{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T22:25:24Z","timestamp":1793312724686,"version":"4.5.0"},"reference-count":68,"publisher":"Cambridge University Press (CUP)","issue":"4","license":[{"start":{"date-parts":[[2021,1,1]],"date-time":"2021-01-01T00:00:00Z","timestamp":1609459200000},"content-version":"unspecified","delay-in-days":731,"URL":"https:\/\/www.cambridge.org\/core\/terms"},{"start":{"date-parts":[[2019,1,1]],"date-time":"2019-01-01T00:00:00Z","timestamp":1546300800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J. Law. Med. Ethics"],"published-print":{"date-parts":[[2019]]},"abstract":"<jats:p>Several lines of evidence suggest that children born via Cesarean section (C-section) are at greater risk for adverse health outcomes including allergies, asthma and obesity. Vaginal seeding is a medical procedure in which infants born by C-section are swabbed immediately after birth with vaginal secretions from the mother. This procedure has been proposed as a way to transfer the mother's vaginal microbiome to the child, thereby restoring the natural exposure that occurs during vaginal birth that is interrupted in the case of babies born via C-section. Preliminary evidence indicates partial restoration of microbes. However, there is insufficient evidence to determine the health benefits of the procedure. Several studies, including trial, are currently underway. At the same time, in the clinic setting, doctors are increasingly being asked to by expectant mothers to have their babies seeded. This article reports on the current research on this procedure and the issues it raises for regulators, researchers, physicians, and patients.<\/jats:p>","DOI":"10.1177\/1073110519897732","type":"journal-article","created":{"date-parts":[[2020,1,20]],"date-time":"2020-01-20T07:11:06Z","timestamp":1579504266000},"page":"568-578","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":22,"title":["Bacterial Baptism: Scientific, Medical, and Regulatory Issues Raised by Vaginal Seeding of C-Section-Born Babies"],"prefix":"10.1017","volume":"47","author":[{"given":"Noel T.","family":"Mueller","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suchitra K.","family":"Hourigan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diane E.","family":"Hoffmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lauren","family":"Levy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erik C.","family":"von Rosenvinge","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Betty","family":"Chou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria-Gloria","family":"Dominguez-Bello","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"56","published-online":{"date-parts":[[2021,1,1]]},"reference":[{"key":"S1073110500025900_bib13","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2018.06.044"},{"key":"S1073110500025900_bib40","unstructured":"40. Austin, J. , \u201cXX Factor: Forget What You've Read. Swabbing Your Baby with Vaginal Juices is Pointless and Weird,\u201d Slate, February 10, 2016, available at <https:\/\/slate.com\/human-interest\/2016\/02\/dousing-your-newborn-in-vaginal-juices-is-pointless-and-weird.html> (last visited October 1, 2019)."},{"key":"S1073110500025900_bib11","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwr242"},{"key":"S1073110500025900_bib7","doi-asserted-by":"publisher","DOI":"10.1136\/archdischild-2011-301141"},{"key":"S1073110500025900_bib41","unstructured":"41. Tuteur, A. , \u201cWarning: Vaginal Seeding Doesn't Work and May Be Harmful,\u201d The Skeptical OB, Feb. 24, 2016, available at <http:\/\/www.skepticalob.com\/2016\/02\/warning-vaginal-seeding-doesnt-work-and-may-be-harmful.html> (last visited October 1, 2019)."},{"key":"S1073110500025900_bib14","doi-asserted-by":"publisher","DOI":"10.1016\/j.molmed.2014.12.002"},{"key":"S1073110500025900_bib56","unstructured":"56. Id. at 1320\u201321 (citing United States v. Dianovin Pharmaceuticals, Inc., 475 F.2d 100 (1st Cir. 1973))."},{"key":"S1073110500025900_bib20","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.i227"},{"key":"S1073110500025900_bib34","unstructured":"34. Standard of care testing includes gonorrhea, chlamydia, hepatitis B, HIV, and syphilis."},{"key":"S1073110500025900_bib59","doi-asserted-by":"publisher","DOI":"10.1093\/jlb\/lsv032"},{"key":"S1073110500025900_bib67","first-page":"13","article-title":"\u201cThe Ethics of Alternative Medicine: An Alternative Standard?\u201d","volume":"12","author":"Glazer","journal-title":"Family Practice Management"},{"key":"S1073110500025900_bib62","doi-asserted-by":"publisher","DOI":"10.1136\/medethics-2016-103955"},{"key":"S1073110500025900_bib52","unstructured":"52. 