Regulation · 2 November 2026 · Stefan Bensmo

VELO's First FDA Authorizations: 24 Mini Pouches at 4 mg – Not VELO Plus

Short answer: yes, but only partly. On October 30, 2026, the US FDA authorized 24 VELO products from Modoral Brands, part of Reynolds American and BAT. All are VELO Mini Pouch or Mini Pouch 2 with 4 mg of nicotine. VELO Plus and the stronger products that make up most of VELO’s US sales are not included, and VELO has no authorized reduced-risk claim.

Exactly what the FDA authorized

The FDA authorized eight product names across two lines. Each name comes in three package types, giving 24 products. All three package types use certified child-resistant packaging (FDA).

The decision is listed as marketing granted orders for Modoral Brands Inc. in the FDA’s register on October 30 (FDA). The product names also include “400 mg”, which neither the FDA nor Reynolds explains. Tobacco Reporter reads it as the pouch weight (Tobacco Reporter), but that is not confirmed. Reynolds’ press release does not say whether the products are already on sale or when they will launch (Reynolds American).

What the decision does not cover

• VELO Plus and stronger products. The line that drives VELO’s US volume is not included. Reynolds says only that it will keep working with the FDA on its applications for further products (Reynolds American).
• A reduced-risk claim. VELO has no such order. ZYN remains the only nicotine pouch allowed to be marketed with an authorized claim of lower risk than cigarettes (FDA).
• Europe. A US authorization applies only in the US and gives no right to make health claims in Sweden or the EU.

The scoreboard after the decision

The FDA says it has now authorized 67 nicotine pouches (FDA). Its own list of authorized pouches still showed 43 products and no VELO on November 2 (FDA). Until the list is updated, rely on the announcement and the register of marketing orders.

Why the FDA said yes

According to the FDA, the products contain lower levels of harmful and potentially harmful constituents than cigarettes and smokeless tobacco, and several carcinogens could not be measured at all. The agency weighed the benefit to adults over 21 who use tobacco against the risks to young people and non-users. The applications were reviewed under the FDA’s nicotine pouch pilot programme, which the agency says has led to faster resolution of issues and shorter response times on deficiency letters (FDA).

The flavours are worth noting. Crema, Orange Crema, Passion Fruit and Cinnamon are neither tobacco nor mint. The FDA has previously authorized ZYN in flavours such as Cinnamon, Citrus and Coffee, so the decision confirms that flavoured pouches can be authorized – at least at low strength.

What it means

Our read BAT now has a regulatory foothold, but at the weakest end of its range. The part of VELO that competes with ZYN Ultra and on! PLUS is still sold while its applications are pending. ZYN keeps its lead: more authorized products, higher strengths and the only reduced-risk claim.

• Read the headlines carefully. “VELO is FDA-authorized” is true only for 24 specific products. Check the exact product name and strength.
• The pilot programme works. VELO was reviewed under it, as were 23 of the 43 earlier authorizations. Challengers with pending applications can expect faster handling than before, but not a faster yes.
• Every product is assessed on its own. Strength, flavour and package are separate decisions. ZYN Ultra at 11 mg was authorized in August, so high strength alone does not block authorization, but each variant needs its own evidence.
• Watch VELO Plus. A decision on VELO Plus, either way, will move the US price war more than this one.

See also how the PMTA process works, ZYN vs VELO, ZYN Ultra and ZYN’s reduced-risk claim.