What the scanner
checks against.

Stem cell therapy

Cord blood, MSC, and adult stem cell offerings for orthopedic, cosmetic, and wellness use.

Status: Only cord-blood-derived HPCs (e.g., HEMACORD, DUCORD) are FDA approved, and only for blood disorders. All other stem cell therapies are unapproved. HCT/Ps are governed by 21 CFR Part 1271: §1271.10 sets the four criteria for regulation solely under section 361 (minimal manipulation, homologous use, no combination with another article, no systemic effect or limited to autologous/first-degree-allogeneic/reproductive use); §1271.15(b) provides the same-surgical-procedure exception; §1271.350 sets adverse-event reporting via Form FDA-3500A within 15 calendar days.

Exosomes

Exosome injections marketed for orthopedic, aesthetic, and wellness applications.

Status: NO FDA-approved exosome products exist. Education only. FDA issued an explicit Consumer Alert in 2019/2020 (https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/public-safety-notification-exosome-products). Exosomes are 351 biologics requiring a BLA; they do not satisfy the four 21 CFR 1271.10 criteria for 361 HCT/P regulation, and §1271.350 adverse-event reporting still applies where distributed.

PRP / PRF (autologous)

Platelet-rich plasma and fibrin for joints, hair restoration, aesthetics, and dental use.

Status: 510(k) cleared ONLY for bone graft handling. All other uses (joints, hair, face) are off-label. The term 'PRP' refers specifically to AUTOLOGOUS platelet-rich plasma derived from the patient's own peripheral blood; products marketed as 'cord-blood PRP', 'placenta PRP', 'umbilical-cord PRP', or 'birth-tissue PRP' are NOT autologous PRP - they are perinatal HCT/Ps (or unapproved 351 biologics) and fall under the prp_birth_tissue modality, not this one.

Peptide therapy

Compounded peptides used in regenerative, recovery, and longevity protocols.

Status: BPC-157, TB-500, and many others banned from compounding by FDA. No FDA-approved peptide therapies for regenerative use.

IV therapy

Vitamin, mineral, and amino acid IV drips marketed for wellness, recovery, or immunity.

Status: No disease claims allowed. Wellness framing only. NAD+ and vitamin IVs are not FDA approved for any disease.

BHRT

Bioidentical hormone replacement for perimenopause, andropause, and longevity programs.

Status: Compounded bioidentical hormones are NOT FDA approved. Only manufactured BHRT products with NDAs are approved.

SVF / adipose stem cells

Stromal vascular fraction and adipose-derived cell therapies.

Status: SVF/adipose stem cells are unapproved 351 biologics. Cannot be marketed as therapy. Enzymatic SVF preparation generally fails 21 CFR 1271.10(a)(1) ('minimally manipulated' criterion) per FDA's HCT/P framework; courts have upheld this (US v. US Stem Cell Clinic, 11th Cir. 2021). The 21 CFR 1271.15(b) same-surgical-procedure exception is narrow and does not cover most SVF clinical models. 21 CFR 1271.350 adverse-event reporting applies where distributed.

Hyperbaric oxygen (HBOT)

Hyperbaric chambers marketed for wound care, recovery, neurological, or anti-aging use.

Status: FDA cleared for 13 specific indications (decompression, wounds, CO poisoning, etc.). All other uses are off-label.

Compounded GLP-1

Compounded semaglutide and tirzepatide programs run by 503A/503B pharmacies for medically supervised weight loss.

Status: Compounded semaglutide/tirzepatide/retatrutide are not FDA-approved drugs. Compounding under 21 USC 353a (503A pharmacies) or 353b (503B outsourcing facilities) is permitted only under narrow shortage-list / patient-specific exceptions; FDA removed semaglutide and tirzepatide from the drug shortage list in 2024-2025 and clarified that compounding 'essentially a copy' of an approved drug is prohibited (https://www.fda.gov/drugs/human-drug-compounding/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize). FDA issued warning letters to US Chem Labs (Feb 7, 2024, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/us-chem-labs-669074-02072024) and Synthetix/Helix Chemical Supply (Feb 7, 2024) for selling unapproved semaglutide and tirzepatide as 'research only.' FTC has flagged misleading GLP-1 weight-loss marketing under Section 5 of the FTC Act.

Ketamine therapy

IV, IM, intranasal, and Spravato ketamine programs for mood and pain.

