Unredacted version of NJOY e-cig TPL shows what FDA is withholding from the public

When FDA authorized the sale of NJOY e-cigarettes in April 2022, it did not release the full Tobacco Product Lead (TPL) document that summarizes its scientific justification for doing so. In response to a Freedom of Information Act request for the full TPL, FDA inadvertently released an unredacted copy (details below). As of November 30, 2022, FDA had still not posted even the redacted copy on its website.

I went through and compared the unredacted and redacted versions of the TPL; here is a copy with the redacted material highlighted. The redactions were all justified as necessary to protect trade secrets; that’s what the b(4) designation on the redactions means.

Here are the things that the FDA withheld from the public:

Shelf Life

Shelf life of e-cigarettes is important because e-cigarettes get more toxic over time while sitting on the self: the chemicals in the e-liquid react with each other and there is microbial (biological) deterioration.

NJOY said the shelf life for their e-cigarettes was 12 months but only presented chemical stability for 9 months and microbial stability for 6 months.  (p. 6)  Nevertheless, FDA said “the lack of stability data for 12 months does not preclude an APPH [appropriate for the protection of public health] finding for these products.”

The specific humectants that can affect microbial stability (glycerine, propylene glycol, water) were redacted (p. 12) as was the cutoff level of concern for endotoxins. (p. 13) Endotoxins are bits of bacterial cell membranes that, when inhaled, can cause a wide range of problems, including when inhaled as a component of secondhand smoke.

There were more redactions on these points. (p. 13-14, 15, 26, 28, 35-36)

The fact that these issues came up repeatedly in the FDA’s analysis shows how important they are.

I don’t see how long NJOY reported shelf deterioration or the fact that the FDA allowed NJOY to claim longer shelf life than the data NJOY submitted could be trade secrets. This knowledge is of no commercial value to NJOY’s competitors. Rather, it seems that these redactions serve to hide the fact that FDA gave NJOY a pass (as it has done for all the companies) on the important issue of product stability from the public.

Flavors and kids

FDA redacted the specific flavors that NJOY studied, mostly leaving out any mention of menthol when discussing kids:

  • [Youth] studies also showed that curiosity and intention to try for Rich and Classic Tobacco Flavors were lower than those of Blueberry and Watermelon flavors among youth. (p. 25)  [Note no mention of menthol.]
  • In applicant’s Youth Perception study, curiosity to use the tobacco-flavored products was lower than the menthol, blueberry and watermelon varieties. (p. 35)
  • Among youth, curiosity to try Blueberry and Watermelon NJOY ACE products are higher compared to Rich and Classic Tobacco Flavors. (Curiosity : 15.55%, 16.45% for fruit- and 9.72% and 9.39% for tobacco-flavored).  Intention to try Blueberry and Watermelon flavor (12.90% and 12.94%, respectively) was higher among youth compared to tobacco flavors (11.75% and 9.24% for rich and classic tobacco flavors, respectively). (p. 18-19) [Again, no mention of menthol]

Flavors and adults

The findings on adults generally do not support the assertion that flavors — including menthol — make e-cigarettes more appealing to adults.

  • Curiosity to use tobacco flavor products was lower than menthol, blueberry and watermelon. (p. 6)
  • [NJOY] state[d] that Vuse Alto [a competiting e-cigarette sold by RJR] flavors and nicotine content were similar to the new [NJOY] products with Menthol, Blueberry and Watermelon.  (Flavors redacted).  (p.9)
  • There were no statistically significant differences in curiously among adults comparing tobacco flavored products to fruit and menthol flavors.  Specific numbers on curiosity about products also redacted: 4.6% among current smokers, 1.7% among former smokers, 1,1% among never smokers. (p. 17)
  • There was little variation (no statistically significant differences) in intention to try fruit- and menthol-flavored NJOY products relative to the tobacco-flavored NJOY ACE products.  A similar proportion of current adult smokers intended to try Rich and Classic Tobacco flavors (0.79 and 2.19%, respectively). (p. 17)
  • [Adult smokers] do not differentially prefer flavored NJOY ACE products (Blueberry, Watermelon, and Menthol) compared to the Classic and Rich Tobacco Products. (p. 24)

There was little evidence that NJOY would attract adults. This further raises questions about the FDA’s assumption that potential reduced harm among adults would more than offset attracting kids to NJOY e-cigarettes.

  • Intention to try product was low among adult current smokers  (4.1%) but was greater than among former smokers (1.2%) and never smokers (0.6%).  Numbers were redacted. (p. 17)
  • Prevalence of NJOY ACE among adults: 0.4%.  Proportion of adult smokers who used NJOY ACE: 2.3%.  Overall 4.1% reported use on any ENDS product.  Numbers were redacted. (p. 17)
  • In adult current smokers, curiosity and intentions to try NJOY ACE were low (4.6% and 4,1%, respectively).  Numbers redacted. (p. 24)

Chemistry

FDA pointed out measurement validation issues for glycidol, ethyl acetoacetrate, benzyl acetate and propionic acid.  Nevertheless, FDA said “effect of the method validation issues in minimal because the concentrations of these four analytes are low in the e-liquids.” (p. 14) The questions are: If there are problems with the measurements, how can FDA be sure the levels were law? Why didn’t FDA require NJOY to fix this problem before making a decision?

Butyraldehye and furfural were redacted among a long list of other toxicants that were lower in e-cigarette than cigarette aerosols. (p. 26, 27) It is not clear why these specific toxicants were redacted.

