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ch18 - Consumer Protection Chapter 18 FDA Food and Drug...

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Consumer Protection Chapter 18
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FDA Food and Drug Regulation FDCA Food, Drug, and Cosmetic Act of 1938 allows FDA to control false advertising of drugs, prescription drugs, expanded enforcement and inspection systems, and set safe levels of additives in foods See Drug Exporting Regulation Other nations adopt FDA regulations as part of their drug standards Food Quality Protection Food Additives Amendment (Delaney Clause) added to FDCA in 1958 more authority (very strict) on additives amended by flexible Food Quality Protection Act: “reasonable certainty of no harm” Enforcement FDA can force existing products--food, cosmetics, medical devices--removed from the market, i.e. silicone breast implants
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Nutrition Labeling and Education Act 1990 Required new regs: apply to more than 250,000 products prevent misleading product claims help consumers make informed decisions Nutrients by serving size labels must show certain components in foods by realistic serving size Standards for health claims words must have certain meanings fresh--can’t have been processed, frozen or preserved low fat--3 or fewer grams of fat per 100 grams of food low calorie--fewer than 40 cal per 100 grams
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Tobin v. Astra Pharmaceutical Tobin, pregnant with twins, was placed on ritodrine to suppress contractions. She complained of side effects such as racing heart and swelling, but was told that it was normal. In mid-March she was admitted into the hospital with fluid in the lungs and congestive heart failure. She delivered healthy twins. Within a month, she needed a heart transplant. She sued Astra, the distributor of ritodrine. Astra moved to have the case dismissed because the drug was approved by the FDA. The motion was denied and the drug company appealed. HELD : Appeals court affirmed. “We reject the argument that FDA approval preempts state product liability claims based on design defect.”
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Federal Trade Commission (FTC) Helps enforce antitrust laws (Bureau of Competition) But also devotes resources to the Bureau of Consumer Protection protect against “unfair and deceptive acts or practices in or affecting commerce”
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Federal Trade Commission (FTC) Complaint begins legal process Many complaints settled by consent decree - terms of settlement frequently include prohibition of practices redress for consumers payment of civil penalties A few cases get administrative trials at FTC may appeal to Commissioners for review may next appeal to federal Court of Appeals
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Unfair and Deceptive Acts and Practices FTC has considerable leeway Deception: 1) misrepresentation or omission of information 2) likely to mislead reasonable consumer 3) deception is material Clarifying the elements: 1) not all omissions are deceptive 2) look at entire content 3) reasonable consumer is ordinary person ads for very young or the ill have tougher standard 4) must be likely to affect consumer’s product choice 5) no proof of injury to consumer is needed
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