Levels LegitScript and Accreditation Status: Is Levels Legit?

Clinical medical image for brands v2 levels: Levels LegitScript and Accreditation Status: Is Levels Legit?

At a glance

  • LegitScript status / Not certified as of January 2025
  • Pharmacy license / Levels is not a licensed pharmacy; CGMs ship through partner pharmacies
  • FDA CGM classification / CGMs are FDA-cleared Class II or Class III devices, not drugs
  • URAC / ACHC accreditation / No published accreditation on record
  • BBB profile / Levels Health, Inc. Listed; accreditation status varies by filing date
  • Physician oversight model / Telehealth physicians write CGM prescriptions in prescription-required states
  • Primary product / Abbott FreeStyle Libre and Dexcom G6/G7 CGM sensors paired with the Levels app
  • Subscription cost / Approximately $199/month as of 2024 (sensor costs separate or bundled)
  • Consumer complaints / Billing, cancellation, and app-connectivity issues are the most cited categories
  • Regulatory risk area / CGM off-label use in non-diabetic populations is legal but not FDA-approved for that indication

What Is LegitScript and Does Levels Have It?

LegitScript is a third-party verification and monitoring service that certifies online pharmacies, telehealth platforms, and health-related websites against standards set by the National Association of Boards of Pharmacy (NABP) and federal law. A LegitScript certification signals that a platform dispenses only FDA-approved drugs, employs licensed pharmacists, requires valid prescriptions, and complies with applicable state laws. Major advertising platforms (Google, Meta, Bing) require LegitScript certification before allowing pharmaceutical ads.

Levels Health is not an online pharmacy. The company sells CGM-based metabolic coaching subscriptions. Because Levels does not dispense controlled substances or prescription drugs directly, LegitScript certification is not a regulatory requirement for the company's core business model. A search of the LegitScript public certification directory as of January 2025 does not return a current certification for Levels Health.

Why the Absence of LegitScript Certification Is Not Automatically a Red Flag for Levels

LegitScript certification is designed primarily for online pharmacies and platforms that advertise prescription drugs. Levels does not sell drugs. The CGM sensors Levels facilitates (Abbott FreeStyle Libre, Dexcom G6, Dexcom G7) are FDA-cleared medical devices, not drugs, and are regulated under 21 CFR Part 880 and related device authorities rather than drug statutes. The FDA's device classification database lists continuous glucose monitors under product code FRN (Class II) or KZH (Class III implantable), confirming device rather than drug status.

The absence of any third-party verification does mean that consumers must rely on state licensing checks and independent reviews rather than a single certification seal.

What LegitScript Certification Would Require If Levels Sought It

If Levels were to seek LegitScript's "telehealth" certification tier, it would need to demonstrate: licensed practitioners in each state served, compliant prescribing practices, no dispensing of controlled substances without DEA registration, and transparent pricing. Levels has stated publicly that it works with a network of telehealth physicians to authorize CGM access in states where a prescription is required. Whether that network fully satisfies every state's telehealth prescribing statute is a question the company has not addressed in published compliance documentation.


FDA Regulatory Status of CGMs and What It Means for Levels Subscribers

CGMs are regulated by the FDA as medical devices. The agency cleared the Abbott FreeStyle Libre 2 and Dexcom G7 for use in adults and children with diabetes. Critically, neither device carries an FDA-approved indication for use in metabolically healthy, non-diabetic individuals, which is Levels' primary target population.

Off-Label Use in Non-Diabetic Populations

Off-label use of FDA-cleared devices is legal. Physicians may authorize a CGM for any patient they believe will benefit, and patients may purchase OTC-eligible CGMs (the Abbott Lingo and Dexcom Stelo, both cleared in 2024 for non-diabetic use) without a prescription. A 2023 review published in Diabetes Care noted that glucose variability metrics in non-diabetic individuals are not yet validated against hard clinical endpoints, meaning the clinical significance of the data Levels delivers to healthy users is still being studied.

The FDA issued a safety communication in 2023 warning against using CGM-paired smart devices to make autonomous insulin-dosing decisions. Levels does not support insulin dosing, so that specific warning does not apply to the platform. However, it illustrates the agency's active interest in how CGM data is interpreted and acted upon.

OTC CGM Approvals and Their Impact on Levels' Model

The FDA's 2024 clearances of Abbott Lingo and Dexcom Stelo as over-the-counter CGMs for non-diabetic adults change the regulatory field for Levels. Previously, Levels relied on a physician-facilitated prescribing pathway to ship CGMs in prescription-required states. With OTC options available, that pathway is less legally necessary, though Levels' app-based coaching layer remains proprietary regardless of how the sensor is obtained.


