Nik SharmaTELI marketing rulesFull rulebook

Updated August 12, 2026

TELI marketing rules

I spent some time working through the launch plan, the staging site, and the questions from our August 12 call. This is the working guide for what can go on the site, in ads, and in customer proof.

Scope: U.S. consumer marketing for the Elysium telehealth launch.

The short answers

Can we use landing pages?

Yes. Review the ad, landing page, intake, checkout, and follow-up as one experience. A new domain does not create a new set of rules.

Can customer reviews live on product pages?

Yes, with limits. Start with care, support, shipping, and the experience of using the service. Hold pounds lost, side effects, before-and-after photos, and treatment outcomes for now.

One launch detail: the August 12 call confirmed branded GLP-1 products only. Compounded GLP-1s are not part of this launch.

Go straight to

Full rulebook

This is a working guide, not a legal opinion. Anything marked review or hold needs the owner named in that rule to sign off.

All sections

Status language: Okay with proof, Needs review, and Hold.

Start here

Immediate product verdict

Product class Launch status Marketing rule
FDA-approved prescription drug, dispensed exactly as approved Conditional Promote only the approved product, indication, population, route, dose, limitations, and current risk information. Do not guarantee eligibility or prescription.
Compounded injectable or oral GLP-1 Not in confirmed launch; red future gate The August 12 call confirmed branded GLP-1 products only. Do not add a compounded GLP-1 later without a new legal, pharmacy, clinical, claims, privacy, and platform review.
Injectable GHK-Cu No-go pending written legal basis FDA identifies potential immunogenicity and limited human safety information, and the injectable bulk-drug nomination was withdrawn. Do not advertise or offer it without a route-specific written opinion from compounding counsel and the dispensing pharmacy.
Non-injectable/topical GHK-Cu Conditional / classification gate Confirm whether the exact product is a cosmetic, approved drug, or lawfully compounded drug. Cosmetic pages may make truthful appearance claims only; structure, disease, healing, or systemic claims turn it into drug territory.
Sermorelin Red / counsel gate Assume the intended product is sermorelin. A former pediatric approval does not make a current compound FDA-approved or validate weight-loss, muscle-growth, wellness, or anti-aging claims. Require a formulation- and pharmacy-specific compounding memo before any consumer promotion.

Confirmed 18-product launch inventory

“Launch status” below governs consumer promotion, not a clinician's independent prescribing decision. Yellow and red items require the written gates named in this rulebook.

Launch item Preliminary status Launch marketing rule
NAD+ injection Red claims / counsel gate Compounded, not FDA-approved. Do not claim proven energy, mitochondrial, longevity, anti-aging, or systemic outcomes from oral-precursor or mechanistic evidence.
NAD+ nasal spray Red claims / counsel gate Compounded, not FDA-approved. The staging claim that supplementation is “proven” to restore “youthful levels” must not publish. Require route- and formulation-specific evidence.
Glutathione injection Red claims / counsel gate Compounded, not FDA-approved. Avoid “detox,” mitochondrial recovery, disease, anti-aging, and systemic efficacy claims without exact-product evidence and clearance.
Glutathione nasal spray Red claims / counsel gate Same rule; injection, oral, topical, or endogenous-glutathione evidence cannot simply be transferred to this nasal formulation.
Metformin Yellow; off-label-claims gate FDA-approved for type 2 diabetes, not longevity, healthy aging, age-related-disease prevention, or weight loss. Do not use those off-label outcomes to acquire consumers.
Low-dose naltrexone Red claims / exact-product gate Naltrexone's approvals do not establish low-dose compounded claims for neuroinflammation, endorphins, longevity, or generalized wellness.
MICC-B12 Red claims / exact-mixture gate Compounded mixture, not FDA-approved as a TELI product. Do not promise fat burning, weight loss, energy, or metabolic improvement; identify every ingredient and lawful compounding basis.
Lipo+ B6 Red claims / exact-mixture gate Same rule. “Lipotropic,” “metabolism,” and energy language can imply unsupported efficacy; exact ingredient, dose, route, and evidence are required.
Sermorelin injection Red claims / counsel gate Compounded and not FDA-approved. Remove sleep, recovery, vitality, muscle, fat-loss, anti-aging, and “patients often notice” language unless counsel and medical/regulatory owners clear an exact claim.
Sermorelin troche Red claims / counsel gate Same rule, with an additional route-evidence problem: injection or historic product evidence does not validate a troche.
GHK-Cu cream Yellow; classification gate Confirm cosmetic versus compounded-drug path. Limit cosmetic marketing to substantiated appearance claims; do not claim collagen production, tissue repair, wound healing, regeneration, or systemic effects.
Bremelanotide (PT-141) Red until identity and route clear The launch screenshot lists PT-141, but no staging page was found. If it is Vyleesi, stay within its narrow FDA-approved population and indication. If compounded, do not borrow Vyleesi's approval or evidence.
Mounjaro® (tirzepatide) Red for weight-acquisition claims; clinical/counsel gate FDA-approved for type 2 diabetes, not weight management. Remove promotional off-label weight language and obesity-outcome expert quotes from acquisition pages.
Zepbound® (tirzepatide) Yellow; on-label branded promotion FDA-approved for chronic weight management in eligible adults. Benefits, population, limitations, material risks, price, and prescribing information must be presented in fair balance.
Ozempic® (semaglutide) Red for weight-acquisition claims; clinical/counsel gate FDA-approved for type 2 diabetes and specified risk reduction uses, not chronic weight management. Remove obesity-treatment promotion from acquisition pages.
Wegovy® injection (semaglutide) Yellow; on-label branded promotion FDA-approved for chronic weight management in defined populations and other labeled uses. Use only the indication and population relevant to TELI, with current risks and limitations.
Wegovy® oral (semaglutide) Yellow; on-label branded promotion FDA-approved for adult chronic weight management and cardiovascular-risk reduction in defined populations. Remove the visible staging placeholder saying approval remains to be confirmed; use the current tablet label.
Foundayo™ (orforglipron) Yellow; on-label branded promotion FDA-approved April 1, 2026 for adult chronic weight management in defined populations. Use the exact label and risk presentation; do not use speculative adherence or superiority claims.

How to use this

Every proposed product and claim receives one of three statuses:

  • Green , allowed with proof: The format is generally acceptable when the statement is accurate, current, approved in the claim registry, and supported before publication.
  • Yellow , conditional: The format can be used only after the named medical, regulatory, pharmacy, privacy, state, or platform condition is satisfied.
  • Red , prohibited or launch-blocking: Do not publish, target traffic, accept payment, or let a clinician select the therapy until the blocker is resolved in writing.

Disclosures do not rescue a false, misleading, unsubstantiated, or unlawfully marketed claim. A truthful sentence can still mislead because of images, page structure, omissions, links, testimonial selection, or the combined impression of the full funnel.

