Food & Chemicals Unpacked: Making-up for Lost Time: FDA’s Increased Oversight of Cosmetics [Podcast]
In this episode of Food & Chemicals Unpacked, we are joined by guest speakers, Partners Cynthia Lieberman and Rick Stearns, who dive into the recent evolution of FDA’s cosmetics regulations. They explore the Modernization of Cosmetics Regulation Act (MOCRA), including new requirements relating to adverse event reporting, Good Manufacturing Practices, and other topics. The discussion also provides insights on how cosmetics and personal care product manufacturers and their suppliers can ensure that finished products (makeup, soaps, sunscreen, shampoo, etc.) maintain compliance with MOCRA and other current legal obligations in the United States.
The EU Suspends Certain Sanctions on Syria to Support Economic Stabilisation, Political Transition and Reconstruction
To help the Syrian people achieve a peaceful and inclusive political transition, to aid the swift economic recovery and reconstruction of the country and to facilitate its eventual reincorporation into the global financial system, the EU has suspended with immediate effect a number of sanctions and restrictive measures that had targeted key sectors of the Syrian economy, including its banking, energy and transport sectors.
The five specific actions that EU foreign ministers took following a meeting yesterday in Brussels are as follows:
Suspending sectoral measures in the energy (oil, gas and electricity) and transport sectors
Removing five entities (Agricultural Cooperative Bank, Industrial Bank, Popular Credit Bank, Saving Bank and Syrian Arab Airlines) from the list of those subject to asset freezes, and allowing financial resources to be made available to the Syrian Central Bank
Introducing exemptions to the prohibition on banking relations between Syrian banks and financial institutions in EU member states to permit transactions related to the energy and transport sectors, as well as those necessary for reconstruction purposes
Extending the existing exemption for transactions for humanitarian purpose indefinitely
Introducing an exemption to the prohibition on the export of luxury goods to Syria for personal usage
The European Council announced that it will continuously monitor the situation in Syria to assess whether the suspensions remain appropriate, and/or whether further sanctions could be suspended.
While many commentators will champion the deferral of sweeping sectoral sanctions because of the unintended negative consequences that they can have, such as impeding economic stability and denying the ordinary person access to essential services such as electricity, water, healthcare and education, the EU has seen fit to maintain other important sanctions and restrictive measures that were imposed during the previous regime, including those related to:
Arms trafficking
Chemical weapons
Dual-use goods
Equipment misused for internal repression
Narcotics smuggling
Software misused for interception and surveillance
Trade of Syrian cultural heritage items.
The EU’s stated goal when it enacted these sanctions was to protect the civilian population from the previous regime. Under new leadership, Syria now has the opportunity to earn a wind-down of all remaining sanctions and restrictive measures, and for its war-torn economy to benefit from resurgent EU-Syria economic relations and trade flows.
Last-Minute Changes to Michigan’s Earned Sick Time Law: What Employers Need to Know
Takeaways
Changes to eliminate, modify or clarify certain provisions of the Michigan ESTA were signed by the governor on 2/21/25 and became effective immediately. The law requires most Michigan employers to permit employees to accrue and use paid earned sick time annually.
Under the amended ESTA, paid earned sick time begins to accrue as of 2/21/25. Small businesses have until 10/1/25 to start providing 40 hours of sick time and may cap usage at 40 hours in one year. All other employers may cap usage at 72 hours in one year.
Employers should review the changes and take immediate steps to comply with the amended ESTA.
Article
After the Michigan Supreme Court’s opinion in Mothering Justice v. Attorney General and State of Michigan, No. 165325 (July 31, 2024), Michigan’s Earned Sick Time Act (ESTA), which expanded employee paid sick time rights, was set to take effect on Feb. 21, 2025, late on Feb. 20, 2025, a bill was passed to amend the ESTA. The amended ESTA became effective at 12:02 a.m. on Feb. 21, 2025, and was signed by Governor Gretchen Whitmer later that morning.
The amended ESTA still requires most Michigan employers to permit employees to accrue and use paid earned sick time annually. However, the amended ESTA removes certain rebuttable presumptions that an employer had violated the ESTA and eliminates an employee’s right to file a private cause of action for a violation of the ESTA, all of which were in the previous version of the ESTA.
The amended ESTA also modifies or clarifies certain provisions of the ESTA, and there are key changes employers should be cognizant of to ensure compliance with the amended law.
