REGULATORY: Nicotine Water Denied by FDA

Food Ingredient News, August, 2002

The Food and Drug Administration (FDA, 5600 Fishers Lane, Rockville, MD 20857; Tel: 888/463-6332) responded to a Citizen's Petition by preventing Nicotine Water, or Nicowater from hitting store shelves. The FDA considered several factors, including statements in labeling and evidence of intended use. The FDA determined the product should be regarded as an unapproved new drug. Therefore it cannot be legally marketed as a dietary supplement.

"FDA's decision underscores our commitment that consumers be protected from drug products that have not undergone our rigorous review process," says Lester M. Crawford, FDA deputy commissioner.

The petition was submitted on behalf of several groups including the National Center for Tobacco-Free Kids, the American Medical...