Corporate Transparency Act— Nationwide Injunction Update and Key Considerations

On December 3, 2024, the U.S. District Court for the Eastern District of Texas issued a nationwide injunction halting enforcement of the Corporate Transparency Act (“CTA”).1 In response, the U.S. Department of the Treasury’s Financial Crimes Enforcement Network (“FinCEN”) confirmed it will comply with the injunction while also appealing the decision. FinCEN also states on its website that reporting companies are not required to file beneficial ownership information during the injunction and will not incur penalties for failing to do so.

For so long as the injunction remains in place, it is safe not to make CTA filings. On the other hand, it is impossible to know whether and when the injunction may be lifted. And if it is lifted, there may be limited time for filings to be made before penalties accrue. Filers who choose not to file now may wish to assemble their information so they are ready to file on short notice should the need arise. We also recommend that filers who do not have particular privacy or other concerns consider filing notwithstanding the injunction to ensure that they are compliant no matter the outcome of the lawsuit.2 Ultimately, the decision to file is a personal and business decision that will vary by client.

Below are key points to consider:

  1. If you have already applied for a FinCEN Identifier, your sensitive information is already submitted, so there is less risk in proceeding with the filing.
  2. If privacy and business concerns are minimal, consider filing now to avoid a potential rush if the injunction is lifted and filings become due immediately.
  3. For entities formed in 2024 with a non-12/31 filing deadline, consider filing if privacy is less of a concern. Although FinCEN may provide an extension in these situations, penalties remain steep and the outcome is uncertain.

1See Texas Top Cop Shop, Inc., et al. v. Merrick Garland, et al.

2We previously published some advisories on the general application of the CTA and its specific application for those with entities for estate planning purposes and the rules and guidelines are largely unchanged.

Copyright 2024 Goulston & Storrs PC.
For more on the CTA, visit the NLR Corporate Business Organizations section

Litigants Beware: Unjust Enrichment v. Quantum Meruit

The distinction between unjust enrichment claims and quantum meruit claims have long bedeviled courts and practitioners. In Core Finance Team Affiliates v. Maine Medical Center, the Law Court provided important guidance regarding the differences between these claims while leaving open a difficult question relating to the implications of pursuing one claim but not the other.

Core Finance involved a suit by a contractor against hospitals relating to the provision of services for reimbursement submittals. The contractor asserted claims for breach of contract and unjust enrichment. After a jury concluded that the contractor failed to prove the existence of a contract, the court held a bench trial and awarded damages to the contractor for unjust enrichment.

The Law Court reversed the judgment on narrow grounds—namely, that the contractor failed to “prove the damages recoverable under either a quantum meruit theory or an unjust enrichment theory.” The Court concluded that, absent proof of conscious wrongdoing, “the appropriate measure of damages” for an unjust enrichment claim is the same as for a quantum meruit claim: “the market value of [defendant’s] uncompensated contractual performance.” The contractor had not presented evidence of the value of its services; rather, its evidence focused on the increase in reimbursement to the hospitals (i.e., the value to the defendants of the services). Thus, the record did not contain a sufficient basis for correctly determining damages.

Although this holding is of note in its own right, it was preceded by a particularly notable discussion of the differences between a quantum meruit claim and an unjust enrichment claim. The parties had disputed whether the trial court should have considered the unjust enrichment claim at all, absent any quantum meruit claim. The hospitals argued that the contractor had to exhaust its legal remedies by pursuing a quantum meruit claim before pursuing an unjust enrichment claim.

Discussing this issue, the Court emphasized that a quantum meruit claim involves “recovery for services or materials provided under an implied contract.” It thus involves enforcement of a promise, and is a legal remedy. An unjust enrichment claim, by contrast, does not involve an implied contract, but rather involves compelled performance “of a legal and moral duty to pay.” Unjust enrichment does not involve any express or implied promise, and is an equitable remedy.

The Court went on to observe that it had “never stated that an unjust enrichment claim involving the rendition of services cannot be adjudicated until after the court has rejected a quantum meruit claim involving the same services.” Importantly, it then acknowledged that this “premise can readily be inferred” for two reasons: (1) the limitation on the availability of equitable remedies if there is an adequate legal remedy, and (2) the primacy over contract over unjust enrichment in the remedial scheme, which requires determining whether an express contract exists before considering quantum meruit or unjust enrichment claims. The Court noted that equitable remedies should be granted “only when there is not an adequate legal remedy,” and that “the court need not consider unjust enrichment if quantum meruit is an adequate remedy.” Having said all that, however, the Court declined “to explore the dilemma further,” instead resolving the case on the damages issue.

The Court’s lengthy discussion is dicta, but it is important nevertheless. Although the Court did not hold that the failure to bring a quantum meruit claim barred an unjust enrichment claim, the Court walked right up to that line. Its language certainly is suggestive that it would so hold if it had to resolve the issue. As such, Core Finance is an important guidepost for litigants considering which claims to bring in the alternative to a breach of contract claim.

©2024 Pierce Atwood LLP. All rights reserved.
For more on Unjust Enrichment Claims and Quantum Meruit Claims, visit the NLR Government Contracts Maritime Military section

Trial Tactics: It Starts in Discovery

Trial preparation starts in discovery.

Yes, that statement seems a bit ridiculous – especially considering the fact that the majority of civil matters will never see a courtroom – but working a case backwards with trial prep as a starting point is truly the only way to ensure you are truly doing everything in your power to zealously protect your client’s interests and fully develop your client’s defenses in each case. This is especially important if the majority of your practice is within the same subset of law, such as toxic torts.

Embracing the “work backwards” approach has a few key benefits:

  1. It ensures that nothing will be missed or overlooked in discovery.
  2. It prepares you for the unexpected.
  3. It will ultimately save you time and effort down the line.

Thorough Discovery

The eve of trial is not the time to realize you still have questions about the allegations or facts in a case. Hindsight is always 20/20, and by working backwards you can ensure your path forward in a case is clear.

Preparing a trial cross of the witnesses offered for deposition forces you to conduct a more thorough examination during their deposition, which ensures that no questions are left unanswered – or worse, never even asked. You will also have to look at potential exhibits you would want to use at trial which will ensure discovery is fully developed with all the avenues explored.

If an expert deposition is coming up, drafting potential Daubert motions or motions in limine can help you to fully develop what you need to obtain from their deposition prior to same.

The Unexpected

During settlement negotiations, Plaintiff’s Counsel unexpectedly demands double what the case is worth, in an attempt to catch you off guard and force your hand as trial is approaching. However, since you have worked backwards for this case, you are ready to call their bluff or, better yet, go forward with trial on your client’s behalf.

By embracing this approach, you have already developed potential Daubert motions, motions in limine, and cross examinations of Plaintiff’s expected witnesses, which you used to draft your cross outlines for each deposition. Further, you also identified all the key documents you plan to use as exhibits and have already incorporated those in discovery or witness depositions.

Time Saved

It is true that some trial prep is best saved for right before trial – such as the final draft of your opening statement, cross examinations, etc. However, by taking the work backwards approach, the large portion of the substance – or the most time-consuming part – should already be completed for each trial task.

Arguably, it is an injustice to your client if you are not adequately preparing for all potential outcomes – no matter how unlikely or distant trial may be – but also just as important is it allows you to think outside the box and continue to develop your skills as a trial attorney.

