Ch. 6

Dow Chemical v. United States

(EPA requested onsite inspection that was refused; commercial aerial photographer did it and Dow sued on grounds that their 14th Am. rights violated but SC ruled no because "open field" and thus couldn't claim right to privacy

benefits of regulation

1. allocation of resources more efficient- can correct imperfections in market system; 2. relief to some duties traditionally held by government who couldn't handle it; many issues politically sensitive and difficult for members of Congress to vote and lose voters; 3 employ experts with specialized knowledge in the fields they regulate- over time, agency develops expertise in making certain rules in certain subject and ALJs acquire level of expertise

types of agencies

1. executive- placed within hierarchy of executive branch usually with cabinet member as head but can have several subparts; initially created by an executive order of the President, receive most of their power from Congress in an enabling statute; heads appointed by Pres, confirmed by Senate normally, and can be removed by President for any reason, meaning much of President's policy can be implemented (EX. FEMA, Hurricane Katrina); 2. independent executive- not placed under cabinet but Pres. still appoints and removes head; sometimes truly administrative and sometimes have other purposes like regulation; usually one person; Ex. CIA, NASA 3. independent regulatory- created by Congress and given broad powers over regulations in a particular area; typically headed by a board or commission whose members are appointed by the President, but normally requires confirmation by Senate; President does NOT have removal power in order to maintain some stability and continuity in policies; restriction that makeup of board or commission can only contain a bare majority from the same political party; but Congressional control over the budgets of independent agencies means that never completely independent but act independent on daily basis 4. government corporation- government has right to operate corporation as established in McCullough v. Maryland

Medical Devices Amendment

1938 Act giving FDA the power over medical devices including breast implants; breast implants- class-action lawsuit; FDA determined leakage of silicone could have possibly caused issues and that FDA ignored warning signs of scientists and that manufacturers never provided proof of safety; 1991: FDA Advisory Panel unanimously recommended that FDA continue to allow implants to remain on market; 1992, second Panel called for voluntary moratorium on distribution and use of breast implants until further research could be conducted; took off market because no proof of safety yet, then Congress and FDA hearings found no causal linl

Food Additives Amendment to the Food, Drug, and Cosmetic Act of 1938 (Delany Clause)

1958; began with Delany committee; investigated the safety of food additives (any ingredient that is added to food that was not naturally occurring in the food or that was naturally occurring but was lost during preparation of the food production process; prevents approval to ANY food additive shown to cause cancer; food manufacturers bear burden of proof and must show the FDA that there were no food additives that could cause cancer in their products before the food additive could be used; recognized exceptions called 200 GRAS substances, things generally recognized as safe by qualified substances

Fair Packaging and Labeling Act

1966 act requiring retail products sold to consumers in interstate commerce to be honestly and informatively labeled; consumers supposed to be able to get accurate information about the quantity of the contents and guide them in comparing value; need for consistent, understandable, and generally usable nutrition information not met by this law because no consistent serving size, etc. mostly voluntary so many businesses didn't do because costed money; only mandatory if producer made nutritional claims on the labels or in advertising, or if there was a food additive included in the product; final rules: calorie number, grams of protein, carbs, fat, % of US Recommended Daily Allowance (RDA) of protein, vitamins A and C, etc.; RDAs determined by National Academy of Sciences (NAS); terminology not uniform;

Regulatory Flexibility Act

1980 reform law on administrative agencies; whenever nee regulation will have "substantial impact upon substantial number of small entities", agency must conduct a flexibility analysis; agency must measure costs it will impose and consider less burdensome benefits; must alert small businesses about forthcoming regulations by appropriate methods

Nutrition Labeling and Education Act

1990 act that changed how FDA would list basic nutritional information; after this in 1994 allowed such supplements to make substantiated claims about the role of these products in health but they also had to issue statement that FDA had not evaluated the said statements and required FDA to have burden to prove dietary supplement was in fact misbranded or adulterated;

Nutrition Labeling and Education Act (NLEA)