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Neb. 1966) (holding that a physician was not exempt from the requirements of the FDCA when he used misbranded devices in the treatment of his patients even though he did not sell the devices in the commercial sense)."},{"key":"S1073110500025900_bib55","unstructured":"55. Id. at 1320."},{"key":"S1073110500025900_bib25","unstructured":"25. Mueller, supra note 14; Haahr et al., supra note 22."},{"key":"S1073110500025900_bib36","unstructured":"36. Stein, R. , \u201cDoctors Test Bacterial Smear After Cesarean Sections to Bolster Babies' Microbiomes,\u201d Morning Edition, National Public Radio, October 30, 2018, available at <https:\/\/www.npr.org\/sections\/health-shots\/2018\/10\/30\/658254175\/doctors-test-bacterial-smear-after-cesarean-sections-to-bolster-babies-microbiom> (last visited October 1, 2019)."},{"key":"S1073110500025900_bib48","unstructured":"48. 21 U.S.C. \u00a7 379(a)."},{"key":"S1073110500025900_bib42","unstructured":"42. 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Committee on Obstetric Practice, supra note 14."},{"key":"S1073110500025900_bib65","unstructured":"65. 45 C.F.R. 46.404, 46.405, 46.406, 46.407."},{"key":"S1073110500025900_bib6","doi-asserted-by":"publisher","DOI":"10.1038\/s41366-018-0239-2"},{"key":"S1073110500025900_bib50","unstructured":"50. 21 U.S.C. \u00a7 331(k)."},{"key":"S1073110500025900_bib17","doi-asserted-by":"publisher","DOI":"10.1038\/nm.4039"},{"key":"S1073110500025900_bib53","unstructured":"53. Id."},{"key":"S1073110500025900_bib32","unstructured":"32. 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Biological products are a subcategory of drugs, defined by FDA as \u201ca virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product \u2026 applicable to the prevention, treatment, or cure of a disease or condition of human beings.\u201d 42 U.S.C. \u00a7 262(i)."},{"key":"S1073110500025900_bib37","unstructured":"37. Committee on Obstetric Practice, supra note 14."},{"key":"S1073110500025900_bib16","article-title":"\u201cSixty Seconds on \u2026 Vaginal Seeding,\u201d","volume":"352","author":"Iacobucci","year":"2016","journal-title":"BMJ"},{"key":"S1073110500025900_bib24","unstructured":"24. Dominguez-Bello et al., supra note 15."},{"key":"S1073110500025900_bib18","unstructured":"18. Id."},{"key":"S1073110500025900_bib54","unstructured":"54. 741 F.3d 1314 (D.C. Cir. 2014)."},{"key":"S1073110500025900_bib1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)31928-7"},{"key":"S1073110500025900_bib63","unstructured":"63. The Nuremburg Code (1949), available at <https:\/\/history.nih.gov\/research\/downloads\/nuremberg.pdf> (last visited October 1, 2019)."},{"key":"S1073110500025900_bib45","unstructured":"45. U.S. Food & Drug Administration, Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies, Guidance for Industry, July 2013, available at <https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/enforcement-policy-regarding-investigational-new-drug-requirements-use-fecal-microbiota> (last visited October 1, 2019)."},{"key":"#cr-split#-S1073110500025900_bib47.1","unstructured":"47. U.S. Food & Drug Administration, Pre-IND Meeting Denial Letter, Jan. 29, 2018. Provided by authors"},{"key":"#cr-split#-S1073110500025900_bib47.2","unstructured":"U.S. Food & Drug Administration, Guidance for Clinical Investigators, Sponsors and IRBs, Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND, Sept. 2013, available at <https:\/\/www.fda.gov\/downloads\/drugs\/guidances\/ucm229175.pdf> (last visited October 1, 2019)."},{"key":"S1073110500025900_bib30","doi-asserted-by":"publisher","DOI":"10.1038\/s41467-019-09252-4"}],"container-title":["Journal of Law, Medicine &amp; Ethics"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1073110519897732","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/1073110519897732","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.cambridge.org\/core\/services\/aop-cambridge-core\/content\/view\/S1073110500025900","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,1,14]],"date-time":"2021-01-14T14:58:01Z","timestamp":1610636281000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.cambridge.org\/core\/product\/identifier\/S1073110500025900\/type\/journal_article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019]]},"references-count":68,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2019]]}},"alternative-id":["S1073110500025900"],"URL":"https:\/\/doi.org\/10.1177\/1073110519897732","relation":{},"ISSN":["1073-1105","1748-720X"],"issn-type":[{"value":"1073-1105","type":"print"},{"value":"1748-720X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019]]}}}