©2024 CMBG3 Law, LLC. All rights reserved.
For more on Trial Tactics, visit the NLR Litigation Trial Practice section

Federal District Court Issues Nationwide Preliminary Injunction Barring Enforcement of Corporate Transparency Act

In Texas Top Cop Shop, Inc., et al. v. Garland, et al., a federal district court judge issued a nationwide preliminary injunction barring enforcement of the Corporate Transparency Act (“CTA”), finding that the CTA likely exceeds Congress’s powers. Therefore, at present, a reporting company is not obligated to comply with the CTA and the government is enjoined from enforcing the CTA’s reporting requirements. As expected, on December 5, 2024, the government entered a notice of appeal of the preliminary injunction and may still seek a stay of the preliminary injunction pending the appeal. If a stay is granted by the Court of Appeals, the reporting obligations would once again be in effect. The Court of Appeals could also decide to keep the preliminary injunction in place while an appeal is pending.

At this time, companies are not required to file Beneficial Ownership Information (“BOI”) reports, although they are free to do so should they choose. Indeed, the Financial Crimes Enforcement Network (“FinCEN”) issued guidance after the entry of the notice of appeal, stating as much: “In light of a recent federal court order, reporting companies are not currently required to file beneficial ownership information with FinCEN and are not subject to liability if they fail to do so while the order remains in force. However, reporting companies may continue to voluntarily submit beneficial ownership information reports.” (available at https://www.fincen.gov/boi.)

At present, it is unknown how long companies would be given to file if the preliminary injunction is stayed, modified or the law is ultimately upheld. However, FinCEN’s statement suggests that a reasonable extension of time for filing can be expected, though that is not a certainty. Of course, if the CTA is ultimately struck down, no filing would be required.

© 2024 Blank Rome LLP
For more on the CTA, visit the NLR Corporate Business Organizations section

FCA Enforcement & Compliance Digest — Fall 2024 False Claims Act Newsletter

Welcome to the Fall 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance tips. We bring you the most recent and significant insights in an accessible format, concluding with our main takeaways — aka “And the Fox Says…” — on what you need to know.

In this Fall 2024 edition, we cover:

  1. Enforcement Trends: Manufacturers challenge AKS intent requirement as reflected in recent denials of OIG Advisory Opinion requests.
  2. Litigation Developments: Implications of Florida judge’s ruling that the FCA qui tam provision is unconstitutional.
  3. Compliance Corner: What health care companies need to know about AI.
  4. ICYMI: Federal Court Permits Investors to Resume Kickback Suit Against Teva

1. Enforcement Trends

Do Violations of the AKS Require a ‘Corrupt’ Intent? Manufacturers Challenge the OIG’s Interpretation of the Statute

In a series of recent lawsuits filed by the pharmaceutical industry against the US Department of Health and Human Services (HHS) Office of the Inspector General (OIG), manufactures are challenging the OIG’s interpretation of the Anti-Kickback Statue (AKS), arguing that violations of the statute require a corrupt intent. While courts have so far ruled in OIG’s favor, should a court accept this argument, the AKS regulatory landscape could be upended, providing health care providers and suppliers the opportunity to develop and implement arrangements that have historically been prohibited by the OIG.

The challenges to OIG’s interpretation of the AKS come in the context of OIG Advisory Opinion requests submitted by the manufacturers (or a related charity) proposing various forms of patient assistance programs under which the manufacturers or their related charities offer financial assistance to patients on the manufacturers’ products. The OIG denied each of the Advisory Opinion requests, finding that the proposed forms of patient assistance would constitute remuneration intended to induce patients to purchase the manufacturers’ drugs in violation of the AKS.

The OIG has consistently reiterated its opposition to manufacturer-operated patient assistance programs, with both the OIG’s 2005 Special Advisory Bulletin: Patient Assistance Programs for Medicare Part D Enrollees and the 2014 Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs noting that manufacturers cannot provide co-pay assistance to federal health care program beneficiaries, as doing so would constitute a kickback. However, the guidance also described the parameters under which independent charities can provide co-pay assistance, including assistance to federal health care program beneficiaries (i.e., Medicare beneficiaries). One of the key factors with respect to the operation of charitable patient assistance programs, is the independence of the charities operating the programs. While the independent charities are primarily funded by manufacturers, to be considered independent for OIG’s purposes, the charities must retain independence from donors. This means the donors cannot influence the design or operation of the patient assistance programs, and the programs cannot favor patients on the donor’s drug (e.g., assistance cannot be contingent upon the patient being prescribed a donor’s drug).

In three separate litigations, Pfizer Inc. v. United States Department of Health and Human Services, Vertex Pharmaceuticals Incorporated v. United States Department of Health and Human Services et al., and Pharmaceutical Coalition for Patient Access v. United States of America et al., manufacturers are challenging OIG’s long-held position that manufacturers cannot provide patient assistance, including co-pay assistance, to federal health care program beneficiaries. In doing so, the goal of the manufacturers is to provide assistance to patients, including co-pay support, either directly or through a charity that is not considered independent by OIG’s standards due to the relationship of the proposed charities to the manufactures and the level of influence by the manufacturers over the proposed charities. In each litigation, the manufacturer or, in the case of the Pharmaceutical Coalition for Patient Access (PCPA), the charity controlled by the manufacturers, is challenging an unfavorable Advisory Opinion issued by OIG concluding that the proposed patient assistance programs would constitute remuneration intended to induce patients to use a particular manufacturer’s products.

Under the arrangements proposed by Pfizer and PCPA, the proposed charities would be funded exclusively by manufacturers and would only provide support to patients on those funders’ drugs. In Pfizer’s Advisory Opinion request, the company proposed two potential co-pay assistance programs: (1) a direct co-pay assistance program and (2) a Pfizer-supported charity co-pay assistance program. Similar to the proposed Pfizer-supported charity co-pay assistance program, PCPA, an organization funded by manufacturers of Part-D-covered oncology drugs, proposed to create its own patient assistance program that would provide co-pay assistance to patients who meet certain qualifying criteria and then invoice each participating manufacturer for “the total amount of cost-sharing subsidies provided to eligible Part D enrollees.”

Vertex’s Advisory Opinion request focused on a proposed “Fertility Preservation Program” under which Vertex would pay fertility providers through a third-party vendor for the treatments provided to patients enrolled in the program. While this proposed program involved coverage of related treatment costs (i.e., the costs of the fertility treatments) rather than coverage of the co-pay costs associated with the Vertex drug itself, OIG nonetheless applied the same reasoning as in the Pfizer and PCPA opinions, concluding that the program would constitute remuneration to the patients in violation of the AKS.

In each litigation, the manufacturer (or, in the case of PCPA, the manufacturer-related charity) is challenging OIG’s position that the manufacturer’s subsidies constitute “remuneration” meant “to induce” patients to purchase manufactures’ products. The manufacturers argue that the AKS criminalizes conduct that “leads or tempts to the commission of crime” through “remuneration” that corrupts medical decision-making, as part of a quid pro quo transaction. In other words, according to the manufacturers, “to induce” requires a corrupt intent. Therefore, because the manufactures’ efforts to assist patients with meeting Medicare co-pay obligations or gaining access to Medicare-covered treatments (or treatments otherwise covered by the federal health care programs) are not done with malice or corrupt intent, such programs would not violate the AKS.

To date, no court has agreed with the manufacturers’ position. While Vertex is still pending trial in the District Court for the District of Columbia, the District Court for the Southern District of New York ruled against Pfizer, noting that “the law is clear that absent an express carve-out, the Anti-Kickback Statute prohibits any remuneration intended to induce someone to purchase or receive a drug or medical service.” Similarly, the District Court for the Eastern District of Virginia ruled against PCPA, concluding that HHS OIG’s “interpretation of the AKS adheres faithfully [to] the statute’s plain text, comports with its context, and does not offend its history.” On appeal, the Second Circuit affirmed the District Court’s decision in Pfizer, finding that an AKS violation does not require “corrupt intent.” Pfizer then appealed to the US Supreme Court, which denied certiorari. PCPA’s case is currently on appeal with the Fourth Circuit.

