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ABD, FDA PartnershipRetail Tobacco Compliance

IGIA WEBINAR

FEBRUARY 16, 2012, 10:00 AM

ABD, FDA PartnershipRetail Tobacco Compliance

ABD, FDA PartnershipRetail Tobacco Compliance

I. ABD, FDA partnership

II. What is a Retailer?

III. Federal Laws

IV. Tobacco Control Act & Law Summary

V. Inspections

VI. Tools for Retailers

VII. Iowa Pledge

VIII. Contact Information

I. ABD, FDA PARTNERSHIP

ABD, FDA PartnershipRetail Tobacco Compliance

Annual Compliance Checks

• All tobacco retailers checked annually

• Approximately 215 retailers checked per month

• Contract of 1 year

• Option to renew for 2 years

Reporting Procedure

• FDA Commissioned investigator conducts check

• All potential violations reported to FDA

• FDA brings enforcement actions:

• Warning letters

• Civil penalties

• No-tobacco sales orders

II. WHAT IS A RETAILER?

ABD, FDA PartnershipRetail Tobacco Compliance

What is a Retailer?

• Sells cigarettes, smokeless tobacco, or roll-your-own tobacco to individuals for personal consumption

• Operate a facility where a vending machine or self-service display is present

III. FEDERAL LAWS

ABD, FDA PartnershipRetail Tobacco Compliance

Federal Laws

• Federal Food, Drug, and Cosmetic Act as amended by:

• Family Smoking Prevention and Tobacco Control Act

• Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents

• Title 21 of the Code of Federal Regulations, Part 1140 (21 C.F.R. Part 1140)

Federal Laws

Tobacco Control Act:

• Prevent and reduce tobacco use by underage people

• Enforce the minimum legal

• Prohibits false or misleading labeling

• Prohibits false or misleading advertising

• Gives authority to FDA to enforce the law

IV. TOBACCO CONTROL ACT & LAW SUMMARY

ABD, FDA PartnershipRetail Tobacco Compliance

What the Tobacco Control Act Does

Restricts cigarettes and smokeless tobacco retail sales to youth:

• Require proof of age to purchase tobacco products

• Require face-to-face sales, and limits vending machines and self-service displays

• Ban the sale of packages of fewer than 20 cigarettes 

• Allow certain exemptions in adult-only facilities 

http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm246129.htm

What the Tobacco Control Act Does

Restricts tobacco product advertising and marketing to youth:  

• Limit color and design of packaging and advertisements

• Ban tobacco product sponsorship of sporting or entertainment events

• Ban free cigarettes and promotional products

http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm246129.htm

What the Tobacco Control Act Does

The Tobacco Control Act specifically:

• Prohibits “reduced harm” claims including “light,” “low,” or “mild”  

• Requires industry to submit marketing research documents 

http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm246129.htm

What the Tobacco Control Act Does

Requires bigger, bolder warning labels

• Packaging and advertisements for cigarettes and smokeless tobacco must have warning labels

• Cigarette package health warnings will be required to cover the top 50 percent of both the front and rear panels of the package

• Smokeless tobacco packages product warnings must cover 30 percent of the two principal display panels

http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm246129.htm

What the Tobacco Control Act Does

Gives FDA authority over:

• Registration and inspection of tobacco companies 

• Requires owners and operators of tobacco companies to register and be inspected  

• Standards for manufacturing tobacco products 

• Allows FDA to require changes to tobacco products to protect public health.

http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm246129.htm

What the Tobacco Control Act Does

Gives FDA authority over:• Bans flavored cigarettes• “Premarket Review” of new tobacco products• Requires manufacturers to obtain a marketing

order• “Modified risk” products • Requires manufacturers who wish to market a

tobacco product with a claim of reduced harm to obtain a marketing order from FDA

http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm246129.htm

What the Tobacco Control Act Does

Gives FDA authority over:

• Enforcement action plan for advertising and promotion restrictions

• FDA published a document entitled “Enforcement Action Plan for Promotion and Advertising Restrictions”

• The action plan details FDA’s current enforcement strategy

http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm246129.htm

What the Tobacco Control Act Does

Role of FDA:

• Established the Center for Tobacco Products

• Established the Tobacco Products Scientific Advisory Committee

• Assesses fees on tobacco companies/traders

• Encourages companies to develop innovative products that help people stop smoking 

• Prevents illicit trade in tobacco products 

• Convenes a panel of experts to study the public health implications of raising the minimum

http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm246129.htm

What the Tobacco Control Act Does

Limits on FDA’s authority, FDA cannot:

• Ban an entire class of tobacco products 

• Require the total elimination of nicotine from tobacco products

• Require prescriptions to purchase tobacco products 

• Regulate tobacco farming 

• Ban tobacco sales in any particular type of sales outlet 

http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm246129.htm

Law Summary

Check the photo ID for anyone under age 27

Only sell tobacco products to people age 18 or older

Only sell tobacco in a direct, face-to-face exchange

Do not give away free samples

Do not open cigarette or smokeless tobacco packages to sell products in smaller amounts

Law Summary

Do not sell single cigarettes

Do not sell cigarette packages containing fewer than 20 cigarettes

Do not give away free samples of smokeless tobacco

Do not sell or give away items with cigarette and smokeless tobacco brands or logos

Do not give away gifts or items in exchange for the purchase of cigarettes or smokeless tobacco products

Do not sell flavored cigarettes

V. INSPECTIONS

ABD, FDA PartnershipRetail Tobacco Compliance

Inspections

Inspections may:

• Conduct undercover buys

• Advertising inspections

• Labeling inspections

• Sale and distribution restrictions

Inspections

Inspections focus on:

• Age and ID verification

• Requirements for labeling and advertising of smokeless tobacco products

• Restrictions on the sale of single cigarettes

• Prohibited self service displays and vending machines

Will I know that FDA Is Inspection Me?

• Compliance check inspections are unannounced

• FDA inspectors may announce themselves

• If so they will issue you an Inspection Form 482- Official Notice of Inspection

What Happens during a Compliance Check Inspection?

• Minor attempts to purchase tobacco product to ensure:

• Licensee checks photo ID

• Sales are only made to individuals age 18 or older

• Inspector checks that you comply with all advertising and labeling requirements:

• May take pictures of establishment and/or tobacco products

• Will not take pictures of employees or customers

• May issue a Notice of Inspection (Form FDA 482)

• May ask you questions

What Are Some of the Things That FDA Will Be Looking for during a Compliance Check

Inspection?

• Only sell tobacco products in a direct, face to face, exchange

• If a vending machine or self-service display is present, that you DO NOT allow minors to be present at any time

• NO free samples of cigarettes

• NO opening packages to sell products in smaller amounts

• NOT sell single cigarettes

• No selling cigarette packages containing fewer than 20

What Are Some of the Things That FDA Will Be Looking for during a Compliance Check

Inspection?

• NO offering free samples of smokeless tobacco

• NO selling or giving away items with tobacco brands or logos

• NO offering gifts in exchange for the purchase of tobacco products

• NO selling flavored cigarettes or flavored cigarette tobacco

What If a Retailer Is Inspected But There Were

No Violations Observed?

• FDA does not send a letter or email

• FDA posts names of all inspected retailers

• Search function allows looking for just retailers that have no violations observed

What If a Retailer is Inspected and There Are Violations Observed?

• The first time an FDA tobacco compliance check inspection reveals a violation, FDA generally issues a Warning Letter

• A Warning Letter is an agency advisory action that is used to achieve voluntary compliance

What If a Retailer is Inspected and There Are Violations Observed?

• The Warning Letter contains a description of each violation observed

• FDA gives firms an opportunity to take voluntary corrective action

• A Civil Money Penalty example of an enforcement action if additional violations are observed

Will a Retailer Know the FDA Has Issued a Warning Letter to Them?

• Warning Letters are posted on the FDA websitehttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/Tobacco/default.htm

• Anyone can sign up to receive email updates when new tobacco compliance checks are updated

• For more information view the archived webinar “Warning Letters for Tobacco Retailers” http://www.fda/TobaccoProducts/ResourcesforYou/ForIndustry/Retailer/ucm217770.htm

When may FDA Seek A Civil Money Penalty?

