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  1. Home
  2. Compare
  3. PlushCare vs Hello Cake
Ben KowalskiWritten by Ben KowalskiStaff Writer
Updated onAugust 22, 2026
PlushCare telehealth platform
PlushCare
VS
Hello Cake telehealth platform
Hello Cake
Visit PlushCareRead Our Hello Cake Review

PlushCare vs Hello Cake

Complete 2026 Comparison for Erectile Dysfunction

Erectile Dysfunction

Quick Answer

Best overallPlushCare

PlushCare is our overall pick for erectile dysfunction, based on our rating and feature coverage.

Top Erectile Dysfunction Providers

Our Top Choice
1
Strut logo

Start for Free - Daily Tadalafil & Custom ED Formulas

  • FDA-approved generic Tadalafil and Sildenafil prescribed online by U.S.-licensed physicians
  • Once-daily Tadalafil dosing available for always-ready spontaneity
  • Strut Mojo: oral Enclomiphene + Tadalafil combo (compounded, not FDA-approved)
  • Optional at-home test kit measures Testosterone, DHEA-S, Estradiol, Cortisol and SHBG
9.4
OutstandingScore based on review by ManyTreatments editors, popularity, brand reputation, features and benefitsLearn how we score
★★★★★
See PricingRead full review
Best Value
2
Taurus Meds logo

NEW Charge™ Liquid ED - Just $12.99/Dose or Less

  • Charge™ liquid ED treatment from $12.99 per dose, a compounded four-drug formula the FDA has not approved or reviewed for safety, effectiveness, or quality
  • Charge™ blends sildenafil, tadalafil and vardenafil with apomorphine, whose US approvals are all for Parkinson's disease rather than ED
  • 100% online - prescribed and monitored by licensed clinicians, then shipped to you
  • Part of a full men's health platform: TRT, peptides and hair regrowth
9.6
ExceptionalScore based on review by ManyTreatments editors, popularity, brand reputation, features and benefitsLearn how we score
★★★★★
See PricingRead full review
Most Popular
3
Hims logo

ED Treatment From $22/mo - Sildenafil or Tadalafil Chews From $30/mo

  • Generic sildenafil and tadalafil plus prescription-strength flavored chews (compounded, not FDA-approved)
  • Combo plans: Sex Rx + Hair Health from $35/mo, Sex Rx + Climax Control from $39/mo
  • Daily options available so you're never caught off guard
  • 100% online consultation, free and discreet shipping
9.4
OutstandingScore based on review by ManyTreatments editors, popularity, brand reputation, features and benefitsLearn how we score
★★★★★
See PricingRead full review

Provider Overview

PlushCare logo
8.6

Our editorial rating 8.6/10Trustpilot: 3.4/5 from 2,766 reviews, checked Sep 11, 2026

PlushCare is a full-service telehealth platform offering virtual urgent care, primary care, and treatment for various conditions including ED, weight loss, and women's health.

Rating8.6/10
Free ConsultationNo
Free ShippingYes
HSA/FSAYes
Founded2014
HQSan Francisco, CA
Visit PlushCareRead Full Review
Hello Cake logo
8.8

Our editorial rating 8.8/10Trustpilot: 3.8/5 from 1,003 reviews, checked Sep 11, 2026

Hello Cake offers sexual wellness products for both men and women, including ED treatments, lubricants, and intimacy products with a fun, modern approach.

Rating8.8/10
Free ConsultationNo
Free ShippingYes
HSA/FSANo
Founded2018
HQNew York, NY

We don't list Hello Cake, and we earn nothing if you choose it.

