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II. Regulation Law in Saftey The Federal Food & Drug Administration (FDA)
Food Safety (1/3 of FDA) o Pure Food and Drug Act of 1906 (USDA) 1. Historical Reason Spanish American War o Bad canned food The Jungle o Upinson Sinclairs book on the meat packing industry. 2. Sanitation and Misbranding Things it targeted. 3. Administered by Department of Agriculture FDA Established in 1927 Food, Drug and Cosmetic Act 1938 o expanded regulatory power of FDA To foods other than just canned goods False advertising Classifying unsafe food as adulterated New enforcement powers Form inspection systems Set the safe levels of additives in food o Anything added to food even if it cooks out.. o Ex. Vitamins o Switched burden of proof from consumer to company Ex. Pepsi People claimed that when they took a sip of Pepsi they were stuck with needles. Pepsi showed that there was no human contact because the machines move so fast there would be no way to get the needles in. Pepsi had to prove that it was Not Possible. o Made corporate executives responsible for violations Get down to make sure everything is going smoothly. Delaney Clause 1958 o Gave FDA authority to set the safe-use level of food additives o Zero risk standard Any potential of causing harm. (Would pump rats full) Food Quality Protection Act1996 o Changes Delaney clause: Change zero risk standard to reasonable certainty of harm standard Expanded FDA jurisdiction to include over 9000 pesiticides Nutrition Labeling 1973 and Nutrition Labeling and Education Act of 1990 (New nutritional labels where to be in effect by 1994) FDA- 250,000 food products Department of agriculture meat and poultry Purpose- prevent misleading product claims and help consumers make informed choices Standard serving size

6- 2 o Is a serving size realistic? NO Ceralone cup & half cup milk Ice creamhalf cup Standards for Health Claims o Fresh-raw food (not processed, frozen/ preserved) o Low fat- 3 or less grams of fat per serving per 100 grams of food o Low calorie- fewer than 40 calories per serving and per 100 grams of food o Light or lite- has 1/3 fewer calories then comparable product o Health claims must be accurate Ex. If you eat oatmeal for 30 days it will lower your cholesterol. Drug Safety FDA must approve drugs for sale after 1938 o Major change, pharmacists were druggists and use to make and sell the drugs FDA designates prescription drugs (sold with physicians permission) [prior to 1938 drugs were just simple, legal or illegal.] Drug effectiveness o KefauverHarris Amendment1962 Must be safe, effective and FDA approved Resultaverage of $250 million, 12 years to develop drug and clear FDA. ( eats up a lot of patent time.) o Major area of criticism Ex. Aids, if it isnt FDA approved then you cant use it. But would die of aids if they didnt try it. o Recent changed Bill Clinton changed it and made it easier. FDA is now wanting to make it stricter Enforcement Activities Removal of product from market o claims are misleading o product not as safe as originally thought Ex. Silicon Breast Implants (all from same producer) o Now back on the market with a different producer.

The Consumer Product Safety Commission

Very Active 1972, Consumer Product Safety Act o Only applies to consumer productsthose produced or distributed for personal use, consumption or enjoyment, in a household, in school or in recreation o Excludes industrial products and consumer products covered elsewhere Tobacco, drugs, cosmetics, food, cars Established the Consumer Product Safety Commission o 5 members Appointed by president 7 years staggered terms No more than 3 members of one political party. o Independent Regulatory Agency

6- 3 o CPSC was created during the Historical Era o Had to come up with safety rules for each one. Started with the most dangerous, but the most common are also dangerous.. Ex. Bikes, Chairs and Stair Cases. o If a product is made, then CPSC must approve it. CPSC can also callback and change safety rules. Ex. CPSC Lawn darts appeal through agency and get to CPSC and lose. Court of appeals said that the darts were safe, but the warning wasnt good enough. Then killed more people and business took them off the market. o CPSC is tough on baby/ child goods ages on the toys. Activities of CPSC Information, Collection and Dissemination o Consumer needs to be aware of potential defects o CPSC has several different activities to gather information Injury information clearinghouse collects and analyzes consumer product injury reports National Electronic Injury Surveillance Systemcomputerized system to receive reports of consumer product injury data from hospitals. Manufactures must o Keep records o Supply CPSC with information regarding safety o Furnish CPSC with notice and description of new products o Conduct hearings on consumer safety o Once CPSC has information Release information to the public Take action to force correction Remove the product from the market o Ex. Lawn darts Product Safety Standards o CPSC is authorized to develop and issue consumer product safety standards for all products CPSC covers o CPSC test products, if defective (hazard of injury, illness or death) then issue 1 of 2 types of standards 1. Performance standard specifies minimum performance criteria 2. Labeling StandardRequires warning labels on products o Manufacturers are required to test and certify that their products meet these standards o Safety Standards follow formal rule making requirements Substantive rule o Judicial Review