FDA Regulation of Tobacco:  What does it mean? When does it start?  And what’s next?
Effective  FDA Authority Over Tobacco Products Is Necessary to Protect Our Children, Protect the Public Health and to Redu...
Overview of Key Elements <ul><li>Requires the Tobacco Industry to provide  information  to the government that allows the ...
<ul><li>4. Informs   consumers through: </li></ul><ul><ul><li>Improved warning labels </li></ul></ul><ul><ul><li>Better te...
Disclosures to the FDA <ul><li>Requires tobacco companies to disclose to FDA  anything  they add as well as chemicals foun...
<ul><li>Tobacco Marketing Restrictions </li></ul>
New Limits on the Marketing and Sales of Tobacco Products <ul><li>Imposes specific limits on industry marketing, sales, an...
More Marketing Restrictions! <ul><li>Bans remaining tobacco brand sponsorships of sports and entertainment events </li></u...
… and MORE marketing restrictions! <ul><li>Limits in-store point-of-sale tobacco advertising to  black-and-white text only...
SEC. 906( d) <ul><li>“ The Secretary  may by regulation impose additional restrictions  on the advertising and promotion o...
Why Do We Need to Improve Efforts to Prevent Illegal Sales to Minors? <ul><li>In 1996,  the FDA established nation wide st...
<ul><li>Power to Regulate the Content of Tobacco Products </li></ul>
BEFORE NOW, TOBACCO PRODUCTS WERE  EXEMPT   FROM FDA PROTECTIONS  <ul><li>NO  product review  </li></ul><ul><li>NO  ingred...
Harm From Cigarettes <ul><li>Cigarettes contain 69 known cancer causing agents falling into five major classes  </li></ul>...
Did you know…?  Data suggests that up to one half of current lung cancer occurrence may be due to changes in cigarette des...
Product Regulation gives the FDA  authority   to …   <ul><li>… require product changes that the FDA finds are “appropriate...
<ul><li>Applies to  BOTH  existing and new products –  NO  tobacco products exempted or grandfathered </li></ul>
Limitations on FDA Authority <ul><li>FDA can’t ban  all  cigarettes,  all  smokeless tobacco products, … or  all  roll you...
How does FDA regulation affect tobacco consumers? <ul><li>Improved warning labels for cigarettes and smokeless tobacco   <...
MEANINGFUL  Warning Labels <ul><li>Cigarettes  - Replaces current small, hard-to-read warning labels with  larger , more s...
Cigarette pack now Cigarette pack under FDA Regulation Front Back Front Back WARNING LABEL WARNING LABEL
Warning Labels Abroad Brazil Thailand Canada
FDA regulation = Better Product Testing <ul><li>Since the mid 1960’s, the only reported testing of cigarettes has been for...
  FDA regulation = Better Product Testing <ul><li>Tests prove that products labeled Low Tar based on the current testing m...
A NEW Product Testing Method <ul><li>FDA is authorized to create regulations that require new testing in a manner to be se...
Unproven Health Claims  (Section 911) <ul><li>Prohibits claims until science is adequate to reach meaningful conclusions <...
 
Implementation When does all this new regulation start? <ul><li>Immediately </li></ul><ul><ul><li>Preemption of state/loca...
Implementation <ul><li>12 months </li></ul><ul><ul><li>No “light,” “low,” or “mild,” descriptors </li></ul></ul><ul><ul><l...
The Process
Opportunities for Public Input
FDA Seeks Public Input on Tobacco Regulation <ul><li>Docket No. FDA-2009-N-0294 </li></ul><ul><li>Deadline: September 29, ...
FDA IS NOT THE END! There’s still work to be done!
FDA Preserves States’ Rights To… <ul><li>Increase  Tobacco Taxes </li></ul><ul><li>Implement & Enforce  Smoke-free Laws </...
FDA Legislation Does Nothing to Restrict States from… <ul><li>Prohibiting the sale of any other tobacco products to person...