Read Full Review
VS

Feature Comparison

Feature comparison between PlushCare and Hello Cake
FeaturePlushCarePlushCareHello CakeHello Cake
Rating8.6/108.8/10
Founded20142018
Free ConsultationNoNo
Free ShippingYesYes
Accepts InsuranceYesNo
HSA/FSA AcceptedYesNo
Mobile AppYesNo
Consultation TypeVideo, PhoneOnline questionnaire
Shipping Time3-5 business days3-5 business days

Pricing Comparison

Pricing comparison between PlushCare and Hello Cake across treatment categories
TreatmentPlushCareHello Cake
Erectile DysfunctionN/A$12$12-$75

Prices shown are starting costs. Actual pricing varies by treatment plan and medication.

Pros and Cons

PlushCare

Pros

  • Accepts most major insurance plans
  • Primary care and urgent care available
  • Board-certified physicians only
  • Same-day appointments often available
  • full-service care options

Cons

  • Consultation fee ($99 without insurance)
  • More expensive than specialists
  • Requires appointments
  • Not specialized in any single condition
Hello Cake

Pros

  • Fun, approachable branding
  • Products for both partners
  • No prescription needed for many products
  • Affordable pricing
  • Discreet packaging

Cons

  • Limited medical treatments
  • Primarily wellness products
  • No full-service telehealth
  • Limited conditions treated

Which Should You Choose?

PlushCareChoose PlushCare if you:
  • Patients with insurance
  • Those wanting video consultations
  • Patients needing full primary care
  • Those seeking same-day appointments
Visit PlushCare
Hello CakeChoose Hello Cake if you:
  • Couples seeking intimacy products
  • Those preferring lifestyle brand
  • Patients seeking OTC options
  • Those wanting non-medical solutions
Read Our Hello Cake Review

Who This Is For

This is for
  • Men seeking ED medication who want to compare costs and options across multiple online providers before committing.
  • Men comparing prescription availability, pricing, and dosage options across telehealth services in their state.
  • Men who want a licensed prescriber and pharmacy, but prefer an independent comparison over going direct to one brand.
Not for
  • If you take nitrates for heart conditions, online ED treatment is not safe - see a cardiologist first.
  • Sudden or unexplained ED alongside chest pain or shortness of breath needs in-person cardiac evaluation, not telehealth.
  • An erection lasting over 4 hours requires emergency care, not an online consultation.

About This Comparison

Our Editorial Standards

This plushcare vs hello cake provider comparison is independently researched by our editorial team. We compare telehealth services based on publicly available information including pricing, available treatments, and service areas. Our ratings are editorial judgments, not tallies of reviews.

Independent Research: We do not accept payment for rankings or favorable reviews
Affiliate Disclosure: We may earn commissions from qualifying purchases at no extra cost to you
Regular Updates: Content is reviewed and updated monthly for accuracy
Licensed Providers Only: All listed services employ US-licensed healthcare providers

Not Medical Advice: This comparison is for informational purposes only. We are not healthcare providers. Always consult with a licensed physician before starting any treatment. Read our full medical disclaimer and editorial policy.

Independent ResearchNo paid placements
Fact-Checked InformationVerified against official sources
Regularly UpdatedLast updated August 22, 2026
Licensed Providers OnlyAll listed services are US-licensed

PlushCare vs Hello Cake: Complete Comparison Guide

Ben KowalskiWritten by Ben KowalskiStaff Writer
12 min readUpdated August 22, 2026

Table of Contents

Hello Cake and PlushCare represent fundamentally different approaches to erectile dysfunction telehealth - focused specialty platform versus full primary care integration. Hello Cake provides generic sildenafil and tadalafil through brief NP/PA questionnaire reviews at $240-360 annually (cash-pay only), while PlushCare offers ED treatment within full-service primary care model through board-certified physician video consultations at $300-800 annually depending on insurance coverage. Insurance acceptance critically impacts value equations: PlushCare's consultation coverage may reduce effective costs below Hello Cake for insured patients, while uninsured individuals pay substantial premiums for care they may not fully utilize. This comparison examines which service model better serves different patient populations based on insurance status, care coordination needs, and treatment complexity.

