Earlier in 2014, the DOH issued Administrative Order No. 2014-0008, requiring all manufacturers or distributors of e-cigarettes or vapes to apply for Certificate of Product Registration (CPR) after passing quality checks before the products can be sold in the Philippine market, classifying the products as health or consumer products under the jurisdiction of the Food and Drug Administration (FDA). Local government units (LGU's), such as Baguio City, however, are free to pass their own ordinances independent of the FDA.
Notwithstanding this administrative order (AO), vape outlets continue to proliferate without seeking CPRs from the FDA. Hence, on June 14 2019, the DOH issued Administrative Order No. 2019-0007, entitled Revised Rules on Electronic Nicotine and Non-Nicotine Delivery Systems (ENDS/ENNDS). This order prescribed regulations on the manufacture and sale of nicotine and non-nicotine delivery systems, popularly known as e-cigarettes, which are being marketed as safer alternatives to combustible cigarettes and was published on July 9 2019, taking effect on July 24 2019. The DOH gave makers, sellers, distributors, importers and exporters of ENDS/ENNDS three months or until October to comply with the revised regulations and register with the FDA, or their products could be confiscated, and they run the risk of being barred from selling these products in the Philippines.
AO 2019-0007 supports Executive Order No. 26 issued by President Duterte which imposed, from 2017, a ban on cigarette and tobacco smoking in public places, by including vaping or the use of e-cigarettes or electronic nicotine and non-nicotine delivery systems (ENDS) implemented nationwide. The DOH also wants containers of ENDS products to incorporate the labelling warning requirements imposed on cigarettes, but the regulations are not yet clear on how this would appear.
On November 7 2019, the FDA announced the temporary suspension on the implementation of AO 2019-0007 to comply with the writ of preliminary injunction issued by the regional trial court of Pasig City on September 26 2019, enjoining the DOH and FDA from implementing the AO. The action was filed by Planet Vape, a seller, which prides itself as "a one-stop shop that caters to all types of vapers – from newbies to modified users…"
With this development, the FDA is placing all applications for a licence to operate and product registration on hold until the court resolves the issue. It is reported that there are industry association and consumer groups lobbying in favour of vaping, for example, the Philippine E-Cigarette Industry Association (PECIA), the Philippine E-Liquid Manufacturers Association of the Philippines, Inc. (PEMA) and the consumer groups, The Vapers Philippines (TVP), Vapers Association of the Philippines (VAP), and the United Vapers Alliance (UVA) consisting of vape users and manufacturers. These organisations are for regulating the vaping industry, and claim that e-cigarettes are safer alternatives to smoking, should not be treated similarly to tobacco products and that individuals have the "right to vape." In an interview on a TV show, the UVA president claims to be representing small businesses, and working with the FDA and the Department of Trade and Industry (DTI) for the issuance of the necessary regulations for e-cigarettes. There is also a move to remove the regulation of ENDS from the FDA which imposes stricter controls, to the DTI which regulates consumer products. However, the DTI's jurisdiction is limited to prime commodities or basic necessities such as food, cement, steel, etc.
There are a number of pending proposed laws filed with the Philippine Congress, all designed to regulate ENDS such as: House Bill (HB) Nos. 532, 4325, 4810, 3330, 7289, 1744, 7935, 7993, and Senate Bill (SB) Nos. 1538, 1744, and there may still be other bills. These bills have different definitions of ENDS, and the commonality is in the reference to ENDS as a product with or without tobacco. Some have viewed these bills as a way of weakening the regulations on tobacco products.
Public health or the right to trade? It seems that the vaping community and its champions have to really show convincing evidence that vaping is indeed the safer alternative to smoking, and should not be as heavily regulated as the tobacco industry.
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Editha R Hechanova |
Hechanova & Co., Inc.Salustiana D. Ty Tower104 Paseo de Roxas AvenueMakati City 1229, PhilippinesTel: (63) 2 812-6561Fax: (63) 2 888-4290editharh@hechanova.com.ph
