2026-08-31

SEC false adviser filings, FDA approvals, and FTC final orders - August 24-30, 2026

A sourced weekly digest of 18 SEC, FDA, and FTC developments from August 24-30, 2026, with procedural status, operational implications, and calendar-ready actions.

SEC / FDA / FTC Regulatory Watch @NeoDrop Official

The week of August 24–30, 2026 produced 18 new developments across the SEC, FDA, and FTC. The SEC proposed a targeted change for European Union debt futures and filed actions involving false adviser filings, offering claims, trading conduct, a prior judgment, and a dismissal. The FDA approved three drugs, authorized a dual-monitoring device and an animal-drug EUA, and posted two warning letters. The FTC filed a proposed Zillow-Redfin order, finalized an ambulatory-surgery-center divestiture order, finalized three AI-marketing orders, and set FY2027 Do Not Call Registry fees.

The practical work is spread across three queues: test adviser and offering controls against the SEC allegations, translate new FDA labels and warning letters into operating procedures, and calendar FTC implementation, divestiture, marketing, and telemarketing obligations. No independently verified market reaction was identified for the covered actions; the items below state the compliance, operational, or procedural consequence supported by the agency material.

At a glance

Agency	Matter	Status and amount	Next action
SEC	European Union debt obligations under Rule 3a12-8	Proposed rule; comment period runs 60 days after Federal Register publication	Futures market participants and counsel should assess the proposed jurisdiction and product treatment. 1
SEC	38 entities and false Forms ADV	Complaints filed August 27; injunctions and civil penalties sought; ERA filings removed	Verify adviser identities, ERA status, addresses, phone numbers, ownership data, audit claims, and SEC registration claims. 2
SEC	Ichcoin Tech Corp.	Complaint filed August 27; injunctions, Form ADV filing ban, and civil penalty sought	Preserve and verify adviser identity and Form ADV substantiation records. 3
SEC	GenesisAI Corp. and Archil Cheishvili	Settled action filed August 26; more than $5.3 million raised from more than 4,000 investors; proposed payments total $109,184.53 for Cheishvili	Review Regulation Crowdfunding and Regulation A projections, valuation support, partnership evidence, and customer-demand records. 4
SEC	Mayur Baviskar	Settled action filed August 25; $6,078.16 alleged trading profits; proposed disgorgement, interest, and penalty total $57,992.57	Review instant-credit, returned-deposit, stop-payment, and connected-account controls. 5
SEC	Evarist C. Amah	Modified final judgment entered July 15 and announced August 26; $10,000 disgorgement, $1,617.82 interest, and $446,458 civil penalty	Treat the Securities Act and Exchange Act injunction as final and track the Advisers Act dismissal. 6
SEC	Stephen E. Buyer and Joni L. Buyer	Joint stipulation filed August 24 to dismiss the civil action with prejudice	Track the court's disposition; classify the matter as a dismissal rather than a merits judgment. 7
FDA	Libre Duo 10 Day, Abbott Diabetes Care	De Novo authorization on August 25 for people with diabetes aged 2 and older	Review special controls, labeling, performance testing, alerts, and clinical-use procedures. 8
FDA	Rasonque, Revolution Medicines	Approval on August 26 for specified adults with metastatic pancreatic adenocarcinoma; priority, breakthrough, orphan, and national-priority-voucher review pathways	Update indication, safety, access, and post-launch medical-affairs controls. 9
FDA	Lisraya, Priovant Therapeutics	Approval on August 27 for adult dermatomyositis; boxed warning covers serious infections, mortality, malignancies, cardiovascular events, and thrombosis	Align prescribing, safety communications, and pharmacovigilance procedures with the boxed warning. 10
FDA	Mimrylo, Takeda	Approval on August 28 for adults with polycythemia vera; 76.9% versus 32.9% avoided phlebotomy in the VERIFY study period	Review hematology protocols, weekly subcutaneous dosing, and monitoring for injection-site reactions and anemia. 11
FDA	Bimectin, Bimeda Animal Health	EUA on August 27 for cattle NWS prevention under specified conditions; 35-day slaughter withdrawal	Confirm cattle eligibility, administration timing, labeling, and withdrawal controls. 12
FDA	R3 Medical Companies, Bello Bio, and Regen Suppliers	Warning letter posted August 25; letter issued August 14; unapproved drugs, unlicensed biologics, and CGMP violations alleged	Respond within 15 working days of receipt and address inventory, manufacturing, BLA/IND, and corrective-action records. 13
FDA	Vargas Produce LLC	Warning letter posted August 25; letter issued July 27; FSVP violations alleged	Respond within 15 working days of receipt and build FSVPs for the listed imported foods. 14
FTC	Zillow and Redfin	Proposed stipulated order; 10-year term; Redfin would re-enter internet listing services within six months after a final order	Track court approval and prepare for the proposed re-entry, investment, hiring, and contract changes. 15
FTC	Ascension and AmSurg	Final consent order for $3.9 billion transaction; seven ambulatory surgery centers divested	Track divestiture implementation to SC Affiliates and Florida Gastroenterology Center. 16
FTC	CMG Media Corporation/Cox Media Group, MindSift, and 1010 Digital Works	Final orders; $930,000 total, allocated $880,000, $25,000, and $25,000	Review AI-marketing claims, voice-data consent claims, and geographic-targeting substantiation. 17
FTC	FY2027 National Do Not Call Registry fees	Fees begin October 1, 2026; $85 per area code and up to $23,425 nationally	Update telemarketing budgets, registrations, and exemption checks before FY2027 begins. 18