Key Changes in Amended ESTA
Scope
The definition of “employee” was modified to exclude:
An individual employed by the U.S. government;
An unpaid trainee or unpaid intern;
An individual employed in accordance with the Youth Employment Standards Act; and
An individual who works in accordance with a policy of an employer if: (a) The policy allows the individual to schedule the individual’s own working hours; and (b) The policy prohibits the employer from taking adverse personnel action against the individual if the individual does not schedule a minimum number of working hours.
Accrual of Earned Sick Time
Employees must accrue one hour of paid earned sick time for every 30 hours worked, not including hours used as paid time off.
Small employers (defined as an employer with up to 10 employees on payroll during at least 20 calendar workweeks in either the current or preceding calendar year) may cap usage of paid earned sick time at 40 hours in one year.
All other employers may cap usage of paid earned sick time at 72 hours in one year.
Frontloading
As an alternative to the accrual of paid earned sick time, an employer may provide an employee not less than 72 hours of paid earned sick time (40 hours for small employers) at the beginning of the year for immediate use. If earned sick time is frontloaded, employers are not required to:
Allow an employee to carry over any unused paid earned sick time;
Calculate and track an employees’ accrual of paid earned sick time; or
Pay out unused accrued paid earned sick time at the end of the year in which the time was accrued.
“Use-it-or-lose-it” applies if time is frontloaded.
Carryover
Unlike the original ESTA, unlimited carryover of unused paid earned sick time is not required under the amended Act. Under the amended ESTA, employers may cap carryover of unused paid earned sick time at 72 hours (40 hours for small businesses).
Waiting Period
Employees hired after Feb. 21, 2025, can be required to wait 120 days after beginning employment before using accrued paid earned sick time.
Notice Requirements
If the need for paid earned sick time is foreseeable, employers can require up to seven days’ advanced notice.
If unforeseeable, employers may require employees to give notice either:
As soon as practicable; or
In accordance with the employer’s policy on using sick time, if: (a) The employer notifies the employee of their policy in writing after Feb. 21, 2025; and (b) The policy allows employees to provide notice after the employee is aware of the need to use sick time.
Employers can require “reasonable documentation” for paid earned sick time of more than three consecutive days. Employers must give employees not more than 15 days to provide such documentation upon request and are required to pay all out-of-pocket expenses the employee incurs to obtain that documentation.
Unlike the original version of the ESTA, the amended ESTA permits employers to take adverse personnel action if employees use paid earned sick time for a purpose other than one allowed under the Act.
Usage Increments
Paid earned sick time can be used in either one-hour increments or the smallest increment the employer uses for absences.
Rate of Paid Sick Time
Employees using paid earned sick time must be paid at a rate equal to the greater of either the normal hourly or base wage for that employee, or the established minimum wage. Employers are not required to include overtime pay, holiday pay, bonuses, commissions, supplemental pay, piece-rate pay, tips, or gratuities in calculating a normal hourly wage or base wage.
No Payout Upon Separation
Like the original ESTA, the amended ESTA does not require payout of accrued, unused paid earned sick time upon the employee’s separation from employment.
No Retaliation
The amended ESTA prohibits an employer, or any other person, from interfering with, restraining, or denying the exercise of, or the attempt to exercise, any right protected under the ESTA. It also prohibits an employer from taking retaliatory personnel action or discriminating against an employee because the employee has exercised a right under the ESTA.
Removal of Rebuttable Presumption
The amended ESTA removed the rebuttal presumption of a violation of the ESTA if an employer took an adverse personnel action against a person withing 90 days after that person engaged in certain protected activities under the ESTA.
No Private Right of Action
Unlike the original ESTA, the amended ESTA does not provide employees a private cause of action.
Required Posters and Notice
Employers have 30 days from Feb. 21, 2025, to post posters consistent with the amended ESTA and provide written notice to employees as required by the ESTA.
The Department of Labor and Economic Opportunity is required to create and make available to employers notices and posters for employers’ use in complying with the amended ESTA. The Department is required to provide the notices and posters in English, Spanish, and any other language deemed appropriate by the Department. Posters reflecting the amendments to the ESTA, however, are not currently available.
Takeaways
Under the amended ESTA, paid earned sick time begins to accrue as of Feb. 21, 2025. Small businesses have until Oct. 1, 2025, to start providing 40 hours of sick time. New businesses with up to 10 employees have a three-year grace period after forming.
