Promising Steps from Gottlieb’s FDA

With the arrival of the Trump administration, we have been anxiously awaiting any new potential revisions to the deeming regulations. On Friday, July 28, 2017, we scored a massive victory for the industry. The FDA released a new “comprehensive regulatory plan to shift trajectory of tobacco-related disease, death.” While the deeming regulations remain in place and any past deadlines will still be enforced, the deadline for the PMTA submission has now been delayed.

The Trump administration delivered us the appointment of Dr. Scott Gottlieb in May 2017 to serve as FDA Commissioner. As a physician and cancer survivor, he brings a refreshing perspective to the vaping industry, as he seems to recognize the direct correlation of vaping to tobacco cessation, and he has made several encouraging remarks as of late.

“The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes –  the only legal consumer product that, when used as intended, will kill half of all long-term users…Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts – and we believe it’s vital that we pursue this common ground.”

Bloomberg Businessweek claims that this “proposal to make cigarettes less addictive could lead to the most sweeping effort to reduce smoking in the U.S. since 1965, when President Lyndon Johnson signed a law requiring packs of cigarettes to carry a health warning.” Indeed, Altria Group (home to Phillip Morris USA) stock prices plummeted in response to the July 28th release and lobbyists scrambled to respond.

To date, the FDA has already rejected 362 PMTAs without so much as an explanation.  This only further proves that the deeming regulations were a hurried, ill-informed governance that appeared to favor big tobacco in lieu of the many small businesses currently comprising the heart and soul of the vaping industry.  SFATA’s appointed lobbyist firm, Keller and Heckman LLP, refers to the original deeming regulations as a “one-size-fits-all approach,” an appropriate reference to laws that refused to take into account the varied products available and the differing needs of the consumers who rely on them.

However, Gottlieb’s approach is responsible and cautious; rather than outlawing an emerging industry, he instead seeks to study and fully understand it, using these new technologies to further what we in the industry have always stood for – saving lives through the cessation of smoking tobacco. He recognizes that the vaping industry has made great strides in reducing smoking, and rather than eliminating the industry, he seems to embrace a collaborative approach to vaping regulation.

So what does this all mean?

Any (non-combustible) products sold before August 8, 2016 have now been given a temporary reprieve, as the PMTA submission deadline has been moved from August 8, 2016 to August 8, 2022. 

However, this new deadline will not apply to any new products that entered the market after August 8, 2016. These new products will instead be subject to the immediate submission of a PMTA before the products may enter the market for sale, and even then, they may only stay on the market for one year without an approved PMTA from the FDA.

Keller Heckman, LLP notes: “Specifically, the the Agency noted in its press release that its new policy will not (1) apply to provisions of the Deeming Rule for which compliance deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors, or (2) affect future deadlines for other provisions of the rule, including, but not limited to, required warning statements, ingredient listing, health document submissions, harmful and potentially harmful constituent reports, and the removal of modified risk claims, i.e., ‘light,’ ‘low,’ or ‘mild,’ or similar descriptors.”

Below is an updated timeline of upcoming deadlines.

September 30, 2017 – Registration of US manufacturing establishments and submission of List of Products manufactured in such establishments

February 8, 2017 – Submission of Health Document Notification

November 8, 2017 – Submission of Ingredient Listing Reports

November 8 2017 – Submission of Harmful and Potentially Harmful Constituents (HPHCs) reports

August 10, 2018 – Nicotine Addiction Warning on Labels and Advertisements (any products not containing this label cannot be sold after 9/10/18)

August 8, 2022 – PMTAs Submission

Any vendors requiring more details are welcome to contact me directly at lena@bumblebeevapor.com, and I can provide the appropriate forwarding information.

This marks a huge turning point in the battle to save the vaping industry, but the war is far from over. It is more important now than ever to continue contacting your state senators and governmental agencies – including the FDA now that we know someone is listening!

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