SEC

European Union debt obligations: a narrow Rule 3a12-8 change

On August 28, the SEC proposed adding European Union debt obligations to the foreign-government debt obligations treated as exempted securities under Exchange Act Rule 3a12-8, solely for futures marketing and trading. Futures contracts on EU debt would fall under the CFTC's exclusive jurisdiction under the proposal, while offerings of the underlying debt would remain subject to the federal securities laws. The SEC says the comment period will remain open for 60 days after Federal Register publication. 1

The affected parties are futures exchanges, intermediaries, dealers, EU debt market participants, and counsel mapping SEC and CFTC boundaries. The proposal leaves Rule 3a12-8's other substantive requirements unchanged. The SEC's proposed rule is pending, and the precise calendar deadline awaits Federal Register publication. 19

38 entities: false Forms ADV used to appear legitimate

On August 27, the SEC charged 38 entities in complaints filed in the District of Colorado. The SEC alleges that the entities used Forms ADV filed during 2025 and 2026 to present themselves as legitimate U.S. advisory firms and attract retail investors. The alleged filings included Colorado addresses where the entities had no presence, disconnected or unrelated phone numbers, copied or unsubstantiated ownership and financial data, false audit-firm information, and fake SEC registration certificates. 2

The SEC seeks permanent injunctions, conduct-based injunctions barring the entities from filing Forms ADV as exempt reporting advisers, and civil penalties. The 38 entities' ERA filings have been removed from the SEC website. The cases remain filed complaints, so the requested relief remains pending. Compliance and diligence teams should verify an ERA's identity, office, phone number, ownership, audit firm, and registration claims through independent records before onboarding or referring investors. 20

Ichcoin Tech: a second false-filing complaint

On August 27, the SEC filed a complaint against Ichcoin Tech Corp. in the Northern District of New York. The SEC alleges that Ichcoin's January 25, 2024 Form ADV falsely claimed ERA eligibility, an Albany office, a Colorado telephone number, and a FINRA Central Registration Depository number. The complaint says the CRD number belonged to an 87-year-old individual with no identifiable connection to Ichcoin and alleges that Ichcoin failed to substantiate its filing when SEC staff requested records. 3

The SEC seeks a permanent injunction, a conduct-based injunction preventing Ichcoin and people acting for it from filing Form ADV as an ERA, and a civil monetary penalty. The matter is a pending complaint. Adviser onboarding and vendor-diligence teams should retain the evidence supporting every identifying field and eligibility representation submitted to the SEC.

GenesisAI: offering projections and customer demand

On August 26, the SEC filed a settled action against GenesisAI Corp. and founder and former CEO Archil Cheishvili in the Southern District of Florida. The SEC alleges that the defendants raised more than $5.3 million from more than 4,000 investors through Regulation Crowdfunding and Regulation A offerings between December 2019 and December 2024. The alleged pitch included revenue projections reaching $250 million by 2024, valuations exceeding $200 million in 2022, as many as 25 purported partnerships, and a customer waitlist. The SEC says the marketplace remained in testing through 2022, never became commercially viable, the partnerships were unenforceable, and the waitlist did not exist. 4

The defendants did not admit the allegations. They consented, subject to court approval, to final judgments permanently enjoining Securities Act Section 17(a)(2) violations. Cheishvili would pay $50,000 disgorgement, $9,184.53 prejudgment interest, and a $50,000 civil penalty. The proposed judgments remain subject to court approval. Issuers and counsel should tie every projection, valuation, partnership description, and demand metric to dated source records and a review owner.

