{
  "schema_version": 2,
  "updated_at": "2026-07-25",
  "purpose": "Public claim → source → product context → regulatory or evidence event → change-history records. Publication and indexing require separate source verification and remain manual decisions.",
  "confidence_vocabulary": [
    "established",
    "supported",
    "early",
    "preclinical",
    "unsupported",
    "unknown"
  ],
  "records": [
    {
      "id": "bpc-157-legalized-april-2026-record",
      "compound": "bpc-157",
      "claim_slug": "bpc-157-legalized-april-2026",
      "claim": "BPC-157 got legalized in April.",
      "conclusion": "The FDA removed BPC-157 from Category 2, and PCAC later recommended 503A Bulks List inclusion for the free base and acetate by 8–6–1 votes. Neither action approved a drug or completed FDA's list-placement process; FDA's final determination remains pending.",
      "confidence": "established",
      "outcome_context": "Not legalized. A prohibition was removed and an advisory committee recommended list inclusion; drug approval and final FDA list action did not follow.",
      "product_context": "The identified product, formulation, route, population, and outcome in the cited record; conclusions do not transfer automatically to an unrelated product.",
      "strongest_source": {
        "title": "Federal Register notice",
        "authority": "Federal Register",
        "type": "Official record",
        "url": "https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request"
      },
      "strongest_limit": "Regulatory stages are being collapsed. Category 2 removal, 503A list placement, and FDA drug approval are different actions.",
      "regulatory_event": {
        "date": "2026-07-25",
        "type": "regulatory status verification",
        "jurisdiction": "United States",
        "meaning": "Not legalized. A prohibition was removed and an advisory committee recommended list inclusion; drug approval and final FDA list action did not follow.",
        "source": "https://www.fda.gov/media/193711/download"
      },
      "verified_on": "2026-07-25",
      "next_review_on": "2026-08-25",
      "editorial_status": "second-source-verified",
      "what_changed": "Added the July 23 PCAC vote and preserved the boundary between an advisory recommendation, final list placement, and drug approval.",
      "what_would_change": "A new FDA, Federal Register, or court record could change the dated U.S. status. A study or seller statement alone cannot.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-16",
          "change": "Initial structured record created from the reviewed Claim Check.",
          "source": "https://www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request"
        },
        {
          "version": 2,
          "date": "2026-07-25",
          "change": "Recorded the 8–6–1 PCAC votes for free base and acetate; final FDA action remains pending.",
          "source": "https://www.fda.gov/media/193711/download"
        }
      ]
    },
    {
      "id": "bpc-157-tendon-repair-clinically-proven-record",
      "compound": "bpc-157",
      "claim_slug": "bpc-157-tendon-repair-clinically-proven",
      "claim": "BPC-157 is clinically proven for tendon repair.",
      "conclusion": "A 2025 systematic review screened 544 papers and found one human study: 12 people with chronic knee pain, no control group, and no blinding. It found no human tendon-repair trial.",
      "confidence": "supported",
      "outcome_context": "Preclinical interest is real. Human tendon-repair proof is not.",
      "product_context": "The identified product, formulation, route, population, and outcome in the cited record; conclusions do not transfer automatically to an unrelated product.",
      "strongest_source": {
        "title": "Vasireddi et al., 2025",
        "authority": "PubMed / National Library of Medicine",
        "type": "Systematic review",
        "url": "https://pubmed.ncbi.nlm.nih.gov/40756949/"
      },
      "strongest_limit": "Animal injury models and a small uncontrolled knee-pain series are being described as clinical proof of tendon repair.",
      "regulatory_event": {
        "date": "2026-07-16",
        "type": "claim-record verification",
        "jurisdiction": "Not jurisdiction-specific",
        "meaning": "Preclinical interest is real. Human tendon-repair proof is not.",
        "source": "https://pubmed.ncbi.nlm.nih.gov/40756949/"
      },
      "verified_on": "2026-07-16",
      "next_review_on": "2026-08-18",
      "editorial_status": "second-source-verified",
      "what_changed": "Added the independently reviewed Claim Check to the structured claim/source/change registry.",
      "what_would_change": "A well-controlled human study tied to the exact product, population, route, and claimed outcome could change the answer. Mechanism, anecdotes, or a different product cannot substitute for that evidence.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-16",
          "change": "Initial structured record created from the reviewed Claim Check.",
          "source": "https://pubmed.ncbi.nlm.nih.gov/40756949/"
        }
      ]
    },
    {
      "id": "tb-500-heals-any-injury-record",
      "compound": "tb-500",
      "claim_slug": "tb-500-heals-any-injury",
      "claim": "TB-500 is the Wolverine peptide, it heals any injury.",
      "conclusion": "The injury-healing evidence is preclinical. Human studies discussed in the evidence review involved an eye condition and a leg ulcer, not broad repair of torn tendons, ligaments, or muscles.",
      "confidence": "supported",
      "outcome_context": "No human evidence supports “heals any injury.”",
      "product_context": "The identified product, formulation, route, population, and outcome in the cited record; conclusions do not transfer automatically to an unrelated product.",
      "strongest_source": {
        "title": "Published review, 2026",
        "authority": "mdpi.com",
        "type": "Scoping review",
        "url": "https://www.mdpi.com/2076-3417/16/12/6202"
      },
      "strongest_limit": "A broad marketing nickname turns specific laboratory findings into a universal clinical promise.",
      "regulatory_event": {
        "date": "2026-07-16",
        "type": "claim-record verification",
        "jurisdiction": "Not jurisdiction-specific",
        "meaning": "No human evidence supports “heals any injury.”",
        "source": "https://www.mdpi.com/2076-3417/16/12/6202"
      },
      "verified_on": "2026-07-16",
      "next_review_on": "2026-08-18",
      "editorial_status": "second-source-verified",
      "what_changed": "Added the independently reviewed Claim Check to the structured claim/source/change registry.",
      "what_would_change": "A well-controlled human study tied to the exact product, population, route, and claimed outcome could change the answer. Mechanism, anecdotes, or a different product cannot substitute for that evidence.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-16",
          "change": "Initial structured record created from the reviewed Claim Check.",
          "source": "https://www.mdpi.com/2076-3417/16/12/6202"
        }
      ]
    },
    {
      "id": "tb-500-product-identity-record",
      "compound": "tb-500",
      "claim_slug": "tb-500-product-identity",
      "claim": "You don't even know what's actually in your TB-500.",
      "conclusion": "There is no pharmacopeial standard defining “TB-500.” The label may refer to full Thymosin Beta-4 or a shorter fragment, and evidence for one substance may not describe the other.",
      "confidence": "supported",
      "outcome_context": "The name alone does not establish identity, purity, sterility, or equivalence to a study material.",
      "product_context": "The identified product, formulation, route, population, and outcome in the cited record; conclusions do not transfer automatically to an unrelated product.",
      "strongest_source": {
        "title": "PubChem: Thymosin beta-4",
        "authority": "pubchem.ncbi.nlm.nih.gov",
        "type": "Official database",
        "url": "https://pubchem.ncbi.nlm.nih.gov/compound/Thymosin-beta-4"
