Enforcement record

The FDA Peptide Crackdown, Dated

2020-2026|Last updated: Aug 24, 2026

The FDA peptide crackdown escalated in waves: warning letters to GLP-1-compound sellers in December 2024, more than 50 letters during September 2025 (most dated September 9), widely reported but unconfirmed accounts of a vendor warehouse raid in June 2025, and criminal sentencing by July 2026. Alongside it ran pharma litigation from Eli Lilly and Novo Nordisk, payment-processor exits per industry coverage, and, in early 2026, the SAFE Drugs Act (H.R. 6509 / S. 3794) targeting compounded and counterfeit weight-loss drugs.

The Enforcement Timeline

  1. Oct 2020

    Early case: Tailor Made Compounding, a Kentucky compounding pharmacy, pleads guilty over distributing unapproved new drugs (2018-2020), with $1,788,906.82 in forfeiture.

    Source: DOJ, U.S. Attorney’s Office, E.D. Kentucky (sentencing press release)
  2. Dec 2, 2020

    FDA issues a warning letter to Rat’s Army, a SARMs and research-compound vendor; the site later ceases operating (FDA’s 2026 debarment order describes operations running through about March 30, 2022).

    Source: FDA warning letter to Rat’s Army (December 2, 2020)
  3. Oct 19, 2023

    Eli Lilly files a U.S. International Trade Commission complaint over tirzepatide (supplemented November 10, 2023); respondents include Strate Labs, which is found in default in May 2024 and receives a cease-and-desist order in early 2025.

    Source: USITC news release on the Lilly tirzepatide complaint (November 2023)
  4. Dec 2024

    FDA issues a wave of warning letters to companies selling GLP-1-class compounds. (Recipients that remain in business are not named in this log.)

    Source: FDA warning letters index (December 2024 wave)
  5. Apr 2025

    Eli Lilly sues telehealth firms and importers over tirzepatide, per press coverage.

    Source: Wilson Sonsini client insight on FDA peptide enforcement and related litigation
  6. May 15, 2025

    The former owner of Rat’s Army, Tyler Jordan Hall, is convicted as defined in the FD&C Act when a Montana federal court accepts his plea of guilty and enters judgment for felony introduction of unapproved drugs into interstate commerce.

    Source: FDA final debarment order for Tyler Jordan Hall, FR doc 2026-01296 (published January 23, 2026)
  7. Jun 2025

    Amino Asylum goes offline overnight amid widely reported but unconfirmed community accounts of a federal enforcement action at its warehouse, described in coverage as possibly the first physical raid on a major peptide vendor.

    Source: Muscle & Brawn report on the June 2025 events (community accounts, unconfirmed)
  8. Aug 2025

    Novo Nordisk sues more than a dozen semaglutide distributors.

    Source: Law360: Novo Nordisk lodges suits over knockoff semaglutide meds
  9. Sep 2025

    FDA issues more than 50 warning letters during September 2025, most dated September 9. (Recipients that remain in business are not named in this log.)

    Source: Wilson Sonsini insight: FDA sends warning letters to more than 50 GLP-1 compounders and manufacturers
  10. Dec 10, 2025

    The owner of Paradigm Peptides, Matthew Kawa, and his sister Jennifer Stechkober plead guilty in federal court, per the DOJ.

    Source: DOJ: United States v. Matthew Kawa (N.D. Indiana)
  11. Jan 23, 2026

    FDA publishes a final order debarring the former owner of Rat’s Army for five years from importing or offering for import any drug into the United States.

    Source: FDA final debarment order for Tyler Jordan Hall, FR doc 2026-01296 (published January 23, 2026)
  12. Jan 27, 2026

    Science.bio announces permanent closure; contemporaneous industry coverage records a commitment to fulfill or refund outstanding orders.

    Source: science.bio (permanent-closure notice)
  13. 2026

    The SAFE Drugs Act (H.R. 6509 / S. 3794) is introduced in the 119th Congress, with provisions on compounding-pharmacy limits, labeling, reporting, and inspections aimed at compounded and counterfeit weight-loss drugs.

    Source: H.R. 6509, 119th Congress (govinfo)
  14. Mar 6, 2026

    Peptide Sciences announces a voluntary shutdown in a brief notice with no refund guidance.

    Source: Peptide Sciences shutdown notice
  15. Jul 1, 2026

    Strate Labs posts a closure notice citing a shifted regulatory landscape and stating pending orders will ship as scheduled or be refunded automatically.

    Source: Strate Labs closure notice (stratelabs.com)
  16. Jul 30, 2026

    Paradigm Peptides sentencing: Kawa receives 70 months in prison, approximately $5 million in forfeiture, and $78,317.52 in restitution owed jointly with his co-defendant; Stechkober receives 16 months.

    Source: DOJ, U.S. Attorney’s Office, N.D. Indiana (sentencing press release)

Warning-letter waves are described in aggregate; this log names only companies that are no longer operating.

What Is the SAFE Drugs Act?

The SAFE Drugs Act is legislation introduced in early 2026 as H.R. 6509 in the House and S. 3794 in the Senate (119th Congress). Its sponsors describe it as a crackdown on risky and fraudulent weight-loss drugs; official descriptions cover limits on compounding pharmacies, labeling requirements, reporting, and inspections. Its introduction marks the enforcement wave moving from agency action and litigation toward statute. This page will be updated as the bills move.

The Crackdown, Vendor by Vendor

Sources