<ul><li>Supplement the new FDA requirement that all retail ads for cigarettes and smokeless consist only of black text on ...
What can YOU do? <ul><ul><li>Continue to push for … </li></ul></ul><ul><ul><ul><li>Smoke-free air laws </li></ul></ul></ul...
 
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  • The FDA bill can be divided into six major categories. The first category allows the government to collect better information to provide consumers The second category restricts tobacco marketing that appeals to kids and misleads adults The third category adds additional restrictions on sales to youth
  • The fourth area allows us to more accurately inform consumers through warning labels, a new testing system for the harmful substances in tobacco products, and higher standards for making health claims The fifth area regulates what is in the tobacco products And the sixth protects and expands state authority. Nothing in this bill limits or prevents a state from doing anything that it has previously already done.
  • Section 904 of the FDA bill requires the tobacco companies to disclose to the FDA not just anything they add, but also what we find in tobacco smoke, both in quantity and quality. They also must disclose not just what’s added, but also what’s found naturally. Requires the tobacco companies to disclose their internal research not just in terms of health effects, but also research regarding marketing and anything that would influence consumers Specifically, all new research must be handed over to the FDA. And the FDA has the authority to request all research conducted prior to this bill. The bill also requires the tobacco companies to notify the FDA of ANY changes to a product. FDA will have to be informed in advance before the tobacco company can start marketing any of those changes. Additionally, the FDA has the authority to tell the tobacco companies that they cannot make those changes.
  • The FDA bill imposes a number of restrictions on the marketing and sales of tobacco products. Section 906 gives the FDA the authority to add additional restrictions. For instance, they can adopt additional restrictions on tobacco marketing whenever it is in the interest of public health, up to the limits of the first amendment. For the first time, this gives us an agency that has the authority to focus on what the tobacco industry is doing and develop solutions. That’s particularly important because this is partially where all of you come in. As you see new forms of tobacco marketing and changes in emphasis of tobacco marketing, you can be the eyes for the FDA. Additionally, the legislation also changes the power of the states. Since 1969, states have been preempted from any regulation of any form of tobacco marketing for public health purposes. Now, states are permitted to restrict local forms of marketing in terms of the time, place and manner of those restrictions. But not the content. Such as the placement, colors, etc.
  • Section 102 of the FDA bill reinstates the FDA rule from 1996 that never went into effect, banning brand sponsorships of sports and entertainment events, free giveaways of any non-tobacco item with the purchase of a tobacco product, and free samples of cigarettes as well as the sale of cigarettes in packages that contain fewer than 20 cigarettes. Outdoor tobacco advertising near schools and playgrounds will only be banned after further FDA review to ensure that it is within the limits of the constitution
  • These regulations are scheduled to go into effect 1 year from the day the bill was signed. There has been a decrease in tobacco marketing in magazines with significant teen readership recently, but that decrease was said by the tobacco industry to be voluntary, and perhaps temporary. This regulation will ensure that it’s neither voluntary nor temporary by limiting the advertising in publications with more than 15 percent, or 2 million, teen readers to black-and-white text only.
  • Section 906d lays out the authority of the FDA to go beyond these restrictions and impose additional restrictions.
  • The next broad area is about illegal sales to kids. In 1996, the FDA established nationwide standards requiring every retailer to ask anyone appearing to be under the age of 27 for a government-issued ID for over-the-counter sales. This legislation will provide additional resources to states that have been doing well with compliance. For states that are struggling with compliance, additional money and resources will be provided for enforcement.
  • Today, no one regulates the content of tobacco products. No one other than the tobacco industry knows exactly what is the tobacco products and no one knows when the content of a product changes. This bill changes that very quickly. Section 907 of the bill authorizes the FDA to require product changes whenever the FDA finds that the changes are “appropriate for the protection of public health” For instance, it gives the FDA the power to eliminate harmful substances and adjust nicotine levels.
  • This bill gives the FDA the authority to look at the broader effect a product change or existing ingredient has on the population. In other words, the FDA will look at it and ask “Does this encourage more people to smoke?”