This baseline assumes a U.S. launch. It does not replace the required 50-state provider, pharmacy, telehealth, corporate-practice, fee-splitting, privacy, auto-renewal, and professional-advertising matrix.

Before anything goes live

No treatment page, paid campaign, influencer post, intake path, or checkout may launch until all applicable gates are green.

Gate Evidence that must exist Approval owner
Exact product identity Brand or compound name; active ingredient; salt form; concentration; dosage form; route; dose; packaging; NDC if approved; source pharmacy Clinical + pharmacy
Regulatory status Current approved labeling, or a written 503A/503B and state-law compounding basis for the exact product FDA/healthcare counsel
Compounding source Legal name, address, state licenses, 503A or 503B status, state nonresident licenses, inspection history, and current agreement Pharmacy operations + counsel
Clinical protocol Eligibility, contraindications, labs, dosing, titration, adverse-event, escalation, discontinuation, and follow-up protocol Medical director
State availability Patient-location rules, provider licensure/registration, modality, consent, prescribing, pharmacy license, CPOM/MSO, fee-splitting, and auto-renew requirements Healthcare counsel + operations
Claims dossier Exact approved wording, source, population, product/route/dose fit, limitations, required disclosure, expiration date, and prohibited variants Medical + regulatory + legal
Price and subscription Total and recurring price, medication/labs/consult/shipping inclusions, minimum commitment, renewal, cancellation, refund, and taxes Finance + legal
Privacy data map Every field, event, URL parameter, pixel, replay tool, audience export, vendor, BAA/DPA, consent, retention, deletion, and breach path Privacy + security
Platform approval Required LegitScript, Google, Meta, TikTok, pharmacy, or telehealth certification and approved destination Growth + legal
Versioned launch artifact Final ad, page, mobile screenshots, intake, terms, consent, risk copy, email/SMS, and confirmation experience QA + launch owner

If any product is described internally only as “GLP-1 tablet,” “peptide,” “GHK-Cu,” or “sermorelin protocol,” the product identity gate is not complete.

Product rules

3.1 FDA-approved prescription drugs

Yellow: permissible only within the approved product's actual labeling and operating footprint.

Green examples, when true and approved:

  • “Meet online with a licensed clinician to discuss whether [approved product] may be appropriate for you.”
  • “Medication is prescribed only if a clinician determines it is medically appropriate.”
  • “Available to eligible adults in [verified states].”
  • An exact, on-label indication and population drawn from the current FDA-approved Prescribing Information.
  • A complete, accurate price that states whether medication, visits, labs, and shipping are included.

Required controls:

  • Use the exact approved name, dosage form, route, indication, population, and limitations.
  • Keep benefit and risk information in fair balance and comparably noticeable. Product-claim promotion may require a brief summary or other risk presentation appropriate to the format. FDA's Office of Prescription Drug Promotion identifies risk omission, benefit overstatement, omitted material facts, and unsupported comparisons as common violations (FDA Bad Ad Program; OPDP advertising FAQ).
  • Use the current approved Prescribing Information and Medication Guide; do not borrow evidence from a different route, formulation, salt, dose, brand, or population.
  • Name the actual prescribing and dispensing entities accurately. Do not imply Elysium manufactures or dispenses a drug if it does not.
  • Maintain an FDA-label change watch. Pause affected assets when labeling, warnings, shortages, or safety communications change.

Red examples:

  • Off-label weight-loss, anti-aging, longevity, cognitive, muscle, sexual-health, or wellness benefits used to sell the product.
  • “Guaranteed prescription,” “everyone qualifies,” “no labs needed,” or any architecture that makes clinical review look automatic.
  • “Safe,” “risk-free,” “no side effects,” “works for everyone,” or a benefit headline without appropriate risk and limitation context.
  • Using an approved injectable's trials to substantiate a compounded oral, sublingual, nasal, topical, or different-salt formulation.

Important tablet fork: an oral dosage form is not automatically compounded or unapproved. FDA has approved specific semaglutide tablets for defined uses, including the 2025 approval reflected in this FDA approval letter. Elysium must identify the exact product and label; the word “tablet” is not enough.

3.2 Compounded GLP-1 products

Red until the exact product clears the launch gates. Compounded products are not FDA-approved and are not the generic versions of branded GLP-1 drugs. In March 2026, FDA warned 30 telehealth companies about claims that implied compounded products were the same as approved drugs and about branding that obscured the actual compounder (FDA announcement).

The shortage-era assumption is no longer a launch basis. FDA declared the semaglutide injection shortage resolved in February 2025, and the corresponding 503A and 503B enforcement-discretion periods ended in April and May 2025. The agency's current policy also limits regular or inordinate compounding of essential copies and requires the applicable patient-specific or statutory basis (FDA shortage and compounding update). In April 2026, FDA also proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list because approved products can meet clinical need (FDA proposal).

Required before marketing:

  1. Written counsel analysis of the exact 503A or 503B basis, including essential-copy restrictions and any documented significant-difference process.
  2. Verification of the compounder's identity, facility type, licenses, route and formulation capability, labeling, shipping states, quality agreement, and adverse-event process.
  3. Exact API and salt-form verification. FDA says semaglutide sodium and acetate are different active ingredients and has not identified a lawful basis for their use in compounding (FDA unapproved GLP-1 concerns).
  4. A clinical rationale that is specific to the identified patient and recorded in the manner counsel and the pharmacy require; a marketing preference for a cheaper or more convenient copy is not a clinical rationale.
  5. Formulation-specific stability, potency, dosing, container, beyond-use-date, storage, and route documentation.
  6. Clear identification of the actual compounder on labels and consumer materials. Elysium branding cannot make Elysium appear to be the pharmacy or manufacturer.

Green/conditional wording, only when verified:

  • “A licensed clinician may prescribe a compounded medication when they determine it is appropriate for an individual patient's clinical needs.”
  • “This is a compounded drug. Compounded drugs are not FDA-approved, and FDA does not review them for safety, effectiveness, or quality before marketing.”
  • “[Legal pharmacy name] is a state-licensed pharmacy” or “[legal facility] is registered with FDA as a 503B outsourcing facility,” only when current and accompanied by no suggestion that registration or licensure is product approval.
  • The exact ingredients, strength, form, route, price, and source, with no implied branded equivalence.

