MANILA, Philippines — The Department of Trade and Industry (DTI) has issued the implementing rules and regulations (IRR) of the law regulating vaporized nicotine and non-nicotine products.
DTI Administrative Order 22-16 Series of 2022, dated Dec. 5, issues the IRR of Republic Act 11900 or the vaporized nicotine and non-nicotine products regulation act.
“This IRR shall apply to any person, natural or juridical, that is engaged in the importation. assembly, manufacture, sale, packaging, distribution, advertisement promotion, and sponsorship of Vaporized Nicotine and Non-Nicotine Products, and their devices, and Novel Tobacco Products, whether locally manufactured or imported, in an online or offline platform, or purchase or use of the same, as well as to all those responsible for ensuring compliance on public use and in Designated Vaping Areas,” the IRR said.
The IRR covers vapor products/refills, vapor product devices, heated tobacco products (HTP)s, HTP consumables and devices, as well as novel tobacco products.
Under the IRR, all manufacturers and importers of the covered products shall apply for product registration and certification with the DTI- Bureau of Philippine Standards (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,”the IRR stated.
It said the BPS, in consultation with the Food and Drug Administration (FDA), shall set the product standards for the safety, consistency, and quality of the covered products,provided, that vapor product with nicotine content shall not exceed 65 milligrams per milliliter.
“Compliance with the product standards shall be mandatory,”the IRR said.
In addition, the BPS shall issue separate technical regulations for the covered products.
The IRR also states that vaporized nicotine and non-nicotine products or novel tobacco products bearing an explicit medicinal, therapeutic, or reduced risk claim or statement shall require FDA approval prior to registration and certification from the BPS.
Meanwhile, the DAO states that e-marketplaces, e-commerce platforms, selling facilities embedded in social media websites/applications, and/or other similar selling platforms shall only allow DTI and Bureau of Internal Revenue (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.
It said distributors, merchants and retailers of products with reduced risk statements medicinal or therapeutic claims shall also present the approval from the FDA to the e-marketplaces, e-commerce platforms, selling facilities embedded in social media websites/applications, and/or other similar selling platforms before posting of such products.
“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 approvals shall be posted conspicuously at the landing page of their websites and/or selling platforms,”the IRR said, adding that the same rule applies to brick-and-mortar stores.
Moreover, the IRR has delineated the duties and responsibilities of the implementing agencies.
It said the Department of Health (DOH) shall have jurisdiction on the issuance of the Graphic Health Warning templates and guidelines on warnings for product packaging.
The DOH will also conduct vaping restriction awareness campaigns with concerned government agencies, and implement appropriate intervention programs with the Department of Social Welfare and Development (DSWD) for minors and their parents or guardians caught to be selling, buying or using any vaporized nicotine and non nicotine products and novel tobacco products.
For its part, the FDA shall have exclusive jurisdiction on vapor product refills, heated tobacco product consumables and novel tobacco products with express therapeutic, medicinal, or reduced risk claims.
The BIR, on the other hand, will have exclusive jurisdiction over taxpayer registration;floor price setting for the products; and the formulation, drafting and publication of revenue regulations covering the said products.
Source:
Catherine Talavera – The Philippine Star
December 23, 2022 | 12:00am