Following the introduction of PreMarketing Tobacco Applications to be submitted for all new tobacco products on the US market , FDA have outlined their proposed post-PMTA reporting requirements for marketing orders in order to ensure that e-cigarette manufacturers’ products continue to be in the interest of public health following the acceptance of their PMTA.
Here is our understanding of the guidance and the requirements you will need to fulfil following your PMTA submission.
All reports submitted to FDA should include a cover letter which contains your company name, PMTA STN, tobacco product names, the date of your report and the reporting period it covers.
Periodic reports
Periodic reports should be submitted annually, unless otherwise specified in your PMTA marketing order from FDA.
The report should include ( information as proposed by FDA ):
- “Description of the changes made to the manufacturing, facilities, or controls that do not modify the finished tobacco product
- Inventory of ongoing and completed studies of the tobacco product
- Summary of sales and distribution data
- Data on current product purchasers
- Final labeling specimens and labeling changes
- Marketing and advertising implementation plans and reports”
Adverse experience reports
An adverse experience report must be submitted to the HHS Safety Reporting Portal within 15 days of identification.
An “adverse experience” requiring a report would include serious or unexpected experiences caused by the products such as hospitalization, incapacitation or death, or a manufacturing deviation that could cause serious health consequences or death.
The report should include ( information as proposed by FDA ):
- “Summary and analysis of serious and unexpected adverse experiences identified during the reporting period
- Summary of all manufacturing deviations, including those associated with processing, testing, packing, labelling, storage, holding and distribution
- Summary of changes made to manufacturing, facilities, or controls that do not modify the finished tobacco product (i.e., manufacturing process changes) compared to what was submitted in PMTA and rationale for change(s)”
Modifications to authorized products
Any changes to an authorized product should be notified in the periodic report.
However, as the PMTA marketing order approves a specific product set out in the PMTA, there is a chance that a modification could result in what is defined as a new tobacco product, as defined in Section 910(a)(1):
“ A change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2017. ”
If this is the case, the new product must be authorized as below.
Authorization of new tobacco products
If you intend to introduce a new tobacco product to the market, including a modification to a previously authorized product which means that it is defined as a new product, you are required to submit a new PMTA before you are legally able to sell the product in the US.
You may be able to submit a supplemental PMTA or request an exemption from substantial equivalence if your product meets the requirements.
If you need assistance in fulfilling your post-PMTA reporting requirements, our regulatory team can help. Contact info@inter-scientific.com to find out how we can help you and get a quote.
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