FDA says distributors must stop selling vapes covered by marketing denial orders

FDA has told distributors that a marketing denial order (MDO) is not a manufacturer-only problem: products covered by one cannot legally enter interstate commerce, and FDA says it intends to check compliance among distributors and retailers as well as manufacturers.

The position sits on the agency’s Tobacco Products Marketing Orders page, which also lists the decisions behind it and notes that order documents typically appear several weeks after they are issued.

No marketing order means no legal interstate commerce

To sell a new tobacco product legally in the United States, a company must hold a written marketing order from FDA, according to the agency. Products without authorisation, including those under an MDO, cannot be legally introduced into interstate commerce, and FDA lists administrative, civil and criminal enforcement as the consequences.

FDA states it intends to secure distributor and retailer compliance with issued MDOs, not just manufacturer compliance. That sentence carries the practical weight for warehouses and wholesale buyers: holding stock does not place a distributor outside the enforcement scope FDA describes.

Three routes to authorisation, one shared standard

FDA authorises new tobacco products through a PMTA, an SE Report or an EX REQ. The agency says its medical-product “safe and effective” standard does not apply to tobacco; instead it assesses products against a public health standard covering risks and benefits to the population as a whole, users and non-users alike.

An SE Report can be filed by any manufacturer and depends on a valid predicate product with the same characteristics, or on different characteristics that raise no different public health questions. An EX REQ comes from the original manufacturer and covers changes such as adding or deleting an additive or changing its quantity.

Recent denial orders span large and small brands

FDA’s decision list puts denial orders against major U.S. names alongside Shenzhen-linked manufacturers. Denials include Fontem US (blu Disposable) on 19 August 2025 and 5 February 2024, and Bidi Vapor (Bidi Stick—Classic) on 22 January 2024.

Several Shenzhen manufacturers appear in the January 2024 entries: Shenzhen Yibo Technology (MNGO Disposable Stick, 15 April 2024), Shenzhen Youme Information Technology (Suorin, 19 January 2024) and Shenzhen IVPS Technology (SMOK, 16 January 2024).

Grants in the same period went to Modoral Brands (Velo Mini Pouch, 30 October 2026), JUUL Labs (JUUL2, 28 August 2026), Swedish Match USA (ZYN ULTRA, 21 August 2026) and Helix Innovations (19 August 2026 and 4 August 2026). A denial is a product-specific decision, so the list mixes outcomes across categories and companies.

Retailers won the right to sue in 2025

The Supreme Court held 7-2 on 20 June 2025 in FDA v. R.J. Reynolds Vapor Co. that retailers count as persons adversely affected by a denial order and may petition for review. Writing for the Court, Justice Barrett reasoned that retailers lose the chance to profit from the product or, if they sell it anyway, risk imprisonment and other sanctions.

The decision means a challenge can be filed in the D.C. Circuit or in a circuit where the retailer resides or has its principal place of business, according to the Gibson Dunn client alert. The underlying statutory text, 21 U.S.C. § 387l(a)(1), lets any person adversely affected petition for review.

Two things follow for distributors. An MDO does not necessarily close on the day it is issued; litigation is possible, with retailer standing now confirmed. And the order text may not be public immediately, since FDA redacts and reviews documents for accessibility before posting, which the agency says usually takes several weeks.

Pre-existing products sit outside the authorisation queue

Products commercially marketed in the U.S. as of 15 February 2007 are pre-existing tobacco products and need no premarket authorisation, FDA states. Any modification makes the product new and sends it back through one of the three pathways.

FDA also restates the court-ordered deadline: a deemed product that was new and on the market as of 8 August 2016 required a marketing application by 9 September 2020, with an exception for premium cigars.

What changes for manufacturers and exporters

Analysis: every SKU shipped into the U.S. now needs its authorisation status documented before it leaves the factory, because a denial order removes the legal basis for interstate commerce rather than merely disappointing a launch plan. Shenzhen manufacturers named in denial orders face a separate question of whether an importer or retailer will carry the product at all while litigation is possible.

What happens next

Distributors can check each product against the MGO and MDO lists and treat the posting lag as a reason to confirm status directly with the manufacturer rather than assume silence means authorisation. The next dated step in FDA’s list is the 30 October 2026 grant to Modoral Brands.

Questions readers ask

Can a distributor still sell a vape covered by an FDA marketing denial order?

FDA states that new tobacco products without a written marketing order, including those covered by an MDO, cannot be legally introduced into interstate commerce, and that sale or distribution is subject to administrative, civil and criminal enforcement. The agency says it intends to ensure compliance by distributors and retailers as well as manufacturers.

When does a denial order become public?

FDA says order documents are usually posted several weeks after issue, because they are first redacted under applicable statutes and regulations and reviewed for Section 508 accessibility compliance.