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Karen Knudsen said in a statement

Lack of action has also emboldened tobacco companies to be even more brazen in producing and marketing products squarely aimed at kids, such as fruit and candy flavored products, and the JUUL e-cigarettes that look like an easily concealed USB drive, which now dominate the market due to youth use

While the FDAs review timelines have extended far beyond the 180-day statutory requirement, Helix has complied with all regulatory requirements to bring On Plus to marketdisclosing ingredients, opening facilities for inspection, and submitting marketing materials for review, the company said on X