Does risk exist, and if it does, where does it live and how do we find it?
FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?
-
Upload
emma-perkins -
Category
Documents
-
view
218 -
download
0
Transcript of FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?
![Page 1: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/1.jpg)
FDA Regulation of Tobacco: What does it mean? When does it start?
And what’s next?
![Page 2: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/2.jpg)
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
![Page 3: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/3.jpg)
Overview of Key Elements1. Requires the Tobacco Industry to
provide information to the government that allows the government to better inform consumers
2. Restricts marketing that appeals to kids, misleads adults, and deceptively encourages tobacco use
3. Strengthens restrictions on sales to youth
![Page 4: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/4.jpg)
4. Informs consumers through:• Improved warning labels• Better testing of tar, nicotine and other
harmful substances• Standards to prohibit false health claims
5. Regulates the contents of the product to protect consumers
6. Protects and expands state authority
Overview Key Elements
![Page 5: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/5.jpg)
Disclosures to the FDA
• Requires tobacco companies to disclose to FDA anything they add as well as chemicals found in both the product and the product’s smoke
• Requires disclosure of industry research and can require additional research
• Requires tobacco companies to notify FDA of any changes to a product
• Gives the FDA the right to disclose critical information to the public
![Page 6: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/6.jpg)
Tobacco Tobacco Marketing Marketing
RestrictionsRestrictions
![Page 7: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/7.jpg)
New Limits on the Marketing and Sales New Limits on the Marketing and Sales of Tobacco Productsof Tobacco Products
• Imposes specific limits on industry marketing, sales, and promotions, including (but not limited to) marketing that appeals to young people
• Provides FDA the authority to further restrict tobacco marketing
• Expands the power of the states: Permits states to restrict time, place and manner of tobacco marketing
![Page 8: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/8.jpg)
More Marketing Restrictions!More Marketing Restrictions!
• Bans remaining tobacco brand sponsorships of sports and entertainment events
• Bans free giveaways of any non-tobacco items with the purchase of a tobacco product or in exchange for coupons
• Bans free samples of cigarettes and the sale of cigarettes in packages that contain fewer than 20 cigarettes
• Bans outdoor tobacco advertising near schools and playgrounds after further FDA review
![Page 9: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/9.jpg)
……and MORE marketing restrictions!and MORE marketing restrictions!
• Limits in-store point-of-sale tobacco advertising to black-and-white text only
• Limits advertising in publications with significant teen readership (more than 15 percent or 2 million) to black-and-white text only
• Restricts vending machines and self-service displays to adult-only facilities
![Page 10: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/10.jpg)
SEC. 906(d)
“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.”
![Page 11: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/11.jpg)
Why Do We Need to Improve Why Do We Need to Improve Efforts to Prevent Illegal Sales to Efforts to Prevent Illegal Sales to
Minors?Minors?• 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
• Between 2006 and 2007, 27 states reported increases in sales to minors
![Page 12: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/12.jpg)
Power to Regulate the Power to Regulate the Content of Tobacco Content of Tobacco
ProductsProducts
![Page 13: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/13.jpg)
BEFORE NOW, TOBACCO PRODUCTS WERE EXEMPT FROM FDA PROTECTIONS
• NO product review
• NO ingredient review
• NO ingredient disclosure
– The ammonia, arsenic and other
toxic chemicals found in cigarettes
remain unregulated and unreported
to consumers• EXAMPLE: A new ingredient in
Marlboro cigarettes can simply be added to the product - no tests needed, no disclosure necessary, no questions asked
![Page 14: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/14.jpg)
Harm From CigarettesHarm From Cigarettes
• Cigarettes contain 69 known cancer causing agents falling into five major classes
• 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
![Page 15: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/15.jpg)
Did you know…? 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
![Page 16: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/16.jpg)
Product Regulation gives the FDA Product Regulation gives the FDA authorityauthority toto……
• …require product changes that the FDA finds are “appropriate for the protection of the public health”
• …require manufacturers to reduce or eliminate harmful substances, including those found in tobacco smoke - whether added or naturally occurring
• …reduce nicotine levels to below the point they cause addiction
![Page 17: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/17.jpg)
• Applies to BOTH existing and new products – NO tobacco products exempted or grandfathered
![Page 18: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/18.jpg)
Limitations on FDA AuthorityLimitations on FDA Authority
• FDA can’t ban all cigarettes, all smokeless tobacco products, … or all roll your own tobacco products;
or
• Require the reduction of nicotine yields of a tobacco product to zero.