Red wording and architecture:

  • “Generic Ozempic,” “generic Wegovy,” “generic Mounjaro,” or “generic Zepbound.”
  • “Same as,” “same active ingredient as,” “equivalent to,” “works just like,” “Ozempic alternative,” “Wegovy in a tablet,” or “clinically proven to deliver the same results.”
  • “FDA-approved compounded semaglutide,” “made with FDA-approved ingredients,” or “from an FDA-approved/FDA-licensed pharmacy.” FDA approves products and registers certain facilities; it does not approve or license pharmacies in the manner those phrases imply. FDA lists these exact themes as misleading in its telehealth promotion guidance.
  • Approved-brand logos, pens, packaging, signature colors, comparison tables, crossed-out brand prices, competitor keywords, URL paths, metadata, or imagery that communicates sameness even if the body copy contains a disclaimer.
  • Elysium-branded dispensing labels that obscure the compounder's identity. FDA's 2026 letters to Ready Med, FITISH, and Altru Telehealth address these practices directly.
  • Claims derived from trials of an approved injection when promoting a compounded tablet, sublingual product, altered concentration, different salt, or combination.
  • “Personalized” as a cosmetic label for a standardized mass-market copy. State the actual patient-specific difference, if one exists, in the clinical record, not as a generalized acquisition promise.

3.3 Injectable GHK-Cu

Red / no-go without a written route-specific legal and pharmacy basis.

FDA's current safety-risk page says injectable GHK-Cu may present immunogenicity risk because of aggregation and peptide-related impurities and that human safety information is limited (FDA bulk-substance safety risks). FDA's May 2026 503A nomination list records that the injectable nomination was withdrawn, while a non-injectable nomination returned to Category 1 for further evaluation (FDA 503A nomination list). Category 1 is an interim enforcement category, not approval or proof of safety or effectiveness.

Do not:

  • Sell, pre-sell, waitlist for, name in paid ads, list in a quiz result, or let a provider select injectable GHK-Cu until counsel signs the exact legal basis.
  • Say “FDA compliant,” “medical grade,” “safe peptide,” “natural,” “clinically proven,” “regenerative,” “heals tissue,” “reverses aging,” “restores collagen,” or “systemically rejuvenates.”
  • Use research-only, animal, in-vitro, cosmetic, or topical evidence to support human injection claims.
  • Combine a disclosure with promotional efficacy claims and assume the disclosure cures the problem.

3.4 Non-injectable or topical GHK-Cu

Yellow: exact classification first.

  • A cosmetic may make truthful, substantiated claims about appearance, such as the appearance of fine lines or skin hydration, when the intended use remains cosmetic.
  • Claims to treat disease, alter living tissue, increase collagen production, heal wounds, regenerate tissue, change hormones, or produce systemic effects create drug risk and require a lawful drug pathway.
  • Do not call a cosmetic “prescription strength,” “medical grade,” or a “peptide therapy.”
  • Do not use the non-injectable FDA nomination status as a safety endorsement or approval claim.

3.5 Sermorelin

Red until the exact formulation, route, source, compounding category, and patient use have written clearance. This rulebook assumes “semoralin” means sermorelin; verify that before any work proceeds.

Sermorelin was previously approved for a narrow pediatric growth-hormone indication. That history does not make a present compounded product FDA-approved and does not approve anti-aging, weight-loss, metabolism, body-composition, sleep, recovery, or muscle-growth uses. FDA has treated claims that sermorelin supports growth hormone, metabolism, weight loss, and muscle growth or repair as unapproved new-drug promotion in a 2024 warning letter.

FDA's current 503B nominations document lists sermorelin acetate in Category 1 and marks it as a component of a formerly FDA-approved drug. The same document states that 503B compounds still must satisfy the rule against making essential copies, subject to FDA's stated enforcement policy for certain discontinued products (FDA 503B bulk-substance categories). Category 1 is under evaluation; it is not product approval, a clinical endorsement, or a complete compounding authorization.

Red wording:

  • “Anti-aging injection,” “turn back your biological clock,” “reverse aging,” or “fountain of youth.”
  • “Boosts your own growth hormone safely,” “restores youthful GH levels,” or “no risks of growth hormone.”
  • “Burns fat,” “builds lean muscle,” “improves sleep,” “speeds recovery,” or similar claims used to sell the drug without an approved indication and adequate substantiation.
  • “FDA-approved peptide” or any suggestion that the former product approval transfers to Elysium's compound.

3.6 Branded weight-management portfolio

The August 12 call confirmed that the launch GLP-1 portfolio is branded, not compounded. That removes compounded-copy risk from this launch but does not make every product or every weight claim on-label.

On-label weight-management paths: Zepbound injection, Wegovy injection, Wegovy tablets, and Foundayo tablets may be promoted only for the populations and uses in their current labels, with benefits and risks in fair balance. The current Wegovy label covers both injection and tablets; the Foundayo label reflects its April 2026 approval.

Off-label acquisition problem: Mounjaro and Ozempic are approved for type 2 diabetes and other specified labeled uses, not chronic weight management under those brand names. A provider may sometimes prescribe an approved drug off-label in the practice of medicine, but that does not make consumer weight-loss promotion launch-safe. At minimum:

  • Do not place Mounjaro or Ozempic in weight-loss acquisition ads, outcome comparisons, “best for” quizzes, or obesity-focused expert quotes without a written healthcare/FDA advertising analysis.
  • Do not use Zepbound data to promote Mounjaro or Wegovy data to promote Ozempic merely because the active ingredient overlaps.
  • If the products remain available for clinician consideration, separate the clinical pathway from promotional weight claims and state the actual FDA-approved use accurately.

The staging quote that Mounjaro produced “some of the most impressive clinical outcomes … in obesity medicine,” and the quote calling Ozempic a “cornerstone of modern obesity … treatment,” are promotional off-label claims and must not publish in the current acquisition context.

For every branded page:

  • Put material risks and the approved population close enough to the benefit claim and CTA to be noticed and understood; a distant safety page is not the only risk presentation.
  • Link the current Prescribing Information and Medication Guide.
  • Source every expert quote. A clinician endorsement is still an advertising claim and cannot exceed the label or evidence.
  • State the cash charge, billing interval, what the plan includes, supply assumptions, dose-related price changes, and what happens if the person is ineligible.
  • Do not imply manufacturer affiliation, authorization, or endorsement.

3.7 Metformin and low-dose naltrexone

Metformin is FDA-approved for type 2 diabetes, not longevity, age-related-disease prevention, general metabolic optimization, or weight loss. The staging language that it may “encourage weight loss” or “reduce the risk of certain age-related diseases” is not launch-safe acquisition copy merely because a lower section calls the use off-label. Limit consumer promotion to accurate service/process facts unless counsel and medical/regulatory owners approve a specific off-label communication with adequate evidence and context.

Naltrexone's approved labeling does not establish the claims made for a low-dose compounded product. “Raises endorphins,” “calms neuroinflammation,” pain, autoimmune, longevity, mood, or generalized wellness claims require an exact-product, dose, population, evidence, and legal review. Do not describe low-dose naltrexone as FDA-approved.