      },
      "strongest_limit": "A familiar nickname can hide differences in chemical identity, formulation, and evidence.",
      "regulatory_event": {
        "date": "2026-07-16",
        "type": "claim-record verification",
        "jurisdiction": "Not jurisdiction-specific",
        "meaning": "The name alone does not establish identity, purity, sterility, or equivalence to a study material.",
        "source": "https://pubchem.ncbi.nlm.nih.gov/compound/Thymosin-beta-4"
      },
      "verified_on": "2026-07-16",
      "next_review_on": "2026-08-18",
      "editorial_status": "second-source-verified",
      "what_changed": "Added the independently reviewed Claim Check to the structured claim/source/change registry.",
      "what_would_change": "A well-controlled human study tied to the exact product, population, route, and claimed outcome could change the answer. Mechanism, anecdotes, or a different product cannot substitute for that evidence.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-16",
          "change": "Initial structured record created from the reviewed Claim Check.",
          "source": "https://pubchem.ncbi.nlm.nih.gov/compound/Thymosin-beta-4"
        }
      ]
    },
    {
      "id": "ghk-cu-4000-genes-younger-record",
      "compound": "ghk-cu",
      "claim_slug": "ghk-cu-4000-genes-younger",
      "claim": "GHK-Cu resets 4,000 genes to make you younger.",
      "conclusion": "The number comes from a cultured-cell gene-expression analysis, not a clinical trial in living people. A laboratory expression signal is not proof of rejuvenation or a patient benefit.",
      "confidence": "supported",
      "outcome_context": "Gene-expression findings in cultured cells do not show that a person becomes younger.",
      "product_context": "The identified product, formulation, route, population, and outcome in the cited record; conclusions do not transfer automatically to an unrelated product.",
      "strongest_source": {
        "title": "Pickart et al., 2014",
        "authority": "PubMed Central / National Library of Medicine",
        "type": "Published analysis",
        "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC4180391/"
      },
      "strongest_limit": "A real laboratory readout is being translated into a much larger clinical claim.",
      "regulatory_event": {
        "date": "2026-07-16",
        "type": "claim-record verification",
        "jurisdiction": "Not jurisdiction-specific",
        "meaning": "Gene-expression findings in cultured cells do not show that a person becomes younger.",
        "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC4180391/"
      },
      "verified_on": "2026-07-16",
      "next_review_on": "2026-08-18",
      "editorial_status": "second-source-verified",
      "what_changed": "Added the independently reviewed Claim Check to the structured claim/source/change registry.",
      "what_would_change": "A well-controlled human study tied to the exact product, population, route, and claimed outcome could change the answer. Mechanism, anecdotes, or a different product cannot substitute for that evidence.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-16",
          "change": "Initial structured record created from the reviewed Claim Check.",
          "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC4180391/"
        }
      ]
    },
    {
      "id": "research-use-only-legal-sale-record",
      "compound": "cross-cutting",
      "claim_slug": "research-use-only-legal-sale",
      "claim": "“Research use only” makes a peptide sale legal.",
      "conclusion": "A disclaimer does not control when the surrounding marketing and context show intended human use. FDA has treated peptide products labeled “Research Use Only” as unapproved drugs after reviewing the claims and products sold with them.",
      "confidence": "established",
      "outcome_context": "“Research use only” is not a magic phrase that overrides human-use marketing.",
      "product_context": "The identified product, formulation, route, population, and outcome in the cited record; conclusions do not transfer automatically to an unrelated product.",
      "strongest_source": {
        "title": "FDA warning letter, 2026",
        "authority": "U.S. Food and Drug Administration",
        "type": "Official enforcement record",
        "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gram-peptides-721806-03312026"
      },
      "strongest_limit": "The label is being treated as a legal shield, while FDA evaluates intended use from the full context.",
      "regulatory_event": {
        "date": "2026-07-16",
        "type": "claim-record verification",
        "jurisdiction": "Not jurisdiction-specific",
        "meaning": "“Research use only” is not a magic phrase that overrides human-use marketing.",
        "source": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gram-peptides-721806-03312026"
      },
      "verified_on": "2026-07-16",
      "next_review_on": "2026-08-18",
      "editorial_status": "second-source-verified",
      "what_changed": "Added the independently reviewed Claim Check to the structured claim/source/change registry.",
      "what_would_change": "A well-controlled human study tied to the exact product, population, route, and claimed outcome could change the answer. Mechanism, anecdotes, or a different product cannot substitute for that evidence.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-16",
          "change": "Initial structured record created from the reviewed Claim Check.",
          "source": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gram-peptides-721806-03312026"
        }
      ]
    },
    {
      "id": "vendor-tirzepatide-same-as-zepbound-record",
      "compound": "tirzepatide",
      "claim_slug": "vendor-tirzepatide-same-as-zepbound",
      "claim": "Peptide vendors sell the same tirzepatide as Zepbound.",
      "conclusion": "Sharing an ingredient name does not make an online product the FDA-approved drug. FDA warning letters have targeted tirzepatide sold as a research peptide without the approved product's verified manufacturing and labeling framework.",
      "confidence": "established",
      "outcome_context": "Same word on a label does not mean same product.",
      "product_context": "The identified product, formulation, route, population, and outcome in the cited record; conclusions do not transfer automatically to an unrelated product.",
      "strongest_source": {
        "title": "FDA warning letter, 2026",
        "authority": "U.S. Food and Drug Administration",
        "type": "Official enforcement record",
        "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gram-peptides-721806-03312026"
      },
      "strongest_limit": "An ingredient name is being used as proof of product equivalence.",
      "regulatory_event": {
        "date": "2026-07-16",
        "type": "claim-record verification",
        "jurisdiction": "Not jurisdiction-specific",
        "meaning": "Same word on a label does not mean same product.",
        "source": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gram-peptides-721806-03312026"
      },
      "verified_on": "2026-07-16",
      "next_review_on": "2026-08-18",
      "editorial_status": "second-source-verified",
      "what_changed": "Added the independently reviewed Claim Check to the structured claim/source/change registry.",
      "what_would_change": "A well-controlled human study tied to the exact product, population, route, and claimed outcome could change the answer. Mechanism, anecdotes, or a different product cannot substitute for that evidence.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-16",
          "change": "Initial structured record created from the reviewed Claim Check.",
          "source": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gram-peptides-721806-03312026"
        }
      ]
    },
    {
      "id": "tirzepatide-microdosing-fewer-side-effects-record",
      "compound": "tirzepatide",
      "claim_slug": "tirzepatide-microdosing-fewer-side-effects",
