ENDS Directory Certification

Type of Certification(Required)

Initial Certification

Annual Recertification

Supplemental Certification

Part I: ENDS Manufacturer Identification

Legal Name of Entity(Required)

Trade Name (doing business as or d/b/a)(Required)

Office Address(Required)

Street Address Address Line 2 City State / Province / Region ZIP / Postal Code Country

Do you have a different Mailing Address?(Required)

Yes

Mailing Address(Required)

Street Address Address Line 2 City State / Province / Region ZIP / Postal Code Country

Telephone Number(Required)

Please include Country Code if not in the United States

Factory Address(Required)

Street Address Address Line 2 City State / Province / Region ZIP / Postal Code Country

Factory Telephone Number(Required)

Please include Country Code if not in the United States

Factory Manager Name(Required)

First Last

Do you have additional factories?

Yes

Factory Address(Required)

Street Address Address Line 2 City State / Province / Region ZIP / Postal Code Country

Factory Telephone Number(Required)

Please include Country Code if not in the United States

Factory Manager Name(Required)

First Last

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Section Break

Name of Designated Contact(Required)

First Last

Email Address Designated to Accept all Official Communication(Required)

Name of Legal Counsel for cc (optional)

First Last

Legal Counsel Email Address

Company Website Address(Required)

Manufacturer Federal Taxpayer ID(Required)

Have your manufacturing facilities changed locations within the last certification year? If so, please include the location where the brand style is manufactured on the Brand list template.(Required)

Yes

Provide photos and a diagram of the manufacturing facility(Required)

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Max. file size: 100 MB.

For all Initial Certifications, attach photographs and a diagram of the manufacturing facility?(Required)

Initial certification

Not an initial certification

Attach photographs and a diagram of the manufacturing facility(Required)

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Max. file size: 100 MB.

Part II: Importer Information

1. Are your ENDS products manufactured outside the United States?(Required)

Yes

Legal Name of Importer(Required)

Trade Name of Importer (doing business as or d/b/a)(Required)

Address(Required)

Street Address Address Line 2 City State / Province / Region ZIP / Postal Code Country

Is the Mailing Address Different?(Required)

Yes

Mailing Address (if different)(Required)

Street Address Address Line 2 City State / Province / Region ZIP / Postal Code Country

Telephone Number(Required)

Importer Federal Taxpayer ID#(Required)

US Customs ID#(Required)

Do you have additional importers?

Yes

Legal Name of Importer

Trade Name of Importer (doing business as or d/b/a)(Required)

Address(Required)

Street Address Address Line 2 City State / Province / Region ZIP / Postal Code Country

Is the Mailing Address Different?(Required)

Yes

Mailing Address (if different)(Required)

Street Address Address Line 2 City State / Province / Region ZIP / Postal Code Country

Telephone Number(Required)

Importer Federal Taxpayer ID#(Required)

US Customs ID#(Required)

Part III: General Questions for the Manufacturer

2. Are you the actual manufacturer (fabricator) of the ENDS products listed in this certification?(Required)

Yes

Both

Explain the reason for certifying.(Required)

3. Are you the Trademark Owner of the brands listed in this certification?(Required)

Yes

Both

Upload Live Trademark(s) – A copy of your full live trademark(s) from the last 30 days from the USPTO website. Ensure all fields of the trademark are expanded, displaying all details.(Required)

Drop files here or

Max. file size: 100 MB.

Provide the name and contact information of the owner, attach a copy of the live trademark from the USPTO website and a copy of any agreement that defines trademark rights and/or control over the manufacturing (such as an exclusive manufacturing agreement) and attach an executed copy of such agreement.

If ownership or rights to trademark or brand have changed, please explain and attach any applicable trademark(s) and/or licensing agreement(s).

Name(Required)

Owner Contact Information(Required)

Upload Live Trademarks and Agreements(Required)

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Max. file size: 100 MB.

Name(Required)

Owner Contact Information(Required)

Upload Live Trademarks and Agreements(Required)

Drop files here or

Max. file size: 100 MB.

4. Have you ever been denied ENDS Directory Listing in any U.S. jurisdiction? If “Yes,” provide details below regarding any such denial.(Required)

Yes

Details Regarding Denial(Required)

Provide details below regarding any denial.

5. Do you have any Pennsylvania Other Tobacco Products Licenses?(Required)

Yes

Upload a copy of any Pennsylvania Other Tobacco Products Licenses.(Required)

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Max. file size: 100 MB.

Explanation for not having any Pennsylvania Other Tobacco Products Licenses(Required)

6. Are the responsible parties current with their monthly report filings to the PA Department of Revenue in accordance with the federal Prevent All Cigarette Trafficking (PACT) Act/Jenkins Act 15 U.S.C § 375 – 378?(Required)

Yes

Explain why not(Required)

7. Upload a list of all licensed Pennsylvania wholesalers that will be distributing your ENDS products.(Required)

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Max. file size: 100 MB.