Mayur Baviskar: instant credit and reversed deposits

On August 25, the SEC filed a settled action against Mayur Baviskar in the Eastern District of North Carolina. The complaint alleges that Baviskar bought and sold more than $1.4 million in securities without sufficient funds and withdrew $6,078.16 in trading profits. From March 2019 through September 2024, he allegedly initiated $377,200 in unfunded deposits across nine broker-dealers, used instant credit, and caused transfers to reverse through insufficient funds or stop-payment orders. 5

Baviskar did not admit the allegations. Subject to court approval, the proposed final judgment would impose permanent and conduct-based injunctions, $6,078.16 disgorgement, $1,914.41 prejudgment interest, and a $50,000 civil penalty. The amount proposed for disgorgement, interest, and penalty is $57,992.57. Broker-dealers should test instant-deposit credit controls against returned transfers, stop-payment patterns, multiple-account activity, and the timing of trades and withdrawals.

Evarist C. Amah: modified judgment after appellate remand

The SEC announced the matter on August 26, while the court action occurred on July 15. On July 15, the Southern District of New York entered a modified final judgment against Evarist C. Amah. The SEC's earlier case alleged that Amah raised approximately $698,000 from fellow members of his religion through false statements about investment performance. The Second Circuit had affirmed the Securities Act and Exchange Act liability and remedies, then vacated and remanded the Advisers Act portion. 6

The modified judgment permanently enjoins Securities Act and Exchange Act antifraud violations, orders $10,000 disgorgement and $1,617.82 prejudgment interest, and imposes a $446,458 civil penalty. The court dismissed the Advisers Act claims on remand. This is a final judgment on the surviving claims, with the SEC's August 26 release serving as the in-window publication event. Counsel tracking older enforcement matters should keep the July 15 entry date separate from the August 26 announcement date.

Stephen E. Buyer: dismissal with prejudice

On August 24, the SEC, Stephen E. Buyer, and relief defendant Joni L. Buyer filed a joint stipulation seeking dismissal with prejudice of the SEC's civil enforcement action. The SEC's release describes the dismissal as a discretionary decision and states that it does not necessarily reflect the Commission's position on another case. The release identifies no monetary relief. 7

The procedural status is a requested dismissal, rather than a new liability finding. The next step is the court's disposition of the stipulation. Legal and compliance teams should label the matter as a dismissal with prejudice and avoid treating that procedural outcome as a merits judgment.

FDA

Libre Duo 10 Day: continuous glucose and ketone monitoring

On August 25, the FDA authorized Abbott Diabetes Care's Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 years and older living with diabetes. The FDA describes it as the first U.S. wearable to continuously monitor ketones and the first single device to continuously monitor ketones and glucose together. The device measures both levels every minute, sends readings to a compatible smartphone, and can alert users when ketones reach a concerning threshold. 8

The FDA granted marketing authorization through the De Novo pathway and established special controls for labeling and performance testing. The clinical program included six studies with more than 600 participants. Device manufacturers, healthcare providers, and health systems should map the special controls and the instruction to interpret ketone readings with glucose readings and symptoms into labeling review, training, alert handling, and clinical escalation procedures.

Rasonque: first-in-class targeted therapy for metastatic pancreatic cancer

On August 26, the FDA approved Rasonque (daraxonrasib), a once-daily tablet from Revolution Medicines, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. In a randomized open-label trial of 500 adults, median overall survival was 13.2 months with Rasonque versus 6.7 months with standard chemotherapy. 9

The FDA granted Breakthrough Therapy, Orphan Drug, and Priority Review designations and reviewed the application through the Commissioner's National Priority Voucher pilot. The most common side effects listed by the FDA include rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage. Medical-affairs, labeling, pharmacovigilance, and access teams should update materials for the approved population and the listed safety profile.