  • Section 907 applies not just to new products, but to existing products as well.
  • The FDA can’t ban all cigarettes. It can’t ban ALL smokeless tobacco products. Nor can FDA require the reduction of nicotine to zero. Anything above zero, FDA can do. The bill only limits FDA authority, however. If you lived in a state that wanted to ban all tobacco products, there is nothing in this bill that would prohibit you from doing so.
  • The sections on information to consumers has 3 core parts: warning labels, accurate testing of tar and nicotine, and standards to review health claims.
  • First, it requires the graphic warning labels on the top 50% of both the front AND back of all cigarette products. Because it will take the FDA some time to pick out the graphics and messages to determine which ones are best, the FDA has up to 2 years to do it. The industry has 15 months afterwards to put those labels on. Smokeless is different. Smokeless is 30% of the front and back because of the difference in size, and it’s text only. But the FDA has the authority to increase the size and require graphic warning labels.
  • Graphic warning labels on the front and back are going to make a fundamental difference.
  • It will give us the strongest warning labels in the world.
  • The bill gives the FDA the authority to replace the current testing system and to devise a testing system that will provide meaningful information to consumers.
  • It bans the use of the terms low tar and light. The ban on the terms low tar and light takes place 12 months after the bill was signed. So this is where science is going to play a huge role and is going to eliminate a system that’s been doing harm for decades.
  • The product manufacturers may have to disclose the results of the testing if the Secretary determines the disclosures will not mislead consumers about the risk of tobacco related disease .
  • Section 911 sets standards that the tobacco companies must meet before being allowed to make any explicit or implicit health claim. It will cut off one of the major ways that the tobacco companies have gotten people to switch rather than quit.
  • Here are a few examples of products that are marketed as “light”
  • The regulations that went into effect immediately have been in effect since June 20, 2009 In 3 months, the candy flavored cigarettes will be prohibited for sale.
  • In 12 months, the light and low descriptors, youth access, the new marketing restrictions and warning labels on smokeless, will be in place. 1 year after the scientific advisory committee is appointed, there will be a study and report on menthol. After the study, the Scientific Advisory Committee will recommend some kind of regulation or ban on menthol. And 2 years after the committee is appointed, there will be a similar study and report on dissolvable tobacco products.
  • In red are the key opportunities for public participation and citizen engagement. In the prelude, which is what the FDA is engaged in right now, the FDA solicits public input. If you submit comments before the deadline, the FDA must address your comments in the rulemaking. These comments are collected in something called a docket. All of the comments that are submitted, including tobacco industry comments, are put in the docket and the docket is available for public viewing. If the FDA is working through a rulemaking, they will also refer things to the scientific advisory committee. They also accept comments. Then FDA shifts to the drafting stage, where they consult with other agencies and conduct the required analysis of the issue at hand. This leads to the proposal, and then there will be another opportunity for public comments. If the hearings during the proposal stage are in a city near you, we are going to want to pack the house with tobacco control advocates. Then the FDA considers all of the comments, does a review and possibly creates a revised proposal. Ultimately, the final rule is published in the federal register and it will contain the date that the new regulation will begin. It could be anywhere from 30 days to a year later. Then, the FDA will proceed with implementation. At this stage, there is the potential for litigation if the tobacco industry attempts to block the rule from going into effect or if tobacco control advocates don’t think the rule is effective or goes far enough.
  • Again, there are many opportunities for public input during the rulemaking process. It’s very important to have citizen comments.
  • The FDA has already opened a docket seeking public input on tobacco regulation. The deadline to submit comments is September 29th.
  • The restrictions in this bill do not apply to cigars. However, this legislations gives the FDA authority over all tobacco products, so they CAN issue a rule with regard to cigars. The FDA now has the authority to create a rule banning flavored little cigars. But additionally, the states have the power to ban flavored little cigars.
  • Fda Presentation

    1. 1. FDA Regulation of Tobacco:  What does it mean? When does it start? And what’s next?
