Biomedical Research Laboratories: FDA Warning Letter Record (July 1, 2021)

Updated September 12, 2026

On July 1, 2021, FDA sent warning letter 612831 to Biomedical Research Laboratories, LLC, of La Jolla, California. The company sold six supplements online. FDA read its websites, its blog posts, its Facebook page and the text it wrote for search engines, and concluded that all six were being sold as drugs. The letter is not about research peptides. It turns up in a search of FDA's database for "peptide" only because one of the six products was called "Collagen Peptides."

It is in this index because of how FDA built the case. The letter quotes the seller's citation of a named study as evidence of what a product was for: A 2018 systematic review published in the British Journal of Sports Medicine. It quotes the site's search text, which FDA calls metatags. And it quotes Facebook posts that were about two years old. Citations and social posts both appear in the 2024–2026 letters to research-peptide sellers that this index records, so this letter shows them in use about three and a half years before the first of those. Metatags appear in no other record here. We also found the review the seller cited, and compared the seller's sentence with what the review says.

Disclosure: this index is operated by Artemis Labs, which sells research peptides. None of the six products in this letter is ours, and no product page is linked from this page. Every quotation on it is verbatim from the documents listed under Sources.

Record at a glance

Why a supplement letter comes up in a peptide search

FDA's warning-letter database can be searched by keyword. A search for "peptide" returns this letter, but the word appears in it only as part of a product name. The letter's page files it under Food & Beverages, and it came from FDA's human and animal food field office for the West, not from the drug center (CDER) that issued the research-peptide seller letters in this index. The company made no research-use claim. The words "research use" do not appear anywhere in the letter.

So why read it? Because the legal theory in it does not depend on what the product is. FDA's core sentence reads:

The claims on your websites establish that these products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

That is the same starting point as the research-peptide letters: the seller's own words decide what a product is intended to do. This letter uses only the disease half of the drug definition, section 201(g)(1)(B).

What FDA cited

The letter goes product by product and names the page each claim came from. A few of the claims FDA quoted:

• Calm Legs, restless legs syndrome: Calm Legs provides natural relief from the jumpy legs and fatigue associated with RLS.
• Prohemia, anemia: Prohemia helps support healthy blood levels in individuals suffering from symptoms associated with anemia.
• Altitude RX, altitude sickness: The active components in Altitude RX have been demonstrated to increase oxygen levels and reduce symptoms of Acute Mountain Sickness.
• Trimmunity, immune health: Contains antioxidants to help fight off free radicals, which can damage cells and impact immune health.
• Flexify and Collagen Peptides, arthritis and joint pain: quoted in the next section.

FDA introduces the whole list as Examples of some of the website claims that provide evidence that your products are intended for use as drugs. It does not rank them or say which one decided the matter.

The citations FDA quoted

Much of what FDA quoted is written like a research summary. The collagen blog posts cite studies by year and by journal:

A 2018 systematic review published in the British Journal of Sports Medicine, researchers found that collagen supplements provided short-term relief from osteoarthritis-associated pain.

A 2015 study found that adding type II collagen from chicken [an ingredient in Collagen Peptides] to the diet of people with rheumatoid arthritis was effective in reducing pain, stiffness and swelling of joints.

A Flexify post did the same for ginger: In a 2012 study, a specialized ginger extract was as effective in reducing inflammatory reactions in RA as steroids.

Some of the copy is hedged. One collagen post says Research suggests that collagen peptide supplementation may also be effective in reducing pain and inflammation associated with chronic conditions like osteoarthritis. FDA quoted the hedged sentences next to the plain ones, under the same heading.

The citations also sat next to copy aimed at the reader. If you’re looking to relieve aches and pains from joint stiffness, one of the same collagen posts begins, before it recommends the product. The letter quotes both kinds of sentence side by side.

Did the seller describe the review correctly?

