ANTBAR is an atomization technology company with 10 years of professional experience, focusing on the production and sales of disposable vape, always adheres to the compliance of regulations and laws, and is committed to providing users with high-quality e-cigarette products. Now, we will provide you with a detailed explanation of the U.S. e-cigarettes on the market and sales of related regulations. Let’s take a deeper look at this field!
Hot News: On January 16, 2024, the U.S. Food and Drug Administration (FDA) issued a press announcing the implementation of a marketing denial order for premarket tobacco product applications for SMOK products. The denial involves a total of 22 products, primarily because the applications failed to provide sufficient data to demonstrate the safety of ingredient delivery, product stability, and product abuse. As a leading brand in the e-cigarette industry, SMOK’s headquarters, Shenzhen IVPS Technology Co., Ltd. filed an appeal against this decision on January 18th.
Since 2023, the FDA has continued to increase its regulatory efforts, and the new CTP Director Brian King has pushed hard for several important initiatives since he took office. These include mass warning letters to offline retailers, import alerts, and joint enforcement with Customs.
Going into 2024, the FDA’s regulatory efforts will be further strengthened, with the implementation of PMTA regulations on the ground becoming a priority. The transition of the e-cigarette market from unorganized development to compliance is a long and tortuous process, and the market is bound to become more regulated in the future. In the European market, whether the product has been registered under the TPD is an important prerequisite for entering the local market. In the U.S. market, there will be some related regulations that strictly control market compliance same as the European market, and PMTA has been submitted will become a key factor for product quality and demonstrates a product is appropriate for the protection of public health.
What is PMTA?
PMTA, or Premarket Tobacco Product Applications, is the cornerstone principle for new tobacco products to enter the U.S. market. This guidance document requires manufacturers or importers of electronic nicotine delivery systems (ENDS) to provide evidence to the U.S. Food and Drug Administration (FDA) that their new product will be marketed with a commitment to public health. Meanwhile, manufacturers must properly maintain all relevant records from the application process to verify the legitimacy of their tobacco product sales. These stringent requirements are intended to promote the standardization of the tobacco market and ensure safe and reliable products for consumers.
What kind of products need to submit a PMTA application?
- E-liquid: E-liquid is the main part of e-cigarettes and usually contains nicotine and other ingredients. Since the liquid flows directly into the user’s body, a PMTA application is required to ensure its safety and effectiveness.
- E-cigarette kits and related accessories: Vape kits include components such as e-cigarette devices, batteries, atomizers, and liquids, and these components and accessories require a PMTA application to ensure their safety and compatibility with the device.
Requirements for PMTA application
- Basic Information
a.Applicant information
b.Product identification
c.PMTA type
d.Tobacco products previously submitted information
e.Statements of compliance with the federal food, drug and cosmetic (fd&c) act
f.Marketing protection statement
g.Packaging and labeling list
- Descriptive Information
a.Brief description of the new tobacco product
b.Declaration of compliance with tobacco product standards
c.Product label name
d.Description of prototype issues
f.Description of sales, distribution, advertising, or promotion
- Product Samples
FDA requires the submission of samples of new tobacco products.
- Labeling and description of the marketing plan
Include all proposed sample labels and a marketing plan for at least the first year.
- Environmental Assessment Statement
An environmental assessment prepared under 21 CFR Part 25.
- Abstract/Summary
A summary of all information contained in the application. Includes sections on product formulation, manufacturing, and health risk investigation.
- Product Formulation
A complete list of the ingredients, materials, components, additives, and hazardous substances of the tobacco product. Description of other characteristics including dimensions, structure, design parameters, etc.
- Manufacturing
A complete description of the mechanism, manufacture, packaging, and storage of the tobacco product demonstrates that the product complies with manufacturing specifications.
- Health Risk Assessment
a.Health effects of product ingredients, especially HPHCs.
b.Toxicological data regarding the product’s ingredients and emissions and mode of administration of the new tobacco product.
c.Pharmacological properties, involving ingredients, additives, and pharmacokinetics of HPHCs.
d.Health risks compared to other tobacco products.
e.Behavioral studies of tobacco use, especially the impact on groups such as youth.
f.Potential impact of initiation of tobacco use by non-users.
g.Cognitive and intent to use studies.
h.Influence of human factors on product risk.
i.Literature reviews and research reports describing specific products, objectives, methods, results, and recommendations.
How to Submit PMTA Information
PMTA Submission Methods
FDA offers three ways to submit a PMTA, including:
1.Online submission through the CTP portal.
