Strut Safety, Regulation & Compliance: What Patients Should Know

What Strut Health Actually Is

Strut Health operates as a direct-to-consumer telehealth platform connecting patients with licensed prescribers who can order compounded medications. The company does not manufacture drugs. Instead, it partners with compounding pharmacies that mix custom formulations, such as topical finasteride-minoxidil combinations for hair loss or tretinoin-niacinamide blends for acne.

This model sits in a specific regulatory gray zone. The FDA permits compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act, which allows licensed pharmacies to prepare patient-specific medications based on valid prescriptions. These compounded products do not go through the standard FDA drug approval process, meaning they lack the same evidence base as commercially manufactured medications [1]. The FDA has stated plainly that compounded drugs "are not FDA-approved" and that the agency "generally does not verify the safety or effectiveness of compounded drugs" [2].

That distinction matters. A patient filling a prescription for branded Propecia (finasteride 1 mg) receives a product backed by Phase III trial data from the Prostate Cancer Prevention Trial and years of post-marketing surveillance. A patient receiving a compounded finasteride-minoxidil topical from Strut's pharmacy partner receives a formulation that has not undergone equivalent independent testing, though its individual active ingredients are well-studied.

Compounding Pharmacy Oversight and 503A Requirements

State-licensed compounding pharmacies operating under Section 503A must meet specific conditions. The prescription must be for an individual patient. The pharmacy cannot compound drugs that are "essentially a copy" of a commercially available product unless that product is on the FDA shortage list. The pharmacy must comply with United States Pharmacopeia (USP) Chapter 795 (nonsterile compounding) or Chapter 797 (sterile compounding) standards [3].

Strut's pharmacy partners are required to hold active state licenses. State boards of pharmacy conduct periodic inspections, though inspection frequency varies. A 2019 Pew Charitable Trusts analysis found that only 16 states required annual inspections of nonsterile compounding facilities, and 7 states had no routine inspection schedule at all [4]. This means the level of oversight a patient receives depends partly on which state's pharmacy fills their prescription.

The FDA can and does take enforcement action against compounding pharmacies that violate 503A conditions. Between 2020 and 2024, the FDA issued over 70 warning letters to compounding pharmacies for violations including using bulk drug substances not on the FDA's approved list and compounding copies of commercially available drugs [5]. Whether Strut's specific pharmacy partners have received such letters requires checking the FDA warning letter database directly.

Telehealth Prescribing: How Strut's Model Works

Strut uses an asynchronous consultation model. Patients complete an online questionnaire, upload photos (for dermatology), and a licensed prescriber reviews the submission. No video or phone visit is required. This is legal in most states under telehealth prescribing regulations that expanded during and after the COVID-19 public health emergency.

The Ryan Haight Act historically required an in-person exam before prescribing controlled substances online [6]. Strut's current formulary does not appear to include Schedule II-V controlled substances, so this federal restriction does not apply to most of its offerings. Finasteride, minoxidil, tretinoin, and sildenafil are not scheduled drugs.

Still, the asynchronous model raises clinical quality questions. The American Medical Association's 2023 telehealth policy guidelines recommend that telehealth encounters establish a "meaningful patient-provider relationship," which the AMA defines as involving bidirectional communication, informed consent, and follow-up availability. A text-based questionnaire can meet that standard, but only if the prescriber is genuinely reviewing each case rather than rubber-stamping templates.

Dr. Jack Resneck Jr., former AMA president, stated in 2023: "The concern isn't telehealth itself. The concern is when the technology becomes a shortcut that replaces clinical judgment with an algorithm and a checkbox." That concern applies broadly to all asynchronous telehealth platforms, not just Strut.

Are Strut's Formulations Safe?

The individual active ingredients in Strut's products have strong safety profiles when used as directed. Topical finasteride (0.1% to 0.25%) has been studied as an alternative to oral finasteride for androgenetic alopecia. A 2022 systematic review published in the Journal of the American Academy of Dermatology analyzed 12 studies (N=1,094 total) and found that topical finasteride reduced serum DHT levels significantly less than oral finasteride while producing comparable hair count improvements at 24 weeks [7].

Topical minoxidil has decades of safety data. The original Olsen et al. trial (N=393) established 5% topical minoxidil as effective for male-pattern hair loss with mild local side effects (scalp irritation in 6% of participants) [8]. Tretinoin's safety profile is similarly well-established through the VATTC trial and subsequent studies spanning over 50 years of clinical use [9].

For erectile dysfunction, sildenafil's safety was demonstrated in the original Goldstein et al. trial (N=532) published in the New England Journal of Medicine, showing efficacy with headache (16%), flushing (10%), and dyspepsia (7%) as the most common adverse effects [10]. Compounded sildenafil troches or sublingual tablets use the same active ingredient but in a different delivery form that has not undergone separate bioequivalence testing through FDA channels.

The gap is not in ingredient safety. It is in formulation consistency. The FDA's concern with compounded drugs has always centered on whether the final product contains the labeled dose, is free from contamination, and maintains stability through its expiration date. A 2017 FDA survey tested 93 compounded drug products and found that 33% failed one or more quality tests, with potency failures being most common [11].

Strut vs. Alternatives: A Regulatory Comparison

Comparing Strut to competitors requires distinguishing between platforms that dispense FDA-approved medications and those that also offer compounded formulations.

