SEC/FDA/FTC Regulatory Watch — Week of June 9–15, 2026
The SEC proposes to repeal the 20-year-old trade-through rule (Reg NMS Rule 611) and finalizes FDTA joint data standards; three enforcement cases yield a $3.36B stock fraud complaint against Napster Corp. defendants and final judgments totaling $2.9M. The FDA adds bemotrizinol as the first new OTC sunscreen ingredient in 20 years, clears the first OTC CGM for children (Dexcom Stelo), issues a New World screwworm EUA for generic nitenpyram, and posts a batch of CGMP warning letters. The FTC files a contempt motion against Amare Global and three individuals for violating a 2005 order, finalizes the Sevita/BrightSpring disability-care merger with 128 facility divestitures, and returns nearly $3M to 1,821 mortgage fraud victims.
SEC: equity market structure shakeup, plus three fraud judgments
Reg NMS trade-through rule proposed for repeal
The SEC's most consequential rulemaking of the week targets a 20-year-old pillar of US equity market structure. On June 11, the Commission proposed to rescind Rules 611 and 610(e) of Regulation NMS — the trade-through prohibition and the restriction on locking and crossing quotations. 1
"After two decades of Rule 611, it is high time that the Commission review its unintended consequences that have hindered — rather than enhanced — the long-term growth of our markets," Chairman Paul S. Atkins said in a statement accompanying the proposal. The release also proposes to rescind related defined terms under Rule 600 and make conforming changes throughout Regulation NMS. The 60-day public comment period opens upon publication in the Federal Register; comments may be submitted at SEC.gov under File No. S7-2026-20.
For compliance and trading-desk teams: Rule 611 has governed order routing obligations since 2007, requiring broker-dealers to route orders to the venue displaying the best-quoted price. Its potential repeal would allow exchanges and dark pools to compete on dimensions other than price protection alone. Anyone building or reviewing routing systems should begin internal impact assessments now.
Joint data standards finalized under FDTA
On June 8, the SEC finalized joint data standards required under the Financial Data Transparency Act of 2022 (Press Release 2026-53). The final rule establishes common identifiers for legal entities, geographic locations, dates, and certain products and currencies across eight federal financial regulators — including the Federal Reserve, CFTC, CFPB, FDIC, and Treasury. 2
The standards are designed to ease reporting burdens for institutions that file with multiple agencies by making data submissions interoperable. Separate agency-specific rulemaking will follow; this final rule is the first-step foundation.
Enforcement: $3.36B stock fraud on Napster Corp., two final judgments
The week's most significant new enforcement action came June 11, when the SEC filed charges in LR-26563 against North Carolina resident Charles J. Cole, Utah attorney Torben M. Welch, and three Cole-controlled entities — Beacon Heart LLC, Heart of Humanity LLC, and Avranoc LLC. 3 The complaint (S.D.N.Y.) alleges Cole falsely promised to invest $3.36 billion in Infinite Reality, Inc. (now Napster Corp.) and, together with Welch, falsely represented that Cole and/or Avranoc controlled at least $55 billion in assets. Based on those misrepresentations, Infinite Reality issued over 239 million shares to Cole and his entities in late 2024 and early 2025; no money was ever received. Cole then used nearly 45 million of those shares as collateral to obtain a $1 million loan, with Welch allegedly providing forged documents to the lender.
The SEC seeks permanent injunctions, disgorgement, and civil penalties. A parallel criminal action against Cole was announced by the U.S. Attorney's Office for the Southern District of New York on the same day.
Two earlier-filed cases reached final judgment this week. In LR-26564, a Northern District of Texas court entered judgment against former registered representative Rajesh Markan, who from 2015 through July 2024 solicited approximately ten customers to invest a collective $2.9 million in a fake private equity fund — misrepresenting that a well-known New York firm advised it. The court ordered $2,305,025 in disgorgement plus $132,776.15 in prejudgment interest, amounts deemed satisfied by $2.445 million in restitution imposed in a parallel criminal case. 4
In LR-26565, a Western District of Texas court entered a default judgment against Santos Kiidd, a third-party salesperson who participated in Chimene Van Gundy's mobile-home investment scheme (the "Queen of Mobile Homes" fraud involving ~$18.5 million raised from 600+ investors). 5 Kiidd, now in the Philippines, was ordered to pay $607,779.12 (disgorgement of $285,155.97, prejudgment interest of $37,467.18, and a matching civil penalty) and is permanently barred from acting as an unregistered broker or participating in any securities offering.
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FDA: sunscreen ingredient, pediatric CGM, screwworm EUA, warning letters
Bemotrizinol — first new sunscreen active ingredient in 20 years
On June 9, the FDA finalized a monograph order adding bemotrizinol to the list of permitted OTC sunscreen active ingredients — the first new sunscreen active ingredient since the late 1990s. 6 DSM Nutritional Products LLC submitted the OTC monograph order request; the agency issued a proposed order December 12, 2025, accepted public comments through January 26, 2026, and finalized within seven months of proposing.
Bemotrizinol provides protection against both UVA and UVB rays, has been used in European sunscreens for decades, and is rated GRASE (generally recognized as safe and effective) for adults and children 6 months and older at concentrations up to 6%. It is the first ingredient added to an OTC monograph under the CARES Act's streamlined administrative order process.
For manufacturers: bemotrizinol can be incorporated into OTC sunscreen products without a new drug application provided the product otherwise complies with the monograph. No new comment period is open; the final order is effective immediately upon publication.
First OTC CGM cleared for children (Dexcom Stelo)
On June 12, the FDA cleared Dexcom's Stelo Glucose Biosensor System for over-the-counter use in children 2 years and older who do not use insulin — the first OTC continuous glucose monitor cleared for the pediatric population. 7 The device was previously cleared OTC for adults 18+ in March 2024.
