Search
  • NorthAmericaNicotine

Let's Talk about PMTA pt.1



The PMTA process is becoming a consistent topic for the majority in the industry of vaping, and with the submission deadline being May 2020, pressure is building. Very few companies have openly dedicated a commitment to submit, while others seem to be planning to continue until the deadline, then foresee-ably pulling their products from the market. The fact is, a tremendous amount of work will have to be done.


In this blog series, questions from business owners and vape industry affiliates will be answered in order to address the vast concerns arising from the deadline, the potential cost, and the uncertainty about the process.


While the PMTA process initially presents itself as overwhelming, it is important to remember, "When eating an elephant take one bite at a time."




1. What is my first step to file my PMTA?


The necessary components of the PMTA submission are vital in understanding how to tackle this project, but the first step necessary will be to schedule a meeting with the FDA. The FDA states "Any tobacco product manufacturer, researcher, importer, or investigator involved in the research, development or marketing of a tobacco product, or their representatives, should submit a written meeting request to the Director, Office of Science, CTP, at FDA."


When writing your written request, it is important to have it identified as "OS Meeting Request".

The address to submit your request is:


Food and Drug Administration

Center for Tobacco Products

Document Control Center, Building 71, Room G335

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002


2. What information am I supposed to submit in my PMTA?


There are several categories that the FDA requires in the PMTA submission, those categories are as follows:

  • Full reports of all information, published or known to, or which should reasonably be known to, the applicant, concerning investigations that have been made to show the health risks of such tobacco product and whether such tobacco product presents less risk than other tobacco products;

A full statement of the tobacco product's

  • components

  • ingredients

  • additives

  • properties, and

  • principle(s) of operation;

  • A full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of such tobacco product;

  • An identifying reference to any tobacco product standard, under section 907, which would be applicable to any aspect of such tobacco product, and either adequate information to show that such aspect of such tobacco product fully meets such tobacco product standard or adequate information to justify any deviation from such standard;

  • Such samples of such tobacco product and of components thereof as the Secretary may reasonably require;

  • Specimens of the labeling proposed to be used for such tobacco product; and

  • Other information relevant to the subject matter of the application as the Secretary may require.

3. What company should I use if planning to file a PMTA?


There are several groups that can be utilized in order to assist, and provide in depth information to make the PMTA process easier to breakdown.


North Guide Solutions- www.ngsint.com

Chemular- https://chemular.com/

Ginnamore Law Firm- https://giannamore-law.com/

Bright Consultants- https://www.brightconsvlt.com/


Many of these companies have a history of working with the FDA, and can act as a valuable guiding source to organize all necessary components in order to begin the submission process.


4. Does Small Business Assistance exist for this process, and if so, how does one obtain access?


There is a resource for small businesses provided by The Center for Tobacco Product's (CTP) Office of Small Business Assistance, or OSBA. Assistance is primarily help with answering questions, clarification, interpretation, and compliance.

  • Phone: 1-877-CTP-1373 (1-877-287-1373) *Can use Skype Monday–Friday, 7:30 a.m.–6:00 p.m. EDT

  • E-mail: SmallBiz.Tobacco@fda.hhs.gov

  • FDA/CTP Office of Compliance and Enforcement Document Control Center Building 71, Room G335 10903 New Hampshire Ave. Silver Spring, MD  20993

5.When cigarettes came under the regulatory authority of the FDA, products on the market were grandfathered in and didn't have to submit PMTA's. Why is vapor going through this process?


95-99.9 percent of Eliquid products were not on the market to be able to grandfathered in. If the product was not marketed before February 15, 2007, it is considered a new tobacco product, therefore subject to the PMTA process.

"Before a new tobacco product can be legally marketed, FDA must issue an order permitting marketing of that product. To issue a premarket tobacco product application (PMTA) marketing order, FDA must evaluate that product based on a public health standard that considers the risks and benefits of the product to the population as a whole, including tobacco product users as well as non-users."

6. Have any companies successfully filed?


As of April 2019, Phillip Morris International is the only acknowledged completed PMTA for the IQOS. This approval process took over two years. To see the entire filing process, and all it's components, follow the link below:


https://www.fda.gov/tobacco-products/advertising-and-promotion/philip-morris-products-sa-modified-risk-tobacco-product-mrtp-applications#E


7. What would cause the FDA to deny a PMTA application?



Overall, the FDA can deny a PMTA application if not all information in the draft guidnaceis provided. The first part of the review process can take up to 180 days.The FDA may also request additional information to satisfy their requests. To understand what is necessary, it is important to have a better grasp of the submission process.


There are three categories to the submission process of the PMTA. Here is an excerpt from the Draft Guidance, section 385-396. ( https://www.fda.gov/media/97652/download )


• A marketing application has been “submitted” when a complete application is delivered and received electronically, through the mail, or through a courier to CTP’s Document Control Center (DCC). Once a complete PMTA is submitted and received by CTP’s DCC, FDA will have 180 days to consider the application as described in section 910(c)(A) of the FD&C Act.


• A marketing application “has been accepted” after the Agency completes a preliminary review and determined that the application on its face contains information required by the statutory and/or regulatory provisions applicable to that type of application.


• A marketing application has been “filed” after the Agency completes a threshold review and has determined that a complete, substantive review is warranted. This filing review occurs only for a premarket tobacco application or a modified risk application and results in either a filing letter or a refusal to file letter.


Another excerpt of the PMTA submission process. Page 10:

( https://www.fda.gov/media/127853/download )

  • Accepted: An application has been “accepted” after the Agency completes a preliminary review and determines that the application appears on its face to contain information required by the statutory provisions and any applicable regulations.17

  • Filed: After FDA accepts a PMTA, an application has been “filed” after FDA completes a filing review and determines that the application is sufficiently complete to permit a substantive review. This filing review occurs only for a premarket tobacco application or a modified risk application and results in either a filing letter or a refusal to file letter.

  • Substantive Review of a Complete Application: An application is considered complete when it contains the information required by section 910(b)(1) of the FD&C Act, including product samples, which starts the 180-day review period as set forth in section 910(c)(1)(A) of the FD&C Act. If there are deficiencies identified during the review of the filed PMTA, CTP may issue letters requesting additional information or clarification on deficiencies identified within the application. Issuance of such a letter would pause the 180-day review period until CTP receives a complete response to all the deficiencies identified within the letter.



*We will be answering more submitted questions in next weeks blog spot, "Let's Talk about PMTA pt.2".


-To submit a question about PMTA's, please email:

Ashley@northamericanicotine.com

-To find out more about North America Nicotine, and our products, please email: Taylor@northamericanicotine.com








0 views
  • Facebook Social Icon
  • Instagram
  • Twitter Social Icon

© 2019 by North America Nicotine

www.northamericanicotine.com