---

name: tobacco-vape-compliance description: Use when selling cigarettes, cigars, RYO tobacco, e-cigarettes, vapes, e-liquids, nicotine pouches, heat-not-burn, or any nicotine-delivery product in any market - covers EU TPD2 (2014/40), FDA Deeming Rule + PMTA, plain packaging, FCTC, nicotine concentration caps, age verification, flavor bans

Tobacco & Vape Compliance

Full regulatory workflow for tobacco, e-cigarettes, vapes, e-liquids, nicotine pouches, HnB. TPD2, FDA PMTA, plain packaging, flavor bans, age verification.

Decision Flow

digraph {
  rankdir=TB; node [shape=box style=rounded fontsize=10];
  classify [label="1. Classify product:\ncombustible / e-cig / HnB /\nnicotine pouch / herbal"];
  notify [label="2. Pre-market authorization:\nTPD notification / PMTA / TRPR"];
  conc [label="3. Nicotine concentration\n+ tank volume + e-liquid bottle"];
  ingredients [label="4. Ingredient list:\nTPD emissions / FDA HPHCs"];
  package [label="5. Plain packaging\n+ health warnings"];
  ads [label="6. Advertising restrictions\n(near-total in most markets)"];
  age [label="7. Age verification\n(18 / 21 / +)"];
  sell [label="8. Place on market"];
  classify -> notify -> conc -> ingredients -> package -> ads -> age -> sell;
}

EU -- TPD2 (Directive 2014/40)

Requirement	Detail
Legal basis	Dir 2014/40/EU (Tobacco Products Directive). Implementation deadline 20 May 2016
Scope	Cigarettes, RYO tobacco, cigars, cigarillos, pipe tobacco, e-cigarettes (Article 20), herbal smoking products, novel tobacco products
Notification (Article 19)	6 months before placing tobacco products on market. EU-CEG (Common Entry Gate) system. Per MS notification
Article 20 (E-cigarettes)	6 months notification via EU-CEG. Updated for substantial modifications. Each product per MS
Nicotine cap	E-cigarettes max 20 mg/ml. E-liquid bottles max 10 ml (refill). Tank max 2 ml
Health warnings	65% of front + back of packaging for cigarettes/RYO. Combined picture + text warnings (Annex II). E-cigarettes: 30% of largest sides
Tracking + tracing	Article 15 -- mandatory since 20 May 2019 for cigarettes/RYO, 20 May 2024 for other tobacco. Unique identifier per pack, supply chain tracking
Cross-border distance sales	Per MS option to prohibit. NL, DE, IT prohibit. UK retains restriction post-Brexit
Advertising	Dir 2003/33/EC + AVMSD -- near-total ban. Sponsorship of cross-border events prohibited
TPD3 proposal	Under development. Expected proposals: stricter e-cig + nicotine pouch rules, flavor restrictions, cross-border sales
Cost	TPD notification: EUR 200-500 per product per MS. PMI Track & Trace setup: significant

US -- FDA Deeming Rule + PMTA

Requirement	Detail
Legal basis	Family Smoking Prevention and Tobacco Control Act 2009 (FSPTCA). Deeming Rule 2016 brought e-cigarettes + cigars + pipe tobacco + hookah under FDA Center for Tobacco Products (CTP) jurisdiction
PMTA (Premarket Tobacco Product Application)	Required for new tobacco products marketed after 15 Feb 2007. Section 910(b). Demonstrate "Appropriate for the Protection of Public Health" (APPH)
Substantial Equivalence (SE)	Alternative pathway for products substantially equivalent to predicate marketed before 2007. Limited use
Exemption from SE	For products with minor modifications (e.g., new label color)
Modified Risk Tobacco Product (MRTP)	Separate FDA approval to make reduced-risk claims (e.g., Swedish Match snus, IQOS)
PMTA status	FDA has issued Marketing Granted Orders (MGOs) for limited products: 23 Vuse + Logic + NJOY e-cig products. Millions of synthetic nicotine PMTAs received
Synthetic nicotine	Reclassified Dec 2021 -- now subject to PMTA same as tobacco-derived nicotine. Pre-existing products had until 14 July 2022 to file PMTA
Premium cigars	2022 federal court ruling vacated FDA's deeming over premium cigars. Re-deemed 2023 -- ongoing litigation
Cost	PMTA: USD 500,000-5,000,000 per product application. Toxicology + behavioural studies + manufacturing