1990; consumers got information on label of food products; amended Food, Drug, and Cosmetic Act of 1938 to give FDA explicit authority to require mandatory nutritional labeling on almost all food products and specified nutrients that had to be listed on the label; standardized language and make manufacturers prove health claims; only covers products regulated by FDA

Small Business Regulatory Enforcement Fairness Act

1996 reform law of administrative agencies; permits Congress to review federal regulations for at least 60 days prior to their effective date; gives additional time and an additional forum for opponents to present their arguments; requires agencies to prepare guides that explain the requirements imposed on small businesses in "plain English"; permits small business owners to recover their legal expenses from the government when agency imposes fines or penalties that the court considers excessive; created National Enforcement Ombudsman to serve clearinghouse for comments from small businesses concerning their dealings with federal agencies; based on these comments, agencies are rated and results are published;

Consumer Product Safety Improvement Act (CPSIA)

2008 act requiring nearly all children's products to comply with all children's product safety rules, be tested for compliance by CPSC-accepted lab, have written Children's Product Certificate proving product in compliance, and have permanent tracking information affixed to product; all domestic manufacturers or importers of non-children's products, which are governed by consumer product safety rule, to issue General Certificate of Conformity based on a test of each product

product safety standards

CPSC authorized to develop and issue consumer product safety standards for all products covered by CPSA; product safety research may be performed by or outside CPSC; if test reveals hazard then required to issue standard: either performance standards and labeling standards; procedures for issuing a product safety standard must comply with Administrative Procedures Act's rule-making procedures, like formulating rule, notice in Federal Register, opportunity for people to be heard; sometimes CPSC can ban product completely; all rule-making activities of CPSC subject to judicial review under the APA; basic test if standard is "reasonably necessary" to eliminate unreasonable risk identified by fact-finding process aka cost-benefit analysis; setting of these standards is first area of government intervention to correct market failure caused by information problems where solution has involved government intervention to extent where does not allow consumers to make choice

information collection and dissemination

CPSC establishes and maintains Injury Information Clearinghouse to collect and analyze consumer product injury reports; supplemented by National Electronic Injury Surveillance System, which is computerized system accumulating consumer product injury data from hospitals; facilitated by authority to require manufacturers to keep records, supply CPSC with info. regarding safety, and furnish CPSC with notice and description of an new consumer products before releasing them to the public; used info to detect products that present a higher risk of injury

labeling standards

CPSC typically requires placement of warning labels on products

Hatch-Waxman Act

Drug Price Competition and Patent Term Restoration Act; allowed FDA to approve of generic versions of brand-name drugs without formal investigation of generics; also allowed name-brand companies to apply for up to five years of additional patent protection for time lost in FDA approval process

genetically engineered foods and FDA

FDA chose to encourage voluntary notice by the manufacturers to consumer that the food was engineered; still must go through same inspection process

drugs and FDA

Food, Drug, and Cosmetic Act of 1938; required dangerous drugs to be given only under direction of medical expert, which began requirement for prescription only drugs; 300 deaths due to Sulfathiazole tablets led FDA to develop good manufacturing practices (GMP); Durham-Humphrey Amendment defined what kinds of drugs soley prescription only and if drug not on list, could remain "over-the-counter"; Kefauver-Harris Amendment of 1962- FDA required to approve drugs not only on basis of safety but on effectiveness; pharmaceutical companies must apply to FDA for approval of human clinical testing of drugs; Tylenol cyanide incident led to Federal Anti-Tampering Act of 1983;

Schechter Poultry Corp v. US

National Industrial Recovery Act designed to stabilize the falling prices and deter the cut-throat competition present in almost all industries and violaters subject to prosecution and fines; and individual charged with violating challenged constitution status of delegation; SC ruled law invalid as unconstitutional delegation of legislative authority;

Food and Drug Administration

Wiley's Bureau of Chemistry changed in 1927 to the Food, Drug, and Insecticide Administration and shorted to this in 1930; remained under Department of Agriculture until June 1940 when moved to the Federal Security Agency; then transferred to Department of Health, Education and Welfare, changed Department of Health and Human Services; initially concentrated on chemical additives to food to avoid unnecessary adulterants; seizures of misbranded and adulerated drugs increased into the 20s and 30s; Pure Food and Drug Act expired; FDA tried to fight to renew but lost; so FDA responded with "American Chambers of Horrors";