      "claim": "Microdosing tirzepatide gives the benefits with fewer side effects.",
      "conclusion": "The pivotal efficacy evidence used defined titration and maintenance doses. Randomized evidence has not established that unspecified sub-therapeutic “microdoses” preserve benefits while reducing harms.",
      "confidence": "unknown",
      "outcome_context": "The viral microdosing claim has not been established by a randomized trial.",
      "product_context": "The identified product, formulation, route, population, and outcome in the cited record; conclusions do not transfer automatically to an unrelated product.",
      "strongest_source": {
        "title": "Jastreboff et al., 2022",
        "authority": "PubMed / National Library of Medicine",
        "type": "Randomized trial",
        "url": "https://pubmed.ncbi.nlm.nih.gov/35658024/"
      },
      "strongest_limit": "A plausible-sounding dose strategy is being presented as if it had the same evidence as the tested regimen.",
      "regulatory_event": {
        "date": "2026-07-16",
        "type": "claim-record verification",
        "jurisdiction": "Not jurisdiction-specific",
        "meaning": "The viral microdosing claim has not been established by a randomized trial.",
        "source": "https://pubmed.ncbi.nlm.nih.gov/35658024/"
      },
      "verified_on": "2026-07-16",
      "next_review_on": "2026-08-18",
      "editorial_status": "second-source-verified",
      "what_changed": "Added the independently reviewed Claim Check to the structured claim/source/change registry.",
      "what_would_change": "A well-controlled human study tied to the exact product, population, route, and claimed outcome could change the answer. Mechanism, anecdotes, or a different product cannot substitute for that evidence.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-16",
          "change": "Initial structured record created from the reviewed Claim Check.",
          "source": "https://pubmed.ncbi.nlm.nih.gov/35658024/"
        }
      ]
    },
    {
      "id": "cjc-ipamorelin-build-muscle-sleep-record",
      "compound": "cjc-1295-ipamorelin",
      "claim_slug": "cjc-ipamorelin-build-muscle-sleep",
      "claim": "CJC-1295 and ipamorelin build muscle while you sleep.",
      "conclusion": "Human CJC-1295 research measured growth hormone and IGF-1. It did not demonstrate muscle gain, and PepCurrent found no human trial of the CJC-1295 and ipamorelin combination establishing that outcome.",
      "confidence": "unknown",
      "outcome_context": "Raised biomarkers are not proof of muscle gain.",
      "product_context": "The identified product, formulation, route, population, and outcome in the cited record; conclusions do not transfer automatically to an unrelated product.",
      "strongest_source": {
        "title": "Teichman et al., 2006",
        "authority": "Journal of Clinical Endocrinology & Metabolism",
        "type": "Human study",
        "url": "https://academic.oup.com/jcem/article-abstract/91/3/799/2843281"
      },
      "strongest_limit": "A hormone-level result is being converted into an unmeasured body-composition outcome.",
      "regulatory_event": {
        "date": "2026-07-16",
        "type": "claim-record verification",
        "jurisdiction": "Not jurisdiction-specific",
        "meaning": "Raised biomarkers are not proof of muscle gain.",
        "source": "https://academic.oup.com/jcem/article-abstract/91/3/799/2843281"
      },
      "verified_on": "2026-07-16",
      "next_review_on": "2026-08-18",
      "editorial_status": "second-source-verified",
      "what_changed": "Added the independently reviewed Claim Check to the structured claim/source/change registry.",
      "what_would_change": "A well-controlled human study tied to the exact product, population, route, and claimed outcome could change the answer. Mechanism, anecdotes, or a different product cannot substitute for that evidence.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-16",
          "change": "Initial structured record created from the reviewed Claim Check.",
          "source": "https://academic.oup.com/jcem/article-abstract/91/3/799/2843281"
        }
      ]
    },
    {
      "id": "ipamorelin-prolactin-cortisol-record",
      "compound": "cjc-1295-ipamorelin",
      "claim_slug": "ipamorelin-prolactin-cortisol",
      "claim": "Ipamorelin spikes prolactin and cortisol like other GH peptides.",
      "conclusion": "The original characterization study found no significant ACTH or cortisol increase in swine, even at high experimental doses. That is animal evidence, not proof of the same result or a complete hormone profile in people.",
      "confidence": "unknown",
      "outcome_context": "The cited animal study pushes back on the claim, but human effects remain inadequately characterized.",
      "product_context": "The identified product, formulation, route, population, and outcome in the cited record; conclusions do not transfer automatically to an unrelated product.",
      "strongest_source": {
        "title": "Raun et al., 1998",
        "authority": "PubMed / National Library of Medicine",
        "type": "Animal study",
        "url": "https://pubmed.ncbi.nlm.nih.gov/9849822/"
      },
      "strongest_limit": "The claim overstates one direction; the correction must not overstate the opposite direction.",
      "regulatory_event": {
        "date": "2026-07-16",
        "type": "claim-record verification",
        "jurisdiction": "Not jurisdiction-specific",
        "meaning": "The cited animal study pushes back on the claim, but human effects remain inadequately characterized.",
        "source": "https://pubmed.ncbi.nlm.nih.gov/9849822/"
      },
      "verified_on": "2026-07-16",
      "next_review_on": "2026-08-18",
      "editorial_status": "second-source-verified",
      "what_changed": "Added the independently reviewed Claim Check to the structured claim/source/change registry.",
      "what_would_change": "A well-controlled human study tied to the exact product, population, route, and claimed outcome could change the answer. Mechanism, anecdotes, or a different product cannot substitute for that evidence.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-16",
          "change": "Initial structured record created from the reviewed Claim Check.",
          "source": "https://pubmed.ncbi.nlm.nih.gov/9849822/"
        }
      ]
    },
    {
      "id": "semaglutide-online-vial-same-as-ozempic-record",
      "compound": "semaglutide",
      "claim_slug": "semaglutide-online-vial-same-as-ozempic",
      "claim": "If a vial says semaglutide, it is basically the same as Ozempic or Wegovy.",
      "conclusion": "FDA approval belongs to a specific drug product, formulation, manufacturer, and use. Trials of Wegovy, Ozempic, or Rybelsus do not establish the identity, sterility, strength, or performance of an unrelated vial sold under the ingredient name.",
      "confidence": "established",
      "outcome_context": "Same ingredient name does not mean same FDA-approved product.",
      "product_context": "The identified product, formulation, route, population, and outcome in the cited record; conclusions do not transfer automatically to an unrelated product.",
      "strongest_source": {
        "title": "FDA-approved Wegovy labeling, 2026",
        "authority": "U.S. Food and Drug Administration",
        "type": "FDA labeling",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s029lbl.pdf"
      },
      "strongest_limit": "A shared ingredient name is being used as proof that two products have the same manufacturing controls and clinical evidence.",
      "regulatory_event": {
        "date": "2026-07-16",
        "type": "claim-record verification",
        "jurisdiction": "Not jurisdiction-specific",
        "meaning": "Same ingredient name does not mean same FDA-approved product.",
        "source": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s029lbl.pdf"
      },
      "verified_on": "2026-07-16",
      "next_review_on": "2026-08-18",
      "editorial_status": "second-source-verified",
      "what_changed": "Added the independently reviewed Claim Check to the structured claim/source/change registry.",