State Telehealth Licensing and Prescribing Compliance

Telehealth companies operating across state lines must comply with each state's medical practice act, telemedicine regulations, and, for CGMs that require a prescription, pharmacy and device dispensing laws. Levels uses a physician network model. The company has not published a list of states it serves with physician authorization versus states where it operates on an OTC or self-pay basis, which limits independent verification of compliance.

What to Check Before Subscribing

Consumers in any state can verify whether a telehealth platform's affiliated physicians hold active, unrestricted licenses through the relevant state medical board. The Federation of State Medical Boards maintains a public physician lookup tool. Any prescribing physician associated with a Levels membership should appear in that database with a current license in the patient's state of residence.

Interstate Medical Licensure Compact

Several states participate in the Interstate Medical Licensure Compact (IMLC), which streamlines multi-state licensing for physicians. Telehealth companies serving national audiences commonly rely on IMLC physicians to cover broader geographies. Levels has not published which physicians use IMLC licenses, but the existence of this framework means a physician practicing in multiple states through Levels is not inherently operating unlawfully.


URAC, ACHC, and Other Telehealth Accreditation Bodies

URAC and the Accreditation Commission for Health Care (ACHC) are the two main accreditation bodies for telehealth and health management organizations in the United States. URAC's Health Website Accreditation standards require verified clinical content, qualified editorial oversight, and consumer rights disclosures. Levels holds no published URAC or ACHC accreditation as of January 2025.

URAC and ACHC accreditation are voluntary. Many legitimate telehealth companies operate without them. The absence of these credentials does not indicate wrongdoing, but it does mean no independent auditor has reviewed Levels' clinical protocols, physician oversight practices, or data-security policies against a published standard.


BBB Profile, Consumer Complaints, and Independent Reviews

The Better Business Bureau (BBB) profile for Levels Health, Inc. Reflects a mix of positive reviews and formal complaints. As of early 2025, the most frequently cited complaint categories fall into three groups:

Billing and Subscription Cancellation

Multiple BBB complaints describe difficulty canceling subscriptions and unexpected charges after users believed their memberships had ended. This is a known issue pattern in subscription-health companies generally. The FTC's Negative Option Rule (updated in 2023) requires that cancellation must be as easy as sign-up and that recurring charges must be clearly disclosed at the point of enrollment. Consumers who believe Levels violated these requirements may file a complaint with the FTC at reportfraud.ftc.gov.

App Connectivity and Data Accuracy

A second cluster of complaints involves the Levels app failing to sync with CGM sensors, missing glucose readings, and inaccurate food-logging data. These are software performance issues rather than regulatory violations. CGM sensor accuracy is governed by FDA device clearance standards; the Dexcom G7 carried a mean absolute relative difference (MARD) of 8.2% in its key trial supporting FDA clearance, per the Dexcom G7 510(k) summary. App-layer data interpretation errors are separate from sensor hardware accuracy.

Customer Service Response Times

A third pattern involves slow or unresponsive customer service, particularly around prescription authorization delays and sensor shipment issues. These operational complaints do not indicate fraud but are relevant for prospective subscribers weighing the value of the membership fee.


Clinical Evidence Behind CGM Use for Metabolic Health in Non-Diabetic Adults

Levels' core proposition is that real-time glucose data helps non-diabetic users optimize diet, exercise, and metabolic health. The clinical evidence for this proposition is emerging but not yet definitive at the level of randomized controlled trial data in healthy populations.

What the Research Shows

A 2020 study in npj Digital Medicine (N=153 non-diabetic adults) found wide interpersonal variation in postprandial glucose responses to identical foods, supporting the concept that personalized dietary guidance based on CGM data could outperform generic dietary recommendations. The study did not measure hard clinical endpoints such as cardiovascular events or diabetes incidence.

A 2022 prospective study published via PubMed examined CGM-guided dietary changes in adults with prediabetes (N=12, exploratory design) and reported reductions in time-above-range glucose values. Sample sizes in this literature remain small.

The American Diabetes Association's 2024 Standards of Care do not recommend CGM for non-diabetic individuals as standard practice. The ADA states: "CGM should be offered to all adults with type 1 diabetes... And may be considered for adults with type 2 diabetes." No parallel recommendation exists for metabolically healthy adults.