Child Safety Protection Act (CSPA)

act aimed at better protecting children from choking

Food Safety Modernization Act (FSMA)

act changing FDA food regulation slightly; main goal to shift the focus of making sure US food supply is safe and then responding to any contamination of the food supply to preventing contamination of the food supply in the beginning; since creation, vulnerability assessments conducted and areas identified of highest concern and potential ways to avoid vulnerability; Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food will govern facilities that produce food and other entitled Standards for Growing, Harvesting, Packing, and Holding of Consumption concerns the safety of produce

Family Smoking Prevention and Tobacco Control Act of 2009

act which gave FDA new sweeping powers over tobacco; designed as anti-smoking law and will give FDA power to ban certain labels like those claiming to be in low tar or low nicotine and will also outlaw flavoring the government feels is used to lure teens; gov. can also regulate what goes into cigarettes and require manufacturers to make those ingredients public; can also regulate ads; require larger and more prominent cigarette health warnings on all packages and ads; includes restrictions on products with label "light", "low" etc.; require larger and more visible warnings on packages

FDA's food regulation

activity ranges from complaints and discovery of food-related products that lead to those recalls, as well as food defense in helping reduce the risk of attacks (bioterrorism); FDA still highly involved in long-term effects of consumption of food additives and nutritional labeling

Pure Food and Drug Act of 1906

also called Wiley Act; forbid interstate and foreign commerce in adulterated and misbranded food and drugs; misbranding- false or misleading label claims in food or drugs; if producer violated, they could be fined or jailed; standards of purity and quality set forth; any variation of standards must be on label

why administrative agencies created

as country grew from agrarian to industrial, it was impossible for Congress to regulate all activities that needed attention; enabling statute created and gave powers to them administrative agencies where Congress specifies agencies' regulator mission, organizational structure, procedures, and enforcement powers; 4th branch of gov. but not democratic; originally created early time of nation and meant to attack wealthy and powerful, meaning it had to have power too; rules were relaxed by design to enforce that power;

deregulation

critics believing market functions more efficiently without regulation than with regulation, so better to have none; mostly concentrated industry-specific regulations;

Drug Abuse Control Amendments

gave FDA new controls over amphetamines, barbituates, hallucinogens, and other drugs with potential for abuse leading to the creation of the Drug Enforcement Administration of 1968; after this AIDS common and people wanted remedy quicker even if drug was still experimental; leading Congress to pass several beneficial laws in the drug area such as allowing for approval of generic drugs and giving FDA authority to recall medical devices (some done due to quick passage of unsafe drugs)

history of FDA

came in 1848 during Mexican War and was centered on importation of adulterated drugs- adding something to the product that diminishes the quality of the product; 1886: natural foods v. new artificial substitute; other countries were passing regulation laws and wouldn't accept exports that didn't mean standards; competition proved to b problem in that adulterated foods were improperly prepared could be sold cheaper leading to unfair competition; people began using faith in commercial integrity so states started passing laws to restore the public's faith; Spanish-American War where meat packers accused of shipping "embalmed beef" to troops that sickened them in war; 1906: "The Jungle" leading to Pure Food and Drug Act of 1906; 60s and 70s saw changes where FDA became part of Public Health Service within Department of Health, Education, Welfare and gained responsibility to control over unnecessary radiation from consumer and professional electronic products but lost control over some products that were transferred to CPSC;

reporting issue to FDA

can be done voluntarily by consumers, health professionals, or by the industry member themselves, which can also be a mandatory requirement from the FDA when the industry member discovers problem (must report if find an issue); complaint must be filed with different entity of FDA depending on reporter; FDA acts immediately usually 1. FDA investigator will begin investigation by contacting person or entity that made the complaint 2. investigator will begin investigation by contacting person or entity that made complaint 3. investigator goes to observe, interview, review documents, personally examine the different aspects of the product from raw material to finished product; provides detailed operations manual; FDA investigator creates report subject to public disclosure 1. no action being indicated- didn't find a violation 2. objectional conditions found- not serious enough to require regulatory action (usually results in company's voluntary action) 3. serious objectifiable conditions found resulting in warning letter to company listing FDA's position backed up by statute or FDA rules and company given time to respond to allegations, usually 15 days

