Category: Antitrust & Trade Regulation

Confirming a Negative: CFTC Staff Issue an Advisory Clarifying When Foreign-Organized Entities Are Trading and Brokering Digital Asset Derivatives Outside of the Commission’s Cross-Border Jurisdiction

Derivatives market participants and exchanges can breathe a little easier now that Staff of the Market Participants Division and the Division of Market Oversight of the Commodity Futures Trading Commission (CFTC or Commission) have jointly issued an advisory letter (the Advisory Letter) on May 21 clarifying Staff’s interpretation of whether a person trading digital asset derivatives, which is organized and operating outside of the United States, is:

A “non-U.S. person” as defined under the CFTC’s cross-border regulations;
Not a “U.S. person” as defined by the CFTC’s 2013 Final Swaps Cross Border Interpretive Guidance;
A “foreign located person” as defined for the purposes of determining whether such person is exempt from registration as a futures commission merchant (FCM) or introducing broker (under CFTC Regulation 3.10(c)(1)(ii));
Not a “person located in the United States” for the purposes of determining whether a foreign intermediary must register as an FCM; and
Not a “participant located in the United States” for the purposes of determining whether a foreign exchange must register with the Commission as a foreign board of trade.

If you are asking why CFTC Staff would have to issue such an interpretation, given that there is decades of CFTC precedent addressing many of these cross-border jurisdiction issues, you might be forgetting about the evolution of the previous Commission’s approach to cross-border jurisdiction in digital asset enforcement actions. The CFTC first espoused this novel interpretive theory when it brought an enforcement action against a major offshore crypto exchange in early 2023.1 In that case, the previous Commission advanced an expansive interpretation of “principal place of business” that went beyond the traditional “nerve center” test, focusing on where senior management makes strategic decisions,2 instead looking to factors such as the location of ultimate beneficial owners, key personnel involved in trading operations, and other operational touchpoints with the United States. In response to that complaint and the previous Commission’s expansive theories of US person status, a number of offshore crypto exchanges implemented aggressive onboarding questionnaires that went well beyond the statutory definition of US persons in an attempt to avoid potential CFTC jurisdiction.
The Falcon Labs Enforcement Action: Cementing an Expansive Jurisdictional Test
The previous Commission cemented its expansive view of what constitutes a US person with its enforcement action in May 2024 against Seychelles-organized Falcon Labs, Ltd. (Falcon Labs) for failing to register as an FCM with the CFTC.3 In essence, the CFTC’s enforcement action against Falcon Labs established a new test for the extraterritorial application of the Commodity Exchange Act (CEA) by asserting that Falcon Labs was brokering digital asset futures and swaps transactions with “persons located in the United States.” Acting Chairman Caroline Pham—while a commissioner — noted in her concurring statement that the Commission’s new test in the Falcon Labs case “could have the effect of requiring any non-U.S. legal entity that transacts in futures, options, or swaps that has a U.S. parent entity or beneficial owner, or has personnel located in the U.S. that ‘control’ . . . a non-U.S. prime broker sub-account, to be deemed ‘located in the United States’ even if its location of corporate organization is outside the United States and duly complies with the legal or regulatory obligations of the non-U.S. jurisdiction.”4
Indeed, the CFTC’s expansive interpretation of “U.S. person” had implications that extended far beyond the digital asset space, potentially affecting traditional derivatives market participants with any meaningful US operational nexus. The Advisory Letter was intended to reverse this novel interpretation espoused by the Commission in the Falcon Labs enforcement action, which some industry participants widely criticized for establishing “new regulation through enforcement.”
CFTC’s Extraterritorial Jurisdiction over Futures and Swaps
The CFTC’s extraterritorial jurisdiction regarding futures and swaps is different and based on two separate sections of the CEA.
With respect to futures, Section 4(b) of the CEA grants the CFTC authority to regulate foreign futures activity of persons “located in the United States.”5 To explain the scope of its foreign futures authority, the CFTC promulgated Part 30 of its regulations to address when foreign brokers provide US customers with access to foreign futures and Part 48 of its regulations to address when foreign exchanges provide direct access to US customers. The key criteria used to determine when a customer is considered in scope for these purposes focuses on the customer’s physical location (i.e., is the person “located in the United States, its territories or possessions who trades in foreign futures and options”).6
Concerning swaps, Congress established the CFTC’s extraterritorial jurisdiction under Section 2(i) of the CEA as part of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act). The Dodd-Frank Act establishes the CFTC’s swap jurisdictional authority, which hinges on whether swaps activity occurring outside of the United States has “a direct and significant connection with activities in, or effect on, commerce of the United States.”7 In explaining the scope of its swap jurisdiction, the CFTC first issued its Interpretive Guidance and Policy Statement Regarding Compliance With Certain Swap Regulations in 2013 (2013 Guidance), which defined a “U.S. person” to include, among others, entities “organized or incorporated under the laws of a state or other jurisdiction in the United States or having its principal place of business in the United States.”8 Principal place of business was defined to included entities that are organized outside of the United States but have the “center of direction, control, and coordination” (i.e., the “nerve center”) of their business activities in the United States.9
In 2020, the CFTC adopted final rules in CFTC Regulation 23.23 to supersede, in part, the 2013 Guidance with respect to the extraterritorial application of the swap dealer de minimis threshold calculation. The CFTC adopted a similar US person definition, which for entities also focuses on whether such entity was “organized, incorporated, or established under the laws of the United States or having its principal place of business in the United States.”10 CFTC Regulation 23.23 similarly defines “principal place of business” to mean the location of the legal person’s nerve center.
Notwithstanding the above, the CFTC in the Falcon Labs enforcement action found Falcon Labs to have violated FCM registration requirements when dealing with non-US organized entities with principal places of business outside of the United States, but with beneficial owners located in the United States.
The Requestor’s Specific Facts
The Advisory Letter addressed a request from a digital assets proprietary trading firm organized in the Bahamas. The Requestor’s main office and headquarters are located in the Bahamas, where its high-level officers (including its chief executive officer, chief operating officer, and chief compliance officer) primarily direct, control, and coordinate the firm’s activities. However, the Requestor is indirectly owned by a small number of closely associated natural persons who are residents of the United States, and these persons are also co-owners and co-managers of a separate, US-based proprietary trading firm.
The Requestor sought to expand its activities into the United States through several means: (1) engaging US-based traders, quantitative researchers and software developers (all of whom would be employed by a Bahamas-organized affiliate); (2) licensing trading technology from its related US firm; and (3) hosting trading technology on US-located servers. The Requestor requested a determination that it would nevertheless qualify as “located outside the United States” for purposes of the Commission’s futures regulations and as a “non-U.S. person” for purposes of the Commission’s swap regulations.
CFTC Staff’s Analysis and Conclusions
Based on the facts presented in the request for interpretation, specifically that the Requestor’s “place of organization and the location where its high-level officers primarily direct, control, and coordinate” the Requestor’s activities are outside the United States, the Advisory Letter concluded that the Requestor is (1) not “a person located in the United States” for the foreign futures or options analysis;11 (2) not “a participant located in the United States” for CFTC Regulation 48.2(c); (3) a “foreign located person” for the foreign intermediary exemption in CFTC Regulation 3.10(c)(1)(ii); and (4) a non-US person for the CFTC’s swap cross border jurisdiction.
Significantly, CFTC Staff clarified that the Requestor’s proposed expansion activities—including engaging US-based personnel, licensing technology from a US firm, and hosting technology on US servers — would not impact the Requestor’s status. Notwithstanding this expansion, the Requestor would continue to not be “a participant located in the United States” for Commission Regulation 48.2(c), remain a “foreign located person” for the foreign intermediary exemption in CFTC Regulation 3.10(c)(1)(ii), and continue to be a non-US person for the CFTC’s swap cross border jurisdiction.
Implications for the Digital Asset Industry and Beyond
The Advisory Letter represents a significant course correction for the CFTC’s approach to cross-border jurisdiction, with implications that extend well beyond the digital asset space. By returning to the traditional “nerve center” test for determining principal place of business and rejecting the more expansive factors used in the Falcon Labs case, the Commission has provided much-needed clarity for market participants operating across jurisdictions.
The Advisory Letter’s key takeaways for market participants include:

Offshore digital asset firms can now maintain non-US status while engaging meaningfully with the US market. The letter’s express approval of the Requestor’s ability to employ US-based personnel, license technology from US firms, and host technology on US servers demonstrates that operational touchpoints with the United States do not automatically trigger CFTC jurisdiction.
Traditional derivatives market participants receive reassurance that routine US. operational connections will not automatically trigger registration requirements. The expansive interpretation rejected by Staff would have potentially captured any foreign entity with meaningful US operational connections — including foreign banks, asset managers, and commodity trading firms — but the Advisory Letter reaffirms the traditional jurisdictional tests that focus on place of organization and management control rather than broader operational touchpoints.
Market participants can return to relying on decades of established precedent rather than navigating novel enforcement theories. This should reduce compliance costs and encourage legitimate market participation by removing the specter of unexpected jurisdictional exposure that had emerged from recent enforcement cases.