Other redactions

It’s hard to see how these redactions are trade secrets, except perhaps the company that did the testing.

  • Cross-referenced tobacco product master file names redacted. (p. 7)
  • The fact that applicant submitted manufacturing process for purified water. (p.12)
  • The fact that bulk e-liquid blending and filling is done in Class 8 clean room; fact that is it Class 8 is redacted. (p. 12)
  • The fact that GoodCat Analytical did testing is redacted. (p. 12)

The bottom line

It’s hard to see how most of these redactions qualify as legitimate trade secrets. Most seem designed to cover up FDA’s ongoing practice of giving applicant companies the benefit of the doubt.

Here are the TPLs: redacted, unredacted with redactions highlighted, unredacted clean.

The backstory

One June 9, 2022, FDA inadvertently released an unredacted copy of the TPL to the person who submitted the FOIA. The person who requested it shared the unredacted document with me that day. FDA later recognized its error, and on August 5, 2022, FDA’s FOIA officer sent the requestor an email requesting recipients to not use or distribute the unredacted version. On August 11, 2022,  the original recipient forwarded FDA’s August 5 email to me per FDA’s request. On September 28, 2022, FDA provided the requestor with a redacted copy to replace the unredacted version.

Published by Stanton Glantz

Stanton Glantz is a retired Professor of Medicine who served on the University of California San Francisco faculty for 45 years. He conducts research on tobacco and cannabis control and cardiovascular disease/

3 thoughts on “Unredacted version of NJOY e-cig TPL shows what FDA is withholding from the public

  1. Stan, I started looking at the unredacted copy. You may know this, but it was signed off by Matt Holman PhD. Apparently shortly after that good old Matt went to work at Philip Morris International.

    Linked:

    Matt Holman

    Transformational leader with 20 years of experience applying law and science to enhance U.S. public health policy

    Frederick, Maryland, United States

    517 followers 487 connections

    https://www.linkedin.com/signup/public-profile-join?vieweeVanityName=matt-holman-2ab773a1&trk=public_profile_top-card-primary-button-join-to-connect Join to connect

    https://www.linkedin.com/company/insidepmi?trk=public_profile_topcard-current-company Philip Morris International

    https://www.linkedin.com/school/university-of-maryland/?trk=public_profile_topcard-school University of Maryland College Park

    About

    I am a scientist with 20 years of experience at the U.S. Food & Drug Administration (FDA), where I have developed the following competencies: • Executive leadership • Science-based public health policy • Innovation • Communication • Organizational transformation

    Activity

    https://www.linkedin.com/signup/cold-join?session_redirect=https%3A%2F%2Fwww%2Elinkedin%2Ecom%2Fposts%2Fgizelle-baker_if-youre-asking-how-does-she-do-it-you-activity-6965368596159938560-H8ju&trk=public_profile_like_view Why is asking a woman with kids and a career, “how do you do it” somehow acceptable, but is not even something we consider to ask a man in the same…

    Why is asking a woman with kids and a career, “how do you do it” somehow acceptable, but is not even something we consider to ask a man in the same…

    Liked by https://www.linkedin.com/in/matt-holman-2ab773a1?trk=public_profile_like_view_actor-name Matt Holman

    https://www.linkedin.com/signup/cold-join?session_redirect=https%3A%2F%2Fwww%2Elinkedin%2Ecom%2Fposts%2Finsidepmi_we-are-not-the-first-company-to-introduce-activity-6969005617374007296-_HGs&trk=public_profile_like_view We are not the first company to introduce the concept of harm reduction. There is a demand for better alternatives to cigarettes, and adult smokers…

    We are not the first company to introduce the concept of harm reduction. There is a demand for better alternatives to cigarettes, and adult smokers…

    Liked by https://www.linkedin.com/in/matt-holman-2ab773a1?trk=public_profile_like_view_actor-name Matt Holman

    Experience

    https://www.linkedin.com/company/insidepmi?trk=public_profile_experience-item_profile-section-card_image-click

    Vice President, U.S. Scientific Engagement & Regulatory Strategy

    https://www.linkedin.com/company/insidepmi?trk=public_profile_experience-item_profile-section-card_subtitle-click Philip Morris International

    Aug 2022 – Present5 months

    Washington, District of Columbia, United States

    https://www.linkedin.com/company/fda?trk=public_profile_experience-group-header

    https://www.linkedin.com/company/fda?trk=public_profile_experience-group-header

    https://www.linkedin.com/company/fda?trk=public_profile_experience-group-header FDA

    https://www.linkedin.com/company/fda?trk=public_profile_experience-group-header 20 years 8 months

    o Director, Office of Science

    Jan 2017 – Jul 20225 years 7 months

    Silver Spring, MD

    o Director, Division of Product Science

    Dec 2001 – Jan 201715 years 2 months

    Silver Spring, MD

    Joel Dunnington MD

    1981 Hunters Cove

    New Braunfels, TX 78132-3386

    jsdunnington@gvtc.com jsdunnington@gvtc.com

    281-387-6770

    Retired Professor of Radiology UT MD Anderson Cancer Center

    Past President Lindheimer Chapter Master Naturalists

    President Elect Lindheimer Chapter NPSOT

    Like

  2. Thanks for this blog Stan.
    I have written a letter to Brian King at FDA expressing my disappointment on the handling of this. I am even more pissed off that the Director of Science who signed off on this NJOY application left the FDA 6 months later to join PMI as a Vice President for Regulatory Affairs.

    Like

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