Proposed Deeming Regulations: What s the Path Forward?

Transcription

1 Proposed Deeming Regulations: What s the Path Forward? Gal Cohen, Ph.D. Head of Scientific and Regulatory Affairs Ploom, Inc.

2 James & Adam Vision and mission Vaporization technology company Obsolete combustion Modern iconography No me-too products Leaf closed system Corporate San Francisco HQ Founded 2007 Venture backed Profitable, growing JTI SA alliance Pax #1 portable loose leaf vaporizer Leaf open system

3 The opportunity and challenge This law Congress has given me strict statutory reading vs. regulatory risk-benefit (Congressional intent) Adult Smokers Kids & Cessation Innovation

4 The opportunity and challenge ~4M Vapers, US This law Congress has given me strict statutory reading vs. regulatory risk-benefit (Congressional intent) Adult Smokers Kids & Cessation Innovation

5 FDA questions Ø Risks Associated with Variance? Ø Standards? Ø Assays?

6 Key issues Ø Definition of product categories Ø Approval pathway Path definition Grandfather date / predicate Enforcement date Ø Tobacco regulation Composition standards Flavors Ø Device regulation

7 Vaporization includes a continuum of products Leaf e-liquid Open Systems Closed Systems 0% Nico(ne?

8 Key issues Ø Definition of product categories Ø Approval pathway Path definition Grandfather date / predicate Enforcement date Ø Tobacco regulation Composition standards Flavors Small business impact? Ø Device regulation

9 FDA s Proposed Deeming Regulations Small Business Issues and Alternatives Stacy L. Ehrlich Partner Kleinfeld Kaplan & Becker LLP October 21,

10 Grandfather Date February 15, 2007 Legislative artifact Benefits traditional combustible products Because this date is written into the statute, we do not believe that we have the authority to amend it with respect to e- cigarettes or other products 24 month compliance period from effective date of final rule 10

11 No Predicates No viable 2007 predicate products for ENDS and other novel products so required to use PMTA process Lack of information regarding first generation products Dramatic changes in technology since 2007; many new entrants 11

12 Huge Number of SKUs Numerous flavors and variations Components/parts vs accessories Industry is consistently innovating and improving technology-based products FDA expects to receive only PMTAs during the first 24 months and in subsequent years 12

13 Regulatory Alternatives Enforcement Discretion for or Change to Grandfather Date Extended/Staggered Compliance Periods Standardized Reference Products Abbreviated PMTA Process Categorical SE Exemptions 13

14 Grandfather Date Decline to apply Sec. 910 to all or certain deemed products Change the grandfather date for deemed products by regulation or enforcement discretion policy Decline to enforce Sec. 910 against deemed products launched by a specified date 14

15 Compliance Periods Stagger deadlines for product category and/or submission at least 24 months from date of publication of applicable final guidance or regulation FDA can establish review priority based on relative risk by timing its guidance/reg publication Guidance/reg must be product-specific, detailed, and final (after comment period) 15

16 Standardized Reference Product Use as surrogate predicate product in SE reports FDA could control specifications to set base standard for comparison Predicate tobacco product not defined in Act Similar to OTC monograph system 16

17 Abbreviated PMTA For specified categories of products, e.g., ENDS or other non-combusted products Provisional approval + marketing conditions and post-marketing commitments Priority meetings, rolling review, etc. Expedited withdrawal of provisional approval 17

18 Abbreviated PMTA (cont.) Full reports of investigations in possession of applicant Full description of components, ingredients, additives, properties, processes HPHC testing (per guidance) Samples of product, labeling, promotional materials 18

19 Abbreviated PMTA (cont.) Commitment to: Submit samples of promotional materials at least 30 days prior to dissemination Conduct post-market surveillance and report post-marketing data at set time intervals Comply with any conditions of approval on the labeling as directed by FDA Generate data as requested by FDA 19

20 Categorical SE Exemptions Issue regulation or guidance setting forth the kinds of changes that can be made without submitting a full SE report Similar to 510(k) process for medical devices (e.g., flow chart) Particularly essential for quickly evolving technologies or for responding to emergency supply chain issues 20

