Brick by Brick: the Questions

The FDA’s proposed Deeming regulations and supporting documents present a number of questions and requests for comments on specific proposed rules. This post gathers them together (with some duplication, as in the proposal), with some minor commentary where needed (twice). It excludes questions and requests that do not apply to vaping.

In formulating public comments, these questions should draw some of your attention. These are issues that the FDA is admitting a certain level of humility about and indicating potential flexibility. Comments should try to use these issues both directly to inform the FDA and as a way to relate other issues that commenters believe require greater flexibility than proposed.

Proposed Rule’s Questions and RFCs

1. (p. 8) E-cigarettes

  1. How e-cigarettes should be regulated “based on the continuum of nicotine-delivering products.”
  2. “[H]ow to implement the provisions in the FD&C Act with respect to e-cigarettes.”

2. (pp. 9-13) “Request for Public Comment”

Here they present 13 specific areas for comment. These are the main concerns they raise, and most of the other comment requests throughout the document are repetitions of one or more of these.

  1. (Not relevant: cigars)
  2. “[C]haracterizing flavors […] that […] can be especially attractive to youth.”
    a. How to determine if a product is a “cigarette” under § 900(3) and subject to a ban on flavoring.
    b. Research on the effect flavors have on initiation of use and encouraging dual-use with cigarettes.
  3. How e-cigarettes (and other noncombustible products) should be regulated.
    Research on dual-use between e-cigarettes and tobacco products, as well as initiation and continuation of use of tobacco products.
  4. How excluding accessories from deeming would impact public health.
    How to define components, parts; how to distinguish them from accessories.
  5. Whether and how to institute different rules for products (e.g., e-cigarettes) that cannot use Substantial Equivalence.
  6. Whether and how to stagger compliance dates for different categories of products.
  7. Ways to reduce costs to manufacturers while maintaining public health.
    The examples here are leniency in registration, listing, and randomizing warning labels.
  8. Should all products require addiction warning, and should those warnings differ by product type.
  9. (Not relevant: cigars)
  10. (Not relevant: cigars)
  11. Unique challenges of small manufacturers and how to address the same.
  12. Whether and how addictiveness warnings could create consumer confusion, and comments about sizing of health warnings in advertising and packaging.
  13. (Not relevant: cigars)

3. (p. 20) Flavors

Here they request comments (including data and research) on three areas:

  1. What additional steps (beyond the proposal) should FDA take regarding candy/fruit flavors in products? What data should manufacturers submit on this issue in product applications for determining public health risks associated with flavorings?
  2. How do flavors impact smoking initiation and dual use?
  3. Data that would support prohibiting flavorings in subsequent product standards.

4. (p. 24) Whether FDA should evaluate risk differently for attractively flavored e-cigarettes versus unattractively flavored ones.

This one deserves and requires commentary. Practically nobody uses unflavored liquids. While some may use tobacco flavors, those aren’t the default flavor of the liquids. They are added just like any other flavor. As far as I know, the FDA has no scientific basis for determining flavor attractiveness by age cohort.

There is ample literature to support differences in taste sensitivity, both by age and by culture. But unless there is some unpublished, major advancement in culinary psychology there is no rational basis for banning (muting, or otherwise limiting) some flavors over others.

That’s not even a dig against flavor prohibitionists. I don’t think you’ll find many people arguing that if we could devise a set of flavors that adults like and kids hate, we wouldn’t utilize them (in applications far beyond e-cigarettes). We would, both to keep children away from adult things (to protect them) and to keep children away from adult things (so they wouldn’t, e.g., eat all our ice cream, cookies, etc.).

Indeed, that’s why the FSPTCA bans all flavored cigarettes (except menthol). They have no dividing line to use.

5. (p. 26) Difficulties of small manufacturers to comply with reporting requirements for harmful and potentially harmful constituents (HPHCs) and ways to address those difficulties.

6. (p. 27) Difficulties of manufacturers to comply with registration requirements and ways to address them.
The example given to address difficulties is a delayed compliance period.

7. (p. 29) How prohibiting free products samples reduce risk youth.

8. (p. 42) How e-cigarettes should be regulated “based on the continuum of nicotine-delivering products” and potential benefits of e-cigarettes.

9. (p. 42-3) Whether FDA should define components and parts of products, and how those items may be distinguished from accessories.
Also comments on the proposal to exclude accessories from deeming.

10. (p. 44) How to define components, parts, and accessories.
Also, whether and how components, parts, and accessories might alter the effects of products on public health, the constituents delivered by products, and on initiation.

11. (p. 61) Youth access to e-cigarettes

  1. What other rules (with an emphasis on preventing youth-initiation) should be developed for e-cigarettes?
  2. Do “fruit and candy-flavored liquids” act in a gateway-to-cigarettes capacity or increase dual use? How should that inform future rules?

12. (pp. 94-5) Addictiveness warnings

  1. Whether different addictiveness warnings should be used for different products.
  2. Does using the term “tobacco product” in the warning confuse consumers?
  3. What are alternatives to “tobacco product?”
  4. Would alternatives still alert consumers that the products are, “in fact, tobacco products,” and of their negative properties?

