Prepare to feel sick, but here are some FDA questions.

I suspect the reason these were not posted by CASAA is because the questions are SO loaded that they are no easier to answer intelligently AND truthfully than the famous example: “When did you stop beating your wife?”

As an example:  most questions ask about “tobacco products” in a way that obfuscates the differences between combustible tobacco, smokeless tobacco, and nicotine (e-cigs)

To answer one of these, you’d have to give a 2-part answer, “I don’t know, if you mean a REAL tobacco product, but here’ s the ecig answer…….”

Other questions specifically ask for data FOR THE FDA’s SIDE OF THE ARGUMENT

And NONE of the questions are the ones I thought they would ask.  Like what to do about efficacy testing.  The right answer would be “The same thing you do about hairspray efficacy testing — efficacy is defined as customer satisfaction for consumer products.”  But the question isn’t asked because they are probably going to make folks prove efficacy.

 As a personal note, the medical definition of efficacy could probably never be met by shoes because you could not prove that a significant proportion of the population would be able to walk comfortably, and be successfully prevented from taking off their shoes, if you were testing exactly ONE style and size of shoe for everybody’s use.  Say, a women’s size 9 high heel in B width.  Bright purple.  Or Caterpillar work boots in Men’s 11 D with steel toes.  Imagine if ONE had to prove to be “the one.”

As an engineer with 1 year pre-med, 2 years college chemistry-for-chemistry-majors and 1.5 years of similar physics, a minor in mathematics, and a lot of doctors, nurses, etc in my family, I feel I want to take a shot at one or more of theses questions.

Another issue is that Stanton Glantz pointed out it is likely that they’ll give all of question, say, 20 to the same person and someone else will get question 35.  (No, they are NOT numbered anywhere near that helpfully!!!! In fact they’re not numbered at all.  Or indexed or anything else.)

So not sure if I should send in my original comment as per the 4th CTA from CASAA and then write an answer to 1-2 questions that I feel my education allows me to answer.

However, the REAL kicker here is the FDA keeps saying they can’t hire anybody with half a brain to look at any of the data they’re claiming not to have until we grant them the Deeming Doom.

I’m pretty sure that’s bull* so maybe the fact that these questions are either already answered or freakin’ moot is why there are no suggested answers.

Anyway, if someone is curious and educated in either medicine, statistics, logic (formal logic) or debate, I suspect you could grab one question to answer.   I’m not going to risk missing the deadline, so I’ll submit the CTA answer first THEN submit a second  comment narrowly on my question of choice.  I doubt I’ll have the time or energy for two.  Or stomach.  But I want someone to be able to show  (in court) that some of us TRIED.

 

So, here are the ones I found by looking through the PDF for “questions” or “comments” with the ‘find’ function:

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FDA questions: page numbers refer to this: https://antithrlies.files.wordpress.com/2014/04/fda-proposed-deeming-regulation-manuscript-format.pdf

Page 10: List of question types that occur later, below

Page 20:

Aside from this proposed rule, what additional actions, if any, should FDA take to address the sale of candy and/or fruit-flavored tobacco products to children and young adults?

For example, what data should FDA request manufacturers submit in new tobacco product applications to establish that flavorants either do not raise different questions of public health, in the case of SE reports, or are appropriate for the protection of public health in the case of premarket tobacco product applications?

What is the likelihood that individuals who engage in flavored tobacco product use will initiate cigarette use and/or become dual users with cigarettes?

The prohibition against characterizing flavors established in the Tobacco Control Act applies to cigarettes only. Consequently, when this regulation is finalized and other tobacco products are deemed subject to FDA’s tobacco product authority, the statutory prohibition against characterizing flavors will not apply automatically to those products. However, once they are deemed, FDA may establish a product standard prohibiting flavors in those products. FDA requests information and data that would support establishing such a standard.

Page 94:

FDA realizes that while all tobacco products are potentially harmful and potentially addictive, different categories of tobacco products may have the potential for varying effects on public health. For example, some have advanced views that certain new tobacco products that are non-combustible (such as e-cigarettes) may be less hazardous than combustible products, given the carcinogens in smoke and the dangers of secondhand smoke. Thus, FDA is seeking comments, including supporting research, facts, and other evidence, as to whether all tobacco products should be required to carry the proposed addictiveness warning and if different warnings should be placed on different categories of products.

In addition, we note that this requirement would apply to products that are derived from tobacco, and not just products that themselves contain tobacco, based on the definition of

Page 95:

“tobacco product” in section 201(rr) of the FD&C Act. As a result, FDA recognizes that the use of the words “tobacco product” in the warning might be thought to have the potential to confuse consumers. Accordingly, FDA request comments, including supporting facts, research, and other evidence regarding the following questions:

Do the words “tobacco product” in this proposed warning have the potential to cause confusion for consumers?

