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

Keeps vs Hello Cake

Complete 2026 Comparison for Erectile Dysfunction

Erectile Dysfunction

Quick Answer

Best overallKeeps

Keeps 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
Strut displays LegitScript certificate 11142478, checked September 19, 2026Cert. 11142478September 19, 2026
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
Taurus Meds displays LegitScript certificate 44265708, checked September 19, 2026Cert. 44265708September 19, 2026
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

Keeps logo
9.0

Our editorial rating 9.0/10Trustpilot: 3.6/5 from 274 reviews, checked Sep 11, 2026

Keeps specializes in hair loss treatment for men, offering FDA-approved finasteride and minoxidil at affordable prices. Known for their focused approach to preventing and treating male pattern baldness.

Rating9/10
Free ConsultationYes
Free ShippingYes
HSA/FSAYes
Founded2018
HQNew York, NY

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

Read 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 Keeps and Hello Cake
FeatureKeepsKeepsHello CakeHello Cake
Rating9/108.8/10
Founded20182018
Free ConsultationYesNo
Free ShippingYesYes
Accepts InsuranceNoNo
HSA/FSA AcceptedYesNo
Mobile AppNoNo
Consultation TypeAsynchronousOnline questionnaire
Shipping Time3-5 business days3-5 business days

Pricing Comparison

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

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

Pros and Cons

Keeps

Pros

  • Most affordable hair loss treatment
  • Specialized hair loss expertise
  • Free online consultations
  • Doctor photo reviews available
  • Simple, focused approach

Cons

  • Limited treatment categories
  • No mobile app
  • Does not accept insurance
  • Only men's hair loss focus
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?

KeepsChoose Keeps if you:
  • Men specifically seeking hair loss treatment
  • Budget-conscious patients
  • Those wanting a specialist provider
  • First-time hair loss treatment users
Read Our Keeps Review
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 keeps 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

Keeps vs Hello Cake: Complete Comparison Guide

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

Table of Contents

Hello Cake and Keeps both specialize in erectile dysfunction treatment through generic sildenafil and tadalafil access, but differ substantially in clinical oversight and platform maturity. Hello Cake operates as a minimal-touchpoint medication access service with nurse practitioner/physician assistant reviews, while Keeps provides board-certified physician-supervised care within the established Thirty Madison telehealth portfolio. Both offer identical generic medications at similar budget-conscious pricing ($40-80 annual cost difference), but diverge significantly on provider credentials, consultation depth, and long-term reliability. This comparison examines which ED specialist delivers superior value for budget-focused men seeking reliable erectile dysfunction treatment.

