[' ', "'", 'Washington,', 'D.C.', '20515', 'DEPARTMENT', 'OF', 'HEALTH', '&', 'HUMAN', 'SERVICES', 'Public', 'Heath', 'Senvce', '-', ' ', 'Food', 'and', 'Drug', 'Admunustration', 'Rockville', 'MO', '20887', 'September', '29,', '1987', 'The', 'Honorable', 'Henry', 'A.', 'Waxman', 'Chairman,', 'Subcommittee', 'of', 'Health', 'and', 'the', 'Environment', ';', 'Committee', 'on', 'Energy', 'and', 'Commerce', 'House', 'of', 'Representatives', 'Dear', 'Mr.', 'Waxman:', 'This', 'is', 'in', 'further', 'response', 'to', 'your', 'letter', 'of', 'July', '1', 'concerning', 'two', 'nicotine-containing:', 'products,', '“IPCO', 'Creamy', 'Snuff"', 'and', '"Masterpiece', 'Tobacs."', 'I', 'would', 'first', 'like', 'to', 'respond', 'to', 'your', 'inquity', 'concerning', 'the.', 'extent', 'and', 'limits', 'of', 'the', "Agency's", 'general', 'authority', 'over.', 'food', 'and', 'drug', 'products', 'containing', 'nicotine.', 'The', 'Agency', '“ay', 'assert', 'jurisdiction', 'over', 'nicotine-containing', 'food', 'or', 'drug', 'products', '{f', 'those', 'products', 'meet', 'the', 'relevant', 'definitions', 'of', 'the', 'Federal', 'Food,', 'Drug,', 'and', 'Cosmetic', 'Act', '_(FDEC', 'Act).', '<A', 'more', 'complete', 'discussion', 'follows.', ':', 'Under', 'section', '201(g)(1)', 'of', 'the', 'FDSC', 'Act,', '21', 'U.S.C.', '321(g)(1),', '"aruge”', 'ate', 'defined', 'as:', '(A)', 'articles', 'recognized', 'in', 'an', 'official', 'compendium,', '(B)', 'articles', 'intended', 'for', 'use', 'in', 'the', 'diagnosis,', 'cure,', 'mitigation,', 'treatment', 'or', 'prevention', 'of', 'disease,', '(C)', 'articles', '(other', 'than', 'food)', 'intended', 'to', 'affect', 'the', 'structure', 'or', 'a', 'function', 'of', 'the', 'body,', 'and', '(D)', 'articles', 'intended', 'for', 'use', 'as', 'a', 'component', 'of', 'a', 'drug.', 'Under', '201(f)', 'of', 'the', 'FD&C', 'Act,', '21', 'U.S.C.321(f),', '"food"', 'is', 'defined', 'as:', '(1)', 'articles', 'used', 'for', 'food', 'or', 'drink,', '(2)', 'chewing', 'gum,', 'and', '(3)', 'articles', 'used', 'for', 'components', 'of', 'food.', 'The', 'circumstances', 'in', 'which', 'nicotine-containing', 'products', 'have', 'satisfied', 'these', 'definitions', 'are', 'limited.', 'Historically,', 'FDA', 'has', 'not', 'considered', '|.', 'traditional', 'tobacco-containing', 'products,', 'as', 'customarily', 'marketed,', 'to', 'be', 'subject', 'to', 'regulation', 'under', 'the', 'FD&C', 'Act.', 'Examples', 'of', 'these', 'types', 'of', 'products', 'are', 'smoking', 'tobacco,', 'cigarettes,', 'cigars,', 'chewing', 'tobacco,', 'and', 'snuff.', 'On', 'December', '5,', '1977,', 'FDA', 'denied', 'a', 'citizen', 'petition', 'that', 'requested', 'that', 'it', 'assert', 'jurisdiction', 'over', 'traditionally-marketed', 'forms', 'of', 'cigarettes', 'as', 'drugs.', 'This', 'denial', 'was', 'upheld', 'in', 'Action', 'on', 'Smokin', 'and', 'Health', 'v.', 'Harris,', '655', 'F.2d', '236', '(D.C.', 'Cir', '1980).', 'FDA', 'has', 'in', 'the', 'past,', 'however,', 'regulated', 'tobacco', 'products', 'as', 'drugs', 'when', 'health', 'claims', 'were', 'made', 'by', 'the', 'manufacturers', 'or', 'vendors,', 'such', 'as', 'representations', 'that', 'tobacco', 'products', 'were', 'effe..‘ve', 'for', 'the', 'prevention', 'or', 'treatment:', 'of', 'respiratory', 'or', 'other', 'diseases', 'or', 'for', 'weight', 'reduction.', 'For', 'example,', 'FDA', 'brought', 'an', 'action', 'against', 'cigarettes', 'that', 'contained', 'tartaric', 'acid,', 'a', 'component', 'that', 'was', 'represented', 'to', 'be', 'effective', 'for', 'combatting', 'obesity.', 'The', 'court', 'held', 'that', 'these', 'cigarettes', 'were', 'indeed', 'a', 'drug', 'because', 'of', 'weight-reducing', 'claims', 'made', 'in', 'advertising', 'and', 'on', 'the', 'cigarette', 'packaging.', '(See', 'United', 'States', 'v.', '354', 'Bulk', 'Cartons', 'Trim', 'Reducing-Aid', 'Cigarettes', '178', 'F.', 'Supp.', '847', '(D.N.J.', '1959).', 'G', 'ESSLELITVG']