UPDATE ON FDA CENTER FOR
TOBACCO PRODUCTS
Mitch Zeller
Director, CTP
April 23, 2015
OVERVIEW OF TODAY’S PRESENTATION
• Background on FDA’s authority
• Update on regulatory activities
• Update on research
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| January
| NATO
– April 9,
23,2015
2015
BACKGROUND ON FDA’S
AUTHORITY
2
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| NATO
– April 9,
23,2015
2015
CARRYING OUT HISTORIC LEGISLATION
CTP has authority to regulate tobacco products intended for
human consumption to reduce harm across the population
• Regulate the manufacture, marketing, and
distribution of cigarettes, cigarette tobacco,
roll-your-own, and smokeless
• Assert jurisdiction over other products that
meet the definition of a tobacco product,
including e-cigarettes, cigars, and hookah
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23,2015
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DEFINING A PUBLIC HEALTH STANDARD
• The Tobacco Control Act created the Center for Tobacco Products
(CTP) to regulate tobacco products under a new standard
“appropriate for the protection of the public health.”
• The ultimate public health objective is to reduce death and
disease from the use of tobacco products.
• As regulators, we have to assess risks and benefits for the
population as a whole, including among users and non-users of
tobacco products.
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23,2015
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USING OUR REGULATORY AUTHORITY
• Understand the regulated products
• Restrict product changes to protect public health
• Prohibit modified risk claims that state/imply reduced exposure
or risk without an order
• Restrict marketing and distribution to protect public health
• Decrease the harms of tobacco products
• Ensure industry compliance with FDA regulation through
education, inspections, and enforcement
• Educate the public about FDA’s regulatory actions
• Expand the science base for regulatory action and evaluation
5
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| NATO
– April 9,
23,2015
2015
EXPLAINING LIMITATIONS OF THE TOBACCO CONTROL ACT
In general, CTP’s regulatory authorities do not extend to:
• Setting tax rates for tobacco products
• Regulating therapeutic products, such as those marketed to treat
tobacco dependence (regulated by other parts of FDA)
• Setting clean indoor air policies
• Regulating tobacco growing
• Requiring the reduction of nicotine yields to zero
• Providing cessation services
• Banning all cigarettes, smokeless tobacco products, little cigars,
other cigars, pipe tobacco, or roll-your-own tobacco products
• Raising the minimum age to purchase tobacco
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23,2015
2015
UTILIZING USER FEES EXCLUSIVELY
• Entirely funded through industry-paid user fees based on
market share (not applications)
• User fees are the sole allowable source for FDA tobacco
program spending, and the FDA tobacco program is the sole
allowable use of the funds
• TCA permanently authorizes CTP collections and spending;
• Funding levels started at $85M in 2009, grow to $712M in
2019, and remain at that level
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23,2015
2015
UPDATE ON REGULATORY ACTIVITIES
•
Deeming
•
FDA-Wide Nicotine Policy
•
Product Standards
•
Pre and Post Market Pathways
•
MRTPA
•
Compliance and Enforcement
•
Public Education
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23,2015
2015
DEEMING
• April 2014: FDA proposed a new rule that would extend CTP’s authority to
cover additional tobacco products
– Received over 135,000 comments
• Products that would be “deemed” to be subject to FDA regulation are those
that meet the statutory definition of tobacco product
– Includes e-cigarettes, cigars, pipe tobacco, certain dissolvables that are
not “smokeless tobacco,” gels, and waterpipe tobacco
• Automatic provisions (e.g., industry registration, product listing, ingredient
listing, and the adulteration and misbranding provisions of the statute)
• Additional provisions (e.g., minimum age and identification restrictions,
health warnings, and prohibition of vending machine sales unless in a facility
that never admits youth)
• Unified Agenda Goal to publish final rule by end of June
9
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– April 9,
23,2015
2015
NICOTINE POLICY