Hims, Keeps, and Ro all dispense FDA-approved generic finasteride (oral, 1 mg) and FDA-approved generic minoxidil (topical, 5%) through licensed pharmacies. These products have undergone FDA review for safety, efficacy, and manufacturing quality. Hims also sells compounded topical finasteride-minoxidil sprays, placing part of its business in the same regulatory category as Strut.

Roman (Ro) fills prescriptions through Ro Pharmacy, a state-licensed retail pharmacy that dispenses commercially manufactured generics. This is a different regulatory posture than compounding. Keeps similarly dispenses FDA-approved generics.

The key comparison point: if a patient can obtain an FDA-approved version of the same active ingredient, the Endocrine Society and the FDA both recommend using the commercially approved product over a compounded version unless there is a documented clinical reason for compounding (such as allergy to an inactive ingredient or need for a dose not commercially available) [12].

Strut's value proposition centers on combination formulations. A single topical product containing both finasteride and minoxidil is not commercially available as an FDA-approved product in the United States, so compounding is the only legal route to obtain it. That is a legitimate 503A use case, and it is the strongest regulatory argument in Strut's favor.

Patient Complaint Patterns and Review Analysis

Online reviews of Strut show patterns consistent with other direct-to-consumer telehealth companies. Common positive themes include convenience, lower cost than dermatologist visits, and satisfaction with combination hair loss topicals. Common complaints include difficulty reaching customer service, auto-renewal charges, and delays in prescription processing.

The Better Business Bureau does not show a current accreditation for Strut Health. This is not inherently a red flag. Many legitimate telehealth companies do not pursue BBB accreditation. But it means there is no centralized complaint resolution mechanism through that channel.

State medical board complaints against telehealth prescribers are public in most states but are filed against the individual provider, not the platform. This makes it difficult to assess Strut's aggregate prescriber quality. Patients can verify their assigned prescriber's license status through their state medical board's online lookup tool.

Trustpilot and Reddit threads reveal a recurring concern: patients report feeling that the prescriber did not thoroughly review their medical history before approving a prescription. This aligns with the broader criticism of asynchronous telehealth models. A 2021 JAMA Internal Medicine study of direct-to-consumer telehealth platforms found that 83% of encounters resulted in a prescription being written, compared to approximately 50% of in-person dermatology visits for comparable conditions [13]. That prescribing rate does not prove inadequate care, but it does raise questions about selection bias and diagnostic thoroughness.

Red Flags to Watch and Green Flags to Recognize

Not all compounding telehealth platforms operate with the same rigor. Patients evaluating Strut (or any similar service) should check for specific markers.

Green flags include: the platform names its pharmacy partner(s), the pharmacy holds accreditation from the Pharmacy Compounding Accreditation Board (PCAB), prescribers are identifiable by name and license number, and the platform provides a mechanism for follow-up questions after prescription.

Red flags include: inability to identify the dispensing pharmacy, no option for prescriber follow-up, automatic refills with no clinical reassessment, and marketing claims that compounded drugs are "FDA-approved" or "equivalent to" branded medications.

Strut does identify its prescribers by name on patient accounts. Its pharmacy partners are state-licensed. The company does not appear to make explicit claims of FDA approval for its compounded products. These are appropriate compliance markers.

The FDA's Evolving Stance on Telehealth Compounding

The regulatory environment is shifting. The FDA finalized guidance in 2024 clarifying that it intends to increase enforcement against compounding pharmacies that ship across state lines without meeting Section 503B (outsourcing facility) requirements [14]. Section 503B facilities must register with the FDA, submit to regular FDA inspections, and follow current good manufacturing practices (cGMP). Most 503A pharmacies, including those that Strut partners with, operate under less stringent state-level oversight.

Several states have also introduced legislation to tighten telehealth prescribing standards. Texas SB 1620 (effective September 2025) requires a synchronous component (video or phone) for initial prescriptions of certain medication categories [15]. If more states adopt similar requirements, asynchronous-only platforms like Strut may need to modify their consultation model.

The FDA's 2024 enforcement actions against compounding pharmacies producing semaglutide and tirzepatide copies also signal a broader crackdown. While Strut does not appear to compound GLP-1 receptor agonists, the increased scrutiny on compounding pharmacies overall may result in more frequent inspections of all 503A facilities, which could benefit patient safety across the industry.

What "Legit" Actually Means for a Compounding Telehealth Platform

Strut operates within the current legal framework for compounding telehealth. Its prescribers hold active state licenses. Its pharmacy partners are state-licensed. Its products contain active ingredients with established safety data.

"Legit" does not mean "equivalent to FDA-approved." Patients should understand that compounded medications carry inherent variability in potency, purity, and stability that commercially manufactured drugs do not. The National Association of Boards of Pharmacy (NABP) recommends that patients ask their compounding pharmacy whether it holds PCAB accreditation or has passed a recent state inspection, and Strut patients should do the same.

For patients who want the convenience of a combination topical (finasteride plus minoxidil) that is not commercially available, Strut fills a real gap. For patients who can use commercially available generics, the FDA-approved route offers stronger quality assurance at comparable or lower cost. Generic oral finasteride 1 mg costs approximately $3 to $15 per month through GoodRx-partnered pharmacies, while Strut's hair loss formulations range from $40 to $70 per month.