Corporate Structuring & Asset Protection
Separating the operating risk from the cash, the IP, and your personal name — before there is a reason to.
The rules just moved.
Your structure didn't.
Research-Use-Only Peptides · Compliance Launch Program
On Jul 23–24, 2026 an FDA advisory committee voted to open a compounding pathway for six peptides — against the recommendation of the agency's own scientists. It redraws the map for every RUO brand in this market. It changes nothing about the thing that actually gets founders in trouble.
$7,500 program. It begins with a $2,000 consultation with Dustin Robinson — one hour, credited in full against the program. No obligation to continue afterward.
PCAC · 503A Bulks List VoteJul 23–24, 2026
BPC-157
Reviewed for ulcerative colitis
8–6–1Recommended
KPV
Wound healing, inflammatory conditions
8–6–1Recommended
TB-500
Wound healing
8–6–1Recommended
MOTS-c
Obesity, osteoporosis
7–5–2Recommended
Semax
Cerebral ischemia, migraine, trigeminal neuralgia
8–5–1Recommended
Epitalon
Insomnia
7–4–1Recommended
Emideltide (DSIP)
Opioid withdrawal, chronic insomnia, narcolepsy
6–7–1Rejected
Docket FDA-2025-N-6895. FDA career staff recommended against all seven. These votes are advisory and non-binding. Nothing is legal to compound until FDA completes notice-and-comment rulemaking.
The distinction the market keeps collapsingThree separate legal events.
Three separate legal events.
Everyone is treating them as one.
If your marketing team, your supplier or your affiliates read “FDA panel approves BPC-157” and changed how they talk about your product this week, you have a problem that started on Friday.
Complete · Apr 23, 2026
Removal from Category 2
Twelve peptides lost the “significant safety risks” designation that had barred compounding since 2023. This removed a prohibition. It granted nothing.
Complete · Jul 24, 2026
PCAC recommendation
An advisory committee voted. Six of seven cleared. The FDA is not bound by any of it, and the agency’s own reviewers argued the other way.
Not started
Placement on the 503A list
Requires formal notice-and-comment rulemaking. Until that concludes, the compounding pathway does not exist. Practitioners generally expect this to take many months.
Why we built a practice around this
The money is real. So is the window.
When you scale this quickly in a gray market — all of a sudden you're doing millions of dollars a month and you don't have a good compliance foundation — we're now spending a lot of time setting up offshore trusts, doing asset protection, corporate restructuring.
Dustin Robinson · PepTalk with Gregory Gopman
Most of the founders we take on are under thirty. A lot are running seven and eight figures a year out of a single LLC with their own name on the operating agreement and a merchant account that could be gone on a Tuesday.
They are excellent at demand. That is the skill that got them here. It is also the skill that creates the exposure — because in this industry the marketing is the regulatory violation, not the molecule.
The clients who came to us early are not the ones losing sleep right now. That is the entire pitch.
Intended use doctrine“Research use only” is a label.
“Research use only” is a label.
It is not a shield.
Under FDCA §201(g)(1), a product becomes a drug the moment it is intended to affect the structure or function of the body. Intent is not what your disclaimer says. It is inferred from your product page, your COAs, your email flows, your affiliate copy, your Reddit presence, your reviews, and what else is in the cart. §505(a) then makes shipping that product across state lines without approval unlawful.
SEP 2025 →
Sustained enforcement against research-peptide vendors
FDA has issued a steady stream of warning letters to online sellers since September 2025. The pattern is consistent: the agency is reading the page copy, the cart, and the adjacent products — not the disclaimer at the bottom.
Warning letters
SEP 2025
Import Alert 66-80 established
A “green list” mechanism aimed at stopping GLP-1 active ingredients with quality concerns from entering the U.S. supply chain. If you import API, your supplier’s status is now your problem.
Import / supply chain
Mar 31, 2026
Seven letters to online peptide sellers, published Apr 7
Issued to vendors marketing GLP-1 analogues as research use only. In each case the RUO language sat directly alongside dosing guidance, comparative claims and outcome language. The disclaimer did not survive contact.
Unapproved new drug
2026
Letters to a wave of telehealth companies marketing compounded GLP-1s
Prescriber-model structures are not automatically safe. Advertising, affiliate arrangements and the substance of the clinical relationship are all in scope.
Telehealth / advertising
ONGOING
Vendors going dark
Several well-known sellers have shut down or been forced to restructure. In this market the fatal event is rarely a court date — it’s a processor termination, a bank exit, or a supplier that stops answering.
Business continuity
Dates and actions above reflect publicly reported FDA activity. Nothing here is a prediction of how any agency will treat any specific business.
Two minutes · No email required to see your result
Where does your business actually sit?
Six questions. It maps your operation against the specific things enforcement has actually turned on. You'll get a classification and the flags behind it before you decide whether to talk to anyone.
Exposure assessment
RUO · Compounding · Telehealth
Question 1 of 6
What does your business actually sell right now?
A Program Built to Get Your Peptide Business RUO Ready
RUO Compliance Launch Program
A comprehensive compliance launch program for RUO peptide entrepreneurs who want to protect their business before they launch, scale, or attract regulatory attention.
Built around the risk points that actually end RUO businesses — from structure and claims to processors and enforcement.