Should the Vertex court or a court of appeals agree that the statutory terms “induce” and “remuneration” should be construed more narrowly and require a corrupt intent to violate the AKS, AKS regulatory interpretation and much of OIG’s guidance could be called into question. Arrangements that have historically been viewed as suspect by the OIG could be considered compliant to the extent the parties lacked a corrupt intent to violate the law.

And the Fox Says… Ongoing efforts challenging OIG’s statutory interpretation of the AKS demonstrate manufacturers’ interests in narrowing the scope of prohibited activities under the law. Providers and suppliers should continue monitoring the ongoing litigation and any future efforts to challenge OIG’s interpretation of the AKS, as any judicial narrowing of the interpretation could provide opportunities to develop innovative arrangements that may be beneficial to patients. Regardless, developing compliant arrangements to benefit patients can be complicated, and legal counsel can help to ensure you remain apprised of all relevant developments and assist in structuring compliant arrangements.

2. Litigation Developments

What Is the FCA Without Its Qui Player? A Look Into Zafirov’s Future Implications and the Enforceability of the FCA Without a Qui Tam Device

As we previously discussed, a Florida federal district court recently held in Zafirov v. Florida Medical Associates LLC that the FCA qui tam provision is unconstitutional. The court reasoned that a relator who litigates an FCA lawsuit on behalf of the United States is not a properly appointed “officer” under Article II of the US Constitution and, thus, does not have the authority to serve in that position. This article examines several questions: What does FCA enforcement look like without a qui tam device? What questions did Zafirov leave unresolved? And what should one expect in the coming years as this issue is litigated on appeal and among other courts?

Can the government successfully enforce the FCA without a qui tam device? If, in the end, the qui tam provision is voided, that does not spell doom for the FCA. This is because the government still has the authority to file FCA actions itself and could hire many more attorneys to investigate and prosecute them. The government also has other mechanisms to entice whistleblowers to come out of the woodwork and inform it of wrongdoing. For example, recently, the US Department of Justice (DOJ) announced the “Corporate Whistleblower Awards Pilot Program.” This enforcement program compensates whistleblowers who inform the DOJ of original and truthful information concerning corporate misconduct. If the information leads to a successful forfeiture of over $1 million, the whistleblower is compensated. Currently, however, the program does not cover FCA claims. But the DOJ or US Congress could theoretically expand this program, or create a new one, to attract whistleblowers who have information concerning FCA violations. Under such a program, the government’s litigation of FCA claims would not be all that different from what happens currently. Rather than intervene in a meritorious FCA case brought by a relator, the government would file its own case based on information provided by a whistleblower. This would avoid the constitutional pitfalls identified in Zafirov. A post-qui tam landscape will certainly see fewer FCA claims being filed overall, but the government would likely file more FCA claims than it does now.

Still, many questions remain unresolved under Zafirov concerning the extent to which relator suits are constitutionally permissible. In Zafirov, the relator was litigating an FCA suit in which the United States declined to intervene. But what happens if the United States does intervene and takes over the case? Are those suits permissible? Does the relator act as an “officer” if her role is just limited to filing a lawsuit? Could the government get around Zafirov by intervening in more cases? Or are all FCA lawsuits filed by a relator invalid ab initio even if the government intervenes? If so, would Congress have to create a mechanism to appoint a relator as an officer for FCA purposes? In short, it is unclear how broadly Zafirov will be read. On one hand, it could be read to only apply to non-intervened cases. On the other hand, the very act of filing a complaint on behalf of the United States may require a constitutional appointment, and the government’s intervention would not cure that taint. These questions will remain unresolved until they are addressed by the Supreme Court.

Only time will tell what will happen as this issue percolates in the courts. Already, several circuit courts have upheld the constitutionality of the qui tam provisions. In the district courts located in circuits that have not yet addressed this issue, defendants are filing dispositive motions arguing that the relator’s appointment is unconstitutional. Though the decision in Zafirov is currently an outlier, it soon may not be as more courts consider arguments that rely on Zafirov’s reasoning.

And the Fox Says… Zafirov is significant because it may be the first blow to a significant enforcement mechanism on which the government heavily relies. But the qui tam provision’s fate is not set in stone. The relator in Zafirov will almost certainly appeal the decision to the Atlanta-based Eleventh Circuit Court of Appeals. That court’s decision may then be appealed to the Supreme Court. The appeals process for Zafirov may take years before the Supreme Court grants certiorari on the issue (if it does at all). In the meantime, the issue is not going away, and Zafirov is unlikely to be a one-off case. Those who are in the throes of an FCA investigation or litigation should raise this issue as a possible litigation risk or as an affirmative defense. The best possible time to raise this issue amid litigation is on a Rule 12(b)(6) motion to dismiss. Even if a case is past this point, Zafirov supports the position that such an argument is not waived, given that the issue goes to the relator’s very authority to bring the suit. So, defendants litigating a case brought by a relator should raise this issue as soon as possible. We at ArentFox Schiff will continue to monitor developments to help our clients navigate this ever-changing legal landscape.

3. Compliance Corner

AI Under the DOJ Microscope: How Health Care Companies Should Respond

Many companies, including health care companies, have incorporated artificial intelligence (AI) into their business practices. While historically, AI has largely been unregulated, that is starting to change. Recently, state governments have begun regulating the use of AI in the health care setting, as our colleagues summarized here regarding recently passed California legislation requiring health care facilities, clinics, and physician practices in the state to disclose the use of AI in communications regarding patient clinical information. Now, AI has the attention of the DOJ.

This past March, Deputy Attorney General Lisa Monaco indicated the DOJ’s interest in AI, stating at the American Bar Association’s 39th National Institute on White Collar Crime that “fraud using AI is still fraud.” Following Monaco’s statement, in September, the Criminal Division of the DOJ updated its Evaluation of Corporate Compliance Programs (ECCP) guidelines to require DOJ prosecutors to consider whether a company’s compliance program safeguards against misuse of AI or other emerging technologies. As a brief primer, the ECCP is a DOJ document that prosecutors use to evaluate the effectiveness of a corporate compliance program in determining whether to criminally charge a company. The document is published publicly and provides helpful insight into the DOJ’s expectations for companies as they build and implement their corporate compliance programs.

Under the updated guidance, the DOJ emphasizes that companies need to assess AI-related risks as part of their overall enterprise risk management systems. Specifically, a corporate compliance program must consider whether it has specific policies and procedures to prevent “any potential negative or unintended consequences” resulting from the use of AI in its business practices and compliance program. Additionally, a company should proactively conduct risk analyses of its use of AI and mitigate the potential for “deliberate or reckless misuse of technologies” by company insiders. Other key considerations are whether the company trains its employees on the use of AI, whether there is a baseline of human decision-making used to assess AI-generated content, and how the company implements accountability over the use of AI.

In its September update, the DOJ also revised a section of the ECCP, asking whether compliance personnel have access to relevant data sources to allow for “timely and effective monitoring and/or testing” of policies, controls, and transactions. A key consideration is whether the assets, resources, and technology available to compliance programs are comparable to those available elsewhere in the company. An imbalance in access to technology and resources may indicate a compliance program’s inability to detect and mitigate risks, particularly if a business unit is given unfettered access to AI tools while compliance lags behind.

Compliance officers at health care companies should take steps now to ensure that the implementation and use of AI within their organizations do not raise any compliance red flags. Consider the recent Texas Attorney General settlement with Pieces Technologies, a company that markets generative AI products, which resolved allegations that the company made misleading statements regarding the accuracy of its products. As part of the settlement, Pieces agreed to provide more explicit disclosures to customers related to how the company’s products should be used and the potential harm that could result from the products.