Employers should take immediate steps to comply with the ESTA.
The Top 10 Things Every Employer Should Know About OSHA
In the evolving landscape of workplace safety regulations, it is essential for construction employers to stay well-informed about the Occupational Safety and Health Administration’s (OSHA) protocols and guidelines. Our series, “Top 10 Things Every Employer Should Know About OSHA,” breaks down critical aspects ranging from the rights and responsibilities during OSHA inspections to intricacies of compliance standards and potential citation scenarios. This comprehensive guide aims to empower employers with the knowledge needed to navigate OSHA regulations effectively, ensuring safer work environments and minimizing legal risks.
Here’s a recap of our list of the top 10 things every employer should know about OSHA:
No. 1 – Walkaround Representatives
Employers and employees have the right to have representatives present during an OSHA site inspection.
According to 29 CFR 1903.8(c), employers and employees have the right to authorize a representative to accompany OSHA officials during workplace inspections for the purpose of aiding the inspection (also known as walkaround representatives). OSHA regulations require no specific qualifications for employer representatives or for employee representatives who are employed by the employer. We encourage all employers to have a designated walkaround representative present during OSHA inspections, which could include legal counsel.
No. 2 – Be Present in Manager Interviews
We all know that OSHA has the right to interview folks as part of an investigation. Whether a company representative and the company attorney can also attend an interview depends on the position of the person being interviewed.
If the person to be interviewed is a non-managerial employee, OSHA can conduct the interview in private, outside the presence of the employer or the employer’s representatives. Not so with managerial employees. If OSHA wants to interview a management-level employee, the employer has the right to have a company representative and/or attorney present.
No. 3 – Employees Have Rights When It Comes to OSHA Interviews
Although OSHA has the right to conduct private, one-on-one interviews with a company’s non-managerial employees, those same employees have rights too. Read the full article for details and things to consider.
No. 4 – OSHA Must Issue a Citation Within Six Months
OSHA has a time limit on issuing citations. It must issue a citation within six months of the occurrence of any violation. The only exception to this rule is where the employer has concealed the violative condition or misled OSHA. If such a situation occurs, OSHA must issue the citation within six months from the date that OSHA learns, or should have known, of the condition.
So, the moral of the story is just because it’s been a couple months since an OSHA inspection does not mean OSHA has decided not to issue a citation. You can check on the status of OSHA’s investigation by reviewing the OSHA establishment search page to see whether OSHA has closed its inspection or not.
No 5. – OSHA Can Issue Citations for Unsafe Work Conditions That Have Not Resulted in an Employee Injury
Most frequently, employers do not hear from OSHA unless there is a reported workplace injury. When a reported workplace injury occurs, OSHA performs a walkthrough inspection of the worksite and may ultimately issue a citation for hazardous conditions OSHA believes may have caused or contributed to the incident. However, OSHA is not limited to issuing citations for hazardous conditions that may have caused or contributed to a workplace injury. Rather, OSHA can cite employers for any and all hazardous conditions to which workers may have been exposed regardless of whether the cited condition was in any way related to the incident.
No 6. – But No One Was There? OSHA Can Still Cite for Unsafe Work Conditions Where Workers Were Not Exposed
We often hear, “OSHA can’t cite me because I didn’t employ the injured worker.” Unfortunately, this statement is often untrue.
Under OSHA’s Multi-Employer Doctrine, if you are an employer on a worksite where other companies are also performing work (e.g., construction sites and oil/gas well sites), you can be subject to citation for workplace hazards to which other companies’ employees are exposed. OSHA created the Multi-Employer Doctrine in recognition that there are many circumstances in which multiple employers will be working on a single worksite at the same time thereby affecting the working conditions to which all workers are exposed.
No. 7 – OSHA Can Issue Citations for Unsafe Work Conditions That Do Not Violate Any Specific OSHA Standard
Many employers have a false notion that OSHA can’t issue a citation if there is no specific standard violated.
The reality is, however, that OSHA has a catchall/gap filler provision that allows it to cite an employer even if no specific standard was violated: the “General Duty Clause,” Section 5(a)(1) of the Occupational Safety and Health Act. OSHA can cite employers for violations of the General Duty Clause if a recognized serious hazard exists in the workplace and the employer doesn’t take reasonable steps to prevent or abate the hazard. The General Duty Clause is used only where there is no standard that applies to the particular hazard.
