FDA exec: Vape products illegal

ALL e- cigarettes and vape products being sold in the market are illegal since not one of them had been registered with the regulatory agency, an official from the Food and Drug Administration ( FDA) said.

FDA Cosmetics Regulation and Research director Ana Trinidad Rivera said no one has applied for a certificate of product registration for e- cigarette or vape products.

“Unfortunately, no one has applied yet for the CPR because of the requirements for clinical trials, because it is considered as part of the smoking cessation,” Rivera said.

“The evidence is still not there that it can be used for smoking cessation. So we are waiting, we are encouraging them to do their own clinical studies if they have, and then submit it to the FDA,” she added.

Since vape products have not been registered with the FDA, these are “technically illegal.”

Rivera said officials of the FDA and the Department of Health are discussing the possible regulations that may be imposed.

“There are a lot of proposals right now in the House (of Representatives) and the Senate, including bills from Senators Sotto and JV Ejercito and also from the House, there are bills pending,” she added.

The bills referred to are Senate Bill (SB) 1538 authored by Senator Vicente Sotto 3rd that seeks to regulate vaping in schools, government offices, public utility vehicles (PUVs), churches, and hospitals. The other bill, SB 1744 or the porposed “E- Cigarette Regulation Act of 2018, seeks to regulate the sale, distribution and use of electronic cigarettes.

Rivera said some vaping stations are being monitored.

She clarified that they are monitoring only products with nicotine content since the FDA has no regulations for non-nicotine vaping products.

Last year, Executive Order 26 took effect, banning the sale of tobacco products. However, e- cigarettes and vapes were not included.