    2. 2. Effective FDA Authority Over Tobacco Products Is Necessary to Protect Our Children, Protect the Public Health and to Reduce the Toll from Tobacco July 2009
    3. 3. Overview of Key Elements <ul><li>Requires the Tobacco Industry to provide information to the government that allows the government to better inform consumers </li></ul><ul><li>Restricts marketing that appeals to kids , misleads adults, and deceptively encourages tobacco use </li></ul><ul><li>Strengthens restrictions on sales to youth </li></ul>
    4. 4. <ul><li>4. Informs consumers through: </li></ul><ul><ul><li>Improved warning labels </li></ul></ul><ul><ul><li>Better testing of tar, nicotine and other harmful substances </li></ul></ul><ul><ul><li>Standards to prohibit false health claims </li></ul></ul><ul><li>5. Regulates the contents of the product to protect consumers </li></ul><ul><li>6. Protects and expands state authority </li></ul>Overview Key Elements
    5. 5. Disclosures to the FDA <ul><li>Requires tobacco companies to disclose to FDA anything they add as well as chemicals found in both the product and the product’s smoke </li></ul><ul><li>Requires disclosure of industry research and can require additional research </li></ul><ul><li>Requires tobacco companies to notify FDA of any changes to a product </li></ul><ul><li>Gives the FDA the right to disclose critical information to the public </li></ul>
    6. 6. <ul><li>Tobacco Marketing Restrictions </li></ul>
    7. 7. New Limits on the Marketing and Sales of Tobacco Products <ul><li>Imposes specific limits on industry marketing, sales, and promotions, including (but not limited to) marketing that appeals to young people </li></ul><ul><li>Provides FDA the authority to further restrict tobacco marketing </li></ul><ul><li>Expands the power of the states: Permits states to restrict time, place and manner of tobacco marketing </li></ul>
    8. 8. More Marketing Restrictions! <ul><li>Bans remaining tobacco brand sponsorships of sports and entertainment events </li></ul><ul><li>Bans free giveaways of any non-tobacco items with the purchase of a tobacco product or in exchange for coupons </li></ul><ul><li>Bans free samples of cigarettes and the sale of cigarettes in packages that contain fewer than 20 cigarettes </li></ul><ul><li>Bans outdoor tobacco advertising near schools and playgrounds after further FDA review </li></ul>
    9. 9. … and MORE marketing restrictions! <ul><li>Limits in-store point-of-sale tobacco advertising to black-and-white text only </li></ul><ul><li>Limits advertising in publications with significant teen readership (more than 15 percent or 2 million) to black-and-white text only </li></ul><ul><li>Restricts vending machines and self-service displays to adult-only facilities </li></ul>
    10. 10. SEC. 906( d) <ul><li>“ The Secretary may by regulation impose additional restrictions on the advertising and promotion of a tobacco product consistent with and to the full extent permitted by the first amendment to the Constitution.” </li></ul>
    11. 11. Why Do We Need to Improve Efforts to Prevent Illegal Sales to Minors? <ul><li>In 1996, the FDA established nation wide standards requiring retailers to verify age for over-the-counter sales and provided funds for states to enforce </li></ul><ul><li>Between 2006 and 2007, 27 states reported increases in sales to minors </li></ul>
    12. 12. <ul><li>Power to Regulate the Content of Tobacco Products </li></ul>
    13. 13. BEFORE NOW, TOBACCO PRODUCTS WERE EXEMPT FROM FDA PROTECTIONS <ul><li>NO product review </li></ul><ul><li>NO ingredient review </li></ul><ul><li>NO ingredient disclosure </li></ul><ul><ul><li>The ammonia, arsenic and other toxic chemicals found in cigarettes remain unregulated and unreported to consumers </li></ul></ul><ul><li>EXAMPLE: A new ingredient in Marlboro cigarettes can simply be added to the product - no tests needed, no disclosure necessary, no questions asked </li></ul>
