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The International Bottled Water Association (IBWA) emphasizes that water-based products that contain nicotine and are intended for drinking are not considered by federal regulatory authorities to be "bottled water" and are not produced, marketed or regulated as such. The U.S. Food and Drug Administration (FDA) fully regulates bottled water as a packaged food product, with specific standards for quality, labeling, and manufacturing practices, among others, that relate to all foods including the bottled water category. Packaged waters with nicotine content are not considered bottled water, since they do not meet the applicable FDA regulatory requirements and standards required of bottled water products.
FDA is reportedly considering how to classify water with nicotine for regulatory purposes. At this point, it is evident that packaged waters containing nicotine do not meet FDA definitions of "bottled water," although they may fall under FDA regulatory authority in some other category. In previous correspondence on the matter, FDA's Center for Food Safety and Applied Nutrition (CFSAN), the FDA branch responsible for the regulation of conventional foods, nutritional products and dietary supplements, concluded that nicotine is not recognized as an approved food additive, nor is it Generally Recognized As Safe (GRAS), a classification applied to ingredients added to conventional food products.* Bottled water is classified as a "conventional food."
Water-based products containing nicotine are not representative of the traditional bottled water industry and, to our knowledge, no member of the IBWA produces such a product. The Association wants to clarify its viewpoint on this matter so that like products are not inappropriately classified as "bottled water."
For those interested in additional information with regard to water products containing nicotine, contact FDA's Center for Drug Evaluation and Research:
U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Division of Drug Information, telephone number: (301) 827-4573 or 1-888-INFOFDA (463-6332) or on the web www.fda.gov/cder
For more information, visit www.bottledwater.org