• Share
  • Email
  • Embed
  • Like
  • Save
  • Private Content
Igia fda webinar
 

Igia fda webinar

on

  • 676 views

ABD, FDA Partnership Retail Tobacco Compliance

ABD, FDA Partnership Retail Tobacco Compliance
Iowa Alcoholic Beverage Division
Ankeny Iowa
February 16, 2012
Tonya Dusold

Statistics

Views

Total Views
676
Views on SlideShare
676
Embed Views
0

Actions

Likes
0
Downloads
2
Comments
0

0 Embeds 0

No embeds

Accessibility

Upload Details

Uploaded via as Microsoft PowerPoint

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment
  • If your computer does not have speakers and you’ve called in to the long distance number to participate, we have set up a toll free option. If you choose to participate by phone, please be sure to mute your line. We will only accept questions and comments through the webinar interface. Also remember, if you put the conference call on hold, we will all hear your hold music. If you need to, disconnect the line and then call back in when you are ready.
  • Welcome, Iowa Grocery Industry Association members. This is a webinar being held by the Iowa Alcoholic Beverages Division covering contract FDA retail tobacco compliance checks. There will be time for questions at the end. Please submit those through the webinar portal. The ABD is under contract to conduct checks for the FDA, but much of the information is confidential. The information I am presenting today can be found on the FDA’s website at FDA.gov/tobacco
  • Today’s webinar will cover the following 8 categories
  • Late last year, the ABD was awarded a contract by the FDA to conduct federal retail tobacco compliance checks. All Iowa tobacco retailers will be checked annuallyThat equates to approximately 215 retailers checked per monthThe checks have begun nowThe contract is for a period of 1 year, but has the option of being renewed for two subsequent years.
  • What is a retailer? You are a retailer for the purposes of these regulations if you sell cigarettes, smokeless tobacco, or roll-your-own tobaccoTo individuals for personal consumptionOr operate a facility where a vending machine or self-service display is presentThe regulations apply to all types of retail establishments such as grocery stores, pharmacies, convenience stores, gas stations, bars, restaurants, bowling alleys, hotels, etc.
  • Restricts cigarettes and smokeless tobacco retail sales to youth by directing the FDA to issue regulations which: Require proof of age to purchase tobacco products – the federal minimum age to purchase tobacco products is 18 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
  • Restricts tobacco product advertising and marketing to youth by directing the FDA to issue regulations which:   Limit color and design of packaging and advertisements, including audio visual advertisements Ban tobacco product sponsorship of sporting or entertainment events Ban free cigarettes and promotional products, including non-tobacco products linked to tobacco products
  • The Tobacco Control Act specifically: Prohibits “reduced harm” claims including “light,” “low,” or “mild”  without an FDA order to allow the marketing Requires industry to submit marketing research documents 
  • Requires bigger, bolder warning labels for cigarettes and smokeless tobacco products Packaging and advertisements for cigarettes and smokeless tobacco must have warning labels with specific, larger font size. Font colors are limited to white on black background or black on a white background. Cigarette package health warnings will be required to cover the top 50 percent of both the front and rear panels of the package. 9 specific warning messages must rotate randomly over the course of the year. These messages must be accompanied by color graphics showing the negative health consequences of smoking cigarettes. Smokeless tobacco packages product warnings must cover 30 percent of the two principal display panels.4 specific warning messages must rotate randomly over the course of the year.
  • Gives FDA authority over: Registration and inspection of tobacco companies  Requires owners and operators of tobacco companies to register and be inspected every two years Standards for manufacturing tobacco products  Allows FDA to require changes to tobacco products to protect public health. For example tar and nicotine levels.
  • Gives FDA authority over: Bans flavored cigarettes “Premarket Review” of new tobacco products Requires manufacturers who wish to market a new tobacco product to obtain a marketing order from FDA prior to marketing that new product “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