    14. 14. Harm From Cigarettes <ul><li>Cigarettes contain 69 known cancer causing agents falling into five major classes </li></ul><ul><li>In addition to the known cancer causing agents, cigarettes contain literally hundreds of ingredients that contribute to the risk of heart disease, lung disease and other serious diseases </li></ul>
    15. 15. Did you know…? Data suggests that up to one half of current lung cancer occurrence may be due to changes in cigarette design and that current lung cancer rates might be reduced by up to 50% through regulatory control of cigarette design and composition. David Burns and Christy Anderson, UCSD School of Medicine Abstract for Poster Presentation: Society for Research on Nicotine and Tobacco (SRNT) Joint Conference of SRNT and SRNT-Europe, April 30, 2009, Dublin, Ireland
    16. 16. Product Regulation gives the FDA authority to … <ul><li>… require product changes that the FDA finds are “appropriate for the protection of the public health” </li></ul><ul><li>… require manufacturers to reduce or eliminate harmful substances , including those found in tobacco smoke - whether added or naturally occurring </li></ul><ul><li>… reduce nicotine levels to below the point they cause addiction </li></ul>
    17. 17. <ul><li>Applies to BOTH existing and new products – NO tobacco products exempted or grandfathered </li></ul>
    18. 18. Limitations on FDA Authority <ul><li>FDA can’t ban all cigarettes, all smokeless tobacco products, … or all roll your own tobacco products; </li></ul><ul><li>or </li></ul><ul><li>Require the reduction of nicotine yields of a tobacco product to zero . </li></ul>
    19. 19. How does FDA regulation affect tobacco consumers? <ul><li>Improved warning labels for cigarettes and smokeless tobacco </li></ul><ul><li>More accurate testing of tar, nicotine and other harmful substances </li></ul><ul><li>Standards to review health claims and prohibit unsubstantiated health claims </li></ul>
    20. 20. MEANINGFUL Warning Labels <ul><li>Cigarettes - Replaces current small, hard-to-read warning labels with larger , more specific warning labels covering 50% of the top half of the front and back of each pack with graphics depicting the health consequences of tobacco use </li></ul><ul><li>Smokeless - Replaces current small, hard to read warning labels with larger , more specific warning labels covering 30% of the top half of the front and back of each package </li></ul><ul><li>Gives FDA the authority to revise the warning labels. </li></ul>
    21. 21. Cigarette pack now Cigarette pack under FDA Regulation Front Back Front Back WARNING LABEL WARNING LABEL
    22. 22. Warning Labels Abroad Brazil Thailand Canada
    23. 23. FDA regulation = Better Product Testing <ul><li>Since the mid 1960’s, the only reported testing of cigarettes has been for tar, nicotine and CO – by a machine test originally overseen by the FTC. </li></ul><ul><li>FTC has concluded that these test results do not accurately show how much tar and nicotine consumers receive . </li></ul>
    24. 24. FDA regulation = Better Product Testing <ul><li>Tests prove that products labeled Low Tar based on the current testing method are not less hazardous . </li></ul><ul><li>“Low Tar” claims based on these tests mislead consumers. </li></ul>Low Tar Deception
    25. 25. A NEW Product Testing Method <ul><li>FDA is authorized to create regulations that require new testing in a manner to be set by FDA. </li></ul><ul><li>The testing will go beyond tar and nicotine to include tobacco product constituents, ingredients, and additives, including the ingredients found in smoke . </li></ul><ul><li>The regulations may require that tobacco product manufacturers disclose the results of the testing … </li></ul>