MedWatch

collects reports from health professionals on problems with drugs

Children's Gasoline Burn Prevention Act (CGCPA)

concern portable gasoline containers

Consumer Product Safety Commission

consists of 5 members appointed by President for staggered seven-year terms; but only takes 3 commissioners to act and no more than 3 from same political party; activities are 1. information collection and dissemination 2. setting and enforcing product safety standards

cost of regulation

costs of complying bear no relationship to benefits; all regulations alters behavior away from the least-cost way of conducting business; Congress generally not required agencies to consider costs and benefits of rules; American Textile Manufacturers Institute, Inc. v. Donovan- OSHA promulgating standards necessary to control health hazards doesn't mean they had to conduct cost-benefit analysis; Congress must be explicit in language if want analysis; when agency imposes regulations, business responds by finding ways around it; Federal Crop Insurance Corporation v. Merrill- reasonable ignorance of government regulation not defense to agency action

enabling statute

document in which Congress specifies the agencies' regulatory mission, organizational structure, procedures, and enforcement powers; operationally broad leaving agencies to fill details; Congress has power to alter statutory language to clarify purposes of the matter; starts as executive order then passed by law or just executive order;

Food Quality Protection Act (FQPA)

during Clinton administration, Congress passed; added pesticides to jurisdiction of FDA and also ended zero-risk standards in food additives that are a result of the use of pesticides in the food; replaced with certainty of no-harm standards so food additives due to pesticides can be used unless FDA can show that there's reasonable certainty that it's harmful to humans; Delaney Clause still exists for the regulation of normal, non-pesticide related food additives

legislative powers and procedures; APA

enabling statute generally commands agency to take actions necessary to achieve the stated public-interest goals of the legislation; agency usually authorized to adopt rules and regulations to further the purposes of the statute through delegation of legislative power; procedural laws on how agency should operate; allow interested parties the opportunity to be heard when agencies are proposing to adopt rules that will have an impact on their lives; require notice to interested parties and in some cases the holding of public hearings; 1. informal rule making- 1. agency identifies need for a rule or regulation 2. drafts proposed regulation in comprehensive language to induce commentary from the public, proper notice be given to all interested parties satisfied by "Notice of Proposed Rule Making" in Federal Register, daily publication; notice contains information regarding legal authority under which the rule is proposed and either the terms of the proposed regulation or description of issues involved; must be submitted at least 30 days in advance of date of final draft; written comments can then be submitted "notice and comment" but not the status of testimony and can be ignored; used most often; procedural rules and regulations can be informal 2. formal rule making- 1. still need "Notice of Proposed Rule Making" published in Federal Register after the agency determines that it needs the rule and promulgates the rule; notice contains info. regarding time, place, and nature of description of the issues and subjects involved; notice must be at least 30 days prior to the proceedings; 2. formal trial-like hearing held and a record made of oral testimony and documentary evidence; interested parties can introduce exhibits and call expert witnesses who are subject to examination and cross-examination; party opposing regulation can delay by calling a lot of witnesses and introducing a large amount of evidence 2. agency writes final draft of regulation giving due deference to the evidence contained in record 3. regulation published and effective no less than 30 days later; substantive rules changed thorough this method; also used when adversarial proceeding is expected to generate information that the agency could not otherwise assemble; the greater the impact of a regulation on a specific group, the more formal the procedure