Status: Ketamine is a DEA Schedule III controlled substance (21 CFR 1308.13(b)(7)). FDA-approved ketamine is an IV/IM anesthetic; it is NOT FDA approved for depression, PTSD, or any psychiatric indication - those uses are off-label. Esketamine (Spravato) is the only FDA-approved ketamine-class product for treatment-resistant depression and is restricted under a REMS program requiring in-office administration and observation. Compounded oral and nasal ketamine carry FDA safety alerts (https://www.fda.gov/drugs/human-drug-compounding/fda-warns-patients-and-health-care-providers-about-potential-risks-associated-compounded-ketamine and https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-professionals-potential-risks-associated-compounded-ketamine-nasal-spray). The Ryan Haight Act, 21 USC 829(e), requires at least one in-person medical evaluation before any controlled-substance prescription via telemedicine (subject to time-limited DEA flexibilities).

NAD+ IV therapy

NAD+ IVs and injectables marketed for wellness, longevity, and recovery.

Status: NAD+ injectable/IV products are not FDA-approved finished drugs for any indication. They are compounded preparations subject to 21 USC 353a/353b. FDA has issued recalls of compounded NAD products for being out-of-specification (e.g., Olympia Pharmacy nationwide recall covering compounded NAD injectables, https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts). FTC Section 5 unfair-and-deceptive-practices authority applies to anti-aging or disease-treatment claims for any IV therapy; FTC's 2022 Health Products Compliance Guidance requires randomized controlled human clinical trials to substantiate disease and structure/function claims for health products.

Ozone therapy

Major autohemotherapy, insufflation, and prolozone offerings.

Status: FDA has no approved medical use for ozone. 21 CFR 801.415 states 'ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy.' Devices that generate ozone for therapeutic use are unapproved/unauthorized devices; FDA issued a warning letter to O3UV, LLC on July 7, 2025 for marketing autohemotherapy/EBOO (extracorporeal blood oxygenation and ozonation) devices without authorization (https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/o3uv-llc-668840-07072025). Earlier warning letters include Living Foods LLC (July 5, 2022) for ozone-based products marketed as new drugs without approval.

BPC-157 peptide

BPC-157 marketed for tendon, gut, and recovery support.

Status: BPC-157 is not an FDA-approved drug. It is not on the section 503A bulks list permitted for compounding, and FDA has stated it does not qualify as a USP/NF monograph substance or a component of an FDA-approved drug; under 21 USC 353a(b)(1)(A), bulk drug substances used in 503A compounding must satisfy one of those criteria. FDA placed BPC-157 (free base and acetate) on Category 2 of the interim 503A bulks list as a substance presenting significant safety risks (https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks). BPC-157 is scheduled to be discussed at the July 23-24, 2026 Pharmacy Compounding Advisory Committee meeting (https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026). FDA has issued warning letters to peptide compounders selling BPC-157 (Summit Research Peptides, Dec 10, 2024, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024; Xcel Research LLC, Dec 10, 2024, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024).

TRT / men's hormone optimization

Testosterone replacement and men's hormone programs.

Status: Testosterone is a DEA Schedule III controlled substance (21 CFR 1308.13). FDA-approved testosterone products are indicated only for men with low testosterone levels caused by certain medical conditions (classical hypogonadism). FDA issued a Drug Safety Communication on March 3, 2015 requiring class-wide labeling changes warning of possible increased risk of heart attack and stroke and clarifying that the benefit and safety of testosterone has NOT been established for low testosterone due to aging (https://www.fda.gov/drugs/drug-safety-and-availability/fda-issues-class-wide-labeling-changes-testosterone-products). Compounded testosterone preparations are not FDA approved. FTC has acted against 'Low T' marketing under Section 5 of the FTC Act for unsubstantiated claims about energy, libido, and vitality.

Sermorelin

Growth hormone-releasing hormone analogue compounded for anti-aging and recovery protocols.

Status: Sermorelin acetate is a GHRH analog. It was previously FDA approved as Geref (Serono) NDA 19-863 (0.05 mg base/amp diagnostic) and Geref NDA 20-443 (0.5 / 1.0 mg base/vial therapeutic) for pediatric growth hormone deficiency and as a diagnostic agent. EMD Serono discontinued the 0.05 mg form by letter dated July 11, 2008 and the 0.5/1.0 mg forms by letter dated December 2, 2008. FDA announced withdrawal of approval of both NDAs at 74 FR 23407 (May 19, 2009), effective June 18, 2009 (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019863). FDA later confirmed in a March 4, 2013 Federal Register notice that the Geref products were NOT withdrawn for reasons of safety or effectiveness (https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams) - that determination is the basis 503A compounding pharmacies cite under 21 USC 353a(b)(1)(A)(ii) for continued use. Sermorelin was NOT placed on FDA's Category 2 list in the September 2023 peptide action that captured CJC-1295, ipamorelin, BPC-157, and others (https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks).

