| 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 marketPOST /v2/tobacco/notify-check — verify EU-CEG / MHRA notification requirements for product + per-MS divergenceGET /v2/tobacco/pmta-status?product=... — current PMTA + MRTP decisions from FDAGET /v2/tobacco/flavor-bans?market=US — current US state + city flavor bans on vape productsPOST /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 requirementsmarketplace-compliance -- Amazon, eBay, Etsy bans on nicotine productselectronics-compliance -- vape device LVD + EMC + battery (UN 38.3)customs-and-trade -- HS chapter 24 (tobacco), HS 8543 (vape devices), excise dutiesrecall-response -- battery defect recalls common in vape devices