21 Representative voices hyperlinks to submitted comments Category Entity Major tobacco Altria Reynolds Lorillard Independent e-cig Logic njoy Ballantyne Devices Ploom Evolv Innokin E-liquid manuf Vaping community & associations & retailers Thought Leaders AEMSA SFATA ecig CASAA NACS Vapers (individuals) C. Bates S. Ballin Farsalinas / Polosa S. Glantz TCLC Tobacco-Free Kids AG s, Congress 29 AG s H. Waxman Public Health Associations Pharma GSK Pfizer ASCO (Cancer) AHA (Heart) FIRS (Respiratory) AAFP Legacy Robert Wood Johnson Testing Labs* Arista Enthalpy Celerion *Did not submit comments

22 Approval pathway: public health Is harm reduction a goal? Disclaimer: the following includes an interpreta(on of the viewpoint of each en9ty, and have not been reviewed by the submi4ng en((es Legacy for Health Robert Wood Johnson American Heart Association (Cardiovascular) AACR / ASCO (Cancer) FIRS (Respiratory) AAFP (24 orgs) Harm reduction offers possible benefit least restrictive Not proponents of harm reduction most restrictive FDA should determine through research if and how e-cigarettes can play a beneficial role in reducing tobacco-related morbidity and mortality. Conversely, the agency should also conduct or support research to identify whether e-cigarettes are used as a bridge to the smoker's next cigarette, delaying or inhibiting complete smoking cessation

23 Approval pathway: public health Is harm reduction a goal? Disclaimer: the following includes an interpreta(on of the viewpoint of each en9ty, and have not been reviewed by the submi4ng en((es Legacy for Health Robert Wood Johnson American Heart Association (Cardiovascular) AACR / ASCO (Cancer) FIRS (Respiratory) AAFP (24 orgs) Harm reduction offers possible benefit least restrictive Not proponents of harm reduction most restrictive Over the course of many decades the introduction of new tobacco products has been detrimental to public health. This is even more true for products, such as e-cigarettes, for which little is known about the product, its contents, and the actual public health impact of the product.

24 Key issues Ø Definition of product categories Ø Approval pathway Path definition Grandfather date / predicate Enforcement date Ø Tobacco regulation Composition standards Flavors Ø Device regulation

25 Tobacco regulation: e-liquid (composition) Disclaimer: the following includes an interpreta(on of the viewpoint of each en9ty, and have not been reviewed by the submi4ng en((es AEMSA Lorillard Altria Vaping community TCLC Reynolds Not enforced Standards, No pre-market approval Full SE, PMTA Open nicotine problematic least restrictive most restrictive Highest available purity for each ingredient USP nicotine PG VG; GRAS flavors e-liquid constituents do not raise HPHC concerns beyond reference Novel constituents: tiered evidence level depending on potential risk Stability per FDA guidance Q3B(R2) - Impurities in New Drug Products Don t need to prove population effects pre-launch

26 Tobacco regulation: e-liquid (flavors) Disclaimer: the following includes an interpreta(on of the viewpoint of each en9ty, and have not been reviewed by the submi4ng en((es CASAA Ballantyne AAFP (24 orgs) H. Waxman njoy Logic AACR / ASCO (Cancer) 29 AG s AEMSA Altria FIRS (Respiratory) Robert Wood Johnson S. Glantz Vaping community Reynolds GSK TCLC No limits Non-candy / cartoon least restrictive Adult-oriented flavors ok No characterizing flavors most restrictive Flavors are essential to provide a viable alternative to cigarettes for adult tobacco users. Don t ban adult-oriented flavors. Many consumable products intended for adults offered in fruity, candy and other flavors, such as flavored alcohol beverages Use age verification to prevent use by youth, similar to alcohol

27 Tobacco regulation: e-liquid (flavors) Disclaimer: the following includes an interpreta(on of the viewpoint of each en9ty, and have not been reviewed by the submi4ng en((es CASAA Ballantyne AAFP (24 orgs) H. Waxman njoy Logic AACR / ASCO (Cancer) 29 AG s AEMSA Altria FIRS (Respiratory) Robert Wood Johnson S. Glantz Vaping community Reynolds GSK TCLC No limits Non-candy / cartoon least restrictive Adult-oriented flavors ok No characterizing flavors most restrictive Flavors may contribute to youth initiation FDA should use every tool available to protect youth