3.8 NAD+, glutathione, MICC-B12, and Lipo+ B6

These launch items require an exact formula and pharmacy memo; category labels such as “cellular health,” “detox,” “energy,” and “lipotropics” can themselves communicate efficacy.

  • Do not transfer evidence about endogenous NAD/glutathione, oral precursors, dietary nutrients, another route, or an ingredient in isolation to TELI's exact compounded product.
  • Do not use age-decline charts to imply that administering the product restores youthful physiology or produces a clinical benefit unless the exact route and formulation have reliable human evidence and an approved claim.
  • “Supports mitochondrial function,” “supports detoxification,” “cellular recovery,” “energy,” “metabolism,” and “healthy aging” are not harmless wellness phrases when used to sell a prescription drug; each needs claim-level substantiation and approval.
  • Identify every active ingredient, strength, route, source pharmacy, compounding status, price, contraindication, and evidence limitation.
  • Do not call an injectable or nasal product a supplement.

The staging sentence on the NAD+ nasal page, supplementing is “a proven way to restore youthful levels”, is a red claim. The page's own admission that nasal administration differs from the oral precursors studied underscores the evidence mismatch.

3.9 Bremelanotide (PT-141)

The launch screenshot lists bremelanotide/PT-141, but it is absent from the staging navigation and /treatments/bremelanotide returned a 404 on August 12. Do not launch traffic or an intake result until the exact product, route, strength, source, population, and page are reconciled.

If the product is FDA-approved Vyleesi, its label is limited to premenopausal women with acquired, generalized hypoactive sexual desire disorder meeting the labeled conditions; it is not indicated for postmenopausal women, men, or sexual-performance enhancement (FDA-approved Vyleesi labeling). If it is compounded bremelanotide, it is not Vyleesi and may not borrow Vyleesi's approval, studies, brand, indication, or net impression.

Red claims include “female Viagra,” “boost libido,” “for men and women,” “enhances performance,” “better sex on demand,” and any casual wellness framing that erases the diagnostic criteria, population, risks, and clinician assessment.

Landing pages

Permitted page types

Page type Status What it may do What it may not do
Unbranded condition education Green/conditional Discuss a condition, symptoms, screening, lifestyle, and speaking with a clinician Name, show, strongly imply, or link so tightly to one drug that the combined experience becomes a product claim
Telehealth service page Green/conditional Explain care access, verified states, clinician evaluation, process, support, transparent pricing Promise a prescription, use drug-outcome claims, imply everyone qualifies, hide clinical/legal entities
FDA-approved product page Yellow Use exact on-label product claims with appropriate risks, limits, label, and price Off-label claims, guarantee results, omit material risks, borrow evidence from another product
Compounded-product page Red until cleared After clearance, accurately describe exact compound, route, source, non-approved status, process, price, and limitations Approved-brand equivalence, generic/same-active claims, safety/effectiveness approval implications, hidden compounder
Quiz or “treatment finder” Yellow Collect only necessary data, state that it is not a diagnosis, and route to clinician evaluation Return “you qualify,” recommend a prescription automatically, use answers for ad targeting, collect unsupported sensitive data
Checkout or membership page Yellow Present the full price, inclusions, recurring terms, consent, cancellation, and clinical contingency Charge for medication before lawful prescription, disguise a commitment, precheck consent, make cancellation harder than signup

Landing-page operating rules

  1. The net impression controls. Headline, body, imagery, charts, reviews, URL, metadata, ad copy, form questions, CTA, and linked content all count.
  2. One product status per claim. An approved brand's evidence cannot migrate to a compound, altered route, or peptide bundle.
  3. No regulatory cloaking. Do not show a clean page to ad reviewers and different claims to consumers. Do not use redirects, domain rotation, geography, or post-approval edits to evade platform review.
  4. Separate domains are not shields. They may separate analytics and PHI risk, but regulators and platforms can consider common ownership, branding, destination paths, and account behavior.
  5. The CTA must preserve clinical uncertainty. Prefer “See if a consultation is available” or “Start your clinical assessment.” Avoid “Get semaglutide,” “Start losing weight,” or “Claim your prescription.”
  6. State availability must be real. Geofence before collecting detailed health information or payment, and verify patient location again at the encounter.
  7. Price must be complete. State what is included and excluded, the billing interval, minimum term, renewal, cancellation, refund, lab, consultation, drug, shipping, and eligibility conditions.
  8. Do not place ad-tech tags on clinical paths by default. See the privacy zones below.

An FDA “reminder” format is not a shortcut for Elysium's launch. A qualifying reminder ad for an approved prescription drug is limited to the product name and certain identifying information; it cannot state or imply a use or benefit and is not available for every drug. It does not apply to a compounded or unapproved product. An unbranded help-seeking ad may discuss a condition without naming a drug, but paired creative, links, retargeting, or destination content can turn the combined presentation into product promotion. Counsel should classify the complete campaign, not only the headline.

Safe starting-page copy

Subject to fact verification and approval:

Online visits with licensed clinicians for eligible adults in [states]. A clinician will review your health history and determine whether treatment is appropriate. A prescription is not guaranteed.

Plans start at $[amount] per [period]. The price [includes/excludes] clinician visits, medication, labs, and shipping. If you are not eligible for treatment, [refund/cancellation rule].

For a cleared compound:

This is a compounded drug, not an FDA-approved drug. FDA does not review compounded drugs for safety, effectiveness, or quality before marketing. If prescribed, it is compounded and dispensed by [legal pharmacy name and status].

The disclosure must be prominent and close to the first product/price presentation. It does not authorize the product or cure other misleading claims.

Claims

Green or lower-risk claims, when accurate

  • “Online visits with licensed healthcare professionals.”
  • “A clinician determines whether treatment is medically appropriate.”
  • “A prescription is not guaranteed.”
  • “Available to eligible adults in [verified states].”
  • “Your clinician may request labs or follow-up visits.”
  • “Message the care team with questions” when response scope and times are accurate.
  • Precise operational facts: visit length, shipping method, support hours, verified pharmacy name and state license, refund process, and total price.
  • For cosmetic topical products, carefully substantiated appearance claims that do not imply treatment or structural change.

Yellow claims requiring a named approval file

  • “Personalized” or “tailored”: define what actually varies and do not imply a standardized compound is legally patient-specific merely because a quiz was completed.
  • “Evidence-based” or “evidence-informed”: identify the evidence, exact product and route, population, limitations, and medical approver.
  • “High quality,” “rigorous,” “pharmaceutical quality,” or “tested”: identify the measurable standard, facility, test, lot, frequency, and results. Do not imply comparative superiority or FDA endorsement.
  • “State-licensed pharmacy” or “503B outsourcing facility”: verify it at publication and explain status accurately.
  • Clinical statistics: exact source, endpoint, time frame, population, dose, formulation, absolute/relative framing, generally expected result, and adjacent limitations.
  • Physician or scientist names and institutional affiliations: written permission, accurate role and dates, no implied institutional endorsement, and conflict disclosure.
  • “Oxford,” “Yale,” or another institution: exact written authorization and an accurate description of the relationship. Employment, education, or one investigator's affiliation is not automatically an institutional partnership.
  • Comparisons: same population, product, route, dose, endpoint, and material conditions; disclose the comparator and basis. Never compare a compound to an approved brand in a way that implies equivalence.

