European Union
The word "probiotic" is effectively barred on food labels
EFSA classifies the term "probiotic" itself as a health claim under Regulation (EC) 1924/2006. It has rejected every probiotic health-claim application except one: live yogurt cultures for lactose digestion (requiring at least 10^8 CFU per gram). Food makers therefore avoid the word and label products as "live cultures."
European Ombudsman, case 2273/2023/MIK · Food Safety Authority of Ireland, Probiotic Health Claims
Canada
Licensed as Natural Health Products with permitted strain claims
Probiotics are regulated as Natural Health Products. A 2009 probiotics monograph requires premarket licensing and allows a general "source of probiotics / supports intestinal health" claim for listed species, plus strain-specific claims (for example, Lactobacillus rhamnosus GG for acute infectious and antibiotic-associated diarrhea). A prebiotics monograph followed in 2026.
Health Canada Probiotics Monograph (NNHPD) · Regulation of NHPs in Canada (FDA briefing)
Japan
FOSHU, the world's first functional-food framework, trial-gated claims
Japan regulates probiotic health claims chiefly through FOSHU ("Foods for Specified Health Uses"), established 1991, the world's first legal functional-food framework. A product-specific health claim requires human clinical trials and approval by the Consumer Affairs Agency, across roughly 13 claim categories including "gut conditioning." A lighter "Foods with Function Claims" system was added in 2015.
History and current status of functional food regulations in Japan (ScienceDirect) · Functional food products in Japan: A review
United States
Sold as supplements under DSHEA; no probiotic approved for infants
Probiotics are sold as dietary supplements under DSHEA (1994): no premarket approval, only structure/function claims carrying the standard disclaimer. The FDA has not approved any probiotic product for infants of any age.
FDA warning on probiotics for preterm infants (Oct 2023)
United States
DSHEA, market-first, no premarket approval
Dietary supplements are regulated under the Dietary Supplement Health and Education Act of 1994. Products need no FDA approval before sale; manufacturers are responsible for safety and may make structure/function claims (not disease claims) with the disclaimer that statements are not FDA-evaluated.
FDA, Dietary Supplements overview
European Union
Harmonized food-supplement rules with a pre-cleared claims register
Supplements are regulated as food under the Food Supplements Directive (2002/46/EC) and the Nutrition and Health Claims Regulation (EC) 1924/2006. Only health claims authorized on the EU register, after EFSA assessment, may be used.
EFSA, Nutrition and health claims
Australia
"Complementary medicines" on a risk-tiered register (AUST L / AUST R)
Supplements are regulated as "complementary medicines" by the TGA and must be on the Australian Register of Therapeutic Goods. Low-risk products are Listed (AUST L): only permitted ingredients, only low-level claims, not pre-evaluated for efficacy but subject to audit. Higher-risk or higher-claim products are Registered (AUST R) and are fully evaluated for safety, quality and efficacy before sale.
TGA, Complementary medicine regulation basics · What does TGA approval mean? (Australian Prescriber)
United Kingdom
Split system: FSA regulates as food, MHRA captures medicinal claims
The Food Standards Agency regulates supplements as food (no premarket approval, retained EU-style food law). The MHRA separately regulates any product that makes medicinal claims or works by a pharmacological, immunological or metabolic mode of action, classifying "borderline products" case by case.
MHRA, Borderline products guidance (GN8) · NHS SPS, Understanding food supplements
United Kingdom
Traditional Herbal Registration (THR), tradition as a legal basis
Over-the-counter herbal remedies sold with health indications must hold a Traditional Herbal Registration and carry the THR logo, under the Traditional Herbal Medicinal Products regime. A THR is granted for minor, self-limiting conditions and rests on evidence of long-standing traditional use plus quality and safety, rather than modern efficacy trials.
MHRA, Apply for a Traditional Herbal Registration · HSIS, Food Supplements Regulations
Australia
Traditional medicines listed as complementary medicines
Herbal, Ayurvedic and traditional Chinese medicines are regulated as complementary medicines on the ARTG, mostly through the listed (AUST L) low-risk pathway using permitted ingredients and low-level indications. Traditional-use indications are allowed where supported by evidence of tradition.
