REVENUE MEMORANDUM CIRCULAR NO. 35-2023 issued on March 20, 2023 clarifies that the application of the eighteen (18)-month transitory period in Republic Act (RA) No. 11900 (Vaporized Nicotine and Non-Nicotine Product Regulation Act), as reiterated in its Implementing Rules and Regulations (IRR) and Revenue Regulations (RR) No. 14-2022 applies only to the requirements of Product Standards and Product Registration. The rest of the executory provisions of the law, or the other requirements, are effective immediately. This is the clear tenor of Section 2, Rule XVII of the IRR, thus:
“Section 2. Transitory Provision. Manufacturers, distributors, importers
and retailers of Vaporized Nicotine and Non-Nicotine Products or their devices,
and Novel Tobacco Products shall be given an eighteen (18)-month transitory
period from the issuance of this IRR to comply with the requirements of product
standards and product registration. The rest of the executory provisions are
effective immediately.” (underlining supplied).
The requirements of Product Standards and Product Registration referred to herein are found in Rules X and Xl of the IRR, which read:
“Rule X
Product Standard Requirements
The BPS1 in consultation with the FDA, shall set the product standards for the safety, consistency, and quality of the covered products requiring registration under Rule 1 Section 3 of this IRR;2 Provided, that vapor product with nicotine content shall not exceed sixty-five milligrams per milliliter (65mg/ml). Compliance with the product standards shall be mandatory.
The BPS shall issue separate technical regulations for the covered products.
Rule Xl
Product Registration
All manufacturers and importers of the covered products shall apply for product registration and certification with the BPS by submitting information demonstrating conformity with the technical regulations set by the office. Only BPS registered and certified Vaporized Nicotine and Non-Nicotine Products, their devices, and Novel Tobacco Products with the applicable graphic health warning may be sold to the general public.”
Therefore, the requirements set forth in RA No. 11900, its IRR and RR No. 14-2022 other than Products Standards and Product Registration shall be effective immediately. Among
those important requirements are:
a. Registration with the BIR of the business as manufacturer or importer of
Vaporized Nicotine and Non-Nicotine Products and Novel Tobacco Products,
including registration of online sellers or distributors (RR No. 14-2022);
b. Registration with the BIR of brand and variants of Vaporized Nicotine and NonNicotine Products and Novel Tobacco Products (RR No. 14-2022);
c. E-marketplaces, e-commerce platforms, selling facilities embedded in social media
websites/applications, and/or other similar platforms shall only allow DTI and BIR
duly registered distributors, merchants or retailers of Vaporized Nicotine and
Non-Nicotine Products, their devices, and Novel Tobacco Products to sell in their
website or platform (IRR);
d. For duly-registered distributors, merchants and retailers of Vaporized Nicotine and
Non-Nicotine Products, their devices, and Novel Tobacco Products selling on their
own websites and/or selling platforms, the required government certificates and
approval shall be posted conspicuously at the landing page of their websites
and/or selling platforms (IRR); and,
e.Duly-registered distributors, merchants or retailers of Vaporized Nicotine and NonNicotine Products, their devices, and Novel Tobacco Products shall conspicuously
post in their brick-and-mortar stores the required government certificates
and approvals of the products (IRR).
Non-compliance with the aforesaid requirements and the rest of the requirements in RA No. 11900, its IRR and RR No. 14-2022 shall warrant the imposition of corresponding penalties prescribed therein.