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Second FDA Seminar Looms

Yes, the second in a series of mind-numbing seminars on vaping, brought to you by the people entrusted with regulating our ingestion of substances affecting health, plods inexorably toward grim reality. This would not be terribly distressing if they were merely wasting taxpayers' money fretting over trace elements of substances that could cause harm in massive doses. Alas, it is worse – this three-part exercise creates the illusion that the FDA is doing something about e-cigarettes, at a time when at least two urgent issues cry, unheeded, for FDA action – a national, enforceable ban on youth sales, and a universal child-proofing rule for e-liquid. Meanwhile, the public, flim-flammed by CDC and UCSF pronouncements, thinks the vaping supplies industry and community are responsible for these unconscionable delays, while it is actually Center for Tobacco Products (CTP) at the FDA that is dragging its heels, as it dithers about trace nitrosamines. Meanwhile, Big Tobacco sits back and clucks with enjoyment, hoping the upshot could be a ban on vapor-tank systems.

Speaking of unconscionable, the barring of Igor Burstyn from the platform at the first seminar comes readily to mind. Burstyn, a well-credentialed specialist in environmental health and control of potentially harmful substances in the workplace, has produced a significant study finding e-cig vapor to be well below sensible thresholds. Since the first FDA seminar was to be on that subject, Professor Burstyn naturally heeded the call for papers. He was turned down, although the call had asked for “scientific information from individuals with a broad range of perspectives on technical topics.” Not that broad, it would appear. Fortunately, Burstyn's colleague Konstantinos Farsalinos surrended 3 minutes of his own platform time for Burstyn to deliver the message: “The poison is in the dose.” The FDA does not seem to have been interested in that message, as the proceedings continued with a host of panelists (quite a few of them CTP employees) rambling on about trace concentrations of carcinogens.

The next session promises to be equally riveting. On the agenda are (in the first rubric) toxicological considerations (didn't they already do that?) including the role of non-clinical models like in vitro and animal studies, ways of measuring deposition/absorption, comparison of levels in experienced and new users, and comparisons with other NRTs, toxicity of flavorings and strategies for evaluating them, and more. The second rubric is “topography”, by which they mean things like puff volume-velocity-duration.

This rubric asks the penetrating question: “What strategies can be used to quantitate e-cigarette use?” Since it's been a while since I've heard the word “quantitate” in everyday conversation, I took the trouble to look it up in my fave dictionary. Turns out it means the same thing as “quantify”. Exactly the same. This elicited from me a cogitation on the theme of failure to eschew obfuscation on the part of prosaists who employ the term quantitate when they mean “quantify”. I hereby promise my readers that I take the “no quantitate pledge”: Henceforth I will not use the word quantitate when I mean “quantify”, “enumerate”, “add up”, “determine the number of”, and so forth, and I will strive to avoid texts that so use it. Trust me.

I will go further and say that writers who say “quantitate” are trying to pull a snow job on you. It gives the illusion that lofty scientific matters, beyond the grasp of the hoi polloi, are at issue. Precisely what the CTP, the CDC, and UCSF want us to think.

Further topics include: Clinical Pharmacology and Abuse Liability, Health Effects in Users, Considerations for Health Effects in Specific User Populations, Human Factors. I will spare you the sub-headings. Click here to read 'em, and be prepared to glaze over. My eyes remained crossed for a half an hour afterwards.

The authors state forthrightly (or as forthrightly as they seem capable of) that these seminars are not intended to have any effect on the fate of the stalled “deeming regulations”. “The information presented and discussed during the workshop series is not intended to inform the Agency’s rulemaking related to deeming additional tobacco products to be subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (Deeming Tobacco Products to Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products; Proposed Rule, 79 FR 23141, published April 25, 2014).”

Got that?

. . . and furthermore: “These workshops are intended to better inform FDA about these products. Should the agency move forward as proposed to regulate e-cigarettes, additional information about the products would assist the agency in carrying out its responsibilities under the law. This would be true regardless of the details of any such final rule. Accordingly, FDA is working to obtain such information now rather than waiting for the conclusion of the deeming rulemaking.”

Sounds like scientific and bureaucratic onanism to me, and not only on the public dime, but in lieu of urgently needed action.

The third seminar is to be on “population effects”. That could be the big one, since it will include topics like gateway, “re-normalization”, “glamorization”, popularity among youth, dual use – a veritable UCSF/CDC festival of vape-bashing can be expected.

 

Anything but action.

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