Platform Overview & Service Scope

Hello Cake operates as a single-category sexual wellness brand focused exclusively on erectile dysfunction medication access through streamlined asynchronous provider evaluations. The platform offers generic sildenafil and tadalafil exclusively, targeting men seeking discrete prescription access without medical consultation, ongoing care relationships, or multi-category health services. With 2-3 years of history, Hello Cake emphasizes privacy, minimal clinical friction, and budget-friendly pricing as core differentiators in the competitive ED telehealth market.
PlushCare functions as a primary care telehealth platform providing erectile dysfunction treatment within a full-service medical practice model covering 50+ health conditions including acute care, chronic disease management, mental health, preventive care, and specialist referrals. The ED service integrates generic sildenafil and tadalafil prescriptions through board-certified physicians conducting synchronous video consultations, with treatment occurring within established primary care relationships enabling coordination across multiple health domains. With 10+ years of history and insurance acceptance for consultations, PlushCare positions itself as virtual primary care rather than condition-specific specialty platform.
The fundamental distinction centers on service breadth and clinical integration: Hello Cake delivers isolated erectile dysfunction medication through minimal touchpoints optimized for transaction speed, while PlushCare provides ED treatment within primary care framework enabling medical coordination, insurance-based payment, and established physician relationships addressing overall health. This comparison examines whether PlushCare's integrated care model justifies higher consultation costs and complexity versus Hello Cake's focused simplicity for men seeking only ED medication access, according to FDA prescribing information, according to FDA prescribing information, according to GoodRx ED medication pricing.

Treatment Options & Medication Formulary

Hello Cake provides standard generic erectile dysfunction medications exclusively: sildenafil 20mg-100mg tablets and tadalafil 5mg-20mg tablets in conventional oral formulations dispensed through partner pharmacy networks. The platform offers 30-day or 90-day supplies with no brand-name Viagra or Cialis, no compound formulations, no specialty dosing protocols, and no alternative delivery methods. Treatment selection based on brief questionnaire responses without provider discussion or personalized dosing optimization beyond standard FDA-approved protocols.
PlushCare offers generic sildenafil and tadalafil at standard FDA-approved dosages through pharmacy fulfillment (patients use preferred pharmacy with insurance or cash-pay). The platform does not maintain proprietary medication formulary or offer compound preparations - ED medications prescribed following standard community pharmacy model where patients fill prescriptions at retail or mail-order pharmacies of choice. Physicians may prescribe brand-name Viagra or Cialis if specifically requested and justified, though insurance coverage determines actual access and cost.
Clinical efficacy for both platforms rests on identical FDA-approved PDE5 inhibitor medications: generic sildenafil and tadalafil demonstrate 70-85% response rates in erectile dysfunction across diverse etiologies per systematic reviews. The medication options are functionally equivalent between platforms - both provide standard generic access without specialty formulations. The critical difference lies in consultation model rather than formulary: PlushCare's physician video consultations enable medication selection discussion and dosing optimization based on in-depth medical assessment.
Treatment options comparison reveals essential parity in medication access with differences in prescribing context: Hello Cake's questionnaire-based approach provides rapid prescription approval for straightforward cases, while PlushCare's video consultation model enables nuanced treatment planning considering comorbidities, medication interactions, cardiovascular risk, and patient preferences. For uncomplicated erectile dysfunction, medication outcomes likely equivalent. For complex presentations requiring medical assessment, PlushCare's evaluation model provides diagnostic advantages despite identical generic formulary, according to FDA prescribing information, according to FDA prescribing information.