However, the Advisory Letter comes with important limitations that market participants should carefully consider:

The guidance addresses only the specific factual situation presented by the Requestor. Firms with different fact patterns — particularly those with US-based senior management or where strategic decision-making occurs in the United States — may still face jurisdictional exposure under traditional tests.
Staff guidance, while generally respected, could theoretically be superseded by future enforcement actions or formal rulemaking. The Advisory Letter represents Staff guidance rather than a formal Commission interpretation or binding regulation.
The Commission has not completely retreated from aggressive enforcement theories. Market participants should not assume that all jurisdictional concerns have been resolved, particularly for firms with more extensive US connections than the Requestor.

Looking forward, the Advisory Letter suggests that the Commission may be stepping back from the more aggressive jurisdictional theories advanced in recent enforcement cases, potentially signaling a more measured approach to cross-border regulation. For an industry that has faced significant regulatory uncertainty, this return to established precedent and traditional jurisdictional tests should provide a more stable foundation for compliance planning and business development across international markets.

[1] See CFTC v. Changpeng Zhao et al., No. 1:23-cv-01887 (N.D. Ill. Mar. 27, 2023).
[2] Cross-Border Application of the Registration Thresholds and Certain Requirements Applicable to Swap Dealers and Major Swap Participants, 85 Fed. Reg. 56,924, 56,936-937 (Sept. 14, 2020) (quoting Hertz Corp. v Friend, 559 U.S. 77, 80 (2010)).
[3] The CFTC alleged that Falcon Labs facilitated access to digital asset exchanges to U.S.-located customers to trade spot crypto as well as crypto derivatives, including futures and swaps. Falcon Labs’ CFTC settlement included a cease and desist from acting as an unregistered FCM, disgorgement of $1,179,008 in fees earned from its activities and a civil monetary penalty of $589,504. In short, the Commission found as the basis for Falcon’s alleged violation of the FCM registration requirement that Falcon had customers “located in the United States,” “such as non-U.S. incorporated entities operated and controlled by U.S.-based trading firms.”
The Commission determined that Falcon Labs was offering FCM services to entities, which were “located in the United States” as a result of: (1) the location of entities’ ultimate beneficial owners; (2) the location of entities’ places of organization; (3) the principal place of business of each entity; and (4) the location of personnel controlling a non-US prime broker sub-account. None of these criteria, however, are set forth in the CEA’s statutory language, and the CFTC has not issued an interpretation or adopted a regulation expanding its exterritorial jurisdiction over futures or swaps to capture such activity.
[4] Caroline D. Pham, Concurring Statement of Commissioner Caroline D. Pham on Novel U.S. Location Test and FCM Registration, CFTC (May 13, 2024), https://www.cftc.gov/PressRoom/SpeechesTestimony/phamstatement051424.
[5] 7 U.S.C. § 6(b).
[6] See the definition of “foreign futures or foreign options customer” in CFTC Regulation 30.1(c).
[7] 7 U.S.C. § 2(i).
[8] 2013 Guidance, 78 Fed. Reg. 45,292, 45,302 (July 26, 2013).
[9] Id. at 45,309.
[10] 17 C.F.R. § 23.23(23)(i)(B).
[11] Note that for futures analysis, the test is location-based (i.e., whether a person is “located in the United States”) rather than the “principal place of business” test used for swaps analysis.

DOJ’s Antitrust Leadership Emphasizes Procedural Fairness and Targeted Enforcement in Merger Reviews

In a recent speech, Deputy Assistant Attorney General Bill Rinner of the DOJ Antitrust Division[1] outlined the Division’s approach to merger enforcement in the Trump administration under the leadership of Assistant Attorney General Gail Slater. Rinner emphasized a balanced, law-driven, and transparent merger review process aimed at vigorously enforcing antitrust laws without deterring lawful transactions.
Below are key takeaways from the speech:

Antitrust Enforcement Grounded in Law, Not Ideology. The Division views itself as an enforcement agency, not a regulator, focused on preventing mergers that harm competition instead of blocking transactions for broader policy goals. Rinner rejected the idea of using merger review as a tool for social policy or regulatory overreach, drawing a clear boundary between antitrust enforcement and broader public interest regulation.
Procedural Fairness as a Foundation for Enforcement. Rinner emphasized predictability and fairness in merger review, warning that abuse of investigatory tools can undermine due process and public trust. Specific practices the Division will avoid include (1) so-called “Scarlet letter” warnings that implore parties to “close at their own risk;” (2) off-the-books relief or “shadow decrees” neither grounded in the Clayton Act nor transparent to the public; and (3) leveraging the merger review process to impose a “regulatory review tax” or fish for unrelated conduct violations.
Commitment to Vigorous, Case-Specific Enforcement. The Division will continue to pursue strong enforcement where evidence shows harm, but will treat each transaction on its own merits. Vigorous enforcement means using a scalpel, not a sledgehammer.
Preference for Structural Remedies. Rinner reaffirmed the DOJ’s institutional preference for structural remedies (e.g., divestitures), citing their effectiveness and clarity. However, he acknowledged that behavioral remedies may supplement structural relief in fact-specific cases. Settlements must be transparent and subject to public oversight, including under the Tunney Act.
Respect for the Adversarial Process. Rinner encouraged good-faith advocacy from merging parties and their counsel and economists, reaffirming that DOJ values substance over political affiliation or stature in the antitrust bar. He stressed that the DOJ will scrutinize underhanded efforts to conceal documents or abuse privilege claims and will pursue sanctions where necessary.

***
Rinner’s remarks signal that the DOJ Antitrust Division does not view dealmaking with inherent suspicion. When necessary, however, the agency will pursue vigorous, case-specific enforcement grounded in procedural fairness and legal principles. Merging parties should expect a transparent review process focused on competitive effects, with a strong preference for – but not absolute adherence to – structural remedies. Companies should align deal strategies accordingly and be prepared for active engagement before the Division.
[1] The Division has broad antitrust enforcement authority and commonly reviews mergers and competitive conduct in industries such as technology, healthcare (often involving health plans), financial services, and industrials.

Customs Fraud Makes the Big Leagues: DOJ’s New White-Collar Priorities Confirm Heightened Risk

Last month, the Department of Justice put trade, customs, and tariff fraud squarely in the spotlight. This isn’t just another line item on the compliance checklist, it’s a loud-and-clear signal that import-related enforcement is no longer just an administrative concern. It’s now a front-and-center DOJ priority.
On May 12, DOJ Criminal Division Chief Matthew Galeotti announced 10 high-impact white-collar enforcement priorities. Sitting alongside health care fraud, corporate recidivism, and national-security-linked corruption was something you would not have seen from prior administrations: customs and trade fraud, including tariff evasion.
It’s not a surprising move — at least not to us. Back in March, our International Trade team at Foley predicted this turn in two separate publications:

Criminal Enforcement of Trade, Import, and Tariff Rules: A Growing Risk for Businesses
The Rising Risk of Customs False Claims Act Actions in the Trump Administration

We noted then that customs enforcement was moving out of the regulatory shadows and toward the aggressive tactics historically reserved for FCPA, health care, and financial crimes. With this new DOJ announcement, that evolution is now official policy.
What’s Driving the DOJ’s Shift?
This enforcement focus is no accident. It reflects the broader “America First” priorities of the Trump administration, a strategy aimed at reshaping global trade in favor of U.S. interests, as well as a means of collecting additional revenue. From sweeping tariffs to heightened scrutiny of Chinese imports, the administration is using every tool at its disposal — civil, criminal, and regulatory — to protect domestic industry, to close perceived trade loopholes, and to ensure collection of all tariffs. As Galeotti summarized the DOJ’s new approach, “[t]rade and customs fraudsters, including those who commit tariff evasion, seek to circumvent the rules and regulations that protect American consumers and undermine the Administration’s efforts to create jobs and increase investment in the United States. Prosecuting such frauds will ensure that American businesses are competing on a level playing field in global trade and commerce.” For companies that import goods, the message is clear: Compliance with trade laws is no longer just a regulatory obligation, it’s a frontline national priority.
What In-House Counsel Should Do Now: A Practical Framework
In response, manufacturers should elevate trade compliance to the same level of urgency as anti-corruption or sanctions compliance. Drawing from our comprehensive white paper, Managing Import and Tariff Risks During a Trade War, here’s a practical framework for GCs and compliance officers:
Identify Your Risks

Retrieve and analyze your company’s ACE (Automated Commercial Environment) import data.
Conduct a customs risk audit, focusing particularly on ensuring that HTS classifications and countries of origin are accurately (and consistently) reported to Customs for all imports.
Map supply chain and broker relationships.

Plan for Disruption

Diversify sourcing and build supply chain flexibility.
Collaborate with finance to model tariff impact scenarios.
Establish rapid-response strategies for emerging duties or bans.

Manage Contractual Exposure

Build tariff pass-through mechanisms into commercial agreements.
Include change-in-law clauses that allow flexibility in sourcing.
Clearly define responsibility for customs classifications and compliance.

Minimize Legal Exposure

Review and correct import declarations regularly.
Confirm compliance with UFLPA and other partner agency rules.
Implement internal controls around broker instructions and tariff engineering.

Identify Cost-Saving Opportunities

Explore bonded warehouses, FTZs, and drawback programs.
Assess opportunities for tariff engineering and preferential treatment under trade agreements like USMCA.
Consider use of temporary importation bonds (TIBs) where appropriate.