No. 8 – Employers Have 15 Working Days to Contest a Citation but Have the Option to Negotiate a Settlement with OSHA Before That Deadline
What happens if OSHA issues a citation and you do not agree with any or all of it? You have 15 working days from the date you receive the citation to contest in writing the citation, proposed penalty, and/or the abatement date. Read the full article to learn more about your options and how to reach a favorable settlement.
No. 9 – The Particulars on OSHA Violations: How Much Notice Is Enough?
Just what does an OSHA citation have to include? Section 9(a) of the Occupational Safety and Health Act requires that citations “describe with particularity the nature of the violation, including a reference to the provision of the Act, standard, rule, regulation, or order alleged to have been violated.”
This statutory mandate is designed to ensure that OSHA properly informs employers of alleged violations so they can correct hazards promptly and avoid unnecessary litigation. However, the Occupational Safety and Health Review Commission and the courts have consistently interpreted this requirement to mean that citations need only provide employers with “fair notice” of the violation. In other words, as long as an employer is put on notice that a particular condition may violate OSHA standards, additional specifics can be obtained through discovery. As a result, OSHA often issues citations with broad language rather than granular detail.
No. 10 – Unlocking the Secrets of OSHA Inspections Through FOIA Requests
Did you know that you can request files from OSHA? Under the Freedom of Information Act (FOIA), employers, employees, and third parties have the right to request documents from OSHA’s inspection files. These records provide valuable insight into the evidence and reasoning behind OSHA’s decisions, including citations issued during site inspections. They can also be critical in legal proceedings, including lawsuits related to workplace safety.
IRS Roundup February 10 – 14, 2025
Check out our summary of significant Internal Revenue Service (IRS) guidance and relevant tax matters for the week of February 10, 2025 – February 14, 2025.
TAX-CONTROVERSY-RELATED DEVELOPMENTS
The previous IRS Roundup provided general coverage of the proposed Taxpayer Assistance and Service (TAS) Act. This post highlights Section 310 of the TAS Act, which would give the US Tax Court authority to hear general refund suits similar to those currently heard in the US district courts and the US Court of Federal Claims.
Historically, taxpayers could only contest their tax liability by first paying the tax and then suing for a refund in a district court or the Court of Federal Claims. The Board of Tax Appeals (BTA), the forerunner to the Tax Court, was created in 1924 to give taxpayers a prepayment forum in which to dispute their tax liability. The BTA was initially proposed to have general refund suit jurisdiction, but Congress limited its jurisdiction to cases brought in response to a notice of deficiency. Several proposals have been made over the years to expand the jurisdiction of the BTA and (now) the Tax Court to include general refund suits, which they would share with the district courts and the Court of Federal Claims. Recent support for this approach has come from National Taxpayer Advocates Nina Olson and Erin Collins. As one commentator noted, the proposed expansion to the Tax Court’s jurisdiction has the potential to improve access to justice for taxpayers and reduce the burden on district courts and the Court of Federal Claims.
IRS GUIDANCE
February 12, 2025: The IRS issued Revenue Procedure 2015-16, which provides depreciation deduction limitations for “passenger automobiles” (including trucks and vans) placed in service during 2025 and income inclusion amounts for lessees of such vehicles. The revenue procedure also includes two tables detailing depreciation limits based on whether the Internal Revenue Code (Code) § 168(k) additional first-year depreciation deduction applies. Additionally, the revenue procedure outlines the inflation adjustment calculation for these limits and provides a table for determining income inclusions for leased passenger automobiles. The tables reflect the automobile price inflation adjustments required by Code § 280F(d)(7).
February 12, 2025: The IRS released Notice 2025-14, which provides guidance on the corporate bond monthly yield curve, spot segment rates under Code § 417(e)(3), and 24-month average segment rates under Code § 430(h)(2). The notice also provides guidance as to the interest rate on 30-year Treasury securities under Code § 417(e)(3)(A)(ii)(II) as in effect for plan years beginning before 2008 and the 30-year Treasury weighted average rate under Code § 431(c)(6)(E)(ii)(I).
