CLAIMS about the reduced harm of electronic cigarettes (or e-cigarettes) are unsubstantiated and remain unproven, the Department of Health (DOH) said.
The DOH added that reports even link them to chemicals that may cause disease.
The DOH gave the statement in response to House Resolution 1885 “A Resolution Urging the Department of Health to Promote Harm Reduction Measures, as Part of Its National Tobacco Control Strategy, Particularly the Use of Electronic Cigarettes as an Alternative for Smokers.”
To date, no company nor product has applied for a License to Operate or a Certificate of Product registration with the Food and Drugs Administration (FDA).
Since 2014 the DOH has issued Administrative Order (AO) 2014-008 on the regulation of e-cigarettes which are classified as combination drugs and medical devices, and not tobacco products or conventional cigarettes.
The said AO provided pertinent guidelines in the licensing of e-cigarette establishments and registration of their products under the FDA.
The DOH reminded the public that any health product, to be authorized by the FDA to be made available in the market, need to follow the requirements for ingredient listing, reporting of harmful and potentially harmful constituents and submission of health research documents if there would be claims for their use as smoking cessation aides.
“It is recommended that manufacturers, importers, distributors and retailers of nicotine-containing, and non-nicotine containing e-liquids and cartridges with claims to aid quitting smoking and/or harm reduction for smoking to follow Pharmaceutical Inspection Cooperation Scheme for the Good Manufacturing Practice guidelines [AO 2012-0008]. Non-nicotine containing e-liquids and cartridges with no claims in cessation or harm reduction should secure a License to Operate,” the DOH said.
A series of long-term epidemiological and peer-reviewed studies are required to conclude that e-cigarettes are less harmful than conventional smoking. Contrary to the claim regarding the effectiveness of e-cigarette as a smoking cessation aid, tthe DOH said, there is barely any evidence based researches to prove so.
“The lack of conclusive data regarding the long-term effects of using e-cigarettes, its health risks cannot be ignored. The precautionary principle recommends that, until conclusive data regarding their safety have been established, regulatory measures should aim at reducing exposure to these products.”