Strengthen Supply Chain Integrity

Perform due diligence on upstream suppliers.
Map materials and origin to avoid forced labor violations.
Implement traceability protocols and audit programs.

This isn’t just a customs compliance issue anymore, it’s a corporate integrity and reputational risk issue. The whistleblower incentives are real, especially under the False Claims Act. The penalties are large. And the prosecutorial appetite is growing.
The Takeaway
We’ve said it before, and we’ll say it again: Customs fraud has moved from the margins to the mainstream of DOJ enforcement.
If your company imports goods, trade compliance should be a priority. DOJ is not waiting for egregious cases; it is actively looking for systemic vulnerabilities, misclassifications, and tariff evasion strategies dressed up as “logistical creativity.”
The time for general counsel to engage is now. Audit. Adjust. Contract. Train. Fix. Because enhanced enforcement is not coming someday — it’s already here.

Court Of International Trade Halts Trump’s “Liberation Day” Tariffs As Administration Appeals Ruling; What Is The Court Of International Trade?

On May 28, the U.S. Court of International Trade (“CIT”) blocked President Trump’s tariffs enacted under the International Emergency Economic Powers Act (“IEEPA”).[1] The CIT held that the IEEPA does not authorize presidential tariffs for trafficking or for worldwide/retaliatory purposes.[2] A day later, the U.S. District Court for the District of Columbia issued a preliminary injunction staying the same tariffs on the same grounds.[3]
In response to the adverse CIT ruling, the Trump administration filed an appeal with the U.S. Court of Appeals for the Federal Circuit. The Federal Circuit, which reviews CIT rulings on appeal, granted an immediate injunction preventing the ruling from taking effect while the case proceeds through the appellate process. However, if the CIT’s decision is affirmed, it would eliminate the tariffs imposed on April 2, 2025 as part of the Trump administration’s “Liberation Day” trade initiative.
While the appeal is being decided, this post will explain the specialized role and jurisdiction of the CIT, which many readers may not be familiar with. 
The CIT operates as a federal court with exclusive jurisdiction over the nation’s international trade disputes. Seated in New York City, the CIT functions with the same legal authority as a U.S. district court but focuses exclusively on international trade matters. The court’s jurisdiction extends to any civil action brought against the United States, its officers, or agencies involving international trade law.[4] This broad mandate includes cases arising from:

U.S. Customs and Border Protection decisions regarding import disputes
Antidumping and Countervailing Duties determinations[5]
U.S. government actions to recover import-related penalties

The CIT’s evolution reflects the increasing complexity of international trade in the United States. Originally established as the Board of General Appraisers in 1890, it became the U.S. Customs Court in 1926 before taking its current form in 1980 under the Customs Courts Act. This legislation aimed to provide the international trade community, domestic interests, consumer groups, labor organizations, and concerned citizens with an improved judicial forum for reviewing government import-related actions.[6]
The CIT is composed of nine life-tenured judges, appointed by the president and confirmed by the Senate. Importantly, no more than five judges may belong to the same political party, with a goal of ensuring balanced representation in international trade dispute adjudication.[7] The case that struck down President Trump’s IEEPA tariffs was decided by a three-judge panel, appointed by Presidents Reagan, Obama, and Trump.[8]
The CIT’s chief judge typically assigns cases to a single judge, unless a case involves the constitutionality of a congressional act, presidential proclamation, executive order, or an issue with significant implications for customs laws. In such cases, the chief judge may assign a three-judge panel, as here.[9]
The Federal Circuit’s eventual decision will likely establish important precedent for future presidential trade actions. If the CIT’s interpretation of IEEPA is upheld, it could constrain how presidents utilize emergency powers to achieve trade policy objectives.

[1] The International Emergency Economic Powers Act (IEEPA) provides the president authority in some circumstances to regulate a variety of economic transactions following a declaration of national emergency. President Trump declared a national emergency under the IEEPA on April 2, 2025 as part of his administration’s “Liberation Day” trade initiative. See 50 U.S.C. § 1702; see generally https://www.congress.gov/crs-product/R45618; https://www.whitehouse.gov/fact-sheets/2025/04/fact-sheet-president-donald-j-trump-declares-national-emergency-to-increase-our-competitive-edge-protect-our-sovereignty-and-strengthen-our-national-and-economic-security/
[2] V.O.S. Selections, Inc. v. United States, No. 25-66, slip op. at 29, (Ct. Int’l Trade May 28, 2025).
[3] Learning Resources, Inc. v. Trump, No. CV 25-1248 (RC), 2025 WL 1525376 (D.D.C. May 29, 2025).
[4] See 28 U.S.C. §§ 1581-1584.
[5] “Antidumping” and “Countervailing Duties” issues address unfair trade practices that provide relief to U.S. industries and workers that are injured due to imports. This can be from like products sold in the U.S. market at less than fair value (antidumping) or subsidized by a foreign government or public entity (countervailing duties). https://www.congress.gov/bill/114th-congress/house-bill/644/text
[6] https://www.cit.uscourts.gov/about-court
[7] 28 U.S.C. § 251.
[8] https://www.cit.uscourts.gov/judges-united-states-court-international-trade
[9] 28 U.S.C. §§ 253-255.

NY Attorney General Secures Over $3.2M from Nissan Dealers for Allegedly Cheating Consumers

On May 6, 2025, New York Attorney General Letitia James announced that the agency secured more than $3.2 million from eight Nissan dealerships in New York City, the Hudson Valley and on Long Island – Action Nissan, Bay Ridge Nissan, Legend Nissan, Garden City Nissan, Huntington Nissan, Rockaway Nissan, Smithtown Nissan, and Teddy Nissan – for allegedly overcharging more than 1,700 New Yorkers that purportedly wanted to purchase their leased vehicles at the end of their lease term.
An investigation by the Office of the Attorney General allegedly found that these dealerships added junk fees or falsified the price of leased vehicles that customers wanted to buy when their lease ended, purportedly forcing them to pay higher costs.
Attorney General James has now stopped deceptive practices at 15 Nissan dealerships and recovered more than $1 million in penalties and $4.5 million in restitution for more than 2,800 New Yorkers, according to the announcement.
“Buying a car is a major financial decision, and no one should have to worry about dealers using illegal junk fees to drive up the price,” said Attorney General James. Attorney General James also stated that “[t]hese car dealers misled their customers with bogus fees and other costs to cheat them out of their hard-earned money. My office’s investigation will put money back in the pockets of defrauded New Yorkers and require these dealers to steer clear of violating our laws and deceiving consumers,” according to Attorney General James.
The OAG opened an investigation into Nissan dealerships after consumers alleged they were being overcharged and given inaccurate receipts for end-of-lease buyouts after the onset of the COVID-19 pandemic.  The investigation allegedly found that the consumers leased their Nissan cars under an agreement that gave them the option to purchase the vehicle for a set amount after the lease term ended.
However, when they returned to the dealerships to buy their car when their leases were up, the dealerships allegedly substantially overcharged them.   The dealers purportedly either added miscellaneous “dealership fees” or “administrative fees,” or inflated the vehicle’s price on the invoice given to the consumer.
Under the agreements announced today:

Action Nissan in Rockland County will pay $157,958.59 to 192 alleged overcharged consumers and pay a $47,920 penalty;
Bay Ridge Nissan in Brooklyn will pay $23,624 to 46 alleged overcharged consumers and pay a $11,960 penalty;
Garden City Nissan in Nassau County will pay $824,013 to 361 alleged overcharged consumers and pay a $89,624 penalty;
Huntington Nissan in Suffolk County will pay $426,654 to 275 alleged overcharged consumers and pay a $68,750 penalty;
Legend Nissan in Syosset, Nassau County will pay $333,482 to 233 alleged overcharged consumers and pay a $20,000 penalty;
Rockaway Nissan in Queens will pay $308,918 to 177 alledged overcharged consumers and pay a $44,250 penalty;
Smithtown Nissan in Suffolk County will pay $643,640 to 321 alleged vercharged consumers and pay a $80,250 penalty; and
Teddy Nissan in the Bronx will pay $108,773 to 156 alleged overcharged consumers and pay a $35,560 penalty.

According to the OAG, the dealerships have also agreed to reform their invoicing practices to ensure all lease buyout customers are neither overcharged nor provided with inaccurate receipts.
The OAG commenced the investigation into the alleged unlawful and deceptive charges pursuant to General Business Law § 349, General Business Law § 350, Personal Property Law §§ 330-53 and Executive Law § 63(12).  Consult with an attorney general defense lawyer to discuss legal regulatory requirements set forth in the aforementioned statutory section.
Attorney General James has secured settlements with 15 different Nissan dealerships for allegedly cheating customers with illegal fees and inflated prices when they attempted to buy out the leases on their cars.  In June 2024, Attorney General James secured $350,000 from two Nissan dealers on Long Island.  In March 2024, Attorney General James secured over $1.9 million from five Nissan dealers in New York City and Long Island.
This matter was handled by the Assistant Attorney General of the Consumer Frauds and Protection Bureau, under the supervision of the Bureau Chief and Deputy Bureau Chief.  The Consumer Frauds and Protection Bureau is a part of the Division of Economic Justice, which is led by the Chief Deputy Attorney General and overseen by the First Deputy Attorney General.