![Page 19: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/19.jpg)
How does FDA regulation affect How does FDA regulation affect tobacco consumers?tobacco consumers?
1. Improved warning labels for cigarettes and smokeless tobacco
2. More accurate testing of tar, nicotine and other harmful substances
3. Standards to review health claims and prohibit unsubstantiated health claims
![Page 20: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/20.jpg)
MEANINGFUL Warning Labels
• 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
• 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
• Gives FDA the authority to revise the warning labels.
![Page 21: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/21.jpg)
Cigarette pack now Cigarette pack under FDA Regulation
Front
Back
Front
Back
WARNINGLABEL
WARNINGLABEL
![Page 22: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/22.jpg)
Warning Labels Abroad
Brazil
Thailand
Canada
![Page 23: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/23.jpg)
FDA regulation = Better Product TestingFDA regulation = Better Product Testing
• 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.
• FTC has concluded that these test results do not accurately show how much tar and nicotine consumers receive.
![Page 24: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/24.jpg)
FDA regulation = Better Product TestingFDA regulation = Better Product Testing
• Tests prove that products labeled Low Tar based on the current testing method are not less hazardous.
• “Low Tar” claims based on these tests mislead consumers.
Low Tar Deception
![Page 25: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/25.jpg)
A NEW Product Testing Method
• FDA is authorized to create regulations that require new testing in a manner to be set by FDA.
• The testing will go beyond tar and nicotine to include tobacco product constituents, ingredients, and additives, including the ingredients found in smoke.
• The regulations may require that tobacco product manufacturers disclose the results of the testing …
![Page 26: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/26.jpg)
Unproven Health Claims (Section 911)
• Prohibits claims until science is adequate to reach meaningful conclusions
• Bans terms like “Light” and “Low Tar” as misleading
• When a Manufacturer claims that a tobacco product is less harmful than other tobacco products they must prove that…
…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.
![Page 27: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/27.jpg)
![Page 28: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/28.jpg)
ImplementationWhen does all this new regulation start?
• Immediately– Preemption of state/local efforts to restrict marketing
repealed– No health claims without review– Review of new products– Broader advertising authority
• 3 months– No candy-flavored cigarettes
![Page 29: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/29.jpg)
Implementation• 12 months
– No “light,” “low,” or “mild,” descriptors– Marketing restrictions – magazines, points
of sale, sponsorship, etc– New warning labels on smokeless tobacco– Scientific Advisory Committee appointed
within 15 months
• A little further out … – Larger, stronger graphic warning labels
on cigarettes• Rule issued within two years• Implementation – 15 months later
![Page 30: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/30.jpg)
The Process
![Page 31: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/31.jpg)
Opportunities for Public Input
![Page 32: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/32.jpg)
FDA Seeks Public Input on Tobacco Regulation
• Docket No. FDA-2009-N-0294
• Deadline: September 29, 2009.
• Comments– Electronic: http://www.regulations.gov.– Written: Division of Dockets Management
(HFA- 305)
Food and Drug Administration,
5630 Fishers Lane, rm. 1061
Rockville, MD 20852.
![Page 33: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/33.jpg)
FDA IS NOT THE END!There’s still work to be done!
![Page 34: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/34.jpg)
FDA Preserves States’ Rights To…• Increase Tobacco Taxes
• Implement & Enforce Smoke-free Laws
• Fully fund effective comprehensive tobacco control programs
• Provide coverage of cessation services
• Take action to restrict sale & distributions of tobacco
![Page 35: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/35.jpg)
FDA Legislation Does Nothing to Restrict States from…
• Prohibiting the sale of any other tobacco products to persons of any age
• Increasing the age of sale
• 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).
![Page 36: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/36.jpg)
• 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
• Restrict or eliminate “power walls” of cigarettes being offered for sale at retail outlets
• Limit the number or size of tobacco product ads at retail outlets;
• 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.
States may now do such things as…
![Page 37: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/37.jpg)
What can YOU do?
– Continue to push for …• Smoke-free air laws• Comprehensive tobacco control program
funding• Tax increases• Cessation coverage• Smoke-free facilities• Restrictions on sale and distribution at the
state level
![Page 38: FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?](https://reader035.fdocuments.net/reader035/viewer/2022070415/56649e7f5503460f94b83317/html5/thumbnails/38.jpg)