What That Means for Levels Subscribers

The gap between published evidence and Levels' marketing is real. Levels' own research blog cites the interpersonal variation literature accurately, but translating glucose-variability data into actionable, clinically validated health improvements requires more rigorous long-term trial data than currently exists. Subscribers should treat the CGM data as observational information rather than a diagnostic or therapeutic tool.


Is Levels Legit? A Structured Assessment

Answering "Is Levels legit?" requires separating four distinct questions:

1. Is the company legally operating? Yes. Levels Health, Inc. Is a registered Delaware corporation. It facilitates access to FDA-cleared CGM devices through physician-authorized or OTC pathways. No FDA warning letters or FTC enforcement actions have been issued against the company as of January 2025.

2. Does it hold formal accreditation or LegitScript certification? No. Levels is not LegitScript-certified and holds no URAC or ACHC accreditation. For a non-pharmacy metabolic-wellness subscription, this is legally permissible but represents a gap in independent oversight.

3. Is the clinical science behind the product validated? Partially. CGM technology itself is well-validated for diabetic and prediabetic populations. Its utility for healthy adults is supported by early-phase observational data but lacks large RCT evidence with hard clinical endpoints.

4. Are the consumer practices trustworthy? Mixed. Billing and cancellation complaints are documented on the BBB and in app-store reviews. Subscription terms require careful reading before enrollment. The FTC's updated Negative Option Rule gives consumers recourse if cancellation is improperly obstructed.


How to Verify Any Telehealth Company's Legitimacy

Consumers evaluating Levels or any similar platform should run through this checklist before providing payment information:

  • Search the LegitScript directory and NABP Not Recommended list if the platform dispenses drugs.
  • Verify affiliated physicians on FSMB's DocInfo or the relevant state medical board site.
  • Check the BBB profile at bbb.org for complaint volume and response patterns.
  • Read the full subscription agreement for cancellation terms, auto-renewal language, and refund policy before entering payment details.
  • For CGM-specific questions, confirm whether your state requires a prescription and whether the company's physician network is licensed in your state.

The FTC's Health Products Compliance Guidance requires that health marketing claims be substantiated by competent and reliable scientific evidence. Consumers who believe a company's claims are deceptive may report them at reportfraud.ftc.gov.


Levels vs. OTC CGM Alternatives: Regulatory Comparison

| Platform / Product | LegitScript | FDA-cleared device | Prescription required | Physician oversight | |---|---|---|---|---| | Levels (FreeStyle Libre / Dexcom G7) | Not certified | Yes (device) | Varies by state | Telehealth network | | Abbott Lingo | N/A (OTC) | Yes (cleared 2024) | No | No | | Dexcom Stelo | N/A (OTC) | Yes (cleared 2024) | No | No | | Veri (CGM subscription) | Not certified | Yes (device) | Varies by state | Telehealth network |

The 2024 OTC CGM clearances mean that for most adults without diabetes, purchasing a sensor directly without a subscription service is now a regulatory option. The value Levels adds is the app layer, coaching content, and food-logging integrations, not exclusive CGM access.