Ipamorelin

Selective GHRP marketed for sleep, recovery, and body composition.

Status: Ipamorelin acetate is a growth-hormone-releasing peptide (GHRP). It is NOT an FDA-approved drug. On September 29, 2023 FDA placed ipamorelin acetate on Category 2 of the interim 503A bulks list (substances FDA has identified significant safety risks for), alongside BPC-157, CJC-1295, GHK-Cu (injectable), Melanotan II, MOTS-c, Selank, Thymosin Alpha-1, and Thymosin Beta-4 (https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks). FDA announced on September 20, 2024 that AOD-9604, CJC-1295, ipamorelin acetate, Thymosin Alpha-1 (Ta1), and Selank acetate (TP-7) were being removed from Category 2 effective September 27, 2024 because the original nominators withdrew the nominations, and stated it would consult the Pharmacy Compounding Advisory Committee (PCAC) for potential future inclusion on the 503A bulks list. Under 21 USC 353a(b)(1)(A), bulk drug substances used in 503A compounding must be the subject of an applicable USP/NF monograph, be a component of an FDA-approved drug, or appear on the 503A bulks list; ipamorelin satisfies none of those criteria.

CJC-1295

Long-acting GHRH analogue often paired with ipamorelin for growth hormone stacks.

Status: CJC-1295 (with or without DAC, Drug Affinity Complex) is a GHRH analog. It is NOT an FDA-approved drug. CJC-1295 was placed on FDA's Category 2 of the interim 503A bulks list on September 29, 2023 as a substance presenting significant safety risks (https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks). FDA removed CJC-1295 from Category 2 on September 27, 2024 because the nominator withdrew the nomination, and announced PCAC would review CJC-1295 for potential future inclusion on the 503A bulks list (PCAC meeting scheduled December 4, 2024 for CJC-1295, AOD-9604, and Thymosin Alpha-1; FDA's pre-meeting briefing recommended NOT including these substances on the bulks list). 21 USC 353a(b)(1)(A) criteria are not satisfied (no USP/NF monograph, not a component of an FDA-approved drug, not currently on the bulks list).

Tesamorelin (Egrifta)

FDA-approved for HIV-associated lipodystrophy; widely marketed off-label for weight loss.

Status: Tesamorelin (Egrifta, Egrifta SV, Egrifta WR) IS FDA approved, BUT only for one narrow indication: reduction of excess abdominal fat in adults with HIV-associated lipodystrophy. The original Egrifta NDA 22505 approval issued November 10, 2010 (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022505lbl.pdf); Egrifta SV was approved November 1, 2019; the F8 concentrated formulation Egrifta WR was approved March 2025. The current FDA-approved Egrifta WR labeling states tesamorelin is NOT indicated for weight loss management (https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022505s020lbl.pdf). Use of tesamorelin for general fat-loss, body-recomposition, anti-aging, or non-HIV abdominal-fat marketing is off-label and not supported by the approved labeling. Compounded tesamorelin sold as 'research only' or as a body-composition peptide for non-HIV patients is unapproved-drug marketing under 21 USC 355(a) and likely misbranding under 21 USC 352. Tesamorelin is frequently sold by peptide compounders in multi-ingredient stacks (CJC-1295 / tesamorelin / ipamorelin); the BPC-157 / TB-500 peptide enforcement wave (Summit Research Peptides 12/10/2024, Xcel Research LLC 12/10/2024) covers compounders selling these stacks, but no FDA warning letter with tesamorelin as primary subject has been publicly indexed as of 2026-05-20 - the off-label exposure rides on the broader GLP-class enforcement umbrella (https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss).

TB-500 / thymosin beta-4

Peptide marketed for soft-tissue and tendon recovery.

