FDA Updates Regulatory Documents to Include "Non-Tobacco Nicotine" Products
In response to the increase of non-tobacco nicotine in popular tobacco products, Congress passed a federal law that went into effect April 14, 2022, granting the U.S. Food and Drug Administration (FDA) authority to regulate tobacco products containing nicotine from any source, including synthetic nicotine. This new law extended the tobacco product requirements in the Federal Food, Drug, & Cosmetic Act to manufacturers, importers, retailers and distributors of non-tobacco nicotine products. Previously, the FDA’s tobacco product authority only extended to tobacco products that contain nicotine made or derived from tobacco. Under this legislation, the definition of “tobacco product” in the FDA’s
regulations
and
guidances
has been considered to be amended since April 14, 2022. On March 17, the FDA issued two notices in the Federal Register updating the definition of “tobacco product” in its existing regulations and guidances, and has also posted nine revised guidances to
FDA’s website.