TGA, Registered complementary medicines
United States
Most research peptides are not lawful dietary ingredients
The FDA has taken the position that many popular peptides (for example, BPC-157) are not lawful dietary ingredients, and in 2023 placed a set of peptides into a category that effectively bars their use in compounded drugs. Peptides sold "for research use only" sit outside the supplement and drug pathways.
FDA, Compounding and the 503A Bulks List categories
United States
The committee overruled FDA's own scientists six times in two days
On 23 and 24 July 2026 the FDA's Pharmacy Compounding Advisory Committee considered seven peptides for the list of bulk substances pharmacies may compound under section 503A: BPC-157, KPV, TB-500, MOTS-c, emideltide, epitalon and semax, each in free base and acetate form. FDA put fourteen voting questions, two per substance, and had already answered all fourteen itself: keep every one of them off the list. The committee voted for inclusion six times. BPC-157, KPV and TB-500 each passed 8 to 6 with one abstention. MOTS-c passed 7 to 5 with two abstentions. Epitalon passed 7 to 4 with one abstention, and semax 8 to 5 with one abstention. Only emideltide failed, 6 for and 7 against with one abstention. The vote is advice. A substance joins the 503A list only through notice and comment rulemaking, which the Secretary of Health and Human Services must complete, and none of the six has joined it. There is still no lawful compounding route for any of them.
FDA, Pharmacy Compounding Advisory Committee meeting, 23 to 24 July 2026 · FDA, briefing document introduction and points to consider · FDA, the fourteen voting questions put to the committee · McDermott Will and Emery, vote tallies from the two day meeting · Pharmaceutical Executive, report of the 23 July votes · FDA, Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act
United States
Seventeen peptides were flagged as risky, then the people who nominated them pulled out
FDA keeps a category 2 list of bulk substances that may present significant safety risks. Alongside it sits a second list, of nominations the nominators themselves withdrew, and seventeen of those are peptides: AOD-9604, BPC-157, cathelicidin LL-37, CJC-1295, dihexa acetate, emideltide, epitalon, GHK-Cu for injection, ipamorelin acetate, KPV, PEG-MGF, melanotan II, MOTS-c, selank acetate, semax, thymosin alpha 1, and the thymosin beta-4 fragment sold as TB-500. Withdrawing a nomination removes the paperwork, not the substance, and FDA took seven of the seventeen to a public vote anyway. FDA's stated reasons across the list repeat two phrases: risk of immunogenicity, and no human exposure data. Three peptides remain in category 2 for outsourcing facilities under section 503B, all added on 29 September 2023: GHRP-2, GHRP-6 and ipamorelin acetate.
FDA, bulk drug substances for use in compounding that may present significant safety risks · FDA, Pharmacy Compounding Advisory Committee meeting, 23 to 24 July 2026
United States
Five more peptides go to the same committee before the end of February 2027
The July 2026 meeting cleared seven of the seventeen withdrawn peptide nominations. Five more are scheduled for a second advisory committee meeting to be held before the end of February 2027: GHK-Cu, cathelicidin LL-37, dihexa acetate, PEG-MGF and melanotan II. FDA's existing safety notes on those five are not neutral. Melanotan II already carries published case reports of melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome and priapism. For dihexa acetate and PEG-MGF, FDA records that it has identified no human exposure data by any route at all.
FDA, bulk drug substances for use in compounding that may present significant safety risks · McDermott Will and Emery, vote tallies from the two day meeting
United States
BPC-157: the one trial's headline number, and the number underneath it
Wells Pharmacy Network and LDT Health Solutions nominated BPC-157 for ulcerative colitis, as oral capsules of 250 to 1,000 micrograms and a 2,000 microgram per milliliter injection under the skin. The entire effectiveness case was one study, Ruenzi 2005, published only as a meeting abstract: 53 people with mild to moderate disease given an 80 milligram rectal enema daily for two weeks. Disease activity fell 3.2 points on BPC-157 and 1.6 on placebo, and the difference between the groups was 1.6 points with a confidence interval running from minus 4.84 to 1.62. That interval crosses zero, which is the finding. No study has ever given BPC-157 to a person by the oral, injected, nasal or skin routes that sellers use. In 28 day animal studies it disturbed clotting times in both rats and dogs, and raised triglycerides and liver enzymes in females of both species. It was not genotoxic. Three adverse event reports reached FDA: an injection site reaction, shortness of breath severe enough for an emergency room, and darkening of the skin and gums that returned when the person used it again. No country has approved it. The committee voted to recommend it 8 to 6, with one abstention.