Providers using such technologies may encounter data privacy and security risks, including cybersecurity risks such as ransomware and malware attacks, bias and fairness concerns with respect to the training of the AI systems that may result in preference for a particular drug or treatment, and reliability and accountability concerns affecting a health care professional’s ability to provide patient care. With that being said, the DOJ could conduct investigations similar to the Pieces investigation against health care providers that use AI without considering these risks.

To help mitigate the risks associated with AI, including in the event of a DOJ investigation, compliance officers should be involved during all stages of discussions around AI initiatives, including through implementation and use. Compliance officers should ensure their companies have appropriate policies and procedures governing the use of AI once it is introduced to their organizations and provide training to employees both on the AI technology and on the policies governing its use. Finally, compliance officers should ensure they have the necessary access to AI systems to conduct compliance oversight measures. Such oversight measures may include assessing AI-related risks as part of their organization’s annual risk assessment, conducting AI-related auditing, and monitoring to help identify potential issues with the technology as they arise.

And the Fox Says… The DOJ’s AI-focused compliance guidance is a call to action for companies to proactively address the legal and regulatory implications of AI technologies, reminding them that the age of AI requires more than just innovation — it demands robust compliance strategies. Companies that conduct regular risk assessments of their practices must consider the use of AI, update policies and procedures to address its use, provide compliance teams with equal data access, and regularly update training on the lawful use of these technologies. Empowering compliance personnel and working with outside compliance experts to make these regular updates will put a company in a good position to meet these new standards. By embracing these guidelines, companies can mitigate legal and regulatory risks while leveraging the capabilities of AI technologies.

4. In Case You Missed It

Our most popular blog post from the last quarter: Federal Court Permits Investors to Resume Kickback Suit Against Teva.

© 2024 ArentFox Schiff LLP
For more on the FCA, visit the NLR Criminal Law Business Crimes section

CFPB Takes Aim at Data Brokers in Proposed Rule Amending FCRA

On December 3, the CFPB announced a proposed rule to enhance oversight of data brokers that handle consumers’ sensitive personal and financial information. The proposed rule would amend Regulation V, which implements the Fair Credit Reporting Act (FCRA), to require data brokers to comply with credit bureau-style regulations under FCRA if they sell income data or certain other financial information on consumers, regardless of its end use.

Should this rule be finalized, the CFPB would be empowered to enforce the FCRA’s privacy protections and consumer safeguards in connection with data brokers who leverage emerging technologies that became prevalent after FCRA’s enactment.

What are some of the implications of the new rule?

  • Data Brokers are Now Considered CRAs. The proposed rule defines the circumstances under which companies handling consumer data would be considered CRAs by clarifying the definition of “consumer reports.” The rule specifies that data brokers selling any of four types of consumer information—credit history, credit score, debt payments, or income/financial tier data—would generally be considered to be selling a consumer report.
  • Assembling Information About Consumers Means You are a CRA. Under the rule, an entity is a CRA if it assembles or evaluates information about consumers, including by collecting, gathering, or retaining; assessing, verifying, validating; or contributing to or altering the content of such information. This view is in step with the Bureau’s recent Circular on AI-based background dossiers of employees. (See our prior discussion here.)
  • Header Information is Now a Consumer Report. Under the proposed rule, communications from consumer reporting agencies of certain personal identifiers that they collect—such as name, addresses, date of birth, Social Security numbers, and phone numbers—would be consumer reports. This would mean that consumer reporting agencies could only sell such information (typically referred to as “credit header” data) if the user had a permissible purpose under the FCRA.
  • Marketing is Not a Legitimate Business Need. The proposed rule emphasizes that marketing is not a “legitimate business need” under the FCRA. Accordingly, CRAs could not use consumer reports to decide for an advertiser which consumers should receive ads and would not be able to send ads to consumers on an advertiser’s behalf.
  • Enhanced Disclosure and Consent Requirements. Under the FCRA, consumers can give their consent to share data. Under the proposed rule, the Bureau clarified that consumers must be provided a clear and conspicuous disclosure stating how their consumer report will be used. It would also require data brokers to acknowledge a consumer’s right to revoke their consent. Finally, the proposed rule requires a new and separate consumer authorization for each product or service authorized by the consumer. The Bureau is focused on instances where a customer signs up for a specific product or service, such as credit monitoring, but then receives targeted marketing for a completely different product.

Comments on the rule must be received on or before March 3, 2025.

Putting It Into Practice: With the release of the rule so close to the end of Director Chopra’s term, it will be interesting to see what a new administration does with it. We expect a new CFPB director to scale back and rescind much of the informal regulatory guidance that was issued by the Biden administration. However, some aspects of the data broker rule have bipartisan support so we may see parts of it finalized in 2025.

Listen to this post

Copyright © 2024, Sheppard Mullin Richter & Hampton LLP.
For more on the CFPB, visit the NLR Financial Institutions Banking section

…But Wait, There’s More!

In 2025, eight additional U.S. state privacy laws will go into effect, joining California, Colorado, Connecticut, Montana, Oregon, Texas, Utah, and Virginia:

  1. Delaware Personal Data Privacy Act (effective Jan. 1, 2025)
  2. Iowa Consumer Data Protection Act (effective Jan. 1, 2025)
  3. Nebraska Data Privacy Act (effective Jan. 1, 2025)
  4. New Hampshire Privacy Act (effective Jan. 1, 2025)
  5. New Jersey Data Privacy Act (effective Jan. 15, 2025)
  6. Tennessee Information Protection Act (effective July 1, 2025)
  7. Minnesota Consumer Data Privacy Act (effective July 31, 2025)
  8. Maryland Online Data Privacy Act (effective Oct. 1, 2025)

While many of these eight state privacy laws are similar to current privacy laws in effect, there are some noteworthy differences that you will need to be mindful of heading into the New Year. Additionally, if you did not take Texas, Oregon and Montana into consideration in 2024, now is the time to do so!

Here is a roadmap of key considerations as you address these additional state privacy laws.

1. Understand What Laws Apply to Your Organization

To help determine what laws apply to your organization, you need to know the type and quantity of personal data you collect and how it is used. Each of the eight new state laws differ with their scope of application, as their thresholds vary based on the 1) number of state residents whose personal data controlled or processed and 2) the percentage of revenue a controller derives from the sale of personal data.

Delaware, New Hampshire, and Maryland have the lowest processing threshold – 35,000 consumers.

Nebraska’s threshold requirements are similar to Texas’ threshold requirements: the law applies to any organization that operates in the state, processes or sells personal data, and is not classified as a small business as defined by the U.S. Small Business Administration.

Notably, Maryland and Minnesota will apply to non-profits, except for those that fall into a narrow exception.

See our chart at the end of this article for ease of reference.

2. Identify Nuances

Organizations will need to pay particular attention to Maryland’s data minimization requirements as it is the strictest of the eight. Under Maryland, controllers will have unique obligations to meet, including the following:

  • Limit the collection or processing of sensitive data to what is “reasonably necessary and proportionate to provide or maintain a specific product or service requested by the consumer to whom the data pertains.”
  • Cannot process minors’ (under 18 years old) personal data for targeted advertising.
  • A broad prohibition on the sale of sensitive data.

If a controller engages in the sale of sensitive data, under Texas’ privacy law, which went into effect in July 2024, requires controllers to include the following notice in the same place your privacy policy is linked: “NOTICE: We may sell your sensitive personal data.” Similarly, if a controller engages in the sale of biometric personal data, the following notice must be included in the privacy policy: “NOTICE: We may sell your biometric personal data.” Nebraska requires companies to obtain opt-in consent before selling sensitive data. Maryland prohibits the sale of sensitive data altogether.

Minnesota takes data inventory a step further, requiring companies to maintain an inventory of personal data processed and document and maintain a description of the policies and procedures that they adopt to comply with the act.

3. Refine Privacy Rights Management

All states provide consumers with the right to access, delete, correct (except Iowa), and obtain a copy of their personal data.

