Philippines empowers FDA to strictly regulate e-cigarettes

E-cigarettes are slowly becoming a more common sight for many Filipinos, especially in the cities. Vape shops have found their niche alongside bars and restaurants, kiosks stand besides department stores in shopping malls, and e-cigarette devices and e-juices are increasingly sold in major convenient stores.

Settling Regulatory Jurisdiction over ENDS and similar products

The Department of Health (DOH) and the Food and Drugs Administration (FDA) have early on attempted to regulate e-cigarettes—taking cue from the warnings of the World Health Organization (WHO). In 2014, the DOH released its first administrative issuance on e-cigarettes or, more technically, electronic nicotine delivery systems (ENDS). E-cigarette companies were required to secure a license to operate and register their products.

Despite this policy initiative, the issuance was not strictly enforced and no e-cigarette company has received a Certificate of Product Registration. A high-ranking official of the FDA even described these products as “technically illegal.”¹

In the 17th Congress, legislative hearings were rife with pro-industry representatives aggressively arguing that e-cigarettes fell outside the purview of DOH and FDA regulation. Instead, they argued that their products should be under the Department of Trade and Industry’s standards like ordinary household appliances.²

Last year, the DOH issued a more comprehensive set of regulations over ENDS and similar products through Administrative Order No. 2019-0007 (“Revised Rules and Regulations on Electronic Nicotine and Non-Nicotine Delivery System”). The e-cigarette industry, rather than complying, immediately sued the government before local courts to invalidate the regulation.

In a win for the industry, a Pasig City trial court ordered both DOH and FDA not to implement the Administrative Order which would have taken effect on October 24, 2019.³

The Administrative Order was, however, effectively superseded by the enactment of Republic Act No. 11467, as well as the passing of Executive Order (E.O.) No. 106 this year.

Both policies cemented the regulatory power of FDA over e-cigarettes, as well as related product called “heated tobacco products.” The landmark law also taxed both products, prohibited sales to anyone below 20 years old, and banned flavorings. Meanwhile, the President’s E.O. restricted their marketing, distribution, and use.

ASEAN Regulation of ENDS through Health Ministries

With the law and E.O. in place, the Philippines is now similarly situated with other ASEAN countries that lodged primary jurisdiction over e-cigarette regulation in their respective ministries of health (see Table 1).

Table 1. Regulation of E-Cigarettes in the ASEAN*

The battle is, however, far from over.

There are currently several bills in Congress which, if passed, would severely diminish the regulatory powers of the DOH and the FDA.

Groups like the so-called “Coalition of Asia Pacific Tobacco Harm Reduction Advocates,” the Vapers Philippines, the Philippines E-Cigarette Industry Association, and even tobacco industry front groups are expected to lobby strongly for the amendment of RA 11467.

They have, in the past, been vocal at opposing measures aimed at prohibiting untested health claims, banning e-juice flavors that are appealing to children, and restricting advertisements.³ Weakening existing regulations and reducing—if not, removing—the FDA’s regulatory powers will be on their Christmas wish list.

The e-cigarette and tobacco industries profit from addiction with every shop or kiosk opened, or brands placed into the market. The laws and orders recently put in place stand in their way.

Public health advocates must continue to be vigilant in ensuring that the FDA retains regulatory jurisdiction over ENDS and similar products.

This is critical to ensure that public health will be protected. The Filipino people’s welfare, after all, should be given a primordial consideration. This is especially true if advocates were to safeguard the future of the country’s youth, as they are the targets of these new agents of nicotine dependence. The President himself has taken a firm position against these products, calling them “toxic.”⁵

¹ Jose Rodel Clapano, ‘FDA: No e-cigarettes registered in Philippines’, Philippine Star (June 1, 2018). Available at https://www.philstar.com/nation/2018/06/01/1820466/fda-no-e-cigarettes-registered-philippines.

² HealthJustice Philippines. Tobacco and E-Cigarette Industry Interference in the Philippines (2019). Available at http://www.healthjustice.ph/wp-content/uploads/2019/05/Tobacco-and-E-Cigarette-Industry-Interference-in-Public-Health-Policy-in-the-Philippines.pdf

³ ‘Court stops DOH, FDA from implementing ‘restrictive’ regulations on e-cigs, vapes’, BusinessMirror (October 24, 2019). Available at https://businessmirror.com.ph/2019/10/24/court-stops-doh-fda-from-implementing-restrictive-regulations-on-e-cigs-vapes/.

⁴ ‘Regional consumer group backs local vapers’, Manila Standard (April 2, 2019). Available at https://manilastandard.net/business/biz-plus/291601/regional-consumer-group-backs-local-vapers.html.

⁵ ‘President Duterte says to ban ‘toxic’ e-cigarettes and arrest users’, Philippine Star (November 20, 2019). Available at https://interaksyon.philstar.com/trends-spotlights/2019/11/20/157710/president-duterte-says-to-ban-toxic-e-cigarettes-

and-arrest-users/.

Download here:  FDA Regulation Write-Up 11.30.2020