['Privileged', 'and', 'Confidential', 'Summary', 'of', 'FristMcCain', 'FDA', 'Bill', '(May', '2000)', 'Below', 'is', 'a', 'summary', 'of', 'the', 'National', 'Youth', 'Smoking', 'Reduction', 'Act', 'of', '2000,', 'introduced', 'by', 'Senators', 'Frist', 'and', 'McCain', 'on', 'May', '16,', '2000.', 'The', 'bill', 'is', 'an', 'attempt', 'to', 'create', 'a', 'comprehensive', 'regulatory', 'regime', 'for', 'tobacco', 'products,', 'which', 'contains', 'many', 'elements', 'that', 'are', 'more', 'moderate', 'than', 'the', 'so-called', '"Frist', 'provisions"', 'that', 'comprised', 'the', 'FDA', 'segment', 'of', 'the', '1998', 'McCain', 'bill.', 'However,', 'there', 'remain', 'elements', 'that', 'co', 'not', 'track', 'well', 'with', 'the', 'principles', 'that', 'we', 'have', 'articulated', 'regarding', 'tough,', 'but', 'sensible', 'tobacco', 'regulation.', 'Drug/Device', 'Regulation.', 'A', 'separate', 'chapter', 'is', 'created', 'for', 'tobacco', 'products,', 'which', 'initially', 'will', 'apply', 'to', 'cigarettes', 'and', 'smokeless', 'tobacco', 'products,', 'and', 'can', 'apply', 'to', 'other', 'products', 'in', "FDA's", 'discretion.', 'Products', 'for', 'which', 'health', 'claims', 'are', 'made', 'are', 'to', 'be', 'regulated', 'as', 'a', 'drug/medical', 'device,', 'and', 'not', 'under', 'the', 'new', 'chapter.', 'Definitions.', 'The', 'bill', 'contains', 'what', 'appears', 'to', 'be', 'a', 'sensible', 'definitions', 'section', 'that,', 'for', 'example,', 'defines', '"cigarette"', 'in', 'a', 'way', 'that', 'would', 'include', 'Accord,', 'and', 'sets', 'forth', 'definitions', 'of', '"constituent"', 'and', '“ingredient”', 'that', 'correctly', 'distinguish', 'between', 'the', 'two.', 'The', '1998', 'McCain', 'bill', 'failed', 'to', 'make', 'this', 'distinction.', 'Performance', 'Standards/Reduction', 'in', "'Tar", 'and', 'Nicotine’.', 'Like', 'the', 'McCain', 'bill,', 'the', 'new', 'Frist', 'bill', 'permits', 'FDA', 'to', 'impose', 'mandatory', 'performance', 'standards,', 'including', 'the', 'ability', 'to', 'ban', 'added', 'ingredients', 'and', 'substantially', 'reduce', '‘tar’', 'and', 'nicotine,', 'if', 'it', 'finds', 'that', 'the', 'standard', 'would', 'be', '"appropriate', 'for', 'the', 'protection', 'of', 'public', 'health".', 'However,', 'unlike', 'the', 'McCain', 'bill,', 'this', 'one', 'expressly', 'reserves', 'to', 'Congress', 'the', 'authority', 'to', '"eliminate', 'all', 'cigarettes",', 'and', 'to', '"require', 'the', 'reduction', 'of', 'nicotine', 'yields', 'of', 'a', 'tobacco', 'product', 'to', 'zero."', 'Moreover,', 'in', 'another', 'new', 'provision,', 'FDA', 'is', 'forbidden', 'from', 'issuing', 'a', 'performance', 'standard', 'that', 'would', '"render', 'the', 'tobacco', 'product', 'unacceptable', 'for', 'adult', 'consumption".', 'Without', 'judicial', 'interpretation,', 'it', 'is', 'difficult', 'to', 'predict', 'how', 'much', 'of', 'a', 'limitation', 'this', 'language', 'would', 'put', 'on', "FDA's", 'discretion', 'as', 'a', 'practical', 'matter.', 'Marketing', 'and', 'Access.', 'The', 'bill', 'empowers', 'FDA', 'to', 'impose', 'additional', 'restrictions', 'on', 'marketing', 'and', 'access.', 'However,', 'unlike', 'the', 'McCain', 'bill', '(which', 'conferred', 'unfettered', 'authority', 'over', 'marketing', 'and', 'access),', 'this', 'one', 'creates', 'a', 'statutory', 'standard', 'that', 'any', 'such', 'additional', 'restrictions', 'must', 'be', '"appropriate', 'for', 'the', 'prevention', 'of,', 'or', 'decrease', 'in,', 'the', 'use', 'of', 'tobacco', 'products', 'by', 'children', 'under', 'the', 'age', 'at', 'which', 'tobacco', 'products', 'may', 'be', 'legally', 'purchased.”', 'In', 'addition,', 'FDA', 'is', 'expressly', 'prohibited', 'from', 'requiring', 'that', 'tobacco', 'products', 'be', 'limited', 'to', 'prescription', 'use,', 'and', 'from', 'prohibiting', 'face-to-face', 'transactions', 'in', 'one', 'category', 'of', 'retail', '060902802', ' ']