Color Additive Amendment

enacting regulating color additives that required food color additives to be proven to be safe before they could be used as well as regular food additives; led to zero-risk standard for any additives that could cause cancer Ex, Red M&Ms

enforcement powers and procedures

enforcement powers of agencies allow them to 1. gather information by requesting the voluntary submission of information by companies- companies usually comply to avoid more costs of formal means; agencies generally not able to exchange info. gathered through self-reporting bc 5th Amendment self-incrimination issues; corporations do not have this protection; methods of getting info- 1. subpoena: legal instrument that orders a business to appear to give testimony or produce documents, 2. physical inspection; physical inspection: can be done with warrant, 3. business being open to public- "open field doctrine"; seen in Dow Chemical Co. v. United States , 4. at businesses' consent; administrative warrant- doesn't require probable cause under 14th Amendment; limitations- 14th Amendment protection against unreasonable searches and seizures; warrant must be obtained prior to searches to avoid misuse in power or business harassment; probable cause requirement more relaxed; as long as legit gov. interest- warrant can be obtained; but in closely regulated industries, warrant not required to search (ex. liquor) because less reasonable expectation to privacy; emergency circumstances also justify warrantless search; 2. power to force businesses to comply with rules/regulations; enabling statute typically defines punishments; informal enforcement- used in areas where easy for business to inadvertently violate regulation Ex. threat of public exposure; also punitive damages- power to fine without trial, fines, court aciton, usually combination of these; but no power to imprison; levying penalty doesn't require pre-determinative hearing in administrative setting as ruled in Dixon v. Love; failure to comply with court order is separate offense

Improving Regulation and Regulatory Review

executive order requiring limited form of cost justification for new regulation, requirement that new regulation must impose least burden on society and where practical consider costs, select approach that maximizes net benefits, specify performance objectives, and identify and assess available in regulation adoption and be notified of the proposed rule of regulation and post the proposed or final rule online and give the public opportunity to comment online; also calls agencies to work together to avoid redundant, inconsistent, or overlapping regulatory requirements; agencies also ordered to conduct retrospective analysis of existing rules to reduce outdated, ineffective, and overly burdensome rules and regulations; also called for some consolidation of some agencies

Yakus v. United States

federal gov. created Office of Price Administration to set maximum rents and commodity prices in effort to control inflationary pressures that accompanied shortages of consumer goods in domestic markets during WWII; Congress directed that agency be guided by prices prevailing on a particular date and listed the factors to be considered when deviating from those prices; SC upheld delegation of rule-making authority if sufficient standards were set forth and powers limited

Consumer Product Safety Act (CPSA)

first direct control of product safety by federal government enacted in 1972; goal to stop death or injury; applies only to consumer products which are used in home, school, or vacation; specifically excludes products intended for industrial purposes; as well as consumer products already covered by other regulatory agencies; also established independent regulatory agency, Consumer Product Safety Commission;

Food Labeling Guide for United States manufacturers

guide for labeling food products for domestic and foreign goods; manufacturers responsible for the accuracy of the content and information; must act in good faith

history of federal regulatory activity

historical era: passage of regulations aimed at specific industries such as railroads (ICC- did business across state lines so interstate commerce clause allowed intervention and started "antitrust"), drug companies, and securities, not many in general; New Deal era: FDR trying to get country out of Great Depression and protect people from similar economic situation; Socially Conscious Era: passage of legislation aimed at particular activities that could be identified with many industries; wanted to get people to do what's right

Food, Drug, and Cosmetic Act of 1938

in 1937, a Tennessee company drug called Elixir Sulfanilamide marketed as drug for children but contained antifreeze and killed children sparking this act due to public outrage; gave FDA new powers in regulation; required those types of drugs and others only to be dispensed with doctor's prescription and only after the manufacturer proved safe and had drug approved by FDA; however still debate over prescription v. over-the-counter drug leading to Durham-Humphrey Amendment in 1951 defining it; each food referred to by common/unusual name, given reasonable definition and standard of identity as well as a reasonable standard of quality and reasonable standard as to the fill of the container; FDA also developed recipes for foods that included the ingredients that producers could lawfully use in the product; extended FDA control to include cosmetics and therapeutic devices; added new enforcement provisions including court injunctions to the previous penalties under Pure Food and Drug Act;

National Commission on Product Safety

in 1972, bipartisan organization established to investigate adequacy of state law in protecting consumers from unreasonable risks caused by "hazardous household products"

