Harm reduction advocates in the Philippines celebrated the U.S. Food and Drug Administration’s (FDA) marketing authorizations for 20 ZYN nicotine pouch products, hailing it as a significant step for a smoke-free campaign globally.
The decision marks the first time the FDA has authorized nicotine pouches, igniting hope for wider acceptance of smoke-free alternatives.
“The U.S. 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 Adolph Ilas, chairman of Consumer Choice Philippines.
It followed a rigorous scientific review process, including the FDA’s premarket tobacco product application pathway.
Matthew Farrelly, director of the Office of Science in the FDA’s Center for Tobacco Products, noted the stringent 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,” Farrelly said.
This development resonates strongly in the Philippines, where advocates see it as complementing existing harm reduction efforts.
“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.
The FDA’s evaluation concluded that ZYN nicotine pouches contain substantially lower amounts of harmful constituents compared to cigarettes and most smokeless tobacco products. This aligns with the core principle of THR, which focuses on providing less harmful alternatives to combustible cigarettes.
Philip Morris International’s local affiliate, PMFTC Inc., recently launched three new variants of the Zyn nicotine pouch in the Philippines, highlighting the product’s smoke-free nature and ease of use. It continues to expand its portfolio of smoke-free products which includes heated tobacco.
PMFTC President Gijs de Best addressed common misconceptions surrounding nicotine, citing studies that reveal a widespread misunderstanding of its role in smoking-related illnesses. Scientific data from organizations like the BFR in Germany and Public Health England have consistently shown that it is the smoke from burning cigarettes, not nicotine itself, that is the primary cause of smoking-related diseases.
The U.S. FDA itself said in a 2020 article that “tobacco and tobacco smoke contain thousands of chemicals. This mix of chemicals – not nicotine – is what causes serious disease and death in tobacco users.”
ZYN’s growing popularity in the U.S., where it has captured a significant market share, offers a promising outlook for its potential in the Philippines.
While currently imported from Sweden, plans are underway to establish repacking operations in the Philippines.
Swedish Match, a subsidiary of PMI, provided evidence indicating that a significant proportion of adult smokers and smokeless tobacco users have completely transitioned to ZYN.
Tom Hayes, president of Swedish Match North America LLC, emphasized the potential of ZYN to contribute to public health. “An estimated 45 million Americans regularly consume nicotine, and about 30 million of them smoke, the most harmful form of nicotine consumption,” Hayes said.
“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,” said Hayes.
The FDA’s decision on ZYN nicotine pouches represents a significant milestone in the ongoing debate surrounding tobacco harm reduction. Its impact is expected to be felt globally, potentially paving the way for wider acceptance of alternative nicotine products as a means of reducing the harms associated with smoking.
