It appears so, following a series of significant recent FDA announcements regarding Harmful and Potentially Harmful Constituent (HPHC) reporting and Premarket Tobacco Product Application (PMTA) deadlines.
HPHC deadline revision
Firstly, on March 8, 2019 FDA issued a new guidance for industry document with an important deadline revision for manufacturers of electronic nicotine delivery systems (ENDS) and other newly deemed tobacco products.
The new guidance indicates that the Harmful and Potentially Harmful Constituents (HPHC) reporting deadline is no longer November 8, 2019. Instead, the HPHC reporting will be due on a date that is six (6) months from the publication date of a final guidance regarding HPHC reporting under section 904(a)(3)18, or nine (9) months from the publication date of a final guidance regarding HPHCs, for small tobacco product manufacturers. It is important to note that a small tobacco product manufacturer is defined in the guidance as a manufacturer that employs fewer than 350 employees. FDA considers a manufacturer to include employees of each entity that it controls, is controlled by, or is under common control with.
For products entering the market after the publication date of a final guidance regarding HPHC reporting, meaning, products that receive a marketing order under the Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (PMTA) or Substantial Equivalence (SE) premarket pathway, the HPHC reporting will be due 90 days prior to marketing, in addition to, and separate from, any HPHC testing within the premarket tobacco application, which arise from a FDA guidance document on PMTAs.
When may we expect the HPHC reporting guidance for the industry? ENDS emissions constituents are at the forefront of regulators’ concerns, because it is the emissions that reach ENDS users lungs. The Commissioner expressed concerns regarding the addiction potential of certain ENDS products. Research has been published discussing formaldehyde and diacetyl in ENDS emissions. Therefore characterizing the chemical profile of ENDS liquids and emissions, and identifying and quantifying known HPHCs is a regulatory priority. Moreover, FDA’s May 2016 guidance document on “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems” contemplates that applicants test 29 selected HPHCs in ENDS. The full list of these and an outline of legal requirements can be found in our HPHC Testing – Reporting in the United States article.
It is anticipated that the HPHC guidance will be published within a reasonably short period of time, thus triggering the HPHC reporting requirements through Section 904(a)(3).
PMTA deadline revision
Hot on the heels of this announcement, on March 13, 2019, FDA issued new draft guidance - "Modifications to Compliance Policy for Certain Deemed Tobacco Products", as part of the agency’s commitment to limit youth access to, and appeal of, tobacco products.
In the guidance, which will come into force 30 days after issuing final guidance, FDA is proposing to prioritize enforcement of its compliance policy regarding PMTAs by focusing on flavored ENDS products (other than tobacco-, mint-, and/or menthol-flavored) that are offered for sale in ways that pose a greater risk for minors to access the products, and those that are targeted to minors or likely to promote use of ENDS by minors. Importantly, the draft guidance details FDA’s expectation that manufacturers of flavored ENDS products covered by the new policy submit their premarket applications by August 8, 2021.
The date for submission of PMTAs of tobacco, mint and/or menthol flavored ENDS products remains as August 8, 2022. However, in the draft guidance document FDA has requested comments on whether to adjust the premarket review compliance date to August 8, 2021 for all ENDS products.
How we help ENDS companies
Broughton has been working with companies in the ENDS market since 2009. Our mission is ‘To accelerate safer nicotine-delivery products to market; advancing a smoke-free future.’ We are committed to working with the ENDS industry to achieve this, and have an experienced team in place to develop and deliver HPHC compliance and PMTA full-service delivery plans.