Editing Probiotic (section)

== Regulation ==
{{As of|2019}}, the [[European Food Safety Authority]] has rejected all petitions by commercial manufacturers for health claims on probiotic products in Europe due to insufficient evidence for a [[causality|cause-and-effect mechanism]] for benefit,  thus inconclusive proof of effectiveness.<ref name="bridging" /><ref name=efsa-heinz/><ref name=heinz/> The [[European Commission]] placed a ban on putting the word "probiotic" on the packaging of products because such labeling misleads consumers to believe a health benefit is provided by the product when no scientific proof exists to demonstrate that health effect.<ref name="bridging" /><ref>{{Cite report |url=http://www.ylfa.org/images/file/Probiotics%20generic%20descriptors-2012.pdf |title='Probiotic' As A General Descriptor |publisher=Yogurt & Live Fermented Milks Association (YLFA) |access-date=12 December 2014 |archive-url=https://web.archive.org/web/20141213035214/http://www.ylfa.org/images/file/Probiotics%20generic%20descriptors-2012.pdf |archive-date=13 December 2014 |url-status=live |df=dmy-all}}</ref><ref name="ireland">{{Cite web |date=2014 |title=Probiotic health claims |url=https://www.fsai.ie/faq/probiotic_health_claims.html |url-status=live |archive-url=https://web.archive.org/web/20170710214129/https://www.fsai.ie/faq/probiotic_health_claims.html |archive-date=10 July 2017 |access-date=13 December 2014 |publisher=Food Safety Authority of Ireland, Dublin |df=dmy-all}}</ref><ref>{{Cite web |date=2006 |title=Regulation (EC) No 1924/2006 of the European Parliament and of the Council on 20 December 2006 on nutrition and health claims made on foods |url=http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2006R1924:20080304:EN:PDF |url-status=live |archive-url=https://web.archive.org/web/20160202203417/http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2006R1924:20080304:EN:PDF |archive-date=2 February 2016 |access-date=13 December 2014 |publisher=European Commission, Brussels |df=dmy-all}}</ref>

In the United States, the [[Food and Drug Administration]] (FDA) and [[Federal Trade Commission]] (FTC) have issued warning letters and imposed punishment on various manufacturers of probiotic products whose labels claim to treat a disease or condition.<ref name="fda" /><ref name="ftc2010">{{Cite web |date=15 December 2010 |title=Dannon Agrees to Drop Exaggerated Health Claims for Activia Yogurt and DanActive Dairy Drink FTC Charges that Evidence Supporting Benefits of Probiotics Falls Short |url=https://www.ftc.gov/news-events/press-releases/2010/12/dannon-agrees-drop-exaggerated-health-claims-activia-yogurt |url-status=live |archive-url=https://web.archive.org/web/20170514073358/https://www.ftc.gov/news-events/press-releases/2010/12/dannon-agrees-drop-exaggerated-health-claims-activia-yogurt |archive-date=14 May 2017 |access-date=9 May 2017 |publisher=Federal Trade Commission, US Government |df=dmy-all}}</ref><ref name="schmidt" /> [[Food label|Food product labeling]] requires language approved by the FDA, so probiotic manufacturers have received warning letters for making disease or treatment claims.<ref name="fda" /><ref name="schmidt">{{Cite web |last=Schmidt |first=Nancy |date=30 July 2014 |title=Warning letter to Plexus Worldwide Inc. |url=https://www.fda.gov/iceci/enforcementactions/warningletters/2014/ucm411287.htm |url-status=dead |archive-url=https://web.archive.org/web/20170508043647/https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm411287.htm |archive-date=8 May 2017 |access-date=9 May 2017 |publisher=Compliance Branch, Inspections, Compliance, Enforcement, and Criminal Investigations, US Food and Drug Administration |df=dmy-all}}</ref> The FTC has taken punitive actions, including a US$21 million fine coordinated by 39 different state governments against a major probiotic manufacturer for deceptive advertising and exaggerated claims of health benefits for yogurt and probiotic dairy drink.<ref name="ftc2010" />