Lisraya: oral dermatomyositis treatment with a boxed warning

On August 27, the FDA approved Lisraya (brepocitinib) tablets from Priovant Therapeutics for adults with dermatomyositis. A phase 3 randomized, double-blind, placebo-controlled study enrolled 241 adults and measured Total Improvement Score at week 52; the 30 mg once-daily group had a higher average score than the placebo group and showed improvements in physical function and skin disease activity. 10

Lisraya carries a boxed warning for serious infections, increased all-cause mortality, malignancies, major adverse cardiovascular events, and thrombosis. The FDA granted Orphan Drug and Priority Review designations. Prescribers, specialty pharmacies, and safety teams should align patient selection, risk communication, adverse-event capture, and corticosteroid-reduction documentation with the approved label and boxed warning.

Mimrylo: hepcidin-mimicking treatment for polycythemia vera

On August 28, the FDA approved Mimrylo (rusfertide) from Takeda Pharmaceuticals America for adults with polycythemia vera whose disease has remained inadequately controlled with existing therapies. Mimrylo is the first approved treatment for the disorder that mimics hepcidin, a hormone involved in iron regulation, and it is administered subcutaneously once a week. 11

In the phase 3 VERIFY study of 293 adults, 76.9% of patients receiving Mimrylo required no phlebotomy during the study's weeks 20 through 32, compared with 32.9% receiving placebo. The most common adverse reactions were injection-site reactions and anemia. Hematology practices and product teams should review dosing, hematocrit-control workflows, phlebotomy documentation, and adverse-event monitoring.

Bimectin: EUA for New World screwworm prevention in cattle

On August 27, the FDA issued EUA 006729 for Bimectin (ivermectin) injection, sponsored by Bimeda Animal Health Ltd., to prevent New World screwworm myiasis in cattle. The authorized administration windows are within 24 hours of birth, at castration, or when a wound appears. The EUA excludes lactating dairy cows and calves intended for veal, and it requires a 35-day slaughter withdrawal period. 12

Bimectin is available over the counter under the product labeling and fact sheet. The EUA remains effective until FDA revokes it or the HHS Secretary terminates the relevant emergency declaration. Producers, distributors, and food-safety teams should verify animal eligibility, administration timing, dosage-form limits, labeling, and withdrawal records.

R3 Medical Companies: unapproved biologics and CGMP findings

The FDA posted its warning letter to R3 Medical Companies on August 25; the letter itself is dated August 14, 2026. The Center for Biologics Evaluation and Research addressed David L. Greene, CEO of R3 Medical Companies, after inspecting the co-located Bello Bio, LLC and Regen Suppliers, LLC facilities in Scottsdale, Arizona, from November 17 through December 16, 2025. FDA describes products including ReBellaWJ, ReBellaXO, ReBellaXOL, and ReBellaCB as unapproved new drugs and unlicensed biological products, and it cites CGMP deficiencies. 13

The letter cites disease-treatment and prevention claims for umbilical-cord-derived and exosome products, a lack of an approved BLA, and failures involving aseptic-process validation, manufacturing-process validation, laboratory controls, cleaning and disinfection, stability testing, and quality-unit procedures. FDA says the response to earlier Form FDA-483 observations was inadequate and asks for a written response within 15 working days of receipt. The letter warns that further action may include seizure or injunction. The next action is a documented response covering distribution, inventory disposition, manufacturing corrections, product impact, and the regulatory basis for any continued activity.

Vargas Produce: FSVP warning letter

The FDA posted its warning letter to Vargas Produce LLC on August 25; the letter itself is dated July 27, 2026. FDA inspected the McAllen, Texas importer on June 17–18, 2026, and alleges that Vargas failed to develop, maintain, and follow a Foreign Supplier Verification Program for imported foods including cookies, soft drink, and spicy potato chips. 14

FDA says it had not received a response to the June 18 Form FDA 483a FSVP observations. The letter asks for a written response within 15 working days of receipt and warns that FDA may refuse admission or place imported foods on detention without physical examination if the issue remains unresolved. Importers should assemble supplier-specific FSVPs, implementation records, corrective documentation, and a response that addresses the listed foods and suppliers.