FDA, briefing document for BPC-157-related bulk drug substances · FDA, presentations to the committee, 23 July 2026 · McDermott Will and Emery, vote tallies from the two day meeting · FDA, Pharmacy Compounding Advisory Committee meeting, 23 to 24 July 2026
United States
KPV: no human data at all, and the skin study cuts both ways
Wells Pharmacy Network nominated KPV as a 0.1 percent cream and gel for wound healing and inflammatory conditions. KPV is three amino acids, the eleven to thirteen fragment of the hormone that controls skin pigment, with the pigment activity removed. Its molecular target is unknown. FDA found no clinical study, no pharmacokinetic data, no adverse event report and no food complaint report, because nobody has published giving KPV to a human being by any route. The one laboratory finding that bears on the nominated cream is double edged: in human cadaver skin KPV barely penetrates, which limits how much could poison you and equally limits how much could reach the tissue it is meant to treat. Websites sell it anyway as injections, capsules, creams and nasal sprays, for inflammation, bowel disease, wound healing, nerve damage and stroke. The committee voted to recommend it 8 to 6, with one abstention.
FDA, briefing document for KPV-related bulk drug substances · FDA, presentations to the committee, 23 July 2026 · McDermott Will and Emery, vote tallies from the two day meeting · FDA, Pharmacy Compounding Advisory Committee meeting, 23 to 24 July 2026
United States
TB-500: the wound peptide that did not close a wound in the one test of it
Wells Pharmacy Network nominated TB-500 as a 3 milligram per milliliter powder for injection into muscle or under the skin, for wound healing, without ever specifying what kind of wound. TB-500 carries the actin binding stretch of thymosin beta-4 that is thought to do the healing. FDA found one published experiment testing that: at 50 micrograms per milliliter, TB-500 did not close scratch wounds in cultured fibroblasts. There are no animal wound studies, no animal toxicity studies, and no human study of any kind. The only pharmacokinetic data come from thoroughbred geldings given 10 milligrams under the skin, where blood levels peaked within two hours and were undetectable by ten. It was first synthesised in 2003, and FDA cites an analysis of doping forums showing discussion climbing steadily since 2010. It is banned in sport as a growth factor. FDA could not find a single pharmacy that compounds it. The committee voted to recommend it 8 to 6, with one abstention.
FDA, briefing document for TB-500-related bulk drug substances · FDA, presentations to the committee, 23 July 2026 · McDermott Will and Emery, vote tallies from the two day meeting · FDA, Pharmacy Compounding Advisory Committee meeting, 23 to 24 July 2026
United States
MOTS-c: the blood test that asks whether an injection could work at all
Wells Pharmacy Network nominated MOTS-c as a 5 or 10 milligram injection for insulin resistance, obesity, osteoporosis, vascular calcification, fat and muscle metabolism, and longevity. It is sixteen amino acids, encoded inside mitochondrial RNA and described only in 2015. The animal work is real: it suppressed diet induced obesity and insulin resistance in mice, promoted bone formation in rat cells, and reduced vascular calcification in rats. It is also all in mice, rats and dishes, with no dose response established and no known molecular target, which FDA said leaves it unable to predict which organs the peptide would even reach. One finding goes to the heart of the nominated product: incubated in human whole blood, MOTS-c is broken into shorter peptides within fifteen to sixty minutes, so it is unclear whether injecting it could ever produce an active concentration. There are no human studies and no adverse event reports. It is banned in sport as a metabolic modulator. The committee voted to recommend it 7 to 5, with two abstentions.
