Month: September 2020

A recent rulemaking policy change by the Trump administration may have been partially prompted by concern over a vaping industry lawsuit challenging the FDA Deeming Rule. That lawsuit is currently being appealed on the grounds that the old rulemaking procedure is unconstitutional.

If the vaping industry plaintiffs are successful, the case could open the floodgates for challenges to other rules issued by federal agencies.

A federal appeals court heard online oral arguments last week in the appeal of Moose Jooce, et al v. Food and Drug Administration, which challenges the FDA Deeming Rule on grounds that it violates the Appointments Clause and First Amendment of the Constitution. The lawsuit, which consolidated three separate complaints by small vaping businesses, was decided in favor of the FDA in February in the Washington D.C. federal District Court by Judge Christopher Cooper.

The vape industry plaintiffs claim that the Appointments Clause of the Constitution requires federal rules that carry the force of law (like the Deeming Rule) to be signed by officials who have been appointed by the President and approved by the Senate. The Deeming Rule was signed by a career civil servant, Associate FDA Commissioner Leslie Kux.

In February, District Judge Cooper had found against the plaintiffs, noting that regulations not signed by a Senate-confirmed officer can be constitutional if they are confirmed later by a Senate-confirmed official. Judge Cooper cited previous rulings that “consistently held that a rulemaking ‘that would otherwise be unlawful due to procedural or technical defects . . . can be cured through a subsequent lawful ratification of that action’.”

The judge said that two FDA commissioners ratified the Deeming Rule after it was issued, and that the D.C. Circuit Court of Appeals has “repeatedly” confirmed that “an agency’s ratification of a prior decision or action cures any potential Appointments Clause violation.”

But last week a three-judge panel of the federal Circuit Court of Appeals in Washington D.C.—the same court cited by Judge Cooper—heard lawyers for the plaintiffs argue that Judge Cooper had been wrong—and some of them seemed to indicate they might agree.

“This court should absolutely be concerned about FDA’s whack-a-mole approach to the Appointments Clause,” attorney Jonathan Wood told the appeals court during oral arguments. Wood works for the Pacific Legal Foundation, the conservative/libertarian public interest law firm representing the Moose Jooce plaintiffs.

The circuit court judges seemed to concur, according to Courthouse News. All three questioned whether rules issued by officials not confirmed by the Senate were valid, with one even wondering whether the procedure of ratifying rules after the fact makes the Appointments Clause a “something of a dead letter.”

The lawsuit (and appeal) also challenges the Deeming Rule on First Amendment grounds, asserting that communication by vape shop employees about vaping risks and benefits can’t be preemptively prohibited by limitations in the Deeming Rule.

On the First Amendment claim, Judge Cooper had said in February that he was bound by precedent set in the December 2019 U.S. Circuit Court of Appeals decision in the Nicopure Labs vs FDA appeal. In that case, a three-judge panel unanimously upheld the 2017 ruling against the vapor industry, issued by D.C. District Court Judge Amy Berman Jackson.

“The Circuit [Court of Appeals] quite clearly held that placing the burden on manufacturers to substantiate their marketing claims does not violate the First Amendment,” Judge Cooper wrote. “Bound by that precedent, the Court holds that the Tobacco Control Act’s premarket review provisions do not impermissibly burden speech.”

The appeal is likely to take months to be decided. Should the circuit court panel overturn the original decision based on the Appointments Clause, it could open the federal government to an avalanche of lawsuits challenging other improperly issued rules. An FDA loss could also invalidate the Deeming Rule and force the agency to start the process of regulating vaping products from the beginning.

The Appointments Clause challenge in the Moose Jooce case, and other similar cases, may have pushed Health and Human Services Secretary Alex Azar to recently change the method by which HHS agencies like the FDA issue rules.

Sec. Azar issued a memo, just days before oral arguments in the vaping industry appeal were set to begin, saying that future rules by HHS agencies would be signed by the secretary himself, rather than agency employees. The announcement was interpreted by many in Washington as a power grab by Azar and the Trump administration, intended to prevent the FDA from issuing rules politically unpopular in the White House. But it may simply be a way for the HHS to protect itself from additional Appointments Clause lawsuits.

In any case, even if the Azar memo and Moose Jooce appeal puts previous HHS agency rules in jeopardy, challenging them would have to be done on a case-by-case basis. An appeals court decision against the FDA wouldn’t automatically invalidate every other previously issued rule by the FDA or other federal agencies.

Michigan Governor Gretchen Whitmer is again trying to ban flavored vaping products through executive rulemaking. But this time, instead of a temporary “emergency” rule like the one she sought last year, Whitmer is attempting to impose a permanent ban.

Michigan citizens who vape are actually facing two threats from their state government: Whitmer’s attempt to ban flavors, and an unrelated package of bills from the state legislature that includes a tax and a law mandating the creation of a list of legally available products, which was lobbied for by a tobacco company.

Both actions threaten the availability and affordability of vaping products, but the governor’s proposed flavor ban is the greater and more pressing threat. It needs immediate action by Michigan vapers and vape businesses.

Gov. Whitmer is proposing a complete ban on flavored vaping products. As with last year’s proposed “emergency” flavor ban, the governor’s action is being advanced through rulemaking by the Michigan Department of Health and Human Services (MDHHS), an executive agency run by the governor.

