FDA · Regulatory tracker · 21+

FDA Nicotine Pouch PMTA Tracker

Name: FDA Nicotine Pouch PMTA Tracker
Creator: Clean Nicotine Pouch
License: https://creativecommons.org/licenses/by/4.0/

Live status of FDA marketing authorization for every nicotine pouch SKU we track. PMTA — the Premarket Tobacco Product Application — is the FDA pathway every nicotine pouch product must clear to be legally marketed in the US.

SKUs tracked

FDA Authorized

PMTA Pending

Denied

Not Submitted

By brand

Brand-level PMTA rollup

Brand	SKUs Tracked	FDA Authorized	Status
ZYN	31	31	✅ Full lineup authorized
on! PLUS	12	12	✅ Full lineup authorized
FRE	4	0	PMTA pending / not submitted
Lucy	6	0	PMTA pending / not submitted
Rogue	8	0	PMTA pending / not submitted
VELO	2	0	PMTA pending / not submitted
Zar	8	0	PMTA pending / not submitted

Every SKU

Per-SKU PMTA status

SKU	Brand	Strength	Status
on! Autumn Spice 2mg	on! PLUS	2 mg	FDA Authorized (PMTA)
on! Autumn Spice 4mg	on! PLUS	4 mg	FDA Authorized (PMTA)
on! Cappuccino 2mg	on! PLUS	2 mg	FDA Authorized (PMTA)
on! Cappuccino 4mg	on! PLUS	4 mg	FDA Authorized (PMTA)
on! PLUS Mint 6mg	on! PLUS	6 mg	FDA Authorized (Dec 2025, PMTA Pilot)
on! PLUS Mint 9mg	on! PLUS	9 mg	FDA Authorized (Dec 2025, PMTA Pilot)
on! PLUS Tobacco 6mg	on! PLUS	6 mg	FDA Authorized (Dec 2025, PMTA Pilot)
on! PLUS Tobacco 9mg	on! PLUS	9 mg	FDA Authorized (Dec 2025, PMTA Pilot)
on! PLUS Wintergreen 6mg	on! PLUS	6 mg	FDA Authorized (Dec 2025, PMTA Pilot)
on! PLUS Wintergreen 9mg	on! PLUS	9 mg	FDA Authorized (Dec 2025, PMTA Pilot)
on! Rich Berry 2mg	on! PLUS	2 mg	FDA Authorized (PMTA)
on! Rich Berry 4mg	on! PLUS	4 mg	FDA Authorized (PMTA)
ZYN Chill 3mg	ZYN	3 mg	FDA Authorized (Jan 2025, PMTA)
ZYN Chill 6mg	ZYN	6 mg	FDA Authorized (Jan 2025, PMTA)
ZYN Cinnamon 3mg	ZYN	3 mg	FDA Authorized (Jan 2025, PMTA)
ZYN Cinnamon 6mg	ZYN	6 mg	FDA Authorized (Jan 2025, PMTA)
ZYN Citrus 3mg	ZYN	3 mg	FDA Authorized (Jan 2025, PMTA)
ZYN Citrus 6mg	ZYN	6 mg	FDA Authorized (Jan 2025, PMTA)
ZYN Coffee 3mg	ZYN	3 mg	FDA Authorized (Jan 2025, PMTA)
ZYN Coffee 6mg	ZYN	6 mg	FDA Authorized (Jan 2025, PMTA)
ZYN Cool Mint 3mg	ZYN	3 mg	FDA Authorized (Jan 2025, PMTA)
ZYN Cool Mint 6mg	ZYN	6 mg	FDA Authorized (Jan 2025, PMTA)
ZYN Menthol 3mg	ZYN	3 mg	FDA Authorized (Jan 2025, PMTA)
ZYN Menthol 6mg	ZYN	6 mg	FDA Authorized (Jan 2025, PMTA)
ZYN Peppermint 3mg	ZYN	3 mg	FDA Authorized (Jan 2025, PMTA)
ZYN Peppermint 6mg	ZYN	6 mg	FDA Authorized (Jan 2025, PMTA)
ZYN Smooth 3mg	ZYN	3 mg	FDA Authorized (Jan 2025, PMTA)
ZYN Smooth 6mg	ZYN	6 mg	FDA Authorized (Jan 2025, PMTA)
ZYN Spearmint 3mg	ZYN	3 mg	FDA Authorized (Jan 2025, PMTA)
ZYN Spearmint 6mg	ZYN	6 mg	FDA Authorized (Jan 2025, PMTA)
ZYN Ultra Chill 9mg	ZYN	9 mg	FDA Authorized (Aug 2026, PMTA)
ZYN Ultra Citrus 9mg	ZYN	9 mg	FDA Authorized (Aug 2026, PMTA)
ZYN Ultra Cool Mint 9mg	ZYN	9 mg	FDA Authorized (Aug 2026, PMTA)
ZYN Ultra Deep Freeze 9mg	ZYN	9 mg	FDA Authorized (Aug 2026, PMTA)
ZYN Ultra Menthol 9mg	ZYN	9 mg	FDA Authorized (Aug 2026, PMTA)
ZYN Ultra Peppermint 9mg	ZYN	9 mg	FDA Authorized (Aug 2026, PMTA)
ZYN Ultra Smooth 11mg	ZYN	11 mg	FDA Authorized (Aug 2026, PMTA)
ZYN Ultra Smooth 9mg	ZYN	9 mg	FDA Authorized (Aug 2026, PMTA)
ZYN Ultra Spearmint 9mg	ZYN	9 mg	FDA Authorized (Aug 2026, PMTA)
ZYN Ultra Wintergreen 9mg	ZYN	9 mg	FDA Authorized (Aug 2026, PMTA)
ZYN Ultra Wintergreen Chill 9mg	ZYN	9 mg	FDA Authorized (Aug 2026, PMTA)
ZYN Wintergreen 3mg	ZYN	3 mg	FDA Authorized (Jan 2025, PMTA)
ZYN Wintergreen 6mg	ZYN	6 mg	FDA Authorized (Jan 2025, PMTA)
FRE Mint 3mg	FRE	3 mg	PMTA Submitted (Not Authorized as of May 2026)
FRE Mint 9mg	FRE	9 mg	PMTA Submitted (Not Authorized as of May 2026)
FRE Watermelon 12mg	FRE	12 mg	PMTA Submitted (Not Authorized as of May 2026)
FRE Wintergreen 15mg	FRE	15 mg	PMTA Submitted (Not Authorized as of May 2026)
Lucy Berry Citrus 4mg	Lucy	4 mg	PMTA Submitted May 2022 (Not Authorized; under FDA review as of May 2026)
Lucy Berry Citrus 8mg	Lucy	8 mg	PMTA Submitted May 2022 (Not Authorized as of May 2026)
Lucy Cinnamon 8mg	Lucy	8 mg	PMTA Submitted May 2022 (Not Authorized as of May 2026)
Lucy Mango 12mg	Lucy	12 mg	PMTA Submitted May 2022 (Not Authorized as of August 2026)
Lucy Mango 4mg	Lucy	4 mg	PMTA Submitted May 2022 (Not Authorized as of May 2026)
Lucy Mint 8mg	Lucy	8 mg	PMTA Submitted May 2022 (Not Authorized as of May 2026)
Rogue Apple 3mg	Rogue	3 mg	PMTA Submitted (Not Authorized as of August 2026)
Rogue Apple 6mg	Rogue	6 mg	PMTA Submitted (Not Authorized as of August 2026)
Rogue Honey Lemon 3mg	Rogue	3 mg	PMTA Submitted (Not Authorized as of May 2026)
Rogue Honey Lemon 6mg	Rogue	6 mg	PMTA Submitted (Not Authorized as of May 2026)
Rogue Mango 6mg	Rogue	6 mg	PMTA Submitted (Not Authorized as of May 2026)
Rogue Peppermint 6mg	Rogue	6 mg	PMTA Submitted (Not Authorized as of May 2026)
Rogue Wintergreen 3mg	Rogue	3 mg	PMTA Submitted (Not Authorized as of May 2026)
Rogue Wintergreen 6mg	Rogue	6 mg	PMTA Submitted (Not Authorized as of May 2026)
VELO Citrus 4mg	VELO	4 mg	PMTA Submitted (Not Authorized as of May 2026)
VELO Spearmint 7mg	VELO	7 mg	PMTA Submitted (Not Authorized; under FDA review as of May 2026)
ZAR Citrus 6mg	Zar	6 mg	Not authorized by FDA (absent from the FDA nicotine pouch list, current as of 2026-08-21)
ZAR Cola 6mg	Zar	6 mg	Not authorized by FDA (absent from the FDA nicotine pouch list, current as of 2026-08-21)
ZAR Fresh Mint 16mg	Zar	16 mg	Not authorized by FDA (absent from the FDA nicotine pouch list, current as of 2026-08-21)
ZAR Fresh Mint 3mg	Zar	3 mg	Not authorized by FDA (absent from the FDA nicotine pouch list, current as of 2026-08-21)
ZAR Fresh Mint 6mg	Zar	6 mg	Not authorized by FDA (absent from the FDA nicotine pouch list, current as of 2026-08-21)
ZAR Spearmint Fresh 6mg	Zar	6 mg	Not authorized by FDA (absent from the FDA nicotine pouch list, current as of 2026-08-21)
ZAR Strawberry Lush 6mg	Zar	6 mg	Not authorized by FDA (absent from the FDA nicotine pouch list, current as of 2026-08-21)
ZAR Watermelon 6mg	Zar	6 mg	Not authorized by FDA (absent from the FDA nicotine pouch list, current as of 2026-08-21)

