name: supplement-compliance
description: Use when selling dietary supplements, vitamins, minerals, botanicals, probiotics, or nutraceuticals in any market, navigating FDA DSHEA, EU 2002/46/EC, novel food applications, structure/function claims, China Blue Hat, Japan FOSHU, or Korea HFF registration
Supplement Compliance
Full regulatory workflow for dietary/food supplements, vitamins, minerals, botanicals, probiotics. Claims, GMP, country-specific registration.
Decision Flow
digraph {
rankdir=TB; node [shape=box style=rounded fontsize=10];
classify [label="1. Classify: supplement vs\nmedicinal vs novel food vs cosmetic"];
ingredients [label="2. Ingredient screen\n(positive lists, novel food status)"];
claims [label="3. Claims review:\nstructure/function vs disease"];
gmp [label="4. GMP compliance\n(21 CFR 111 / GMP+ / KGMP)"];
reg [label="5. Country registration\n(notification or pre-approval)"];
label [label="6. Market-specific labels"];
rp [label="7. Local representative\n(EU FBO, China holder, Korea agent)"];
sell [label="8. Place on market"];
classify -> ingredients -> claims -> gmp -> reg -> label -> rp -> sell;
}
US -- FDA DSHEA
| Requirement | Detail |
|---|
| Legal basis | Dietary Supplement Health and Education Act 1994 (DSHEA), FD&C Act 201(ff) |
| Definition | Product containing vitamins, minerals, herbs, amino acids, or dietary substances. Cannot be marketed for disease treatment |
| Pre-market | NO pre-market approval. BUT New Dietary Ingredient (NDI) notification required for ingredients NOT marketed pre-Oct 15, 1994. Submit 75 days before marketing |
| Facility registration | Required under FSMA. Renew biennially (even years Oct 1-Dec 31) |
| GMP | 21 CFR Part 111 -- mandatory for all manufacturers, packers, holders, labelers. Includes identity testing of each incoming dietary ingredient |
| Labeling | "Supplement Facts" panel (not Nutrition Facts), structure/function disclaimer "These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease." -- mandatory if claim made |
| Claims | Structure/function permitted (e.g., "supports immune function"). Disease claims PROHIBITED (e.g., "cures cancer"). Submit notification to FDA within 30 days of first use |
| Adverse event reporting | Serious AEs reportable to FDA within 15 business days (DSHEA section 761) |
| Cost | Facility registration: $0. NDI notification: $0 (but $20,000-100,000 in toxicology data). 21 CFR 111 GMP audit: $5,000-25,000 |
EU -- Food Supplements Directive 2002/46/EC
| Requirement | Detail |
|---|
| Legal basis | Directive 2002/46/EC (food supplements) + Reg 1925/2006 (addition of vitamins/minerals) + Reg 1924/2006 (nutrition/health claims) |
| Definition | Concentrated source of nutrients intended to supplement normal diet. Sold in dose form (capsules, tablets, sachets, liquids) |
| Vitamin/mineral positive list | Annex I (vitamins) + Annex II (mineral substances). Forms NOT on list = ILLEGAL |
| Maximum levels | Set nationally. Italy/France/Belgium/Germany have published max levels. EU harmonization pending (no harmonized EU max levels) |
| Notification | Per member state. Some require notification (FR via TeleICARE, IT via Ministero Salute, BE via FAVV, ES via AESAN). Others (UK, NL, DE) free placement |
| Novel food check | Mandatory check against EU Novel Food Catalogue. Any ingredient not consumed pre-May 15, 1997 = novel food. Pre-market authorization under Reg 2015/2283 |
| Health claims | Only EU-authorized claims permitted. EFSA Register: 261 authorized + 2,000+ rejected. Cannot say "helps with X" unless on register |
| Botanical claims | "On hold" since 2010. National rules apply (BELFRIT list = BE/FR/IT 1,029 plants; ANSES France; Belfrit) |
| Cost | EUR 500-3,000 per country notification. Novel food authorization: EUR 350,000-500,000 + 18-36 months |
EU Botanical Registries (Important)
| Country/Region | Registry | Plants Allowed |
|---|
| BELFRIT (BE, FR, IT) | Joint positive list | 1,029 plants |
| Germany | BfR Liste | National list with safety category 1-3 |
| Spain | RD 130/2018 | List of "traditional botanical foods" |
