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G&FIRE INC was warned that it was selling and distributing e-liquid products containing nicotine without required FDA premarket authorization. The company failed to comply with the Federal Food, Drug, and Cosmetic Act, which classifies nicotine-containing e-liquid products as tobacco products subject to FDA jurisdiction regardless of nicotine source. Under current regulations, "new tobacco products" must obtain a marketing authorization order before being legally marketed in the United States, a requirement the company had not met.