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Igia fda webinar


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

Published in: Education, Health & Medicine
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Igia fda webinar

  1. 1. 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!
  2. 2. ABD, FDA PartnershipRetail Tobacco Compliance IGIA WEBINAR FEBRUARY 16, 2012, 10:00 AM
  3. 3. 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
  4. 4. ABD, FDA PartnershipRetail Tobacco Compliance I. ABD, FDA PARTNERSHIP
  5. 5. Annual Compliance Checks• All tobacco retailers checked annually• Approximately 215 retailers checked per month• Contract of 1 year• Option to renew for 2 years
  6. 6. 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
  7. 7. ABD, FDA PartnershipRetail Tobacco Compliance II. WHAT IS A RETAILER?
  8. 8. 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
  9. 9. ABD, FDA PartnershipRetail Tobacco ComplianceIII. FEDERAL LAWS
  10. 10. 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)
  11. 11. 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
  12. 12. ABD, FDA PartnershipRetail Tobacco Compliance IV. TOBACCO CONTROL ACT & LAW SUMMARY
  13. 13. 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
  14. 14. 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
  15. 15. 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
  16. 16. 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
  17. 17. 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.
  18. 18. 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
  19. 19. 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
  20. 20. 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
  21. 21. 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
  22. 22. 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
  23. 23. 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
  24. 24. ABD, FDA PartnershipRetail Tobacco Compliance V. INSPECTIONS
  25. 25. InspectionsInspections may: • Conduct undercover buys • Advertising inspections • Labeling inspections • Sale and distribution restrictions
  26. 26. 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
  27. 27. 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
  28. 28. 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
  29. 29. 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
  30. 30. 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
  31. 31. 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
  32. 32. 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
  33. 33. 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
  34. 34. Will a Retailer Know the FDA Has Issued a Warning Letter to Them?• Warning Letters are posted on the FDAwebsite• 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
  35. 35. 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/ You/ForIndustry/Retailer.ucm21770.htm
  36. 36. Inspection ResultsFull inspection results posted on FDA’s feature( warning letters( compliant checked retailersSign up for email notifications(
  37. 37. ABD, FDA PartnershipRetail Tobacco Compliance VI. TOOLS FOR RETAILERS
  38. 38. FDA Website
  39. 39. FDA WebsiteResources for Retailers:Retailer Education Materials( and Guidelines( Training and Enforcement( Training Series
  40. 40. Other FDA Tools• Webinars: live and archived2012:(• 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
  41. 41. Other FDA Tools• Mobile Texting(• Email updates(• Widget: “News You Can Use” or“Tobacco Retailer Quiz”(• Twitter: @FDAtobacco(!/fdatobacco)
  42. 42. Other FDA Tools• Publications Clearinghouse(• Download and print materials for display on premisesor in employee only areas • Posters, bookmarks, window clings, stickers and mailers • English and Spanish versions
  43. 43. Publications Clearinghouse
  44. 44. ABD, FDA PartnershipRetail Tobacco Compliance VII. IOWA PLEDGE PROGRAM
  45. 45. 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
  46. 46. 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
  47. 47. ABD, FDA PartnershipRetail Tobacco Compliance VIII. CONTACT INFORMATION
  48. 48. FDA Contact InformationQuestions regarding the federal compliance checksmust be directed to the FDA 1.877.287.1373
  49. 49. 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 •
  50. 50. QUESTIONS?
  51. 51. This PresentationThis presentation, along with all ABD presentationswill be available for download at
  52. 52. THANK YOU!