Platform Overview & Treatment Focus

Hello Cake operates as a discrete sexual wellness brand focused exclusively on erectile dysfunction medication access through minimal clinical touchpoints. The platform offers generic sildenafil and tadalafil exclusively via brief asynchronous questionnaires reviewed by state-licensed providers, targeting men seeking straightforward prescription access without full consultation or ongoing medical relationships. Founded relatively recently (2-3 years of history), Hello Cake emphasizes privacy, rapid fulfillment, and budget-friendly cash-pay pricing.
Keeps positions itself as an erectile dysfunction specialist operating within the broader Thirty Madison family of condition-specific telehealth brands. The ED service provides generic sildenafil and tadalafil through both asynchronous questionnaires and physician-messaging support, emphasizing clinically-guided treatment with board-certified physicians overseeing all prescriptions. With approximately 5 years of history and substantial brand recognition in men's health telehealth, Keeps maintains extensive provider oversight and established fulfillment infrastructure.
The fundamental distinction centers on clinical depth: Hello Cake operates as a transaction-focused medication access point with minimal provider engagement, while Keeps provides physician-supervised ED treatment with ongoing messaging access, clinical guidance for dosage optimization, and integration within a medically-validated brand family. This comparison examines whether Hello Cake's streamlined simplicity offers advantages over Keeps' clinically-supported specialist approach for erectile dysfunction management, 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 tablet formulations. The platform offers 30-day or 90-day supply options dispensed through partner pharmacy networks. No brand-name Viagra or Cialis available, no compound formulations, no specialty dosing protocols (such as daily low-dose tadalafil for continuous readiness), and no alternative delivery methods beyond standard tablets. Treatment selection based solely on brief questionnaire responses without detailed provider consultation or personalized dosing recommendations.
Keeps offers identical generic medication range: sildenafil 25mg-100mg tablets and tadalafil 5mg-20mg tablets, also limited to conventional oral formulations without compound alternatives or specialty options. The platform similarly provides 30-day and 90-day supply options. Like Hello Cake, Keeps does not offer brand-name medications, custom compound formulations, or alternative delivery methods. Both platforms provide FDA-approved generic PDE5 inhibitors following standard prescribing protocols.
Clinical efficacy for both platforms rests on identical medication foundations: generic sildenafil and tadalafil demonstrate 70-85% response rates in men with erectile dysfunction across diverse etiologies, per systematic reviews in the Journal of Sexual Medicine. The FDA-approved medications available through both services provide equivalent therapeutic potential when dosed appropriately. Neither platform offers treatment advantages through formulary differentiation - both provide standard generic options without enhanced customization.
The treatment options comparison reveals essential parity: Hello Cake and Keeps offer functionally identical medication access for erectile dysfunction. Patients requiring specialty formulations, compound preparations, daily dosing protocols, or brand-name medications must seek alternative platforms (such as hims, Ro, or Strut) providing expanded formularies. For standard generic sildenafil/tadalafil access, neither Hello Cake nor Keeps provides formulary-based competitive advantage, according to FDA prescribing information, according to FDA prescribing information, according to NIH StatPearls - PDE5 Inhibitors.

Medical Consultation & Provider Oversight

Hello Cake conducts erectile dysfunction evaluations exclusively through brief asynchronous questionnaires reviewed by state-licensed providers, typically nurse practitioners or physician assistants. The questionnaire collects basic medical history, cardiovascular risk screening, current medications for interaction assessment, and ED severity using standardized tools. Provider review occurs within 24-48 hours, resulting in prescription approval or brief rejection without detailed explanation. No synchronous consultations available, no video visits offered, and limited provider messaging for follow-up questions. Clinical relationship terminates after initial prescription; refills require new questionnaire submissions without continuity.
Keeps provides erectile dysfunction evaluations through asynchronous questionnaires reviewed by board-certified physicians (MD/DO), distinguishing physician oversight from advanced practice provider models. The questionnaire covers thorough medical history, cardiovascular assessment, medication interactions, and treatment preferences with greater clinical depth than minimal screening approaches. Provider messaging available for follow-up questions, dosage adjustments, side effect management, or treatment optimization without requiring detailed re-evaluation. Physicians provide ongoing oversight with established care continuity supporting long-term ED management.
Clinical evaluation quality depends substantially on provider credentials and consultation depth. Erectile dysfunction requires careful assessment of cardiovascular health (PDE5 inhibitors contraindicated with nitrates and risky in unstable cardiac disease), medication interactions affecting safety or efficacy, underlying conditions influencing treatment selection, and psychological factors potentially benefiting from counseling referral. Brief questionnaires provide contraindication screening but may miss nuanced presentations.
Keeps' physician oversight model provides meaningful advantages: board-certified physicians bring training exceeding nurse practitioner scope for complex presentations, physician messaging enables ongoing clinical relationship supporting treatment optimization, and continuity of care prevents dangerous gaps when medical needs evolve. Hello Cake's minimal provider interaction suits uncomplicated presentations but constrains clinical support for patients experiencing suboptimal response or developing complications requiring dosage adjustment or medication switching.