      "what_would_change": "A well-controlled human study tied to the exact product, population, route, and claimed outcome could change the answer. Mechanism, anecdotes, or a different product cannot substitute for that evidence.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-16",
          "change": "Initial structured record created from the reviewed Claim Check.",
          "source": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s029lbl.pdf"
        }
      ]
    },
    {
      "id": "pt-141-approved-libido-men-women-record",
      "compound": "bremelanotide-pt-141",
      "claim_slug": "pt-141-approved-libido-men-women",
      "claim": "PT-141 is FDA-approved as a general libido peptide for men and women.",
      "conclusion": "Vyleesi is FDA-approved for a narrow population: premenopausal women with acquired, generalized hypoactive sexual desire disorder. Its label says it is not indicated for men, postmenopausal women, or enhancement of sexual performance.",
      "confidence": "established",
      "outcome_context": "The approval is real, but it is much narrower than the viral claim.",
      "product_context": "The identified product, formulation, route, population, and outcome in the cited record; conclusions do not transfer automatically to an unrelated product.",
      "strongest_source": {
        "title": "FDA-approved Vyleesi labeling",
        "authority": "U.S. Food and Drug Administration",
        "type": "FDA labeling",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210557s002lbl.pdf"
      },
      "strongest_limit": "A product-specific approval is being widened into a general claim about an ingredient, multiple populations, and an outcome the label does not support.",
      "regulatory_event": {
        "date": "2026-07-16",
        "type": "claim-record verification",
        "jurisdiction": "Not jurisdiction-specific",
        "meaning": "The approval is real, but it is much narrower than the viral claim.",
        "source": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210557s002lbl.pdf"
      },
      "verified_on": "2026-07-16",
      "next_review_on": "2026-08-18",
      "editorial_status": "second-source-verified",
      "what_changed": "Added the independently reviewed Claim Check to the structured claim/source/change registry.",
      "what_would_change": "A well-controlled human study tied to the exact product, population, route, and claimed outcome could change the answer. Mechanism, anecdotes, or a different product cannot substitute for that evidence.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-16",
          "change": "Initial structured record created from the reviewed Claim Check.",
          "source": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210557s002lbl.pdf"
        }
      ]
    },
    {
      "id": "melanotan-ii-approved-safe-tan-record",
      "compound": "melanotan-ii",
      "claim_slug": "melanotan-ii-approved-safe-tan",
      "claim": "Melanotan II is an approved, safer way to get a tan.",
      "conclusion": "Melanotan II is not FDA-approved. FDA identifies it among substances that may present significant safety risks and describes serious adverse events in the published case record.",
      "confidence": "established",
      "outcome_context": "It can change pigmentation; that does not make it FDA-approved or safe.",
      "product_context": "The identified product, formulation, route, population, and outcome in the cited record; conclusions do not transfer automatically to an unrelated product.",
      "strongest_source": {
        "title": "FDA compounding safety-risk page",
        "authority": "U.S. Food and Drug Administration",
        "type": "FDA safety record",
        "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks?pg=3"
      },
      "strongest_limit": "A visible tanning effect is being treated as evidence of regulatory approval and overall safety.",
      "regulatory_event": {
        "date": "2026-07-16",
        "type": "claim-record verification",
        "jurisdiction": "Not jurisdiction-specific",
        "meaning": "It can change pigmentation; that does not make it FDA-approved or safe.",
        "source": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks?pg=3"
      },
      "verified_on": "2026-07-16",
      "next_review_on": "2026-08-18",
      "editorial_status": "second-source-verified",
      "what_changed": "Added the independently reviewed Claim Check to the structured claim/source/change registry.",
      "what_would_change": "A well-controlled human study tied to the exact product, population, route, and claimed outcome could change the answer. Mechanism, anecdotes, or a different product cannot substitute for that evidence.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-16",
          "change": "Initial structured record created from the reviewed Claim Check.",
          "source": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks?pg=3"
        }
      ]
    },
    {
      "id": "retatrutide-already-approved-record",
      "compound": "retatrutide",
      "claim_slug": "retatrutide-already-approved",
      "claim": "Retatrutide already passed Phase 3, so it is basically FDA-approved.",
      "conclusion": "Retatrutide now has a published phase 3 diabetes trial. The separate TRIUMPH-1 phase 3 obesity registry is completed but posts no results. It remains investigational and not FDA-approved. Neither record validates an unrelated online product.",
      "confidence": "supported",
      "outcome_context": "Published phase 3 evidence is meaningful. It is not FDA approval, and separate trial populations are not interchangeable.",
      "product_context": "The identified product, formulation, route, population, and outcome in the cited record; conclusions do not transfer automatically to an unrelated product.",
      "strongest_source": {
        "title": "FDA concerns with unapproved GLP-1 drugs",
        "authority": "U.S. Food and Drug Administration",
        "type": "Official FDA status",
        "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss"
      },
      "strongest_limit": "The published trial studied diabetes monotherapy; the separate phase 3 obesity registry posts no results, and neither record is an FDA approval action.",
      "regulatory_event": {
        "date": "2026-07-26",
        "type": "FDA status verification",
        "jurisdiction": "United States",
        "meaning": "FDA states that retatrutide is not a component of an FDA-approved drug and has not been found safe and effective for any condition.",
        "source": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss"
      },
      "verified_on": "2026-08-02",
      "next_review_on": "2026-09-02",
      "editorial_status": "second-source-verified",
      "what_changed": "Separated the published phase 3 diabetes trial from the completed, no-results-posted TRIUMPH-1 obesity registry.",
      "what_would_change": "An FDA approval action and final labeling would change the approval answer. Direct-comparator results would change only their defined comparison questions.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-16",
          "change": "Initial structured record created from the reviewed Claim Check.",
          "source": "https://clinicaltrials.gov/study/NCT05929066"
        },
        {
          "version": 2,
          "date": "2026-07-26",
          "change": "Separated the published phase 3 diabetes trial from the separate TRIUMPH-1 obesity record and refreshed the FDA boundary.",
          "source": "https://pubmed.ncbi.nlm.nih.gov/42250575/"
        },
        {
          "version": 3,
          "date": "2026-08-02",
          "change": "Removed sponsor-announcement sourcing and limited the TRIUMPH-1 statement to the official completed, no-results-posted registry record.",
          "source": "https://clinicaltrials.gov/study/NCT05929066"
        }
      ]
    },
    {
      "id": "tesamorelin-general-weight-loss-approved-record",
      "compound": "tesamorelin",
      "claim_slug": "tesamorelin-general-weight-loss-approved",
