FDA issues Guidance for Meetings on the Research and Development of Tobacco Products

[Bill Godshall]

FDA issues Guidance for Industry and Investigators
Meetings with Industry and Investigators on the Research and Development of tobacco Products
Meetings with Industry and Investigators on the Research and Development of Tobacco Products
http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM305282.pdf

Please note that this guidance ONLY pertains to tobacco products regulated by Chapter IX of the FSPTCA (i.e. cigarettes, cigarette paper, RYO and smokeless tobacco products). It does NOT pertain to e-cigarettes, cigars, pipe tobacco, shisha/hookah, nicotine skin creams, nicotine dissolvables, etc. unless/until the FDA proposes and subsequently gives final approval to a "deeming" regulation.

Unfortunately, the FDA failed to mention this critically important fact in its new guidance, just as it has in many other guidances and regulations the agency has issued since 2009.

By confusing tobacco manufacturers and the public to believe that Chapter IX regulations currently apply to unregulated tobacco products, the FDA has been greasing the skids for railroading the "deeming" regulation through before providing any scientific evidence of any public health benefit of applying Chapter IX to currently unregulated products.

Yet another example of FDA trying to impose its "quit or die" regulatory agenda that conflicts with scientific and empirical evidence, ethics, human rights, consumer and public health.

 

[DaveP]

I have to wonder if the FDA actually has sufficient understanding of electronic cigarettes to regulate them at this point. It seems to be more about gaining control than it is about understanding. I see references to taxation at times in federal documents, but not anything that leads me to the conclusion that they understand what they are controlling.

In the document above, there was a reference to tobacco, filters, and several piece parts that could be used to create a tobacco smoking device. I'd hate to see batteries, atomizers, and other ecig hardware included in regulation. Juice I can understand, but past that it's just hardware that has no ability to operate without consumables.

 

[Bill Godshall]

Title I, Section 101(a)(rr)(1) of the FSPTCA states:

The term "tobacco product" means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).

If the FDA proposes and approves a deeming regulation for e-cigarettes, the agency is likely to cite this clause and assert broad and excessive regulatory jurisdiction over many different e-cigarette components, parts and accessories, which is yet another reason why the deeming regulation could/would decimate the e-cigarette industry.

And yet, Congress authorized the Consumer Product Safety Commission to regulate batteries.

 

[Vocalek]

If the FDA succeeds in "deeming" electronic cigarettes to be covered under the Tobacco Act, and imposes the requirements below, innovation and improvements to products would come to a screeching halt.

You must generally obtain an order from FDA authorizing the commercial marketing of a new tobacco product, including when you modify a tobacco product, before the product may be introduced or delivered for introduction into interstate commerce (section 910(a)(2) of the Federal Food, Drug, & Cosmetic Act (FD&C Act) (21 U.S.C. 387j(a)(2))). Modification includes “a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery, or form of nicotine, or any other additive or ingredient” (section 910(a)(1)(B)).

Anyone who has ever worked in a technology field knows that high-tech products change and improve at a lightning pace. Biology works much more slowly. I agree with DaveP that the folks who work in the CTP, as well as all the scientists selected so far to advise the Agency in this matter, have no qualifications to regulate rapidly-changing products of this type.