Republic Act (R.A.) No. 9711, otherwise known as The Food and Drug Administration (FDA) Act of 2009, declares as a policy that the State shall protect and promote the right to health of the Filipino people and help establish and maintain an effective health product regulatory system based on the country’s health needs and problems. Thus, the law, in defining health products, included products that may have an effect on health which require regulations as determined by the FDA, other than food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents, and household/urban hazardous substances and/or a combination of and/or a derivative thereof.
Under Sections 144(B) and 144(C) of R.A. No. 11467 entitled “An Act Amending Sections 109, 141, 142, 143, 144, 147, 152, 263, 263-A, 265, and 288-A, and Adding a New Section 290-A to R.A. No. 8424, as Amended, Otherwise Known as the National Internal Revenue Code of 1997, and For Other Purposes”, the FDA is mandated to periodically determine and regulate, consistent with evolving medical and scientific studies, the manufacture, importation, sale, packaging, advertising, and distribution of vapor products and heated tobacco products (HTPs), including the sale to nonsmokers or persons below twenty-one (21) years old.
In accordance with Executive Order (E.O.) No. 106, s. 2020 entitled “Prohibiting the Manufacture, Distribution, Marketing, and Sale of Unregistered and/or Adulterated Electronic Nicotine/Non-Nicotine Delivery Systems, Heated Tobacco Products, and Other Novel Tobacco Products, Amending EO No. 26 s. 2017 and for Other Purposes,” Section 3 stated that all establishments engaged in the manufacture, distribution, importation, marketing and sale of ENDS/ENNDS, HTPs, or their components, shall secure a license to operate from the FDA. Likewise, under Section 6-A(1) of Administrative Order (A.O.) No. 2020-0055, all establishments engaged in the manufacture, distribution, importation, exportation, retail, and sale, including online sale or distribution, of vapor products and/or HTPs shall first secure a License to Operate (LTO) from the FDA, prior to the involvement in the aforementioned activities.
This Circular is being issued to provide the FDA’s guidelines for the licensing of vapor product and HTP establishments under the jurisdiction of the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR).
This Circular shall apply to all individuals, organizations, and entities engaged in the manufacture, distribution, importation, exportation, sale, offering for sale, including online sale/distribution of vapor products and HTPs, under the CCHUHSRR pursuant to A.O. No. 2020-0055.
IV. DEFINITION OF TERMS
For the purpose of implementing this Circular, the terms shall be defined for the purpose of greater clarity:
A. FDA user account refers to the FDA-issued online account to a company in order to access the FDA eportal system for the application and processing of FDA authorizations.
B. License to Operate (LTO) refers to the authorization issued by the FDA to establishments prior to engagement in manufacture, distribution, importation, exportation, retail, and sale, including online retailing/ wholesaling.
C. Onsite inspection refers to regulatory visits conducted by authorized personnel of the Field Regulatory Operations Office (FROO) or the Regulatory Enforcement Unit (REU) on a company’s declared premise to verify compliance to current regulations of the FDA.
D. Post Licensing Inspection (PLI) refers to the onsite inspection conducted by the FROO at any time within the validity of the company’s LTO.
E. Pre-assessment is the process whereby the FDA evaluates and verifies the documents submitted by the establishments for completeness prior to the processing of the application.
F. Site Master File (SMF) refers to the specific information about the quality assurance, the production and/or quality control of manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings.
G. Verified Customer account refers to the account created and owned by customers that have been evaluated and approved by the establishments for compliance to the implementing rules and regulations of the FDA..
A. License to operate (LTO)
- All establishments engaged in the manufacture, distribution, importation, exportation, retail, and sale, including online retailing/wholesaling, as described under Annex A (Description of Activities) of vapor products and HTPs shall secure the appropriate License to Operate (LTO) from the FDA.
- Applications shall be submitted electronically through the FDA ePortal system, following the procedure provided under Annex B (Procedure on the Application for License to Operate for Vapor Product and Heated Tobacco Product Establishments through the Food and Drug Administration (FDA) Electronic Portal (E-Portal) System) of this issuance prior to operation.