Status: TB-500 (thymosin beta-4 fragment / LKKTETQ) is not an FDA-approved drug. FDA placed TB-500 (along with full-length thymosin beta-4) on Category 2 of the interim 503A bulks list as a substance presenting significant safety risks (https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks). Section 503A bulk-substance criteria under 21 USC 353a(b)(1)(A) are not satisfied. TB-500 (free base and acetate) is scheduled to be reviewed by the Pharmacy Compounding Advisory Committee at the July 23-24, 2026 meeting (https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026); the PCAC outcome does not change the current Category 2 status until FDA acts on the committee's recommendation. TB-500 is prohibited in sport under WADA's S2 class (peptide hormones / growth factors). FDA has issued warning letters to peptide compounders selling BPC-157, TB-500, and related substances (Summit Research Peptides, Dec 10, 2024, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024).

GHK-Cu copper peptide

Copper-binding tripeptide promoted for skin repair, hair regrowth, and wound healing.

Status: GHK-Cu (copper tripeptide-1, also written as copper peptide GHK) is used in two regulatory contexts. (a) As a cosmetic ingredient applied to intact skin in serums and creams, GHK-Cu is regulated as a cosmetic (FDCA section 201(i)) and is not approved or evaluated by FDA for any therapeutic use. (b) As an injectable, GHK-Cu was placed on Category 2 of the interim 503A bulks list specifically for injectable routes of administration. Status as of May 2026: GHK-Cu (except for injectable routes) was removed from Category 1 on April 22, 2026 because the original nominators withdrew their nominations; on May 5, 2026 one nominator clarified that it intended to withdraw only its injectable-route nomination and would retain its non-injectable nomination, and FDA accordingly will add non-injectable GHK-Cu back to Category 1 (https://www.fda.gov/media/94155/download). FDA has stated it intends to consult the Pharmacy Compounding Advisory Committee regarding the potential inclusion of GHK-Cu on the 503A bulks list before the end of February 2027. Injectable GHK-Cu remains outside the 21 USC 353a(b)(1)(A) bulk-substance criteria; topical / cosmetic GHK-Cu in skincare remains a cosmetic and is not implicated by the compounding rules, but marketing topical GHK-Cu with drug claims (e.g., reverses photoaging, treats wounds) converts the cosmetic to an unapproved drug under FDCA section 201(g).

PT-141 (bremelanotide)

Melanocortin receptor agonist marketed for sexual function.

Status: PT-141 (bremelanotide, brand name Vyleesi) is FDA approved ONLY for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Vyleesi was approved June 21, 2019 (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210557s000lbl.pdf). Use in men, in postmenopausal women, or for erectile dysfunction is off-label and not supported by the approved labeling. Vyleesi labeling carries warnings for transient blood pressure increase and focal hyperpigmentation. Compounded bremelanotide marketed as 'PT-141' for general libido or male sexual function falls outside the approved use and, where compounded as essentially a copy of Vyleesi, may run afoul of 21 USC 353a/353b compounding limits.

Tirzepatide (Mounjaro / Zepbound)

Dual GIP/GLP-1 receptor agonist for type 2 diabetes and chronic weight management.

Status: Tirzepatide is the active ingredient in FDA-approved Mounjaro (approved May 13, 2022 for type 2 diabetes) and Zepbound (approved November 8, 2023 for chronic weight management in adults with obesity or overweight with at least one weight-related condition; https://www.fda.gov/news-events/press-announcements/fda-approves-new-medication-chronic-weight-management). FDA removed tirzepatide from the drug shortage list on October 2, 2024 and reaffirmed that determination in December 2024 (https://www.fda.gov/drugs/drug-safety-and-availability/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss). Once a drug is no longer on the shortage list, 503A and 503B compounders generally may not compound essentially a copy of the FDA-approved product (21 USC 353a(b)(1)(D) and 353b(a)(5)). Eli Lilly has filed multiple civil lawsuits against compounders, weight-loss clinics, and telehealth sellers offering compounded tirzepatide. FDA has issued letters and consumer alerts about counterfeit Mounjaro/Zepbound seized at the border. FTC Section 5 applies to weight-loss claims for compounded tirzepatide.

Retatrutide (investigational)

Investigational triple agonist; not FDA approved and widely flagged in compounder warning letters.

