FEDERAL FOOD, DRUG, AND COSMETIC ACT

Articles and editorials

Acorn Amendment for Pfizer, H10489 [6OC]

E. Coli Path Shows Flaws in Beef Inspection, H10535 [7OC]

Vote for Safer Food, H9132 [30JY]

White House Affirms Deal on Drug Cost, S10184 [7OC], S12753 [9DE]

Women's Heart Disease—It's the Leading Killer, but Patient Care Lags That for Men—As Cardiac Science Advances, Women Find Treatment Lagging, S2231 [12FE]

Bills and resolutions

Drugs: allow for medicinal use of marijuana in accordance with State laws (see H.R. 2835), H6618 [11JN]

———amend relative to distribution of the drug dextromethorphan (see H.R. 1259), H2923 [3MR]

———increase penalties relative to counterfeit drugs (see H.R. 1450), H3338 [11MR]

———prohibit marketing of authorized generic drugs (see S. 501), S2558 [26FE] (see H.R. 573), H380 [15JA]

FDA: define term ``first applicant'' for purposes of filing an abbreviated application for a new drug (see S. 1315), S6887 [22JN] (see H.R. 3777), H11166 [8OC]

———ensure safety and quality of medical products and enhance authorities (see S. 882), S4669 [23AP]

———establish a user fee for follow-up reinspections (see S. 1477), S7779 [21JY]

———establish recall authority for drugs and increase criminal penalties for sale or trade of knowingly adulterated or misbranded prescription drugs (see H.R. 2726), H6264 [4JN]

———establish standards for the inclusion of risks, benefits, and comparative clinical effectiveness information in drug and device labeling and advertising (see S. 1142), S5819 [21MY]

———evaluate evidence on whether to add more folic acid to enriched grain products and expand folic acid fortification into cornmeal and corn-based food products to help prevent birth defects (see H. Res. 202), H2886 [2MR]

———improve capacity to prevent, detect, and respond to food safety problems and the safety of imported food (see S. 510), S2691 [3MR]

———improve safety of food, drugs, devices, and cosmetics in the global market (see H.R. 759), H778 [28JA]

———improve safety of food in the global market (see H.R. 2749), H6305 [8JN]

———improve safety of food in the global market (H.R. 2749), consideration (see H. Res. 691), H9054 [29JY]

———use consumer information maintained by retailers to improve recalls of food (see H.R. 1907), H4520 [2AP]

Fish and fishing: ensure sale and consumption of raw oysters and direct the FDA to conduct an education campaign on the risks associated with consuming raw oysters (see S. 2752), S11290 [9NO]

———prohibit additional requirements for the control of Vibrio vulnificus applicable to post-harvest processing of oysters (see S. 2735), S11205 [5NO] (see H.R. 4022), H12364 [4NO]

Food: amend inspection laws to notify consumers of products produced from crops, livestock, or poultry raised on sewage sludge-treated land (see H.R. 185), H34 [6JA]

———ensure safety (see H.R. 999), H1247 [11FE] (see H.R. 1332), H3053 [5MR]

———ensure safety of imported food (see S. 429), S2229 [12FE] (see H.R. 2800), H6537 [10JN]

———ensure the safety of imported seafood and seafood products (see S. 92), S41 [6JA]

———extend food labeling requirements to enable customers to make informed choices about nutritional content of standard menu items in large chain restaurants (see S. 1048), S5501 [14MY] (see H.R. 2426), H5665 [14MY]

———include freshness dates on food labeling (see H.R. 2087), H4732 [23AP]

———require disclosure of nutritional information on food offered for sale in food service establishments (see S. 558), S2964 [10MR] (see H.R. 1398), H3104 [9MR]

———require foods containing certain ingredients derived from meat, poultry, or other animal products to bear labeling that states that fact and the names of such ingredients (see H.R. 2086), H4732 [23AP]

Food industry: ban use of the arsenic compound known as roxarsone as a food additive (see H.R. 3624), H9806 [22SE]

———improve public health and food safety through enhanced enforcement (see H.R. 815), H920 [3FE]

———improve safety of meat and poultry products through enhanced traceability (see S. 425), S2229 [12FE] (see H.R. 814), H920 [3FE]

———require processors of food products to certify that the processed food products are not adulterated (see S. 2819), S12008 [30NO]

Food Protection Training Institute: establish (see S. 1101), S5700 [20MY] (see H.R. 2513), H5890 [20MY]

Government: prohibit from awarding contracts, grants, or other agreements to, providing any other Federal funds to, or engaging in activities that promote certain companies convicted of felonies (see H.R. 3679), H10407 [30SE]

Hazardous substances: reduce human exposure to mercury through vaccines (see H.R. 2617), H6011 [21MY]

Health: ensure the FTC bears the burden of proof in false advertising cases involving dietary supplements and dietary ingredients (see H.R. 3394), H9055 [29JY]

———review claims about effects of foods and dietary supplements on health-related conditions and diseases (see H.R. 3395), H9055 [29JY]