RUO Positioning · FDA & FTC Risk Zones
Where intended use is actually inferred from, and which of your surfaces are being read.
Website Compliance
Product pages, COAs, reviews, UGC and the cart — audited the way a regulator reads them.
Labeling & Disclaimers
What the label has to say, what it must not say, and why the disclaimer alone has never been enough.
Payments, Banking & Processor Risk
The failure mode that actually ends businesses in this category, and how to build against it.
Supply, Importing & Cash Management
API sourcing, import alerts, and the obligations you inherit from your suppliers.
Affiliate Marketing
Third-party claims are attributed to you. Contracts, monitoring, and enforcement of both.
Scaling Without Triggering Enforcement
What changes about your risk profile at each revenue step, and what has to change with it.
Government & Private Enforcement
Who can come at you, through which mechanism, and what the first ninety days look like.
How it worksTwo payments. The first one
Two payments. The first one
counts toward the second.
Step one · Start here
$2,00060 min
A full hour with Dustin. He walks you through the program, reviews the core legal and compliance issues facing your business, and answers your questions. You decide afterward whether to continue.
Step two · If you continue
$5,500balance
Unlocks the full program: modules, templates, remaining consultation calls, and newsletter access.
The $2,000 is credited in full against the $7,500 program. If you decide the program is not right for you after the call, you owe nothing further — but the entry fee has been earned and is not refunded.
How it unfolds
Your Path to Launch
- 01
Pay $2,000 and meet with Dustin
- 02
Unlock your full program and ongoing RUO support
- 03
Launch your RUO business
What’s included
16 high-value legal and compliance assets.
Three consultation calls, nine modules, and four templates — sixteen assets you can count on this screen. Designed to help RUO founders understand the rules and build on a stronger foundation.
Consultation
3 one-hour consultation calls with Dustin
Schedule within 60 days of purchase. Recommended: after purchase, mid-implementation, and pre-launch. Topics include website review, labels, disclaimers, regulatory issues, tax, and corporate structuring.
Education
9 RUO compliance learning modules
The nine risk areas above, each as a working reference rather than a lecture.
Templates
4 legal templates
Terms & Conditions, Privacy Policy, Affiliate Agreement, and SDS Template — the core documents your website and affiliate program need before you scale.
Also included with the program.
E-book
Nearly 100-page RUO compliance e-book
Core reference material walked through on your consultation call.
Updates
Peptide regulatory newsletter
Proactive alerts on regulatory changes — including FDA announcements on the 503A bulk list — the same day they occur.
Templates
Legal template review and Q&A
Attorney review of your use of program templates — not a substitute for bespoke drafting on every fact pattern, but a practical checkpoint before you ship.
Before you pay
Who this is for.
Good fit
- Peptide entrepreneurs preparing to launch an RUO business
- Existing RUO sellers who need stronger legal and compliance infrastructure
- Founders concerned about website claims, disclaimers, terms and risk exposure
- Operators who want attorney-led guidance instead of generic online templates
- Anyone who has been told by a processor or bank that they are under review
Not a fit
- Businesses looking for a guarantee of regulatory approval
- Companies seeking medical, clinical or drug approval advice
- Operators unwilling to adjust risky marketing or sales practices
- Anyone who wants the asset protection and none of the compliance work
- Active criminal exposure or a filed enforcement action — you need defense counsel, and we will refer you
- Founders who plan to sell these peptides for human or animal consumption
Choose how to get started
Door 1 · Ready now
Start with the $2,000 consultation
$2,00060 minutes
A working session, not a sales call. You bring your structure, revenue, channels and concerns. You leave with a written summary of what to fix and in what order.
- Direct read on your regulatory exposure
- Corporate and asset protection gaps identified
- A prioritized action list you keep either way
- Confidential treatment of what you share on the call
- Written summary delivered within two business days.
Payment is processed securely through Clio. You acknowledge the consultation terms before paying.
Door 2 · Not ready yet
Get the written brief
FreeNo call
Tell us where you sit and we'll send a written breakdown of what the current rules mean for your specific model — plus the checklist we run on every new client's marketing surface.
Who you are actually talking to
The bench behind the program.
Peptide RUO experience on the call — plus tax, estate, and federal regulatory specialists when your facts require it.
Dustin Robinson
Founding Partner
Florida · Attorney · CPA · Real Estate Agent
Attorney and CPA in one seat — so the tax and structuring conversation and the regulatory conversation happen with the same person. Trained at Deloitte and Holland & Knight, then operated a multi-state manufacturer to nearly $50M.
You get him on the call. Not an associate, not an intake coordinator.
Full bio →Edgar J. Asebey
Of Counsel
Florida · Washington, D.C.
Practices before the FDA, USDA, CBP, EPA and FTC on compliance and enforcement defense.
He can handle federal regulatory matters in all fifty states — the depth you need when a product, claim, or supply path crosses agency lines.
Full bio →Ian Horowitz
Of Counsel
Florida
Focuses on domestic and foreign trusts, estate and generation-skipping taxation, and bona fide Puerto Rico residency under IRC §937.
That matters when asset protection and personal tax posture have to move with the operating company — not after a problem appears.
Full bio →Next step
Ready to get your RUO business on stronger legal footing?
Start with the $2,000 consultation on the legal and compliance issues your peptide business needs to understand before going to market.