Medical Consultation Model & Provider Access

Hello Cake conducts erectile dysfunction evaluations through brief asynchronous questionnaires reviewed by state-licensed providers (typically nurse practitioners or physician assistants) without synchronous video consultations or direct provider interaction. The questionnaire collects basic medical history, cardiovascular risk factors, current medications, and ED severity assessment. Provider review occurs within 24-48 hours, resulting in prescription approval or rejection messaging. No ongoing provider relationship; follow-up consultations require new questionnaire submissions without care continuity or established medical home.
PlushCare provides erectile dysfunction evaluation through synchronous video consultations (typically 15-30 minutes) with board-certified physicians (MD/DO) licensed in patient's state. Initial consultations cover thorough medical history, cardiovascular assessment, medication review, ED etiology discussion, treatment options education, and medication selection. Physicians integrate ED treatment within broader primary care context - addressing related health concerns (diabetes, hypertension, obesity), coordinating with existing providers, and establishing ongoing care relationships. Follow-up access via video consultations ($99-129 per visit) or secure messaging for simple questions.
Clinical evaluation quality differs substantially between models: PlushCare's synchronous physician consultations enable real-time clarification of medical history, discussion of cardiovascular risk factors critical for safe PDE5 inhibitor use, identification of underlying conditions contributing to ED (diabetes, testosterone deficiency, mental health), and patient education improving treatment adherence. Hello Cake's brief questionnaires capture contraindication screening but miss nuanced presentations benefiting from medical discussion.
The consultation model advantage favors PlushCare significantly for patients with: (1) complex medical histories requiring physician expertise for safe medication selection, (2) multiple comorbidities necessitating coordinated care across conditions, (3) preference for established primary care relationships versus transactional specialty services, (4) need for insurance-based payment for medical consultations. Hello Cake suits patients seeking minimal clinical interaction for straightforward ED medication access without desire for medical assessment or ongoing care relationships.

Pricing Structure & Cost Comparison

Hello Cake pricing (January 2026, verified from current public rates): Generic sildenafil $15-40/month depending on dosage and quantity (30-day supplies). Generic tadalafil $30-70/month based on strength and frequency. No consultation fees - medication cost only. Promotional campaigns offer first-month discounts ($10-20). No membership fees or subscription requirements; per-prescription pricing with optional auto-refill. Insurance not accepted; all pricing cash-pay only. Annual cost for standard treatment: approximately $240-360 for on-demand sildenafil usage.
PlushCare erectile dysfunction pricing: Initial physician video consultation $99-129 (insurance accepted for consultation, check coverage). Generic sildenafil prescription filled at patient's choice of pharmacy - cost varies by pharmacy and insurance coverage (typically $10-40/month with insurance, $20-60/month cash-pay at major retail pharmacies). Generic tadalafil similarly filled at patient's pharmacy ($20-80/month depending on insurance and pharmacy). Follow-up consultations $99-129 per visit as needed. Annual cost: approximately $300-600 including initial consultation, 1-2 follow-ups, and pharmacy medication costs with insurance; $500-800 without insurance.
Cost comparison complexity arises from different payment models: Hello Cake bundles minimal provider review with medication in single cash price, while PlushCare separates physician consultation (often insurance-covered) from pharmacy medication costs. For patients with insurance covering telehealth consultations, PlushCare's effective cost may approach or match Hello Cake when consultation coverage offsets higher per-visit fees. For cash-pay patients, Hello Cake maintains $150-300 annual advantage including consultation cost differences.
Value assessment depends on insurance status and service preferences: insured patients benefit from PlushCare's consultation coverage (potentially $200-400 annual savings) while accessing physician-quality care and full primary care coordination. Cash-pay patients face higher PlushCare costs ($500-800 versus $240-360 for Hello Cake) purchasing physician consultations and integrated care versus minimal questionnaire review. The cost differential reflects fundamental service scope differences - isolated ED medication access versus comprehensive primary care integration, according to FDA prescribing information, according to FDA prescribing information, according to GoodRx ED medication pricing.