The rule would permanently ban all flavors of nicotine-containing e-liquid except for tobacco-flavored products. If the rule is adopted, it is unlikely that vape shops in Michigan could survive. That would leave vapers who use flavored products to find them on the black and gray markets or learn to make DIY e-liquid. For most adults who smoke, neither of those are options they will jump through hoops to seek out. However, there’s no reason to believe that determined adolescents will be unable to get hold of flavored products.

The MDHHS will hold an online public hearing Oct. 20, and is accepting public comment until Oct. 23. CASAA has issued a call to action, urging Michigan residents to tell the MDHHS that flavors are an essential feature of vaping for adult vapers. You can make comments through the call to action (linked below), which also has suggestions for what to discuss in your comments, and information on how to take part in the virtual hearing.

CASAA has an excellent series of talking points to consider when writing your comment, including telling your personal vaping story, explaining why flavors work for you, describing what you’ll do if flavors are unavailable, and talking about how vaping improved your health.

Since the MDHHS is supposed to be using science to advance this (obviously political) rule, you might also remind the agency that a recent CDC survey shows that flavors are not a key reason youth try vaping (don’t link the Vaping360 story; use the actual CDC document), but surveys of adult ex-smokers prove that they rely on flavored vaping products (Farsalinos study, Russell study).

The governor’s proposed rule is being backed by a Campaign for Tobacco-Free Kids front group consisting of dozens of tobacco control, public health, medical, hospital and academic organizations. They’ve hired a powerful public relations firm to push a “petition” supporting the flavor ban, which will be turned over to the MDHHS as individual public comments by the signatories.

After the comment period and hearing, the MDHHS will theoretically have to consider public comments when drafting its final rule, which could take up to a year. The final rule will be approved or rejected by the legislative Joint Committee on Administrative Rules. At that point, the fight may begin all over again.

Gov. Whitmer never bothered to attempt advancing her 2019 anti-vaping agenda through the Michigan legislature—not because a flavor ban would have been impossible to pass, but because she wanted to be the first governor to score politically with vaping, and burnish her image in the Democratic Party. (In fact, she beat New York Gov. Andrew Cuomo to the punch by less than two weeks.)

Democrats tend to follow the positions of anti-tobacco activists on the vaping issue, and the Whitmer administration has connections to Bloomberg Philanthropies and Bloomberg-associated anti-tobacco organizations. Whitmer’s political ambitions extend beyond Michigan, but to earn recognition as a future national Democratic candidate she needs to be seen as a bold political trendsetter by national party leaders.

Unlike other governors who followed her flavor ban lead, Whitmer did not position her rule as a response to the lung injury outbreak caused by contaminated illicit THC products. (But her health agency waited until residents actually died from vitamin E acetate-contaminated THC vaping before warning the public that legal nicotine vapes might not be the “only cause”—probably the last state to do that.)

Whitmer’s call for eliminating flavors was based entirely on the “epidemic” of vaping teenagers, which anti-vaping groups claim is caused in large part by flavored vaping products. Her rationale precisely followed the playbook laid out by the Campaign for Tobacco-Free Kids, which is spearheading the national anti-flavor campaign funded by former New York City mayor Michael Bloomberg. In fact, Bloomberg’s $160 million campaign was publicly launched just one week after Whitmer’s emergency ban was announced, leading many to conclude that the Bloomberg/Tobacco-Free Kids campaign and the Michigan flavor ban were coordinated to garner publicity and maximize political impact.

Earlier this month, Whitmer received an award from Tobacco-Free Kids for what that group’s president Matthew Myers called her “leadership in Michigan” that “changed the national debate.” Whitmer’s attempted ban, said Myers, “became the catalyst for other states to act.” In fact, Myers and Bloomberg were the catalysts, and Whitmer was simply the first eager puppet.

Her “emergency” flavor ban was almost immediately put on hold by a state Court of Claims injunction, following hearings at which Whitmer’s lead medical official proved that she knew nothing about vaping except what she had gleaned from Tobacco-Free Kids pamphlets. The injunction has since been upheld twice—first by the Michigan Court of Appeals, and more recently by the state Supreme Court.

Now Gov. Whitmer is back with the same old flavor ban, once again looking to make headlines and please her Bloomberg handlers on the backs of vapers and the small businesses that serve them. And it will be vapers—again—that will have to stop her and her tragically uninformed health agency from succeeding.

The Michigan House of Representatives is considering a package of bills that would add an 18 percent wholesale tax to vaping products, create a licensing system for vaping retailers and a list of products allowed for sale (only products that have submitted Premarket Tobacco Applications and those that have been approved), and provide penalties for retailers selling to minors. There are also bills that change the legal age in Michigan to buy tobacco and vaping products to 21, and restrict some advertising rules.

The bills have already passed the Senate with bipartisan support, and are waiting for a hearing in the House Ways and Means Committee, after having passed another committee. Michigan vaping advocates are hopeful that some of the worst elements can be stripped from the legislation before it goes to the full House for a vote, so although there is no immediate call to action, that may change at any time.

The language in the bill that creates a list of products allowed for sale apparently comes from tobacco company RJ Reynolds (maker of Vuse vaping products), which unsuccessfully attempted to include similar restrictions earlier this year in Missouri legislation.

Vaping360 will update this story with any news about the House bills.