February 13, 2025: The IRS issued Revenue Procedure 2025-15, which provides discount factors for the 2024 accident year for insurance companies to use when computing discounted unpaid losses under Code § 846 and discounted estimated salvage recoverable under Code § 832. The revenue procedure includes tables with discount factors for various lines of business (both short- and long-tail) and addresses the use of the composite method for computing these factors. The IRS requests comments on the composite method and changes by the National Association of Insurance Commissioners to Schedule P of the annual statement.
Corporate Transparency Act Update: Reporting Requirements Now Back in Effect
Beneficial ownership information (BOI) reporting requirements under the Corporate Transparency Act (CTA) are now back in effect. As a result, all entities subject to the CTA are once again obligated to file BOI reports with FinCEN.
Following the most recent order from the U.S. District Court for the Eastern District of Texas in Smith v. U.S. Department of Treasury, FinCEN’s regulations are no longer stayed. With that being said, FinCEN has extended the reporting deadline to March 21, 2025 (30 calendar days from February 19, 2025). In its recent notice extending the deadline, FinCEN also announced that during this 30-day period, reporting deadline modifications will be further assessed in order to reduce regulatory burdens on businesses.
While additional updates from FinCEN are expected prior to the March 21 deadline, reporting companies that were previously required to file before March 21 are currently obligated to file BOI reports by the extended deadline. Companies should continue to closely monitor for updates over the course of the next 30 days.
For information on filing, see our prior alert here.
For more information on the recent update, see the recent FinCEN Notice here.
Courtroom Chemistry: How Trial Team Dynamics Shape Case Outcomes – Speaking of Litigation [Video] [Podcast]
In this episode, Epstein Becker Green attorneys Shruti Panchavati, Melissa Jampol, and Diana Costantino Gomprecht share their trial team experiences, breaking down how trial team dynamics can directly affect courtroom outcomes.
Tune in as the panel uncovers signs of dysfunction that can derail momentum and explores how jury, judge, and arbitrator perceptions hinge on a team’s professionalism, chemistry, and preparation.
With practical insights, real-world anecdotes, and nods to courtroom cinema classics, this episode offers a compelling glimpse into what it takes to handle complex litigation with precision and skill. Listen now to gain a deeper understanding of the factors that drive success in the courtroom.
SEC Approves Nasdaq Proposed Rules Modifying Minimum Bid Price Compliance Periods and Delisting Process
On January 17, the US Securities and Exchange Commission (SEC) approved Nasdaq’s proposed rule changes addressing companies that fail to meet the minimum bid price requirements of $1 per share and the subsequent delisting process.
The Previous Framework
The rule changes revise Nasdaq Rules 5810 and 5815, which require that a company with equity listed on Nasdaq maintain a minimum bid price of at least $1 per share. Pursuant to Nasdaq Rule 5810(c)(3)(A), a company that fails to meet the minimum bid price requirement is granted an automatic compliance period of 180 calendar days from the date Nasdaq notifies the company of the deficiency to achieve compliance. Certain circumstances may grant a company a second 180-day compliance period. If a company is not eligible for the second compliance period, or the company fails to cure the bid price deficiency during the second compliance period, the company is issued a Delisting Determination which suspends a company’s ability to trade on Nasdaq. This determination may be appealed to a Nasdaq Listing Qualifications Hearings Panel. Under the previous framework, a request for a hearing ordinarily would have stayed the Delisting Determination, pending the issuance of a written Hearings Panel decision. Additionally, the Panel may grant a company an additional 180 days from the date of the Delisting Determination to regain compliance. This effectively allowed a company to continue trading on Nasdaq for over 360 days (but not more than 540) while remaining noncompliant with the minimum bid price requirement.
Nasdaq proposed, and the SEC approved, the following amendments to Rules 5810 and 5815.
Suspension After Second Compliance Period (360 Days)
The SEC approved an amendment to Rule 5815 to provide that a request for a hearing will no longer stay a delisting action where a company that was afforded the second 180-day compliance period failed to comply with the minimum bid requirement during that period. Instead, companies will be suspended from trading on Nasdaq and its securities will trade on the over-the-counter market while awaiting a determination from the Hearings Panel. Rule 5815 still permits the Hearings Panel discretion, where it deems appropriate, to provide an exception to the suspension for up to 180 days from the Delisting Determination date for the company to regain compliance with the bid price requirement. The new rules clarify that a company achieves compliance with the bid price requirement by meeting the applicable standard for a minimum of 10 consecutive business days.
