The Battle over Flavor: FDA Wins This Round!

On June 24, 2026, the Fifth Circuit denied a petition brought by VDX Distro (VDX), an e-cigarette company, asking the court to review FDA’s decision to reject marketing authorization for its e-cigarette products. See VDX Distro, Inc. v. FDA, No. 24-60537 (5th Cir. 2026).

By way of background, e-cigarettes, considered a healthier alternative to combustible cigarettes, have been very popular among the younger generations, including children as young as middle schoolers. This phenomenon has been largely attributed to the various child-friendly flavors in which they have been made available. A 2024 survey found that a whopping 87.6% of middle and high schoolers who vape opted for a non-tobacco-flavored products, with “fruit” leading the polls and “candy” a not-so-close second.

FDA has long been concerned with this trend, publishing a guidance document in 2020 in which it laid out its enforcement priorities for e-cigarettes and stressed that “flavors increase youth appeal of tobacco products.” On the other hand, the benefits of e-cigarettes in helping current smokers quit, or at the very least, providing a less dangerous alternative to combustible cigarettes, cannot be ignored. Thus, FDA has found itself in a delicate balancing act between helping adult smokers quit and preventing young people from starting.

In response to this quagmire, FDA adopted a “comparative-efficacy standard,” used to determine whether a tobacco product is “appropriate for the protection of the public health” (or APPH). Under this standard, a company wishing to market non-tobacco-flavored products must show that it is more successful than tobacco-flavored products in encouraging adult smokers to switch to e-cigarettes or to quit smoking entirely. “Only then would a non-tobacco-flavored e-cigarette’s benefit to adults outweigh its risk to minors.”  VDX Distro, at 6.

Now to the Fifth Circuit case. VDX applied for market authorization for its menthol-flavored e-cigarette products. (Note that as per the Family Smoking Prevention and Tobacco Control Act (TCA), without FDA approval, e-cigarette companies cannot legally market their products). FDA denied the request, finding that VDX failed to prove that the benefits of the menthol-flavored products to adult smokers outweigh the risks to youths. VDX petitioned the Fifth Circuit for review of FDA’s decision.

In a 19-page decision, the Fifth Circuit rejected each of the four challenges brought by VDX, ultimately denying its request for review.

First, VDX claimed that the delegation by Congress of deeming authority to FDA on the issue of what constitutes a tobacco product violated the major questions doctrine. The Court found that VDX conflated the major-questions doctrine with the nondelegation doctrine, which “is squarely foreclosed.”

Next, VDX claimed that the TCA’s requirement that FDA deny pre-market applications unless it is APPH is unconstitutionally vague. The Court disagreed, stating that because the APPH standard does not prohibit conduct, but rather, sets a standard through which FDA assesses applications for marketing authorization, the “unconstitutionally vague” standard does not apply.

Third, VDX argued that the comparative-efficacy standard is in fact a “tobacco product standard,” which FDA is authorized to promulgate under the TCA, but only through notice-and-comment rulemaking. The Court disagreed, classifying the comparative-efficacy standard as “a balancing test, not a ban.”  More specifically, under the TCA, a “tobacco product standard” draws “hard-and-fast lines as to certain attributes of tobacco products” while the comparative-efficacy standard is “a methodology developed by FDA to apply the TCA’s APPH standard.”  FDA simply chose to interpret the APPH standard more narrowly for non-tobacco-flavored e-cigarettes. Thus, notice-and-comment rulemaking is not required. To support its position, the Court cited the 2025 Supreme Court case, FDA v. Wages and White Lion Investments, in which the Supreme Court categorized the APPH standard as “inherently comparative,” allowing for comparisons “between different types of new tobacco products that may attract new smokers.” Wages, 604 U.S. at 578-79.  The Fifth Circuit further noted that the Wages decision supported that agencies may develop regulatory standards through either adjudication or rulemaking.

Last, the Court rejected VDX’s claim that FDA’s denial was arbitrary and capricious, in violation of the Administrative Procedure Act (APA). More specifically, VDX claimed that FDA relied on stale data, impermissibly focused on adult and youth populations, rather than the TCA required “population as a whole,” and arbitrarily applied the APPH standard to VDX’s marketing plan. The Court rejected each argument, holding that (1) FDA was aware that the current data showed a decline in youth smoking but determined it was still a problem, (2) the TCA permits FDA to focus on subpopulations, and (3) FDA reviewed VDX’s marketing plan and adequately explained why it was insufficient, namely, that it did not propose anything FDA has not previously considered and found insufficient and that it lacked safeguards to prevent youths from obtaining the products.

In sum, the Court was happy to reject each of VDX’s four arguments one by one.

It is interesting to compare this case with FDA’s decision on May 5, 2026 to authorize the marketing of four non-tobacco-flavored electronic nicotine delivery systems (ENDS), including two non-menthol-flavored products. FDA found that the applicant, Glas, Inc., sufficiently demonstrated its ability, through access-restriction and age-verification technology, to mitigate access of its products among youths. This marked the first time FDA authorized non-tobacco and non-menthol ENDS products, and gives us an idea of the types of safeguards FDA considers sufficient with regards to preventing access to youths. See here.

Even more interesting is that FDA approved these ENDS products even though they did not meet the requirements of the comparative-efficacy standard. FDA summarized its decision in a memo, explaining that “[c]entral to these decisions was the FDA’s conclusion that the device access restrictions sufficiently mitigate the risk to youth such that the four applications for blueberry, mango and two menthol flavored e-liquid products did not need to demonstrate an added adult benefit relative to tobacco-flavored ENDS.” We note that Glas did provide a product-specific randomized actual use study to prove comparative efficacy, but FDA found that “the data did not demonstrate statistically significant differences in the rates of complete switching among adult smokers or significant cigarette reduction between the flavored new products compared to tobacco-flavored ENDS.” FDA approved the products anyway.

Based on FDA’s 28(j) letter sent on May 14, 2026, the agency views this approval as further support that its comparative-efficacy standard falls under the TCA’s adjudicatory framework rather than its rulemaking provision (“[t]he authorizations reflect that FDA is engaged in case-by-case adjudication, weighing the risks and benefits of each individual product to determine whether marketing the product would be appropriate for the protection of the public health.”). VDX disagrees, writing its own 28(j) letter in response and claiming that FDA still applied its “check-the-box fatal flaw review,” since Glas provided a comparative-efficacy study.

The Fifth Circuit has ultimately decided that FDA was acting within its adjudicatory powers when it denied VDX’s marketing application.

It will be interesting to see what happens next and we will be sure to keep you posted!