On June 23, 2022, FDA denied Juul’s application for authorization to sell its e-cigarettes in the USA. While FDA quickly backed down and allowed Juul to remain on the market while the FDA considered “scientific issues unique to the JUUL application that warrant additional review,” there is a lot of interest in FDA’s reasoning for denying Juul. This is particularly important given FDA’s decision to authorize several other e-cigarettes, including RJR’s Vuse Solo (commentary), Vuse Vibe and Ciro, JTI’s Logic (commentary) and NJOY (commentary).
Given this history, many people have wanted to understand FDA’s reasoning. To this end, my colleague Lauren Lempert submitted Freedom of Information Act requests for FDA’s Marketing Denial Order and Technical Project Lead (TPL) report so we could evaluate it.
Surprisingly, FDA refused to provide even a redacted copy on the grounds of protecting Juul’s trade secrets. This claim is particularly surprising given that tobacco companies routinely analyze their competitors’ products, reverse engineer them, and often produce knockoffs of popular products, so much of their product information is publicly known or available and by definition not trade secrets.
In addition, Juul knows FDA’s thinking because they are now discussing it.
Only the public and scientific community are being kept in the dark.
To try and remedy this situation, Lempert submitted a formal appeal. Her logic is compelling and reproduced below (with the introduction and citations dropped; see PDF of full request for those details):
1. FDA’s policy on disclosure of its records provides that FDA “will make the fullest possible disclosure of records to the public… consistent with the need for the agency to promote frank internal policy deliberations and to pursue its regulatory activities without disruption” while also protecting trade secrets and confidential commercial or financial information. (21 CFR 20.20(a)).
2. FDA has repeatedly stated that it is committed to transparency. In June 2009 FDA launched a Transparency Initiative, and in January 2011 FDA recommitted its focus “on increasing the transparency of FDA operations and decision-making.” As recently as August 3, 2022, CTP Director Brian King published his “Perspective: Update on FDA Review and Enforcement of Non-Tobacco Nicotine Products” in which he stated, “Our goal is clear communication and
3. The Supreme Court has found that the basic objective of FOIA is disclosure, and the “(b)(4)” [trade secret] exemptions for trade secrets are permissive, not mandatory. The Supreme Court stated, Congress did not design the FOIA exemptions to be mandatory bars to disclosure.” Therefore, while FOIA permits FDA and other agencies to withhold information containing trade secrets, it does not require them to do so.
4. I am not seeking information that constitutes industry trade secret or confidential commercial or financial information; rather, I am seeking information contained in the Marketing Denial Orders which describe FDA’s reasons for reaching its decision and reveal FDA’s decision-making processes which are neither privileged nor confidential information.
5. FDA’s Tobacco Products Marketing Orders website5 provides information on FDA’s Tobacco Products Marketing Orders website5 provides information on companies that have been issued marketing denial orders “only if products from that company are currently marketed.” JUUL products are currently marketed in the US and abroad. Moreover, Neither FDA nor JUUL has made a secret of the fact that FDA initially issued Marketing Denial Orders for JUUL. On June 23, 2022, FDA published a News Release to announce that FDA “issued marketing denial orders (MDOs) to JUUL Labs Inc. for all of their products currently marketed in the United States.” (On July 5, 2022, FDA administratively stayed the marketing denial order.)
7. However, FDA provided no justification for denying the entire request. 45 CFR 5.2(a) provides that FOIA requests for HHS records will be administered “with a presumption of openness.” Further, 45 CFR 5.2(a) states that HHS “will consider whether partial disclosure is possible whenever we determine that a full disclosure of a requested record is not possible. This includes taking reasonable steps to segregate and release nonexempt information.” 21 CFR 20.22 provides, “If a record contains both disclosable and nondisclosable information, the nondisclosable information will be deleted and the remaining record will be disclosed unless the two are so inextricably intertwined that it is not feasible to separate them or release of the disclosable information would compromise or impinge upon the nondisclosable portion of the record.” FDA offered no justifcation for why they considered the clearly non-exempt information in the Marketing Denial Order (for example, statements of FDA’s decision-making processes or rationale) is “inextricably intertwined” with purportedly exempt information.
8. FDA provides a link to a “Sample Decision Summary Document” on its website which demonstrates how FDA is able to disentangle non-exempt information from information that claims (b)(4) trade secret protection. This sample document is a PDF of the 20-page Technical Project Lead (TPL) Review of PMTAs for certain unnamed “ENDS (VAPES)” for which the PMTA submission tracking numbers and a few other small sections on only three pages (pages 14, 15, 16) have been redacted. This TPL recommended that FDA issue marketing denial orders for the new tobacco products which were the subject of the review and provides FDA’s reasoning and scientific review explaining why the applications lacked evidence to demonstrate that permitting the marketing of the subject products would be appropriate for the protection of the public health. FDA did not offer any reason why it did not provide similar information in response to my FOIA request. Indeed, there is no rational explanation for denying my request.
9. In situations where there is a request for public disclosure, the burden is on the person (in this case, Juul Labs) to demonstrate that the information should not be disclosed, not on FDA to prove that the information may be disclosed. (21 CFR 20.47)
10. A “trade secret” is defined as any information that benefits a business commercially and is kept secret. Matters of public or general knowledge in an industry are therefore not trade secrets, nor is information that can be gleaned by examining a product that is sold on the open market. Tobacco companies routinely analyze their competitors’ products, reverse engineer them, and often produce knockoffs of popular products, so much of their product information is publicly known or available and by definition not trade secrets. Notably, not only has JUUL been continuously marketed in the US since 2015, but also many counterfeit JUUL products are on the market, and JUUL has filed multiple lawsuits11 against “fake,” “copied”, and “counterfeit” rivals. Therefore, it is nearly certain that to the extent that FDA’s Marketing Denial Orders contain information about JUUL, it has already been discovered by competitors and/or is publicly available. Therefore, it is no longer confidential commercial information, it is not commercially valuable, and it is not entitled to (b)(4) trade secret exemption from disclosure.
As Lempert concludes:
FDA should honor its commitment to transparency by providing me and other members of the public valuable information on how it arrives at its marketing authorization and denial decisions and how it determines whether products are or are not appropriate for the public health. If FDA determines that some parts of the requested documents do, in fact, contain information that is legitimately entitled to (b)(4) trade secret protection, FDA should redact just those portions and otherwise produce the records as required by the Freedom of Information Act. There is no justification for FDA’s denial of my entire request.
If FDA is not moved by this argument, perhaps the media or people in Congress who are concerned about FDA’s regulation of e-cigarettes can also press for release of this important information.
UPDATE (Aug 15, 2022): Ms. Lempert also requested the Juul Tobacco Product Lead (TPL), which provides a summary of the technical reasons for FDA’s decision on Juul. She has also appealed that rejection (appeal letter). This appeal letter is a slightly edited version of the one she sent (summarized above) about the denial of the Juul MDOs. As in the previous appeal, she pointed out that FDA’s website includes a link to a “sample decision summary” of an actual TPL for an MDO for a different e-cig. In the new appeal, she emphasized that FDA managed to make a few redactions to that TPL, so how do they justify denying the entire TPL in this case? Also, she also mentions that since FDA’s letter indicates that the entire TPL that they are denying is only 45 pages, it wouldn’t be unduly burdensome for FDA to examine each page and redact only those portions that legally qualify as (b)(4) exemptions.