Pricing Comparison & Cost Analysis

Hello Cake pricing (January 2026, verified from current public rates): Generic sildenafil 20mg-50mg tablets $15-30/month for 30-day supply (price varies by dosage and quantity), higher dosages (100mg) approximately $35-40/month. Generic tadalafil 5mg-10mg approximately $30-45/month, higher dosages (20mg) $55-70/month depending on quantity. Promotional campaigns frequently offer first-month discounts ($10-20 for initial orders). No membership fees or subscription requirements; patients pay per prescription fill with optional auto-refill. Insurance not accepted; all pricing cash-pay only.
Keeps erectile dysfunction pricing: Generic sildenafil starting at $20-25/month for 25mg-50mg tablets (typically 4-8 tablet monthly supply based on usage frequency), higher dosages approximately $35-45/month. Generic tadalafil starting at $40-50/month for 5mg-10mg tablets, higher strength 20mg tablets approximately $60-75/month. No membership fees required for ED service access. Pricing structured for flexibility across different usage frequencies. Insurance not accepted; cash-pay only pricing model.
When comparing equivalent generic medications at comparable dosages, Hello Cake maintains marginal pricing advantage of approximately $5-10/month ($60-120 annually) for standard sildenafil and similar narrow advantage for tadalafil. However, pricing differences narrow when accounting for promotional variability, quantity discounts, and supply duration. Both platforms operate in similar budget-conscious pricing tiers below premium telehealth services (hims, Ro, Strut) but without ultra-budget pricing of newer startups.
Annual cost comparison for standard on-demand erectile dysfunction treatment (50mg sildenafil, 8 tablets monthly): Hello Cake approximately $240-320/year, Keeps approximately $280-360/year. The $40-80 annual difference represents modest savings insufficient to justify platform selection without considering service quality factors: provider credentials (Hello Cake's NP/PA versus Keeps' board-certified physicians), consultation depth, ongoing messaging access, and reliability. For budget-sensitive patients, the cost difference merits consideration; for most men, service quality differences outweigh marginal pricing distinctions, according to FDA prescribing information, according to FDA prescribing information.

Platform Experience & Customer Support

Hello Cake provides mobile-optimized website with streamlined three-step process: health questionnaire → provider review → pharmacy fulfillment. The platform employs minimalist design prioritizing rapid transaction completion over full education or clinical resources. No mobile app; all interactions occur through responsive web interface. Account dashboard shows basic order history and refill scheduling. Customer support operates via email and limited-hours chat with typical response times 12-24 hours for non-urgent inquiries. Educational content minimal beyond basic medication information and dosing instructions.
Keeps offers mobile app (iOS/Android) and web platform providing integrated prescription management, provider messaging within the same interface, and broad educational content about erectile dysfunction causes, treatment options, and lifestyle factors. The platform includes progress tracking, refill reminders with flexible scheduling, and integrated customer support. Support operates via phone, email, and chat with extended availability and faster response times (typically 4-8 hours) compared to Hello Cake's email-dependent model.
Prescription fulfillment timelines similar for both platforms: Hello Cake delivers 5-7 business days after approval, Keeps delivers 5-7 days with occasional faster fulfillment depending on location and pharmacy capacity. Both use discrete packaging without external identification of contents. Neither platform offers expedited shipping for urgent needs, distinguishing from full-service competitors providing next-day delivery options.
The platform experience advantage favors Keeps moderately: mobile app convenience, responsive customer support, extensive educational resources, and provider messaging access create superior user experience for patients valuing clinical engagement and ongoing support. Hello Cake's minimalist approach suits patients preferring transactional simplicity without platform engagement, but the bare-bones experience may frustrate users encountering questions, side effects, or treatment optimization needs requiring responsive support.

