Food and Drug Administration (FDA)

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Jennifer G

The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services that is responsible for regulating food, dietary supplements, drugs, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics in the United States.

The FDA was established in 1930 as a part of the US Department of Health and Human Services (HHS), regulates products accounting for roughly 25% of the United States gross national product.

Regulation of Food and Dietary Supplements

The United States Food and Drug Administration (FDA) has issued two interim final regulations, requiring registration of food facilities and prior notice of food imports to FDA. These interim final regulations are the first two of four FDA regulations implementing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act).

The regulations affect most U.S. and foreign entities that manufacture, hold, process, distribute, grow, or import food products for the United States market. “Food” is defined very broadly in these regulations to cover all human and animal food regulated by FDA, including food ingredients, dietary supplements, fresh produce, fish and seafood, alcoholic beverages, live animals to be processed into food, animal feed, and pet food. It does not include food contact substances, such as food packaging.

Regulations

US Food Regulations

• Food Safety and Inspection Service - The Food Safety and Inspection Service (FSIS) is the public health agency in the U.S. Department of Agriculture responsible for ensuring that meat, poultry, and egg products are safe, wholesome, and accurately labeled.

• Federal Register - Online via GPO Access - The Federal Register is the official publication for Presidential Documents and Executive Orders as well as Notices, Rules and Proposed Rules from Federal Agencies and Organizations.

• U.S. FDA Press Releases - An up-to-date source of announcements from the FDA regarding food.

• Federal Register - Contains a number of sites with access to the full text of the Federal Register which are also searchable by keyword.

• U.S. Code of Federal Regulations - A searchable database containing the text of the U.S. Code of Federal Regulations

• FDA Centre for Food Safety and Applied Nutrition - Contains information on food additives, pesticides, food labeling, inspections, HACCP and more.

• Pesticides and Food Safety - EPA, USDA, FDA - Contains information from the Environmental Protection Agency (EPA), U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) related to pesticides and food safety.

Canadian Food Regulations

• Canadian Food Inspection Agency - A look at the new Canadian Food Inspection Agency.

• Regulations for Country-of-Origin labeling of Food Products in Canada - An Inter-Governmental Working Group has prepared a document describing Country-of-Origin labeling regulations for food products in Canada.

• Guide to Food labeling and Advertising - Providing labeling and advertising requirements, policies and guidelines which deal with statements and claims made for foods, including alcoholic beverages.

• New Customs Tariff - Description of proposed simplified Customs Tariff which is intended to be implemented in 1998.

• Health Canada Field Compliance Guides - Health Canada has prepared compliance guides that provide good background information on a variety of food safety issues.

• Treasury Board Secretariat - Regulatory Affairs - Brings you up to date on regulatory initiatives of the federal government.

• AAFC Regulatory Initiatives - Contains an overview of Agriculture & Agri-Food Canada's Regulatory Initiatives for 1995 and the Future.

• Canadian Tariffs and Customs Procedures - Revenue Canada's Electronic Bulletin Board.

Approval

The FDA regulates an enormous number of companies. As of November 2000, the FDA's Official Establishment Inventory, the FDA's database of establishments regulated by the agency, included 135,885 firms including these [1]:

• 64,756 food and cosmetic firms
• 37,839 device and radiological health firms (of which roughly 9,500 are mammography facilities)
• 17,625 Pies
• 7,702 animal drug and feed firms
• 4,223 biologic firms
• 2,320 storage warehouses
• 1,420 miscellaneous food-related facilities

In addition, there are about 1,500 dietary supplement manufacturers, ingredient suppliers, and wholesalers.

Some establishments, such as drug and medical device firms, are required to register with the FDA. Other companies such as dietary supplement manufacturers, warehouses, and, until recently, food firms are not required to register with the FDA. These numbers are subject to fluctuation. Indeed, a report from the HHS Office of the Inspector General took the agency to task after a telephone survey of 100 randomly selected firms suggested that as many as 16% of the businesses listed in the Official Establishment Industry (21,742 firms) may no longer be in operation.

