TO: Professor Loretta Whonic FROM: Kimberley Hoff DATE: 28 Oct 2012 SUBJECT: Administrative agency powers and

mandate of the FDA ISSUE #1: What are the general powers of a federal administrative agency? ANALYSIS: At the federal level, administrative agencies are created either by legislation passed in Congress or through executive order by the President1. Administrative agencies hold only those powers delegated to them, which may be executive, legislative or judicial in nature, and fall into the general categories of rulemaking, licensing, adjudication, and investigation. The legislative power of administrative agencies consists of the authority to create both substantive and interpretive rules within the purview of their statutory mandate. Substantive rules have the force of law and failure to adhere to them may lead to civil or criminal liabilityhence, they may only be enacted after public notice and comment. Interpretive rules explicate the meaning of existing statutes and are not themselves endowed with the force of law. An agency may issue interpretive rules and statements of policy without the notice and comment period. Executive powers of administrative agencies include licensinggranting an applicant the right to enter a certain industryand investigation. Licensing powers are generally given to agencies that regulate specific industries rather than businesses in general. The subject matter expertise of the agencys staff is vital in these proceedings. Prosecutorial powers of administrative agencies include the right to conduct warrantless searches in certain circumstances, such as in especially hazardous industries where working conditions must be regularly conducted. Administrative agencies also have judicial powers to adjudicate complaints against parties who have violated agency rules or authorizing statutes. Cases are decided before an administrative law judge who issues their opinion as a written order, which may be appealed to the agency for initial review, and then in federal court. Administrative law hearings are much like trials: both sides may be represented by counsel, evidence and witnesses are presented and cross-examined, etc. All administrative agencies are subject to limitations on these powers. The Administrative Procedure Act of 1946 established uniform operating procedures that must be followed to ensure the Constitutional right to due process2, and agencies can be sued for violations under the Equal Access to Justice Act3. Agencies must make non-sensitive documents available to the public under the Freedom of Information Act4, conduct most meetings in public in accordance with the Government in the Sunshine Act5, and protect citizens personal information per the Privacy Act6.
1 2

Goldman, Thomas F. and Henry R. Cheeseman. The Paralegal Professional. 3 ed. Prentice Hall: 2009. 5 USC 551-706 3 28 USC 2412. 4 5 USC 552 5 5 USC 552(b) 6 5 USC 552(a)

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ISSUE #2:What are the powers of the federal Food and Drug Administration? ANALYSIS: The federal government first exercised regulatory authority over the meatpacking and pharmaceutical industries through the 1903 Pure Food and Drug Act7. The Act prohibited adulteration of food and drug products, set cleanliness standards for production facilities, and outlawed misleading labeling or advertising. It was superseded by the 1938 Federal Food, Drug, and Cosmetic Act8, which created the Food and Drug Administration (FDA) as the oversight agency for the three industries it covered. Since its creation, the FDAs mission has been extended several times to cover medical devices, devices that emit radiation, biologic products like vaccines and blood transfusion units, veterinary devices and drugs, and tobacco products9. The FDAs primary mission is to ensure that products consumers put in on or on their bodies, such as food or prescription drugs, are safe to use. Given the very serious health risks posed by contamination, the agency has very broad powers over those two general areas of authority. The FDA is empowered to create both substantive and interpretive rules for how food products are prepared, manufactured, packaged, and distributed to ensure that conditions are sanitary and the end product is safe to use10. Raw meat products are regulated by the US Department of Agriculture but all other food products and the facilities that produce them fall under the purview of the FDA, including food products produced overseas, which must comply with FDA standards to be legal to import. It is empowered to conduct inspections of food production facilities to ensure compliance and to shut them down if it deems the conditions unsanitary. It also regulates animal feed production and distribution. Labeling of food products is controlled by the FDA and must accurately reflect the ingredients and nutritional information of the product and cannot contain any misleading claims. The FDA is charged with conducting and promoting research into nutrition and food safety as well. The FDAs second general area of authority is regulation of pharmaceuticals. It has rulemaking, inspection, and enforcement authority over the production, distribution, and labeling of prescription and OTC drugs (both domestically and overseas for important products) as well as other personal hygiene products like shampoo and toothpaste11. It oversees the approval process for prescription drugs to ensure that their effectiveness is proven, side effects are known and safe, and instructions for use are clear. The FDA also encourages research into new potential drugs and determines which drugs may be sold without a prescription12. It has a similar level of power over medical devices and biologic products, which it can regulate both before and after they are placed on the market13. Consumer devices that emit

Barkan, Ilyse D. Industry Invites Regulation: The Passage of the Pure Food and Drug Act of 1906. American Journal of Public Health, 1985 Jan 75(1): 18-26.00 8 21 USC 9 9 What Does FDA Regulate? FDA Basics. www.fda.gov. 6/21/2012 http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194879.htm 10 How Do the Activities of the FDAs Food Safety and Inspection Service Differ from the Activities of the FDAs Center for Food Safety and Applied Nutrition? FDA Basics. www.fda.gov. 3/17/2011. http://www.fda.gov/AboutFDA/Transparency/Basics/ucm242648.htm 11 Drugs. FDA Basics. www.fda.gov. 6/19/2012.

http://www.fda.gov/AboutFDA/Transparency/Basics/ucm192696.htm
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What is the Approval Process for a New Prescription Drug? FDA Basics. www.fda.gov. 1/5/2010. Vaccines, Blood, and Biologics. FDA Basics. www.fda.gov. 6/5/2012.

http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194949.htm
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http://www.fda.gov/AboutFDA/Transparency/Basics/ucm193816.htm

radiation (such as microwaves, tanning bets, and MRI machines) are also regulated for safety by the FDA. Outside of its major mission, the FDAs powers are considerably more limited. The FDA does not test dietary supplements or herbal remedies for effectiveness and has limited power over manufacturing processes and conditions but does investigate consumer complaints about adulteration or mislabeling14. The agency has approximately the same level of authority over the cosmetics industry as well, where it can require clear and accurate labeling and can investigate complaints (such as claims of dangerous ingredients) but does not have the broad rulemaking and inspection authority it is granted over foods and drugs. As the nations drug regulator, the FDA also sets labeling and advertising regulation for the tobacco industry (such as the ban on tobacco ads on television).

14

Tainted Products Marketed as Dietary Supplements. Consumer Updates. www.fda.gov. 8/9/2012.

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm236774.htm