      "claim": "Tesamorelin is FDA-approved for belly fat and general weight loss.",
      "conclusion": "EGRIFTA products have a narrow FDA-approved use: reducing excess abdominal fat in adults with HIV and lipodystrophy. The label explicitly says the product is not indicated for weight-loss management.",
      "confidence": "established",
      "outcome_context": "The approval is real. The general weight-loss claim is not.",
      "product_context": "The identified product, formulation, route, population, and outcome in the cited record; conclusions do not transfer automatically to an unrelated product.",
      "strongest_source": {
        "title": "FDA-approved EGRIFTA WR labeling",
        "authority": "U.S. Food and Drug Administration",
        "type": "FDA labeling",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022505s020lbl.pdf"
      },
      "strongest_limit": "A real product approval is being widened from one defined HIV-associated condition to anyone seeking weight loss or body-composition change.",
      "regulatory_event": {
        "date": "2026-07-17",
        "type": "claim-record verification",
        "jurisdiction": "Not jurisdiction-specific",
        "meaning": "The approval is real. The general weight-loss claim is not.",
        "source": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022505s020lbl.pdf"
      },
      "verified_on": "2026-07-17",
      "next_review_on": "2026-08-18",
      "editorial_status": "second-source-verified",
      "what_changed": "Added the independently reviewed Claim Check to the structured claim/source/change registry.",
      "what_would_change": "A well-controlled human study tied to the exact product, population, route, and claimed outcome could change the answer. Mechanism, anecdotes, or a different product cannot substitute for that evidence.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-17",
          "change": "Initial structured record created from the reviewed Claim Check.",
          "source": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022505s020lbl.pdf"
        }
      ]
    },
    {
      "id": "aod-9604-proven-fat-burning-record",
      "compound": "aod-9604",
      "claim_slug": "aod-9604-proven-fat-burning",
      "claim": "AOD-9604 is clinically proven to burn fat without the usual growth-hormone effects.",
      "conclusion": "FDA's evidence review found a lack of support for effectiveness in obesity. The largest identified study enrolled 536 people and found no significant weight-loss difference from placebo at 12 weeks.",
      "confidence": "supported",
      "outcome_context": "The best-described large obesity study in FDA's review was negative.",
      "product_context": "The identified product, formulation, route, population, and outcome in the cited record; conclusions do not transfer automatically to an unrelated product.",
      "strongest_source": {
        "title": "FDA AOD-9604 briefing document",
        "authority": "U.S. Food and Drug Administration",
        "type": "FDA evidence review",
        "url": "https://www.fda.gov/media/183584/download"
      },
      "strongest_limit": "A proposed mechanism and early development story are being presented as if a large controlled clinical outcome were positive.",
      "regulatory_event": {
        "date": "2026-07-17",
        "type": "claim-record verification",
        "jurisdiction": "Not jurisdiction-specific",
        "meaning": "The best-described large obesity study in FDA's review was negative.",
        "source": "https://www.fda.gov/media/183584/download"
      },
      "verified_on": "2026-07-17",
      "next_review_on": "2026-08-18",
      "editorial_status": "second-source-verified",
      "what_changed": "Added the independently reviewed Claim Check to the structured claim/source/change registry.",
      "what_would_change": "A well-controlled human study tied to the exact product, population, route, and claimed outcome could change the answer. Mechanism, anecdotes, or a different product cannot substitute for that evidence.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-17",
          "change": "Initial structured record created from the reviewed Claim Check.",
          "source": "https://www.fda.gov/media/183584/download"
        }
      ]
    },
    {
      "id": "thymosin-alpha-1-immune-boost-record",
      "compound": "thymosin-alpha-1",
      "claim_slug": "thymosin-alpha-1-immune-boost",
      "claim": "Thymosin alpha-1 is a proven immune boost that helps people fight infections.",
      "conclusion": "Thymosin alpha-1 has human research in specific serious illnesses, but that does not establish a general immune benefit. In a 1,106-person phase 3 sepsis trial, 28-day mortality did not differ significantly from placebo.",
      "confidence": "supported",
      "outcome_context": "Condition-specific research exists; a general proven immune boost does not.",
      "product_context": "The identified product, formulation, route, population, and outcome in the cited record; conclusions do not transfer automatically to an unrelated product.",
      "strongest_source": {
        "title": "Wu et al., 2025 — TESTS phase 3 trial",
        "authority": "PubMed / National Library of Medicine",
        "type": "Randomized trial",
        "url": "https://pubmed.ncbi.nlm.nih.gov/39814420/"
      },
      "strongest_limit": "“Immune boost” merges different diseases, populations, outcomes, and products into one unmeasurable wellness promise.",
      "regulatory_event": {
        "date": "2026-07-17",
        "type": "claim-record verification",
        "jurisdiction": "Not jurisdiction-specific",
        "meaning": "Condition-specific research exists; a general proven immune boost does not.",
        "source": "https://pubmed.ncbi.nlm.nih.gov/39814420/"
      },
      "verified_on": "2026-07-17",
      "next_review_on": "2026-08-18",
      "editorial_status": "second-source-verified",
      "what_changed": "Added the independently reviewed Claim Check to the structured claim/source/change registry.",
      "what_would_change": "A well-controlled human study tied to the exact product, population, route, and claimed outcome could change the answer. Mechanism, anecdotes, or a different product cannot substitute for that evidence.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-17",
          "change": "Initial structured record created from the reviewed Claim Check.",
          "source": "https://pubmed.ncbi.nlm.nih.gov/39814420/"
        }
      ]
    },
    {
      "id": "liraglutide-vials-interchangeable-record",
      "compound": "liraglutide",
      "claim_slug": "liraglutide-vials-interchangeable",
      "claim": "Saxenda, Victoza, generics, compounded liraglutide, and online liraglutide vials are all basically interchangeable.",
      "conclusion": "A shared ingredient name does not erase differences in reference product, approved indication, labeling, strength, manufacturing controls, or product identity. Large trials establish outcomes for identified products and study conditions, not every vial bearing the word liraglutide.",
      "confidence": "established",
      "outcome_context": "Same ingredient name is not the same as same drug product.",
      "product_context": "The identified product, formulation, route, population, and outcome in the cited record; conclusions do not transfer automatically to an unrelated product.",
      "strongest_source": {
        "title": "Current Saxenda labeling on DailyMed",
        "authority": "DailyMed / National Library of Medicine",
        "type": "FDA labeling and randomized trials",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3946d389-0926-4f77-a708-0acb8153b143"
      },
      "strongest_limit": "Ingredient identity is being used as a shortcut for product approval, manufacturing equivalence, and indication.",
      "regulatory_event": {
        "date": "2026-07-17",
        "type": "claim-record verification",
        "jurisdiction": "Not jurisdiction-specific",
        "meaning": "Same ingredient name is not the same as same drug product.",