FDA Flavor Restrictions

• Cigarettes: Flavored cigarettes banned 2009 (menthol exception). Menthol cigarette ban final rule April 2024, enforcement timeline delayed
• Cartridge-based e-cigarettes: Flavors other than tobacco/menthol prohibited Jan 2020 (closed-system)
• Open-system / disposable / bottled e-liquid: No federal flavor restriction. Many states ban (NY, NJ, RI, MA, CA, OR -- check current)

UK -- TRPR + Brexit Divergence

Requirement	Detail
Legal basis	Tobacco and Related Products Regulations 2016 (TRPR) -- retained EU TPD2. MHRA + Trading Standards enforcement
Nicotine cap	20 mg/ml e-cig (aligned with EU)
Notification	MHRA notification 6 months before placing on UK market. e-Notification system
Disposable vape ban	UK ban on single-use disposable vapes from 1 June 2025 (Tobacco and Vapes Bill -- timing subject to passage)
Plain packaging	All tobacco products since May 2017 (Standardised Packaging of Tobacco Products Regs 2015)
Vaping advertising	TRPR 2016 prohibits most ads. CAP/BCAP code -- limited retail-environment ads
Smoke-free generation	Tobacco and Vapes Bill -- progressively raising legal age (anyone born on/after 1 Jan 2009 never legally sold tobacco). Bill in Parliament 2025
Cost	Notification: GBP 150-500 per product

Plain Packaging Countries

Country	Effective Date	Scope
Australia	Dec 2012 (world's first)	Cigarettes + RYO + cigars
France	Jan 2017	Cigarettes + RYO
UK	May 2017	Cigarettes + RYO
Ireland	Sep 2018	All tobacco
Norway	Jul 2018	All tobacco + e-cigs
New Zealand	Mar 2018	Cigarettes + RYO
Hungary, Saudi Arabia, Uruguay, Turkey, Slovenia, Israel, Singapore, Canada, Netherlands, Denmark, Finland, Belgium, Spain, Mexico	Various 2019-2025	Varying scope

Plain packaging: no logos, no brand color, standardized fonts, large health warnings.

FCTC (WHO Framework Convention on Tobacco Control)

Tool	Detail
Treaty	First global public health treaty under WHO. Entered force 2005. 183 parties (US signed but not ratified)
Key articles	Art 5 (national strategies), Art 8 (smoke-free public spaces), Art 11 (packaging + labelling), Art 13 (advertising ban), Art 14 (cessation), Art 15 (illicit trade)
Protocol to Eliminate Illicit Trade in Tobacco Products	2018 entry into force. Track + trace, supply chain control
MPOWER framework	WHO implementation roadmap

Nicotine Pouches (Tobacco-Free Nicotine)

Market	Status
EU	Not covered by TPD2 (not "tobacco" technically). Some MS regulate as tobacco substitute (NL, FR, ES). DE has no specific rules. PMTA-equivalent rare
UK	Not under TRPR. Sold under General Product Safety Regs + age restrictions vary
US	FDA Center for Tobacco Products has authority over nicotine products (incl synthetic), PMTA required
Sweden	Long history of snus + new tobacco-free pouches. Regulated as tobacco substitute
TPD3 proposal	Expected to bring nicotine pouches into EU scope

Heat-Not-Burn (HnB)

Product	Regulator
IQOS (Philip Morris)	EU: under TPD2 as "novel tobacco product". US: FDA PMTA + MRTP authorization (first 2019)
glo (BAT)	EU: novel tobacco. US: PMTA pending
lil (KT&G/Altria partnership)	Various markets

HnB devices are dual-regulated: device under TPD electronics + tobacco stick under TPD tobacco.

Country-Specific Concentration Caps

Market	E-Liquid Nicotine Max	Tank/Bottle
EU + UK	20 mg/ml	10 ml refill, 2 ml tank
US	NO federal cap. Each PMTA assessed individually. Some products approved >50 mg/ml (Juul 5%)
Australia	Prescription-only for nicotine e-liquid (since Oct 2021). No OTC retail sale
Canada	20 mg/ml federal cap (Vaping Products Labelling Reg 2020). Provincial restrictions vary
Japan	Nicotine e-cigs regulated as medicinal products under PMDA -- effectively not on market. HnB widely sold (under TBA)
Brazil	E-cigarettes banned (ANVISA RDC 855/2024 confirmed prohibition)
Thailand	E-cigarettes banned (Customs Act + Tobacco Products Control Act). Possession can lead to fine + jail
Singapore	E-cigarettes banned (Tobacco Control of Advertisements and Sale Act). Sale + possession illegal