Status: Retatrutide (LY3437943) is an investigational triple-agonist (GLP-1 / GIP / glucagon) being developed by Eli Lilly. It is NOT FDA approved for any indication. Lilly's Phase 3 TRIUMPH program is ongoing and Lilly has not submitted a New Drug Application as of the latest publicly reported timelines (https://www.lilly.com/news/stories/what-to-know-about-retatrutide). Because retatrutide is not an approved drug and is not an article of an approved drug, it cannot satisfy 21 USC 353a(b)(1)(A) bulk-substance criteria for 503A compounding, and it does not appear on the 503A or 503B bulks lists. FDA has stated that compounded 'retatrutide' products being sold by telehealth clinics and compounders are unapproved new drugs (https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss). Marketing any compounded or 'research only' retatrutide as a weight-loss therapy is per se unlawful as introduction of an unapproved new drug into interstate commerce (21 USC 355(a)) and misbranding (21 USC 352). FTC Section 5 substantiation rules also apply to associated weight-loss claims. Specific FDA warning letters targeting retatrutide sellers include: Summit Research Peptides 695607 (Dec 10, 2024, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/summit-research-peptides-695607-12102024), Xcel Research LLC 694608 (Dec 10, 2024, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/xcel-research-llc-694608-12102024), GLP-1 Solution 715883 (Sept 9, 2025, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glp-1-solution-715883-09092025), ASN-LABS 716459 (Sept 9, 2025, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/asn-labs-716459-09092025), Darmerica LLC 716152 (Dec 8, 2025, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025), Mile High Compounds LLC 721600 (Mar 31, 2026, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mile-high-compounds-llc-721600-03312026), and Gram Peptides 721806 (Mar 31, 2026, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gram-peptides-721806-03312026).

HCG weight loss

Human chorionic gonadotropin marketed for weight loss despite FDA's unapproved-use determination.

Status: Human chorionic gonadotropin (HCG) is FDA approved for specific endocrine indications (e.g., infertility, hypogonadotropic hypogonadism, prepubertal cryptorchidism). FDA has explicitly prohibited the use and marketing of HCG for weight loss. On December 6, 2011 FDA and FTC sent seven joint warning letters to companies marketing 'homeopathic' HCG and HCG-related products for weight loss, stating these products are unapproved drugs and that HCG is not approved for any weight-loss indication (https://www.ftc.gov/news-events/news/press-releases/2011/12/fda-ftc-act-against-companies-marketing-illegal-hcg-weight-loss). FDA-approved HCG injectable labeling explicitly states HCG has no recognized effectiveness as adjunctive therapy in the treatment of obesity and that there is no substantial evidence HCG increases weight loss beyond that resulting from caloric restriction. Over-the-counter 'homeopathic' HCG drops, sprays, or pellets for weight loss are illegal.

Wharton's jelly

Umbilical-cord-derived product marketed for orthopedic and regenerative use; FDA enforcement target.

Status: Wharton's jelly is the gelatinous connective tissue from the umbilical cord. Wharton's jelly products are perinatal HCT/Ps under 21 CFR Part 1271. FDA has consistently treated Wharton's jelly products marketed for orthopedic, anti-aging, or systemic conditions as unapproved new drugs and unlicensed biologics requiring a BLA, because they fail one or more of the four 21 CFR 1271.10(a) criteria for regulation solely under section 361 (most commonly failing the homologous-use requirement). FDA's enforcement-discretion period for certain HCT/Ps ended May 31, 2021 (https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/questions-and-answers-regarding-end-compliance-and-enforcement-policy-certain-human-cells-tissues-or). Notable enforcement: FDA warning letter to Regenative Labs (2022) classifying Wharton's-jelly tissue products as unapproved drugs; Liveyon Labs / Liveyon LLC warning letter (Dec 6, 2019) plus subsequent criminal prosecution of owner John Kosolcharoen, who pled guilty and was sentenced (Sept 2024) to 36 months in federal prison for introducing an unapproved new drug into interstate commerce, with CDC documenting 19 patient hospitalizations across eight states tied to bacterial infections from Liveyon's umbilical-cord-derived products. Several states (e.g., Florida 2024 stem-cell law) layer state notice and consent requirements on top of federal status.

Bone marrow aspirate concentrate (BMAC)

Autologous bone marrow concentrate for orthopedic and wound applications.