Pharmaceuticals: importation of prescription drugs (see S. 80), S41 [6JA] (see S. 525), S2766 [4MR] (see S. 1232), S6452 [10JN] (see H.R. 1298), H2978 [4MR]

———preserve effectiveness of medically important antibiotics used in treatment of human and animal diseases (see S. 619), S3163 [17MR] (see H.R. 1549), H3525 [17MR]

———prevent certain delays by pharmaceutical companies in allowing introduction of generic drugs (see S. 1778), S10434 [14OC]

———provide for disposal of controlled substances by ultimate users and care takers through State take-back disposal programs and prohibit drug label recommendations on disposal by flushing (see S. 1336), S6993 [24JN] (see H.R. 1191), H2834 [25FE]

———provide tax credit to retirement age individuals, remove barriers to importation, and prohibit certain regulation of Internet sites relative to prescription drugs (see H.R. 163), H34 [6JA]

Product safety: ban use of bisphenol A in food and beverage containers (see S. 593), S3074 [12MR] (see H.R. 1523), H3437 [16MR]

———preserve ability to file State product liability lawsuits relative to defective medical devices (see S. 540), S2828 [5MR] (see H.R. 1346), H3054 [5MR]

———prohibit manufacture, sale, or distribution in commerce of children's food and beverage containers composed of bisphenol A (see S. 753), S4063 [31MR]

———require a warning on label of food containers composed, in whole or in part, of bisphenol A or could release bisphenol A into food (see H.R. 4341), H15499 [16DE]

Virgin Islands: authorize shipment of prescription drugs between States and the Virgin Islands (see H.R. 91), H31 [6JA]

Water: require manufacturers of bottled water to submit annual reports (see S. 2848), S12708 [8DE]

Women: improve prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women (see S. 422), S2229 [12FE] (see H.R. 1032), H1518 [12FE]

Factsheets

Swine Production, Diseases and Antimicrobial Consumption: National Food Institute, Danish Technical University, H10534 [7OC]

Letters

Food Safety Enhancement Act: Representative Peterson, Committee on Agriculture (House), H9014 [29JY]

———Representative Rangel, Committee on Ways and Means (House), H9014 [29JY]

———Representative Waxman, Committee on Energy and Commerce (House), H9014 [29JY]

Heart Disease Education, Analysis and Research, and Treatment (HEART) for Women Act: David A. Josserand and Timothy J. Gardner, American Heart Association, S2231 [12FE]

Importation of prescription drugs: Margaret A. Hamburg, FDA, S12778 [9DE], S13227 [15DE]

Non-therapeutic use of antibiotics on livestock prohibition: Frank M. Aarestrup, National Food Institute, Danish Technical University, H10534 [7OC]

Pharmaceutical Market Access and Drug Safety Act: Senator Reid, S10184 [7OC]

———Susan Eckerly, National Federation of Independent Business, S9714 [23SE]

Phase out nontherapeutic use of antimicrobial drugs in food animals: several health organizations, E2093 [31JY]

Motions

FDA: improve safety of food in the global market (H.R. 2749), H9161 [30JY]

Remarks in House

Drugs: amend relative to distribution of the drug dextromethorphan (H.R. 1259), H4086, H4087 [30MR]

FDA: define term ``first applicant'' for purposes of filing an abbreviated application for a new drug (H.R. 3777), E2487 [8OC]

———funding, H7816, H7817 [8JY]

———grant quarantine authority in a geographic area if there is evidence of food-borne health risk, H9136 [30JY]

———improve safety of food, drugs, devices, and cosmetics in the global market (H.R. 759), H3148 [11MR]

———improve safety of food in the global market (H.R. 2749), H8272 [16JY], H8990-H9016 [29JY], H9140-H9165 [30JY], E2093, E2143, E2154, E2177 [31JY], E2356 [24SE]

———improve safety of food in the global market (H.R. 2749), consideration (H. Res. 691), H9131-H9138 [30JY]

———improve safety of food in the global market (H.R. 2749), motion to recommit, H9162 [30JY]

———phase out nontherapeutic use of antimicrobial drugs in food animals, H14945 [15DE], E2093 [31JY]

———use of food facility registration fees to purchase food for inspection purposes, H9162-H9164 [30JY]

Food: require disclosure of nutritional information on food offered for sale in food service establishments (H.R. 1398), E597 [9MR]

Government: prohibit from awarding contracts, grants, or other agreements to, providing any other Federal funds to, or engaging in activities that promote certain companies convicted of felonies (H.R. 3679), H10489 [6OC]

Hazardous substances: reduce human exposure to mercury through vaccines (H.R. 2617), E1243 [21MY]

Health: ensure the FTC bears the burden of proof in false advertising cases involving dietary supplements and dietary ingredients (H.R. 3394), E2086 [29JY]

———review claims about effects of foods and dietary supplements on health-related conditions and diseases (H.R. 3395), E2086 [29JY]

Pharmaceuticals: preserve effectiveness of medically important antibiotics used in treatment of human and animal diseases, H14746 [11DE]