California’s “Auto Renewal Law” Takes Effect on July 1

Amendments to California’s Automatic Renewal Law (ARL) will take effect on July 1, 2025. Enacted in September 2024 through Assembly Bill No. 2863, the amendments expand disclosure, consent, and cancellation obligations for businesses offering subscription or continuous service plans to California consumers.
The amendments impose several new requirements related to consumer consent, cancellation, and disclosures, including:

Affirmative consent. Businesses must obtain a consumer’s express affirmative consent to the renewal terms and retain proof of consent for at least three years or one year after termination, whichever is longer. The law also prohibits contract terms that undermine a consumer’s ability to provide meaningful consent.
Clear and conspicuous disclosures before enrollment. Businesses must disclose key terms—such as renewal conditions, billing frequency, cancellation policies, and pricing changes—clearly, conspicuously, and in proximity to the enrollment request.
Channel-specific cancellation. Businesses must allow cancellation through the same method the consumer used to sign up or typically uses to communicate, such as phone, email, mail, or online. 
Click-to-cancel requirement. For online subscriptions, businesses must offer a “click to cancel” option. Businesses may present retention offers only if cancellation remains immediate and unobstructed.
Prohibition on material misrepresentations. The law prohibits misleading statements or omissions about any material aspect of the transaction, including the renewal terms.

Putting It Into Practice: The amended ARL closely tracks the FTC’s Negative Option Rule, particularly in its expanded requirements for disclosure, consent, and cancellation—setting a new compliance benchmark for businesses operating in California. While the CFPB has pulled back in this area, the FTC and state lawmakers continue to advance rulemaking related to unfair or deceptive subscription practices (previously discussed here).
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FTC Permanently Bans Debt Collector for UDAP and FDCPA Violations

On April 30, the FTC filed a stipulated order for a permanent injunctive relief and a monetary judgment against a Georgia-based debt collection company and its owner, which the court granted on May 9, to resolve allegations that the company used false claims, threats, and harassment to collect more than $7.6 million in bogus debts.
The FTC’s complaint alleged violations of Section 5(a) of the FTC Act, the Fair Debt Collection Practices Act (FDCPA) and Regulation F, the Gramm-Leach-Bliley Act, and the FTC’s Impersonation Rule. Under the order, the defendants are permanently banned from participating in debt collection or brokering activities. The judgment imposes a $9.6 million in monetary relief, which was partially suspended based on the defendants’ inability to pay.
The FTC alleged the company engaged in several unlawful practices, including:

Making false claims. The company allegedly fabricated or misrepresented debts to extract payments from consumers.
Threatening consumers with arrest or lawsuits. Consumers were told they would face arrest, wage garnishment, or civil litigation unless they paid immediately.
Harassing consumers and family members. The company made repeated, unsolicited calls and contacted relatives to pressure consumers into paying.
Obtaining financial information through false pretenses. The company misrepresented its purpose to gain access to consumers’ bank accounts and personal data.
Pretending to be affiliated with other businesses. The company used fictitious names and falsely claimed to represent, or be associated, with legitimate lenders or mediation firms.

Putting It Into Practice: The enforcement action highlights the FTC’s ongoing focus on UDAP violations, particularly those involving threats, impersonation, or deception (previously discussed here). Debt collectors and affiliated vendors should ensure their practices comply not only with the FDCPA and Regulation F, but also with broader federal UDAP standards and the FTC’s Impersonation Rule.
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FDIC and Maryland End Joint Consent Orders Against Regional Bank

On April 7, the FDIC and the Maryland Office of Financial Regulation terminated two consent orders against a regional bank headquartered in Maryland. The termination concludes joint federal and state enforcement actions that required the bank to remediate deficiencies in its anti-money laundering (AML) program, interest rate risk management, and consumer protection practices.
The now-terminated 2022 and 2024 orders stemmed from examinations that identified significant deficiencies in the bank’s AML program, oversight of interest rate risk, corporate governance, and consumer credit disclosures. The bank allegedly provided misleading disclosures in connection with a consumer credit product involving a third-party lender, raising UDAAP concerns. The orders imposed broad corrective obligations, including:

Remediation of AML compliance failures. The bank was required to implement a revised risk-based AML/CFT program, enhance suspicious activity monitoring, strengthen customer due diligence procedures, review prior transactions, and validate its transaction monitoring system. The order also mandated board-level compliance oversight and the establishment of a dedicated OFAC compliance program.
Risk management and governance reforms. The order directed improvements to board supervision, succession planning, and internal audit responsiveness. The bank was required to establish a risk management framework with metrics for capital, liquidity, asset growth, and concentration risk.
Liquidity and capital planning enhancements. The bank had to submit revised capital and liquidity plans, including scenario-based testing, contingency funding strategies, and funding diversification.

Putting It Into Practice: The termination of these consent orders reflects a continued federal pullback from enforcement actions initiated under the prior administration (previously discussed here and here). While federal regulators may be retreating, state agencies and the FTC have demonstrated ongoing interest in policing the financial services industry (previously discussed here and here). 
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CODEX ALIMENTARIUS: Main Outcome of the 44th Committee on Methods of Analysis and Sampling (CCMAS44)

