FDA Timelines and future rulemaking November 19 2009 1 Stacy Ehrlich Esq Partner Kleinfeld Kaplan amp Becker LLP Washington DC wwwkkblawcom 2009 92209 No characterizing flavors in cigarettes and component parts ID: 496886
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Slide1
CITMA Seminar:FDA Timelines and future rulemaking
November 19, 2009
1
Stacy Ehrlich, Esq.
Partner
Kleinfeld Kaplan & Becker LLP
Washington, DC
www.kkblaw.com
Slide2
2009
9/22/09 – No “characterizing flavors” in cigarettes and component parts9/30/09 – 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 additivesSlide3
2009
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 likelySlide4
2010
6/22/10 – Advertising and marketing restrictions of 1996 regs (as revised by Act) become effective Remove non-compliant advertising
Trade name restrictionsNo package with less than 20 cigarettesNo 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 sponsorshipSlide5
20106/22/10 – 1996 regulations (continued)
Audio advertising: words only with no music or soundVideo advertising: static black text only with no music or sound effects
No outdoor advertising within 1,000 feet of playground or schoolPrint labeling and advertising: black text on white background except in defined adult publications or adult-only facilitiesSlide6
2010
6/22/10Advertisements must contain (1) established name and (2) uses, relevant warnings, precautions, side effects and contraindicationsNo 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”Slide7
20106/22/10
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 statementsLabel, packaging and shipping containers of smokeless must state “sale only allowed in US”Slide8
Late 2010 to 2011
10/01/10 – FDA to establish TPSACNo 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 mentholSlide9
FDA Regulations by 2011
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 productsSlide10
2012
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 productsSlide11
Regulations by 2012
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 productsSlide12
FDA Regulations by 2013
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.Slide13
Additional FDA Regulations
No required promulgation dateRecordkeeping 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
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Additional FDA Regulations
No required promulgation dateTobacco 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/varianceSlide15
Thank you
Stacy L. Ehrlich, Esq.Kleinfeld Kaplan and Becker LLP1140 19
th St. NW Suite 900Washington, DC 20036(202) 223-5120
sehrlich@kkblaw.com