Red claims

  • “The most successful clinical outcomes in aging research.”
  • “Superior safety and quality standards” without a defined comparator and reliable substantiation; for unapproved products, the implication is especially misleading.
  • “World's best scientists, clinicians, and institutions.”
  • “Safe,” “risk-free,” “no side effects,” “zero downtime,” or “no long-term risk.”
  • “Guaranteed,” “works for everyone,” “everyone qualifies,” or “prescription guaranteed.”
  • “Lose [X] pounds by [date]” or “average [X] pounds” without product-specific, generally expected-results evidence and all material conditions. Avoid in launch advertising even with a disclaimer.
  • “Reverse aging,” “biological age reversal,” “anti-aging injection,” “regenerates,” “heals,” “repairs DNA,” or “rejuvenates the body.”
  • “Natural,” “bioidentical,” or “uses your body's own pathways” when the wording implies safer or more effective.
  • “FDA approved ingredients,” “FDA compliant,” “FDA registered product,” or “FDA licensed pharmacy” used as a quality or approval halo.
  • “Clinically proven” based on preclinical research, ingredients rather than the exact product, another route, another dosage form, or uncontrolled observations.
  • “Best,” “#1,” “leading,” “only,” “most advanced,” “highest quality,” or similar superiority without a defined, current, complete market basis.
  • Broad “peptide protocol” advertising that collapses multiple products with different legal and evidence status into one promise.

Elysium page rewrites

Current TELI language Status Launch-safe direction
“The most successful clinical outcomes in aging research” Red “Online visits with licensed clinicians who assess eligibility for available treatment options.”
“Superior safety and quality standards” Red Replace with verifiable process facts: the actual pharmacy, licensure, testing, prescribing, follow-up, and safety-escalation process.
“Partnerships with the world's best scientists, clinicians, and institutions, including Oxford and Yale” Red until documented Name only the exact person or agreement, role, dates, permission, and non-endorsement context. Remove superlatives.
“Prescription therapies and peptide protocols tailored to each individual” Yellow “Licensed clinicians develop an individualized care plan. Treatment and prescriptions, if any, depend on clinical eligibility.”
Email-only waitlist with a Privacy link Yellow Add purpose, sender, sensitive-data treatment, communication choice, retention/deletion path, and separate SMS consent if collected. Do not add the email to ad audiences without a lawful, disclosed basis.

Reviews and social proof

The governing distinction

  • Hosted review: a consumer independently submits an authentic review and Elysium applies a neutral, consistently enforced moderation policy.
  • Testimonial/advertising claim: Elysium solicits a particular outcome, edits, selects, pins, features, syndicates, puts in an ad, gives talking points, or otherwise adopts the content.

FTC's Consumer Reviews and Testimonials Rule has applied since October 21, 2024. It prohibits fake or false reviews and testimonials, sentiment-conditioned incentives, undisclosed insider reviews, and certain review suppression. A business that merely hosts reviews has a narrower role, but once it uses a review in marketing, it becomes a testimonial and ordinary claim-substantiation rules apply (FTC review rule Q&A). Health testimonials cannot communicate a result Elysium could not claim directly, and “results not typical” does not replace evidence of generally expected outcomes (FTC Health Products Compliance Guidance).

PDP review policy

Allowed at launch:

  • Verified, authentic reviews about scheduling, clinician communication, support, packaging, shipping, and overall service.
  • A neutral prompt such as “How was your care experience? Please do not include private medical details.”
  • Incentives for any honest review only when the reward is not conditioned on positive or negative sentiment and the incentive is clearly disclosed with the review.
  • Publication of positive and negative reviews under the same rules.

Conditional:

  • Product-effect reviews only after medical/regulatory approval of the exact implied claims.
  • Weight-loss numbers only with exact product/formulation fit, reliable substantiation, evidence of generally expected results, material conditions, and adjacent qualification.
  • Featuring a patient identity or story only with written permission and, when Elysium or a covered clinical entity is using protected health information for marketing, a valid HIPAA authorization. General treatment consent is not a marketing authorization (HHS authorization guidance; HHS marketing guidance).
  • Creator or clinician testimonials only with material-connection disclosures and accurate credential/context disclosures.

Prohibited:

  • Fake, AI-generated, employee, insider, agency-written, stock-person, or copied competitor reviews presented as patients.
  • Buying a positive rating, compensating only positive reviewers, or requiring a minimum star rating.
  • Suppressing legitimate negative reviews while presenting the remaining set as representative.
  • Tying a refund, support, or clinical resolution to removal or revision of a review.
  • Editing a patient's words in a way that changes the result, product, timing, side effects, or certainty.
  • A compound review that says it is “just like Ozempic,” “generic Wegovy,” “safe,” or FDA-approved.
  • Before/after images without identity and date verification, consistent capture standards, written rights, product-specific substantiation, generally expected-result context, and regulatory approval.
  • Responding publicly in a way that confirms patient status, medication, diagnosis, result, or side effect. Use a privacy-safe response and move the conversation to a secure channel.

Moderation SOP

  1. Show a pre-submission notice asking users not to include diagnoses, medication names, contact information, or other sensitive details.
  2. Verify that the reviewer had a real transaction or care interaction without publishing the verification data.
  3. Apply written, viewpoint-neutral removal categories: spam/fraud, threats, unlawful content, personal identifiers, another person's health information, irrelevant content, or dangerous medical instructions.
  4. Do not use “medical misinformation” as a pretext to remove negative experiences. Escalate clinical inaccuracies for a neutral response or annotation under the approved policy.
  5. Log every rejection, edit, redaction, incentive, permission, and reason. Preserve the original.
  6. Route adverse-event language immediately to the medical/pharmacy safety process; do not delay safety handling while deciding publication.
  7. Keep hosted reviews out of paid ads and hero modules unless they separately clear the testimonial approval process.
  8. Audit agencies, review vendors, affiliates, and syndication feeds. Elysium remains exposed when a vendor creates or suppresses reviews on its behalf.

FTC's case against telehealth company NextMed is a direct warning: the agency alleged fake testimonials, stolen before/after images, unsubstantiated average weight-loss claims, hidden fees, negative-review suppression, and difficult cancellation in one funnel (FTC v. NextMed announcement).