The 44th session of the Codex Alimentarius Com­mittee on Methods of Analysis and Sampling (CCMAS44) successfully addressed all topics on its agenda. CCMAS44 endorsed methods of analysis from commodity standards and recommended ap­proval of others e.g., on chocolate, chocolate prod­ucts and other cocoa-based products, fruits juices and nectars, fish products, follow-up formulas, food grade salt. CCMAS44 held intense discussions on methods of analysis for the protein content in quinoa and on the method for the determination of the moisture content in whey powder. CCMAS44 agreed also to establish an expert group under the auspice of the IFU to inform the work on the methods pro­posed for fruit juices and nectars. CCMAS44 finally agreed on rounded numeric performance criteria for the determination of nitrate and nitrite ions in food matrices. CCMAS44 decided also to start working on methods for the identity of “sugars and honey”. It also endorsed the method discussed during the last CCNFSDU44 meeting on dietary fiber with a further question back to CCNFSDU with a proposed amend­ment to a more comprehensive footnote. CCMAS44 adopted a comprehensively amended information document about sampling plans (with an entire new part 3 on Bayesian sampling plans) to inform the im­plementation of the current guidelines on sampling. CCMAS44 advanced the work on a consolidated list of methods for the presence of allergens that would be subject to another intersessional work. CCMAS44 re-established EWGs (including one to advance the harmonization of names for principles in the general standard of methods of analysis) and agreed to con­vene a working group in person immediately prior its CCMAS45 session (2026) [ii].
See more information available about CCMAS44 working documents quoted in this article [iii], as well as in the official report of the CCMAS44 meeting [iv]. Codex standards, guidelines, codes of practices and related miscellaneous texts quoted in this article are readily and freely available [v].
ENDORSEMENT OF METHODS OF ANALYSIS AND SAMPLING AND REVIEW OF METHODS INCLUDED IN THE GENERAL STANDARD FOR METHODS OF ANALYSIS (CXS 234, 2024 version)
Methods applicable cocoa products and chocolate; fish and fishery products; foods for special dietary uses; fruit juices and nectars; milk and milk products; and miscellaneous products such as dried meat and food grade salt
CCMAS44 agreed to (i) endorse all the methods and amended methods resulting from the work of pre-ses­sion VWG and an in-Session WG (IWG as summa­rized in CCMAS44’s CRD02 Rev.1 working docu­ment); (ii) revoke and retype the methods, as included in Appendix II of CCMAS44 report); (iii) inform the CCNFSDU that the methods of analysis submitted by it to CCMAS were forwarded for adoption by CAC48 and all the relevant methods of analysis be revoked consequentially. CCMAS44 agreed to re-establish its EWG on methods chaired by Canada (and not customarily by Australia), for further consideration on (a) cocoa products and chocolate; (b) foods for special dietary uses; and (c) fruit juices and nectars. CCMAS44 praised the work of Dr Richard Coghlan (Australia), as the outgoing chair of the EWG, VWG and IWG. CCMAS44 also agreed to re-establish a Physical Working Group (PWG) on methods endorse­ment led by the USA and co-led by Hungary, Japan and Uruguay to meet immediately prior to CCMAS45, to (a) consider all methods of analysis and sampling submitted by Codex Committees for endorsement, (b) the outcomes of the work of the EWGs on meth­ods including retyping of the ISO 1871 method for determining protein in quinoa (see further below); the proposals on the workable packages on chocolate and cocoa-based products as well as on sugars and honey, and any other matters referred by other Codex Com­mittees or submitted by Members and Observers.
CCMAS44 concluded favorably its work on methods applicable to (a) cocoa products and chocolate; (b) fish and fishery products; (c) foods for special dietary uses; (d) fruit juices and nectars; (e) milk and milk prod­ucts; and (f) miscellaneous products such as dried meat and food grade salt. CCMAS44 did not propose changes to existing methods already included in CXS 234 applicable to (a) cereals, pulses and legumes and derived products; (b) fruit juices and nectars; (c) milk and milk products; and (d) miscellaneous prod­ucts (e.g., dried meat and food grade salt). CCMAS44 also revoked methods as consequential changes from other adopted for the same standardized food [vi].
In order to advance the technical discussions on the remaining work package of methods in fruit juices and nectars, CCMAS44 agreed to convene an expert group under the auspices of the International Fruit and Vegetable Juices and Nectars Association (IFU) to (a) determine the ranges of parameters relevant for quality and authenticity; (b) determine the range of measurements or maximum LOD; (c) evaluate the list of endorsed methods included in CXS 234 and those listed in the commodity standard CXS 247 (2024 version) ; (d) determine/consider if the presently en­dorsed methods are still appropriate and “fit-for-pur­pose” to control the “quality and authenticity” of fruit juices; (e) determine/consider if any of the presently endorsed methods should be revoked and eliminated from CXS 234 and CXS 247; (f) assess whether any new method(s) could be considered by the CCMAS endorsement working group in the future, for ad­dition to CXS 234 for the general provision of juice “quality and authenticity”; and (g) collate relevant validation data for any new procedures that CCMAS could consider in the future. In particular, the expert group shall identify clearly which methods should be maintained in CXS 234, revoked, or replaced. Codex Members were invited in contributing to this work by contacting directly IFU and nominate nationally rele­vant fruit juice experts to participate eventually to the work of that IFU-led expert group, in their individual capacity. CCMAS44 praised the coordinating work ensured by Dr David Hammond [vii] at IFU.
With regards the work package on methods for choc­olate and chocolate products and other cocoa-based products, CCMAS44 agreed to re-establish an EWG chaired by Serbia and co-chaired by USA to continue reviewing the relevant methods listed. With regards to the work package of relevant methods for sugars and honey, CCMAS44 agreed to establish an EWG chaired by Uruguay to review these methods applicable to sugars and honey. Both EWGs should submit their report sufficiently in advance to CCMAS45.
As examples of methods endorsed, CCMAS44 agreed to retain the method for determination of amino acid nitrogen in fish sauce, AOAC 920.04 and AOAC 920.03, in CXS 234. CCMAS44 endorsed AOAC 935.47 and AOAC 937.09B as Type III methods. CCMAS44 agreed to transfer the method for the determination of sodium chloride in food grade salt as described in the Standard for food grade salt (CXS 150) with editorial amendments to CXS 234. CCMAS44 also agreed with an update to the hyperlink in the footnote referencing the method for iodine in food grade salt in CXS 234. In addition, CCMAS44 agreed to transfer the related sampling plan to CXS 234. CCMAS44 noted that the sampling plan was currently incompatible with the provision for sodium chloride and would require further review and agreed that such review could be taken up later under the work on the review of sampling plans and inform CCFA accordingly. CCMAS44 also noted the editorial amendment to the principle for the example methods AOAC 2015.06 / ISO 21424 |IDF 243 that meet the numeric performance criteria for copper in milk fat products and agreed to the removal of ISO 5738 | IDF 76 and AOAC 960.40 as example methods. All relevant commodity committees will be informed accordingly.
CCMAS44 further requested CCNFSDU to consid­er (a) whether it would be appropriate to develop numeric performance criteria (NPC) for methods of analysis for Type II and Type III methods; or (b) develop additional methods for follow-up formula to align with those for infant formula for common provisions (see Part 3.2 of Appendix II of CCMAS44 report). With regard to the recommendation for CCNFSDU to consider developing NPC, the chair of the VWG clarified that CCMAS’s preference was for committees to consider this approach. CCMAS44 noted that this approach would provide flexibility for countries to choose methods that meet these criteria. This approach was in accordance with the Procedural Manual that preference should be given to set NPC. CCMAS44 further agreed that the name and format for principles for the corresponding methods for infant formula included in CXS 234 would not be aligned with those agreed for follow-up formula at this stage pending ongoing discussion on the harmo­nization of names and format for principles. It was noted that CCNFSDU was also in the process of re­viewing all methods for provisions in standards under their purview to assess their fitness-for-purpose and to identify additional/replacement methods, or other corrections.
Dietary fibre reference in Table 6 of CXS 234 “Methods of analysis for dietary fibre: Guidelines for use of nutrition and health claims (CXG 23, 2013 version): Tables of conditions for claims”
CCMAS44 endorsed the methods proposed by the outcome of the EWG and VWG (as presented in CCMAS44 CRD02 Rev.1 working document), to­gether with the footnote proposed by CCNFSDU44 which reads “Isolated, purified, and/or synthetic fibres captured by AOAC 2022.01/ICC Standard 191/AACC 32-61.01 that do not meet the Codex definition of di­etary fibre in the Guidelines on nutrition labelling (CXG 2-1985) should be subtracted from the final measure­ment, where deemed appropriate by competent author­ities.” CCMAS44 also agreed to request CCNFSDU to clarify whether the footnote was only applicable to the methods AOAC 2022.01/AACC 32-61.01/ICC Stan­dard No. 191. If not, the footnote should then apply to all methods for dietary fibers included in Table 6 of CXS 234, or a subset of these methods listed in that Table 6. Should CCNFSDU agrees, then CCMAS would delete the footnote applied only to AOAC 2022.01/AACC 32-61.01/ICC Standard No. 191.
CCNFSDU was further asked to consider a proposed amendment to the current footnote 2 included in Table 6 of CXS 234. Such proposed amendment would address the concerns raised that the footnote forwarded by CCNFSDU should be consistently applied to all methods in CXS 234, Table 6. Should CCNFSDU agree to amend footnote two, then the footnote forwarded by CCNFSDU to accompany AOAC 2022.01/AACC 32.61.01/ICC Standard No. 191 could then be deleted. The recommended addi­tional phrase to existing footnote 2 is shown in bold as follows: « Two issues are left for national authorities: to include monomeric units 3-9 and which isolated or synthetic compounds have physiological benefit. (Refer to the Guidelines on nutrition labelling (CXG 2-1985)). Isolated, purified, and/or synthetic fibres captured by the analysis that do not meet the Codex definition of dietary fibre in CXG 2-1985 should be subtracted from the final measurement, where deemed appropri­ate by competent authorities. »
SPECIFIC DISCUSSIONS ON SOME METHODS
Determination of the protein content in quinoa prod­ucts (conforming to CXS 333, 2020 version)
This agenda was very much disputed. CCMAS44 however agreed to retain the method for determining protein in quinoa already in CXS 234 as a Type IV method (method ISO 1871), noting the reservation of Peru. CCMAS44 requested the re-established PWG on endorsement to consider retyping of ISO 1871 meth­od for determining protein in quinoa based on the information provided in CCMAS44’s CRD19, refer­ring to a comprehensive comparative analytical work performed by several national metrological institutes based in Latin America in this matter. Brazil also suggested an extension of Extension of the ISO 20483 method to quinoa offered as an alternative method. It was suggested that the necessary validation studies could be performed and discussed again within ISO to determine if this method could be extended from cereals and pulses to a pseudocereal such as quinoa. ISO indicated that a decision to extend ISO 20483 to quinoa should be subject to a formal request accord­ing to ISO procedures. In that regard, it was also noted that ISO might even end up validating a dedicated method (to Quinoa) instead of extending the existing ISO 20483 to Quinoa [viii].
Determination of the moisture content in whey powders (conforming to CXS 289, 2022 version)
CCMAS44 agreed to forward the 102NP method with the footnote as amended in paragraph 41 to CAC48 for adoption as a Type IV method (Appendix II, Part 1.5), for whey powder, on an exceptional basis, in line with Section 3.9 (v) of the information document “Comprehensive guidance for the process of submission, consideration and endorsement of methods for inclusion in CXS 234” and to make the consequential amend­ments to Appendix XI of CXS 234 (2024 version).
Determination of the particle size of milling products using sieve analysis for use on edible cassava flour and gari
