Enforcement: what FDA, the FTC and the Justice Department have done
The rules matter in practice through enforcement. Three federal bodies are involved, each with a different job. Here are the cases, in the regulators' own words.
Three federal bodies enforce the law around peptides. FDA decides whether a product is an unapproved drug and sends warning letters. The Federal Trade Commission polices advertising and billing. The Justice Department prosecutes, usually on referral from FDA's criminal investigators. A warning letter is a notice, not a finding of guilt; an FTC complaint is an allegation until resolved; a guilty plea or verdict is a conviction. This page keeps those apart.
FDA: "research use only" is not a defence
FDA's position, repeated in letters since at least December 2024, is that a "research use only" label does not decide what a product is. The agency looks at how it is sold. In its letter of 24 August 2026 to Peak Performance Peptides, FDA wrote that "despite statements on your product labeling marketing your products for" research use only and "not for human consumption", "evidence obtained from your website establishes that your products are intended to be drugs for human use." The letter relies on the definition of intended use in 21 CFR 201.128 and cites sections 301(d) and 505(a) of the Act, which bar selling unapproved new drugs.
The same letter treats bacteriostatic water as part of the case: the firm marketed it "as a solvent for reconstituting your products", which provides "the means to prepare an injectable drug for human administration." Recipients have 15 business days to respond.
| Date | Recipient | Products named | FDA's charge |
|---|---|---|---|
| 10 Dec 2024 | Summit Research Peptides | Retatrutide described as a triple agonist | Unapproved new drug |
| 26 Feb 2025 | USApeptide.com | Multiple peptides labelled research use only | Unapproved new drugs |
| 31 Mar 2026 | Gram Peptides | Retatrutide, tirzepatide | Unapproved new drugs |
| 17 Jun 2026 | Wholesale Peptide | Gonadorelin and other products | Unapproved new drugs |
| 24 Aug 2026 | Peak Performance Peptides | Retatrutide ("GLP-3R"), semaglutide, SS-31, PT-141, tesamorelin, bacteriostatic water | Unapproved new drugs |
FDA has also issued a large number of letters to telehealth companies over compounded GLP-1 advertising, starting with its 9 September 2025 campaign. Those are covered on the GLP-1 compounding policy page. Undark, reviewing FDA's database in early 2026, reported that the agency appeared to have taken few steps against pharmacies still selling BPC-157. An HHS spokesperson told Undark that FDA would not comment on its enforcement policies for unapproved peptides.
FTC: the NextMed case
The FTC's main action in this area concerned GLP-1 weight-loss programmes rather than research peptides. On 14 July 2025 it announced charges against Southern Health Solutions, trading as NextMed, and its founders. The complaint alleged that advertised monthly fees of about $138 or $188 did not clearly cover the drug, lab work or consultation; that claims of average losses of 53 pounds and 23% of body weight were unsubstantiated; that before-and-after photos and testimonials came from people who were not customers; and that negative reviews were suppressed. Christopher Mufarrige, director of the FTC's Bureau of Consumer Protection, said: "Consumers who signed up for NextMed's programs faced significant unexpected costs." NextMed and its founders agreed to settle, paying $150,000 for consumer refunds. The FTC approved the final order in December 2025.
Justice Department: prosecutions
Paradigm Peptides (Northern District of Indiana). The most significant recent case. Matthew Kawa, 48, of Grant Park, Illinois, pleaded guilty to introducing unapproved drugs into interstate commerce with intent to defraud or mislead, and to illegally importing merchandise. Local reporting on 3 August 2026 said U.S. District Judge Cristal C. Brisco sentenced him to 70 months in prison and ordered forfeiture of $5 million. A co-defendant, Jennifer Stechkober, 32, received 16 months. Prosecutors said the business sold peptides, SARMs and other unapproved drugs while claiming they were "FDA-approved and manufactured in the United States", and that Kawa received FDA warning letters in 2020 and 2022 and kept selling.
Earlier cases. In the Western District of Pennsylvania, Adam F. Higdon of Palatine, Illinois, pleaded guilty in 2013 to mail fraud, misbranding and money laundering after selling peptides through websites that falsely said products were "for research use only" and "not for human consumption"; he was later sentenced to probation and community service. The pattern of the research label as cover runs through federal cases for more than a decade.
What enforcement does not cover
None of these actions concerns a licensed pharmacy compounding a peptide on prescription. FDA's warning letters on compounded peptides have been rare, and the agency has not said publicly how it treats the 12 peptides it removed from Category 2 in April 2026 while it decides on them. The Category 2 page sets out what the law firms advising pharmacies have said about that gap. At state level, Ohio's pharmacy board has acted directly against clinics holding research-labelled drugs; see state laws.
Supporters of wider compounding, including Secretary Kennedy and Rep. Harshbarger, argue that the research-label market these cases target is the reason to let pharmacies supply peptides. Critics argue the opposite: that listing unproven substances lends them legitimacy. Both arguments are on the Kennedy page.
Rules change faster than most people's records. If you are on a prescribed peptide, the dose log keeps each dose with the product, the pharmacy and the concentration, and bloodwork sits on the same timeline, so a change of product or source is easier to plan with your prescriber. The peptide library grades how much research exists behind each compound, and that grading does not move when a committee votes. The app is on iOS and Android.
Questions people ask
Is it legal to sell peptides labelled research use only?
FDA's position is that the label does not matter if the seller's website shows the products are intended for human use. In that case it treats them as unapproved new drugs and has sent warning letters on that basis, most recently in August 2026.
What happened in the Paradigm Peptides case?
Owner Matthew Kawa pleaded guilty to selling unapproved drugs with intent to defraud or mislead and to illegal importation. Reporting on 3 August 2026 said he was sentenced to 70 months in prison and ordered to forfeit $5 million.
Has the FTC acted on GLP-1 marketing?
Yes. In July 2025 it charged telehealth firm NextMed over hidden costs, unsupported weight-loss claims and fake reviews. NextMed settled for $150,000 in refunds, and the final order was approved in December 2025.
Does a warning letter mean a company broke the law?
Not as a legal finding. It is FDA's notice of what it considers significant violations, with 15 business days to respond. Prosecution or court action can follow if violations continue.
Sources
- Warning letter: Peak Performance Peptides (735127), U.S. Food and Drug Administration, 24 August 2026
- Warning letter: Gram Peptides (721806), U.S. Food and Drug Administration, 31 March 2026
- Warning letter: Wholesale Peptide (729447), U.S. Food and Drug Administration, 17 June 2026
- Warning letter: USApeptide.com (696885), U.S. Food and Drug Administration, 26 February 2025
- Warning letter: Summit Research Peptides (695607), U.S. Food and Drug Administration, 10 December 2024
- FTC takes action against telemedicine firm NextMed over charges it used misleading prices, fake reviews, and deceptive weight loss claims, Federal Trade Commission, 14 July 2025
- FTC approves final order against telehealth provider NextMed, Federal Trade Commission, December 2025
- U.S. v. Matthew Kawa et al., U.S. Attorney's Office, Northern District of Indiana
- Illinois man, Indiana woman sentenced in federal illegal drug sales case, 95.3 MNC, 3 August 2026
- Illinois man illegally purchased and sold peptides, U.S. Attorney's Office, Western District of Pennsylvania
- BPC-157: a MAHA-adjacent peptide, linked to Croatia, Undark, co-published with STAT, 3 February 2026
- FDA launches crackdown on deceptive drug advertising, U.S. Food and Drug Administration, 9 September 2025