Age Verification

Market	Minimum Age	Method
US federal	21 (Dec 2019, "Tobacco 21" law)	Verify at retail. Online: Age Verification per state
EU MS	18 (most). NL: 18. AT: 18 (was 16 until 2019)	ID check at sale
UK	18 (rising progressively under Tobacco + Vapes Bill)	Mandatory Challenge 25
Japan	20	--
Australia	18 (federal). Some states 16/18 mix	--

Common Compliance Traps

• Selling vape without PMTA in US: Selling any non-PMTA-granted nicotine product in US = FDA enforcement action. Customs seizures common.
• Cross-border vape sales prohibited: EU MS can prohibit cross-border distance sales of e-cigs. Selling online into NL, IT, DE from another MS = product seizure + fines.
• Synthetic nicotine PMTA loophole closed: From July 2022, synthetic nicotine = tobacco product for FDA purposes. No more loophole.
• Track + Trace missing UIDs: Cigarettes + RYO without unique identifier + supply chain tracking since 2019 = illicit. Other tobacco since 20 May 2024.
• Disposable vapes after UK ban (June 2025): Selling single-use disposables in UK after ban date = product seizure + fines GBP 200/item.
• Plain packaging in non-plain countries: Selling plain-packaged products in non-plain markets confuses consumers + may violate IP / re-export rules.

MCP Integration

mcp__claude_ai_Cleo_Insight__search_signals(q="TPD3", country="EU")
mcp__claude_ai_Cleo_Insight__search_signals(q="PMTA", country="US")
mcp__claude_ai_Cleo_Insight__get_regulation(id="2014/40")  # TPD2
mcp__claude_ai_CLEO_LEGAL_API__compliance/check
  product_description: "10ml e-liquid 18mg/ml strawberry flavor"
  target_markets: ["EU-FR", "EU-DE", "UK", "US"]

Power This With the Cleo Legal API

Tobacco + vape compliance navigates TPD2 (32 articles + Annexes), FDA PMTA (thousands of FDA decisions tracked weekly), plain packaging laws in 25+ countries, FCTC implementation per country, flavor + advertising restrictions per US state. PMTA marketing decisions + state flavor bans change monthly.

With the Cleo Legal API at https://legaldata-public.cleolabs.co:

• GET /v2/catalog/regulations?vertical=tobacco&country=EU,US,UK,CA,AU — TPD2 + FDA Deeming + TRPR + provincial caps mapped per market
• POST /v2/tobacco/notify-check — verify EU-CEG / MHRA notification requirements for product + per-MS divergence
• GET /v2/tobacco/pmta-status?product=... — current PMTA + MRTP decisions from FDA
• GET /v2/tobacco/flavor-bans?market=US — current US state + city flavor bans on vape products
• POST /v2/webhooks?topic=pmta,plain_packaging,flavor_ban,tpd3 — track PMTA decisions + new plain packaging laws + flavor ban expansions + TPD3 timeline

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 vape brand with 30 SKUs in EU + UK + 20 US states, the API replaces ~40 hours/month of TPD per-MS + state-by-state flavor ban + PMTA tracking.

Common Mistakes

• Treating "tobacco-free nicotine" as unregulated: Nicotine pouches under FDA + national rules apply increasingly. Selling without compliance = enforcement risk.
• Forgetting plain packaging market-specific: Even if you make plain-pack for AU/UK/FR/IE, you need branded packaging for non-plain markets. Custom production runs required.
• No anti-counterfeit / track + trace: TPD Track + Trace + Article 15 UIDs mandatory for all tobacco. Selling without = illicit trade.
• Marketing claims about reduced harm: "Safer alternative" / "less harmful" = MRTP claim. Requires FDA authorization (only 7 MRTPs ever granted).
• Selling vape via Amazon/eBay: Both platforms prohibit nicotine products globally. Listing = account suspension.
• Free samples: Distribution of free tobacco/nicotine samples is illegal in EU (TPD2 + national) + US (Tobacco Control Act).

Cross-references

• labeling-compliance -- health warning placement, multi-language requirements
• marketplace-compliance -- Amazon, eBay, Etsy bans on nicotine products
• electronics-compliance -- vape device LVD + EMC + battery (UN 38.3)
• customs-and-trade -- HS chapter 24 (tobacco), HS 8543 (vape devices), excise duties
• recall-response -- battery defect recalls common in vape devices