Pricing and checkout

Green requirements:

  • State the full amount due now and later before collecting payment.
  • State separately whether the price includes clinician visits, medication, supplies, labs, shipping, taxes, and support.
  • Explain whether the advertised price depends on eligibility, dose, product, prepaid term, insurance, financing, or first-month promotion.
  • Put minimum commitment, renewal interval, cancellation timing, refund consequences, and post-cancellation shipments next to the plan selector and final CTA.
  • Obtain express, informed agreement to recurring charges separately from general Terms acceptance.
  • Provide an easy cancellation path and prompt confirmation. At minimum, the federal Restore Online Shoppers' Confidence Act requires clear material terms, express informed consent, and a simple cancellation method for online negative options; FTC continues to enforce these principles (FTC negative-option enforcement statement). State auto-renewal laws may be stricter.

Red practices:

  • “$99/month” when medication, required labs, a clinician visit, shipping, or a higher dose is an unavoidable extra.
  • “Starting at” without the conditions and a realistic basis for consumers receiving that price.
  • Charging for a prescription drug before a lawful prescription exists, or retaining an undisclosed fee if a patient is ineligible.
  • Prechecked subscription, SMS, marketing, HIPAA, or data-sharing consent.
  • Countdown timers, false scarcity, fabricated waitlists, or “only X left” for medical access.
  • Hiding a 6- or 12-month commitment behind a per-month price.
  • Cancellation by phone only when signup was online, unnecessary retention calls, undisclosed termination fees, or requiring review removal.

Privacy and tracking

Treat a person's interest in a named condition, medication, or telehealth service as sensitive even when a particular data point is not conclusively protected health information. HIPAA is a floor for covered flows, not the whole privacy analysis. FTC's Health Breach Notification Rule can apply to health apps and services outside HIPAA, and unauthorized disclosure can be a reportable breach (FTC HBNR guide). Washington, Nevada, Connecticut, California, and other states impose additional health or sensitive-data duties.

Page-zone controls

Zone Examples Default ad-tech rule Required control
A: General public Elysium home, generic service education with no condition/drug inference Limited first-party analytics after review Data minimization, consent/opt-out, no sensitive URL or event labels
B: Condition or product interest Weight-loss page, peptide page, waitlist, email capture No third-party ad pixels by default Privacy review, separate health-data notice where required, consent and deletion path, no audience upload
C: Screening and intake Quiz answers, symptoms, diagnoses, medications, photos, labs, eligibility No Meta/Google/TikTok pixels, session replay, chat scraping, or ad audiences HIPAA/health-data architecture, vendor agreements, encryption, minimum access, retention, audit logs
D: Authenticated care Portal, messages, visit, prescription, lab, payment tied to care No advertising trackers BAAs where required, access controls, clinical retention, incident process

HHS explains that tracking technologies on authenticated pages and pages where users enter appointment or symptom information can involve PHI. A cookie banner is not a HIPAA authorization, and a business associate agreement or another lawful HIPAA path may be required (HHS tracking-technology guidance). The 2024 court decision narrowed one part of the guidance concerning an unauthenticated page and IP address; it did not create a general pixel safe harbor.

State launch controls include:

  • A separate, prominent consumer-health-data privacy policy and required consent/deletion workflow where Washington's My Health My Data Act applies (Washington AG guidance).
  • State-specific sensitive-data consent, deletion, processor, geofence, and sale/share assessments, including Nevada's consumer health-data law and Connecticut's privacy requirements.
  • California CCPA/CPRA opt-out and sensitive-data controls. California's $1.55 million 2025 Healthline settlement shows the risk of sending health-related page information to advertising partners while failing to honor opt-outs (California AG announcement).

Waitlist rule

The current TELI email-only form can reveal interest in longevity or prescription services by context. Before launch, state:

  • what the person is joining;
  • which Elysium or clinical entity will contact them;
  • the communication channel and frequency;
  • whether the data will be used for care access, general marketing, or both;
  • the privacy policy and health-data notice that apply;
  • how to withdraw, delete, or unsubscribe;
  • that joining does not establish a clinician-patient relationship or guarantee eligibility.

Do not add waitlist users to Meta/Google/TikTok custom audiences, combine them with supplement buyers, or infer a diagnosis without a separately reviewed lawful basis.

Email, SMS, and creators

Email

  • Use accurate sender and subject lines, identify advertising, include a physical postal address, and honor opt-outs promptly under CAN-SPAM (FTC CAN-SPAM guide).
  • Separate service/transactional messages from marketing. Do not hide promotional content in a care reminder.
  • Apply the same product, claim, risk, price, review, and state restrictions as the website.

SMS and calls

  • Obtain channel-specific marketing consent that clearly identifies the sender and is not a condition of purchase; preserve the exact language, timestamp, page, phone number, and source.
  • Honor STOP and revocation promptly and maintain suppression across vendors.
  • Do not combine telehealth informed consent, general Terms, HIPAA authorization, and automated marketing consent into one checkbox.
  • Obtain current TCPA and state-law review before launch; dialing technology, content, seller, lead source, and state change the rule.

Affiliates, creators, and clinicians

  • Approve scripts and destinations before use; monitor live content and require correction/removal rights.
  • Disclose payment, free care, free product, equity, affiliate commission, employment, and other material connections in a clear, unavoidable way.
  • Do not let a creator make a claim Elysium could not make directly. “My experience” is not a substantiation exemption.
  • A clinician's credentials do not transform an off-label or unsubstantiated acquisition claim into lawful promotion.
  • Ban fabricated white-coat content, unlicensed “doctor” implications, scripted patient stories, and approved-brand comparisons for compounds.

State, prescribing, and pharmacy

Care generally occurs where the patient is physically located. Elysium must verify location at the encounter and use a clinician who is licensed or otherwise authorized there (HHS cross-state licensure overview). Obtain and document the state-required telehealth consent before care (HHS informed-consent overview).

Before a state is turned on, the matrix must approve:

  1. Provider profession, license, compact or telehealth registration, and supervision/collaboration rules.
  2. Patient-location verification and permitted audio/video/asynchronous modality.
  3. Standard of care, examination, medical-history, lab, follow-up, and record duties.
  4. Telehealth-specific consent, identity, disclosures, and emergency protocol.
  5. Prescribing limits and any product-specific or controlled-substance rules.
  6. Pharmacy home-state and nonresident licenses, pharmacist access, shipping, labeling, substitution, and compounding authority. Consumers should be able to identify and verify the pharmacy; FDA provides a state-licensed online-pharmacy locator.
  7. Corporate practice of medicine, clinical-entity ownership, MSO scope, professional judgment, fee-splitting, and compensation.
  8. Professional advertising and use of clinician names, titles, testimonials, and outcomes.
  9. Auto-renewal, cancellation, refund, privacy, health-data, and record-retention requirements.
  10. Complaint, adverse-event, emergency, and continuity-of-care routing.

