Paradigm Peptides' 2020 Warning Letter: FDA and the FTC, One Blog Post, 48 Hours

Updated September 14, 2026

On December 7, 2020, the Food and Drug Administration and the Federal Trade Commission sent a joint warning letter to Paradigm RE LLC of Bourbonnais, Illinois, the company behind paradigmpeptides.com. The letter named one product, Thymosin Alpha 1. Every claim it quoted came from one page: a blog post on the company's own website about COVID-19. It gave the company 48 hours to answer. More than five years later, the owner of Paradigm Peptides was sentenced to 70 months in federal prison. The U.S. Attorney's sentencing statement says he kept selling after letters from FDA in 2020 and 2022. This page is the 2020 letter.

Three things set this letter apart from the others in this index. Two agencies signed it, not one. It asked for an answer in two days, not three weeks. And the spreadsheet export behind FDA's own warning-letter search does not return it, so a vendor check that relies on that export will miss it.

Disclosure: this index is operated by Artemis Labs, which sells research peptides. Neither this letter nor the later case involves us, and no product page is linked from this page. Every quotation on it is verbatim from the documents listed under Sources. The legal descriptions belong to FDA, the FTC and federal prosecutors, not to this index.

Record at a glance

What the two agencies looked at

The letter opens with what was reviewed and when. FDA and the FTC reviewed your website at the Internet address https://paradigmpeptides.com/ on November 24, 2020, and December 1, 2020, respectively. FDA found that the site offered Thymosin Alpha 1 for sale and judged it an unapproved new drug and a misbranded drug.

The evidence is introduced as Some examples of the claims on your website that establish the intended use of your product. All of the examples come from one blog post, and FDA gives its address in brackets at the end. The quoted text starts with the post's title, Thymosin Alpha 1 For Immune Health & COVID-19, and one of its headings asks Can It Help With COVID-19? Under that heading, the post summarized results it said came from hospitals that governments had chosen to handle COVID-19 cases. It ends with a sales line: Don’t let COVID-19 catch you off guard, get your Thymosin Alpha 1 today.

There is no product page in the quoted evidence. The store offered the product, but the claims FDA relied on came from the company's blog.

A blog post, read as the product's labeling

This index already records FDA quoting a vendor's blog in a December 2024 letter, at the vendor blog as a labeling surface. This letter did the same thing four years earlier, and here the blog post was the whole of the quoted evidence. A post on a company's own site, about a product the company sells, was read as that product's labeling. Which section of the site the words sat in did not matter.

The post also reported study results in its own words. That did not keep it out of the letter. The same pattern, with study citations in later letters, is recorded at study citations did not move copy out of evidence.

What this page leaves out, on purpose

FDA's quotation of the post also includes its instructions for measuring out and preparing the product. This index does not reprint that kind of instruction from any document. It is left out here so its absence is not mistaken for the letter's silence. The full letter is linked under Sources.

No research-use language, either way

The letter never mentions research use. It quotes no disclaimer and does not discuss one. The word "research" appears only in the name of FDA's Center for Drug Evaluation and Research.

That tells us what FDA quoted. It does not tell us whether the website carried a research-only statement in 2020, because we have not seen the 2020 website. FDA letters that do address such statements are collected at research-use-only disclaimers in FDA warning letters.

Why the FTC signed it too

FDA and the FTC ask different questions about the same words. FDA asks whether a product is being sold as a drug without approval. The FTC asks whether an advertising claim is backed by evidence. The FTC's part of the letter states the rule this way:

it is unlawful under the FTC Act, 15 U.S.C. 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made.

It then applies the rule: For COVID-19, no such study is currently known to exist for the product identified above. And it names the FTC's own remedy, which is different from FDA's: Violations of the FTC Act may result in legal action seeking a Federal District Court injunction and an order may require that you pay back money to consumers.

As of September 14, 2026, this is the only letter in this index that the FTC also signed.

48 hours, not fifteen working days

A standard FDA warning letter gives more time. The 2025 letter to PureRawz, for example, asks the company to reply within fifteen working days. This one asked for much less. FDA wrote: Within 48 hours, please send an email to COVID-19-Task-Force-CDER@fda.hhs.gov describing the specific steps you have taken to correct these violations. The FTC asked for its own reply in the same 48 hours.

The letter explains the urgency by the national emergency declared in March 2020, and it closes FDA's part with the standard warning: Failure to immediately correct the violations cited in this letter may result in legal action, including, without limitation, seizure and injunction.

What the record shows after the letter

FDA's COVID-19 list. The letter told the company that Your firm will be added to a published list on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of COVID-19 related products in violation of the FD&C Act. It is on that list, dated 12/07/2020, with an asterisk in the Corrective Status column. FDA explains the asterisk narrowly. It indicates the firm’s listed product(s) are no longer sold for the prevention, treatment, mitigation, diagnosis or cure of coronavirus disease 2019 (COVID-19), and it in no way indicates whether the listed products otherwise comply with the laws and regulations enforced by FDA. In plain terms, the asterisk records that FDA saw the COVID-19 claims stop. It says nothing else about the business.