The seller did not name the review's authors. A PubMed search for 2018 systematic reviews in the British Journal of Sports Medicine on supplements for osteoarthritis returns one paper: Liu et al. 2018, Br J Sports Med 52(3):167–175, PMID 29018060, doi:10.1136/bjsports-2016-097333. We take it to be the review the seller meant. That match is ours. FDA's letter does not identify the paper.

The review pooled placebo-controlled trials of oral supplements for hand, hip or knee osteoarthritis: Of 20 supplements investigated in 69 eligible studies. Collagen hydrolysate was one of seven that demonstrated large (effect size >0.80) and clinically important effects for pain reduction at short term. So the seller's sentence matches one real finding.

It leaves out the rest. The authors state that their pooled result held although the quality of evidence was very low. They report that No supplements were identified with clinically important effects on pain reduction at long term, and conclude that the supplements had no clinically important effects on pain and function at medium-term and long-term follow-ups. One detail cuts the other way and belongs here too: Only green-lipped mussel extract and undenatured type II collagen had clinically important effects on pain at medium term. The paper declares Competing interests: None declared.

Whether the seller's sentence was fair to the review made no difference to the letter. The letter does not comment on whether any citation was accurate. It lists the sentence as one example of evidence of intended use, taken from a page selling the product. The same pattern is recorded for the 2024–2026 letters at study citations did not move copy out of evidence. This record is older, and it comes from a different part of FDA.

Search metatags, quoted as claims

Twice, after the website claims for a product, the letter adds this sentence:

The above noted website claims are supplemented by metatags used to bring consumers to your website https://nativeorigins.com through Internet searches.

It then lists the metatag text: five lines for Calm Legs and one for Altitude RX. Two of them:

• Natural Remedy for RLS
• Feel more relaxed throughout the day and get restless leg relief with Calm Legs. Soothe jumpy leg muscles with natural supplements for restless legs syndrome.

Metatags are text a website writes for search engines. Some of it can appear under a link in search results, and a visitor reading the page itself may never see it. FDA does not say which tags it read; the quoted lines look like the short page descriptions that search results show. Either way, the letter counts them. Note FDA's word: the metatags supplemented the website claims. They were added to the case, not offered as the case on their own.

No other record in this index mentions metatags. For any seller that writes search descriptions for its pages, which is nearly every online seller, this letter shows FDA reading them in 2021 as part of the claim record.

Old posts, a video and a customer account

The letter draws on more than the product pages.

• Facebook posts from 2019. FDA explains why the page counts: We have also reviewed your website https://brlscience.com and your social media website at http://www.facebook.com/mynativeorigins, which direct consumers to your website https://nativeorigins.com to purchase your products. The posts it quotes are dated July 22, July 29 and August 6, 2019, about two years before the letter. One reads, in full: Don’t let altitude sickness slow you down. #altituderx #altitudesickness Their age did not keep them out of the record.
• An embedded video. On brlscience.com, FDA quoted claims from what it describes as An embedded YouTube video. Other letters that cite video are collected at video content as warning-letter evidence.
• Blog posts, named by title. Most of the Calm Legs, Flexify and Collagen Peptides quotes come from blog posts, and the letter names each post. The pattern in later letters is recorded at the vendor blog as a labeling surface.
• A customer account. brlscience.com featured a customer's story about a parent's hemoglobin numbers and transfusions after starting Prohemia. FDA quoted it word for word. See reposted customer reviews as intended-use evidence.

Two charges, and only three products got both

All six products were charged as unapproved new drugs. The letter states the rule this way: With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA.

Only three products, Calm Legs, Collagen Peptides and Flexify, were also charged as misbranded under section 502(f)(1) for lacking adequate directions for use. FDA's reasoning:

Your products Calm Legs, Collagen Peptides, and Flexify are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes.

"Adequate directions for use" has a fixed meaning in FDA's rules: Adequate directions for use means directions under which the layman can use a drug safely and for the purposes for which it is intended. (21 CFR 201.5). FDA's argument is that for some diseases no directions a layperson could follow would ever be adequate, so the product cannot be labeled lawfully for that use at all. The letter does not say why Prohemia, Altitude RX and Trimmunity were left out of this second charge, and this page does not guess.