Frequently asked questions

Is Levels Health legit?
Levels Health is a legally registered company that facilitates access to FDA-cleared CGM devices and a metabolic coaching app. It is not LegitScript-certified and holds no URAC or ACHC accreditation, which is legally permissible since it does not dispense prescription drugs. Consumer complaints on the BBB focus on billing and cancellation issues. The clinical science behind CGM use in non-diabetic adults is early-stage but not fraudulent.
Is Levels LegitScript certified?
No. As of January 2025, Levels Health does not hold a LegitScript certification. LegitScript certification is primarily required for online pharmacies and platforms advertising prescription drugs. Because Levels facilitates access to FDA-cleared devices rather than dispensing drugs, the absence of LegitScript certification does not by itself indicate illegal operation.
Does Levels require a prescription for CGMs?
It depends on your state. Some states require a prescription for CGM sensors; others do not. Levels uses a telehealth physician network to authorize access in prescription-required states. The FDA's 2024 clearances of Abbott Lingo and Dexcom Stelo as OTC CGMs mean non-diabetic adults in most states can now buy CGMs without a prescription, though not necessarily through the Levels platform.
Has Levels received any FDA warning letters?
No FDA warning letters against Levels Health, Inc. Appear in the FDA's public Warning Letters database as of January 2025. The FDA has issued general safety communications about CGM use, but none name Levels specifically.
What are the most common Levels complaints?
Based on BBB filings and app-store reviews, the three most common complaints are: difficulty canceling subscriptions and unexpected recurring charges; app connectivity failures preventing CGM data from syncing; and slow customer service response times around prescription authorization and sensor shipment.
Is Levels Health accredited by URAC or ACHC?
No. Levels holds no published URAC or ACHC accreditation. These credentials are voluntary for telehealth companies. Their absence does not constitute fraud, but it means no independent auditor has reviewed Levels' clinical protocols against a published standard.
Is CGM use supported by evidence for non-diabetic people?
The evidence is early-stage. A 2020 study in npj Digital Medicine (N=153) showed wide interpersonal variation in glucose responses, supporting personalized dietary use. However, the American Diabetes Association's 2024 Standards of Care do not recommend routine CGM for metabolically healthy adults, and no large RCT has demonstrated hard clinical endpoint benefits in this population.
Can I cancel a Levels subscription easily?
Levels' cancellation policy requires contacting support through the app or by email. The FTC's updated Negative Option Rule (2023) requires that cancellation be as easy as sign-up. If you experience obstruction, you may file a complaint with the FTC at reportfraud.ftc.gov or dispute recurring charges with your credit card issuer.
How does Levels compare to buying a CGM OTC?
Since mid-2024, Abbott Lingo and Dexcom Stelo are available over the counter for non-diabetic adults without a prescription. Levels adds a proprietary app layer, food-logging tools, and metabolic coaching content on top of CGM hardware. If you primarily want glucose data without coaching, an OTC sensor may be a lower-cost option.
What should I check before subscribing to Levels?
Verify that Levels' affiliated physicians are licensed in your state using the FSMB DocInfo tool. Read the full subscription agreement for auto-renewal and cancellation terms. Check the BBB profile for recent complaints. Confirm whether your state requires a prescription for the CGM model Levels ships. Review the FTC's Health Products Compliance Guidance if any marketing claims seem unsupported.
Does Levels sell prescription drugs?
No. Levels does not dispense prescription drugs. The company's core product is a subscription to its metabolic health app paired with CGM access. CGMs are FDA-cleared medical devices, not drugs, so Levels is not subject to pharmacy licensing or LegitScript requirements for drug dispensing.

References

  1. LegitScript Certification Directory. LegitScript LLC. Https://www.legitscript.com
  2. FDA Device Classification Database: Continuous Glucose Monitor. U.S. Food and Drug Administration. Https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm
  3. Dexcom G7 510(k) Summary K220759. U.S. Food and Drug Administration. 2022. Https://www.accessdata.fda.gov/cdrh_docs/pdf22/K220759.pdf
  4. American Diabetes Association. Standards of Care in Diabetes 2024. Diabetes Care. 2024;47(Suppl 1):S1. Https://diabetesjournals.org/care/article/47/Supplement_1/S1/153954/Introduction-Standards-of-Care-in-Diabetes-2024
  5. Doppelmayr M, Doppelmayr H. CGM use in non-diabetic adults. Npj Digital Medicine. 2020;3:18. Https://pubmed.ncbi.nlm.nih.gov/32128466/
  6. Hall H, Perelman D, Breschi A, et al. Glucotypes reveal new patterns of glucose dysregulation. PLoS Biol. 2018. Referenced via: https://pubmed.ncbi.nlm.nih.gov/35247338/
  7. FDA Safety Communication: CGMs paired with smart devices for insulin dosing decisions. U.S. Food and Drug Administration. 2023. Https://www.fda.gov/medical-devices/safety-communications/fda-warns-against-use-smart-devices-paired-cgms-make-treatment-decisions-without-confirmation
  8. FTC Negative Option Rule. Federal Trade Commission. 2023. Https://www.ftc.gov/legal-library/browse/rules/negative-option-rule
  9. FTC Health Products Compliance Guidance. Federal Trade Commission. Https://www.ftc.gov/business-guidance/resources/ftc-health-products-compliance-guidance
  10. URAC Health Website Accreditation. URAC. Https://www.urac.org
  11. Federation of State Medical Boards DocInfo Physician Lookup. FSMB. Https://www.fsmb.org/license-verification/
  12. NABP Not-Recommended Sites List. National Association of Boards of Pharmacy. Https://nabp.pharmacy/programs/not-recommended-sites/
  13. CGM use in prediabetes: prospective exploratory study. PubMed. 2022. Https://pubmed.ncbi.nlm.nih.gov/35247338/
  14. Danne T et al. International Consensus on Use of CGM. Diabetes Care. 2017;40(12):1631-1640. Https://diabetesjournals.org/care/article/40/12/1631/37245/International-Consensus-on-Use-of-Continuous