top of page
Search
  • clarkespositolaw

Submit Your Comments On Our FDA Citizen Petition


On October 6, 2022 we submitted a Citizen Petition on behalf of our client, Vapor Vapes, Inc., to the U.S. Food and Drug Administration (FDA) to address a lack of appropriate guidance and agency regulation for tobacco and vapor companies who export products. In our petition we requested that FDA do the following:

  • Amend the regulation pertaining to the export of tobacco products, namely, 21 C.F.R. §1.101(b)

  • Issue a Guidance document for industry for Tobacco Product Inspections at manufacturing facilities that are engaged, in whole or in part, in the manufacture of tobacco products for export

  • Issue an update to FDA's Investigations Operation Manual (IOM) regarding inspections of manufacturers that export a tobacco product

If FDA does not take these actions the tobacco industry will continue to operate amid a lack of necessary guidance and regulation and will remain at risk of enforcement actions for products intended for export and exempt from domestic tobacco product regulation.


Our petition is now publicly available for comment on Regulations.gov. Click the button below to visit Regulations.gov where you can download and read our full petition.

Once on the page, click the “Comment” button shown in the graphic below to leave your comments on our petition. Please leave your comments within the next 30 calendar days.

Have questions about our Citizen Petition? Give our office a call today.


Ready to Learn More About CBP, OFAC,

BIS, and FDA? - for free! Details below.


We have dozens (literally!) of videos in our educational library on our YouTube channel related to importing, exporting, US Customs, BIS, OFAC, FDA, NFTs, and so much more. Subscribe to our channel now to stay up to date on the latest on these topics!


Our law firm helps growing companies who import and export comply with government regulations. We love what we do and we take our oath of confidentiality over your matters very seriously. How much? Watch this video to learn about it. CLICK HERE


Wondering "why should you have an attorney on your side?" Click here to watch one of our attorneys, Susan Steinman, break down the critical benefits as to why you want to have one on your side - whether you hire us to help you or another law firm.


Have questions? We are determined to help you.


We listen carefully to clients to ensure our understanding of the legal issues at hand, their factual context, and any limitations that might impact a chosen strategy. Feel free to connect with us using the contact form at the bottom of the Home page or send us an email at contact@clarkespositolaw.com.

bottom of page