8. Upload a list of all officers, owners, board members, and partners of your company, including their name, title, address, telephone number, and email address.(Required)

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Max. file size: 100 MB.

9. Do you have any parent, subsidiary, sister, related, associated, or other affiliated entities?(Required)

Yes

List all such entities, their relationship and whether they manufacture, sell or distribute tobacco products or ENDS products for sale in PA. Attach additional sheets if necessary.(Required)

Affiliate Name
Address
Contact Person
Contact Telephone Number
Contact Email Address
Does this company sell or distribute tobacco products for sale in Pennsylvania?

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Max. file size: 100 MB.

10. Upload a copy of any TTB Manufacturer of Tobacco Product permit you have or any TTB Tobacco Importer permit held by you or your importers.(Required)

Currently, 26 U.S.C. §5713 does not require a TTB Manufacturer or Importer permit for electronic nicotine delivery systems (ENDS). If a change in the law would occur copies of the permit(s) would be mandatory.

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Max. file size: 100 MB.

11. Have you, a board member or director, been convicted of violating 18 Pa.C.S. §6305? If so, identify all such violations and explain why you should still be permitted to sell your products.

Yes

Identify all such violations and explain why you should still be permitted to sell your products.

12. Do all applicable products submitted for certification adhere to the federal packaging standards required by 15 U.S.C. §1472A. If not, identify all such products not adhering to such standards and explain why they should be certified notwithstanding such adherence.

Yes

Identify all such products not adhering to such standards and explain why they should be certified notwithstanding such adherence.

13. Have you purchased from or sold to any person listed on the Tobacco Noncompliance Database during a period when they were listed in such database? If so, identify all such instances of purchases and sales and explain why you should be listed on the directory notwithstanding such purchases or sales.

Yes

N/A

Identify all such instances of purchases and sales and explain why you should be listed on the directory notwithstanding such purchases or sales.

14. Have you purchased from or sold your products to any unlicensed entity during a period when they were required to be licensed? If so, identify all such instances of purchases and sales and explain why you should be listed on the directory notwithstanding such purchases or sales.

Yes

Identify all such instances of purchases and sales explain why you should be listed on the directory notwithstanding such purchases or sales.

Identify all such instances of purchases and sales and explain why you should be listed on the directory notwithstanding such purchases or sales.

Part IV: Brand and Brand Style Identification

Upload an electronic color copy of every brand style or promotional packaging. Include views of each side of the packaging with UPC clearly visible.(Required)

Drop files here or

Max. file size: 100 MB.

Upload a completed Brand List. Please use the required Brand List Template provided. Be sure to indicate all styles to add/remove/remain on the directory and the location where each style is manufactured.(Required)

Your brand list should include e-cigarettes that do not contain nicotine if they are sold under the same brand name as an electronic cigarette that is labeled, advertised, or marketed as containing nicotine, or otherwise determined to contain nicotine by the Attorney General or Department of Revenue. E-cigarettes bearing the same brand name as an electronic cigarette that contains nicotine will be listed but are not required to certify PMTA status. However, you are required to certify them as not containing nicotine and provide a test performed by a domestic certified lab attesting to the absence of nicotine in such product.

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Max. file size: 100 MB.

Part V: Residency Status

The undersigned certifies that the above-named ENDS products Manufacturer:(Required)

Is a resident of the Commonwealth of Pennsylvania, or

Has appointed the resident agent identified below for service of process in the Commonwealth of Pennsylvania

If the above-named ENDS products are manufactured outside of the United States, the undersigned certifies that the importer(s) of such ENDS product has executed a declaration prescribed by the Attorney General accepting joint and several liability as required by 72 P.S. §204-1c and (1) is a resident of the Commonwealth of Pennsylvania or (2) has appointed the resident agent(s) identified in the letters attached below for service of process in the Commonwealth of Pennsylvania.(Required)

All of the ENDS products contained in this certification for inclusion on the Pennsylvania ENDS directory are manufactured within the United States

At least one of the ENDS products contained in this certification for inclusion on the Pennsylvania ENDS directory is manufactured outside of the United States

Upload Manufacturer Resident Agent Letter, Importer(s)’ Resident Agent Letter(s) and Importer Declaration form(s).(Required)

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Max. file size: 100 MB.

Part VI: Surety Bond

Calculating the Required Bond Amount
A bond required pursuant to 72 P.S. § 206-I(k) must provide a bond amount of at least $50,000.00. The Attorney General may require a bond amount in excess of $50,000.00 as necessary to ensure compliance with the ENDS Directory Law and may require a manufacturer to produce information to determine whether a greater amount is necessary. Providing sufficient information may help expedite the certification review and approval process.

For an Initial Certification, attach inventory counts by brand and any other information relevant to determining the potential cost of ENDS product seizure and destruction in the event your brand families are removed from the directory.(Required)

Drop files here or

Max. file size: 100 MB.