CCMAS44 acknowledged that no amendment to CXS 234 was necessary for the moment, despite some technical elements presented in CCMAS44’s CRD9 document by the International Association for Cereal Science and Technology (ICC) about the revision of ICC Recommendation N. 207, to render it applicable to edible cassava flour and to gari (in particular to include appropriate sieve sizes). CCMAS noted that the ICC revision work was in its final approval stage at ICC level. It was recalled that the current ICC Rec­ommendation N. 207 had already been endorsed by CCMAS43.
SAMPLING PLANS
Information document to the General guidelines on sampling (CXG 50, 2023 version) – e-book with sampling plans applications
CCMAS44 considered the outcome of an inter-ses­sional EWG chaired by New Zealand and co-chaired by Germany to develop an information document on how implementing the revised Codex Alimenta-rius General guidelines on sampling (CXG 50, 2023 version). Such information document should not be considered as an official Codex text, but simply there to inform countries and food business operators for internal use by CCMAS and other Codex commodity committees. CCMAS44 agreed to publish the revised information document (as presenting in CCMAS44 report’s Appendix IV) and inform Codex committees of the publication of this document. It also agreed to remove the current information document titled “Practical examples of sampling plans” from the Codex website. Finally, it was noted that as other applications (Apps) were being developed, they would be forward­ed to the Codex Secretariat for inclusion to the list of applications in the information document and that CCMAS would be informed accordingly. Other sup­porting resources, such as webinars, would be made available on the CCMAS webpage as well. The agreed information document should also be considered a living document, meaning CCMAS could update it when needed and where warranted [ix].
Review of sampling plans in the general standard for methods of analysis (CXS 234, 2024 version) and de­velopment of sampling plans for lots consisting of bulk material/heterogenous lots, including for mycotoxins
CCMAS44 agreed to continue developing the vari­ous discussion papers on (a) the review of sampling plans in CXS 234, particularly the various approaches to placing the sampling plans in the standard(s), the format and content of the presentation of sampling plans, and the responsibility for assessing the param­eters that determine the selection of the appropriate sampling plan for a given commodity/provision combination; and (b) the development of sampling plans for bulk materials/heterogenous lots, including mycotoxins, including proposed sampling plans for consideration by CCMAS45, and to inform CCCF of this decision. CCMAS44 also noted that work on sampling plans for bulk materials/heterogenous lots, including for mycotoxins, should be conducted in close collaboration with CCCF; and noted the pos­sible need for CCMAS to provide support to com­modity committees in their review of sampling plans. CCMAS44 agreed to re-establish an EWG, chaired by New Zealand and co-chaired by Germany to advance the revisions of these discussion papers and prepare a dedicated discussion paper on sampling plans for bulk materials/heterogenous lots, including for mycotoxins, to be discussed by CCMAS45.
OTHER ASPECTS
Numeric performance criteria for the determination of nitrate and nitrite ions in food matrices
CCMAS44 considered the outcome of an intersessional EWG work led by Australia and co-chaired by the USA, including discussions held by the in session VWG. CCMAS44 agreed with the Numeric Perfor­mance Criteria (NPC) elaborated (and rounded up during the session) for nitrate and nitrite in three food matrices (i.e., ripened cheeses; processed comminuted meat, poultry, and game products; and, heat-treated processed meat, poultry, and game products in whole pieces of cuts) and agreed to forward these NPC back to CCFA for information. Initial CCFA request was for CCMAS to establish NPC for methods of analysis in these specified food matrices; provide information on available analytical methods suitable for both the adopted MLs and the lowest proposed residue levels; and clarify whether the methods measured nitrate and nitrite ions separately or in combination [x].
Methods of analysis for precautionary allergen labelling
CCMAS44 considered the outcome of an EWG led by the USA and its prior consideration by the IWG. Due to several factors related to the presentation of the list of methods, the need for further consideration, and new method validation guidelines, CCMAS44 agreed to re-establish an EWG chaired by USA and co-chaired by UK to finalize the review of the methods presented at CCMAS 44 against the recently updated CEN and AOAC validation guidelines and perfor­mance requirements [xi] and simplify the presentation of the methods and their validation status. CCMAS44 tasked the new EWG to draft a response to CCFL49 for consideration by CCMAS45. CCMAS44 confirmed that the EWG would not have to address the second question from CCFL regarding sampling plans.
Nitrogen to protein conversion factors for commodi­ties approved by Codex Commodity Committees
CCMAS agreed to forward the list of Nitrogen to Protein conversion factors as amended, for approval by CAC48 and future inclusion as an Annex to the General Standard on Methods of Analysis (CXS 234), while noting some inconsistencies with these conver­sion factors especially for various soy products, and it suggested that these factors should be reviewed in the future. CCMAS44 noted that these factors would need to be reviewed by the relevant Codex Commodity Committees to ensure further consistency [xii].
Harmonization of names and format for principles identified in CXS 234, 2024 version
CCMAS44 considered the outcome of an intersessional EWG work led by Brazil and Chile. Purpose of this work was to (i) establish a centralized database consolidating all methods relevant to CCMAS; (ii) harmonize terminology for analytical methods across Codex standards; and (iii) develop a publicly accessible database on methods of analysis and sam­pling for inclusion on the Codex website. The work of the EWG to develop harmonized terminology for analytical methods, format for principles and provi­sion names was thus to support the development of such a structured database. CCMAS44 significantly updated the document but was unable to address all the issues. CCMAS44 agreed to re-establish the EWG, led by Brazil and co-led by Chile to further revise the “Harmonization of Names for Principles in CXS 234-1999”, including its annexes A, B, and C, using the text included in CCMAS44 report Appendix VI as its working basis, with the aim of ensuring that the principles in CXS 234 are properly included and con­tinue discussions on Annex D, focusing on separating the provisions into three distinct groups (editorial or no-change provisions, provisions linked to active committees, provisions linked to inactive committees) and making corresponding recommendations [xiii].
Endnotes
[i] Food Production Systems Engineer; Food Standards, Safety and Regulatory Specialist; Counsellor at Keller and Heckman LLP Brussels office
[ii] CCMAS is the specialised body of the Codex Alimen-tarius Commission Food Standard Program dealing with the most complex scientific and technical matters relating to (a) methods of analysis (i.e., analytical chemistry); (b) sampling plans (i.e., statistical analy­sis) other than those covered by specialised horizontal committees, and (c) any other issues related to these. In addition, CCMAS endorses the methods proposed by Codex Committees developing commodity and food standards. As such, CCMAS outputs are key to help countries and food business operators in performing their conformity assessment to existing Codex food standards, hence ensuring food safety and authenticity of such standardized foods, helping minimizing food fraud, and guaranteeing a better traceability and fair practices in international trade of these food supplies.
CCMAS44 was held virtually through five 3-hour daily sessions from May 5 to 8, 2025 and was preceded by a pre-session virtual working group (VWG) on “En­dorsement”, held on April 29 and 30, 2025 and which prepared decisions for CCMAS44 on nearly all agenda items (item 2, 3, 4, 5, 7 and 8). The PWG also contin­ued its work during part of the plenary as an in-session working group (IWG). CCMAS44 adopted its draft re­port virtually on May 14, 2025. CCMAS44 was attend­ed by 74 Member countries, one Member organization and 21 Observer organizations. The session was chaired by Dr Attila Nagy, Director, National Food Chain Safe­ty Office (NFCSO) and co-chaired by Dr Zsuzsa Farkas, Head of Department, Department of Digital Food Sci­ence, University of Veterinary Medicine, Budapest. The next CCMAS meeting (CCMAS45) was tentatively scheduled from 9 to 13 March 2026, to be held in person in Budapest (Hungary) and be preceded by the PWG on “Endorsement” and a regular meeting of the con­tact group of inter-agencies developing and validating methods of analysis and sampling (i.e., composed of ISO, IDF, AOAC International, FOSFA International, USP-Food Chemical Codex, AACC, ICC, AAFCO, NMKL, ICUMSA, and the international association MoniQA).
[iii] See https://www.fao.org/fao-who-codexalimentarius/ meetings/detail/en/?meeting=CCMAS&session=44&
[iv] See https://www.fao.org/fao-who-codexalimentarius/ meetings/en/
[v] See https://www.fao.org/fao-who-codexalimentarius/ codex-texts/en/
[vi] Adopted methods — Cocoa products and chocolate:  Updated methods on fat-free cocoa solids, fat-free milk solids (determined as milk protein), Total Fat (on a dry basis), Cocoa shell (determined as spiral vessel count), cocoa shell (determined as stone cell count). Fish and  fishery products (Quick Frozen Fish Sticks (Fish Fin­gers), Fish Portions and Fish Fillets – Breaded or in Bat­ter – CXS 166 (2017 version)): Fish content (declara­tion) – Nitrogen, Moisture, Total Fat, Ash. Performance criteria for the methods for sodium chloride and for salt determined as chloride expressed as sodium chloride for boiled dried salted anchovies; fish sauce; salted Atlantic herring and salted sprat; salted fish and dried salted fish of Gadidae family of fishes; Sturgeon caviar. Foods for  special dietary uses: Follow up formulas – Vitamin A palmitate (retinyl palmitate), Vitamin A acetate (retinyl acetate), Vitamin A (two AOAC methods), Vitamin E, Vitamin D, Thiamine, Riboflavin, Niacin, Vitamin B6, Vitamin B12, Pantothenic acid, Folic acid, Vitamin C, Biotin, Iron, Calcium, Phosphorous, Magnesium, Sodi­um, Chloride, Potassium, Manganese, Iodine, Selenium, Copper, Zinc, Total Nucleotides, Choline, Myo-innosi-tol, L-carnitine, Total amino acids (excluding taurine and tryptophan) and Tryptophan both for some selected uses specified in CXS 156 (2023 version), Total fatty ac­ids, Crude Protein, Folic acid (addition of ISO 20631). All Foods: content of insoluble and soluble dietary fibres of higher and lower molecular weight (applicable in food that may, or may not, contain resistant starches (AOAC 2022.01/AACC 32-61.01/ICC Standard n° 191 as type I method) with note relating to the subtraction rule resulting from Codex definition of dietary fiber as deemed appropriate by the competent authority. Fruit juices and nectars: L-Ascorbic acid (4 methods), Citric acid (all uses), High Fructose Corn Syrup and Hydrolyzed Inulin Syrup (in apple juices as permitted ingredi­ents), L-Malic Acid, Saccharin, Soluble solids, Sucrose, Phosphorous/Phosphate. Milk and milk products:amendment to the commodity standard on the mois­ture content to add whey powders to the list, Numeric Performance Criteria for methods used for the quanti­fication of Copper and Iron. Miscellaneous products -­Dried Meat: Chloride as sodium chloride; Food Grade Salt: Iodine (only for products fortified with Iodate) and Sodium Chloride and description of the determination of sodium chloride and related sampling method for food grade salt.
Revoked methods — Fish and fishery products (Salted Fish and Dried Salted Fish of the Gadidae Family of  Fishes – CXS 167 (2018 version): Determination of salt content, Salt saturation. Follow up formulas: Vitamin A by colorimery (AOAC 974.29, Type IV), Iodine (milk-based formula, AOAC 992.224 by Ion selective potentiometry). All foods: previously mentioned methods for dietary fibers (AOAC 2011.25 and AACC Intl 32-50.1). Fruit Juices: Carbon dioxide (additives and processing aids) by IFU n°42, Malic acid by EN 1138.
Unchanged methods — Cereals, Pulses and Legumes and derived products: Quinoa – protein content (type IV) until further work discussed. Fruit Juices and Nectars: Malic acid (additives); Preservatives in fruit juices (sorbic acid and its salts). Milk and milk prod­ucts: Whey powder — Water (moisture) noting that the water content is excluding the crystallized water which is bound to lactose (that part being generally known as the moisture content). Dried meat: Chloride as sodium chloride (≥ 0.25% or ≥ 1.0%).
