Search results

While HR 2330 would have imposed additional restrictions on FDA approved vapor products (i.e. those whose PMTAs are reviewed and subsequently approved by FDA), Text - H.R.2339 - 116th Congress (2019-2020): Protecting American Lungs and Reversing the Youth Tobacco Epidemic Act of 2020 Judge Paul...

According to a Wall St Journal article, JTI apparently submitted PMTAs for their Logic e-cigarettes in August, and NJOY is planning to submit PMTAs for some of its vapor products in January. Reynolds files for FDA review of Vuse e-cigarettes Tobacco giant gets a head start on rivals in seeking...

Unless FDA files an appeal (as it should), it appears to me that Judge Grimm's order will result in: - a sharp increase of vapor product sales (especially open system vaporizers and 100/120ml bottles of e-liquid) as vapers stock up before FDA bans their sale (similar to 100 years ago just...

Pfizer paid each of its Board members >$335,000 last year. Meanwhile, Gottlieb claimed FDA wouldn't approve JUUL's PMTA (i.e. Gottlieb lobbied FDA to not approve JUUL's PMTA) in a Wall Street Journal op/ed the day before Pfizer announced Gottlieb joined its Board. But neither the Wall St...

I strongly suspect that just three manufacturers will be able to submit PMTAs to FDA (that the agency will officially review) for some of their closed system vapor products within the next year, while the other 99.9% of vapor manufacturers will not be able to do so (a defacto ban on the sale of...

While JUUL has conducted some of the hundreds of studies and toxicology data needed for a PMTA (even with the help of many Altria scientists and regulatory affairs staff), JUUL won't be able to submit a PMTA (that FDA would officially review) before the 90 day deadline that vapor...

The bottom line is that FDA cannot politically begin to enforce its Deeming Rule (that banned the sale of ALL vapor products on 8/8/2018, according to Judge Grimm's ruling) unless and until FDA approves at least one or several PMTAs for vapor products. If FDA follows Judge Grimm's order, the...

Here's another news article. Federal judge orders FDA to begin review of e-cigarettes The opinion and court order by Obama appointed US Judge Paul Grimm are below, and appear to written by attorneys representing the Big Pharma funded plaintiffs (CTFK, ACS, AHA, ALA, AAP) that also lobbied for...

FDA's comment claiming IQOS wasn't "FDA approved" traces its roots to my 2004 letter to members of US Congress (below) urging them to reject the Tobacco Control Act legislation (that was negotiated and agreed to in 2003/04 by Philip Morris lawyer Mark Berlind, RWJF financed CTFK's Matt Myers and...

At last year's FDA TPSAC meeting, I urged Mitch Zeller to not approve the PMTA submitted by Altria/PMI for IQOS unless and until FDA rescinds its Deeming Regulation (that bans the sale of >99.9% of vapor products now on the US market on 8/8/2022, that banned sales of nearly all vaporizers sold...

My biggest concern about FDA's draft guidance (that bans sales of vast majority of flavored vapor products at stores that allow youth to enter the store) is that nobody will challenge it in federal court because: - suing the FDA could cost $500,000 - $1M each year for the next three years, -...

Smokefree Pennsylvania comments to FDA continued: Brad Rodu revealed the 2017 NYTS found 38% of 6th-12th graders who used e-cigarettes, cigarettes and cigars in past 30 days frequently used e-cigarettes on 20+ of the past 30 days, compared to 21% who used e-cigarettes and cigars, 20% who used...

I submitted the following comments to FDA on April 30 at Regulations.gov (but removed the section revealing the increase in teens vaping substances that aren't permitted to be discussed on ECF). My Comment Tracking Number: 1k3-99n8-d5pc Food and Drug Administration Center for Tobacco Products...

I'm surprised AEI would want/allow Gottlieb back after he lied about nicotine and teen vaping, and after he proposed/imposed banning flavored vapor products at many retail stores (which violates the TCA), banning all vapor product sales in 2021, banning cigarettes (by sharply reducing nicotine...

I suspect Altria still has millions of Mark Ten products that they're trying to sell. Mark Ten never sold well. Altria spent >$750 Million (probably >$1 Billion) since 2013 researching, developing, manufacturing, advertising, promoting and protecting the brand's planned future FDA PMTA and...

The FDA's draft Guidance violates Section 906 (d) (3) (A) (i) of the 2009 Tobacco Control Act that prohibits DHHS/FDA from banning "the sale of any tobacco product in face-to-face transactions by a specific category of retail outlets"...

I attended and presented at FDA's January 18 public hearing, where Scott Gottlieb read his speech (which was intended to generate lots of news headlines, as it did) and promptly left the hearing. The hearing was as surreal as its hysterical news coverage. Seven vapor prohibitionists...

Goniewicz has been funded by FDA/NIH for many years, and he's made many false fear mongering claims about vaping to the news media that grossly misrepresent his actual research findings. One of Goniewicz' earliest e-cig studies found that vapor aerosol contains exponentially fewer toxicants...

Wells Fargo's Bonnie Herzog is now projecting $9 Billion in US vapor product sales in 2019, up from her estimated $6.6 Billion in 2018.

Please note that last Friday (Dec 7) Altria announced it will stop all sales of vapor products (i.e. Mark Ten), which now have <3% of the US vapor market segment even though they are sold and prominently displayed at >100,000 retailers. Altria has lost more than $500 Million on Mark Ten. If...