28 Key issues Ø Definition of product categories Ø Approval pathway Path definition Grandfather date / predicate Enforcement date Ø Tobacco regulation Composition standards Flavors Ø Device regulation

29 Device regulation: open systems Disclaimer: the following includes an interpreta(on of the viewpoint of each en9ty, and have not been reviewed by the submi4ng en((es Innokin Ploom evolv Stanton Glantz Not enforced ( accessories ) or abbrev. pre-market approval least restrictive Altria Deemed ( components ) Reynolds Open nicotine problematic Most restrictive Pipe grandfathered or not enforced Pipe labeled as Vaporizer must show no HPHC impact beyond reference Vaporizer indicated through supplement to Tobacco master file tobacco indicated for use with that vaporizer, similar to Lilly Humulin insulin indicated for use with Medtronic insulin pump through snda.

30 Device regulation: open systems Disclaimer: the following includes an interpreta(on of the viewpoint of each en9ty, and have not been reviewed by the submi4ng en((es Innokin Ploom evolv Stanton Glantz Not enforced ( accessories ) or abbrev. pre-market approval least restrictive Altria Deemed ( components ) Reynolds Open nicotine problematic Most restrictive Too much inherent variability for FDA to effectively regulate open systems?

31 Questions? Stacy L. Ehrlich Gal Cohen 31

32 Appendix

33 Defining the approval pathway Disclaimer: the following includes an interpreta(on of the viewpoint of each en9ty, and have not been reviewed by the submi4ng en((es Ballantyne njoy Reynolds Lorillard Altria TCLC Vaping community AEMSA Pfizer No review Broader SE / ~510(k) Abbrev. PMTA SE / PMTA least restrictive most restrictive Monograph like system (reference of allowable composition / performance) New e-cigarettes to be compared to a "model" e-cig Key focus should be on the resultant vapor May not require pre-market approval

34 Defining the approval pathway Disclaimer: the following includes an interpreta(on of the viewpoint of each en9ty, and have not been reviewed by the submi4ng en((es Ballantyne njoy Reynolds Lorillard Altria TCLC Vaping community AEMSA Pfizer No review Broader SE / ~510(k) Abbrev. PMTA SE / PMTA least restrictive most restrictive For truly novel products Model population effects pre-launch or study post-launch. Define minor, moderate and major changes; establish corresponding data submitted in PMTA supplement for each type

35 Approval pathway: grandfather date Disclaimer: the following includes an interpreta(on of the viewpoint of each en9ty, and have not been reviewed by the submi4ng en((es Lorillard Ploom AEMSA Logic Vaping community Altria Reynolds TCLC Don t Deem Final Rule 4/25/14 2/15/2007 least restrictive most FDA statutory restrictive reading of Act Grandfather vaporized products on market before final rule These products can serve as predicates for future SE applications

36 Approval pathway: enforcement date Disclaimer: the following includes an interpreta(on of the viewpoint of each en9ty, and have not been reviewed by the submi4ng en((es Ploom AAFP njoy Stanton Glantz Reynolds Lorillard Pfizer TCLC 5 years post publication least restrictive 2 years post guidance / rules 2 years post publication FDA proposal < 2 years post publication most restrictive FDA obligated by Tobacco Act to provide a viable path for any category without a viable SE predicate. Enforcement cannot occur until after definition of path, to provide sufficient time for manufacturers to prepare viable applications.

37 Tobacco regulation: e-liquid (composition) Disclaimer: the following includes an interpreta(on of the viewpoint of each en9ty, and have not been reviewed by the submi4ng en((es AEMSA Lorillard Altria Vaping community TCLC Reynolds Not enforced Standards, No pre-market approval Full SE, PMTA Open nicotine problematic least restrictive most restrictive Too much variability for FDA to effectively regulate open systems Vape shop = manufacturer