Transcript FDA presentation - Tobacco Free Arizona – Blog

The New FDA Law: A Green
Light for Local Policies?
The Center For Tobacco Policy & Organizing
Kimberly Weich Reusche
Justin Garrett
Vanessa Marvin
Technical Assistance Legal Center
Leslie Zellers
Elisa Laird-Metke
Agenda
I. Welcome and Overview
II. TCP Perspective: April Roeseler
III. Overview of FDA Legislation &
Lawsuit
IV. Green Light, Yellow Light, Red
Light Policies
V. How TALC and the Center can Help
VI. Questions
Overview of FDA Law
H.R. 1256 signed into law on June 22, 2009
www.cbsnews.com/blogs/2009/06/22/politics/politicalhotsheet/entry5104008.shtml
New Authority over Tobacco Products
I. Restrictions on marketing of tobacco
products
II. Restrictions on youth access to tobacco
products
III. Authority over tobacco product standards
IV. Require more accurate information for
consumers
www.fda.gov/TobaccoProducts/default.htm
Restrictions on Marketing
of Tobacco Products
Ban giveaways of branded products, such as Tshirts, with purchase of tobacco product
(12 months after enactment)
Restrictions on Marketing
of Tobacco Products
Prohibit free samples
of cigarettes and
smokeless tobacco
except in certain
restricted situations
(12 months)
Restrictions on Marketing
of Tobacco Products
Ban remaining tobacco-brand
sponsorship of sports and
entertainment events (12 months)
www.notobaccoads.org/asp_sponsorship.asp
Restrictions on Marketing
of Tobacco Products
Ban outdoor advertising near schools
and playgrounds (12 months)
Restrictions on Marketing
of Tobacco Products
Limit advertising to black
and white text only for:
• Outdoor advertising
• Point of sale advertising
(except in adult-only facility)
• Publications with
significant teen readership
(12 months)
Restrictions on Youth Access
to Tobacco Products
• Ban on vending machines or self-service
displays (12 months)
• Federal enforcement of prohibition of sales to
anyone under age 18 (9 months)
Restrictions on Youth Access
to Tobacco Products
• Regulations to
prevent sale of tobacco
products to youth via
Internet (18 months)
• Regulations to
prevent promotion and
marketing of tobacco
products to youth via
Internet (18 months)
Authority over Tobacco Product
Standards
FDA has authority to issue product
standards to promote public health,
which can include eliminating or
reducing certain ingredients (upon
enactment)
Authority over Tobacco Product
Standards
• All new products
(introduced or modified
after Feb. 15, 2007) can be
reviewed by FDA.
• Starting 30 months after
enactment, all new
products must be
submitted to the FDA for
review before being sold.
www.trinketsandtrash.org
Authority over Tobacco Product
Standards
• Tobacco companies must provide list of
ingredients and additives to FDA (6 months)
• FDA will establish a list of harmful or
potentially harmful constituents (30 months)
Authority over Tobacco Product
Standards
•Tobacco companies must provide to the FDA
a list of all harmful or potentially harmful
constituents by brand and quantity (36
months)
• FDA will require new testing and reporting
of tobacco products (42 months)
Authority over Tobacco Product
Standards
FDA implements ban on flavored cigarettes
(went into effect September 22, 2009)
www.trinketsandtrash.org
Authority over Tobacco Product
Standards
• The flavored cigarette ban does not apply to
menthol cigarettes
• Menthol report 1-year after scientific advisory
committee appointed
www.trinketsandtrash.org
Require More Accurate
Information for Consumers
Prohibit use of “light,” “low,” and “mild” in
marketing and labeling for all new tobacco
products (30 days) and for existing tobacco
products (12 months)
www.trinketsandtrash.org
Require More Accurate
Information for Consumers
• Larger and strong warning
labels on smokeless tobacco
products and advertisements (12
months)
• Larger and graphic warning
labels for cigarettes
• Regulation within 24 months
after enactment
• Implementation 15 months later
http://whyquit.com/whyquit/addicts.html
Where does the funding for the Center
for Tobacco Products come from?
• Original allocation of $5 million to
begin administrative and
implementation functions
• On October 1, 2009, the FDA started
collecting user fees from tobacco
companies based on each company’s
share of the U.S. tobacco market.
What tobacco products are
covered by the law?
• Most restrictions apply
specifically to cigarettes
or smokeless tobacco
products
• FDA has authority over
all tobacco products and
can issue regulations on
cigars, hookah, pipe
tobacco, etc.
Who is responsible for
enforcement of the law?