  • 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 on how it intends to enforce certain requirements established by the Tobacco Control Act.
  • Role of FDA: Established the Center for Tobacco Products to oversee the implementation of the Tobacco Control Act Established the Tobacco Products Scientific Advisory Committee to review and evaluate health issues relating to tobacco products and provide advice, information, and recommendations to the FDA Assesses fees on tobacco companies/traders based on market share. Fees used to fund FDA tobacco related expenses including industry oversight. 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 to purchase tobacco products
  • Check the photo ID with birthday for anyone under age 27Only sell cigarettes and smokeless tobacco products to people age 18 or olderOnly sell cigarettes and smokeless tobacco in a direct, face-to-face exchangeDo not give away free samples Do not open cigarette or smokeless tobacco packages to sell products in smaller amounts
  • Do not sell single cigarettesDo not sell cigarette packages containing fewer than 20 cigarettesDo not give away free samples of smokeless tobaccoDo not sell or give away items with cigarette and smokeless tobacco brands or logosDo not give away gifts or items in exchange for the purchase of cigarettes or smokeless tobacco productsDo not sell flavored cigarettes
  • Compliance check inspections are unannounced. Often you will not know that the FDA has been in your establishment for a compliance check. However, FDA inspectors may announce themselves upon arrival to conduct a check If so they will issue you an Inspection Form 482- Official Notice of Inspection
  • Minor attempts to purchase tobacco product to ensure: That you do check the photo ID with date of birth of anyone under age 27 who attempts to purchase cigarettes, smokeless tobacco, or roll-your-own tobacco That you do only sell cigarettes, smokeless tobacco and roll-your-own tobacco to individuals age 18 or older. Inspector checks that you comply with all advertising and labeling requirements: Will take pictures of establishment and may take photos of tobacco products Will not take pictures of employees or customers May issue a Notice of Inspection (Form FDA 482) May ask you questions
  • That you do only sell cigarettes, smokeless tobacco and roll-your-own tobacco in a direct face-to-face exchange. The only exception to this is vending machines and self service displays located in facilities or locations where no person younger than 18 is present or permitted to enter at any time.If a vending machine or self-service display is present, that you DO NOT allow minors to be present at any timeThat you do not give away free samples of cigarettesThat you do not break open cigarettes or smokeless tobacco packages to sell products in smaller amountsThat you do not sell single cigarettesThat you do no sell cigarettes in packages containing fewer than 20 cigarettes
  • That you do not offer free samples of smokeless tobacco productsThat you do not sell or give away items such as hats, t-shirts or lighters with tobacco brands or logosThat you do not offer gifts or items in exchange for the purchase of cigarettes, smokeless tobacco or roll-your-own tobacco productsThat you do not offer gifts or items in exchange tobacco products proofs of purchase, coupons or creditsThat you do not sell flavored cigarettes or flavored cigarette tobacco (with the exception of menthol)
  • FDA does not send a letter or email On its website, FDA posts names of all inspected retailers, whether or not a violation was found Search function allows you to look for just retailers that have no violations observed
  • Although not required, The first time an FDA tobacco compliance check inspection reveals a violation, FDA generally intends to issue a Warning Letter A Warning Letter is an agency advisory action that is used to achieve voluntary compliance with the Tobacco Control Act and to establish prior notice. It is not a final agency action.
  • The Warning Letter contains a description of each violation observed It is the FDA’s practice to give firms an opportunity to take voluntary and promptcorrective action before it initiates an enforcement action A Civil Money Penalty example of an enforcement action that would be taken following the issuance of a warning letter if additional violations are observed during a subsequent compliance check inspection