Looking at nicotine differently…
• Recognize that there is a continuum of nicotine-containing products
• Understand that people smoke for the nicotine but die from the tar
• Acknowledge public health opportunity
COMBUSTIBLES
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– April 9,
23,2015
2015
NRT
NICOTINE POLICY
• Ongoing related actions:
– Finalizing Deeming regulation
– Developing jurisdiction policy on nicotine-containing
products across FDA
– Working with CDER and CDRH to determine how regulation
of therapeutic nicotine products (Rx, OTC, drugs, devices)
could evolve
– Exploring options at CTP for an expedited premarket review
policy based on principle of relative toxicity and risk
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23,2015
2015
PRODUCT STANDARDS
• One of the law’s most powerful tools
• Advancing a product standard strategy that
yields strong standards to improve public
health and can withstand legal challenge
• Exploring potential standards for:
– Addictiveness
– Toxicity
– Appeal
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23,2015
2015
SUBSTANTIAL EQUIVALENCE (SE)
• Demonstrating the
Substantial Equivalence
of a New Tobacco Product:
Responses to FAQs guidance
issued March 2015
• SE Review Process graphic
page added
13
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– April 9,
23,2015
2015
SUBSTANTIAL EQUIVALENCE (SE)
4,710 SE Submissions
•
97% of acceptance reviews (jurisdiction and
administrative) are complete
Regular Reports
• Resolved 53% via Order letter, Refuse-To-Accept letter
or Withdrawal
• Review of new regular reports starts upon receipt as
there is no backlog
• Established performance measures for review and
action. For FY15:
•
•
•
Regular
1,115
24%
Provision
al
3,595
76%
Finalize acceptance reviews and issue letter as appropriate for 50% of SE
reports within 21 days of FDA receipt
Review and act on 50% of original SE reports within 90 days of FDA receipt
Review and act on 50% of regular SE reports resubmissions within 90 days of
FDA receipt
Provisional Reports
• Reviews have begun
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2015
Data as of 4/14/15
MODIFIED RISK TOBACCO PRODUCT (MRTP)
FDA will allow reduced risk claims only when scientifically
proven and an order is issued by FDA.
Modified risk
Pre-market review required if the label, labeling, or advertising
represents explicitly or implicitly that:
• The tobacco product presents a lower risk of disease or is less
harmful than one or more marketed products.
• The tobacco product or its smoke contains a reduced level or
presents a reduced exposure to a substance or is free of a
substance.
• The label, labeling, or advertising uses the descriptors “light,”
“mild,” “low,” or similar descriptors.
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– April 9,
23,2015
2015
MODIFIED
RISK
TOBACCORISK
PRODUCT
(MRTP)
UPDATE ON:
MODIFIED
TOBACCO
PRODUCT (MRTP)
Phase 0
• Pre-MRTPA
Meetings
Phase 1
• Acceptance
Review
Phase 2
• Filing or
Refuse to File
Phase 3
•
•
•
•
Public Comment
Scientific Review
TPSAC Meeting
Final Action
Reapplication/Renewal
16
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– April 9,
23,2015
2015
Phase 4
• Post-market
Surveillance for
Authorized MRTPs
MODIFIED RISK TOBACCO PRODUCT (MRTP)
• Swedish Match MRTP applications accepted for filing and review
in August 2014
• Made applications available for comment for 180 days
– Comment period closed Monday, February 23, 2015
– The Tobacco Products Scientific Advisory Committee meeting held April 910 discussed scientific issues related to the Swedish Match North America
modified risk tobacco product applications currently under scientific
review at CTP.
• Published Draft Guidances
– Draft Guidance for Industry and Staff: Preliminary Timetable for the
Review of Applications for Modified Risk Tobacco Products
– Draft Guidance for Industry: Modified Risk Tobacco Products Applications
17
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– April 9,
23,2015
2015
TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE
Based on its review, FDA identified several critical scientific issues for TPSAC
discussion:
• With respect to the relative health risks to individuals:
– The strength of association between snus use and the risk of tooth loss and
gum disease
– The strength of association between snus use and the risk of oral cancers.