In [[Vietnam]], the Vietnam Food Administration (VFA) under the [[Ministry of Health (Vietnam)|Ministry of Health]], in collaboration with other relevant authorities, oversees and addresses violations related to probiotic products. This includes issuing warnings, imposing administrative penalties,<ref>{{Cite web |date=2018-07-28 |title=Phạt 257 triệu đồng với 7 cơ sở vi phạm về an toàn thực phẩm |url=https://giaoduc.net.vn/phat-257-trieu-dong-voi-7-co-so-vi-pham-ve-an-toan-thuc-pham-post188367.gd |access-date=2024-09-24 |website=Giáo dục Việt Nam |language=vi}}</ref> demanding product recalls<ref>{{Cite web |date=2017-01-03 |title=Thu hồi thuốc Men vi sinh sống Biolac |url=https://baochinhphu.vn/thu-hoi-thuoc-men-vi-sinh-song-biolac-102214858.htm |access-date=2024-09-24 |website=baochinhphu.vn |language=vi}}</ref><ref>{{Cite web |title=Bioamicus complete |url=https://bioamicus.vn/men-vi-sinh-bioamicus-complete |access-date=2024-09-24 |website=Bioamicus |language=vi}}</ref> and coordinating with other agencies.<ref>{{Cite web |date=2013-01-01 |title=Siết chặt quản lý thực phẩm chức năng |url=https://nhandan.vn/siet-chat-quan-ly-thuc-pham-chuc-nang-post384951.html |access-date=2024-09-24 |website=Báo Nhân Dân điện tử |language=vi}}</ref><ref>{{Cite web |date=2017-01-05 |title=Đình chỉ lưu hành men vi sinh sống Biolac do không đạt chất lượng |url=https://baotainguyenmoitruong.vn/dinh-chi-luu-hanh-men-vi-sinh-song-biolac-do-khong-dat-chat-luong-272047.html |access-date=2024-09-24 |website=baotainguyenmoitruong.vn |language=vi}}</ref>

=== Yogurt labeling ===
The [[National Yogurt Association]] (NYA) of the United States gives a "Live & Active Cultures Seal" to refrigerated yogurt products that contain 100 million cells per gram, or frozen yogurt products that contain 10 million cells per gram at the time of manufacture.<ref>{{Cite web |title=Live & Active Culture Yogurt |url=http://aboutyogurt.com/index.asp?bid=5 |url-status=live |archive-url=https://web.archive.org/web/20141208022547/http://www.aboutyogurt.com/index.asp?bid=5 |archive-date=8 December 2014 |access-date=12 December 2014 |publisher=National Yogurt Association |df=dmy-all}}</ref> In 2002, the FDA and WHO recommended that "the minimum viable numbers of each probiotic strain at the end of the shelf-life" be reported on labeling,<ref>{{Cite report |url=https://www.fda.gov/ohrms/dockets/dockets/95s0316/95s-0316-rpt0282-tab-03-ref-19-joint-faowho-vol219.pdf |title=Guidelines for the Evaluation of Probiotics in Food, Report of a Joint FAO/WHO Working Group on Drafting Guidelines for the Evaluation of Probiotics in Food |date=April 2002 |publisher=Food and Agriculture Organization and World Health Organization |location=London, Ontario, Canada |access-date=12 December 2014 |archive-url=https://web.archive.org/web/20140801074333/https://www.fda.gov/ohrms/dockets/dockets/95s0316/95s-0316-rpt0282-tab-03-ref-19-joint-faowho-vol219.pdf |archive-date=1 August 2014 |url-status=dead |df=dmy-all}}</ref> but most companies that give a number report the viable cell count at the date of manufacture, a number that could be much higher than that which exists at consumption.<ref>{{Cite journal |last=Sanders |first=ME |date=2000 |title=Considerations for Use of Probiotic Bacteria to Modulate Human Health |journal=The Journal of Nutrition |volume=130 |issue=2S Suppl |pages=384S–390S |doi=10.1093/jn/130.2.384S |pmid=10721912 |doi-access=free |df=dmy-all}}</ref> Because of the variability in storage conditions and time before eating, exactly how many active culture cells remain at the time of consumption is difficult to determine. The survival of probiotics was strongly dependent on the storage temperature and remarkable viability loss occurred in room temperature compared to refrigerated storage.<ref>{{Cite journal |last1=Ferdousi |first1=Rohollah |last2=Rouhi |first2=Millad |last3=Mohammadi |first3=Reza |last4=Mortazavian |first4=Amir Mohamad |last5=Khosravi-Darani |first5=Kianosh |last6=Rad |first6=Aziz Homayouni |date=Winter 2013 |title=Evaluation of probiotic survivability in yogurt exposed to cold chain interruption |journal=Iranian Journal of Pharmaceutical Research |language=en |volume=12 |issue=Suppl |pages=139–144 |issn=1735-0328 |pmc=3813376 |pmid=24250681}}</ref>