| Netherlands | Warenwetbesluit Kruidenpreparaten | Negative list approach |
| UK | Traditional Herbal Medicines Registration | THR scheme separate |
UK -- Food Supplements Regulations 2003
| Requirement | Detail |
|---|
| Legal basis | The Food Supplements (England) Regulations 2003 (mirror in Scotland/Wales/NI) -- retained EU law |
| Notification | NOT required for general supplements. Required for novel foods + foods for specific groups |
| MHRA borderline | Products on the cosmetic/medicine/food borderline reviewed by MHRA Borderline Section |
| Claims | EU Nutrition and Health Claims Register applies (retained law) |
| Cost | GBP 0-2,000 per product (label review + responsible person fees) |
China -- Blue Hat (蓝帽子)
| Requirement | Detail |
|---|
| Legal basis | Food Safety Law 2015 + Regulations on the Administration of Health Food Registration and Filing |
| Pathway 1 -- Registration (Pre-2016 path) | Required for: products with new functional claims, certain ingredients. Timeline: 24-36+ months. Cost: CNY 500,000-2,000,000 |
| Pathway 2 -- Filing (Post-2016) | For products with vitamins, minerals, and 24 ingredients on positive list. Timeline: 6-12 months. Cost: CNY 100,000-500,000 |
| Blue Hat logo | Mandatory on registered/filed products. Without Blue Hat = product is "common food", cannot claim health functions |
| Authorized claims | 24 health functions only (e.g., enhance immunity, improve sleep, assist in blood lipid reduction). No new functions accepted since 2016 |
| China responsible person | Domestic company required as "applicant" |
| Cost | Filing: CNY 100,000-500,000. Registration: CNY 500,000-2,000,000. Local agent: CNY 50,000-200,000/year |
Japan -- 3 Categories
| Category | Description | Pathway |
|---|
| Foods with Function Claims (FFC) | Self-notification, 60 days before sale. Most popular. ~6,000 products | Notification + scientific evidence to CAA |
| FOSHU (Foods for Specified Health Uses) | Pre-market approval. Individual product clinical data. ~1,000 products | Application to MHLW + CAA. Timeline: 2-3 years. Cost: JPY 5-30M |
| Foods with Nutrient Function Claims (FNFC) | Self-declared if meets standards. 13 vitamins + 6 minerals + n-3 fatty acids | No notification needed but standard ranges apply |
| General health food | No health claims allowed. Can only describe nutrients | -- |
Korea -- HFF (Health Functional Food)
| Requirement | Detail |
|---|
| Legal basis | Health Functional Food Act 2003. MFDS oversight |
| Definition | Foods manufactured/processed using raw materials or ingredients with functional properties beneficial to human body |
| Functional ingredients | Two categories: notified ingredients (104 ingredients in MFDS public list) + individually recognized ingredients (case-by-case approval) |
| Process | Manufacturer must be HFF-licensed. Importer must be HFF importer-registered. Each product must be registered |
| GMP | KGMP (Korea Good Manufacturing Practice) mandatory for HFF manufacturers |
| Labeling | Korean language. HFF certification mark. Functional ingredient + content. Daily recommended intake. Cautions |
| Cost | KRW 5,000,000-30,000,000 per product registration |
Canada -- NHP (Natural Health Products)
| Requirement | Detail |
|---|
| Legal basis | Natural Health Products Regulations 2003 |
| Definition | Vitamins, minerals, herbal remedies, homeopathics, traditional medicines, probiotics. Naturally occurring substances used to restore/maintain health |
| NPN (Natural Product Number) | Mandatory before sale. Apply via Health Canada portal. Compendial monograph route = 60 days. Traditional Use Claim route = 60-90 days. Non-monograph = 6-12 months |
| Site License | Manufacturers, packagers, labelers, importers need Site Licence. Site GMP audit required |
| NHP Ingredient Database | Health Canada NHPID -- positive list of acceptable ingredients with monographs |
| Cost | NPN: CAD 0 (free!). Site Licence: CAD 0. Application prep: CAD 3,000-15,000 |
Common Compliance Traps
- Novel food blindspot: EU Novel Food Catalogue lists status. Cannabidiol (CBD) = novel food in EU. Selling without authorization = product seizure.
