supplement-compliance

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 call
• GET /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 market
• GET /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 zone
• food-compliance -- novel foods, allergens, traceability
• labeling-compliance -- Supplement Facts panel (US), nutrition declaration (EU)
• substance-screening -- ingredient CAS resolution, positive list match
• regulatory-intelligence -- Novel Food Catalogue updates, EFSA opinions