Invitation to Comment on Citizen Petition

Are you a vape industry business or customer who believes that the U.S. Food and Drug Administration (FDA) is abusing the law to unfairly shut down businesses who provide vape products and services to adult consumers?

If so, you can take action NOW on two (2) issues by letting FDA know that you support action on many of the regulations (or lack of regulations) that enable FDA to penalize vape businesses who work very hard to legally provide safe products to American and foreign consumers.

CHECK OUT THE SAMPLE TEXT BELOW TO USE IN YOUR COMMENTS!

 

ISSUE #1 – Citizen Petition:

Some vape manufacturers produce vape products both for sale in the United States as well as products intended to be exported out of the United States for sale in other countries. Even though products intended to be exported out of the United States are not subject to most FDA regulations for vape products, FDA frequently takes enforcement action against manufacturers of export products for violations of U.S. vape product regulations.

Why does this matter? – Many such manufacturers who produce products for both U.S. and foreign markets are giving up on operating in the U.S. and have begun to simply move their operations overseas, reducing the number of safe products available for U.S. adult consumers.

YOU can submit a comment in support of our request for reform on this issue, or make your own case for reform on this issue, by going to our petition at the link below and simply clicking the BLUE “Comment” button:

 

https://www.regulations.gov/document/FDA-2022-P-2483-0001

 

ISSUE #2 – Petition for Stay of Administrative Action:

Many vape product manufacturers produce unfinished vape products which are sold to other manufacturers for additional mixing and packaging. These products are “unfinished” and therefore should not be subject to FDA regulations covering finished products intended to be sold direct to consumers. Despite this, FDA indiscriminately takes enforcement actions against vape product manufacturers of unfinished products based on the regulations for finished products – meaning that FDA believes vape products should be subject to DOUBLE REGULATION.

Why does this matter? – Heavy-handed enforcement and double regulation are running many vape manufacturers out of business – especially those manufacturers who produce bulk underlying products which supply smaller operations with the necessary products to mix small batches for local consumers. The vape industry relies on bulk manufacturers to supply the thousands of small and mid-level distributors and retailers across the country with mixing agents to create the finished products we consume.

YOU can submit a comment in support of our request for relief on this issue, or make your own case for relief for all manufacturers of unfinished vape products, by going to our petition at the link below and simply clicking the BLUE “Comment” button:

 

https://www.regulations.gov/document/FDA-2022-P-2514-0001

 

Want to tell FDA what you think? Feel free to use or modify the templates below!

 

USE/MODIFY FOR YOUR COMMENT ON ISSUE #1

Citizen Petition – Vape Product Manufacturers Engaged in U.S. and Export Operations

We would like to voice our support for Petitioner, Vapor Vapes’ request that the U.S. Food and Drug Administration (FDA) clarify the rules, regulations, and FDA guidance for vape product operations where any portion of the business is devoted to manufacturing for export.

Vape product manufacturers, like every American enterprise, are entitled to a regulatory, inspection, and enforcement framework that is accessible, clear, and which can be reasonably complied with.

Further, we implore FDA to facilitate corrective action efforts by vape product manufacturers who have demonstrated good faith compliance efforts in their general approach to FDA’s byzantine and frequently changing regulations for vape products.

FDA’s approach to this petitioner’s lines of business, and indeed, FDA’s overall approach to vape products to-date, suggests that there is no cohesive set of accessible regulations which businesses may follow with any confidence in compliance outcomes.

FDA rules and regulations, industry guidance, and the agency’s Investigations Operations Manual should promote a path which strikes the intended balance sought by the Tobacco Control Act and which facilitates safe, lawful American enterprise.

 

USE/MODIFY FOR YOUR COMMENT ON ISSUE #2

We fully support the arguments put forward by petitioner, Vapor Vapes, who has demonstrated a good faith attempt at compliance with the U.S. Food and Drug Administration’s (FDA) frequently changing – and often contradictory – rules and guidance relating to vape products.

Conscientious and compliance-minded manufacturers and suppliers of unfinished vape products who supply thousands of small businesses nationwide and who adult vape product consumers rely upon are increasingly making it clear that simply shutting down has become a preferable alternative than attempting to navigate FDA’s confused approach to unfinished products. The petition makes a highly valid point – given FDA’s enforcement policy on unfinished goods, is it the case that manufacturers of unfinished tobacco products are expected to obtain a marketing authorization (PMTA) for an underlying product that is sold forward to a business who is expected to obtain yet another PMTA for its finished product? Surely this cannot be the case – yet time and again it is what this industry has come to expect from FDA’s enforcement of vape products.

Vape product manufacturers, like every American enterprise, are entitled to a regulatory, inspection, and enforcement framework that is accessible, clear, and which can be reasonably complied with.

We urge FDA to develop a sensible and cohesive regulatory approach on this issue which reflects the reality of the operations and marketplace of this legal industry.