Methods for further consideration until CCMAS45 with some amended during the IWG/CCMAS44 sessions – Chocolate and Chocolate Products: Cocoa butter (determined as fat); Milk fat; Moisture; Mois­ture (Determined as Water); Non-cocoa butter vege­table fat; Fat; Free fatty acids; Unsaponifiable matter; Cocoa butter equivalents in cocoa butter and plain chocolate; Cocoa butter Equivalents in Milk Chocolate; Determination of center and coating of filled chocolate (all methods approved for the chocolate type used for the coating and those approved for the type of center concerned). Cocoa powders (cocoa) ad dry cocoa-sugar mixtures: Moisture (Determined as Water); Deter­mination of full-fat cocoa powder, fat-reduced cocoa powder, and highly fat-reduced cocoa powder; Deter­mination of cocoa butter (to be developed). Follow-up formula: Riboflavin, Niacin (x2), Vitamin B6 (x2), Vitamin B12 (x2), Folic acid (x2), Biotin, Iron (x2), Calcium (x2), Phosphorous, Magnesium (x2), Sodi­um, Chloride, Potassium, Manganese, Selenium (x4), Copper, Zinc, Choline. Fruit juices and nectars: Benzoic acid and its salts – Sorbic acid and its salts, Benzoic acid and its salts, Sulphur dioxide alts, Sulphur diox­ide (x3), Tartaric acid in grape juices, Total Nitrogen, Acetic acid (acetate), Alcohol (ethanol), Anthocyanins, Ash, Beet sugar, Benzoic acid, C13/C12 ratio of ethanol derived from fruit juices, Carbon stable isotope ratio (x2), Carotenoids (as total carotenoids and as individ­ual groups), Centrifugable pulp, Chloride (expressed as sodium chloride), Chloride, Essential oils, Essential oils in citrus fruit, Fermentability, Formol number, Free amino acids, Fumaric acid, Glucose Fructose and Sucrose/Saccharose, Glycerol, Hesperidin and Naringin (x2), Hydroxymethylfurfural (x2), D-isocitric acid (x2), D- and L- Lactic Acid, L-Malic/Total Malic ratio to detect added D-Malic acid, pH value (x2), Proline, Relatice density (x2), Sodium Potassium Calcium and Magnesium, D-Sorbitol, Starch, Titratable acids, Total dry matter at 70°C, Total solids (by microwave oven drying), Vitamin C (dehydro-ascorbic acid and ascorbic acid). Fruit juices: Carbon stable isotope ratio of sugars from fruit juices. Apple Juice: High Fructose Corn Syrup and Hydrolyzed Inulin. Orange juice: Sugar beet de­rived syrups in frozen concentrated orange juice.
[vii] See https://ifu-fruitjuice.com/page/LCHP2
[viii] CCMAS44 recalled that CCMAS43 endorsed the method for determining protein in quinoa (ISO 1871) as Type IV, noting that the typing could be reconsid­ered should more information be provided. The VWG considered replies to CL 2024/91-MAS, but information provided at that time of the IWG met did not allow the VWG to find any consensus on retyping the ISO 1871 method as a type I method. During the VWG, anoth­er method was also offered as an alternative Type I method for the determination of protein in quinoa (i.e., ISO 20483), but it was noted a lack of specific vali­dation data of that method for pseudocereals such as quinoa. The ISO representative informed the VWG that quinoa could be added in future as a validated ma­trix and that ISO might consider taking up that work if needed (based on an ISO member internal request and ISO working procedures). CCMAS44 extensively discussed the information submitted by seven countries from Latin America (Bolivia, Peru, Ecuador, Colom­bia, Chile, Uruguay, and Argentina), as presented in CCMAS44’s CRD19 document. Such information was recognised to be supportive of a retyping of the method ISO 1871 as Type I (official method). Information in CRD19 informed CCMAS44 on details about the vali­dation studies and process, the reagents used, the con­ditions of the methods, the catalysts used, while noting that a single reference material for quinoa was also used during the validation studies. An explanatory footnote was proposed (e.g. regarding conditions, the catalysts and reagents used), noting that the same footnote would be consequentially applied to the ISO 1871 method for determining protein in Tehena to ensure consistency. It was also reiterated that CCMAS should apply the same decisions regarding the use of ISO 1871 for the deter­mination of protein to Tehena to ensure consistency. Members and Observers which did not support the pro­posal expressed concerns that ISO 1871 was a general guidance and not a step-by-step method, since it did not specify conditions and chemicals. In accordance with the definition for a Type I method, a detailed analysis of the steps taken across the different validation studies would be necessary to retype ISO 1871 from Type IV to Type I, even though there was no issue with the valida­tion data themselves. CCMAS44 agreed that this topic should be deferred to the PWG on endorsement that would meet immediately prior to CCMAS45 to allow more time to review CRD19.
[ix] The document provides additional information about the sampling plans referred to in the CXG 50, by pro­viding examples for each of the main types of sampling plans, additional information on other sampling plans, including Bayesian plans, and links to the Apps for designing and evaluating such sampling plans. App 1 evaluates and designs sampling plans for homogeneous lots, which is included in the information document by link. Apps 2 and 3 were being developed and would be included in the information document once available. As more Apps are developed, links to these Apps would be included also in the information document. Other resources (e.g. video clips, webinars) would be provided to the extent possible on Codex website (such as the one held on April 28, 2025). As recommended during the two previous CCMAS sessions on this matter for including sampling plans involving smaller sample sizes or less testing, part 3 of the document includes presen­tation of Bayesian plans, based on risk- or utility-based approaches, while the overall rest of the document struc­ture remained largely unchanged. CCMAS44 discussed an edited version of the information document, as included in CCMAS44’s CRD35. Some concerns were expressed by Japan about the inclusion of Bayesian plans in the information document, as the scope of cur­rent CXG 50 (2023 version) was restricted to acceptance sampling plans for inspecting isolated homogeneous lots (i.e., and therefore not using Bayesian approaches). It was clarified that Bayesian sampling plans provided a potential way to reduce testing costs and was an area of still on-going international scientific work, including within ISO, about which a technical report on applying Bayesian methods to acceptance sampling was expected to be published end 2025. It was also suggested that the information document may need to be complemented with information relating to the Codex Principles for the Use of Sampling and Testing in International Food Trade (CXG 83, 2015 version).
[x] CCMAS44 noted the NPC were developed for both adopted MLs and the lowest proposed residue levels in the relevant food matrices. It also reviewed the list of methods submitted by CCFA, including one recently published method added and provided a summa­ry of the method validation data (in Appendix 3 of CCMAS44 working document CX/MAS 25/44/10) for assessment against the NPC. “Examples of applicable methods that met the established criteria” that met the NPC had been identified from Appendix 3 and were presented in Appendices 1 and 2 of CX/MAS 25/44/10. The revised versions were therefore presented in Appen­dix VI of CCMAS44 CRD02 Rev.1. It was highlighted that should CCFA decide to revise the lowest proposed residue levels, suitable analytical methods should be selected based on the information provided in Appendix III of CCMAS44 working document CX/MAS 25/44/10.
[xi] (a) Dr. Latimer, George W, Jr. (ed.), ‘Validation Pro­cedures for Quantitative Food Allergen ELISA Methods: Community Guidance and Best Practices’, in Dr. George W Latimer, Jr. (ed.), Official Methods of Analysis of AOAC INTERNATIONAL, 22nd Edition (New York, 2023; online, AOAC Publications, 4 Jan. 2023). (b) EN 17855:2024 Foodstuffs – Minimum performance requirements for quantitative measurement of the food allergens milk, egg, peanut, hazelnut, almond, walnut, cashew, pecan nut, Brazil nut, pistachio nut, macada­mia nut, wheat, lupine, sesame, mustard, soy, celery, fish, mollusks and crustaceans, CEN, 2024.
[xii] The proposed conversion factors for adoption were included in Appendix III of the CCMAS44 report. Nitrogen To Protein Conversion Factors For Commod­ities Approved By Commodity Committees Proposed For approval by CAC48 and Future Inclusion as an Annex to CXS 234: Animal Protein Source: Milk and milk products – 6.38; Meat and meat products – 6.25. Infant formula: The calculation of the protein content of infant formulas prepared ready for consumption should be based on N x 6.25, unless a scientific justifi­cation is provided for the use of a different conversion factor for a particular product. The value of 6.38 is generally established as a specific factor appropriate for conversion of nitrogen to protein in other milk products, and the value of 5.71 as a specific factor for conversion of nitrogen to protein in other soy products. Follow-up formula for older infants and product for young children: The calculation of the protein content of the final product ready for consumption should be based on N x 6.25, unless a scientific justification is provided for the use of a different conversion factor for a particular product. The protein levels set in this standard are based on a nitrogen conversion factor of 6.25. For information the value of 6.38 is used as a specific factor appropriate for conversion of nitrogen to protein in other Codex standards for milk products. In accordance with the Guidelines on nutrition labelling (CXG 2-1985), the calculation of protein for nutrient declaration purposes should be based on a conversion factor of 6.25, unless a different factor is specified in the present annex. Fish and fishery products: Crackers from marine and freshwater fish, crustaceans and molluscan shellfish – 6.25. Plant Protein Source: Wheat, wheat protein products – 5.71; Maize – 6.25; Quinoa – 6.25; Sorghum – 6.25; Millet (grains and flour) – 5.71; Gochujang – 6.25. Soya and non-fermented soybean products: 5.71; Tempe – 5.71; Natto – 5.71; Cheonggukjang – 5.71. Vegetable protein Products (VPP): Products produced by separation from wheat and soya grains and flours of certain non-protein constituents (starch, other carbohy­drates) – 6.25. Soy protein products – 6.25. CCMAS44 noted that the list would continue to be updated as new nitrogen to protein conversion factors were agreed by commodity committees. It was also explained that in cases where such nitrogen to protein conversion factors had been developed by a committee adjourned sine die (or dissolved) and needed further review, the Codex Secretariat would look into some practical modalities for such a review.
[xiii] The document included in Appendix VI of CCMAS44 report is entitled “Harmonization of Names for Prin­ciples in CXS 234-1999” is composed of the following sections: 1. General Guidelines; 2. Definitions (Prin­ciple, Biological assay, Chromatography, Colorimetry, Gravimetry, Potentiometry, Sensory assay, Spectroscopy, Mass Spectrometry (MS), Titrimetry, Visual examina­tion, Volumetry); 3. Criteria Used (3.1. Assays Whose Results are Method Dependent – e.g., Moisture at 105°C – Gravimetry, etc.; 3.2 Assays Whose Results are independent of the method – e.g., Nitrate – UV-Vis (ultraviolet visible) – Spectrophotometry, etc.); 4. Additional information (to consider removing any additional information such as “ashing”, “ceramic filter filtration”, etc.); Annex A — Principles of Methods of Analysis (e.g.; Anodic Stripping Voltammetry (ASV), etc.); Annex B – Acronyms and abbreviations (e.g., AAS Atomic Absorption Spectrophotometry; etc.); An­nex C List of Acronyms for Standard Method References (e.g., AACC, USP, ISO, etc.); and the to-be-developed Annex D – List of Provisions. CCMAS44 also noted the view that the provisions in CXS 234 should remain aligned with those in the commodity standards to avoid misalignment and confusion. It was further emphasized that the provisions in CXS 234 reflected the original commodity standard provisions and should not be oversimplified as this could remove essential context. Some provisions indicated method complementarity and had been the subject of extensive discussions. Some of the proposed changes in Annex D carried significant implications. Therefore, consultation with commodity committees and other relevant committees was nec­essary and for better clarity future proposed changes would be presented in three groups: those requiring no changes or only editorial changes; those changes linked to active commodity committees; and those changes related to adjourned sine die or abolished commodity committees. The Codex Secretariat also clarified that, in general, CCMAS did not have the authority to make such changes to provisions falling within the remit of a Commodity Committee adjourned sine die (or abolished/dissolved). If necessary, such proposals should be referred to the CAC, as per the mechanism followed precedingly with the proposed amendment of a pro­vision in section 3.3 of the Codex Standard for Edible Casein Products (CXS 290).