Platform Maturity & Long-Term Viability

Hello Cake operates with approximately 2-3 years of history, limited public disclosure of patient volume or business metrics, and minimal third-party validation of service quality. The company maintains sparse online presence beyond core e-commerce infrastructure, with limited transparency regarding provider network credentials, pharmacy partnerships, or regulatory compliance documentation. No published patient outcomes data or satisfaction metrics available for independent verification. Financial backing and ownership structure unclear from public information.
Keeps benefits from approximately 5 years of history as part of the Thirty Madison family of condition-specific telehealth brands, which operate across multiple health categories. The parent company has raised substantial venture capital funding (disclosed in financial press), operates proprietary pharmacy infrastructure, and maintains wide-ranging regulatory compliance for multi-state telehealth operations. Brand recognition substantial through direct-to-consumer marketing and media coverage of the Thirty Madison portfolio.
Reliability considerations carry particular weight for chronic erectile dysfunction treatment requiring years-long continuous medication access. Platform stability ensures prescription continuity, provider network sustainability supports ongoing care relationships, pharmacy partnerships guarantee medication supply chain resilience, and financial viability prevents service disruption from business failure. Treatment adherence depends critically on reliable refill access; unexpected service disruptions necessitate emergency provider transitions causing potentially dangerous medication gaps.
Keeps' established scale, integration within financially-backed parent company, and multi-year track record provide substantially greater confidence in long-term platform viability compared to Hello Cake's minimal history and unclear sustainability trajectory. While Hello Cake may offer short-term cost savings ($40-80 annually), patients requiring multi-year treatment should weigh platform continuity risks against modest pricing advantages. Business failure risk higher for standalone startups versus established brands within diversified portfolio companies.

How We Compared Keeps vs Hello Cake

Our Comparison Methodology

This comparison provides evidence-based analysis of Hello Cake and Keeps for erectile dysfunction treatment based on comprehensive evaluation of clinical quality, medication access, cost efficiency, and platform reliability.

Clinical Evidence: Treatment effectiveness analysis reflects FDA-approved prescribing information for sildenafil (Viagra label) and tadalafil (Cialis label), American Urological Association clinical guidelines for ED management (AUA ED guidelines), and established 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. Pricing subject to change; patients should verify current rates during enrollment.

Service Verification: Platform feature comparisons based on direct evaluation of both services' consultation processes, provider credential verification through state medical board databases, prescription fulfillment workflows, and customer support responsiveness. History claims verified through company disclosures, parent company investor relations materials (for Keeps/Thirty Madison), and third-party media reporting.

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 telehealth services matching their clinical needs, budget constraints, and preferences for provider engagement. All medical claims cited to authoritative sources; treatment decisions should involve consultation with qualified healthcare providers assessing individual circumstances.

Final Verdict: Keeps vs Hello Cake

Choose Hello Cake if: You need the absolute lowest cost generic sildenafil or tadalafil access ($40-80 annual savings versus Keeps), have uncomplicated erectile dysfunction unlikely to require provider consultation beyond initial prescription, and prioritize transactional efficiency over clinical relationship depth. Best for budget-sensitive patients with straightforward presentations confident that minimal provider interaction will suffice for successful treatment.

Choose Keeps if: You value board-certified physician oversight versus nurse practitioner/physician assistant care models, want ongoing provider messaging access for treatment optimization and dosage adjustment, prefer established platform with track record and financial stability, or appreciate full customer support and mobile app convenience. The modest pricing premium ($40-80 annually) provides meaningful value through superior clinical oversight and platform reliability.

Bottom line: Hello Cake and Keeps offer functionally identical generic erectile dysfunction medications at similar budget-conscious price points, differentiating primarily on clinical support quality and platform maturity. Hello Cake serves extreme budget minimalists accepting bare-bones service for marginal cost savings, while Keeps delivers physician-supervised specialist care with established reliability justifying modest premium. For most men seeking erectile dysfunction treatment, Keeps' superior provider credentials, ongoing messaging access, and proven platform stability provide better value than Hello Cake's minimal clinical depth despite narrow cost advantage. Unless severe budget constraints dictate decisions, Keeps offers more strong solution for reliable long-term ED management.

Read Our Keeps ReviewRead 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

HimsVSKeepsHimsVSHello CakeHersVSKeepsRoVSKeepsRoVSHello 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
Strut displays LegitScript certificate 11142478, checked September 19, 2026Cert. 11142478September 19, 2026
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
Taurus Meds displays LegitScript certificate 44265708, checked September 19, 2026Cert. 44265708September 19, 2026
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

Keeps Review

Brand Review

Hello Cake Review

Brand Review

Is Keeps Legit?

Brand Review

Is Hello Cake Legit?

Guide

Keeps Alternatives

Guide

Hello Cake Alternatives

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