Proposed Deeming Regulations: What’s the Path Forward? · 2017-01-27 · Proposed Deeming...

Proposed Deeming Regulations: What’s the Path Forward?

Gal Cohen, Ph.D. Head of Scientific and Regulatory Affairs

Ploom, Inc.

Leaf closed system

Leaf open system

James & Adam Vision and mission •  Vaporization

technology company •  Obsolete combustion •  Modern iconography •  No “me-too” products

Corporate •  San Francisco HQ •  Founded 2007 •  Venture backed •  Profitable, growing •  JTI SA alliance •  Pax #1 portable loose

leaf vaporizer

The opportunity and challenge

“This law Congress has given me”

Innovation

Adult Smokers

Kids & Cessation

strict statutory reading vs.

regulatory risk-benefit (Congressional intent)

The opportunity and challenge

“This law Congress has given me”

Innovation

Adult Smokers

Kids & Cessation

strict statutory reading vs.

regulatory risk-benefit (Congressional intent)

~4M Vapers, US

FDA questions

Ø  Risks Associated with Variance ?

Ø  Standards ?

Ø  Assays ?

Ø Definition of product categories

Ø Approval pathway –  Path definition –  Grandfather date / predicate –  Enforcement date

Ø Tobacco regulation –  Composition standards –  Flavors

Ø Device regulation

Key issues

Vaporization includes a continuum of products

Leaf e-liquid Open Systems

Closed Systems 0%

Nico(ne?





Key issues

Small business impact?

FDA’s Proposed Deeming Regulations –

Small Business Issues and Alternatives

Stacy L. Ehrlich Partner

Kleinfeld Kaplan & Becker LLP

October 21, 2014

9

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

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

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 20-80

PMTAs during the first 24 months and 10-20 in subsequent years

12

Regulatory Alternatives •  Enforcement Discretion for or Change

to Grandfather Date •  Extended/Staggered Compliance

Periods •  Standardized Reference Products •  Abbreviated PMTA Process •  Categorical SE Exemptions

13

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

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

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

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

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

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

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

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 AEMSA

Vaping community & associations & retailers

SFATA eCIG

CASAA NACS Vapers (individuals)

Thought Leaders C. Bates S. Ballin Farsalinas / Polosa

S. Glantz TCLC Tobacco-Free Kids

AG’s, Congress 29 AG’s H. Waxman

Public Health Associations

ASCO (Cancer) AHA (Heart) FIRS (Respiratory)

AAFP Legacy Robert Wood Johnson

Pharma GSK Pfizer

Testing Labs* Arista Enthalpy Celerion *Did not submit comments

Approval pathway: public health Is harm reduction a goal?

Harm reduction offers possible benefit Not proponents of harm reduction

least restrictive 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

AACR / ASCO (Cancer)

FIRS (Respiratory)

Robert Wood Johnson

AAFP (24 orgs)

Legacy for Health

Disclaimer: the following includes an interpreta(on of the viewpoint of each en9ty, and have not been reviewed by the submi4ng en((es

American Heart Association (Cardiovascular)

Harm reduction offers possible benefit Not proponents of harm reduction


•  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.


Approval pathway: public health Is harm reduction a goal?


FIRS (Respiratory)

Robert Wood Johnson

AAFP (24 orgs)

Legacy for Health

American Heart Association (Cardiovascular)





Key issues

Tobacco regulation: e-liquid (composition)

Not enforced Standards, No pre-market

approval

Full SE, PMTA

Open nicotine problematic


•  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

Reynolds

Altria

Lorillard

AEMSA

TCLC Vaping community


Tobacco regulation: e-liquid (flavors)

No limits Non-candy / cartoon

“Adult-oriented flavors” ok

No characterizing flavors


•  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

Reynolds

Altria

Logic

AEMSA

GSK Vaping community TCLC

nJoy

Ballantyne

S. Glantz

29 AG’s

H. Waxman


FIRS (Respiratory)

Robert Wood Johnson

AAFP (24 orgs) CASAA


•  Flavors may contribute to youth initiation •  FDA should use every tool available to protect youth

No limits Non-candy / cartoon

“Adult-oriented flavors” ok

No characterizing flavors


Reynolds

Altria

Logic

AEMSA

GSK Vaping community TCLC

nJoy

Ballantyne

S. Glantz

29 AG’s

H. Waxman


FIRS (Respiratory)

Robert Wood Johnson

AAFP (24 orgs) CASAA

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





Key issues

Device regulation: open systems

Not enforced (“accessories”) or abbrev. pre-market approval

Deemed (“components”) Open nicotine problematic

least restrictive Most restrictive

Reynolds Altria

eVolv

•  “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.

Ploom

Stanton Glantz

Innokin


Not enforced (“accessories”) or abbrev. pre-market approval

Deemed (“components”) Open nicotine problematic

least restrictive Most restrictive

•  Too much inherent variability for FDA to effectively regulate open systems?

Reynolds Altria

eVolv

Ploom

Stanton Glantz

Innokin

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

Questions?

Stacy L. Ehrlich [email protected]

31

Gal Cohen [email protected]

Appendix

No review Broader SE / ~510(k) Abbrev. PMTA SE / PMTA


TCLC Altria

nJoy

AEMSA

Reynolds

Pfizer

•  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

Vaping community

Lorillard

Ballantyne


Defining the approval pathway

•  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

No review Broader SE / ~510(k) Abbrev. PMTA SE / PMTA


TCLC Altria

nJoy

AEMSA

Reynolds

Pfizer Vaping community

Lorillard

Ballantyne


Defining the approval pathway

Approval pathway: grandfather date

Don’t Deem Final Rule 4/25/14 2/15/2007


TCLC Altria Reynolds

Lorillard

Logic

AEMSA

Ploom

•  Grandfather vaporized products on market before final rule •  These products can serve as predicates for future SE applications

Vaping community

FDA statutory reading of Act


5 years post publication

2 years post guidance /

rules

2 years post publication

< 2 years post publication


Pfizer Reynolds TCLC Lorillard

nJoy

Ploom

Stanton Glantz

•  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.

AAFP

FDA proposal


Approval pathway: enforcement date

Not enforced Standards, No pre-market

approval

Full SE, PMTA Open nicotine problematic


•  Too much variability for FDA to effectively regulate open systems •  Vape shop = “manufacturer”

Reynolds

Altria

Lorillard

AEMSA

TCLC Vaping community

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

Proposed Deeming Regulations: What’s the Path Forward? · 2017-01-27 · Proposed Deeming...

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