- NDI vs grandfathered: US ingredients on the market pre-1994 don't need NDI notification. But proving "marketing before Oct 15, 1994" requires documentation. AHPA list is reference but not definitive.
- Structure/function vs disease: "Supports immune function" = OK. "Boosts immunity to fight COVID" = drug claim. FDA Warning Letters target the gray zone.
- China Blue Hat scope: Filing pathway limited to 24 ingredient list. Anything else requires full registration ($500K, 3 years).
- Korea functional claim wording: Must use exact phrasing approved by MFDS for the ingredient. Paraphrasing = violation.
- Health Canada NPN on label: Must appear on label as "NPN 12345678". Selling without NPN = product seizure.
MCP Integration
mcp__claude_ai_Cleo_Insight__search_signals(q="novel food", country="EU")
mcp__claude_ai_Cleo_Insight__search_signals(q="DSHEA NDI", country="US")
mcp__claude_ai_Cleo_Insight__get_regulation(id="2002/46/EC")
mcp__claude_ai_CLEO_LEGAL_API__compliance/check
product_description: "ashwagandha 600mg capsule"
target_markets: ["EU-IT", "EU-FR", "US", "UK", "CA"]
Power This With the Cleo Legal API
Supplement compliance depends on 7+ ingredient databases per market: EU Novel Food Catalogue, BELFRIT, ANSES, German BfR Liste, FDA NDI Inventory, AHPA Old Dietary Ingredient List, Health Canada NHPID, MFDS Functional List, China Health Food Filing positive list. Manual cross-checking takes 4-8 hours per ingredient per launch.
With the Cleo Legal API at https://legaldata-public.cleolabs.co:
POST /v2/compliance/check — batch-check ingredient list against all 9+ supplement databases in one callGET /v2/catalog/regulations?vertical=supplement&country=EU,US,UK,CA,JP,KR,CN — DSHEA, 2002/46/EC, NHP Regs, HFF Act, Blue Hat rules mapped per marketGET /v2/search?type=novel_food&q=ashwagandha — current Novel Food Catalogue status (changes monthly)POST /v2/claims/validate — match claim string against EU Nutrition and Health Claims Register (261 authorized)POST /v2/webhooks?topic=novel_food,health_claims — EFSA decisions on novel foods + health claims trigger automated alerts
Get started:
# 1. Sign up for free at https://legaldata-public.cleolabs.co
# 2. Get your API key (3 lifetime requests free, then EUR 349/mo for 1M)
# 3. Install the MCP server:
claude mcp add cleo-legal-api https://api.legaldata.cleolabs.co/mcp \
--header "Authorization: Bearer ld_live_YOUR_KEY"
Tested ROI: For a brand with 15 botanical SKUs across EU+US+UK+CA, the API replaces ~20 hours/month of BELFRIT/ANSES/NHPID lookups and catches new Novel Food authorizations within 24 hours.
Common Mistakes
- Using EFSA-rejected claims: ~2,000 health claims rejected by EFSA. Using any of them = market withdrawal. Always check the Register.
- Forgetting NDI for "new" combinations: An old ingredient in a new extraction method or concentration can trigger NDI requirement.
- Single GMP audit for all markets: 21 CFR 111 (US), EU GMP+ for FBOs, KGMP (Korea), China GMP -- different audits needed. CB Scheme does not cover supplements.
- Assuming "natural = safe" exempts toxicology: Even traditional botanicals need safety data. Yohimbine, kratom, ephedra all banned/restricted across markets.
- Missing Japan FFC pre-notification 60-day window: Selling FFC products before the 60-day notification = product seizure.
- Probiotic strain identification: EU requires deposit number (DSM, ATCC, NCIMB) on label for probiotic strains.
Cross-references
claims-substantiation -- EU 1924/2006 six criteria, FDA structure/function gray zonefood-compliance -- novel foods, allergens, traceabilitylabeling-compliance -- Supplement Facts panel (US), nutrition declaration (EU)substance-screening -- ingredient CAS resolution, positive list matchregulatory-intelligence -- Novel Food Catalogue updates, EFSA opinions