Platform Features & Service Integration

Hello Cake provides streamlined mobile-optimized website with minimalist three-step workflow: questionnaire completion → provider review → pharmacy fulfillment. No mobile app; responsive web interface only. Account dashboard shows basic order history, upcoming refills, and one-click reorder functionality without features. Customer support via email and limited-hours chat with typical 12-24 hour response times. Educational content minimal beyond basic medication information. Platform optimized for transaction speed rather than engagement or medical coordination.
PlushCare offers full-featured telehealth platform including native mobile apps (iOS/Android) and web access providing: integrated video consultation scheduling across all medical specialties, medical records accessible to patients and providers, prescription management with pharmacy integration (patients choose fulfillment location), provider messaging for follow-up questions, health tracking tools, and preventive care reminders. Customer support operates via phone and chat with extended hours. Educational content covering diverse health conditions and wellness topics.
Service integration differences significantly impact user experience: PlushCare's medical records enable care coordination when ED treatment intersects with other health conditions (diabetes management affecting erectile function, cardiovascular medications interacting with PDE5 inhibitors, mental health treatment influencing sexual health). Hello Cake's isolated ED focus prevents medical coordination - patients managing multiple conditions across platforms face fragmented care with information silos creating safety risks and inefficiency.
The platform advantage favors PlushCare substantially for patients: (1) managing multiple health conditions benefiting from coordinated care, (2) seeking established primary care relationship rather than condition-specific transactions, (3) valuing full medical records and provider continuity, (4) preferring insurance-based payment for consultations. Hello Cake suits patients seeking only isolated ED medication without other telehealth needs or desire for comprehensive primary care engagement, accepting fragmented care for simpler transaction-focused experience, according to NIH StatPearls - PDE5 Inhibitors.

Insurance Acceptance & Payment Flexibility

Hello Cake operates exclusively as cash-pay service with no insurance acceptance for provider reviews or medication fulfillment. The platform requires credit card payment at time of service, with costs including both provider evaluation and medication dispensed through partner pharmacies. No HSA/FSA payment infrastructure, no insurance claim submission, and no coordination with health plans. The cash-pay model simplifies transactions but eliminates insurance benefits potentially covering erectile dysfunction evaluation or generic medication costs under prescription drug coverage.
PlushCare accepts major insurance plans for physician video consultations including Aetna, Anthem, Blue Cross Blue Shield, Cigna, Humana, Oscar, UnitedHealthcare, and many regional plans covering telehealth services. Consultation copays typically $10-50 depending on plan benefits, often substantially lower than $99-129 cash rates. ED medications prescribed through standard pharmacies allowing patients to use insurance prescription benefits (coverage varies - some plans exclude ED medications, others cover generics with prior authorization). HSA/FSA accepted for cash-pay consultations and medications.
Insurance acceptance substantially alters cost equations: patients with telehealth consultation coverage through employer plans or individual insurance may pay $10-50 copays for physician visits versus Hello Cake's $240-360 annual medication-bundled costs. When insurance covers both consultations and generic ED medications, PlushCare's effective annual cost may fall below Hello Cake's cash-pay pricing while delivering superior physician care and full primary care access. For uninsured patients, Hello Cake's cash-pay simplicity and lower costs provide clear advantage.
Payment flexibility considerations favor PlushCare for: (1) patients with health insurance covering telehealth and prescription benefits, (2) individuals preferring to maximize insurance benefits rather than cash-pay alternatives, (3) those using HSA/FSA accounts for tax-advantaged medical spending. Hello Cake serves uninsured or underinsured patients seeking lowest cash-pay costs, or individuals preferring transaction simplicity without insurance claim coordination despite potentially higher out-of-pocket costs compared to insurance-covered alternatives.

How We Compared PlushCare vs Hello Cake

Our Comparison Methodology

This comparison provides evidence-based analysis of Hello Cake and PlushCare for erectile dysfunction treatment based on evaluation of clinical quality, payment models, service scope, and care integration.

