The New FDA Law: A Green Light for Local Policies?

The Center For Tobacco Policy & OrganizingKimberly Weich Reusche Justin GarrettVanessa Marvin

Technical Assistance Legal CenterLeslie 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 T-shirts, 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 Consortiumhttp://tclconline.org/FDA-fact-sheets.html

Food and Drug Administrationwww.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. Tombstone advertising requirements

2. Ban on outdoor advertising

3. Sponsorship ban

4. Ban on sampling

5. Ban on brand name merchandise

6. 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)

www.burglaralarm.me.uk/

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

• 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 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

• Yellow policies require further legal research

• May draw a lawsuit if adopted as a local ordinance

• 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

REDRed 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

www.boston.com/bostonworks/galleries/best_jobs?pg=3

Voluntary policy refusing to sell tobacco products in a pharmacy

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

Voluntary Policy Refusing Tobacco Marketing or Sponsorship in AOFs

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Law Requiring That Tobacco Be Shelved Behind Opaque Containers

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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

Law Requiring Counter-ads or Point of Sale Health Warnings

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Law Banning Tobacco Promotions or Marketing at Adult Facilities

www.smoke-free.ca

Laws Restricting Price Manipulation Strategies

http://www.trinketsandtrash.org

Examples:•Retail value added schemes (two for the price of one)•Buydowns•Multi-pack offers

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

www.trinketsandtrash.org

Although it might be legal to ban ALL tobacco advertising, it is not ok to ban advertising for certain tobacco products but not others.

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?

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tune-up?

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

How Can TALC Help?

http://www.flagstaff.az.gov/index.aspx?NID=527

Questions for TALC:

talc@phlpnet.org

www.phlpnet.org/tobacco-questions

Questions for the Center:

jgarrett@alac.org

www.center4tobaccopolicy.org