a result of COVID-19. The emergency declaration requires public health professionals, first responders, and public officials to work together to minimize death while preventing illnesses. The declarations provided the government with the flexibility to waive or modify standard requirements as it relates to both public and private insurance, service providers, and authorizations including telehealth. Telehealth provided access to healthcare to those who face barriers as well as flexibility in being able to manage care while reducing the spread of COVID-19 along with other infectious diseases. There remained uncertainty regarding the freedom to prescribe controlled substances via telemedicine with the Biden administration set to end the public health emergency on May 11, 2023. However, on February 24, 2023, the Drug Enforcement Administration (DEA) released a proposed rule that aims to permanently extend controlled substance prescribing flexibilities.

COVID-19DEAHHSPublic Health Emergency Privacy Acttelehealthtelemedicinethe Ryan Haight Act