The Food and Drug Administration (FDA) informs all concerned stakeholders of the discontinuation of the issuance of the license to operate (LTO) and the product batch declaration (PBD) certification for vapor product and heated tobacco product (HTP) establishments, including inquiries, clarifications, issues, and concerns regarding these products, which shall now be addressed to the Department of Trade and Industry (DTI) pursuant to Republic Act (R.A.) No. 11900, otherwise known as the “Vaporized Nicotine and Non-Nicotine Product Regulations Act,” with an exception for vapor products, HTPs and novel tobacco products (NTPs) with therapeutic, medicinal, or reduced risk claims which will be under the jurisdiction of the FDA pursuant to the express provision of the Republic Act (R.A.) No. 9711 and Republic Act (R.A.) No. 1190.
In this regard, FDA authorizations shall not be a requirement for vapor products, HTPs and NTPs without therapeutic, medicinal, or reduced risk claims and all issued LTO and PBD certifications prior to the effectivity of RA 11900 is no longer valid.
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