Clinical Evidence: Treatment recommendations reflect FDA-approved prescribing information for sildenafil (Viagra label) and tadalafil (Cialis label), American Urological Association guidelines for ED management (AUA ED guidelines), and clinical protocols for PDE5 inhibitor therapy.

Pricing Analysis: Pricing reflects the rates last recorded in our provider database; providers change prices frequently, so confirm current pricing directly at checkout. PlushCare insurance coverage confirmed through plan verification tools and direct consultation with customer service. Pharmacy costs estimated based on GoodRx pricing data and major retail pharmacy rates. Pricing subject to change; patients should verify current rates during enrollment.

Service Verification: Platform comparisons based on direct evaluation of consultation processes, provider credential verification through state medical board databases, insurance acceptance confirmation, and customer support interactions. Care integration capabilities assessed through platform feature analysis.

This analysis is our own editorial work (most providers listed here pay ManyTreatments a commission when you buy through a link on this page; none pays for a placement, a rating, or a listing, and we do not further claim that commissions have never influenced anything, because that is our own conduct and we cannot evidence it) and aims to provide objective comparison enabling patients to select erectile dysfunction services matching their clinical needs, insurance status, and care coordination preferences. All medical claims cited to authoritative sources; treatment decisions should involve consultation with qualified healthcare providers.

Final Verdict: PlushCare vs Hello Cake

Choose Hello Cake if: You lack health insurance covering telehealth consultations, need only isolated erectile dysfunction medication without other telehealth requirements, have straightforward ED responding adequately to generic PDE5 inhibitors without complex medical history, and prioritize lowest cash-pay costs ($240-360 annually) over physician consultations care coordination. Best for uninsured or underinsured patients with simple ED presentations seeking transaction-focused medication access.

Choose PlushCare if: You have health insurance covering telehealth consultations (potentially reducing costs below Hello Cake while accessing physician care), manage multiple health conditions benefiting from coordinated primary care, value board-certified physician video consultations for thorough medical assessment, or prefer integrated care model addressing overall health rather than isolated condition-specific transactions. Best for insured patients or those seeking full-service primary care relationship including ED treatment.

Bottom line: Hello Cake and PlushCare serve different patient populations with distinct payment models and service philosophies. Insurance status critically determines value: insured patients benefit from PlushCare's consultation coverage physician care often at competitive total costs, while uninsured patients face substantially higher PlushCare costs ($500-800 versus $240-360) for services they may not fully utilize. The choice fundamentally reflects preferences for isolated transaction efficiency versus full care integration, with insurance coverage tipping balance strongly toward PlushCare for patients with telehealth benefits and toward Hello Cake for cash-pay situations.

Visit PlushCareRead Our Hello Cake Review

Sources & References

Our comparisons are informed by official sources and regulatory guidelines. We encourage readers to verify information with authoritative sources.

  • FDA Prescribing Information (NDA 20895)Official FDA-approved prescribing information and drug labeling
  • GoodRx - ED Medication Pricing GuideCost comparison of erectile dysfunction medications and generics
  • NIH StatPearls - PDE5 InhibitorsFDA-approved phosphodiesterase-5 inhibitors for erectile dysfunction

Editorial Note: Researched and edited by our editorial team. AI tools assist with initial research and drafting; all content is fact-checked and edited by humans before publication. Learn more about our editorial standards

Related Comparisons

HimsVSPlushCareHimsVSHello CakeHersVSPlushCareRoVSPlushCareRoVSHello CakeKeepsVSPlushCare

Start With a Top Erectile Dysfunction Provider

Our Top Choice
1
Strut logo

Start for Free - Daily Tadalafil & Custom ED Formulas

  • FDA-approved generic Tadalafil and Sildenafil prescribed online by U.S.-licensed physicians
  • Once-daily Tadalafil dosing available for always-ready spontaneity
  • Strut Mojo: oral Enclomiphene + Tadalafil combo (compounded, not FDA-approved)
  • Optional at-home test kit measures Testosterone, DHEA-S, Estradiol, Cortisol and SHBG
9.4
OutstandingScore based on review by ManyTreatments editors, popularity, brand reputation, features and benefitsLearn how we score
★★★★★
See PricingRead full review
Best Value
2
Taurus Meds logo