FDA, briefing document for MOTS-c-related bulk drug substances · FDA, presentations to the committee, 23 July 2026 · McDermott Will and Emery, vote tallies from the two day meeting · FDA, Pharmacy Compounding Advisory Committee meeting, 23 to 24 July 2026
United States
Emideltide: the only one the committee refused, and the trials that cancel each other out
Wells Pharmacy Network and LDT Health Solutions nominated emideltide, sold as delta sleep inducing peptide or DSIP, as a 1 milligram per milliliter injection under the skin for chronic insomnia, narcolepsy and opioid withdrawal. Every human study FDA found used a drip into a vein instead. The insomnia trials contradict each other: four studies by one author, in 6, 6, 18 and 14 subjects, reported better sleep, while two comparable double blind placebo controlled studies by other groups, in 6 and 16 subjects, found no significant difference. A 1986 review of the same data concluded the evidence was preliminary. Narcolepsy rests on a single case report of one 35 year old man. Opioid withdrawal rests on an open label study of 107 people with no control group, in which three had serious adverse events including low blood pressure at the first injection, and one had progressive low blood pressure after a second; some of those effects were blamed on vials that would not dissolve properly. Emideltide works by making neurons release the body's own opioids, and naloxone blocks its effects, so FDA raised addiction as a question and found that no study has asked it. This was the only substance on which the committee agreed with the agency, voting 6 for and 7 against with one abstention.
FDA, briefing document for Emideltide-related bulk drug substances · FDA, presentations to the committee, 24 July 2026 · McDermott Will and Emery, vote tallies from the two day meeting · FDA, Pharmacy Compounding Advisory Committee meeting, 23 to 24 July 2026
United States
Epitalon: sold for sleep, never studied in anyone with a sleep problem
Wells Pharmacy Network and LDT Health Solutions nominated epitalon as an injection for insomnia, at 10 milligrams per milliliter and at 3,000 micrograms per milliliter. FDA found no publication of any kind on epitalon in patients with insomnia, and none by the injected route that was nominated. The single clinical study it identified, Ivko 2021, gave a sublingual spray to 75 women aged 40 to 50 working night shifts for 20 days and measured a melatonin breakdown product in their urine. It did not measure sleep. The safety concern runs opposite to the marketing. In human fetal lung cells epitalon increases telomerase and lengthens telomeres, and FDA notes that long telomeres are associated with a raised risk of malignant tumours, so continuous exposure could let cells evade the ageing that stops them becoming cancerous. The mouse studies the nominators submitted showed fewer spontaneous tumours and longer life, but used one fixed dose given five days a month, which cannot answer the question about continuous use. FDA dates American compounding of epitalon to at least 2018 by way of a criminal case, in which a compounding pharmacy and its owner were sentenced for unlawful distribution. The committee voted to recommend it 7 to 4, with one abstention.
FDA, briefing document for Epitalon-related bulk drug substances · FDA, presentations to the committee, 24 July 2026 · McDermott Will and Emery, vote tallies from the two day meeting · FDA, Pharmacy Compounding Advisory Committee meeting, 23 to 24 July 2026
United States
Semax: a Russian medicine whose usable evidence is two abstracts and a dopamine finding
Wells Pharmacy Network and LDT Health Solutions nominated semax as a nasal spray or injection, at 7,500 or 1,000 micrograms per milliliter, for cerebral ischemia, migraine and trigeminal neuralgia. It was also nominated as a nootropic and for ADHD, which FDA did not evaluate for lack of supporting literature. Semax is a registered medicine in Russia, sold there as 0.1 and 1 percent nasal drops, and seven of the human studies are published in Russian with no English full text, so FDA excluded them. That leaves two usable references. One, a 2002 meeting abstract, gave intranasal semax to an unstated number of people with chronic ischemic brain disease and reported changes to clotting laboratory values without reporting whether anyone improved. The other, from 1996, covered 12 people with migraine and 25 with facial nerve pain. Two findings troubled FDA more than the thin evidence. Semax appears to act against clotting, a bleeding risk that no compounded product carries a label to warn about. And in mice it increased amphetamine driven dopamine release in the striatum, the response typical of drugs of abuse. American clinics meanwhile sell it for anxiety, depression, memory, stroke, ADHD, opioid withdrawal, ALS, Parkinson's disease and Alzheimer's disease. The committee voted to recommend it 8 to 5, with one abstention.