• In most cases the FDA is
responsible for enforcement but
local agencies can report possible
violations to the FDA.
• For the youth access provisions,
the FDA will likely partner with state
enforcement agencies
More Information about the FDA Law
Tobacco Control Legal Consortium
http://tclconline.org/FDA-fact-sheets.html
Food and Drug Administration
www.fda.gov/TobaccoProducts/default.htm
Lawsuit Challenging FDA Law
Brought by 5 tobacco companies (including
RJR and Lorillard) and 1 tobacco retailer chain.
3 of the 4 companies signed
the MSA, 2 did not.
Suit was filed in federal court
in Western Kentucky.
Lawsuit Challenging FDA Law
Suit challenges 10 specific provisions of FDA law:
1.
2.
3.
4.
5.
6.
Tombstone advertising requirements
Ban on outdoor advertising
Sponsorship ban
Ban on sampling
Ban on brand name merchandise
Ban on promotional items with purchase
Lawsuit Challenging FDA Law
Suit challenges 10 specific provisions of FDA law:
7. New package warning labels
8. Ban on saying tobacco is “approved by the
FDA”
9. Ban on marketing tobacco with other
products regulated by the FDA
10. “Reduced harm” claims about certain
products
Lawsuit Challenging FDA Law
The suit also
challenges
FDA’s right to create
further restrictions
on
advertising and
promotion.
Lawsuit Challenging FDA Law
Challenge is based on 3 grounds:
1. The law is too vague to understand
exactly what is prohibited
(violation of the Due Process clause of the Constitution)
www.creditscorecowboy.com/blog/2008_10_01_archive.html
Lawsuit Challenging FDA Law
2. By requiring larger warning labels and
tombstone advertising, the government is
illegally taking something (in this case
package space and color in trademarks)
that belongs to the tobacco companies
(violation of the Takings Clause of the
Constitution)
Lawsuit Challenging FDA Law
3. The law prevents tobacco companies from
communicating truthful information to their
adult customers (violation of First
Amendment free speech protections)
Same argument that won in prior case
(Lorillard v. Reilly)
Some of the new FDA restrictions
challenged here are similar to those
challenged in Lorillard, but many are
different
www.ehow.com/how_4732940_talk-much.html
Lawsuit Challenging FDA Law
Will the lawsuit succeed?
Hard to say.
Lawsuit Challenging FDA Law
Implications for communities right now
• It is still legal to pursue local policies in
any of the challenged areas—there is no
impact on California unless the Supreme
Court makes a ruling in the case
• If the Supreme Court ultimately rules any
part of the FDA law unconstitutional,
similar local laws would become
unenforceable
CX Indicators
Which are ok to pursue?
Explanation of stoplight system
• Green indicates actions that local
governments MAY take with least risk
• The lawsuit pending against the FDA law
may affect the legality of some of the items
GREEN marked “green”
• Use the TALC model ordinances and work
with TALC to ensure that the new laws are as
legally sound as possible
Explanation of stoplight system
• Yellow policies require further legal
research
• May draw a lawsuit if adopted as a local
ordinance
YELLOW • Some communities may be interested in
setting new precedent by pursuing these
indicators
• If your community is particularly interested
in one of the “yellow” indicators, contact
TALC to discuss the related implications
Explanation of stoplight system
RED
Red policy ideas are not legally permissible
at this time and should not be pursued.
Green Light Policies
Policies Not Impacted by FDA
Most of the CX indicators are not
impacted by the new FDA law
Policies Not Impacted by FDA
FDA law specifically does not preempt states
and local authorities from certain polices:
“measure relating to or prohibiting the sale, distribution,
possession, exposure to, access to, advertising and
promotion of, or use of tobacco products by individuals of
any age, information reporting to the State, or measures
relating to fire safety standards for tobacco products. No
provision of this chapter shall limit or otherwise affect any
State, tribal, or local taxation of tobacco products.”
Enforcement of secondhand
smoke laws
Enforcing compliance
with smokefree
workplaces, local
outdoor secondhand
smoke ordinances,
tribal government
policies, etc.
Secondhand Smoke Policies
All policies restricting smoking such as
prohibiting smoking in outdoor dining,
worksites, entryways, recreation areas,
public events, housing units, etc.