The Stelo system uses a wearable sensor paired with a smartphone app to display glucose measurements every 15 minutes; each sensor lasts up to 15 days (wear time may be shorter in pediatric users). The clearance relied on a combination of prior clinical study data and real-world evidence from existing iCGM use — an example of FDA's use of RWE in device regulatory decisions. The device is not for individuals with problematic hypoglycemia or those on dialysis, and must be used under adult caregiver supervision for children.
EUA for generic nitenpyram tablets (New World screwworm)
On June 11, the FDA issued an Emergency Use Authorization for generic Nitenpyram Tablets (nitenpyram) for treatment of New World screwworm (NWS) infestations in dogs, puppies, cats, and kittens weighing at least two pounds. 8 This is the first generic animal drug authorized for use against NWS, sponsored by Felix Pharmaceuticals Pvt. Ltd. (Ireland). The tablets are available OTC in 11.4 mg and 57 mg sizes. Dosing: two doses six hours apart; the drug kills most NWS larvae within hours but does not prevent reinfestation. Acting FDA Commissioner Kyle Diamantas noted the agency has now issued ten EUAs and three conditional approvals across all NWS animal drugs since the August 2025 emergency declaration.
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Warning letters: CGMP and foreign supplier violations
The FDA posted a batch of warning letters on June 9 covering pharmaceutical and food compliance violations. Significant recipients include:
- Macau-Union Pharmaceutical Limited — CGMP/Finished Pharmaceuticals; adulteration and unapproved new drug issues (CDER, letter issued May 29) 9
- Fagron BV — Compounding pharmacy/adulterated drug products (CDER, letter issued May 12) 10
- Hubei Gedian Humanwell Pharmaceutical Co., Ltd. — CGMP/Active Pharmaceutical Ingredient; adulteration (CDER, letter issued June 3) 11
- Revlon Group Holdings, LLC — CGMP/OTC Finished Pharmaceuticals; adulteration (CDER, letter issued June 2) 12
- Bharat Overseas Inc. — Foreign Supplier Verification Program (FSVP) violation (Office of Inspections and Investigations, letter issued May 14) 13
Companies receiving CGMP warning letters should note that FDA warning letter status can affect pending drug applications; CDER will typically refuse-to-file or place applications on clinical hold until manufacturing violations are resolved.
FTC: contempt motion, disability-care merger closed, $3M mortgage relief refunds
Amare Global contempt motion — 2005 order violation
On June 12, the FTC filed a contempt motion against Amare Global Holdings, former Chief Science Officer Shawn Talbott, founding brand partner Patrick Hintze, and former CEO Hiep Tran, alleging they violated a 2005 FTC order stemming from the Window Rock (CortiSlim/CortiStress) case. 14
The 2005 order permanently prohibits Talbott and all persons acting in concert with him from making health-benefit representations about covered products without "competent and reliable scientific evidence." The contempt motion alleges Amare, Talbott, Hintze, and Tran marketed products — including Kids Mood+ and Kids Happy Juice — with claims that they boost neurotransmitters such as serotonin and dopamine, lower cortisol, and can treat or mitigate depression, anxiety, and ADHD. The FTC alleges the supporting studies are deeply flawed: the primary Kids Mood+ study used no placebo control, included only 10 participants, and counted Talbott himself and Amare board members among its authors.
This contempt motion is separate from the direct FTC lawsuit against Amare Global, Talbott, Hintze, and CEO David Chung filed earlier in June. The FTC is seeking compensatory damages equal to the full amount consumers paid for the at-issue products.
Compliance note: The contempt theory here is notable — the FTC is treating Amare, Hintze, and Tran as bound by Talbott's 2005 individual order on the theory that they acted "in active concert or participation" with him. Companies that hire or partner with individuals subject to existing FTC orders face direct contempt exposure.
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Sevita/BrightSpring consent order finalized
On June 10, the FTC finalized its consent order in Sevita Health's acquisition of BrightSpring Health Services Inc.'s community living business (ResCare Community Living). 15 The Commission voted 2-0 to approve the final order following a public comment period.
Sevita must divest 128 intermediate care facilities (ICFs) serving individuals with intellectual and developmental disabilities — located in Indiana, Louisiana, and Texas — to Dungarvin Group Inc. Sevita must also assist Dungarvin in obtaining all required licenses and permits. The FTC's theory was that the combination would reduce competition for ICF services in those specific state markets.
$2.96M returned to mortgage relief fraud victims
On June 9, the FTC announced it is mailing checks to 1,821 homeowners deceived by the Golden Home Services / Home Matters USA mortgage relief scheme, distributing nearly $3 million. 16 The scheme — which operated under at least seven business names — falsely promised to reduce mortgage payments and prevent foreclosures. A 2024 federal court order banned the operators from telemarketing and debt relief and required disgorgement. Recipients should cash checks within 90 days; questions go to refund administrator JND Legal Administration at 1-833-674-0067.
Deadlines at a glance
| Agency | Item | Action deadline |
|---|---|---|
| SEC | Reg NMS Rules 611 & 610(e) rescission proposal (File No. S7-2026-20) | 60 days from Federal Register publication |
| FDA | Draft gene therapy guidance "Leveraging Prior Knowledge" (Docket 2026-11054) | September 1, 2026 |
| FDA | BHT food additive reassessment comment period | July 13, 2026 |
| FTC | Amare Global contempt motion — court proceedings | Pending federal court scheduling |
| FTC | Sevita/BrightSpring — Dungarvin divestiture closing | Per consent order milestones |
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