Minnesota’s law provides consumers with two additional rights:

  1. The right to request the specific third parties to whom a business has disclosed personal data. Controllers may choose to respond to such a request either by providing the names of the specific third parties to which it has disclosed the consumer’s personal data or the name of third parties to which it has disclosed any personal data.
  2. The right to question the results of a controller’s profiling, to the extent it produced legal effects. Consumers will have the right to be informed of the reason that the profiling resulted in a specific decision and be informed of the actions the consumers may take to secure a different decision in the future.

Aligning with California and Utah, Iowa requires controllers to provide notice and an opportunity to opt out of the processing of sensitive data.

Interestingly, Iowa does not affirmatively establish a right to opt-out of online targeted advertising.

4. Conduct Data Privacy Impact Assessments

Most state privacy laws require controllers to conduct data privacy impact assessments for high-risk processing activities such as the sale of personal data, targeted advertising, profiling, and sensitive data processing. Nebraska, Tennessee, Minnesota, and Maryland follow Oregon by including any processing activities that present a heightened risk of harm to a consumer. Maryland takes this a step further in requiring the assessment include an assessment of each algorithm that is used.

5. Update Privacy Notices

All state privacy laws require privacy notices at the time of collecting personal data. It is essential you keep your privacy notice up-to-date and ensure (at a bare minimum) it covers data categories, third-party sharing, consumer privacy rights options, and opt-out procedures. Minnesota also requires controllers to provide a “reasonably accessible, clear, and meaningful” online privacy notice, posted on its homepage using a hyperlink that contains the word “privacy.”

As state privacy laws stack up, having a structured, adaptable, and principles-based approach paves the path to sustainable compliance.

Make 2025 the year your privacy program doesn’t just meet the minimum—it excels.

Click here to view the 2025 US State Privacy Laws Applicability Chart

Copyright © 2024 Womble Bond Dickinson (US) LLP All Rights Reserved.
For more on Privacy Laws, visit the NLR Communications Media Internet section

What’s in a Name Anyway? Trademark Basics for Community Associations

This article explores the essentials of trademark rights, their relevance for community associations, and the balance between protecting these trademarks versus respecting the free speech of homeowners.

I. What is a Trademark?

A trademark is a word, phrase, symbol, design, or any combination thereof that identifies and distinguishes the source of the goods or services of one party from the goods or services of another.

  1. Common Law Trademark Rights

    Common law trademarks arise from the exclusive, continuous use of a mark in commerce. It is not necessary to have a registration to use or protect these designations. However, rights in a common law (or unregistered) trademark are generally limited to the geographic area where the mark has been used. Trademark ownership is perpetual if the owner continues to use the trademark to identify its goods or services.

  2. Registered Trademark Rights

    Registered trademarks provide broader protection. There are two levels of trademark registration: state and federal.

    State registration provides protection within the boundaries of the state where the trademark is registered. This is a simpler and less costly process compared to federal registration, making it suitable for businesses that operate primarily within one state. For North Carolina, state trademark registration is done through the North Carolina Secretary of State.

    Federal registration, managed by the United States Patent and Trademark Office (USPTO), offers nationwide protection and several advantages, such as a legal presumption of ownership and the exclusive right to use the mark on or in connection with the goods/services listed in the registration.

II. Can a Community Association Have a Federally Registered Trademark?

Yes, a community association can register a trademark to protect its name, logo, or other identifying symbols for use in connection with the community association services offered.

  1. What is the Process?

    The process of registering a trademark involves several steps:

  2. Search: Conduct a trademark search to assess if the mark is available for registration.
  3. Application: File an application with USPTO, including a description of the mark, the goods/services it will cover, the dates of first use, and examples of such use.
  4. Examination: The office examines the application to ensure it complies with all legal requirements. If there are any issues, the applicant will receive an initial refusal (called an “Office Action”). There is a three-month window to respond or file a three-month extension to respond. If a Final Office Action is issued, the applicant has the option to request reconsideration and/or file to appeal the Examiner’s decision.
  5. Publication: If approved, the mark is published in the Official Gazette, allowing others to oppose the registration.
  6. Registration: If no opposition is filed, the mark is registered, and the owner receives a certificate of registration.
  7. How Time-Consuming is it?

The federal registration process typically takes about a year from filing, but the process can be longer if there are complications or opposition. State registrations are usually quicker, often taking a few months, but the resulting protection is limited to the state.

  1. What are the Benefits?

Trademarks offer several benefits to community associations. For example, the owner of a registered trademark has the exclusive right to use the mark in commerce. Therefore, the community association can prevent other community associations from using a confusingly similar mark and misleading prospective residents as to source, affiliation, or endorsement as a result. For further example, registered trademarks are listed in the USPTO database. A subsequent application for a similar mark for the same or related services will be blocked by the community association’s registration. Finally, the use of the registration symbol (“®”) acts as increased deterrence against other associations from using similar trademarks.

  1. What Does it Protect?

A registered trademark protects the association’s name, logo, and other branding elements from being used by others in a way that could cause confusion. It helps maintain the association’s reputation and ensures that its identity remains distinct.

  1. What Does it Not Protect?

Trademarks do not protect against every type of use. Notably, they do not protect against non-commercial commentary or criticism, which falls under fair use and is safeguarded by the First Amendment. This means that while trademarks prevent individuals or entities from misusing the trademark, they cannot stop individuals from expressing opinions or criticisms.

III. How does a Community Association Enforce its Trademark?

Enforcing a trademark involves monitoring its use and taking action against unauthorized usage.

  1. Monitoring: Keep an eye on how the trademark is used in the marketplace.
  2. Cease and Desist Letters: If unauthorized use is detected, a cease and desist letter can be sent to the infringing party to resolve the matter without litigation.
  3. Litigation: If the cease-and-desist letter is ignored, litigation may be necessary to

When it comes to property owners using the trademark of a community association, the line between trademark infringement and nominative fair use can be tangled. Property owners using the trademark to offer competitive services or confuse residents into thinking that their use is sponsored by the community association are examples of infringement. Only the community association can use its trademark to offer community association services. Only the community association can market the community to prospective residents. Finally, the community association must monitor and enforce against any uses of the trademark that could tarnish its valuable reputation.

Yet, while enforcing trademark rights is important, it is crucial to consider the potential backlash from property owners and the broader community. Even if there is a legitimate claim, aggressive enforcement actions may jeopardize community trust and invite public criticism. Such efforts, especially against gripe sites, can lead to stronger reactions and widespread publication of enforcement efforts online, further damaging the reputation. Put another way, a community association attempting to protect its reputation must consider if its enforcement efforts do the opposite.

Sometimes, directing energy elsewhere and addressing concerns through dialogue and engagement can be more effective and less costly than legal battles.

IV. Value Proposition for Community Association

Trademark rights are crucial for protecting the identity and reputation of a community association. They help prevent confusion among property owners and prospective residents by ensuring that the association’s name and symbols remain distinct. However, while trademarks are valuable tools for community associations to deter unauthorized use, they cannot be used to silence opinions or criticisms. Understanding this balance is essential for effectively managing and enforcing trademark rights in a manner that respects both legal protections and fundamental freedoms of the property owners.

© 2024 Ward and Smith, P.A.. All Rights Reserved.
For more on Trademarks, visit the NLR Intellectual Property section

Public Urged to Use Encryption for Mobile Phone Messaging and Calls

On December 4, 2024, four of the five members of the Five Eyes intelligence-sharing group (the United States, Australia, Canada, and New Zealand) law enforcement and cyber security agencies (Agencies) published a joint guide for network engineers, defenders of communications infrastructure and organizations with on-premises enterprise equipment (the Guide). The Agencies strongly encourage applying the Guide’s best practices to strengthen visibility and strengthen network devices against exploitation by reported hackers, including those hackers affiliated with the People’s Republic of China (PRC). The fifth group member, the United Kingdom, released a statement supportive of the joint guide but stated it had alternate methods of mitigating cyber risks for its telecom providers.