- The actual physical business address shall be declared in the LTO application. The declared address must be consistent with the address reflected on the submitted documentary requirements. Virtual and PO box addresses shall not be allowed.
- The applicant shall be responsible in ensuring that the declarations and attachments provided in the application are complete and correct. The specifications and list of documentary requirements for LTO application is provided under Annex C (Documentary Requirements for LTO Applications) of this issuance.
- A pre-assessment of the submitted application prior to payment shall be conducted by the FDA to check for completeness of the submission. Pre-assessed applications with incomplete submissions will not proceed to the next step of the process. An e-mail notification stating the reason/s and reference/s for the disapproval of the application shall be sent to the applicant. Pre-assessed applications with complete submissions will be issued an electronic assessment slip for payment of the applicant.
- Applications will be processed within twenty (20) working days. The timeline begins upon the verification of the payment transaction reference number or the official receipt number by the FDA Accounting/Cashier, and ends once the result of the application has been forwarded to the “On-Process” folder of the applicant.
- Onsite inspection shall not be mandatory for the issuance of an LTO. Post licensing inspection (PLI) shall be conducted by the Field Regulatory Operations Office (FROO) for the verification and monitoring of compliance of licensed establishments.
- In lieu of onsite inspection for manufacturers, the company’s Site Master File (SMF) shall be submitted as part of the documentary requirements for LTO application.
B. Online selling/distribution
- Establishments engaged in the conduct of online selling/distribution shall have full responsibility in ensuring that all transactions and activities conducted online, from providing access to customers down to the delivery of the product, are compliant with FDA rules and regulations.
- For online retailing activities, only FDA-licensed retailers with an approved secondary activity as “online retailer” shall be allowed.
- For online wholesaling activities, only FDA-licensed manufacturers, traders, or distributors with an approved secondary activity as “online wholesaler” shall be allowed.
- Online retailers/wholesalers shall only operate and sell on platforms that require customers to have a verified customer account to access the content of the online store.
a. Online retailers/wholesalers shall ensure that the customer is verified prior to the issuance of a customer account.
i. For online retailers, the review of a government-issued identification card or certificate reflecting the age or date of birth of the individual registering for a customer account shall be part of the verification procedure.
(1)Only individuals twenty-one (21) years old and above shall be granted customer accounts with access to the online store.
(2)Application of a customer account for the sole purpose of age verification shall only be required to individuals accessing vapor products and HTPs through online platforms.
b. For online wholesalers, the review of the company’s LTO registering for a customer account shall be part of the verification procedure.
c. Considering the Use and Restriction stated under A.O. No. 2020-0055 Section B(2), this shall only be applied to individuals purchasing vapor products and HTPs. Other products sold by the establishment, if any, shall not be affected.
5. The shipping, transport, and/or delivery of vapor products and HTPs shall comply with the same guidelines and restrictions provided for the sale and distribution of these products provided under E.O. No. 26 s. 2017 as amended by E.O. No. 106 s. 2020 and other pertinent Laws and policies.
The schedule of fees for LTO application is provided under Annex D (Schedule of Fees for Vapor Product and Heated Tobacco Product (HTP) Establishment LTO Applications) of this issuance.
Violation to any provisions of this Circular shall be subject to the penalties/sanctions provided under Book III, Article XI of the Rules and Regulations Implementing R.A. No. 9711, R.A. No. 11346, R.A. No. 11467, E.O. No. 106 s. 2020, and other penalties
provided by other applicable laws.
VIII. SEPARABILITY CLAUSE
If any provision in this Circular, or application of such provision to any circumstances, is held invalid, the remainder of the provisions in this Circular shall not be affected.
IX. TRANSITORY CLAUSE
This issuance shall be enforced eighteen (18) months from the effectivity of the implementing rules and regulations of Republic Act Nos. 11346 and 11467.
This issuance shall take effect fifteen (15) days after publication in a newspaper of general circulation and the Office of National Administrative Register (ONAR) of the University of the Philippines Law Center.