        "source": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3946d389-0926-4f77-a708-0acb8153b143"
      },
      "verified_on": "2026-07-17",
      "next_review_on": "2026-08-18",
      "editorial_status": "second-source-verified",
      "what_changed": "Added the independently reviewed Claim Check to the structured claim/source/change registry.",
      "what_would_change": "A well-controlled human study tied to the exact product, population, route, and claimed outcome could change the answer. Mechanism, anecdotes, or a different product cannot substitute for that evidence.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-17",
          "change": "Initial structured record created from the reviewed Claim Check.",
          "source": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3946d389-0926-4f77-a708-0acb8153b143"
        }
      ]
    },
    {
      "id": "cagrisema-phase-3-not-approval",
      "compound": "cagrilintide-cagrisema",
      "claim_slug": "cagrisema-phase-3-already-approved",
      "claim": "CagriSema finished Phase 3, so cagrilintide products are basically approved.",
      "conclusion": "A large phase 3 result and the sponsor's December 2025 application submission are meaningful milestones, but neither cagrilintide nor CagriSema is an FDA-approved U.S. drug product as of the July 26 review.",
      "confidence": "supported",
      "outcome_context": "Weight change in the identified REDEFINE 1 trial population and products",
      "product_context": "Coadministered cagrilintide and semaglutide used in REDEFINE 1; unrelated online products are not authenticated by the trial",
      "strongest_source": {
        "title": "Garvey et al., 2025 — REDEFINE 1",
        "authority": "New England Journal of Medicine / PubMed",
        "type": "randomized phase 3 trial",
        "url": "https://pubmed.ncbi.nlm.nih.gov/40544433/"
      },
      "strongest_limit": "The trial and application submission do not establish FDA approval or the identity, sterility, concentration, or performance of another product.",
      "regulatory_event": {
        "date": "2026-07-26",
        "type": "application and status verification",
        "jurisdiction": "United States",
        "meaning": "The sponsor announced an NDA submission. No FDA approval action for CagriSema was identified in the reviewed record.",
        "source": "https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=916470"
      },
      "verified_on": "2026-07-26",
      "next_review_on": "2026-08-26",
      "editorial_status": "second-source-verified",
      "what_changed": "Added the sponsor's December 2025 NDA submission while preserving the separation between submission, FDA review, approval, and product identity.",
      "what_would_change": "An FDA approval, complete response, or other official action would change the dated U.S. status. New peer-reviewed trials could change confidence for a specific outcome. Neither would authenticate an unrelated product without product-level evidence.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-17",
          "change": "Initial independently reviewed evidence and status record.",
          "source": "https://pubmed.ncbi.nlm.nih.gov/40544433/"
        },
        {
          "version": 2,
          "date": "2026-07-26",
          "change": "Recorded the sponsor-announced NDA submission; no FDA approval action was identified.",
          "source": "https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=916470"
        }
      ]
    },
    {
      "id": "cagrisema-separate-products-not-study-product",
      "compound": "cagrilintide-cagrisema",
      "claim_slug": "cagrisema-evidence-transfers-to-separate-products",
      "claim": "If semaglutide and cagrilintide are used together, that is basically CagriSema and the phase 3 results apply.",
      "conclusion": "CagriSema trials coadministered defined sponsor study products under controlled protocols. The proposed NDA product is a fixed-dose combination, and neither record authenticates separately obtained ingredients or an unrelated blend.",
      "confidence": "supported",
      "outcome_context": "Clinical outcomes for defined sponsor study products, populations, comparators, durations, and protocols",
      "product_context": "REDEFINE 1 used a double-dummy, two-injection design; trial evidence does not authenticate an online blend, compounded preparation, separately obtained ingredients, or do-it-yourself mixture",
      "strongest_source": {
        "title": "Garvey et al., 2025 — REDEFINE 1",
        "authority": "New England Journal of Medicine / PubMed",
        "type": "randomized phase 3 trial",
        "url": "https://pubmed.ncbi.nlm.nih.gov/40544433/"
      },
      "strongest_limit": "Shared ingredient names do not establish the same formulation, quality controls, stability, sterility, handling, product identity, or study protocol.",
      "regulatory_event": {
        "date": "2026-07-26",
        "type": "product-identity and approval-status verification",
        "jurisdiction": "United States",
        "meaning": "The sponsor announced an NDA submission, but no FDA approval action was identified; FDA states cagrilintide is not a component of an approved drug and cannot be used in compounding under federal law.",
        "source": "https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss"
      },
      "verified_on": "2026-07-26",
      "next_review_on": "2026-08-26",
      "editorial_status": "second-source-verified",
      "what_changed": "Added a separate product-identity check so evidence transfer is not confused with the distinct question of FDA approval.",
      "what_would_change": "Product-level evidence would be required to authenticate another product. An FDA action could change CagriSema's status but would not by itself authenticate unrelated products.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-26",
          "change": "Initial independently reviewed identity-transfer record.",
          "source": "https://pubmed.ncbi.nlm.nih.gov/40544433/"
        }
      ]
    },
    {
      "id": "mazdutide-phase-3-not-us-approval",
      "compound": "mazdutide",
      "claim_slug": "mazdutide-phase-3-us-approved",
      "claim": "Mazdutide's Phase 3 results mean it is an approved weight-loss peptide in the U.S.",
      "conclusion": "GLORY-1 is a positive phase 3 trial in China. It is not U.S. FDA approval and does not establish equivalence for online products.",
      "confidence": "supported",
      "outcome_context": "Weight change in Chinese adults enrolled in GLORY-1",
      "product_context": "Identified mazdutide trial material; no transfer of identity or quality claims to unrelated products",
      "strongest_source": {
        "title": "Ji et al., 2025 — GLORY-1",
        "authority": "New England Journal of Medicine / PubMed",
        "type": "randomized phase 3 trial",
        "url": "https://pubmed.ncbi.nlm.nih.gov/40421736/"
      },
      "strongest_limit": "The trial was conducted in a defined population and does not perform FDA product review or verify products sold online.",
      "regulatory_event": {
        "date": "2026-07-17",
        "type": "status verification",
        "jurisdiction": "United States",
        "meaning": "No FDA-approved mazdutide drug product was identified; FDA has cited online mazdutide products as unapproved new drugs.",
        "source": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prime-sciences-721805-03312026"
      },
      "verified_on": "2026-07-17",
      "next_review_on": "2026-08-17",
      "editorial_status": "second-source-verified",
      "what_changed": "Added the published GLORY-1 phase 3 results and a dated U.S. status check.",
      "what_would_change": "An FDA application or approval action would change the U.S. status. Longer-term or broader-population trials could change confidence for defined outcomes.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-17",
          "change": "Initial independently reviewed evidence and status record.",
          "source": "https://pubmed.ncbi.nlm.nih.gov/40421736/"
        }
      ]
    },
    {