Drug Facts Label Rule

in 1999, FDA exercised power to regulate drug labeling in "over-the-counter" drugs

Dietary Supplement At of 1992

instructed FDA to hold off for one year on regulations based on RDAs; final regulations required nutritional labels on most products in the form of Nutrition Facts panel; still criticism of new regulations so Daily Reference Values created and used in reporting values of fat, saturated fatty acids, cholesterol, total carbs, dietary fiber, etc.; largely based on recommendations from several sources; FDA determined nutrition labeling would use consistent system of percentages;

subpoena

legal instrument that orders a business to appear to give testimony or produce documents

lawn dart

manufacturers agrees to stricter ads and labeling to avoid recall but didn't work; CPSC uncovered violations of lawn dart regulations that had previously been imposed by at least two American manufacturers of lawn darts; Congress banned

structure of FDA and areas of regulation

organized into Office of the Commissioner (1 head) with several offices and four subparts; regulates food, dietary supplements, human drugs, vaccines, cosmetics, veterinary products, tobacco products; shares regulation of pesticides with USDA

economy-wide regulatory agencies

regulate problems not isolated in one particular industry; mostly used during Socially Conscious Era; FTC: preventing anticompetitive, unfair, and deceptive practices; NLRB: governs organizing and bargaining rights of labor unions in virtually all industries; less likely that one particular industry will have such a vested interest that it will dominate the decision-making process of the agency

Labeling of Hazardous Art Materials Act (LHAMA)

regulates art supplies

adjudicatory powers and procedures

power to adjudicate disputes within their jurisdiction; administrative law judge (ALJ); agency acts as both prosecutor and judge and usually no jury right; ALJs can be replaced or reassigned so usually separate prosecutorial and judicial functions; (1. filing of complaint by agency or private party alleging that ind./business violated agency regulation; 2. violator notified and agency's staff investigates 3. after investigation, agency decides whether or not to continue action 4. if pursued and common remedy can't be reached, hearing before ALJ); adjudication must follow procedural due process requiring notice and defendant allowed to present evidence; defendants permitted counsel, but won't be appointed attorney if can't afford one; also not entitled to trial by jury; rules of evidence somewhat relaxed since ALJ is fact finder and expert in the field; burden of proof depends upon sanctions by ALJ; written decision includes findings of fact, conclusions of law, recommended disposition; losing party may appeal to review board; agency decisions have value as precedent for other cases heard within agency, typically interpreted narrowly; losing party can appeal to Circuit Court of Appeals; appellate court usually sides with agency bc they're the experts in their field; agency has choice between promulgating a regulation or charging an alleged violator and setting a precedent; rule-making proceedings are time consuming and precedent saves agency from inconvenience; requirements for appeal: timeliness- party cannot appeal until all remedies within agency exhausted; standing- constitutional requirement that limits jurisdiction of the federal courts to actual cases and controversies so party must show they're members of the class that's affected by the agency action and that they're aggrieved by such action giving them standing to sue; Circuit of Appeals mainly deals with issues of law such as agency procedures, justification for agency actions, whether action was within authority; sometimes agency called to justify promulgation of regulation and level of proof depends on procedure: informal- no record of evidence so agency required to follow own rules and regulations, standard for appeal is whether decision arbitrary or capricious; burden on whether rule was fair usually high; formal- record of testimony/documents made; "substantial evidence" test- agency decision must be based on substantial evidence; Courts of Appeal usually yield to agency's judgment; violations on whether rule itself was fair given lowest amount of review; other means of controlling agencies: 1. President- appoints heads of many 2. Congress- committees oversee and review work, hold hearings, propose changes; "power of the purse"

industry-specific regulatory agencies

predominate from from Historical Era to New Deal; meant to regulate one business; criticized that lose sight of their public-interest mission over time; "regulatory capture"- most agencies eventually adopt the perspective of the members of the regulated industry; why: selection of broad or commission members biased toward choosing individuals from the industry accompanied by the targeted industry donating money to the presidential campaign and reminding him who got him elected; but hiring of insiders may be necessary because those people have special knowledge of the industry required to make meaningful contribution not found in "outsiders" who would be more public interest oriented; industry also has greatest rules and regulations to be promulgated by the agency, thus, their side is likely to be better represented through lobbyists and experts; further, individuals may "free ride" on the efforts of other citizens to promote public good and not participate in process; the more citizens that free ride, the less represented are their views

