Regulatory submissions for tobacco and vape products

Both the US FDA and the US CDC are investigating incidents of severe respiratory illness associated with use of vaping products. After years of little regulatory action, these government Agencies are ramping up oversight of vaping products.

Under section 910 of the FD&C Act, persons or companies intending to market a new tobacco product must first obtain an order to do so. A person or company that seeks pre-marketing authorization order must submit a pre-market tobacco product application (PMTA) under section 910 (b) unless it chooses to pursue the 905(j) pathway and can show substantial equivalence or is exempt from those requirements. This also applies to electronic nicotine delivery systems (ENDS) (

On July 12, 2019, a Court ordered the FDA to require manufacturers of e-cigarettes, cigars and other deemed new tobacco products that are not “grandfathered” (meaning all products commercially marketed in the United States before February 15, 2007), to submit applications for pre-market review by May 12, 2020. Due to the COVID-19 pandemic and reshuffled resources at the FDA, this deadline has been pushed out to 09-Sept-2020 (120-days extension).

It should be noted that not only are new tobacco products subject to the new published regulations and requirements but also any ENDS retail establishment that mixes or prepares combinations of liquid nicotine, flavors, or other e-liquids for direct sale to consumers for use in ENDS, or creates or modifies e-cigarettes for direct sale to consumers for use in ENDS (sometimes known as a vape shop) meets the definition of “tobacco product manufacturer” in section 900(20)15 of the FD&C Act.

Therefore, those establishments engaged in mixing and/or preparing combinations of liquid nicotine, flavors, and/or other e-liquids or creating or modifying e-cigarettes for direct sale to consumers for use in ENDS are both tobacco product manufacturers and retailers, and consequently are subject to all the requirements applicable to manufacturers and retailers including the PMTA requirements.

Importantly, the FDA has also provided enforcement priorities for ENDS products in their recent guideline published on 30-April-2020.

Further, FDA intends to prioritize enforcement of any ENDS product that is offered for sale after September 9, 2020, and for which the manufacturer has not submitted a pre-market application (or after a negative action by FDA on a timely submitted application).

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PharmaLex is a global solutions provider with over 1,000 experts and over twenty-five years of experience in supporting clients in fulfilling their FDA requirements and reporting obligations to maintain regulatory compliance. PharmaLex has a global team of experienced consultants who can author, compile, validate, and perform electronic submissions to the FDA.

With our extensive experience of the constantly evolving regulations to market and maintain products, we have developed and implemented multiple solutions for our hundreds of clients tailored to their needs. The service ranges from small projects or advice on a particular topic to a one-stop end-to-end solution.

PharmaLex has extended our compliance services to include the tobacco/vape industry to address the new FDA requirements. We assist with all regulatory compliance needs including:

  • Guide you through the regulatory requirements to ensure compliance with new requirements and establish the best possible way to pursue for PMTA.
  • Act as US Agent and communication representative on behalf of clients based inside or outside United States.
  • Author and/or submit your PMTA in electronic format (eTTD) via the CTP Portal or FDA Electronic Submissions Gateway (ESG).
  • Act as a designated user for your CTP Portal once your Industry Account Manager (IAM) creates a user account.
  • Submit your establishment registration and product listings online using the tobacco registration and listing module in FDA Unified Registration and Listing System (FURLS).
  • Electronic submission of ingredient listings for tobacco products.

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