Enforcement of sale and
distribution laws
Enforcing prohibitions against sales to minors,
compliance with STAKE Act warning signs,
prohibition of self-service displays, etc.
http://www.cagrocers.com/images/stakeactsign.jpg
Policies related to the sale of
tobacco products
Local tobacco retailer licensing ordinances
• Can include language that allows
penalties for violations of federal laws
www2.tbo.com/content/2009/sep/07/fla-cigarette-sales-down-after-price-hike/
Policies related to the sale of
tobacco products
Policies that regulate the number, location or density
of tobacco retailers through CUP, zoning or retailer
license, policies that permit carton only sales of
cigarettes, and policies that prohibit the sale or
distribution of tobacco products.
http://contexts.org/socimages/2009/08/13/comparing-tobacco-warnings-in-germany-and-the-u-s/
Policies related to the sale of
tobacco products
Voluntary policy refusing to sell tobacco
products in a pharmacy
www.boston.com/bostonworks/galleries/best_jobs?pg=3
Law Banning Sale of
Flavored Tobacco
www.trinketsandtrash.org
sigarettes.blogspot.com
Law Banning All Tobacco Sampling
Voluntary Policy Refusing Tobacco
Company Event Sponsorship
tobaccofreekids.org/pressoffice/aliciakeys/index.shtml
Voluntary Restriction on Time, Place,
or Manner of Ads/Promotions
www.smoke-free.ca/filtertips04/goldclub.htm
Voluntary Policy Refusing Tobacco
Marketing or Sponsorship in AOFs
www.timesunion.com/AspStories/story.asp?storyID=727790
Law Requiring That Tobacco Be
Shelved Behind Opaque Containers
Reporting Violations of the
MSA or FDA law
Yellow Light Policies
Law Restricting Time, Place, Manner
of Advertising and Promotions
http://xroads.virginia.edu/~UG00/3on1/tobaccoads/polimage.htm
Why Are Time, Place, Manner Restrictions
Risky if the FDA Law Says They’re OK?
FCLAA
Preemption
1st Amendment
Changed by
FDA law
NOT changed
by FDA law
Time, Place, & Manner Restrictions
Lorillard v. Reilly (2001)
4-part Central Hudson test applied:
1. Tobacco ads legal? Yes
2. Substantial government interest?
Yes, protecting
kids from tobacco
Time, Place, & Manner Restrictions
3. Regulations directly advance interest?


Outdoor ad limits – maybe
Indoor ad limits - no
4. More extensive than necessary?


Yes, retailers have some right to advertise
product legal for adults
Regulations eliminated nearly 100% of ads
Result: Mass. smokeless regulations
unconstitutional
www.diseaseproof.com/AFPsmoke.jpg
Law Requiring Counter-ads or
Point of Sale Health Warnings
Law Banning Tobacco Promotions
or Marketing at Adult Facilities
www.smoke-free.ca
Laws Restricting Price
Manipulation Strategies
Examples:
•Retail value added
schemes (two for the
price of one)
•Buydowns
•Multi-pack offers
http://www.trinketsandtrash.org
Law Prohibiting Tobacco
Company Event Sponsorship
Law Prohibiting Sale of Tobacco
Products in a Pharmacy
www.rawbw.com/~jpk/stand/Pictures.html
Enforcing Existing Local Laws
Restricting Tobacco Advertising
Some communities already had laws on the
books restricting tobacco advertising before
the Lorillard case made those laws
unenforceable.
The FDA law has language making those laws
enforceable again.
However, more research is needed to determine
whether enforcing those laws will open up
communities to lawsuits from the tobacco
industry.
Red Light Policies
Banning Ads For
Certain Tobacco Products
Although it might be
legal to ban ALL tobacco
advertising, it is not ok to
ban advertising for
certain tobacco products
but not others.
www.trinketsandtrash.org
Requiring Package Warning Labels
in Additional Languages
Requiring Additional Warnings on
Cigarette Packages
fodey.com
Laws Regarding Subjects
Reserved for the FDA Only
No requirements relating to:
–tobacco product standards
–premarket review
–adulteration, misbranding, labeling
–registration
–good manufacturing standards
–modified risk tobacco products
How Can the Center Help?
www.center4tobaccopolicy.org
(916) 554-5864
Need
training?
Need a
little help
with
directions?
Need a
quick
tune-up?
How Can TALC Help?
FREE legal technical assistance throughout California
Research legal issues
• Create model ordinances
• Customize ordinances for
communities
• Consult on specific
tobacco-related issues
Support public health departments, gov’t attorneys,
elected officials, community based organizations
http://www.flagstaff.az.gov/index.aspx?NID=527
Questions for the Center:
[email protected]
www.center4tobaccopolicy.org
Questions for TALC:
[email protected]
www.phlpnet.org/tobacco-questions