Judge Targets E-cigarettes

Warren Albrecht | United States

Paul Grimm, a district court judge for the District of Maryland ordered the Food and Drug Administration (FDA) to begin the process of regulating E-cigarettes. Judge Grim did not believe that the FDA was moving fast enough by the complaints from the American Academy of Pediatrics, the Campaign for Tobacco-Free Kids, Scott Gottlieb, the former commissioner of the FDA and Alex Azar, the Secretary of the HHS among others.

An FDA spokesperson stated:

“[FDA] has and will continue to tackle the troubling epidemic of e-cigarette use among kids. This includes preventing youth access to, and appeal of, flavored tobacco products like e-cigarettes and cigars, taking action against manufacturers and retailers who illegally market or sell these products to minors, and educating youth about the dangers of e-cigarettes and other tobacco products…”

Judge Rules on Standing

 Warning: Using products that place strange chemicals into your body may be dangerous.

Anyone not taking that advice in the year 2019 just wants the freedom of autonomy and be damned with the health results. But Judge Grimm is creating his own behavior economics solution by wanting the FDA to begin regulating these products without any substantial proof of harm.

Spokeo v. Robins is actually a Supreme Court case looking into the importance of a plaintiff having standing to bring the action in federal court.  From the Supreme Court reason for standing:

(a) A plaintiff invoking federal jurisdiction bears the burden of establishing the “irreducible constitutional minimum” of standing by demonstrating (1) an injury in fact, (2) fairly traceable to the challenged conduct of the defendant, and (3) likely to be redressed by a favorable judicial decision.

(b) As relevant here, the injury-in-fact requirement requires a plaintiff to show that he or she suffered “an invasion of a legally protected interest” that is “concrete and particularized” and “actual or imminent, not conjectural or hypothetical.”

Do any of the plaintiffs in the case before Judge Grimm have standing? Have any of them been hurt? Remember Hollingsworth v. Perry? This is the SCOTUS decision which flipped the California citizen passed Proposition 8 which banned same-sex marriage. The liberal administration in California refused to defend it and SCOTUS found the sponsors of Proposition 8 including the citizens of California had no standing. Roe v. Wade needed Norma McCorvey to be Roe in order for the case to have standing.

Judicial Charades

Judge Grimm’s ruling reflects the Administrative Procedure Act of 1946, which guides agencies in creating regulations, and the recent Family Smoking Prevention and Tobacco Control Act of 2009 (FSPTC), which specifically gives the FDA the power to regulate the tobacco industry, including smokeless nicotine products.  Before the FSPTC Act 2009, SCOTUS ruled in FDA v. Brown & Williamson Tobacco Corp. that congress had not given the FDA specific direction to regulate tobacco under the Federal Food, Drug, and Cosmetic Act.  Judge Grimm held that the “Organizational Plaintiffs” have informational standing because their mission of decreasing the addiction from these products in the public is hampered if the FDA does not regulate in a timely manner. From Judge Grimm’s opinion:

FDA’s suspension of premarket review requirements for approximately 25,000 new tobacco products deprives Organizational Plaintiffs of access to vital scientific and health information necessarily generated as a part of that process—information Plaintiffs need to carry out their missions.

These “Organizational Plaintiffs”  gained standing because they did not like the FDA’s timeline, even though they offered no specific information proving that these products were dangerous to the FDA. If there are facts supporting the dangers of these products, why do the plaintiffs need the FDA before educating the public?  What is preventing the American Academy of Pediatrics from initiating their own research and education programs?

Judge’s Playground

Judge Grimm’s opinion included a picture of a vaping product that is packaged like a child’s fruit drink juice box. But, as regulated products, it is not as though they are sold at the local grocery next to the sippy cups where kids might accidentally pick one up.

Teenagers cannot buy these products, so Judge Grimm wants everyone to believe the adults are taken in by the pretty colors and buy a few extra for the kids in the neighborhood. If not that, maybe parents would somehow believe products that require ID to buy over the counter are appropriate to give to their small children.

The Science, or Lack Thereof

From coronary heart disease to lung cancer, peripheral artery disease and other life ending diseases, tobacco and nicotine products are harmful. However, there is no research which specifically points to vaping liquid or e-cigarettes causing health problems in teenagers.

Any study is from observational and relational data, meaning surveys or questionnaires. No one is going to take 200 people between the ages of 13 and 18 and give half nicotine products and half placebos and see what happens after 6 to 12 months.  Judge Grimm and the “Organizational Plaintiffs” think smokeless nicotine products cause increased health risks, but are not willing to ban them outright.

Maryland recently changed the age of selling tobacco products to 21. This includes cigarettes, Juul pods, rolling papers and even nicotine-free vape juice. Vaping has exploded in the teen population, and there is a concern that this may have health issues for the future.

Why is this judgement important? Groups who survive on an issue, really do not want the issue to go away. The lawsuit is a fund raising tool.

Making things you do not like more expensive by government regulation and taxes does not stop their use. If people are willing to go through a black market to get products, then why should the government waste money trying to stop it. Just do not pay for the end result; lung disease and cancer, heart disease, peripheral arterial disease.


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