Status: Bone marrow aspirate concentrate (BMAC) is autologous bone marrow that has been aspirated and concentrated by centrifugation. When BMAC is removed from a patient and reimplanted into the SAME patient during the SAME surgical procedure, it can fall under the 21 CFR 1271.15(b) same-surgical-procedure exception and be outside Part 1271 registration and listing requirements (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/same-surgical-procedure-exception-under-21-cfr-127115b-questions-and-answers-regarding-scope). Where BMAC is processed off-site, stored, expanded, combined with another article, or otherwise more-than-minimally manipulated (21 CFR 1271.10(a)(1)), or used for non-homologous purposes, it loses the 1271.15(b) exception and is regulated as an HCT/P (and often as an unapproved biologic / 351 product requiring a BLA). Marketing BMAC for systemic, anti-aging, or non-homologous indications can convert a permissible same-surgical-procedure use into an unapproved-drug enforcement target. FDA's same-surgical-procedure guidance and the broader 'Regulatory Considerations for HCT/Ps: Minimal Manipulation and Homologous Use' guidance (Nov 2017, updated 2020) set the controlling framework. FDA's HCT/P enforcement umbrella (45+ regulatory letters in a single year per https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-biologics-center-director-peter-marks-md-phd-fdas) and the US Stem Cell Clinic LLC warning letter 524470 (Aug 24, 2017, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/us-stem-cell-clinic-llc-524470-08242017) establish the precedent that processed autologous cell products marketed for non-homologous indications are unapproved biologics; no warning letter has been publicly indexed as of 2026-05-20 where BMAC is the primary cited violation (BMAC enforcement consistently rides alongside SVF, amnio, or umbilical-derived products under the same HCT/P umbrella).

Shockwave ED therapy

Low-intensity extracorporeal shockwave devices marketed for erectile dysfunction.

Status: Low-intensity extracorporeal shockwave therapy (Li-ESWT) for erectile dysfunction, often marketed under brand programs such as GAINSWave or under generic 'shockwave for ED' branding, is NOT FDA cleared or approved for the treatment of erectile dysfunction. The American Urological Association's 2018 ED Guideline (updated 2024) classifies Li-ESWT for ED as investigational and recommends use only within research protocols. Several acoustic-wave devices hold 510(k) clearances for OTHER indications (e.g., activation of connective tissue, pain reduction, improved local blood supply, treatment of chronic diabetic foot ulcers, treatment of certain second-degree burns); using a device cleared for one indication to treat ED is off-label device use, and clinic marketing claims for ED efficacy are subject to FDA misbranding enforcement under 21 USC 352 (intended-use doctrine, 21 CFR 801.4 - intended use can be established by promotional labeling) and FTC Section 5 substantiation rules. The exposure model for shockwave-ED marketing has historically run through FTC consumer-protection enforcement on the unsubstantiated efficacy claims (https://www.ftc.gov/legal-library/browse/cases-proceedings/cases) and state medical-board action against the prescribing physician, rather than through an FDA device warning letter naming GAINSWave or Li-ESWT specifically; no FDA warning letter with GAINSWave or shockwave-for-ED as the primary cited violation has been publicly indexed as of 2026-05-20. Clinics relying on this gap should not - the absence of a primary FDA letter is an enforcement-priority artifact, not an endorsement of the marketing.

Botulinum toxin (Botox / Dysport / Xeomin / Jeuveau)

Neuromodulator injections for aesthetic and therapeutic use.

Status: FDA-approved botulinum toxin products include onabotulinumtoxinA (Botox / Botox Cosmetic, Allergan/AbbVie), abobotulinumtoxinA (Dysport, Galderma), incobotulinumtoxinA (Xeomin, Merz), prabotulinumtoxinA (Jeuveau, Evolus), and daxibotulinumtoxinA-lanm (Daxxify, Revance). FDA-approved indications include glabellar lines (and certain other dynamic facial lines for some products), chronic migraine, cervical dystonia, spasticity, strabismus, blepharospasm, hyperhidrosis (axillary), overactive bladder, and neurogenic detrusor overactivity; specific indications vary by product label. All FDA-approved botulinum toxin products carry a Boxed Warning regarding distant spread of toxin effect (https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103000s5377lbl.pdf). FDA issued 18 warning letters in November 2025 to websites illegally marketing unapproved and misbranded botulinum toxin products (https://www.fda.gov/news-events/press-announcements/fda-warns-companies-over-illegal-marketing-botox-and-related-products) and continues to act against counterfeit/illegally imported botulinum toxin. Use of FDA-approved botulinum toxin for indications outside the approved label (for example 'preventative Botox' marketing for sub-30 patients, masseter slimming for non-dystonia cosmetic shaping, off-label trapezius / scalp / 'Barbie Botox' marketing) is off-label and clinic claims must comply with FDA misbranding rules and FTC substantiation. Injectors must operate within their state scope of practice; unsupervised non-physician injection in some states is itself a regulatory violation.