  • Warning Letters are posted on the FDA website Anyone can sign up to receive email updates when new tobacco compliance checks warning letters are posted to the FDA website For more information on warning letters, please view the archived compliance training webinar “Warning Letters for Tobacco Retailers” on FDA’s website
  • After a tobacco retailer receives a Warning Letter, FDA intends to conduct follow-up compliance check inspections at that retail establishment without further notice If FDA identifies a violation during a follow-up compliance check inspections at that retail establishment, FDA intends to seek Civil Money Penalties through an administrative complaintFor more information on civil money penalties, please view the archived compliance training webinar “The Civil Money Penalty Process” on FDA’s website
  • On the FDA’s tobacco website, in the upper right there is a “Most popular” section. There is a link to “resources for retailers.” This is where you will find the majority of information that will be valuable in preparing for and passing the FDA retail tobacco compliance checks. Some subsections include retailer education materials, regulations and guidelines – which is where much of the information in this webinar was taken from – and retailer training and enforcement. The FDA also holds several live webinars on the retailer tobacco compliance checks throughout the year.
  • These webinars are archived and can be viewed at any time on the FDA’s website. 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
  • On the website, you ca also sign up for the tobacco regulations mobile texting pilot program to receive text messages containing information on compliance checks and laws and regulationsIn addition to emails updates on compliance check results, You can sign up to receive email updated on tobacco products.There are two widgets that can be installed on your computer. “News you can use” covers news and press updates regarding tobacco and tobacco compliance. The “tobacco retailer quiz” widget cycles through a number of questions that you and your employees can answer. It’s like a mini refresher quiz, any time you want.Finally, the FDA tobacco compliance program is on Twitter. Follow them at FDA tobacco to stay up to date on all matters regarding the program.
  • Additionally, on the FDA’s tobacco website, there is a publications clearinghouse. Here you can Download and print materials for display on premises or in employee only areas Resources include Posters, bookmarks, window clings, stickers and mailersAll are available in English and Spanish versions
  • Here are a couple of examples of printables found in the publications clearinghouse. Review items yourself, print and post them in employee only areas or in the public area of your establishment as a reminder to customers that you comply with tobacco regulations and laws.
  • ABD offers a tobacco retailer certification program, which can be found at IowaABD.com. The one-hour training course is free of charge. Retail tobacco employees participate in an interactive class and then must pass a test to become Iowa Pledge certified. the course offers many valuable tips on checking identification, spotting and confiscating fake IDs and how to refuse a sale.
  • Establishments that have employees pass the Iowa Pledge training are granted an affirmative defense, which may be used once in a four-year period. The affirmative defense is only valid for tobacco sale-to-minors found in state compliance checks, not federal. However, the course offers information that can be useful in passing a federal tobacco compliance check, as well as a state check.
  • All questions regarding the federal compliance checks must be directed to the FDA directly. They can be reached via this toll free number or email.
  • If you have questions related to ABD, please contact…
  • This presentation will be available on our website at IowaABD.com. Under the about section in the reports and updates column, there is a link called presentations. This presentation will be posted by the end of the week. You will be able to review it at anytime and/or download it to share with employees.
  • Thank you for participating in our webinar today. As always, your feedback is welcome. This was ABD’s first webinar so I thank you for your patients in dealing with any technical difficulties you may have experienced.