Flammable Fabrics Act (FFA)

regulate flammable clothing and interior furnishings

Government in the Sunshine Act

requires agencies headed by two or more people appointed by the President hold all portions of the meeting in open and subject to public observation; agency may decide, by majority vote, to close meeting under exceptions (ex. day-to-day activities aren't subject and only applies when members of official agency business is conducted or decided);

Freedom of Information Act

requires federal agencies to make agency information available to "any person"; requests for records must be direction to the agency that produced the records, and agency must respond to the request; agency bears burden of showing the records may not be released due to one of the exceptions provided Act (Ex. trade secrets); if agency fails to cooperate, Act provides for court actions to force agency to produce records

Virginia Graeme Baker Pool and Spa Safety Act

requires public pools to install equipment to avoid drain problems

Refrigerator Safety Act (RSA)

requires refrigerators to be able to be opened from inside to prevent accidental suffocations

Poison Prevention Packaging Act (PPPA)

requires several household substances to contain child-resistant packaging

Federal Hazardous Substances Act (FHSA)

requires warning labels on certain hazardous household products such as electric toys, several baby goods, bikes, etc.

sunset laws

some states adopted these laws to require periodic review of many laws and regulations; if not extended by new legislation, then law expires; typically for reevaluation of laws and regulations every five to ten years; up to agency to prove TX legislature that it is doing the job it was designed to do and deserves to be extended

performance standards

specify minimum performance criteria for products by CPSC

organizational structure of regulatory agencies

structure differs with functions and size of agency; head of Executive agency usually directly accountable to cabinet member while Independent not; FTC: five commissioners heading; three bureaus: of Consumer Protection- product safety issues as well as deceptive and unfair practices, Competition- attempts to maintain through enforcement of the antitrust laws; Economics- provides support for the other two bureaus by conducting economic studies; historically agencies used to be able to establish its own procedures through trial and error but now 1947 Administative Procedures Act- rulebook with procedural requirements and while powers of typical administrative agency

Federal Anti-Tampering Act in 1983

tamper-resistant packaging regulations passed by Congress after Tylenol cyanide poisoning

Kefaver-Harris Amendments of 1962

thalidomide sedative that resulted in deformed babies outside US; scared US; drug had to be ruled safe by FDA and effective (max response must be possible); also gave FDA control over regulating prescription drug ads; FDA required stricter control over drug approval, thus drug trials; inspection allowed of drug companies' records;

constitutional status of administrative agencies

when Congress creates, typically delegates to that agency the power to promulgate certain rules and regulations that have the force of law; basic question is the conditions under which it is permissible to allow some government body other than the Congress to make laws; during Great Depression, people started expecting government to help them out, at first most justices against New Deal bc all Republican but then most switched to support "stitch in time saves nine"; first challenge was Schechter Poultry Corp. v. US: National Industrial Recovery Act designed to stabilize the falling prices and deter the cut-throat competition present in almost all industries and violaters subject to prosecution and fines; and individual charged with violating challenged constitution status of delegation; SC ruled law invalid as unconstitutional delegation of legislative authority; Yakus v. US: federal gov. created Office of Price Administration to set maximum rents and commodity prices in effort to control inflationary pressures that accompanied shortages of consumer goods in domestic markets during WWII; Congress directed that agency be guided by prices prevailing on a particular date and listed the factors to be considered when deviating from those prices; SC upheld delegation of rule-making authority if sufficient standards were set forth and powers limited

recent recalls, outbreaks, emergencies

when FDA-product is defective or potentially harmful, FDA can recall; meaning product is removed from market and hopefully corrects problem; usually voluntarily done by the company to avoid further liability; FDA rarely has to order recall but has power to do so if necessary;