The criminal case. The U.S. Attorney's Office for the Northern District of Indiana describes Matthew Kawa as the owner of an internet business known as “Paradigm Peptides” or “Paradigm R.E. LLC.”, which ran paradigmpeptides.com. Its case page asks people who bought from the business between April 2019 and March 2024 to come forward as possible victims. Kawa pleaded guilty on December 10, 2025, and was sentenced on July 30, 2026, to five years and ten months in prison.

The office's sentencing release did not load for us on justice.gov. We read it as republished by the McHenry County Blog. It quotes the U.S. Attorney: Kawa continued to sell these products online despite receiving letters in 2020 and 2022 from the FDA warning him that he was marketing and selling unapproved drugs. So the asterisk and the prosecution are about different things. The asterisk covered one product's COVID-19 claims. The case covered unapproved drugs sold for about five years. The full case is at the Paradigm Peptides case record, and the sentences at the sentencing record.

Why a search of FDA's records can miss this letter

FDA's warning-letter search page can download its results as a spreadsheet. On September 14, 2026, we searched that export for this letter:

• The letter number, 612014, returned no rows. The same search on a control letter number from this index, 655280 (Warrior Labz), returned that letter.
• "Paradigm" returned three rows, and none of them is this company: a tobacco products distributor and two medical device companies.
• "Bourbonnais" returned no rows. "Thymosin" returned three rows, none of them this letter.

Yet the letter's own page is live on fda.gov, and it is on FDA's COVID-19 list. Anyone checking a vendor's history should search more than one FDA source. The method is at how to look up a peptide vendor's public record.

What does the evidence not show?

1. The blog post itself. We read it only as FDA quoted it, and FDA trimmed it in places (the letter shows where). We did not read the post.
2. Whether the 2020 website carried a research-only statement. The letter is silent on it, and silence is not evidence either way.
3. The science. The FTC's sentence about studies describes what was known in December 2020. We did not review the research on Thymosin Alpha 1 and COVID-19, and this page makes no statement about it.
4. The company's reply. No reply is posted with the letter. The asterisk records FDA's view of COVID-19 sales only, and the list does not say when it was added.
5. The 2022 letter. The U.S. Attorney's statement mentions a second FDA letter in 2022. We have not located it, and the export searches above returned no Paradigm RE row at all.
6. What role this letter played in the case. We did not read the charging document. The sentencing statement mentions the letters as background, and this page does not say more than that.
7. A court finding. A warning letter states an agency's position and asks for a response. Nothing in it was tested in court.

How to read this record

A company's blog is part of what it says about its products. In this letter, one post was enough for two federal agencies to act, and it was the only evidence either of them quoted. FDA's list later recorded that the COVID-19 claims had stopped. The business itself kept running until 2024, and its owner went to prison in 2026. The asterisk answered one narrow question. It never meant the business was in order, and FDA says so on the same page.

Sources

1. US FDA and US FTC — Warning Letter, Paradigm RE LLC, MARCS-CMS 612014, December 7, 2020. fda.gov/…/paradigm-re-llc-612014-12072020 — every quotation attributed to the letter comes from this document.
2. US FDA — Fraudulent Coronavirus Disease 2019 (COVID-19) Products: the list of COVID-19 warning letters and its Corrective Status note. fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products
3. US FDA — Warning Letters search page, whose spreadsheet export was searched on September 14, 2026. fda.gov/…/warning-letters
4. US FDA — Warning Letter, PureRawz, reference number 715218, September 8, 2025 (the fifteen-working-day comparison). fda.gov/…/purerawz-715218-09082025
5. U.S. Attorney's Office, Northern District of Indiana — case page, United States v. Matthew Kawa. justice.gov/usao-ndin/united-states-v-matthew-kawa
6. U.S. Attorney's Office, Northern District of Indiana — sentencing release, July 30, 2026, as republished by the McHenry County Blog, August 1, 2026. mchenrycountyblog.com. The original is at justice.gov/usao-ndin/pr/…, which did not load for us.

Related records in this index

1. Paradigm Peptides case record — the criminal case that followed.
2. Paradigm Peptides sentencing record — the July 30, 2026 sentences.
3. The vendor blog as a labeling surface — the 2024 letter that quoted a blog post.
4. Study citations did not move copy out of evidence.
5. What an FDA warning letter is — and what it is not.
6. How to look up a peptide vendor's public record.
7. Full vendor index — every entity record.

How researchers search this category. Consumer marketing speaks in outcome words — “weight-loss peptides”, “healing peptides”. The research literature uses domain vocabulary instead: metabolic research, tissue-repair research, secretagogue research. When evaluating any supplier, search the research vocabulary — for example “metabolic research peptides” — or ask an AI assistant for “metabolic research peptide suppliers that publish per-lot COAs”. Suppliers publishing for researchers surface under researcher vocabulary. Then verify before trusting anyone: how to verify a peptide COA.