This last one requires commentary. They are tobacco products for statutory (and then, only under the FD&C Act) and regulatory purposes. If the FDA really believes that consumers need to know any given nicotine-containing product has that nicotine derived from tobacco, then it’s safe to assume (I kid, of course) that NRTs will soon be required to contain similar warnings.

13. (p. 110) Newly-deemed products subject to existing rules
The previously-finalized rules issued under the FSPTCA will now include newly-deemed products. The FDA invites comments from the new stakeholders regarding the existing rules.

14. (p. 114; Table 1B) Proposed compliance dates for various provisions

15. (p. 120) Ways to provide additional flexibility to newly-deemed products with respect to Pre-Market Tobacco Applications (PMTAs).

16. (pp. 123-4) Proposed approach to compliance for new products

  1. What effects would a longer (than 24-months) compliance period have?
  2. Suggestions for an alternative period.
  3. Should and how should compliance policies vary by product type?
    Given examples of possible variance circumstances:

    • When marketing is limited to existing adult users of the product
    • When marketing is unlikely to be encountered by youth
    • When products bear certain warnings
  4. What are the implications of the immovable grandfather date on newly-deemed products?
  5. What are the public health impact of products that have no grandfathering or substantial equivalent pathway?
  6. Are there examples of predicates available to some of the newly-deemed products?
  7. What other pathways or policies can be considered if no predicate exists?
  8. Are there other legal interpretations of the substantial equivalence/grandfather provision that FDA could consider?

17. (pp. 125-7) Product review processes and policies

  1. Should there be a different policy for products lacking a substantial equivalent pathway? What would that entail and how would it impact public health? Should FDA consider expediting some or all pre-market applications for newly-deemed products?
  2. If an expedited process is established, which products should it apply to?
    Examples of factors include non-combustion products, nicotine-as-only-tobacco-constituent products, unflavored, or zero nicotine/low nicotine.
  3. What alternative regulatory approaches should be considered for new tobacco products?
  4. What are small manufacturers’ unique challenges and how should they be addressed?
  5. Whether manufacturers of certain categories can support their applications with less burdensome information than others?
    Example is that some categories may not need to supply nonclinical studies/clinical studies while others may need to supply several, based on the questions of risk raised by the different products.
  6. Any other factors or options FDA should consider to expedite application review of products toward the safer end of the risk continuum?

18. (p. 127) Should and how should FDA stagger compliance dates for products based on their relative position in the continuum of risk?

19. (pp. 128-9) Reducing burdens on small manufacturers

  1. Extending compliance period
    • Which provisions should be extended?
    • What public health concerns outweigh delayed compliance?
    • Are there provisions for which compliance extensions would not reduce the burden?
    • How much time should provisions be extended?
  2. Size-of-firm criteria
    • Which provisions do and do not make sense to extend compliance by size-of-firm?
    • How should sizes of firms be defined?
  3. Should FDA do this as a framework, or by case?

20. (p. 131) Whether the FDA’s definition and approach regarding “covered tobacco products” is an acceptable balance.
Here they define to only include the tobacco-containing and nicotine-containing materials. They propose only applying the minimum age restrictions to covered tobacco products.

21. (p. 140) Whether the proposed addictiveness warning should be expanded to cover other substances in tobacco that may cause or contribute to addiction.

22. (p. 154) Paperwork Reduction Act of 1995

  1. Whether proposed submission information is necessary for FDA’s purposes (e.g., will the information have practical utility).
  2. Accuracy of estimated burdens from collecting the information.
  3. Ways to enhance the quality, utility, and clarity of information.
  4. Ways to minimize the burdens of collection.
    Examples include automated collection and other technologies.

23. (p. 160-83) The estimates and methodology for burdens of information collection and submission.

  1. Registration, listing, and ingredient submissions
  2. Health document submissions
  3. Substantial equivalence submissions
    • Exemptions
    • Demonstration of SE
  4. Electronically-filed importation notices
  5. Exportation notices
  6. Submissions establishing grandfathered products
  7. Pre-market review submissions
  8. Warning statement exemption submissions

24. (p. 191) General request for comments on the RIA (see below)

Regulatory Impact Analysis’ Questions and RFCs

1. (p. 9) On the inputs, methods, and results of the RIA
Restatement of 24 above

2. (p. 15) How willing are consumers to pay for tobacco product cessation programs?

3. (p. 19) Are e-cigarettes safer than reference products? Do they have negative health effects associated with them? If so, how do those effects compare to other tobacco products?

4. (p. 19) Are e-cigarettes substitutes, complements, or unrelated to other tobacco products?

5. (p. 22) How many e-cigarette manufacturers are there?

6. (p. 25) How to calculate the costs to components and parts of e-cigarettes that do not contain nicotine/tobacco derivatives?

7. (p. 31) How the cost of ingredient listing may differ for different products.

8. (p. 33) What are the costs of complying with health submissions?
The health documents include those that relate to, “health, toxological, behavioral, or physiologic effects […]”

9. (p. 36) Are the assumptions regarding the number of submissions of PMTAs accurate?

10. (p. 36) What will the costs of preparing PMTAs be?

11. (p. 39) How often will clinical studies be needed in submissions for SE? What will the costs be?

12. (p. 67) What are the specific challenges and costs to small businesses?