Delisting Determination If Failure to Meet Bid Price Requirement Occurs Within One Year After Reverse Stock Split
The SEC also approved an amendment of Nasdaq Rule 5810, which provides that if a company’s security fails to meet the bid price requirement and the company has effected a reverse stock split within the prior one-year period, or one or more reverse stock splits over the prior two-year period with a cumulative ratio of 250 shares or more to one, the company is not eligible for any compliance period and will be immediately issued a delisting determination. The change applies to a company even if the company complied with the bid price requirement at the time of its prior reverse stock split. The rule change was motivated by Nasdaq’s observation of companies, particularly those in financial distress, engaging in a pattern of repeated reverse stock splits to regain compliance with the bid price requirement. To protect investors, Nasdaq decided that such companies should face immediate delisting. It should be noted that a company in such circumstance would still be permitted to appeal the delisting determination to the Nasdaq hearings panel, where it could potentially receive up to 180 days to regain compliance.
Commission Findings
In connection with approving the new rules, the SEC determined that the proposed changes align with the Exchange Act’s requirements, which aim to prevent fraudulent and manipulative acts and protect investors and the public interest. The SEC expressed concerns that low-priced securities might lack sufficient public float, investor base, and trading interest, making them vulnerable to manipulation.
Takeaways
These approved rule changes are now effective and underscore the SEC’s focus on maintaining robust market standards and protecting investors from potential risks associated with low-priced securities. Companies listed on Nasdaq should carefully assess their compliance with the new requirements to avoid expedited delisting proceedings, including reviewing their current strategies.
Catrina Livermore contributed to this article
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“Have It Your Way,” California! $20 Minimum Wage Backfires
In late 2023, California supersized the minimum wage for fast food workers by a whopping 25 percent (increasing it from $16 to $20). This law was opposed by the fast food industry, while labor unions (and their many friends and admirers in Sacramento) insisted it would “benefit workers.”
Well, the results are in. According to a new study released by the Berkeley Research Group, the $20 minimum wage has negatively impacted fast food workers and customers. The study reveals that the increase has led to thousands of job losses, a double-digit hike in food prices, and accelerated use of automation and artificial intelligence.
The key takeaways from the study include the following:
The minimum wage increase did not guarantee higher income for workers because fast food restaurants reduced employee hours to offset the costs of the increased wage.
Fast food restaurants lost 10,700 jobs between June 2023 and June 2024, which represents the largest decline in jobs outside of the 2009 recession and COVID-19 pandemic.
Since September 2023, food prices at California’s local restaurants have increased by 14.5 percent.
Fast food restaurants have increased the use of automation in the industry, including through ordering kiosks, AI drive-thru systems, and robotic kitchen automation, further reducing the availability of jobs.
The full study can be found here. Undeterred, the Fast Food Council’s Planning Subcommittee will meet later this month to discuss yet another increase to the minimum wage for 2025. Unsurprisingly, thousands of local restaurant owners have come forward opposing additional wage increases. We will continue to monitor for updates.
California Privacy Protection Agency Clarifies Application of the CCPA to Insurance Companies
The California Privacy Protection Agency board voted on November 8, 2024, to advance a proposed rulemaking package for, among other things, a proposed regulation to clarify the application of the California Consumer Privacy Act (CCPA) to insurance companies.
Quick Hits
The California Privacy Protection Agency voted in November 2024 to advance a proposed regulation to clarify the application of the California Consumer Privacy Act (CCPA) to insurance companies.
The proposed regulation defines “insurance company” and specifies that the CCPA applies to personal data not governed by the California Insurance Code.
Illustrations in the proposed regulation clarify that insurance companies must comply with the CCPA for personal data collected from website visitors and employees.
Information obtained in an insurance transaction is governed by the federal Gramm-Leach-Bliley Act. Given this, there has been uncertainty about the CCPA’s application to insurance companies, which are state regulated. In a brief proposed regulation, the agency attempted to clarify this issue to a certain degree.
As an initial matter, the proposed regulation defines the term “insurance company” as any person or company that is subject to the California Insurance Code and its regulations, including insurance institutions, agents, and insurance support organizations. The term “insurance institution” means “any corporation, association, partnership, reciprocal exchange, interinsurer, Lloyd’s insurer, fraternal benefit society, or other person engaged in the business of insurance.