The BR Privacy & Security Download: June 2025

On May 5, 2025, the newest Commissioner of the Federal Trade Commission (FTC), Mark R. Meador, spoke at the Second Annual Antitrust Conference at George Washington University.
His prepared remarks offer insight into his approach to antitrust enforcement, addressing what he sees as common antitrust enforcement myths.
In dispelling the first myth—“antitrust is regulation”—the Commissioner is very clear: “Antitrust is law enforcement, period. Full stop.”
He similarly and succinctly rejects four other myths related to antitrust enforcement:

“Vertical integration is always procompetitive.” Commissioner Meador makes the contrary case that vertical integration is not always procompetitive, particularly in non-physical markets such as technology.
“Innovation can justify exclusion.” The Commissioner instead asserts the need to identify conduct that forecloses alternatives.
“We need national champions to compete with China.” The Commissioner suggests, to the contrary, that competition is better suited by free enterprise.
“Structural remedies are an extreme measure.” He counters that structural remedies can be a way to restore free markets.

Commissioner Meador concludes his comments with what might be seen as a policy warning, making clear that the current FTC’s interest in antitrust enforcement is not limited to technology platforms or “Big Tech,” but extends to every industry, including “groceries, healthcare, and energy.”
Additional Authors: Daniel R. Saeedi, Rachel L. Schaller, Gabrielle N. Ganze, Ana Tagvoryan, P. Gavin Eastgate, Timothy W. Dickens, Jason C. Hirsch, Adam J. LandyAmanda M. Noonan, and Karen H. Shin.

Commissioner Meador Dispels Myths About Antitrust Enforcement

On May 5, 2025, the newest Commissioner of the Federal Trade Commission (FTC), Mark R. Meador, spoke at the Second Annual Antitrust Conference at George Washington University.
His prepared remarks offer insight into his approach to antitrust enforcement, addressing what he sees as common antitrust enforcement myths.
In dispelling the first myth—“antitrust is regulation”—the Commissioner is very clear: “Antitrust is law enforcement, period. Full stop.”
He similarly and succinctly rejects four other myths related to antitrust enforcement:

“Vertical integration is always procompetitive.” Commissioner Meador makes the contrary case that vertical integration is not always procompetitive, particularly in non-physical markets such as technology.
“Innovation can justify exclusion.” The Commissioner instead asserts the need to identify conduct that forecloses alternatives.
“We need national champions to compete with China.” The Commissioner suggests, to the contrary, that competition is better suited by free enterprise.
“Structural remedies are an extreme measure.” He counters that structural remedies can be a way to restore free markets.

Commissioner Meador concludes his comments with what might be seen as a policy warning, making clear that the current FTC’s interest in antitrust enforcement is not limited to technology platforms or “Big Tech,” but extends to every industry, including “groceries, healthcare, and energy.”

GLP-1 Compounded Medications Targeted by Connecticut Attorney General

On May 21, 2025, the Connecticut Office of the Attorney General released a statement and sent letters to Connecticut weight loss clinics, med spas, medical practices and other businesses regarding allegedly or potentially unfair and deceptive conduct relating to compounded GLP-1 medications. Specifically, healthcare providers in Connecticut that advertise and prescribe compounded GLP-1 medications, such as semaglutide and tirzepatide, may be considered to be violating the Connecticut Unfair Trade Practices Act (CUTPA).
The Attorney General provided several reasons for why providers advertising and prescribing compounded semaglutide and tirzepatide may be violating CUTPA:

Compounding pharmacies are no longer allowed to manufacture semaglutide and tirzepatid injections in bulk (meaning copies of commercially available, U.S. Food and Drug Administration (FDA)-approved GLP-1 semaglutide and tirzepatide products), as they have been removed from the FDA’s shortage list. (More information can be found in Foley’s article “GLP-1 Drugs: FDA Removes Semaglutide from the Drug Shortage List”),
The FDA has raised health and safety concerns about these compounded medications, citing issues such as dosing errors, poor inspection records from overseas manufacturers, and, in some instances, adverse events, some of which required medical intervention,
These compounded medications are often inaccurately labeled as “generic” versions of semaglutide and tirzepatide injections and may contain additives, such as vitamins, which have not been approved by the FDA or evaluated through clinical trials, and
The FDA has not approved any oral GLP-1 medications, nor has it approved the use of GLP-1 medications for cosmetic purposes.

The Connecticut Attorney General has put providers on notice and stated he is prepared to take appropriate action against businesses and individuals who continue to advertise and prescribe semaglutide and tirzepatide in violation of CUTPA.
Weight loss clinics, med spas, medical practices and other businesses advertising and prescribing compounded versions of semaglutide and tirzepatide in Connecticut are advised to come into compliance with the CUTPA.
Special thanks to Alina Mueller, a summer associate in Foley’s Denver office, for her contributions to this article.