      "id": "elamipretide-narrow-forzinity-approval",
      "compound": "elamipretide",
      "claim_slug": "elamipretide-approved-anti-aging-energy",
      "claim": "Elamipretide is FDA-approved for anti-aging, energy, and mitochondrial health.",
      "conclusion": "Forzinity has a real accelerated approval for improving muscle strength in people with Barth syndrome who weigh at least 30 kg; that is not a general anti-aging or energy approval.",
      "confidence": "established",
      "outcome_context": "The exact FDA-approved indication and population, not wellness use",
      "product_context": "Forzinity, NDA 215244",
      "strongest_source": {
        "title": "FDA integrated review for Forzinity",
        "authority": "U.S. Food and Drug Administration",
        "type": "integrated regulatory review",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/215244Orig1s000IntegratedR.pdf"
      },
      "strongest_limit": "The pivotal record was very small, and the randomized portion did not show superiority on its primary endpoint family.",
      "regulatory_event": {
        "date": "2025-09-19",
        "type": "accelerated approval",
        "jurisdiction": "United States",
        "meaning": "Forzinity was approved for a defined Barth syndrome population and outcome.",
        "source": "https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-first-treatment-barth-syndrome"
      },
      "verified_on": "2026-07-17",
      "next_review_on": "2026-08-17",
      "editorial_status": "second-source-verified",
      "what_changed": "Added the 2025 accelerated approval and clarified the exact product, population, endpoint basis, and limits of that approval.",
      "what_would_change": "Label changes, confirmatory-trial results, or a new FDA action could change the approved scope or confidence. Evidence in people without Barth syndrome would need separate review.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-17",
          "change": "Initial independently reviewed approval, evidence, and limitation record.",
          "source": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/215244Orig1s000IntegratedR.pdf"
        }
      ]
    },
    {
      "id": "sermorelin-historical-geref-not-anti-aging",
      "compound": "sermorelin",
      "claim_slug": "sermorelin-current-fda-approved-anti-aging",
      "claim": "Sermorelin is an FDA-approved anti-aging peptide.",
      "conclusion": "Historical Geref products were approved and later discontinued; that history is not a current anti-aging approval and does not authenticate a current product.",
      "confidence": "supported",
      "outcome_context": "Historical diagnostic and pediatric growth uses, not adult wellness outcomes",
      "product_context": "Geref NDA 19-863 diagnostic formulation and NDA 20-443 treatment product",
      "strongest_source": {
        "title": "FDA Federal Register notice on discontinued Geref products",
        "authority": "U.S. Food and Drug Administration",
        "type": "official discontinued-product determination",
        "url": "https://public-inspection.federalregister.gov/2013-04827.pdf"
      },
      "strongest_limit": "The reviewed clinical literature does not establish anti-aging, muscle, fat-loss, sleep, or general-vitality benefits in adults.",
      "regulatory_event": {
        "date": "2013-03-04",
        "type": "discontinued-product determination",
        "jurisdiction": "United States",
        "meaning": "FDA determined the Geref products were not withdrawn for safety or effectiveness reasons; they remain in the Discontinued Drug Product List.",
        "source": "https://public-inspection.federalregister.gov/2013-04827.pdf"
      },
      "verified_on": "2026-07-17",
      "next_review_on": "2026-08-17",
      "editorial_status": "second-source-verified",
      "what_changed": "Corrected the cited clinical review from 2007 to 1999 and separated NDA 19-863 for the diagnostic formulation from NDA 20-443 for the treatment product.",
      "what_would_change": "A current FDA approval or well-controlled adult trial tied to a defined product and outcome could change the answer. Historical discontinuation language alone cannot.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-17",
          "change": "Initial held research draft.",
          "source": "https://public-inspection.federalregister.gov/2013-04827.pdf"
        },
        {
          "version": 2,
          "date": "2026-07-17",
          "change": "Corrected review year and clarified the two Geref NDAs; held for independent re-review.",
          "source": "https://pubmed.ncbi.nlm.nih.gov/18031173/"
        }
      ]
    },
    {
      "id": "kpv-clinically-proven-inflammation-wound-healing-record",
      "compound": "kpv",
      "claim_slug": "kpv-clinically-proven-inflammation-wound-healing",
      "claim": "KPV is clinically proven for inflammation, gut problems, and wound healing.",
      "conclusion": "Cell and mouse studies report anti-inflammatory signals, but FDA's 2026 review says it identified no KPV clinical studies or human exposure data through any route. Preclinical findings cannot establish a human treatment effect.",
      "confidence": "supported",
      "outcome_context": "KPV has preclinical signals. A clinically proven human benefit has not been established.",
      "product_context": "The identified product, formulation, route, population, and outcome in the cited record; conclusions do not transfer automatically to an unrelated product.",
      "strongest_source": {
        "title": "FDA KPV briefing document, 2026",
        "authority": "U.S. Food and Drug Administration",
        "type": "FDA evidence review and preclinical study",
        "url": "https://www.fda.gov/media/193346/download"
      },
      "strongest_limit": "A mechanism and animal-model result are being described as clinical proof even though human administration and outcomes have not been established.",
      "regulatory_event": {
        "date": "2026-07-18",
        "type": "claim-record verification",
        "jurisdiction": "Not jurisdiction-specific",
        "meaning": "KPV has preclinical signals. A clinically proven human benefit has not been established.",
        "source": "https://www.fda.gov/media/193346/download"
      },
      "verified_on": "2026-07-18",
      "next_review_on": "2026-08-18",
      "editorial_status": "second-source-verified",
      "what_changed": "Added the independently reviewed Claim Check to the structured claim/source/change registry.",
      "what_would_change": "A well-controlled human study tied to the exact product, population, route, and claimed outcome could change the answer. Mechanism, anecdotes, or a different product cannot substitute for that evidence.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-18",
          "change": "Initial structured record created from the reviewed Claim Check.",
          "source": "https://www.fda.gov/media/193346/download"
        }
      ]
    },
    {
      "id": "mots-c-injections-proven-weight-loss-performance-record",
      "compound": "mots-c",
      "claim_slug": "mots-c-injections-proven-weight-loss-performance",
      "claim": "MOTS-c injections are proven to improve weight loss, energy, and exercise performance.",
      "conclusion": "Human exercise studies measured the body's own MOTS-c; they did not administer MOTS-c as a treatment. FDA says it did not identify studies administering MOTS-c to humans or human exposure data through any route.",
      "confidence": "supported",
      "outcome_context": "Endogenous biomarker research is not proof that MOTS-c injections improve weight or performance.",
      "product_context": "The identified product, formulation, route, population, and outcome in the cited record; conclusions do not transfer automatically to an unrelated product.",
      "strongest_source": {
        "title": "FDA MOTS-c briefing document, 2026",
        "authority": "U.S. Food and Drug Administration",
        "type": "FDA evidence review and human biomarker study",
        "url": "https://www.fda.gov/media/193347/download"
      },