Do not say “available nationwide” or accept a consumer into a treatment path until every relevant row is green for the person's state and the pharmacy can lawfully dispense there.

Paid media

Platform approval is an additional gate, not proof that the underlying marketing is lawful.

Platform Current U.S. launch implications Elysium rule
Google Ads Online pharmacy and telemedicine promotion is restricted; certification and often LegitScript are required. Unapproved substances and restricted prescription-drug terms may be disallowed (Google healthcare and medicines policy). No campaign until the exact business, domain, geography, product, pharmacy, certification, keyword, creative, and destination are approved.
Meta Prescription-drug, online-pharmacy, and telehealth advertising requires the applicable authorization, lawful status, audience, and country targeting under Meta's pharmacy and telehealth policy. Re-check current Ads Manager eligibility at launch. No health-condition custom audiences, outcome testimonials, prohibited equivalence claims, or circumvention.
TikTok U.S. prescription-medicine advertising may require proof of regulatory approval and age targeting; pharmacy/telehealth activity can require NABP or LegitScript evidence under TikTok's healthcare and pharmaceutical policy. No creator or paid ad until product status, certification, age/state targeting, script, comments, and landing page clear review.

Universal red practices:

  • Reviewer cloaking, domain rotation, redirect chains, or changing the destination after approval.
  • A general-service ad that lands on an unapproved compound claim.
  • Uploading patient, lead, quiz, prescription, or waitlist data to build ad audiences without an approved privacy basis.
  • Using platform approval, LegitScript, NABP, 503B registration, or a pharmacy license as an efficacy or FDA-approval claim.

Safety and adverse events

Marketing cannot launch ahead of safety operations.

  • Every surface must provide an appropriate path for urgent symptoms, clinical questions, and adverse-event reports.
  • The medical director, prescribing entity, Elysium, and pharmacy must define who receives, assesses, documents, forwards, and reports each event and product complaint, and within what time.
  • Review feeds, social comments, support tickets, DMs, cancellations, and refund requests must be monitored for safety language.
  • Do not delete or hide an adverse-event report because it is negative marketing. Move personal details to a secure channel and preserve the report.
  • Do not use support staff to give individualized dosing, contraindication, or emergency advice outside their role.
  • Maintain product/lot/source traceability for compounds and recall communications.

FDA reports hundreds of adverse events associated with compounded semaglutide and tirzepatide through May 2026 and warns that reports are likely undercounted because many state-licensed pharmacies are not federally required to report (FDA unapproved GLP-1 concerns).

Claim approvals

Every externally visible claim should be a reusable registry object rather than freehand copy.

Required fields:

Field Required content
Claim ID and exact wording Approved sentence, statistic, headline, caption, chart, and CTA variants
Status and channel Green/yellow/red; website, paid, organic, email, SMS, provider, review, creator
Product identity Brand/compound, ingredient/salt, route, form, dose, source pharmacy
Intended use and population Exact indication or operational purpose, age, inclusion/exclusion
Evidence Primary source, full study/report, date, owner, product/formulation match
Net-impression notes Images, adjacent copy, URL, metadata, comparison, implied message
Required qualification Risk, limit, material condition, typical result, source, disclosure placement
Prohibited variants Shorthand, superlatives, brand comparisons, creator paraphrases
Permissions Patient, clinician, creator, institution, copyright, HIPAA authorization as applicable
Approval and expiry Medical, regulatory, legal, privacy; approval date; next review or trigger
Live instances URL/ad/email/SMS/template and versioned screenshot

Workflow:

  1. Product identity and legal status clear before copywriting.
  2. Medical owner defines what the evidence actually supports.
  3. Regulatory/legal owner approves exact wording, implications, disclosures, and channel.
  4. Privacy owner approves data collection, vendors, tracking, consent, and reuse.
  5. Growth builds only from registered claims and approved modules.
  6. QA compares the live mobile and desktop experience to the approved artifact, including source code tags and redirects.
  7. Archive the live version, approvals, source, and screenshot.
  8. Re-review on label/safety/shortage/platform/law change, new pharmacy, new route/dose, new testimonial, or material page edit.

What needs fixing

Stop now

  • Do not launch paid telehealth traffic on August 18 until the exact product inventory and pharmacy/legal bases are signed.
  • Remove the visible internal placeholder on the Wegovy oral PDP: “[Approval status of the oral form to be confirmed before publish , Omar / legal.]” Replace it with copy based on the current approved tablet label after medical/regulatory review.
  • Remove or separate Mounjaro and Ozempic weight-acquisition promotion. Their staging PDPs acknowledge that weight use is off-label while using obesity-treatment benefit claims and expert endorsements elsewhere on the same pages.
  • Remove “supplementing is a proven way to restore youthful [NAD+] levels” from the NAD+ nasal page.
  • Remove “patients often notice improvements in sleep, recovery, and vitality” and similar unsourced patient-outcome language from both sermorelin pages.
  • Replace the portal mockup's fictional “better sleep after 3 weeks” exchange with an operationally neutral message about storage, scheduling, shipping, or contacting the care team. A fictional outcome is still an implied testimonial.
  • Remove or rewrite metformin claims that it encourages weight loss or reduces age-related-disease risk from acquisition surfaces.
  • Reconcile the 18-item launch list with the 17 visible staging products: bremelanotide/PT-141 is missing from navigation and /treatments/bremelanotide returned a 404.
  • Remove or hold “most successful clinical outcomes,” “superior safety and quality,” and “world's best”/Oxford/Yale claims from the acquisition page.
  • Do not use separate domains as a strategy to isolate policy risk or preserve ad accounts. Use them only within an approved brand, privacy, and operations architecture.
  • Do not advertise “GLP-1 injections and tablets” as one evidence class.
  • Do not promote sermorelin while the route, compounding basis, source, and intended claims are unresolved. The confirmed GHK-Cu launch item is cream; injectable GHK-Cu remains outside the launch and no-go without separate clearance.
  • Do not install or retain advertising pixels/session replay on waitlist, quiz, intake, or authenticated paths before the data map is approved.
  • Do not import existing supplement-customer lists into telehealth targeting without a separate privacy and consent analysis.

