PH harm reduction advocates welcome US FDA marketing authorizations for ZYN
File image
MANILA, Philippines – Local proponents of tobacco harm reduction have welcomed the recent U.S. Food and Drug Administration’s (FDA) marketing authorizations for 20 ZYN nicotine pouch products through the premarket tobacco product application (PMTA) pathway following an extensive scientific review, saying it marks a significant step in harm reduction efforts.
The FDA said that this is the first time the agency has authorized products commonly referred to as nicotine pouches, which are small synthetic fiber pouches containing nicotine designed to be placed between a person’s gum and lip.
“The US FDA authorizing ZYN nicotine pouches is an encouraging development. It reinforces the global recognition of smoke-free alternatives as viable harm reduction tools that can provide Filipino smokers with better options to reduce health risks,” said Consumer Choice Philippines Chairman Adolph Ilas.
This is the first time nicotine pouches have been authorized through the FDA’s premarket tobacco product application (PMTA) pathway after an extensive scientific review.
“It’s a huge step in the right direction not just in the U.S. but globally. In the Philippines, this complements our Vape Law and builds on our existing harm reduction efforts, giving adult smokers even more options to switch to something less harmful,” said Antonio Israel, President of the Nicotine Consumers Union of the Philippines (NCUP).
Article continues after this advertisementTobacco harm reduction is a strategy designed to provide smokers with less harmful alternatives such as heated tobacco products, e-cigarettes and nicotine pouches, which are scientifically shown to be less harmful than traditional smoking.
Article continues after this advertisementMatthew Farrelly, director of the Office of Science in the FDA’s Center for Tobacco Products, emphasized the rigorous approval process: “To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks. In this case, the data show that these nicotine pouch products meet that bar by benefiting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products.
The FDA’s evaluation concluded that ZYN nicotine pouches contain substantially lower amounts of harmful constituents compared to cigarettes and most smokeless tobacco products, such as moist snuff and snus. The agency determined that these products meet the public health standard required by the 2009 Family Smoking Prevention and Tobacco Control Act.
“An estimated 45 million Americans regularly consume nicotine, and about 30 million of them smoke, the most harmful form of nicotine consumption,” said Tom Hayes, president of Swedish Match North America LLC. “The FDA’s decision recognizes the role that ZYN can play in the protection of the public health by helping people switch from cigarettes and other traditional tobacco products.”
Swedish Match, a subsidiary of PMI, presented evidence indicating that a substantial proportion of adult smokers and smokeless tobacco users completely transitioned to ZYN, further supporting its role in harm reduction.
Philip Morris International’s (PMI) local affiliate PMFTC Inc. launched 3 new variants of the nicotine pouch on January 31, banking on the product’s smoke-free nature and ease of use. PMFTC Inc. is broadening its portfolio of smoke-free products such as heated tobacco products and nicotine pouches, which are scientifically shown to be less harmful than traditional smoking.
ZYN’s growing success in the U.S., where it has captured a significant market share, provides a benchmark for its potential adoption in the Philippines.
“It’s not the same level yet as the U.S., but it has good consumer uptake and good consumer appreciation,” said PMFTC President Gijs de Best during an event launching ZYN in Manila.
De Best also addressed public misconceptions regarding nicotine. “One study shows that majority of the Filipino legal age nicotine user population believe that nicotine is the most harmful constituent, which is factually incorrect.”
Scientific data from the BFR in Germany and Public Health England have concluded that the smoke emitted from burning cigarettes is the main culprit for smoking-related ailments.
In a 2020 article, the U.S. FDA said, “Tobacco and tobacco smoke contain thousands of chemicals. This mix of chemicals – not nicotine – is what causes serious disease and death in tobacco users.”
Although ZYN is currently manufactured in and imported from Sweden, plans are underway to establish repacking operations in the Philippines, reinforcing a long-term investment in the market.