The Office of the Inspector General (OIG) also pointed out that some firms that belong in the inventory may not be included, although the OIG's study did not directly address this issue. New requirements that food establishments register with the FDA and new information technology may help reduce inaccuracies in the database.

FDA requirements vary depending on the type of product being produced. Regulations pertaining to some of the key FDA-regulated commodities are discussed here.

The FDA recently announced plans to take several steps to improve the agency’s review of "innovative" biologic, drug, medical device and veterinary products (FDA, Improving Innovation, 2003).

The FDA ho its efforts will facilitate the use of advanced technology and speed the agency's review and approval of new types of medical treatments. The agency plans to take a number of steps, including publishing information for manufacturers about the "design and execution of clinical trials" for cancer, diabetes, and obesity treatments; attempting to reduce delays in the review of new products by improving communication with manufacturers early in the review process; and providing additional guidance about "three emerging areas of technology": cell and gene therapies, "novel drug delivery systems" or treatments that take advantage of improved scientific understanding about how an individual’s genetic makeup impacts the effectiveness of the medications they are taking (pharmacogenomics)."

Dietary Supplements

More than 115 million Americans consume dietary supplements. Millions of others buy these products for their friends or family. Supplement sales exceeded $17 billion in 2000, according to the FDA. According to CFSAN, It is defined as "[a] dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet." Amino acids, botanical products (herbs), minerals, and vitamins as well as extracts and concentrates are some examples of "dietary ingredients" cited by CFSAN.

Supplements may come in a variety of forms but "whatever their form may be, the Dietary Supplements Health and Education Act (DSHEA) places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement" so that they are not confused with "conventional food[s]" (CFSAN, Overview of Dietary Supplements, 2001).

Regulation of Drugs

Until the 20th century, drugs were regulated primarily by state and local governments. Drugs "could be bought and sold like any other consumer good" (US Regulatory Affairs History, Chapter 1). Regulation became more stringent as medical technology improved and high-profile incidents highlighted the need for at least some degree of government monitoring of these products.

History

Virus-Toxin Law of 1902: One of the first such incidents was associated with a vaccine. After patients suffered injuries from diphtheria vaccine "contaminated with tetanus," Congress passed the Virus-Toxin law (also referred to as the Biologics Control Act), that required licensing of biologics establishments, inspections of vaccine manufacturers, and premarket approval of vaccines and other products (Hyman, 1998; CBER, Commemorating, 2002; CBER, CBER Vision, 2002). This law also is referred to as the Biologics Control Act.

Approval

Drugs are defined in section 201(g) of the FD&C Act as (1) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to these compendia; (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; (3) articles (other than food) intended to affect the structure or any function of the body of man or other animals; (4) ingredients of these products.

• Drugs that include new active ingredients or new excipients (other components of the drug) are formulated differently from existing products, are delivered by new route or are intended for new or additional uses must be approved by the FDA.

• In most cases, at least one and generally more than one clinical study on human beings will be necessary for a drug to be approved. As the FDA points out, there is a need for independent substantiation of results that are subject to variation because clinical investigators and patients participating in one study may differ from those in another study. In some cases, however, the FDA will approve a drug based on the results of a single, multi-center clinical study.

• The FDA has finalized a 1999 rule allowing approval of drug and biological products to treat biological, chemical, or radiological toxicity based on clinical studies conducted in animal models, when tests in humans are not ethical or feasible because of the danger of the substances involved (such as anthrax). Tests in animals may be sufficient to allow approval of the product when the drug's metabolism is well-understood, and when the effect of the product on an animal species will reflect the effect in human beings.

• Before drugs can be tested in humans, extensive preclinical testing in the lab and in animals is required. Drugs may require 4-8 years of preclinical testing before testing in humans begins. Nonclinical tests provide information about how the drug may function within the body and the possible toxicology (adverse effects) of a drug.

• Laboratory tests intended to furnish evidence for drug approval must be conducted in accordance with the FDA's good laboratory practice rules (21 CFR 58), which impose recordkeeping, personnel training, animal handling, and equipment requirements. The FDA inspects laboratories to ensure compliance with these rules and may delay approval or reject an application for drug approval if these rules are not followed.