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FDA authorizes 24 Velo nicotine pouches for U.S. sale

FDA authorizes 24 Velo nicotine pouches for U.S. sale

Rule Changes

Modoral Brands wins marketing orders for two Velo lines at 4 mg, bringing the federal authorized list to 67 pouches

2 days ago: FDA authorizes 24 Velo nicotine pouches

Overview

Updated 1 hour ago

Modoral Brands, a Reynolds American operating company based in Winston-Salem, North Carolina, received FDA marketing orders on October 30 for 24 Velo nicotine pouch products. All 24 contain 4 milligrams of nicotine and cover two product lines, eight flavor-and-name combinations, and three package formats.

The orders matter because the FDA's authorized list works as a legal menu: a nicotine pouch may be sold in the United States only if the agency has named that exact strength, flavor, and container. Velo now sits beside ZYN and on! on a list of 67 authorized pouches, and Reynolds American says it will keep working with the agency on additional products.

Why it matters

Only pouches on the FDA list can be sold legally, so each order decides which smoke-free options adults can actually buy.

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Key Indicators

24
Velo products authorized
Two product lines across eight flavor names and three package formats.
67
Nicotine pouches on the FDA list
The total the agency says may lawfully be sold in the United States.
4 mg
Nicotine strength authorized
Every Velo product in this order is listed at 4 milligrams of nicotine.
$3.2B
Reynolds American smokeless investment
Planned company commitment announced before the authorization, expected to support more than 2,000 jobs.

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Organizations Involved

U.S. Food and Drug Administration
U.S. Food and Drug Administration
Federal agency
Issued the marketing orders and maintains the authorized product list

The federal agency that reviews premarket tobacco applications and decides which nicotine products may be sold.
MB
Modoral Brands Inc.
Tobacco product manufacturer
Holds marketing orders for 24 Velo nicotine pouch products

The Reynolds American operating company that makes Velo nicotine pouches.
Reynolds American Inc.
Reynolds American Inc.
Tobacco company
Parent of Modoral Brands; says more product applications are pending with FDA

The Winston-Salem tobacco company whose subsidiary makes Velo.
HI
Helix Innovations LLC
Tobacco product manufacturer
Competitor already on the FDA authorized pouch list with on! and on! PLUS

The maker of on! nicotine pouches, one of Velo's rivals on the federal list.

Timeline

January 2025 October 2026

4 events Latest: 2 days ago
Tap a bar to jump to that date

  1. FDA authorizes 24 Velo nicotine pouches

    Latest Regulatory

    Modoral Brands receives orders covering Velo Mini Pouch and Mini Pouch 2 at 4 milligrams across eight flavor names and three package formats, all child-resistant.

  2. JUUL2 authorized as the list keeps growing

    Regulatory

    The FDA grants marketing orders to JUUL Labs for JUUL2, one of a series of 2026 authorizations.

  3. on! PLUS clears the FDA list at higher strengths

    Regulatory

    Helix Innovations receives orders for on! PLUS at 6 and 9 milligrams in three flavors.

  4. ZYN becomes the reference pouch on the federal list

    Regulatory

    The FDA grants Swedish Match USA marketing orders for ZYN, setting the product-by-product format later orders follow.

Scenarios

1

FDA adds more Velo products to the authorized list

Likely Resolves by Oct 30, 2027

Discussed by: Reynolds American, which said it will keep working with the FDA on submissions for additional products

Reynolds American said the October orders cover a select number of Velo products and that it will continue working with the agency on the rest. A new marketing order for any additional Velo strength, flavor or package would extend the brand beyond the eight names authorized so far. The FDA's own list is the record that settles it.

2

Velo wins authorization at a strength other than 4 mg

Possible Resolves by End of 2027

Discussed by: Competitor filings show the FDA has cleared pouches at 2, 6 and 9 milligrams, while Velo's orders cover only 4 milligrams

Every Velo product authorized on October 30 is listed at 4 milligrams, while on! holds 2 and 4 milligram orders and on! PLUS holds 6 and 9. If the FDA clears a Velo pouch at another strength, the brand could compete across the same range as its rivals. A denial or continued silence would leave Velo at a single strength.

3

The federal pouch list passes 75 products

Possible Resolves by End of 2027

Discussed by: Market coverage noting the list grows one application at a time and that three major manufacturers now sit on it

The FDA list stood at 67 after the Velo orders. Further grants to Velo, Helix or Swedish Match, or a first order for another manufacturer, would push the count past 75. The count is published and updated by the agency, so the outcome is checkable rather than interpretive.

Historical Context

2 moments from history that rhyme with this story — and how they unfolded.

January 2025

ZYN receives FDA marketing orders (2025)

The FDA granted Swedish Match USA marketing orders for ZYN nicotine pouches, the first large pouch brand to reach the federal authorized list. The orders named specific products rather than approving the brand as a whole.

Then

ZYN became the benchmark entry on a list that initially held only a handful of pouches.

Now

The agency settled into a product-by-product format that every later applicant, including Velo, now works within.

Why this matters now

Velo's 24 orders follow the same pattern: exact strength, flavor and container, not the brand.

December 2025

on! PLUS clears the list at higher strengths (2025)

Helix Innovations received orders for on! PLUS at 6 and 9 milligrams in Mint, Tobacco and Wintergreen, alongside earlier orders for on! at 2 and 4 milligrams. Helix picked up further orders in August 2026.

Then

The authorized list began covering a range of nicotine strengths rather than one standard dose.

Now

Competitors now build their federal portfolios strength by strength, which makes each new order a discrete commercial permission.

Why this matters now

Velo enters with only 4 milligram products, a narrower slice of the strength range than Helix already holds.

Sources

(7)
+2
U.S. Food and Drug Administration Reynolds American Inc. PouchDaily JBizNews Tobacco Insider U.S. Food and Drug Administration U.S. Food and Drug Administration