———preserve effectiveness of medically important antibiotics used in treatment of human and animal diseases (H.R. 1549), H8272 [16JY], H10533, H10534 [7OC], E689 [17MR]

———provide for disposal of controlled substances by ultimate users and care takers through State take-back disposal programs and prohibit drug label recommendations on disposal by flushing (H.R. 1191), E386 [25FE], E489-E492 [26FE]

———provide tax credit to retirement age individuals, remove barriers to importation, and prohibit certain regulation of Internet sites relative to prescription drugs (H.R. 163), E5 [6JA]

Product safety: preserve ability to file State product liability lawsuits relative to defective medical devices (H.R. 1346), E575 [5MR]

Remarks in Senate

Drugs: prohibit marketing of authorized generic drugs (S. 501), S2569 [26FE]

FDA: ensure safety and quality of medical products and enhance authorities (S. 882), S4686 [23AP]

———establish a user fee for follow-up reinspections (S. 1477), S7783 [21JY]

———establish standards for the inclusion of risks, benefits, and comparative clinical effectiveness information in drug and device labeling and advertising (S. 1142), S5848 [21MY]

———improve capacity to prevent, detect, and respond to food safety problems and the safety of imported food (S. 510), S2692 [3MR], S6912 [23JN], S7285 [9JY], S10658 [22OC], S11396 [17NO]

Fish and fishing: prohibit additional requirements for the control of Vibrio vulnificus applicable to post-harvest processing of oysters (S. 2735), S11148 [5NO]

Food: ensure safety of imported food (S. 429), S2239-S2243 [12FE]

———extend food labeling requirements to enable customers to make informed choices about nutritional content of standard menu items in large chain restaurants (S. 1048), S5522 [14MY]

Food industry: improve safety of meat and poultry products through enhanced traceability (S. 425), S2236 [12FE]

———require processors of food products to certify that the processed food products are not adulterated (S. 2819), S12009-S12011 [30NO]

Pharmaceuticals: importation of prescription drugs, S5927-S5929 [2JN], S6171 [4JN], S6233, S6234, S6246, S6247 [8JN], S6415 [10JN], S7299 [9JY], S10182-S10188, S10192 [7OC], S10404 [14OC], S10687-S10689 [22OC], S10804 [28OC], S10955 [30OC], S11876 [20NO], S12546, S12547 [6DE], S12686-S12688 [8DE], S12751-S12759, S12765, S12770-S12774, S12776-S12780, S12784-S12789, S12792 [9DE], S12870-S12872 [10DE], S12978 [11DE], S13082, S13083 [12DE], S13167, S13168, S13177 [14DE], S13212, S13216, S13219, S13221-S13235, S13238, S13239 [15DE], S13622 [20DE]

———importation of prescription drugs (S. 525), S2780 [5MR]

———importation of prescription drugs (S. 1232), S6478 [10JN], S6481 [11JN], S6866 [22JN], S8216 [29JY], S9713-S9715 [23SE], S9898 [29SE]

———preserve effectiveness of medically important antibiotics used in treatment of human and animal diseases (S. 619), S3179 [17MR]

———prevent certain delays by pharmaceutical companies in allowing introduction of generic drugs (S. 1778), S10436 [14OC]

Product safety: ban use of bisphenol A in food and beverage containers (S. 593), S3086 [12MR]

———preserve ability to file State product liability lawsuits relative to defective medical devices, S1861 [6FE]

———preserve ability to file State product liability lawsuits relative to defective medical devices (S. 540), S2846-S2848 [5MR]

Women: improve prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women (S. 422), S2230 [12FE], S2316 [13FE]

Reports filed

Consideration of H.R. 2749, Food Safety Enhancement Act: Committee on Rules (House) (H. Res. 691) (H. Rept. 111-235), H9054 [29JY]

Dextromethorphan Distribution Act: Committee on Energy and Commerce (House) (H.R. 1259) (H. Rept. 111-49), H3833 [24MR]

Food Safety Enhancement Act: Committee on Energy and Commerce (House) (H.R. 2749) (H. Rept. 111-234), H9054 [29JY]

Rulings of the Chair

FDA: improve safety of food in the global market (H.R. 2749), H9162 [30JY]

Texts of

H. Res. 691, consideration of H.R. 2749, Food Safety Enhancement Act, H9131 [30JY]

H.R. 1259, Dextromethorphan Distribution Act, H4086 [30MR]

H.R. 2749, Food Safety Enhancement Act, H8990-H9007 [29JY], H9140-H9156 [30JY]

S. 429, Ending Agricultural Threats—Safeguarding America's Food for Everyone (EAT SAFE) Act, S2240-S2242 [12FE]

S. 510, FDA Food Safety Modernization Act, S2693-S2705 [3MR]

S. 593, Ban Poisonous Additives Act, S3087 [12MR]

S. 1142, Informed Health Care Decision Making Act, S5849 [21MY]

S. 2819, Processed Food Safety Act, S12011 [30NO]