Igia fda webinar Igia fda webinar Presentation Transcript

  • ABD, FDA PartnershipRetail Tobacco Compliance FOR AUDIO, PLEASE CALL TOLL FREE 1.866.685.1580 CONFERECE CODE # 0009991572 PLEASE PRESS *6 TO MUTE YOUR LINE!
  • ABD, FDA PartnershipRetail Tobacco Compliance IGIA WEBINAR FEBRUARY 16, 2012, 10:00 AM
  • ABD, FDA Partnership Retail Tobacco ComplianceI. ABD, FDA partnershipII. What is a Retailer?III. Federal LawsIV. Tobacco Control Act & Law SummaryV. InspectionsVI. Tools for RetailersVII. Iowa PledgeVIII. Contact Information
  • ABD, FDA PartnershipRetail Tobacco Compliance I. ABD, FDA PARTNERSHIP
  • 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
  • ABD, FDA PartnershipRetail Tobacco Compliance II. WHAT IS A RETAILER?
  • What is a Retailer?• Sells cigarettes, smokeless tobacco, or roll-your-owntobacco to individuals for personal consumption• Operate a facility where a vending machine or self-service display is present
  • ABD, FDA PartnershipRetail Tobacco ComplianceIII. FEDERAL LAWS
  • 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 LawsTobacco 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
  • ABD, FDA PartnershipRetail Tobacco Compliance IV. TOBACCO CONTROL ACT & LAW SUMMARY
  • 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 facilitieshttp://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 productshttp://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 documentshttp://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 panelshttp://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 FDAhttp://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 strategyhttp://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 minimumhttp://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 outlethttp://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm246129.htm
  • Law SummaryCheck the photo ID for anyone under age 27Only sell tobacco products to people age 18 or olderOnly sell tobacco in a direct, face-to-face exchangeDo not give away free samplesDo not open cigarette or smokeless tobacco packages tosell products in smaller amounts
  • Law SummaryDo not sell single cigarettesDo not sell cigarette packages containing fewer than 20cigarettesDo not give away free samples of smokeless tobaccoDo not sell or give away items with cigarette and smokelesstobacco brands or logosDo not give away gifts or items in exchange for thepurchase of cigarettes or smokeless tobacco productsDo not sell flavored cigarettes
  • ABD, FDA PartnershipRetail Tobacco Compliance V. INSPECTIONS
  • InspectionsInspections may: • Conduct undercover buys • Advertising inspections • Labeling inspections • Sale and distribution restrictions
  • InspectionsInspections 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 labelingrequirements: • 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 BeLooking 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 BeLooking 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 checkinspection reveals a violation, FDA generally issues aWarning Letter• A Warning Letter is an agency advisory action that isused to achieve voluntary compliance
  • What If a Retailer is Inspected and There Are Violations Observed?• The Warning Letter contains a description of eachviolation observed• FDA gives firms an opportunity to take voluntarycorrective action• A Civil Money Penalty example of an enforcement actionif additional violations are observed
  • Will a Retailer Know the FDA Has Issued a Warning Letter to Them?• Warning Letters are posted on the FDAwebsitehttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/Tobacco/default.htm• Anyone can sign up to receive email updates when newtobacco 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-upcompliance check inspections• If FDA identifies violation during a follow-up FDA willseek Civil Money Penalties• For more information view the archived webinar “TheCivil Money Penalty Process” http://www/fda.gov/TobaccoProducts/Resourcesfor You/ForIndustry/Retailer.ucm21770.htm
  • Inspection ResultsFull inspection results posted on FDA’s websitefda.gov/tobaccoSearch 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 retailersSign up for email notifications(https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_63)
  • ABD, FDA PartnershipRetail Tobacco Compliance VI. TOOLS FOR RETAILERS
  • FDA Website
  • FDA WebsiteResources 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 archived2012:(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 premisesor in employee only areas • Posters, bookmarks, window clings, stickers and mailers • English and Spanish versions
  • Publications Clearinghouse
  • ABD, FDA PartnershipRetail Tobacco Compliance VII. IOWA PLEDGE PROGRAM
  • Iowa Pledge CertificationIowa Pledge online certification programIowaABD.comFree, one-hour online course teaches:• Checking IDs• Spotting fake IDs• Confiscating IDs• Tips for refusing a tobacco sale
  • Iowa Pledge CertificationIowa Pledge online certification programAffirmative 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
  • ABD, FDA PartnershipRetail Tobacco Compliance VIII. CONTACT INFORMATION
  • FDA Contact InformationQuestions regarding the federal compliance checksmust be directed to the FDA 1.877.287.1373 AskCTP@fda.hss.gov
  • ABD Contact InformationKaren Freund, Deputy Director of Regulatory AffairsFDA Program Coordinator(515) 281-7414 • Freund@IowaABD.comJessica Punelli, ABD Licensing ClerkFDA Program Assistant(515) 281-7434 • Punelli@IowaABD.comShannon Pogones, Education & Outreach Coordinator(515) 281-3426 • Pogones@IowaABD.comTonya Dusold, Communications Director(515) 281-7420 • Dusold@IowaABD.com
  • QUESTIONS?
  • This PresentationThis presentation, along with all ABD presentationswill be available for download at IowaABD.com
  • THANK YOU!