– The risks of snus use as compared to cigarettes.
• With respect to the impacts on initiation and cessation:
– The applicability of the Swedish experience to infer impacts on the U.S.
population.
• With respect to the ability of the public to comprehend the modified risk
information:
– The impacts of providing modified risk information in the context of a warning.
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23,2015
2015
COMPLIANCE AND ENFORCEMENT
• Conducted over 400,000 retailer inspections
covering 56 states and territories
• Issued more than 23,800 Warning Letters
• Issued over 3,000 civil money-penalty actions
against tobacco retailers
• Awarded FDA’s first contracts to Tribal
Governments to conduct tobacco retail
inspections within their jurisdictions
Data as of 4/10/15
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23,2015
2015
EDUCATING YOUTH ON THE DANGERS
General “At Risk” Market
Multicultural
Rural
American Indian/
Alaska Native
LGBT
10
Million
Prevention
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– April 9,
23,2015
2015
Investing in
our Future
MEASURING EFFECTIVENESS
Reach
Reaching over 90% of teens more than 20x a quarter, exceeding goal of 75% reach
Engagement
Engaged 6M unique visitors from all 50 states on the website
Motivation to rethink their relationship with tobacco
Produced 1.26M campaign-related unique conversations via social media
“I used to think it
made people look
cool until I saw my
teeth getting yellow
and I got sores on my
gums all the time.”
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23,2015
2015
“I always thought
smoking was foul and
killed people. The
only difference is now
I understand how.”
“Struggling to
breathe has been
happening while I
sleep...I try to stop
but it’s a really hard
addiction to
get over.”
“I don’t think it’s
cool… Not my fault
I got addicted.
Tryna quit.”
UPDATE ON RESEARCH
•
IOM Minimum Age Report
•
PATH Study (Preliminary Findings)
•
NYTS Study
22
| January
| NATO
– April 9,
23,2015
2015
IOM MINIMUM AGE REPORT
• Contracted with Institute of Medicine (IOM) to conduct a
report on the public health implications of raising the
minimum age to purchase tobacco
• Per the TCA, FDA does not have authority to raise the age
• Individual states can, and have, raised age
• Analyzed implications of raising to 19, 21 and 25
• FDA to submit report to Congress under Section 104 of
the statute
Data as of 4/10/15
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| January
| NATO
– April 9,
23,2015
2015
POPULATION ASSESSMENT OF TOBACCO & HEALTH
• First look: Data from first 20,000 participants initially shared at
SRNT in February
• National, longitudinal study of 46,000 people 12 and over,
including tobacco users and nonusers
• Designed to identify factors associated with, and implications
of, quitting tobacco, switching among different tobacco
products, and using multiple tobacco products
• First look at preliminary data
– 40 percent of both youth and adult tobacco users report
currently using two or more products
– Of the youth and adults who use 2 or more tobacco products,
50% are using e-cigarettes.
– Almost 30% of adults and about 8 ½% of youth report use of
tobacco product of any type within the past 30 days.
Joint study with NIH and FDA
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| January
| NATO
– April 9,
23,2015
2015
2014 NATIONAL YOUTH TOBACCO SURVERY
• Joint findings with CDC released April 2015. Data
from 2013 to 2014 showed:
– E-cig use tripled, hookah use doubled in one year
– E-cigs were most-used product
– Overall tobacco use stayed the same
• Increases in e-cig and hookah are threatening
progress made with traditional cigarettes
• Early exposure to nicotine is a real concern
• Underscores importance of FDA regulation
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| January
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– April 9,
23,2015
2015
FDA AND NATO
• Landscape of tobacco products is changing rapidly but proper retailer
compliance and cooperation is still key for protecting the health of your
patrons, particularly youth
• Final deeming rule will require cooperation and communication on
many new provisions
• Stay tuned for additional guidances
and new educational materials for
retail establishments that further
explain how to comply with the law
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2015
THANK YOU
| January 9, 2015