November 19, Stacy Ehrlich, Esq. Partner Kleinfeld Kaplan & Becker LLP Washington, DC

 9/22/09 – No “characterizing flavors” in cigarettes and component parts  9/30/09 – Pay first quarter user fees  12/22/09 – Submit all documents related to health, toxicological, behavioral or physiologic effects of products, constituents, ingredients, components and additives

 12/31/09 – Registration and listing  BUT “FDA does not intend to enforce the requirement to submit registration and product listing information under section 905 of the act by December 31, 2009, provided that the submission is received by FDA on or before February 28, 2010.”  12/22/09 – Submit ingredients  Delay on enforcement likely

 6/22/10 – Advertising and marketing restrictions of 1996 regs (as revised by Act) become effective  Remove non-compliant advertising  Trade name restrictions  No package with less than 20 cigarettes  No vending machines or self-service sales except in qualified adult-only facilities  No free samples with very limited exceptions  No non-tobacco items with tobacco brand or logo  No non-tobacco free gifts  Limited sponsorship

 6/22/10 – 1996 regulations (continued)  Audio advertising: words only with no music or sound  Video advertising: static black text only with no music or sound effects  No outdoor advertising within 1,000 feet of playground or school  Print labeling and advertising: black text on white background except in defined adult publications or adult-only facilities

 6/22/10  Advertisements must contain (1) established name and (2) uses, relevant warnings, precautions, side effects and contraindications  No use of “light,” “mild,” “low” or similar descriptors without approval [can ship non- compliant product manufactured before 6/22 until 7/22]  Smokeless labels must contain (1) established name; (2) name and place of business of manufacturer, packer or distributor; (3) statement of quantity of contents; (4) % of domestic/foreign tobacco; (5) “sale allowed only in the US”

 6/22/10  Cigarette labels must bear established name [can ship non-compliant product manufactured before 6/22 until 7/22]  Smokeless labels must bear warning statements [can ship non-compliant product manufactured before 6/22 until 7/22]  Smokeless advertisements must bear warning statements  Label, packaging and shipping containers of smokeless must state “sale only allowed in US”

 10/01/10 – FDA to establish TPSAC  No later than 3/22/11 – substantial equivalence reports from products introduced between 2/15/07 and 3/22/11  6/22/11 – Cannot use tobacco that contains pesticide residue at a level greater than specified by any tolerance applicable under Federal law to domestic tobacco  10/1/11 – TPSAC report on menthol

 Must be promulgated no later than 6/22/11 – Cigarette color graphic warnings [compliance of non-graphic warnings on labels and in advertising 15 months after promulgation]  Must be promulgated by 10/1/11 – regulations on the remote sale and distribution of tobacco products

 6/22/12 – Submit a list of all constituents identified by FDA as harmful to health by brand and quantity in each brand  Not later than 9/22/12 -- Cigarette labels contain (1) name and place of business of manufacturer, packer or distributor; (2) statement of quantity of contents; (3) % of domestic/foreign tobacco; (4) “sale allowed only in the US” [compliance 15 months after color graphics regs]  TPSAC report on dissolvable tobacco products

 Must be promulgated no later than 4/1/12:  Regulations on promotion and marketing of remote sale and distribution of tobacco products  Regulations on the scientific evidence required for review of modified risk products

 Must be promulgated no later than 4/01/13:  Testing and reporting tobacco product constituents, ingredients, and additives by brand and subbrand  STPMs are not required to comply before the later of (a) 2 years after promulgation of the regulations or (b) the general compliance date.  STPMs are given a 4-year period to complete the testing and reporting: 25% of its tobacco products each year of such 4-year period.  FDA may approve a case-by-case delay for STPMs upon showing of undue hardship but not beyond 5 years after general compliance date.  Extensions available for STPMs based on limited lab capacity.

 No required promulgation date  Recordkeeping and reporting (including adverse tobacco product experiences and corrective actions) – no required date  Submit to FDA description of content, delivery, and form of nicotine in each tobacco product measure in milligrams – no required date  Registration of foreign establishments – no required date

 No required promulgation date  Tobacco product standards relating to nicotine yield, reduction/elimination of other constituents, etc. – no required date for regs and compliance can be required no sooner than 1 year after regs or, if substantial changes to farming methods would be required, no sooner than 2 years after regs.  GMPs – no required date for regs and compliance for STPMs may not be required prior to 4 years after effective date, which cannot be sooner than 6/22/2012  Petition for permanent or temporary exemption/variance

Stacy L. Ehrlich, Esq. Kleinfeld Kaplan and Becker LLP th St. NW Suite 900 Washington, DC (202)