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TOBACCO OUTLET BUSINESS
JULY/AUGUST 2012
FDA Dashboard
FDA Timeline 2012
01-18-2012
—The 11th meeting of theTobacco Products Scientific Advisory Committee (TPSAC) was held in Rockville,
Md. Issue covered: Dissolvable Tobacco Products
02-29-2012
—U.S. District Judge Richard Leon ruled that the FDA’s regulation requiring graphic health warnings on
cigarette packs and advertising violates free-speech rights.
03-01-2012
—The 12th meeting of the Tobacco Products Scientific Advisory Committee was held. Issue covered:
Dissolvable Tobacco Products
03-01-2012
—The TPSAC issued its report and recommendations on the impact of dissolvable tobacco products on the
public health.
03-30-2012
—A list of 93 harmful and potentially harmful constituents in tobacco products, including smoke constituents,
by brand and sub-brand was published.
03-30-2012
—Regulations permitting the filing of a single application for a new tobacco product to be marketed as a
modified risk product was published.
05-25-2012
—The guidance on meetings with industry and investigators on the research and development of tobacco
products was published.
06-22-2012
—The Secretary shall promulgate regulations that: (1) Require testing and reporting of tobacco product
constituents, ingredients, and additives, including smoke constituents, by brand and sub-brand; and (2) may require that
tobacco product manufacturers, packagers, or importers make disclosures relating to the results of the testing of tar and
nicotine through labels or advertising or other appropriate means, and make disclosures regarding the results of the
testing of other constituents, including smoke constituents, ingredients, or additives, that the Secretary determines should
be disclosed to the public to protect the public health and will not mislead consumers about the risk of tobacco-related
disease.
06-22-2012
—The Secretary, after consultation with recognized scientific, medical, and public health experts, shall submit
to the Congress a report that examines how best to regulate, promote, and encourage the development of innovative
products and treatments (including nicotine-based and non-nicotine-based products and treatments) to better achieve, in
a manner that best protects and promotes the public health.
09-22-2012
—Cigarette and roll-your-own tobacco packages must place required color graphic warnings statements on
labels and advertisements.
09-22-2012
—Cigarette packages must place the statement “Sale only allowed in United States” on labels and shipping
containers.
09-22-2012
—Cigarette packages must place name/address, quantity, domestic/foreign leaf percentage statements on
labels.
DELAYS
—Regulations to address the promotion and marketing of tobacco products sold or distributed via the Internet, mail
order and other non-face-to-face exchanges has been delayed from 04-22-2012.
—Regulations on the scientific evidence required to assess and review modified risk tobacco products has also been
delayed from 04-22-2012.
SOURCE: Tobacco Merchants Association (TMA)