Methodology

How we track this

We maintain an internal Brand Facts database of every nicotine pouch SKU sold or in PMTA review in the US. For each SKU, we record the exact FDA status string from public FDA dockets and manufacturer communications. This page is regenerated from that database on every site deploy.

FDA Authorized means the FDA has issued a Marketing Granted Order (MGO) under section 910(c)(1)(A)(i) of the FD&C Act. This is the only pathway by which a nicotine pouch product is legally marketed post-Premarket Tobacco Product Application (PMTA) review.

PMTA Pending means the manufacturer has filed an application and the FDA has it under active review. Denied means the FDA issued a Marketing Denial Order. Not submitted means no PMTA application has been filed for that SKU as of our last review.

FDA marketing authorization is not the same as “FDA approved” or “safe.” No tobacco or nicotine product is safe. Authorization means the FDA determined that marketing of the product meets the public health standard required by the Family Smoking Prevention and Tobacco Control Act.

Primary sources

Where we get the data

FDA Center for Tobacco Products — Oral Nicotine Products
Regulations.gov FDA dockets (search by manufacturer)
Manufacturer press releases on PMTA decisions
Our own SKU-level verification via product packaging and retailer listings

Cite this page

Journalists, researchers, and harm-reduction sites: this page is freely citable. Suggested citation format:

Clean Nicotine Pouch. (2026). FDA Nicotine Pouch PMTA Tracker. https://cleannicotinepouch.com/fda-pmta-tracker

Which nicotine pouches have FDA marketing authorization?
Browse coverage by brand — ZYN, VELO, Rogue, on! PLUS, Lucy
State-by-state legality (50 states)

Brand-level PMTA rollup

Per-SKU PMTA status

How we track this

Where we get the data

More on FDA + nicotine pouches