Tag: approval

  • FDA Releases Environmental Review for Oral Nicotine Products

    FDA Releases Environmental Review for Oral Nicotine Products

    Today (May 21), the U.S. Food and Drug Administration published a programmatic environmental assessment covering nicotine pouches and other oral nicotine products reviewed through the premarket tobacco product application (PMTA) process. The assessment applies to products categorized as “other,” including nicotine pouches, lozenges, tablets, gums, discs, dissolvable tobacco products, and nicotine-infused products, while excluding traditional smokeless tobacco products such as snus, dip, and chewing tobacco.

    The FDA concluded that the environmental impact of these products is generally minimal, citing the absence of airborne emissions during use and relatively limited environmental contamination from product waste. According to the agency, these products reduce or eliminate secondhand and thirdhand exposure risks compared with combustible products, while the waste generated contains comparatively fewer harmful chemicals that persist or bioaccumulate in the environment.

    The agency said the assessment is intended to support transparency and may be referenced by FDA reviewers evaluating individual product applications. However, the FDA emphasized that authorization decisions will continue to be made on a case-by-case basis based on the specific scientific evidence submitted for each product.

  • Taiwan FDA Developing Tests for 27 Additives for Flavorings

    Taiwan FDA Developing Tests for 27 Additives for Flavorings

    Taiwan’s Food and Drug Administration (TFDA) is developing testing methods for 27 additives that will soon be banned from flavored nicotine products, Health Promotion Administration (HPA) Director-General Shen Ching-fen said last week. The move follows amendments to the Tobacco Hazards Prevention Act, announced in March, which aim to strengthen oversight of tobacco ingredients and restrict products that appeal to young people. Shen said the FDA’s detection methods would apply to both traditional and electronic cigarettes once post-market regulatory systems are ready.

    The HPA said 14 flavored cigarette products that previously received conditional approval would soon enter the market, while all others remain illegal.

    To enforce the new rules, authorities have launched nationwide inspection campaigns with local health bureaus to monitor physical stores and online platforms. Inspections will target underage sales and illegal advertising, including social media promotions and “unboxing” videos. Shen said the decision to regulate by listed additives—rather than by flavor—was made to simplify testing procedures, with related regulations expected to be finalized and implemented next year.