- FDA toxicologist Christy Leppanen conducted informal tests showing Zyn nicotine pouches do not dissolve, contrary to initial claims, raising concerns about microplastics risks.
- Leppanen alleges the FDA authorized Zyn without fully understanding the pouch material, ignored her requests for further scrutiny, and published a document falsely stating she signed off on the environmental review.
- The pouch material, identified by Danish researchers as semi-synthetic cellulose similar to cigarette filters, may shed microplastics that could enter the bloodstream and pose health risks.
- Former FDA officials criticized the agency for possibly failing to meet legal obligations in reviewing Zyn, potentially opening it up to litigation under the Tobacco Control Act.
- Despite internal objections, the FDA approved Zyn, later acknowledging in a report that its environmental assessment did not address microplastics from pouch materials, and corrected the false signature attribution months later.