In November 2024, the Federal Bureau of Investigation (FBI) and the U.S. Cybersecurity and Infrastructure Security Agency (CISA) issued a joint statement to update the public on its investigation into the previously reported PRC-affiliated hacks on multiple telecommunications companies’ networks. The FBI and CISA reported that these hacks appeared to focus on cell phone activity of individuals involved in political or government activity and copies of law enforcement informational requests subject to court orders. However, at the time of the update, these U.S. agencies and members of Congress have underscored the broad and significant nature of this breach. At least one elected official stated that the hacks potentially expose unencrypted cell phone conversations with someone in America to the hackers.

In particular, the Guide recommends adopting actions that quickly identify anomalous behavior, vulnerabilities, and threats and respond to a cyber incident. It also guides telecoms and businesses to reduce existing vulnerabilities, improve secure configuration habits, and limit potential entry points. One of the Guide’s recommended best practices attracting media attention is ensuring that mobile phone messaging and call traffic is fully end-to-end encrypted to the maximum extent possible. Without fully end-to-end encrypted messaging and calls, the content of calls and messages always has the potential to be intercepted. Android to Android messaging and iPhone to iPhone messaging is fully end-to-end encrypted but messaging from an Android to an iPhone is not currently end-to-end encrypted. Google and Apple recommend using a fully encrypted messaging app to better protect the content of messages from hackers.

The FBI and CISA are continuing to investigate the hacks and will update the public as the investigation permits. In the interim, telecom providers and companies are encouraged to adopt the Guide’s best practices and to report any suspicious activity to their local FBI field office or the FBI’s Internet Crime Complaint Center. Cyber incidents may also be reported to CISA.

Copyright © 2024 Robinson & Cole LLP. All rights reserved.
For more on Mobile Phones, visit the NLR Communications Media Internet section

Goin’ Down South: How the Southeastern U.S. Became the Current Hotbed of Cannabis Activity

Part of the reason we started a Cannabis Industry team at a Southeastern-based law firm before any Southeastern state had adopted a marijuana program was because we had a hunch that the expansion of cannabis would eventually make its way to our neck of the woods. And we guess it was just kind of a slow day around the office.

It turns out that our hunch – which even we are modest enough to admit was pretty much obvious and inevitable – turned out to be true. In the last seven years, there has been an explosion of cannabis activity and controversy in the Southeast. From marijuana in various forms to hemp and all of its iterations, the Southeast has been playing catchup with the rest of the country and in doing so is experiencing the progression of cannabis reform at an accelerated pace with the benefit of seeing the experiences of earlier cannabis adopters. We aren’t alone in observing this phenomenon. Jessica Billingsley, for Rolling Stone, has written on the topic several times.

Don’t get me wrong, we’re not so naïve as to think that states around the country aren’t also experiencing dramatic and dynamic debates and reforms about the cannabis industry. In fact, we’ve dedicated a great deal of time and effort to writing about those issues and how they reflect – or in some cases depart from – cannabis programs in other states. But the speed of reform efforts and their concentration in a specific portion of the country have made the Southeastern U.S. the – ok, at least a – current hotbed of cannabis activity.

C’mon. What’s Happening in the Southeast That Makes It So Special? Aren’t You Just Writing This Because You Live There? Could You Be More Egocentric?

Wow, that got a little weird and revealing there for a second but we’re back. For those who may not enjoy the privilege of calling the Southeastern U.S. home, here is a sampling of the cannabis activity currently taking place in the region:

Florida’s Medical Marijuana Market Matures, but Voters Narrowly Rejected the Ballot Initiative for an Adult-Use Program; Hemp Program Survives by Governor’s Veto (for Now)

Florida broke the seal on medical marijuana in the Southeast when it adopted a medical program in 2016. While the program has certainly had its hiccups, it has generally proven to be a popular program as it has matured over the years.

On April 1, 2024, the Florida Supreme Court ruled that voters would decide whether Florida will become the 24th state to legalize adult-use marijuana at the ballot boxes in November. The significant opposition that succeeded in keeping a similar initiative off the 2022 ballots evidently prevailed this year. The initiative came short of receiving the required 60% approval to pass with only about 56% of Florida voters voting in favor.

On the hemp front, earlier this year we wrote that the Florida Legislature passed a bill that would limit the amount of THC in hemp-derived products and upend the novel cannabinoid industry in the state by banning delta-8 and delta-10 products. But in a surprising move described by Marijuana Moment as “somewhat contradictory,” conservative Gov. Ron DeSantis vetoed the legislation, even as he campaigns against adult-use marijuana. This being the South and a controversial issue involving potentially extraordinary amounts of money, there are strange bedfellows and innuendo:

The governor of Florida is reportedly planning to veto a bill that would ban consumable hemp-derived cannabinoid products such as delta-8 THC, apparently because he’s hoping the hemp industry will help finance a campaign opposing a marijuana legalization initiative on the state’s November ballot.

As Gov. Ron DeSantis (R) prepares to step up his push against the legalization measure, officials close to the governor… say he’s plotting to leverage the hemp industry’s economic interest in participating in the intoxicating cannabinoid market to convince people to vote against marijuana reform.

Safe to same there’s more to come in the next couple of months for what has become the 5,000 lbs. gorilla in the Southeastern cannabis landscape.

Arkansas’ Medical Program Booms While Adult Use and Hemp in Limbo During Court Battles

Like Florida, Arkansas was one of the pioneers of bringing medical marijuana to the Southeast. Arkansans voted to approve a medical marijuana program in 2016 via Amendment 98, although the first legal sales did not occur until May 2019. The program eclipsed $1 billion in sales by late 2023, and as of August 2024, sales in 2024 exceeded $158.5 million. From all metrics, the program appears to be doing very well.

And, while an effort to place on the November ballot an initiative that would have further expanded the program was stymied by the Arkansas Supreme Court just before the election, a ballot initiative in 2022 to create an adult-use program didn’t fail by an insurmountable margin, with 43.8% voting in favor.

On the hemp front, all eyes are on the United States Court of Appeals for the Eighth Circuit. That court conducted oral arguments in the Sanders v. Bio Gen appeal on September 24, so a decision should be forthcoming. The trial court action was filed by hemp companies challenging an Arkansas law (known as Act 629) that the plaintiffs contended impermissibly outlawed hemp-derived consumable products in Arkansas. The appeal followed issuance of an injunction by U.S. District Judge Billy Roy Wilson blocking enforcement of Act 629.

Mississippi Struggling to Reconcile Supply and Demand on the Marijuana Front; Unsettled Hemp Rules

Mississippi surprised many observers when a statewide ballot initiative in 2020 went overwhelmingly in support of medical marijuana. After a couple of years of frustrating and largely obstructionist legal wrangling, Mississippi’s medical program is fully up and running now, going on almost two years.

One of the most notable and unique aspects of Mississippi’s program is the absence of any limitations on the number of licenses available to operators. While there are components of the Mississippi laws and regulations governing the program that necessarily limit how many licenses can be issued (e.g., local government opt-outs and distance setback limitations) the program is struggling due in large part to an oversupply of product and not enough patients (as of November 21, 2024, the state reports 48,129 patients). Last legislative session, the Mississippi Legislature modified the state’s medical cannabis law in certain ways that were aimed to improve patient access hurdles, and more amendments are expected in the upcoming session.