CTP online submission at https://ctpportal.fda.gov/ctpportal/login.jsp
2.Electronic submission using FDA’s eSubmitter software and the eSubmitter template, “CTP Transmittal Form,” which follows the steps below:
a.Use the eSubmitter software to package regulatory documents into an electronic submission package.
b.Submissions should include ingredient lists, tobacco health documents, reports of harmful and potentially harmful ingredients, product applications, etc.
c.Set the format of the electronic submission through eSubmitter and follow the character limits for file paths and file names.
d.File names and file paths should be concise and avoid special or non-English characters.
f.Save the file as a standard type, such as SAS Transfer File Format or Comma Separated Value File Format.
g.Use PDF format if the dataset or text requires it.
h.For documents over 2GB, you need to split and cross-reference, and also make sure that FDA is aware of all expected documents.
i.Refer to the electronic Common Technical Document (eCTD) model, which is an FDA-supported standard for electronic submissions.
j.Optionally, create a cover letter to attach to the main application document, outlining the organization and including the number of eSubmitter packages and files to be transmitted.
k.Send to the CTP contact (Regulatory Health Program Manager) prior to submission so that FDA is aware of the expected number of documents.
3.If your company does not have an Industry Account Manager (IAM) account, you will need to apply for one, and the brief process is as follows:
a.Only employees of a tobacco manufacturer can apply for an IAM account for their organization. The IAM must be an employee of the organization and cannot be a non-employee attorney or agent.
b.Complete the IAM sheet entirety and make sure it is properly signed. Do not submit the request via email.
c.Submit the signed form to the CTP Portal. Upon successful creation of a CTP Portal account, FDA will notify the designated IAMs at the email address provided.
d.The IAM will receive an email with a link and instructions to complete the account setup. It is important to complete the account setup within 24 hours or the account will need to be reset.
e.IAMs that do not complete account setup within 24 hours should not resubmit the IAM Request Form in case of further delays in accessing the account.
PMTA Review Process
The PMTA review process consists of four main phases.
Pre-submission meeting
During this phase, the applicant is required to hold a voluntary formal meeting with the FDA to discuss the upcoming submission of the PMTA program for tobacco products. This provides a platform for both parties to address any existing issues and to ensure that the submission proceeds smoothly.
Acceptance Review
This phase is a preliminary review that focuses on ensuring that the product falls under the jurisdiction of the Center for Tobacco Products and confirming that the product has met the statutory and regulatory requirements of the standards and applications set forth in Section 910 of the FD&C Act and CFR 1114.27(a)(1).
Filling Review
The application materials are evaluated to determine if they contain sufficient information to warrant a substantive review. This is an important threshold determination process.
Application Review
In this phase, FDA will conduct an in-depth evaluation of the scientific information and data in the application, referring to the recommendations of the Tobacco Products Scientific Advisory Committee (TPSAC).
Action
At the end of the review process, the FDA will determine whether to grant a marketing authorization order (MGO) or a marketing denial order (MDO) based on the results of the evaluation.
Post-Marketing Requirements
Once the product is granted marketing authorization, the applicant is required to establish and maintain relevant records and reports under FDA requirements. This helps to ensure the safety and effectiveness of the product and provides evidence for possible withdrawal or suspension of marketing authorization. Post-market reporting requirements for all products authorized for marketing authorization are set forth in CFR 1114.41, and additional reporting would be required by the FDA under the terms of the marketing authorization.
How long does it take to apply for a PMTA after submitting it?
Stay tuned for feedback on each part of the process, and it will usually take half a month.
Benefits for enterprises filing a PMTA:
Avoid Warning Letters: If the corporation manufactures, sells, or distributes tobacco products in the U.S. that are not authorized by the FDA, then it will receive a warning letter issued by the FDA and be required to comply with the regulations. From January 2021 to May 2023, the FDA has issued more than 560 Warning Letters to companies that manufacture, sell, and/or distribute new tobacco products without authorization. By submitting a PMTA, companies can avoid receiving warning letters by ensuring that their products meet the FDA’s regulatory requirements.
Avoid Injunctions: An injunction is a civil judicial proceeding designed to stop a current violation, prevent its continuation, stop the circulation of the offending product in interstate commerce, and correct the conditions that led to the violation. By filing a PMTA, companies can ensure that their products comply with the regulatory requirements and thus avoid the risk of facing an injunction.
Exemption from Civil Penalty Complaints: The FDA has the authority to assess whether there have been violations of the FD&C Act related to tobacco products, including failure to obtain the required marketing authorization for new tobacco products. If a company violates any provision of the Act, it will face a civil penalty. However, the bill allows for increased fines for certain willful violations. By filing a PMTA, companies can ensure that their products comply with the Act’s requirements and thus avoid facing civil penalties.