    26. 26. Unproven Health Claims (Section 911) <ul><li>Prohibits claims until science is adequate to reach meaningful conclusions </li></ul><ul><li>Bans terms like “Light” and “Low Tar” as misleading </li></ul><ul><li>When a Manufacturer claims that a tobacco product is less harmful than other tobacco products they must prove that… </li></ul><ul><ul><li>… the product, 1) as it is used by consumers , 2) will significantly reduce the risk of tobacco-related disease 3) to individual tobacco users; and 4) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products. </li></ul></ul>
    27. 28. Implementation When does all this new regulation start? <ul><li>Immediately </li></ul><ul><ul><li>Preemption of state/local efforts to restrict marketing repealed </li></ul></ul><ul><ul><li>No health claims without review </li></ul></ul><ul><ul><li>Review of new products </li></ul></ul><ul><ul><li>Broader advertising authority </li></ul></ul><ul><li>3 months </li></ul><ul><ul><li>No candy-flavored cigarettes </li></ul></ul>
    28. 29. Implementation <ul><li>12 months </li></ul><ul><ul><li>No “light,” “low,” or “mild,” descriptors </li></ul></ul><ul><ul><li>Marketing restrictions – magazines, points of sale, sponsorship, etc </li></ul></ul><ul><ul><li>New warning labels on smokeless tobacco </li></ul></ul><ul><ul><li>Scientific Advisory Committee appointed within 15 months </li></ul></ul><ul><li>A little further out … </li></ul><ul><ul><li>Larger, stronger graphic warning labels on cigarettes </li></ul></ul><ul><ul><ul><li>Rule issued within two years </li></ul></ul></ul><ul><ul><ul><li>Implementation – 15 months later </li></ul></ul></ul>
    29. 30. The Process
    30. 31. Opportunities for Public Input
    31. 32. FDA Seeks Public Input on Tobacco Regulation <ul><li>Docket No. FDA-2009-N-0294 </li></ul><ul><li>Deadline: September 29, 2009. </li></ul><ul><li>Comments </li></ul><ul><ul><li>Electronic: http:// www.regulations.gov . </li></ul></ul><ul><ul><li>Written: Division of Dockets Management (HFA- 305) </li></ul></ul><ul><ul><ul><ul><ul><li>Food and Drug Administration, </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>5630 Fishers Lane, rm. 1061 </li></ul></ul></ul></ul></ul><ul><ul><ul><ul><ul><li>Rockville, MD 20852. </li></ul></ul></ul></ul></ul>
    32. 33. FDA IS NOT THE END! There’s still work to be done!
    33. 34. FDA Preserves States’ Rights To… <ul><li>Increase Tobacco Taxes </li></ul><ul><li>Implement & Enforce Smoke-free Laws </li></ul><ul><li>Fully fund effective comprehensive tobacco control programs </li></ul><ul><li>Provide coverage of cessation services </li></ul><ul><li>Take action to restrict sale & distributions of tobacco </li></ul>
    34. 35. FDA Legislation Does Nothing to Restrict States from… <ul><li>Prohibiting the sale of any other tobacco products to persons of any age </li></ul><ul><li>Increasing the age of sale </li></ul><ul><li>Restricting sales to just at certain specified locations (e.g., by prohibiting sales at pharmacies or other health facilities, or at college campuses or any other locations frequented by youth). </li></ul>
    35. 36. <ul><li>Supplement the new FDA requirement that all retail ads for cigarettes and smokeless consist only of black text on white background by applying the same restrictions to cigar and other tobacco product ads </li></ul><ul><li>Restrict or eliminate “power walls” of cigarettes being offered for sale at retail outlets </li></ul><ul><li>Limit the number or size of tobacco product ads at retail outlets; </li></ul><ul><li>Require that all tobacco products or tobacco product ads be kept away from cash registers in order to reduce impulse purchases by smokers trying to quit. </li></ul>States may now do such things as …
    36. 37. What can YOU do? <ul><ul><li>Continue to push for … </li></ul></ul><ul><ul><ul><li>Smoke-free air laws </li></ul></ul></ul><ul><ul><ul><li>Comprehensive tobacco control program funding </li></ul></ul></ul><ul><ul><ul><li>Tax increases </li></ul></ul></ul><ul><ul><ul><li>Cessation coverage </li></ul></ul></ul><ul><ul><ul><li>Smoke-free facilities </li></ul></ul></ul><ul><ul><ul><li>Restrictions on sale and distribution at the state level </li></ul></ul></ul>
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