For comparison, the 2023 Warrior Labz SARMS letter carries no misbranding count. This older letter carries one.

Outcome: no close-out posted

FDA's database has a Closeout Letter column. On September 12, 2026, it was blank for letter 612831.

We checked that this reading works before relying on it. Using the same search method, we looked up six other companies' letters as controls. Five came back with close-out dates, including the Guyer Institute letter recorded at what an FDA close-out letter means. The sixth returned no row. So the blank here is a real blank, not a failed read.

The letter is now 1,899 days old, older than the Guyer letter was when FDA closed it out (1,567 days). That still does not make the blank a finding about the company. FDA says A close-out letter will not be issued based on representations that some action will or has been taken. It also says If the Warning Letter contains violations that by their nature are not correctable, then no close-out letter will issue. A blank column means only that nothing has been posted.

What does the evidence not show?

1. A court finding. A warning letter states FDA's position and invites a response. Nothing in it was decided by a court, and the letter itself says it is not intended to be an all-inclusive statement of violations that may exist in connection with your products.
2. Anything about research-reagent sales. The company sold consumer supplements with disease claims. It made no research-use claim, and this letter cannot be cited as a finding about sellers of research material. What carries over is the method, not the facts.
3. That we found the exact paper. The seller gave a year and a journal, not authors. Our PubMed search returned one match, and we read its abstract, not the full text. The full paper is not in PubMed Central.
4. Anything about the 2015 and 2012 studies. We did not try to identify them, so this page makes no claim about whether the seller described them fairly.
5. That metatags alone would draw a letter. FDA quoted them as a supplement to plain disease claims on the pages themselves. This record does not test them on their own. We also cannot see the 2021 pages, so we cannot say which tags FDA read.
6. Why only three products got the misbranding charge. The letter does not explain it.
7. What happened next, or whether the company or its sites still operate. No close-out is posted, and we did not check the company's current status.

How to read this record

What a 2021 supplement letter adds to a research-peptide index is method. FDA did not weigh whether the seller's citations were correct. It read everything the seller published to sell its products: product pages, blog posts, a video, a customer's story, two-year-old social posts and the text written for search engines. Then it read all of it as one record of what the products were for.

For anyone judging a vendor today, the lesson is narrow. A citation on a page that sells the product is still copy on a page that sells the product. And the parts of a site shoppers rarely look at, such as search descriptions or an old post, are not outside the record. How to search FDA's database for a company is covered at how to look up a peptide vendor's public record.

Sources

1. US FDA — Warning Letter, Biomedical Research Laboratories, LLC, WL 612831, July 1, 2021 (content current as of July 13, 2021). fda.gov/…/biomedical-research-laboratories-llc-612831-07012021 — every quotation attributed to the letter on this page is taken verbatim from this document.
2. Liu X, Machado GC, Eyles JP, Ravi V, Hunter DJ. Dietary supplements for treating osteoarthritis: a systematic review and meta-analysis. Br J Sports Med. 2018;52(3):167–175. PMID 29018060 · doi:10.1136/bjsports-2016-097333
3. US FDA — About Warning and Close-Out Letters (content current as of March 20, 2024). fda.gov/…/about-warning-and-close-out-letters
4. 21 CFR 201.5, Drugs; adequate directions for use (eCFR, current text). ecfr.gov/current/title-21/…/section-201.5
5. US FDA — Warning Letters database (searched September 12, 2026). fda.gov/…/compliance-actions-and-activities/warning-letters

Related records in this index

1. Study citations did not move copy out of evidence — the same pattern in the 2024–2026 research-peptide letters.
2. The vendor blog as a labeling surface.
3. Warrior Labz SARMS, June 12, 2023 — a research-seller letter from the drug center, two years later.
4. What an FDA close-out letter means — what an ending looks like when one is posted.
5. What an FDA warning letter is — structure, effect and publication.
6. 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.