How Probiotics Are Regulated: Food, Supplement or Drug in the US, EU, Canada and UK
How probiotics are classed as food, dietary supplement or drug in the US, EU, Canada and UK according to the sources we read, and what that does and does not tell you about a product.
Content last updated . This page has not been medically reviewed.
This page is information only. It is not legal advice and it does not tell you which product to buy. Several of the sources below are older, and we say so in the table. For the wider picture of supplement rules, see Supplement regulation by country.
Why the category matters
- Food or supplement: NCCIH says many probiotics are sold as dietary supplements, which do not require FDA approval before they are marketed. [1]
- Claims: NCCIH says supplement labels may describe effects on the structure or function of the body, but may not make a health claim such as lowering the risk of a disease without the FDA's consent. [1]
- Drug: a probiotic marketed to treat a disease must be proven safe and effective through clinical trials and approved by the FDA before it can be sold. [1]
- Testing: the NHS says that because probiotics are classed as food, they do not go through the rigorous testing medicines do. [2]
What the sources we read say, place by place
| Place | What the sources say | Source and year | Limits of what we read |
|---|---|---|---|
| United States | Food, supplement or drug depending on intended use. Many probiotics are supplements. | NCCIH (page last updated August 2019) [1] | Describes the general framework only. |
| United States, preterm infants | The FDA has not approved any probiotic product as a drug or biological product for infants of any age. | FDA news release, 2023 [3] | A safety warning for hospital use, not a general rule for adults. |
| European Union | A 2012 report said all health benefit claims in Europe must be government approved. A 2014 expert panel wrote that no probiotic claims had been judged sufficiently substantiated for foods in the EU. | Donovan and colleagues, 2012 [4]; ISAPP consensus statement, 2014 [5] | We did not read the current EU register of authorized claims, so we cannot say what is authorized today. |
| European Union, history | A 2012 symposium report said only one claim (yogurt cultures and lactose digestion) had been deemed adequately supported. A 2010 news report said EFSA had rejected every claim submitted up to then, many for insufficiently characterized strains. | Donovan and colleagues, 2012 [4]; CMAJ, 2010 [6] | Historical. Both predate later decisions we did not read. |
| Italy | The Ministry of Health confirmed in 2013 that the word "probiotic" may be used on foods and supplements under certain conditions. | ISAPP, 2014 [5] | One country's rule; other EU countries may differ. |
| Canada | A Health Canada notice (January 2010, now archived and not updated) says applications for natural health products containing probiotics need strain-level evidence, and that claims should be backed by strain-specific evidence in humans. | Health Canada notice [7]; ISAPP, 2014 [5] | Archived. Current Health Canada rules were not verified. |
| United Kingdom | Generally classed as food rather than medicine. | NHS, page reviewed November 2022 [2] | UK rules on health claims are not described in the sources we read. |
The 2012 report added that there was neither a legally recognized definition of, nor a standard of identity for, the word "probiotic" in the US or Europe. [4] Whether that is still true was not checked in the sources we read.
What the European Union terms mean
The European Food Safety Authority (EFSA) describes a health claim as any statement on labels, in marketing or in advertising that health benefits can result from consuming a food or one of its components. [8] That is why a product sold in one country may carry wording that is not allowed in another.What "regulated as food" does not guarantee
The NHS says that, because of the way probiotics are regulated, we cannot always be sure the product contains the bacteria stated on the label. [2] NCCIH says some probiotic products have been reported to contain microorganisms other than those on the label. [1] A 2014 expert panel said many products carry the word "probiotic" without meeting minimum criteria such as defined contents, an appropriate viable count at end of shelf-life and suitable evidence of benefit. [5] The NHS also notes a huge difference between the pharmaceutical-grade probiotics that show promise in trials and the yoghurts and supplements sold in shops. [2]What to do with this: read the label for the full strain name and a viable count, and see How to read a probiotic label and Quality testing and certifications. Rules about supplements in general are explained in How supplements are regulated.
When a product is treated as a drug
Some live-microbe products are developed as medicines. The FDA defines a live biotherapeutic product as a biological product that contains live organisms, is applicable to preventing, treating or curing a disease or condition, and is not a vaccine, and its guidance covers such products even when they are lawfully marketed as foods or dietary supplements. [9] For how these differ from supplements, see Live biotherapeutic products and fecal microbiota transplant.Safety and who should ask a clinician
Being on a shelf is not a safety test. NCCIH says anyone with a serious underlying health condition should be monitored closely while taking probiotics, and that people should consult a health care provider first, especially with health problems. [1] The FDA says probiotic products can be dangerous for preterm infants in hospital settings. [3] See Probiotic safety. If you take medicines, ask a pharmacist or clinician, and read Medication interactions. Do not stop or change a prescribed medicine because of anything on this page. In the US, call 911 for an emergency.Frequently asked questions
Are probiotics regulated?
Yes, but not in one uniform way. In the US the FDA might regulate a probiotic as a dietary supplement, a food ingredient or a drug, depending on intended use. [1] In the UK probiotics are generally classed as food. [2]
Does a supplement label mean the FDA approved the product?
No. NCCIH says many probiotics are sold as dietary supplements, which do not require FDA approval before they are marketed. [1]
Why do European labels say so little about health benefits?
A 2012 report said all health benefit claims in Europe must be government approved. [4] A 2014 expert panel wrote that no probiotic claims had been judged sufficiently substantiated for foods in the EU. [5] We did not read the current register, so check the latest rules if this matters for you.
Is a probiotic ever a drug?
It can be, if it is developed and approved as a medicine. NCCIH says a probiotic marketed to treat a disease must be approved by the FDA before it can be sold. [1] The FDA has not approved any probiotic product as a drug or biological product for infants of any age. [3]
Does "regulated as food" mean the label is accurate?
Not necessarily. The NHS says we cannot always be sure the product contains the bacteria stated on the label. [2] Third-party testing is explained on the quality page.
References
- NCCIH (US National Center for Complementary and Integrative Health). Probiotics: Usefulness and Safety. Page last updated August 2019 as shown on the page. Read 2026-10-23.
- NHS (UK). Probiotics. Page last reviewed 24 November 2022. Read 2026-10-23.
- US Food and Drug Administration. FDA Raises Concerns About Probiotic Products Sold for Use in Hospitalized Preterm Infants. News release, 2023. Read 2026-10-23.
- Donovan SM, et al. Establishing and Evaluating Health Claims for Probiotics. Adv Nutr. 2012;3(5):723-725. Symposium report; full text read 2026-10-23.
- Hill C, et al. The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nat Rev Gastroenterol Hepatol. 2014. Full text read 2026-10-23.
- Vogel L. European probiotics industry fears regulations will scuttle market for health-promoting or disease-preventing foods. CMAJ. 2010;182(11):E493-E494. News article; full text read 2026-10-23.
- Health Canada. Notice: Product Licence Applications for Natural Health Products Containing Probiotics. Notice dated January 2010; the page is archived and states it will not be updated. Read through a web-fetch tool 2026-10-23.
- European Food Safety Authority. Health claims. Read 2026-10-23.
- US Food and Drug Administration. Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information. Guidance for industry, February 2012, updated June 2016. Full guidance PDF read 2026-10-23.