Participating Manufacturer Certification
DM#6326172-V5 (Revised: 04-06-2020) Page 2 of 4
B. Additional Information: Check the appropriate box(s):
Initial or Supplemental Certification: Included with this Certification is corresponding actual
cigarette or RYO packaging (without tobacco) for each Brand Style for which Applicant requests
Annual Certification – No Packaging Changes: Corresponding actual cigarette or RYO
packaging (without tobacco) has been previously provided and there have been no changes to
Annual Certification – Packaging Changes/Brand Additions:
There have been changes to
the packaging samples previously submitted or new brand styles have been added.
Corresponding actual cigarette or RYO packaging (without tobacco) is included.
(For initial or supplemental certifications or brand additions). Check the
appropriate box and provide the requested documentation for each brand style that is new to
the Oregon Tobacco Directory.
The product was first commercially marketed on or before February 15, 2007. Please
provide correspondence from the FDA showing that the product has been granted
grandfather status from the premarket review process or evidence that the product was
commercially marketed before February 15, 2007.
The product was first commercially marketed after February 15, 2007 but before March 22,
2011. Please provide either (1) evidence that a substantial equivalence application was
filed with the FDA or (2) a substantial equivalence order.
The product was first commercially marketed on or after March 22, 2011. Please provide
either (1) a substantial equivalence order or (2) an order approving a premarket review
application.
Health Warning Rotation Plan: For each Brand Family, list the name and address of the
entity that filed cigarette health warning rotation plan with the Federal Trade Commission.
Attach the Federal Trade Commission’s written approval of the Applicant’s annual Cigarette
Health Warning Rotation Plan. Applies only to cigarettes.
Ingredient Report: For each Brand Family, list the name and address of the entity that
submitted the ingredient reporting information to the U.S. Secretary of Health and Human
Services as required by the Federal Cigarette Labeling and Advertising Act. Attach copies of all
Certificates of Compliance received from the U.S. Secretary of Health and Human Services for
Applicant’s annual ingredient reporting required by the Federal Cigarette Labeling and
Advertising Act (15 USC §1335a). Applies only to cigarettes.
Imported Cigarettes: If applicant sells or intends to sell cigarettes or RYO brands that are not
manufactured in the United States, provide the following:
A copy of the sworn statement of the original manufacturer that it will timely submit
ingredient information to the Secretary of Health and Human Services as required by 19
USC §1681a(c)(1). Cigarettes Only.
A copy of the importer’s certificate under penalty of perjury as required by 19 USC
§1681a(c)(2) regarding the precise format of warnings and the rotation plan for health
warnings. Cigarettes Only.
A copy of the trademark holder’s certificate under penalty of perjury that it has not
withdrawn consent to import into the United States as required by 19 USC §1681a(c)(3)(A)
or a copy of the importer’s certificate under penalty of perjury that the trademark owner
has not withdrawn consent to the import into the United States as required by
§1681a(c)(3)(B).
FSC (Fire Standard Compliance): Attached are: a) letter from the Oregon Fire Marshal’s
Office indicating that the brand styles for which Applicant seeks certification are FSC compliant;
and b) testing verification documentation for each corresponding brand style.