FTC

Zillow-Redfin: proposed order and a six-month re-entry requirement

On August 24, the FTC and five states announced a stipulated order filed in the U.S. District Court for the Eastern District of Virginia to resolve the FTC's antitrust concerns about Zillow's 2025 agreement with Redfin. Under that agreement, Zillow paid Redfin $100 million while Redfin agreed to close its internet listing services, exclusively syndicate Zillow listings, transfer customers, and stay out of the ILS market for as long as nine years. 15

The proposed order would last 10 years, remove those restrictions, require Redfin to re-enter the ILS market within six months after a final order, and require Redfin to invest millions, hire a team, and maintain operations. Zillow would assist with hiring and contract renegotiations. The procedural status is a proposed stipulated order awaiting final court treatment. Real-estate platforms, listing partners, and counsel should track the court docket and prepare for the proposed changes without treating the order as final.

On August 25, the FTC finalized a consent order addressing Ascension Health's $3.9 billion transaction with AmSurg. The order requires divestiture of seven ambulatory surgery centers in Nashville, Panama City, Tulsa, Waco, and Wichita. Six centers will go to SC Affiliates, and the Panama City center will go to Florida Gastroenterology Center. The Commission approved the order by a 2-0 vote. 16

The final consent order is an operative remedy for the transaction. The parties and divestiture buyers should track transfer conditions, purchaser qualifications, separation steps, and continuing reporting obligations in the order.

Active Listening: three final orders and $930,000

On August 27, the FTC finalized orders with CMG Media Corporation, doing business as Cox Media Group, and marketing firms MindSift LLC and 1010 Digital Works LLC. The FTC alleged that the companies claimed an AI-powered service could listen to smart-device conversations, target localized advertising, and rely on consumer opt-in. The agency says the service was not based on voice data and that consumers had not opted into it. 17

CMG must pay $880,000; MindSift and 1010 Digital Works must each pay $25,000, for a total of $930,000. Each final order bars misrepresentations about advertising or marketing services, voice-data collection and consent, and geographic-targeting capabilities. The Commission voted 2-0 after receiving two comments on the proposed settlements. Advertising, privacy, and AI-product teams should preserve substantiation for capability claims, consent claims, and geographic-targeting claims before launch and during renewal.

National Do Not Call Registry: FY2027 fees

On August 26, the FTC announced fees for telemarketers accessing the National Do Not Call Registry for fiscal year 2027, which begins October 1, 2026. The charge is $85 per area code, an increase of $3 from FY2026, and the national maximum is $23,425, up from $22,626. The first five area codes are free, and some exempt organizations may obtain the full list without charge. 18

The FTC's Federal Register notice supplies the fee schedule and FY2027 start date. Telemarketing teams should update budgets, area-code registrations, procurement records, and exemption documentation before the fiscal year begins. 21

Action calendar

Date	Matter	Action
October 1, 2026	FTC FY2027 National Do Not Call Registry fees	Apply the new fee schedule and confirm area-code registrations, budget ownership, and any exemption. 18

The SEC Rule 3a12-8 comment deadline remains a trigger date: comments are due 60 days after Federal Register publication. The Zillow-Redfin order's six-month re-entry period begins after a final court order. R3 Medical Companies and Vargas Produce each have a 15-working-day response period measured from receipt of the warning letter, so the calendar date depends on receipt. Those dates belong in case-specific calendars once the governing event is known. 1 13 14 15

Procedural status

The SEC section contains one proposed rule, three newly filed complaints or settled actions, one modified final judgment announced during the week but entered earlier, and one dismissal stipulation. The 38-entity and Ichcoin complaints seek relief that remains pending. The GenesisAI and Baviskar judgments remain subject to court approval. Amah's modified judgment is final on the Securities Act and Exchange Act claims described by the SEC, while the Advisers Act claims were dismissed on remand. Buyer's matter is a dismissal request with prejudice.

The FDA section contains five approvals or authorizations and two warning letters. The Libre Duo authorization and the three drug approvals create current product, labeling, and safety obligations. Bimectin's EUA carries use, animal-population, and withdrawal restrictions. R3 Medical Companies and Vargas Produce received warning letters with response windows and possible escalation; the letters are regulatory notices and opportunities to correct, rather than final judgments.

The FTC section contains a proposed stipulated order, a final consent order, three final consumer-protection orders, and a fee notice. Zillow-Redfin remains subject to final court treatment. Ascension-AmSurg's divestiture remedy is final. The Active Listening orders are final settlements, and the FY2027 Do Not Call fee schedule starts on October 1.