2026-05-15 FDA Warning Letter: Meta Labs Pharmaceuticals, LLC Cited for Dietary Supplement/New Drug/Misbranded
Letter issued · posted to fda.gov .
Subject as published: Dietary Supplement/New Drug/Misbranded
TL;DR
Key takeaway: FDA issued a Warning Letter to Meta Labs Pharmaceuticals, LLC on 2026-05-15 citing: Dietary Supplement/New Drug/Misbranded. Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/meta-labs-pharmaceuticals-llc-725130-05152026
Argus analysis
Meta Labs Pharmaceuticals, LLC (MARCS-CMS 725130) received an FDA Warning Letter dated May 15, 2026 from the Human Foods Program. The letter cites: Dietary Supplement/New Drug/Misbranded. FDA posts Warning Letters to fda.gov after an internal review period; this one was made public on June 2, 2026.
Dietary supplement letters typically cite 21 USC 343(r)(6) (structure-function claims), 21 USC 321(g) (drug-versus-supplement classification), or 21 CFR Part 111 (CGMP for supplements) — the recurring theme is a product marketed with disease-treatment claims that push it out of DSHEA's supplement carve-out and into unapproved-new-drug territory.
FDA Warning Letters typically specify a 15-working-day response window for the recipient to detail corrective actions. Compliance teams at peer companies in the same dietary supplement category commonly use a newly published letter as a prompt to re-check their own procedures against the same citation, and to watch fda.gov for a close-out letter confirming the cited firm's corrective action was accepted — or, absent one, for escalation to import alert, injunction, or product seizure.
Severity context
Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
Regulatory background
Dietary supplement Warning Letters typically cite 21 USC 343(r)(6) (structure-function claims), 21 USC 321(g) (drug-vs-supplement classification), or 21 CFR Part 111 (CGMP for supplements). DSHEA-era boundaries are the recurring theme.
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
WARNING LETTER Meta Labs Pharmaceuticals, LLC MARCS-CMS 725130 — May 15, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Dietary Supplements Drugs Recipient: Recipient Name Bassam T. Khayat Recipient Title Owner Meta Labs Pharmaceuticals, LLC 1009 Mansell Rd Ste J Roswell , GA 30076 United States sam@meta-pharm.com Issuing Office: Human Foods Program United States May 15, 2026 WARNING LETTER CMS # 725130 Dear Mr. Khayat: The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 1009 Mansell Rd Ste J, Roswell, GA 30076 from December 8 through December 18, 2025. Based on inspectional findings and review of the product labels collected during the inspection, as well as review of your website at www.metalabsinc.com, we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov. At the conclusion of the inspection on December 18, 2025, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). To date, we have not received a response from your firm. Unapproved New Drugs FDA reviewed your website at the Internet address www.metalabsinc.com in April of 2026 and has determined that you take orders there for the products Yacon Root Extract, Nattokinase Max, Viral Immune Booster, Arthritis Bursitis Rheumatism, and Respiratory Response. FDA also reviewed product labels for your Diabetic Advantage, Yacon Root Extract, Nattokinase Max, Viral Immune Booster, Arthritis Bursitis Rheumatism, and Respiratory Response following the inspection of your facility from December 8 to December 18, 2025. The claims on your website and product labels establish that these products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. Examples of some of the claims that provide evidence that your products are intended for use as drugs include: From the label of your Diabetic Advantage: “Diabetic Advantage” “Supports: Glucose management . . . …..“Anti-Inflammatory and Pain” From the website from which you sell your Yacon Root Extract (www.metalabsinc.com): “Yacon has a generally high percentage of fructooligosaccharides (FOS) and inulin . . .. The association of FOS and inulin provides a protective effect against colitis. . . . In addition, FOS has important beneficial physiological effects, such as reducing the risk of colon and rectal cancer, reducing cholesterol, triglycerides, and phospholipids in the blood, promotes a better immune response that increases resistance to infections an allergies, improves calcium and magnesium absorption, magn…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- What FDA violations was Meta Labs Pharmaceuticals, LLC cited for?
- The FDA Warning Letter to Meta Labs Pharmaceuticals, LLC (issuing office: Human Foods Program) cites: Dietary Supplement/New Drug/Misbranded. Classification: Dietary supplement.
- When did FDA issue the warning letter to Meta Labs Pharmaceuticals, LLC?
- FDA issued the letter (MARCS-CMS 725130) on 2026-05-15 and posted it publicly on fda.gov on 2026-06-02.
- Is the FDA warning letter to Meta Labs Pharmaceuticals, LLC publicly available?
- Yes. The full verbatim letter is published at fda.gov. Argus HQ links directly to the source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/meta-labs-pharmaceuticals-llc-725130-05152026.
- What does a "critical" severity rating mean for this letter?
- Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). 2026-05-15 FDA Warning Letter: Meta Labs Pharmaceuticals, LLC Cited for Dietary Supplement/New Drug/Misbranded. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-meta-labs-pharmaceuticals-llc-2026-05-15-dietary-supplement
"2026-05-15 FDA Warning Letter: Meta Labs Pharmaceuticals, LLC Cited for Dietary Supplement/New Drug/Misbranded." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-meta-labs-pharmaceuticals-llc-2026-05-15-dietary-supplement.
Argus HQ Research. "2026-05-15 FDA Warning Letter: Meta Labs Pharmaceuticals, LLC Cited for Dietary Supplement/New Drug/Misbranded." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-meta-labs-pharmaceuticals-llc-2026-05-15-dietary-supplement.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_meta_labs_pharmaceuticals_llc_2026_05_15_dietary_supplement_2026,
title = {2026-05-15 FDA Warning Letter: Meta Labs Pharmaceuticals, LLC Cited for Dietary Supplement/New Drug/Misbranded},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-meta-labs-pharmaceuticals-llc-2026-05-15-dietary-supplement},
note = {Accessed: July 13, 2026}
}