      "strongest_limit": "Measuring a naturally occurring peptide during exercise is being treated as evidence for giving a manufactured peptide as a treatment.",
      "regulatory_event": {
        "date": "2026-07-18",
        "type": "claim-record verification",
        "jurisdiction": "Not jurisdiction-specific",
        "meaning": "Endogenous biomarker research is not proof that MOTS-c injections improve weight or performance.",
        "source": "https://www.fda.gov/media/193347/download"
      },
      "verified_on": "2026-07-18",
      "next_review_on": "2026-08-18",
      "editorial_status": "second-source-verified",
      "what_changed": "Added the independently reviewed Claim Check to the structured claim/source/change registry.",
      "what_would_change": "A well-controlled human study tied to the exact product, population, route, and claimed outcome could change the answer. Mechanism, anecdotes, or a different product cannot substitute for that evidence.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-18",
          "change": "Initial structured record created from the reviewed Claim Check.",
          "source": "https://www.fda.gov/media/193347/download"
        }
      ]
    },
    {
      "id": "semax-clinically-proven-focus-memory-record",
      "compound": "semax",
      "claim_slug": "semax-clinically-proven-focus-memory",
      "claim": "Semax is clinically proven to improve focus, memory, and productivity.",
      "conclusion": "Small human studies measured resting-state brain connectivity after intranasal Semax. They did not establish improved daily function, memory, or productivity, and FDA found the clinical evidence insufficient for the nominated medical uses.",
      "confidence": "supported",
      "outcome_context": "Human mechanistic evidence exists. A clinically proven productivity or memory benefit does not.",
      "product_context": "The identified product, formulation, route, population, and outcome in the cited record; conclusions do not transfer automatically to an unrelated product.",
      "strongest_source": {
        "title": "FDA Semax briefing document, 2026",
        "authority": "U.S. Food and Drug Administration",
        "type": "Small human mechanistic studies and FDA review",
        "url": "https://www.fda.gov/media/193348/download"
      },
      "strongest_limit": "A small brain-imaging signal is being translated into broad real-world cognitive outcomes that the studies did not measure.",
      "regulatory_event": {
        "date": "2026-07-18",
        "type": "claim-record verification",
        "jurisdiction": "Not jurisdiction-specific",
        "meaning": "Human mechanistic evidence exists. A clinically proven productivity or memory benefit does not.",
        "source": "https://www.fda.gov/media/193348/download"
      },
      "verified_on": "2026-07-18",
      "next_review_on": "2026-08-18",
      "editorial_status": "second-source-verified",
      "what_changed": "Added the independently reviewed Claim Check to the structured claim/source/change registry.",
      "what_would_change": "A well-controlled human study tied to the exact product, population, route, and claimed outcome could change the answer. Mechanism, anecdotes, or a different product cannot substitute for that evidence.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-18",
          "change": "Initial structured record created from the reviewed Claim Check.",
          "source": "https://www.fda.gov/media/193348/download"
        }
      ]
    },
    {
      "id": "epitalon-lengthens-telomeres-reverses-aging-record",
      "compound": "epitalon",
      "claim_slug": "epitalon-lengthens-telomeres-reverses-aging",
      "claim": "Epitalon lengthens telomeres and reverses aging in people.",
      "conclusion": "FDA identified one small human biomarker study relevant to circadian-gene expression, not a clinical trial showing age reversal, longer life, or improved patient outcomes. FDA also says it found no clinical human safety studies for Epitalon-related substances.",
      "confidence": "supported",
      "outcome_context": "The human record does not establish telomere-based age reversal or longer life.",
      "product_context": "The identified product, formulation, route, population, and outcome in the cited record; conclusions do not transfer automatically to an unrelated product.",
      "strongest_source": {
        "title": "FDA Epitalon briefing document, 2026",
        "authority": "U.S. Food and Drug Administration",
        "type": "FDA evidence review and human biomarker study",
        "url": "https://www.fda.gov/media/193345/download"
      },
      "strongest_limit": "Biomarker and laboratory findings are being converted into a demonstrated whole-person anti-aging outcome.",
      "regulatory_event": {
        "date": "2026-07-18",
        "type": "claim-record verification",
        "jurisdiction": "Not jurisdiction-specific",
        "meaning": "The human record does not establish telomere-based age reversal or longer life.",
        "source": "https://www.fda.gov/media/193345/download"
      },
      "verified_on": "2026-07-18",
      "next_review_on": "2026-08-18",
      "editorial_status": "second-source-verified",
      "what_changed": "Added the independently reviewed Claim Check to the structured claim/source/change registry.",
      "what_would_change": "A well-controlled human study tied to the exact product, population, route, and claimed outcome could change the answer. Mechanism, anecdotes, or a different product cannot substitute for that evidence.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-18",
          "change": "Initial structured record created from the reviewed Claim Check.",
          "source": "https://www.fda.gov/media/193345/download"
        }
      ]
    },
    {
      "id": "dsip-clinically-proven-insomnia-record",
      "compound": "emideltide-dsip",
      "claim_slug": "dsip-clinically-proven-insomnia",
      "claim": "DSIP is clinically proven to treat insomnia.",
      "conclusion": "Small intravenous human studies from the 1980s exist, including a six-person crossover study, but FDA describes the chronic-insomnia evidence as inconclusive and at best preliminary. FDA found no clinical data for the proposed subcutaneous route.",
      "confidence": "supported",
      "outcome_context": "Human research exists, but it does not establish DSIP as a proven insomnia treatment.",
      "product_context": "The identified product, formulation, route, population, and outcome in the cited record; conclusions do not transfer automatically to an unrelated product.",
      "strongest_source": {
        "title": "FDA emideltide / DSIP briefing document, 2026",
        "authority": "U.S. Food and Drug Administration",
        "type": "FDA evidence review and small human study",
        "url": "https://www.fda.gov/media/193344/download"
      },
      "strongest_limit": "The existence of old human studies is being treated as proof despite tiny samples, mixed results, short follow-up, and a route mismatch.",
      "regulatory_event": {
        "date": "2026-07-18",
        "type": "claim-record verification",
        "jurisdiction": "Not jurisdiction-specific",
        "meaning": "Human research exists, but it does not establish DSIP as a proven insomnia treatment.",
        "source": "https://www.fda.gov/media/193344/download"
      },
      "verified_on": "2026-07-18",
      "next_review_on": "2026-08-18",
      "editorial_status": "second-source-verified",
      "what_changed": "Added the independently reviewed Claim Check to the structured claim/source/change registry.",
      "what_would_change": "A well-controlled human study tied to the exact product, population, route, and claimed outcome could change the answer. Mechanism, anecdotes, or a different product cannot substitute for that evidence.",
      "history": [
        {
          "version": 1,
          "date": "2026-07-18",
          "change": "Initial structured record created from the reviewed Claim Check.",
          "source": "https://www.fda.gov/media/193344/download"
        }
      ]
    }
  ]
}