Hello.
Korean company will launch new products in July.
I have few questions about FDA regulations.
1. Do we need to get approval from FDA to start selling e-cigarettes in USA market if we enter the it before August 8? Will be there any problem if we start selling the product.
2. If the product is already in the market before August 8, and they still can sell the product for 2 years more, why do the retail shop owners and wholesaler so much afraid of the date 08.08?
3. How does FDA know if the product was in the market before August 8 or not
Do we need to register our company somewhere or we can just show import declaration.
Thank you in advance.
This should help for PMTA's:
http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM499352.pdf
For registering products:
http://www.fda.gov/downloads/tobaccoproducts/guidancecomplianceregulatoryinformation/ucm501234.pdf
http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM191940.pdf
http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/reports/economicanalyses/ucm500254.pdf
Pg. 98
c) Annual Registration and Product Listing The FD&C Act requires annual registration by owners and operators of domestic establishments engaged in the manufacture, preparation, compounding, or processing of tobacco products and immediate registration of new owners-operators and new establishments. Product listing is also required for registered establishments. Changes in the product list are to be reported twice a year.
[
here is likely where they could catch 'new products' ]
And the deeming doc on registering products: (pg 117)
https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-10685.pdf
"As of the effective date [aug 8] of this rule, those persons who own or operate domestic
manufacturing establishments engaged in manufacturing newly deemed tobacco products
(including those that engage in the blending of pipe tobacco and the mixing of e-liquids as
discussed in section IX.C) will be required to register with FDA and submit product listings
under section 905."
(pg 273)
"C. Registration and Product Listing (Section 905)
Section 905 of the FD&C Act requires every person who owns or operates an
establishment engaged in the "manufacture, preparation, compounding, or processing of a
tobacco product" to register its establishment with FDA and submit a listing of its tobacco
products to the Agency. If an ENDS retail establishment engages in these activities, section 905
requires the establishment to register and list its products with FDA in accordance with this
section. These requirements apply under the statute for all distinct products manufactured, and
they enable FDA to assess the landscape of products manufactured by these entities. If ENDS
retail establishments are mixing or preparing e-liquids or creating or modifying aerosolizing
apparatus for direct sale to consumers, then they will have to list each e-liquid combination that
they sell. It will be the responsibility of the ENDS retail establishment, as a manufacturer, to
determine how many and which products they plan to manufacture. For shops that prepare an
expansive array of custom mixes, with many gradations of flavor, nicotine strength or other
characteristic, this would mean identifying, listing, and reporting ingredients for a large number
of distinct products. In reality, however, we expect that such entities will elect to narrow the list
of combinations they sell (with more limited distinctions in strength and flavor, etc.), since such
a narrowing will allow them to continue providing custom products and a variety of options
while simplifying their reporting. However, since the time and cost of listing each additional
mixture is expected to be very low, the reduction will not necessarily be significant. In addition,
any narrowing may reflect a reduction in products that are listed but are not actually sold.
More specifics on pg 408 of the deeming doc.