FDA, briefing document for Semax-related bulk drug substances · FDA, presentations to the committee, 24 July 2026 · McDermott Will and Emery, vote tallies from the two day meeting · FDA, Pharmacy Compounding Advisory Committee meeting, 23 to 24 July 2026
United States
Wellness vs medical device turns on the claim made
Whether a red-light panel, PEMF mat or similar product is an FDA-regulated medical device depends on its claims. General wellness claims (relaxation, general fitness) generally fall outside device regulation under the FDA's low-risk general-wellness policy; specific disease-treatment claims trigger device requirements and possible clearance.
FDA, General Wellness: Policy for Low Risk Devices
China
The "Blue Hat" system: register for claims, or file for vitamins
Health food (保健食品) sold domestically must carry the "Blue Hat" (蓝帽子) mark from the State Administration for Market Regulation. Two tracks exist: registration for products making functional claims (which requires testing, often human trials on Chinese subjects, taking 2 to 4 years), and a lighter filing route for vitamin and mineral products drawn from a permitted raw-material catalogue.
ChemLinked, China Health Food Regulation · Shanghai Jungle, China supplement regulations (2026)
India
A dual system: supplements as food (FSSAI), tradition as medicine (AYUSH)
India runs two parallel tracks. The Food Safety and Standards Authority (FSSAI) regulates nutraceuticals and health supplements as food, allowing only approved ingredients and no disease or therapeutic claims. Separately, the Ministry of AYUSH governs Ayurveda, Siddha, Unani and Homoeopathy as traditional medicine, where health claims may rest on references in classical texts.
Bhatt & Joshi, FSSAI / AYUSH jurisdictional conflicts · NutraIngredients, AYUSH on nutraceutical claims (2024)
South Korea
Health Functional Foods: notify from the list, or win pre-market approval
Under the Health Functional Food Act, products must be sold in measured doses and fall into two routes. Ingredients already on the Health Functional Food Code positive list need only a notification to the Ministry of Food and Drug Safety; a new functional ingredient requires pre-market approval after a safety and function review (about 120 days), yielding a certificate with five years of exclusive data protection.
MFDS, Health Functional Food Code · Food Compliance International, South Korea
Brazil
The "Suplemento Alimentar" category, built in 2018
Brazil only created a dedicated food-supplement category in 2018 (ANVISA Resolution RDC 243/2018). Supplements are defined as oral products in pharmaceutical forms for healthy people, built from positive lists of permitted nutrients, bioactive substances, enzymes and probiotics, with no therapeutic claims. Most reach market by notification to ANVISA rather than full registration.
Food Compliance International, Brazil · Pronutrition, ANVISA RDC 843/2024
South Africa
Complementary Medicines (Category D) recognise traditional disciplines by name
Since 2013 SAHPRA regulates supplements under "Complementary Medicines" (Category D) within the Medicines Act. The category splits into discipline-specific medicines, naming six traditions (Aromatherapy, Ayurveda, Homeopathy, Traditional Chinese Medicine, Unani Tibb and Western Herbal Medicine), and modern, low-risk "health supplements." African Traditional Medicine is given its own standing as an indigenous system.
SAHPRA, Complementary Medicines · Schindlers, SCA judgment (ZASCA 49, 2022)
UAE / Gulf (GCC)
Federal registration and Gulf-wide standards, with no disease claims
In the UAE, supplements are registered with the Ministry of Health and Prevention (MOHAP) and, for many products, the Dubai Municipality via the Montaji portal, under Federal Law No. 10 of 2015. They are defined as supporting general health, not treating or curing disease, so disease claims are prohibited. Gulf-wide GSO standards (notably GSO 2571/2021) set common requirements across GCC states.
Mavenrs, Health Supplements in the UAE · Artixio, UAE health supplement registration
Singapore
No pre-approval: the dealer carries the responsibility
Singapore's Health Sciences Authority does not require pre-market approval or a licence to import, manufacture or sell health supplements. Instead the "dealer" (importer, manufacturer, wholesaler or seller) bears full responsibility for ensuring products are safe, of suitable quality and lawfully labelled, backed by strong post-market surveillance and public safety alerts. Notification is voluntary.
HSA, Regulatory overview of health supplements · HSA, Health Supplements Guidelines (Jan 2026)