In the event you haven’t heard, last Friday, FDA announced an extension of the Harmful and Potentially Harmful Constituents (HPHC) reporting deadline.
VTA has been focused on this issue for some time. When we met with FDA last Spring, we explained the importance of having clear guidance on what HPHC testing FDA will require and how there was a lab space shortage that would have made complying within the established deadline of November 2019 next to impossible.
Then, on December 20, 2018, VTA sent a detailed letter to FDA Center for Tobacco Products Director Mitch Zeller and Director of the Office of Science Dr. Matthew Holman asking for detailed guidance and an extension. Specifically, the letter highlighted the following:
- “VTA asserts that it would put the proverbial cart before the horse to require HPHC submissions before the final guidance for such submissions is even available…. In the preamble to the final deeming rule, FDA stated that it “intends to issue a guidance regarding HPHC reporting under section 904(a)(3)” in advance of the compliance date. As of today, FDA has not issued any such guidance, much less a draft of such guidance.”
- “Manufacturers need both clarity and the opportunity to comply with any and all required submissions of HPHC listings for finished, deemed products. To that end, FDA must issue final guidance (or, preferably, a final regulation) that both specifies the constituents and deemed product categories for which the Agency will require HPHC listings and identifies the standardized testing methodologies that have been validated for this purpose for each such constituent for each such product category.”
- “There is precedent for VTA’s request. In March 2012, FDA issued guidance narrowing the constituents and categories of originally regulated products for which the Agency would enforce the section 904(a)(3) HPHC listing requirements. At the same time, FDA extended the statutory compliance date by 6 months for Small Manufacturers and by 3 months for all others.”
- “More importantly, today there is a stronger case for greater clarity and significantly more time to comply. Our investigation has revealed that validated standardized testing methodologies and standard equipment for evaluating the levels of HPHCs in several categories of deemed products simply does not exist today. Also, the enormous number of unique vapor products on the market that would require HPHC testing and submitted listings so greatly outnumber the originally regulated products, that FDA must consider a different timetable.”
- “Importantly, special relief needs to be afforded to Small Manufacturers since virtually all such manufacturers will have to rely on outside laboratories and will not be able to conduct any such testing in house. Congress acknowledged this fact in including special provisions for Small Manufacturers in section 915 of the Act. The Act provided that by April 1, 2013, FDA must issue regulations under section 915 requiring the “testing and reporting of tobacco product constituents, ingredients, and additives, including smoke constituents” of marketed tobacco products.”
- “Accordingly, VTA is respectfully requesting that the compliance date be extended until at least one year after FDA issues a final guidance or final regulation providing recommendations or requirements for HPHC listings for deemed vapor products.”
Friday’s announcement from FDA stated the following: “This revision extends the Harmful and Potentially Harmful Constituents (HPHCs) reporting compliance date to a date that is six months after the publication date of a final guidance regarding HPHC reporting under section 904(a)(3) and nine months after that publication datefor small tobacco product manufacturers.”
Note that the Family Smoking Prevention and Tobacco Control act defines “small tobacco product manufacturers” as those manufacturers “that employ fewer than 350 employees,” including “the employees of each entity that controls, is controlled by, or is under common control with such manufacturer.”
Thus, while the extensions of time are shorter than we asked, (and beg the question of how it would be possible to complete the significant amount of testing that might be required within 6 or 9 months), FDA clearly heard the message that we need clear guidance or a final regulation before testing is undertaken and completed. This development is very significant since it removes the immediate, imminent and onerous burden with which so many companies have been struggling. It is unclear when FDA will come out with its HPHC final guidance. That could happen at any time but given the track record and given the changeover at FDA it could also take some time.
In the meantime, VTA will keep making the case for rational regulation of this important industry.