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

EU -- Food Supplements Directive 2002/46/EC

EU Botanical Registries (Important)

UK -- Food Supplements Regulations 2003

China -- Blue Hat (蓝帽子)

Japan -- 3 Categories

Korea -- HFF (Health Functional Food)

Canada -- NHP (Natural Health Products)

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