On the hemp front, Mississippi lacks any real legislative or regulatory guidance on the subject. Consequently, many in the state view the hemp-derived intoxicating products sold in gas stations and other retail stores as a real problem. Last legislative session, a bill (HB 1676) aimed to regulate intoxicating hemp products failed. Since then, state law enforcement has conducted raids and arrests of retail stores that sell products they believe are illegal under Mississippi law. Also, the Mississippi attorney general recently issued an opinion concluding that hemp-derived THC beverages could be illegal under Mississippi law. We wrote about that opinion here. The Mississippi legislature will almost assuredly revisit legislation governing these products next session while it also explores ways to amend the Medical Cannabis Act.

Texas Low-THC Marijuana Program Continues as Fierce Debates Rage Over Hemp

Texas passed the Texas Compassionate Use legislation in 2015, allowing certain qualified physicians to prescribe low THC products (max of 1% THC by weight) to patients having certain medical conditions. Currently, the state has only licensed three entities, all located in the central region of the state, as “dispensing organizations” to cultivate, process, and dispense low-THC cannabis. While the state has implied it may issue more licenses and a third-party consultant it hired recently recommended that it should, that has not yet occurred. The last application window closed on April 28, 2023. We, along with most everyone in the industry, is watching what Texas ends up doing with this program; everything is supposed to be bigger in Texas, and a real-deal medical cannabis program shouldn’t be any exception.

The hemp world in Texas slightly resembles the one in Arkansas; it’s mired in litigation. Texas has a robust legal and regulatory program that governs hemp and consumable hemp products. That program operated for years without much interruption until the Texas Department of State Health Services (TDSHS) took action in 2020 and 2021 to restrict the sale of certain consumable hemp products. This culminated in the publication of an official statement online in October 2021 stating that Texas law only “allows Consumable Hemp Products in Texas that do not exceed 0.3% Delta-9 . . . THC [, and] [a]ll other forms of THC, including Delta-8 in any concentration and Delta-9 exceeding 0.3% are considered Schedule 1 controlled substances.”

In response, a group of plaintiffs sued the TDSHS and its commissioner seeking to enjoin the “‘effectiveness going forward’ of the amendments to the terms ‘tetrahydrocannabinols; and ‘Marihuana extract’ in the Department’s 2021 Schedule of Controlled Substances.” The trial court granted the requested injunction, ordered the TSDHS to “remove from its currently published Schedule of Controlled Substances the most recent modifications” the subject definitions and any subsequent publications, and “enjoin[ed] the effectiveness going forward of the rule stated on [the Department’s] website that Delta-8 THC in any concentration is considered a Schedule 1 controlled

substance.” The state appealed, the Austin Court of Appeals affirmed, and the matter now sits with the Texas Supreme Court.

THC-infused beverages have also been a focus in Texas recently. As we wrote last month, the Texas Senate Committee on State Affairs held a hearing on October 17, 2024, to discuss how the state might soon regulate THC-infused beverages. That issue will most assuredly be addressed by the Texas legislature this next session.

Louisiana Medical Program Expands Amidst Fight Over Scope of Hemp Program

While Louisiana technically legalized medical marijuana in 1978 and passed several laws in the years that followed in that pursuit, the first products weren’t sold until 2019. The very limited license (only two authorized cultivators and processors) regime is now headed towards a bustling program. The number of dispensaries that can exist in Louisiana is currently capped at 30, but that number will only grow as the patient numbers increase in the regions identified throughout the state.

Louisiana’s hemp program, which is governed by a well-developed regulatory regime, is also in a current state of uncertainty. During the 2024 legislative session, the Legislature amended the hemp laws to restrict where certain hemp-derived products can be sold and their potency. As in Arkansas and Texas, the hemp industry quickly responded with litigation. In that matter, Hemp Assoc. of La. v. Landry, No. 3:24-cv-00871, in the U.S. District Court for the Middle District of Louisiana, was filed on October 18, 2024. The plaintiffs alleged that the 2018 Farm Bill preempts the legislation and is unconstitutional on other grounds. The state disagreed and moved to dismiss, but on November 19, 2024, the state informed the court that it would stay the effective date of the new legislation so that the parties could fully brief the pending motions and the court could reach a decision. The motions are due to be fully briefed in the coming days.

Georgia Trying to Get Its Act Together

The Georgia Access to Medical Cannabis Commission describes the Georgia law as “much more limited than some other states.” The statute does little more than allow registered people to buy and possess low-THC oil from licensed dispensaries. This oil may contain CBD and up to 5% THC by weight.

Only a select number of licensed producers can grow the cannabis that will eventually be turned into the allowed low-THC oil. As in many other states, the application and licensing process is quite strict.

To obtain a registration card, prospective patients must have a qualifying condition or disease and be registered through their physician. Once a patient has their card, they can buy low-THC oil and possess 20 fluid ounces or less so long as they keep it in the manufacturer-labeled pharmaceutical packaging.

On the hemp side, the Georgia Legislature recently passed SB 494, which Gov. Brian Kemp subsequently signed into law. This law introduces substantial changes to the hemp industry. The Georgia Department of Agriculture is in the process of drafting the corresponding and required agency rules. It appears that most hemp extracts like delta-8-THC, delta-10-THC, HHC, and other cannabinoids remain legal under Georgia law as “consumable hemp products.”

Alabama Medical Marijuana Program on the Ropes While Hemp Flourishes

Sigh… where do we even begin when it comes to medical marijuana in Alabama? There have been more twists and turns than a classic Iron Bowl.

The Legislature approved a medical program in 2021, and recent court hearings suggest that we are potentially no further along after three years, with a possibility of the Legislature being forced to take action to modify (or end) the program.

We have written extensively about the years of litigation and dysfunction that have plagued the Alabama medical marijuana program. In a nutshell, the cap on the number of licenses for various categories (cultivators, processors, dispensaries, etc.) has led to a scenario where applicants dissatisfied with the regulators’ decision to award licenses have sued on multiple occasions, and the regulators have either acceded to the demands or ended up in a court that has not acted quickly to impose order on the process.

In the midst of this chaos, the Legislature had an opportunity to tweak the law but overwhelmingly chose not to do so.

We’re choosing to take the optimistic view that the court system will be able to find a resolution to the years of litigation without putting the matter into the Legislature’s hands. We stress that view is very optimistic, but we should know more by the beginning of 2025.

On a brighter note for cannabis advocates, hemp is growing strong in the state, benefiting largely from a relatively liberal regulatory regime. Although the Legislature considered a significant rollback of hemp sales during the last session, the only law passed was a statewide age-limit on products containing hemp. There have been recent reports of law enforcement activity related to hemp businesses being raided for selling unlawful products, but on the whole Alabama should be considered hemp-friendly for the moment.

Tennessee Marijuana Reform Frustrated While Hemp Market Experiences Growth But Tighter Regulation

For years we were astonished that Tennessee was not a huge marijuana (at least medical) spot, but years of hearing over and over from friends and colleagues in the state have finally convinced us of the political complexities at play.

We, likely as most people, tend to view Tennessee as being dominated by Nashville, Memphis, Chattanooga, and other hemp-friendly areas of east Tennessee. If the decision was up to the citizens of those areas, Tennessee would likely have a well-established marijuana program. But, as it turns out, Tennessee is a big state with widely varying views on all ranges of social issues, including marijuana. For that reason, marijuana proposals have had little success in the largely conservative state Legislature. We still think Tennessee could be a monster player with the right program in place, but we’d be lying if we predicted that was imminent.

On the hemp side, Tennessee was an early adopter, and its hemp industry blossomed for years under a hands-off regulatory regime. In May 2023, Tennessee enacted T.C.A. § 43-27-201, which is an industry-friendly statutory framework for products containing hemp-derived cannabinoids like delta-8 and delta-10 THC. The statute delegated rulemaking authority to the Tennessee Department of Agriculture (TDA) to flesh out its requirements.