The term “agents” means a person who is licensed to transact insurance in California and an “insurance support organization” means any person who regularly engages, in whole or in part, in the business of assembling or collecting information about natural persons for the primary purpose of providing the information to an insurance institution or agent for insurance transactions.
Having defined the scope, the proposed regulation states that the CCPA applies “to any personal information not subject to the Insurance Code and its regulations.” Although the statement lacks definite clarity, the proposed regulation provides some guidance with an additional statement that the CCPA’s requirements apply to information “that is collected for purposes not in connection with an insurance transaction, as that term is defined in Insurance Code, section 791.02.” Section 791.02(m) defines insurance transaction as “any transaction involving insurance primarily for personal, family, or household needs rather than business or professional needs that entails either of the following: (1) The determination of an individual’s eligibility for an insurance coverage, benefit, or payment. (2) The servicing of an insurance application, policy, contract, or certificate.”
The proposed regulation provides two illustrations that further clarify the application of the CCPA:
“Insurance company A collects personal information from visitors of its website who have not applied for any insurance product or other financial product or service from Company A. This information is used to tailor personalized advertisements across different business websites. Insurance company A must comply with the CCPA, including by providing consumers the right to opt-out of the sale/sharing of their personal information and honoring opt-out preference signals, because the personal information collected from the website browsing is not related to an application for or provision of an insurance transaction or other financial product or service.”
“Insurance company B collects personal information from its employees and job applicants for employment purposes. Insurance company B must comply with the CCPA with regard to employee information, including by providing a Notice at Collection to the employees and job applicants at or before the time their personal information is collected. This is because the personal information collected in this situation is not subject to the Insurance Code or its regulations.”
Insurers may also want to note that the second illustration applies only to California resident job applicants and employees. The notice to job applicants required under the CCPA should be provided if the company solicits applicants from California.
Finally, the CCPA is not the only privacy law or regulation that needs to be considered with regard to the collection and use of consumer data and information. In particular, California Penal Code sections 630 and 638.51 are currently the subject of numerous lawsuits.
GLP-1 Drugs: FDA Removes Semaglutide from the Drug Shortage List
On February 21, 2025, the U.S. Food and Drug Administration (FDA) issued a Declaratory Order determining that the semaglutide drug shortage has been resolved. The timing of this order was unexpected due to the ongoing litigation between FDA and the Outsourcing Facilities Association (OFA) involving tirzepatide, though the decision was not. Our prior blog “GLP-1 Drugs: FDA Sued Over Removing Tirzepatide from the Drug Shortage List” discusses the litigation. On February 24, 2024, OFA initiated a similar action against FDA challenging the removal of semaglutide from the drug shortage list.
FDA’s Declaratory Order: FDA’s 13-page order describes the process that FDA undertook to come to this conclusion and explains that FDA obtained information both from the manufacturer (Novo Nordisk) as well as from patients, health care providers, and others, including compounders. FDA concluded that based on the available evidence, that the supply of semaglutide “meets or exceeds current demand, and that, based on our best judgment looking at the available information with its limitations, supply will meet or exceed projected demand.”
FDA acknowledges in the Declaratory Order that:
[E]ven when a shortage is considered resolved, patients and prescribers may still see intermittent localized supply disruptions as products move through the supply chain from the manufacturer and distributors to local pharmacies.
Current Status of Compounding of Semaglutide: With respect to the current status of compounding of semaglutide, FDA noted that it wished to “avoid unnecessary disruption to patient treatment,” and outlined the current enforcement policy moving forward:
[T]he agency does not intend to take action against compounders for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) arising from conditions that depend on semaglutide injection products’ inclusion on FDA’s drug shortage list:
For a state-licensed pharmacy under section 503A of the FD&C Act compounding, distributing or dispensing semaglutide injections within 60 calendar days from today’s announcement, until April 22, 2025.
For outsourcing facilities under section 503B compounding, distributing or dispensing semaglutide injections within 90 calendar days from today’s announcement, until May 22, 2025.
FDA may still take action regarding violations of any other statutory or regulatory requirements, such as to address findings that a product may be of substandard quality or otherwise unsafe.
In addition to the Declaratory Order, FDA also published an update to its website entitled “FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize.” This update also included FDA’s enforcement policy described above, as well as stated that although dulaglutide remains “in shortage”, the manufacturers have reported all presentations are available. Liraglutide is also still in shortage, but the manufacturer has reported two presentations are available but three have limited availability. Finally, FDA notes that “[w]hen a status is noted as ‘available,’ that reflects the most current information from the manufacturer but is not an FDA determination that the shortage has been resolved.”
