The Food and Drug Administration (FDA) – Philippines hereby advises all concerned stakeholders that Vapor Product (VP) and Heated Tobacco Product (HTP) Establishments who engage in online selling activities are required to have a License to Operate (LTO) as online seller starting 25 May 2022.
In accordance with Executive Order No. 106 and Administrative Order No. 2020-0055, all establishments engaged in manufacture, distribution, importation, exportation, retail, and sale, including online sale or distribution, of VP and/or HTP shall secure an LTO from the FDA, prior to the involvement in the aforementioned activities.
Pursuant to FDA Circular 2021-016, all concerned establishments that conduct online selling activities should submit Standard Operating Procedure (SOP) on Review and Issuance of User Accounts and SOP on Delivery of Products, and comply with the following provisions:
1. Establishments engaged in the conduct of online selling/distribution shall have full responsibility in ensuring that all transactions and activities conducted online are compliant with FDA rules and regulations.
2. For online-retailing activities, only FDA-licensed retailers with an approved secondary activity as “online retailer” shall be allowed.
3. For online wholesaling activities, only FDA-licensed manufacturers, traders, or distributors with an approved secondary activity as “online wholesale” shall be allowed.
4. 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.
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.
For more information about FDA Circular No. 2021-016, you may access the detailed guidelines posted at the FDA website.
For any concerns or inquiries, kindly contact CCHUHSRR at (02) 857-1900 local 8107 or 8113, or through email at [email protected].
Dissemination of this advisory to all concerned is hereby requested.