If so, what are the product types where such a warning could potentially confuse consumers?

If there are concerns about the use of the word “tobacco product,” what other language should FDA consider utilizing in this proposed warning?

“tobacco product” in section 201(rr) of the FD&C Act. As a result, FDA recognizes that the use of the words “tobacco product” in the warning might be thought to have the potential to confuse consumers. Accordingly, FDA request comments, including supporting facts, research, and other evidence regarding the following questions:

Would such other proposed language still have the ability to notify consumers that certain products (especially those that look like candy) are, in fact, tobacco products and potentially harmful and/or addictive?

P 123:

• What are the benefits and/or disadvantages of a new product compliance period longer than the proposed 24-month period?

• If you disagree with the proposed 24-month new product compliance period, provide an alternative compliance date and supporting information.

• FDA is proposing that this compliance approach should be available to all proposed deemed tobacco products. However, should FDA take into account other factors, such as the type of product or other circumstances? Why or why not? If so, what factors or circumstances would be appropriate? For example, is there a justification for having the compliance policy instead apply to the following circumstances:

When marketing of the new tobacco product is limited to existing adult users of the product?

When marketing of the new tobacco product is unlikely to be seen or received by youth?

○ • Given the express grandfather date and predicate restriction provided in the FD&C Act

that govern the process for legally marketing a tobacco product, what are the implications

for proposed deemed tobacco products?

• What is the impact on public health that proposed deemed tobacco products that entered

the U.S. market after February 15, 2007, and have no viable predicate have available only

the premarket application pathway?

• Provide examples of proposed deemed tobacco products that would likely be able to

proceed to market via the SE pathway. Describe the range of predicates that would be available to demonstrate substantial equivalence.

What other alternative marketing pathways or policy options should FDA consider if, in fact, no predicate is available?

Are there other legal interpretations of the substantial equivalence grandfather provision that FDA should consider?

P 125:

Therefore, as with products that may be eligible for the SE pathway, FDA is proposing a

24-month compliance period for products that may only be eligible for the PMTA pathway. Under FDA’s proposal, FDA would not intend to initiate enforcement action for failure to have a marketing authorization against proposed deemed tobacco products first introduced or delivered for introduction into interstate commerce for commercial distribution after February 15, 2007, and prior to the proposed compliance date (i.e., effective date plus 24 months), provided a PMTA is submitted no later than the proposed compliance date, and FDA has not issued an order denying the PMTA. In these cases, the Agency would not intend to initiate enforcement action against the tobacco product for failure to have a marketing authorization unless and until FDA issues an order denying the PMTA under section 910(c) of the FD&C Act.

•

FDA is seeking data, research, information, and comments related to the following:

Should FDA consider a different compliance policy for proposed deemed tobacco

products that cannot, as a practical matter, use the SE pathway?

If so, what should the compliance policy entail and would it benefit public health? Instead of, or in addition to, such a policy, should FDA consider ways to expedite the review of some or all premarket applications for proposed deemed products?

If FDA does establish a compliance policy or an expedited review process, should the policy or expedited process apply to all proposed deemed products or only to certain categories of products, such as based on their relative impact on public health?

Why or why not? For example, FDA could establish factors based on certain categories of products and their relative impact on public health. FDA could use these factors in guiding its enforcement policy.

Examples of factors FDA might take into account include whether the product is “non-combusted;” contains no tobacco leaf, but contains nicotine, such as some electronic cigarettes; is nonflavored; or is no or low nicotine.

What other FDA actions or regulatory approaches, if any, should FDA consider for proposed deemed tobacco products that are “new tobacco products” under section 910(a)(1) of the FD&C Act and why?

Are there unique challenges faced by small manufacturers of proposed deemed tobacco products and how should they be addressed?

FDA is collecting information as to how it can streamline review of new product applications. FDA expects that, in certain instances, it would be able to determine that a product meets the requirements of section 910 of the FD&C Act using information that might be less burdensome for a manufacturer to gather and submit to the Agency.

For example, in some cases, it is possible that an applicant may not need to conduct any new nonclinical or clinical studies, while in other cases, such as where there is little to no understanding of a product’s potential impact, several nonclinical and clinical studies may be required for market authorization.

Toward that end, FDA is seeking comment on whether manufacturers of certain categories of products (e.g., those that contain fewer or substantially lower levels of toxicants, consistent with the continuum of nicotine- delivering products as discussed in section III) could support their applications, and allow FDA to make its required findings under section 910 of the FD&C Act, with types of information that would be less burdensome to collect than information needed for other product categories.

e. Request for comments regarding possibility of staggered compliance dates.

Different categories of tobacco products may have the potential for varying levels of harm and negative effects on public health. As a result of the potential for differing effects on public health, FDA is considering whether it might be appropriate to stagger the compliance dates for certain provisions for different categories of products.