That is where the trouble began. In December 2023, TDA published emergency rules that largely aligned with T.C.A. § 43-27-201 with respect to its licensing and labeling requirements, leaving those operators that focus on edible hemp-derived cannabinoid products pleased. But the rules contained a bombshell: specifically, the requirement that hemp contain 0.3% or less total THC, which includes both delta-9 THC and THCA. The TDA maintained this total THC standard in the permanent rules it promulgated in September 2024.

The TDA’s total THC requirement is at odds with Tennessee’s hemp statute, which defines hemp as cannabis containing 0.3% or less delta-9 THC (with no mention of THCA). In reliance on this statutory scheme, many Tennessee hemp companies that focus on psychoactive products have made high-THCA smokable products a large part of their offerings. The TDA’s new rules, which go into effect on December 26, 2024, pose a grave danger to those operators.

Industry groups, including the Tennessee Growers Coalition, are preparing for war to prevent these new rules from going into effect. Stay tuned to Budding Trends for updates on the lawsuits against the TDA that are coming down the pike.

Kentucky Begins Medical Marijuana Program and Remains Hemp Stalwart

The OG of hemp, with the help of its powerful Sen. Mitch McConnell, Kentucky has an outsized responsibility for passage of the two most recent farm bills that have led to the explosion of the hemp industry. Kentucky’s hemp program remains strong, and many of its Congressional delegation represent a bulwark against efforts to severely limit the availability of hemp products.

Kentucky’s medical cannabis program is just now off to the races. Licenses are currently being awarded and industry observers are carefully watching the Bluegrass State’s progress as the program gets off the ground.

Nothing to Show Yet, But South Carolina Begins to Show Signs of Life in Cannabis Reform Efforts

Ah, South Carolina. Its siren song has tempted cannabis advocates for years with its diversity – political, geographical, geological, and otherwise. But to date, nada. We’ve written about the fits and starts with the South Carolina Compassionate Care Act in the past few years. The Legislature has not enacted the law as of yet, but we are keeping our eyes on it during the next legislative session.

On the hemp side, coming from a state that has famously been near the back of the line on cannabis liberalization, we’ll admit that we were surprised to read a recent letter from the solicitor general of South Carolina stating that, as a general rule, hemp beverages containing less than .3% delta-9 THC on a dry-weight basis are legal. We suspect that will be a topic of discussion at the next legislative session.

North Carolina Not Quite there on Marijuana , Stalled on Hemp

North Carolina is going to be a monster marijuana jurisdiction, but like Tennessee, the geopolitical makeup of the state has restrained cannabis liberalization to date. Maybe we should have known better than to predict that the Tar Heel State was going to take action on marijuana legislation in an election year in which the speaker of the N.C. House, Tim Moore (R), is running for an open U.S. Congress seat. Passing a marijuana legalization bill was not going to be a political priority and could have given political adversaries an opportunity to paint supporters as soft on crime, even if a majority of the state’s electorate does support some kind of legalization.

For its part, the state Senate passed yet another medical marijuana and hemp regulation bill, House Bill 563, though one of the most restrictive in the country, only to see it stall in the hose. As in years past, Moore has not allowed the House to take a vote on a bill and has cited his “majority of the majority” policy and lack of Republican support in the House as a basis for refusing to bring the Senate bill to the House floor for a vote.

It’s likely not going to move anytime soon, but what’s in HB 563? Half the bill is dedicated to the regulation of hemp, while the second half – the North Carolina Compassionate Care Act – opens the door to legalizing medicinal marijuana. On the medicinal marijuana side, the bill creates a state commission to oversee the distribution of medical marijuana and regulate which medical conditions are eligible for treatment. It also outlines the process for patients to obtain medical cannabis cards, creating restrictions on where cannabis can be smoked, and requires physicians to write prescriptions for patients to use medical cannabis.

Some Senate Republicans expressed concern that legalization of medicinal marijuana was a fast and slippery slope towards legalizing recreational marijuana. To alleviate that concern, an amendment was adopted that clarified that recreational use would remain illegal in North Carolina even if the federal government reclassified or legalized marijuana nationwide.

On the hemp regulation side, HB 563 would require all hemp product manufacturers and distributors to be licensed. In addition, there are new safety and testing standards, marketing and label restrictions, and more strict product regulations on the amount of cannabinoids that can be included in ingestible or inhalable products.

Politically, it makes sense for supporters of medical marijuana to tie its fate to hemp regulation. Hemp regulation has broad bipartisan support and would likely pass both chambers if presented as a standalone bill. By linking hemp regulation to the Compassionate Care Act, medical marijuana supporters are daring their House and Senate colleagues to vote against hemp regulation. For the time being, that leaves the hemp industry with the uncertainty, and opportunity, of North Carolina continuing to have very limited regulations for the industry.

Why Is the Southeast Experiencing Such Explosive, Concentrated Cannabis Activity?

Part of the reason for the accelerated pace of developments of cannabis reform in the Southeast is precisely because the Southeast started cannabis programs later than other parts of the country. As a result, Southeastern cannabis efforts are, on the whole, not as mature as markets in other states. There are examples from other states that legislatures and regulators can look to for how other states in recent years have addressed the issues just now facing Southeastern states.

There is a great scene in the movie Major League where Willie Mays Hayes, played by the wonderful Wesley Snipes, is removed from the Cleveland (then) Indians’ baseball spring training while he sleeps in bed because there is no record of anyone by that name being invited to spring training (because he wasn’t invited). When Willie wakes up in the morning to the sound of potential Indians running sprints, Willie jumps out of bed in his pajamas and starts running, eventually finding himself running between two uniformed players. Because of his remarkable speed (“I hit like Mays, and I run like Hayes”), Willie explodes past the other two even though they had a head start. The manager Lou Brown, played sublimely by the delightful James Gammon, immediately says “[g]et him a uniform.”

What the hell are we talking about? We think the Southeastern cannabis market is a little like Willie Mays Hayes. The market was late to the cannabis industry, but once it arrived it has the benefit of seeing the experiences of other states and, like Willie, has the benefit of hitting the ground running.

Separately, the issue of cannabis reform is ripe for political battles in the Southeast. The region is certain not as socially progressive on most issues like cannabis. After all, in this part of the country there are still knock-down, drag-out fights about whether to allow the sale of beer before noon on Sundays. But the region is proving to be more progressive than many would have thought, in part perhaps because people around these parts have heard anecdotal reports about friends and family who have used cannabis products safely and perhaps in part because we have seen that cannabis liberalization in other parts of the country has not led to the type of Reefer Madness scenarios long feared.

So, What’s Next?

As with most trends, the rapid expansion of cannabis activity mirrors – and is in many ways a microcosm – of the policies, setbacks, and successes experienced across America.

If we were certain what the future holds for cannabis in the Southeastern United States, we would be sitting on an island somewhere instead of writing blog posts. That said, we expect (1) clear, if not sometimes frustratingly paced expansion of medical cannabis across the region; (2) an expansion of qualifying medical conditions and form factors; (3) an eventual tipping point in the direction of adult-use programs; and (4) hemp continuing to see strong sales unless the federal or state governments enact laws to thwart that growth.

At the conclusion of the wonderful Ken Burns’ epic documentary on country music, the great Marty Stuart says the following about the genre:

Country music has something for everybody, and it’s inside the song, it’s inside the characters. It’s really colorful in here. I invite you in.

Cannabis in the Southeastern United States has something for everybody, and maybe not enough for some people. And we certainly have colorful characters making some of the important decisions about the future of cannabis policy in our little corner of the world. We see this area as one of massive potential growth, particularly with the help of the right people. We invite you in.

 

Listen to this Post

© 2024 Bradley Arant Boult Cummings LLP