NEW Charge™ Liquid ED - Just $12.99/Dose or Less

  • Charge™ liquid ED treatment from $12.99 per dose, a compounded four-drug formula the FDA has not approved or reviewed for safety, effectiveness, or quality
  • Charge™ blends sildenafil, tadalafil and vardenafil with apomorphine, whose US approvals are all for Parkinson's disease rather than ED
  • 100% online - prescribed and monitored by licensed clinicians, then shipped to you
  • Part of a full men's health platform: TRT, peptides and hair regrowth
9.6
ExceptionalScore based on review by ManyTreatments editors, popularity, brand reputation, features and benefitsLearn how we score
★★★★★
See PricingRead full review
Most Popular
3
Hims logo

ED Treatment From $22/mo - Sildenafil or Tadalafil Chews From $30/mo

  • Generic sildenafil and tadalafil plus prescription-strength flavored chews (compounded, not FDA-approved)
  • Combo plans: Sex Rx + Hair Health from $35/mo, Sex Rx + Climax Control from $39/mo
  • Daily options available so you're never caught off guard
  • 100% online consultation, free and discreet shipping
9.4
OutstandingScore based on review by ManyTreatments editors, popularity, brand reputation, features and benefitsLearn how we score
★★★★★
See PricingRead full review

Related Resources

Brand Review

PlushCare Review

Brand Review

Hello Cake Review

Brand Review

Is PlushCare Legit?

Guide

PlushCare Alternatives

Guide

Hello Cake Alternatives

Guide

PlushCare Coupons & Deals

Ben Kowalski
Ben KowalskiStaff Writer

Ben Kowalski is a writer and researcher who covers men's health, sexual wellness, and online healthcare services. He stumbled into health writing after realizing how much bad information exists online about topics men are too embarrassed to ask their doctor about. Ben thinks that needs to change. When he is not untangling medical jargon or stress-testing telehealth apps, he is watching Premier League football, grilling something, or losing at trivia nights with the same group of friends he has had since college.

Medical Disclaimer: The information on this page is for educational purposes only and is not medical advice. Always consult with a licensed healthcare provider before starting any treatment. Read our full medical disclaimer.

Regulatory noticeRegulatory note (verified August 22, 2026): The FDA reviewed struthealth.com in December 2025 and, on February 20, 2026, issued Strut Health, LLC a warning letter, MARCS-CMS 721448. It raises two separate problems. Pictured product labels carry the "Strut" name, which the agency said represents Strut as the compounder of the semaglutide and tirzepatide products when it is not. Three site claims are also quoted, among them "Generic Zepbound, Mounjaro" and "Semaglutide is the active ingredient in the brand medications." Because compounded drugs hold no FDA approval, the FDA said wording of that kind implies one, and it cited misbranding under sections 502(a) and 502(bb) of the FD&C Act. FDA’s warning letter index shows no response letter and no close-out letter, so we treat the matter as open. Read the FDA letter

Regulatory noticeRegulatory note (verified August 22, 2026): On September 9, 2025 the FDA sent Hims & Hers Health, Inc. a warning letter covering the Hims brand, MARCS-CMS 716567, drawn from a review of hims.com the previous month. Two lines about compounded semaglutide are quoted in it: "Same active ingredient as Ozempic and Wegovy" and "Clinically proven ingredients." Compounded drug products are not FDA-approved, and the agency said phrasing of this sort suggests otherwise, which is what makes the products misbranded under FD&C Act sections 502(a) and 502(bb). A companion letter went to the same company that day for its Hers brand. No close-out letter appears in FDA’s index; treat this as open. Read the FDA letter