Correct before consumer traffic

  • Label Elysium press logos and research milestones so they do not imply that the outlets, Nobel laureates, Oxford, Yale, or Elysium's supplement research endorse or clinically validate TELI therapies.
  • Replace broad hero language such as “protocols designed to improve your long-term health and performance” with a factual description of clinician-guided access and eligibility.
  • Put the billing reality beside every “from $X/month” card: for example, “$X/month equivalent; $Y charged every three months.”
  • Resolve the site's subscription-control language against the call's “bill once, ship once” model and the PDPs' prepaid two- or three-month billing. Do not promise skip, pause, or cancellation controls that do not exist for the actual plan.
  • Replace “always-on support” with the measured service level, such as “secure provider messaging; responses within one business day,” if accurate.
  • Name the actual prescribing entity and dispensing pharmacy or pharmacies, accurately state state availability, and explain the division of responsibility.
  • Add status badges to every product card: “FDA-approved for chronic weight management,” “FDA-approved for type 2 diabetes; weight use is off-label,” or “Compounded; not FDA-approved,” as applicable and approved.
  • Qualify HSA/FSA eligibility; it can depend on the expense and plan administrator. Do not present every TELI purchase as automatically eligible.
  • Treat “Get a recommendation” as a medical-recommendation claim. The current CTA leads to the general welcome/intake flow, not a neutral multi-product recommender; rename it “Explore options” or “Start your assessment” unless the product actually does what the CTA says.
  • Use neutral internal analytics event names. Do not send drug names, conditions, quiz answers, or eligibility outcomes to Meta or other advertising platforms.

Build before traffic

  • A one-row-per-SKU product inventory with NDC or compounding details.
  • A one-row-per-state provider/pharmacy/consent/business/privacy matrix.
  • The claim registry and banned-phrase linter/checklist.
  • A public page naming the actual clinical and pharmacy roles accurately.
  • Complete price, eligibility, cancellation, refund, lab, shipping, and no-guarantee disclosures.
  • A service-review module and moderation/adverse-event SOP; hold outcome reviews.
  • A privacy architecture that separates public analytics from health and clinical data.
  • Platform certification files and a no-circumvention policy for agencies.
  • An incident/kill-switch owner who can pause ads, pages, SMS, and prescribing paths together.

Launch checklist

The launch owner should be able to answer yes to every applicable item.

Product and clinical

  • Exact approved drug or compound, ingredient/salt, form, route, strength, dose, source, and label are documented.
  • FDA-approved claims match the current label; compounded claims do not borrow approved-product evidence.
  • 503A/503B and state compounding basis is signed for every compound.
  • Injectable GHK-Cu is excluded unless separately cleared in writing.
  • Sermorelin status and intended uses are separately cleared.
  • Eligibility, contraindication, lab, titration, follow-up, emergency, adverse-event, and continuity protocols are live.

Claims and creative

  • Every headline, image implication, statistic, chart, review, CTA, creator line, and metadata claim has a registry ID.
  • Benefits and risks/limitations are balanced and appropriately prominent.
  • No generic/sameness/FDA-approval implication exists for a compound.
  • No guarantee, unqualified safety, superlative, anti-aging, or unsupported outcome claim exists.
  • Patient, clinician, creator, and institution permissions are complete.

Commerce and consent

  • Total price and every included/excluded component are adjacent to the CTA.
  • Renewal, minimum term, cancellation, refund, and ineligibility consequences are explicit.
  • Recurring-charge assent, marketing consent, telehealth consent, privacy consent, and HIPAA authorization are separated where required.
  • Cancellation and suppression paths were tested end to end.

State, pharmacy, and platform

  • The patient's state is green for provider, modality, consent, prescribing, pharmacy, entity, fee, privacy, and renewal rules.
  • Pharmacy identity and licenses are visible and verifiable.
  • Google/Meta/TikTok/LegitScript/NABP approvals required for the exact domain and model are current.
  • Ads, landing page, redirect, intake, and checkout show the same approved offer and claims.

Privacy and QA

  • The data map includes tags, URLs, events, forms, replay, chat, vendors, audiences, retention, deletion, and incident handling.
  • No advertising tracker receives waitlist, quiz, intake, authenticated, prescription, or care data without an approved basis.
  • Mobile, desktop, accessibility, location gates, error states, refund path, adverse-event path, and no-eligibility path were tested.
  • Final live screenshots, source/tag scan, approvals, and rollback instructions are archived.

Still open

The call resolved the consumer launch list, confirmed topical GHK-Cu, and confirmed no compounded GLP-1s at launch. The remaining blockers are:

  1. What are the exact ingredient/salt, concentration, strength, dose, packaging, and intended use for every compounded item?
  2. Which legal pharmacy and facility makes each compound, is it 503A or 503B, and what exact bulk-substance/copy/state basis has counsel approved?
  3. Is bremelanotide the FDA-approved Vyleesi product or a compounded PT-141 product? What route, population, page, safety material, and intake apply, and why is it absent from staging?
  4. Which NDC/package will TELI dispense for Mounjaro, Zepbound, Ozempic, both Wegovy forms, and Foundayo? Are supply and pricing confirmed for every dose?
  5. Will Mounjaro and Ozempic remain in the weight-acquisition catalog? If so, what written legal and medical governance supports the consumer off-label presentation?
  6. Which provider entity employs or contracts the clinicians, and which states and asynchronous/video modalities are live?
  7. Which pharmacies dispense each SKU, and in which states are they licensed to ship it?
  8. Who owns medical, pharmacy, FDA/regulatory, state-healthcare, privacy, platform, claims, and final launch approval?
  9. Which site claims have approved claim IDs and evidence that matches the exact formulation and route?
  10. What do “Oxford,” “Yale,” Nobel laureates, and other institutional relationships actually mean, which TELI claims do they support, and is there written advertising permission?
  11. Is the commercial model a prepaid finite supply, recurring subscription, or both? What does the displayed monthly equivalent include, and what are cancellation, refund, lab, ineligibility, price-change, and dose-change rules?
  12. What data do the waitlist, quiz, intake, portal, support, and checkout collect, and which tags, replay tools, chat tools, analytics vendors, or ad platforms receive any part of it?
  13. LegitScript is reportedly secured. Which exact domain, legal entity, business model, ad accounts, products, and pharmacies does the certification cover, and what additional Google/Meta/TikTok/NABP approvals remain?
  14. Where will reviews come from, how are reviewers verified or incentivized, and who owns neutral moderation, privacy redaction, complaint escalation, and adverse-event intake?
  15. Who has authority to stop traffic, intake, charging, and prescribing if a claim, pharmacy, state, safety, or platform issue appears?

What to monitor

This rulebook should be revalidated immediately before launch and at least monthly during the first six months. High-change items are:

  • FDA actions restricting nonapproved GLP-1 APIs and compounded copy products (February 2026 FDA action statement).
  • GLP-1 shortage status, compounding enforcement, labeling, safety, and warning letters.
  • GHK-Cu and sermorelin bulk-substance category or advisory-committee decisions.
  • State telehealth, compounding, privacy, consumer-health-data, and auto-renewal rules.
  • Google, Meta, TikTok, LegitScript, and NABP certification and advertising policy changes.
  • FTC health-claim, review, testimonial, negative-option, and health-breach enforcement.

Sources