Health dep’t to require FDA licensing for e-cigarette industry

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The Department of Health’s Administrative Order 2019-0007 will require a license from the Food and Drug Administration (FDA) to participate in the business. — BW FILE PHOTO

THE Department of Health (DoH) said it will require licensing for all makers, sellers and distributors of e-cigarettes and vaporizers (vapes) under the new guidelines covering the sector.

Published Tuesday, DoH Administrative Order (AO) 2019-0007 will require a license from the Food and Drug Administration (FDA) to participate in the business.

The AO calls the sector the Electronic Nicotine and Non-nicotine Delivery Systems (ENDS/ENNDS) industry.

“All establishments engaged in the manufacture, distribution, importation, exportation, sale including online sale, offering for sale, and transfer of ENDS/ENNDS products shall first secure a License to Operate (LTO),” according to the AO.

The AO, signed by Health Secretary Francisco T. Duque III on June 14, also gave the FDA the authority to inspect establishments before and after the issuance of the license.

DoH also added that licensed establishments can subsequently apply for “a product marketing authorization, such as Certificate of Product Registration (CPR) or FDA Electronic Regulation Number (FERN).”




Securing marketing authorizations is also needed before an establishment can manufacture, distribute, import, and export ENDS/ENNDS products.

The FDA said it hopes to ban refills formulated to appeal to young users and will require tamper-resistant packaging and health warnings for refills and devices.

Users are also prohibited from vaping in public, which is allowed only in designated vaping areas.

Trade and Industry Secretary Ramon M. Lopez meanwhile called for more consultation with the industry, which he said has the potential to generate jobs.

“It’s a potential industry that we can consider,” he said, adding that the Department of Trade and Industry (DTI) is interested to hear out the concerns of the sector.

“We are asking (the DoH and FDA to) conduct consultations para ma-address nila (so they can address) the needs of stakeholders,” he said, adding that he has received position papers from tobacco and e-cigarette groups regarding this matter.

“But we are pro health,” Mr. Lopez added, adding: “The industry is a job generator but we are considering (whether or not) if it is a healthy industry.” — Gillian M. Cortez

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