• After a Warning Letter, FDA conducts follow-up compliance check inspections

• If FDA identifies violation during a follow-up FDA will seek Civil Money Penalties

• For more information view the archived webinar “The Civil Money Penalty Process” http://www/fda.gov/TobaccoProducts/Resources for You/ForIndustry/Retailer.ucm21770.htm

Inspection Results

Full inspection results posted on FDA’s website fda.gov/tobacco

Search feature (http://www.accessdata.fda.gov/scripts/oce/inspections/oce_insp_searching.cfm)

Lists warning letters (http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm)

Lists compliant checked retailers

Sign up for email notifications (https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_63)

VI. TOOLS FOR RETAILERS

ABD, FDA PartnershipRetail Tobacco Compliance

FDA Website

FDA Website

Resources for Retailers:

Retailer Education Materials (http://www.fda.gov/TobaccoProducts/ResourcesforYou/BreakTheChain/ucm237741.htm)

Regulations and Guidelines (http://www.fda.gov/TobaccoProducts/ResourcesforYou/BreakTheChain/ucm237759.htm)

Retailer Training and Enforcement (http://www.fda.gov/TobaccoProducts/ResourcesforYou/BreakTheChain/ucm249332.htm)

Webinar Training Series

Other FDA Tools

• Webinars: live and archived 2012: (http://www.fda.gov/TobaccoProducts/ResourcesforYou/ForIndustry/Retailer/ucm288657.htm)2011: (http://www.fda.gov/TobaccoProducts/ResourcesforYou/ForIndustry/Retailer/ucm217770.htm)

• Topics include:

• What to expect during a tobacco retailer inspection

• The civil money penalty process

• Tobacco retailer compliance quiz

• Required warnings for cigarette packages and advertisements

• Establishment registration and product listing requirements

Other FDA Tools

• Mobile Texting(http://www.fda.gov/TobaccoProducts/ResourcesforYou/BreakTheChain/ucm219686.htm)

• Email updates(http://www.fda.gov/TobaccoProducts/ResourcesforYou/ucm176164.htm)

• Widget: “News You Can Use” or “Tobacco Retailer Quiz” (http://www.fda.gov/TobaccoProducts/NewsEvents/ucm216404.htm)

• Twitter: @FDAtobacco (https://twitter.com/#!/fdatobacco)

Other FDA Tools

• Publications Clearinghouse (http://www.fda.gov/TobaccoProducts/ResourcesforYou/BreakTheChain/ucm284328.htm)

• Download and print materials for display on premises or in employee only areas

• Posters, bookmarks, window clings, stickers and mailers

• English and Spanish versions

Publications Clearinghouse

VII. IOWA PLEDGE PROGRAM

ABD, FDA PartnershipRetail Tobacco Compliance

Iowa Pledge Certification

Iowa Pledge online certification programIowaABD.com

Free, one-hour online course teaches:• Checking IDs• Spotting fake IDs• Confiscating IDs• Tips for refusing a tobacco sale

Iowa Pledge Certification

Iowa Pledge online certification program

Affirmative Defense for sale-to-minor• For business, not employee• Must be certified at time of sale• Only for state sanctions• Not usable for federal violations• Still a great tool for training employees

VIII. CONTACT INFORMATION

ABD, FDA PartnershipRetail Tobacco Compliance

FDA Contact Information

Questions regarding the federal compliance checks must be directed to the FDA

1.877.287.1373

AskCTP@fda.hss.gov

ABD Contact Information

Karen Freund, Deputy Director of Regulatory AffairsFDA Program Coordinator(515) 281-7414 • Freund@IowaABD.com

Jessica Punelli, ABD Licensing ClerkFDA Program Assistant(515) 281-7434 • Punelli@IowaABD.com

Shannon Pogones, Education & Outreach Coordinator(515) 281-3426 • Pogones@IowaABD.com

Tonya Dusold, Communications Director(515) 281-7420 • Dusold@IowaABD.com

QUESTIONS?

This Presentation

This presentation, along with all ABD presentations will be available for download at IowaABD.com

THANK YOU!