Bond Amount(Required)

Effective Date(Required)

Bond Number(Required)

Surety Name(Required)

Untitled(Required)

The undersigned certifies that the above-named ENDS Product Manufacturer has posted a bond for the sole benefit of the Commonwealth in the amount required by 72 P.S. § 206-I(k) using the bond form prescribed by the Attorney General.

Upload Executed ENDS Manufacturer Bond Form.(Required)

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Max. file size: 100 MB.

Part VII: Required Documentation

E-cigarettes that do not contain nicotine, but that are sold under the same brand name as an electronic cigarette that is labeled, advertised, or marketed as containing nicotine, or have been determined to contain nicotine by the Attorney General or Revenue, will not be required to submit any of the requested documentation in Part VII.

Upload one or more of the following documents for each brand style that you are seeking to certify in the Commonwealth of Pennsylvania. Documentation should be submitted for each brand style included on your brand style list.(Required)

A copy of the marketing granted order from FDA for the ENDS products under 21 U.S.C. § 387j.

A copy of the acceptance letter from FDA which resulted from the timely filed premarket tobacco product application for the ENDS products under 21 U.S.C. § 387j.

A copy of a document evidencing that the application remains under review with FDA.

A copy of any denial order from FDA and a copy of the documentation that the denial order has been and remains stayed by the FDA or Court Order or that the denial order has been rescinded by the FDA or vacated by a court.

Upload documentation demonstrating that an additional premarket tobacco product application was not required because the brand style reflects a change to the name, brand style or packaging of another ENDS product that is covered by or has been certified under Section 206-I(b)(1)(i) or 206-I(b)(1)(ii).

Drop files here or

Max. file size: 100 MB.

Part VIII: Electronic Cigarettes that Bear the Same Brand Name as Electronic Cigarettes Labeled, Advertised, or Marketed as Containing Nicotine

Ensure your brand list uploaded above includes e-cigarettes that do not contain nicotine if they are sold under the same brand name as an electronic cigarette that is labeled, advertised, or marketed as containing nicotine, or otherwise determined to contain nicotine by the Attorney General or Department of Revenue.(Required)

Upload a test performed by a domestic certified lab attesting to the absence of nicotine in such product.

Part IX: Execution by Corporate Officer, Director or Authorized Agent

I understand that any violation of the requirements of the Electronic Nicotine Delivery System Directory is a basis for denial of this certification or removal of the manufacturer or its brand families from the Commonwealth’s Directory of Approved Brands.

I agree that all packaging images submitted with this certification are free of proprietary and confidential information and may be publicly posted on the Pennsylvania ENDS Product Directory website.

I hereby certify, under penalty of perjury, that the ENDS Manufacturer identified in Part I is a resident of the Commonwealth, or, if not, has appointed a registered agent for service of process.

I hereby certify under penalty of perjury that the brand families submitted for inclusion on the Pennsylvania ENDS Product Directory of Approved Brands have received the required Marketing Granted Order from FDA; are still under review by FDA after a timely filed premarket tobacco product application; have, for products containing nicotine or separately sold parts or components subject to PMTA review, received a denial order that remains stayed or vacated by court order or by FDA; or an additional premarket tobacco product application was not required because it reflects a change to the name, brand style or packaging of an ENDS product that is covered by or has been certified for sale under Section 206-I(b)(1)(i) or 206-I(b)(1)(ii).I hereby certify under penalty of perjury that I will continually update the information and documentation provided in this certification if it changes during the year, to ensure the products contained on the Pennsylvania ENDS Product Directory of Approved Brands are able to be legally sold.

I hereby certify that, for any product listed on this certification that is part of a brand family that includes electronic cigarettes that contain nicotine but for which such product does not itself contain nicotine and for which FDA did not require a PMTA, that such non-nicotine containing electronic cigarette or part or component thereof has no nicotine in it.

I hereby certify and declare under penalty of perjury that all of the statements and information contained in the certification, including but not limited to any accompanying statements or attachments herewith, are true, correct and complete and that I am a person authorized to bind the ENDS Product Manufacturer making this certification either under the laws of the Commonwealth of Pennsylvania or of the jurisdiction where the manufacturer resides or is organized.

I hereby certify that if there is any material change in the information provided in this certification form, including any attachment, I will notify the Attorney General of any such change within 30 days. I hereby certify that I have submitted the payment required by 72 P.S. § 206-I(D)(2) for each brand family and brand style of cigarette for which this certification has been submitted.

I hereby certify that I have submitted the payment required by 72 P.S. § 206-I(D)(2) for each brand family and brand style of cigarette for which this certification has been submitted.

Signature(Required)

Print Name(Required)

First Last

Title(Required)

Signatory’s Email Address(Required)

Signatory’s Telephone Number(Required)