In the ongoing case with the OFA involving tirzepatide, the parties are currently filing briefs on the Plaintiff’s motion for preliminary injunction. Briefing will be completed on February 25, 2025. We expect the Court to rule on the motion sometime in March. Depending on the Court’s ruling, the outcome could have an impact on the continued availability of semaglutide as well.
On Monday, February 24, 2025, OFA filed a lawsuit against FDA in Fort Worth Texas over FDA’s decision to remove semaglutide from the drug shortage list. The lawsuit claims the FDA’s finding that there was no longer a shortage of semaglutide was arbitrary and capricious. We expect this case to proceed on a similar track as tirzepatide and the cases may be consolidated.
Key Takeaways. FDA’s determination to remove semaglutide from the drug shortage list is not surprising. The only surprise here is the timing. Compounding of semaglutide will continue until at least May 22, 2025, for 503B Pharmacies (also known as 503B Outsourcing Facilities, which are compounding pharmacies that can produce large batches of medications without patient-specific prescriptions). Whether it will extend beyond that timeframe will depend on the outcome of the OFA litigation and FDA’s reaction to the case.
It will also be very interesting to watch developments on certain GLP-1 products that continue to be compounded under the rationale that certain compounded products are required to meet the individual needs of patients. There are a number of different doses, different dosage forms, and combination of ingredients being compounded, and FDA has not yet taken a position with respect to these compounded products.
Want To Learn More? See our prior blogs.
FDA Targets GLP-1 Providers with Warning Letters
GLP-1 Drugs: FDA Removes Lilly’s Zepbound® and Mounjaro® (semaglutide injection) from its Drug Shortage List
GLP-1 Drugs: Brand Companies Push FDA to Limit Compounding
Contesting a Will in Pennsylvania: Understanding Your Rights
In Pennsylvania, contesting a will is a serious legal action that should not be taken lightly. It can be emotionally challenging, especially if you believe that the will does not reflect the true intentions of the deceased. However, the law in Pennsylvania provides specific grounds and procedures for individuals who wish to contest a will. This blog post will explore the grounds for of contesting a will.
Grounds for Contesting a Will in Pennsylvania
Under Pennsylvania law, there are several valid reasons to contest a will. Common grounds for contesting a will include:
Lack of Testamentary Capacity
A will may be contested if the individual who made the will (the testator) lacked the mental capacity to do so at the time it was executed. To have testamentary capacity, the testator must understand the nature of their estate, know who their heirs are, and comprehend the effect of the will. If the testator was suffering from dementia, mental illness, or was under the influence of medication that impaired their judgment, this could serve as a basis for contesting the will.
Undue Influence
A will may be contested on the grounds of undue influence if it is proven that the testator was coerced or manipulated by another person to create a will that does not reflect their true desires. In Pennsylvania, undue influence is difficult to prove and requires evidence that the person exerted such influence over the testator that the will would not have been made but for that influence.
Fraud or Forgery
If the will was procured through fraudulent means or if it is believed that the testator’s signature was forged, the will can be contested on the grounds of fraud or forgery. This might involve scenarios where the testator was deceived into signing the will or where the will was altered after it was signed.
Improper Execution
Under Pennsylvania law, a valid will must be executed in accordance with strict formalities. This includes the requirement that the will be signed by the testator in the presence of at least two witnesses who also sign the will. If these formalities are not followed, the will may be contested on the grounds of improper execution.
Revocation of the Will
A will can be contested if there is evidence that the testator revoked the will before their death. Revocation can occur through physical destruction (tearing, burning, etc.), a written revocation, or by creating a new will that explicitly revokes the previous one. If there is doubt as to whether the will was revoked, it can be contested.
Contact a Pennsylvania Litigation Attorney to Contest a Will
Contesting a will in Pennsylvania can be a complex and emotionally taxing process. Whether you believe a will is invalid due to lack of capacity, undue influence, fraud, or any other reason, it is crucial to have a clear understanding of the legal grounds and the steps involved. If you are considering contesting a will, it is highly advisable to consult with an experienced probate litigation attorney who can guide you through the process, help build your case, and ensure your rights are protected