HA dermal fillers

Hyaluronic acid filler injections for facial volumization and contouring.

Status: Hyaluronic acid (HA) dermal fillers (Juvederm, Restylane, RHA, Belotero, Versa, Skinvive, and related brands) are FDA-approved Class III medical devices regulated under 21 CFR Part 878 and approved through PMA (premarket approval) for specific anatomic sites and indications (e.g., correction of moderate-to-severe facial wrinkles and folds, lip augmentation, cheek augmentation, hand augmentation in certain products). Use in anatomic locations or for indications not on the device label (notably non-surgical rhinoplasty / nose filler, breast / buttock / body-contouring fillers, and intramammary / intra-glute injection) is off-label and carries elevated risk of vascular occlusion, blindness, and stroke. FDA's General and Plastic Surgery Devices Panel reviewed dermal filler safety on March 23, 2021 (https://www.fda.gov/medical-devices/medical-devices-news-and-events/general-and-plastic-surgery-devices-panel-march-23-2021-meeting-announcement) and FDA has issued multiple consumer warnings against the use of unapproved injectable silicone and unapproved dermal fillers for body contouring (https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/dermal-fillers-soft-tissue-fillers). Claims of 'permanent', 'lifetime', or 'forever' results are false for HA fillers, which are biodegradable. Off-label body-contouring injection by non-physicians has been the subject of state criminal prosecutions and FDA-coordinated enforcement.

Birth-tissue 'PRP' (cord blood / placenta)

Non-autologous birth-tissue products marketed as 'PRP'; flagged by FDA as misbranded HCT/Ps.

Status: Marketing the phrase 'PRP' for any product NOT derived from the patient's own peripheral blood is misbranding. Autologous platelet-rich plasma is regulated as a blood product (and the centrifuge/separator system holds a 510(k) clearance only for handling bone graft material). 'Cord-blood PRP', 'umbilical-cord PRP', 'placenta PRP', 'birth-tissue PRP', and 'allogeneic platelets' are NOT autologous PRP - they are perinatal HCT/Ps under 21 CFR Part 1271 (or, where they fail the four 21 CFR 1271.10(a) criteria, unapproved 351 biologics requiring a BLA). FDA's HCT/P enforcement-discretion period ended May 31, 2021 (https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/questions-and-answers-regarding-end-compliance-and-enforcement-policy-certain-human-cells-tissues-or). Adipose-derived 'PRP' variants overlap with the svf_adipose modality and inherit the SVF regulatory status (US v. US Stem Cell Clinic, 11th Cir. 2021). Calling a non-autologous platelet or birth-tissue product 'PRP' in marketing copy is itself a misbranding signal.

Search, display, and YouTube ad creative subject to Google healthcare policy.

• -No speculative/experimental treatment ads (stem cells, exosomes, PRP, gene therapy)
• -No unproven medical claims
• -Healthcare ads require Google certification

Facebook and Instagram organic posts, reels, and paid creative.

• -18+ targeting required for cosmetic procedures
• -No PHI-based custom audiences
• -No before/after that implies guaranteed results

TikTok organic and paid creative under platform health certification.

• -Health ads require platform certification
• -18+ audience targeting required
• -No cure/treatment promises

Patient newsletters, drip campaigns, and one-off blasts under CAN-SPAM.

• -CAN-SPAM: physical address required
• -Working unsubscribe link required
• -No deceptive subject lines

Patient text messaging under TCPA.

• -Prior express written consent required (TCPA)
• -Time restrictions: no messages before 8am or after 9pm local
• -Opt-out mechanism required in every message

Home pages, service pages, landing pages, and blog posts.

• -Testimonials and endorsements must comply with 16 CFR Part 255 (FTC Endorsement Guides, final revision effective July 26, 2023, 88 FR 48102): truthful, substantiated, material connections disclosed, and not deceptive
• -Consumer testimonials that imply atypical results must include clear and conspicuous disclosure that results are not what most consumers will achieve; a generic 'results not typical' line is insufficient if it is not clear and conspicuous
• -Expert endorsements require that the endorser have qualifications sufficient to give the endorsement (16 CFR 255.3) and must reflect the endorser's actual opinions