Code of Federal Regulations (CFR)

March 18, 2008

The Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation. Each volume of the CFR is updated once each calendar year and is issued on a quarterly basis.

ach title is divided into chapters, which usually bear the name of the issuing agency. Each chapter is further subdivided into parts that cover specific regulatory areas. Large parts may be subdivided into subparts. All parts are organized in sections, and most citations in the CFR are provided at the section level.

Source: GPO Access


What FDA Does Not Regulate!!

March 18, 2008

FDA’s responsibilities are closely related to those of several other government agencies. Often frustrating and confusing for consumers is determining the appropriate regulatory agency to contact. The following contact information is for government agencies that have functions related to that of FDA.

Advertising

The Federal Trade Commission is the federal agency, which regulates all advertising, excluding prescription drugs and medical devices. FTC ensures that advertisements are truthful and not misleading for consumers.

Alcohol

The labeling and quality of alcoholic beverages are regulated by the Treasury Department’s Bureau of Alcohol, Tobacco, and Firearms.

Consumer Products

While FDA regulates a large portion of the products that consumers purchase, the agency has no jurisdiction over many household goods. The Consumer Product Safety Commission (CPSC) is responsible for ensuring the safety of consumer goods such as household appliances (excluding those that emit radiation), paint, child-resistant packages, and baby toys.

Drugs of Abuse

Illegal drugs with no approved medical use–such as heroin and marijuana–are under the jurisdiction of the Drug Enforcement Administration. FDA assists DEA in deciding how stringent DEA controls should be on drugs that are medically accepted but that have a strong potential for abuse. DEA establishes limits on the amount of these prescription drugs that are permitted to be manufactured each year

Health Insurance

FDA does not regulate health insurance, the cost of health care products or procedures, or reimbursement for health and medical expenses. Questions about Medicare should be directed to the Centers for Medicare and Medicaid Services.

Meat and Poultry

The U.S. Department of Agriculture’s Food Safety and Inspection Service is responsible for the safety and labeling of traditional meats and poultry. (FDA regulates game meats, such as venison, ostrich and snake.)

Pesticides

FDA, USDA, and the Environmental Protection Agency share the responsibility for regulating pesticides. EPA determines the safety and effectiveness of the chemicals and establishes tolerance levels for residues on feed crops, as well as for raw and processed foods. These tolerance levels (the amount of pesticide allowed to be present in a food product) are normally set 100 times below the level that might cause harm to people or the environment. FDA and USDA are responsible for monitoring the food supply to ensure that pesticide residues do not exceed the allowable levels in the products under their jurisdiction.

Restaurants and Grocery Stores

Local county health departments typically handle inspections and licensing of restaurants and grocery stores.

Water

The regulation of water is divided between the Environmental Protection Agency and FDA. EPA has the responsibility for developing national standards for drinking water from municipal water supplies. FDA regulates the labeling and safety of bottled water.

Source: FDA


What FDA Regulates?

March 18, 2008

FDA is the federal agency responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. FDA also ensures that these products are honestly, accurately and informatively represented to the public.

Some of the agency’s specific responsibilities include:

 

Biologics

  • Product and manufacturing establishment licensing
  • Safety of the nation’s blood supply
  • Research to establish product standards and develop improved testing methods

Cosmetics

  • Safety
  • Labeling

Drugs

  • Product approvals
  • OTC and prescription drug labeling
  • Drug manufacturing standards

Foods

  • Labeling
  • Safety of all food products (except meat and poultry)
  • Bottled water

Medical Devices

  • Premarket approval of new devices
  • Manufacturing and performance standards
  • Tracking reports of device malfunctioning and serious adverse reactions

Radiation-Emitting Electronic Products

  • Radiation safety performance standards for microwave ovens, television receivers, diagnostic
  • X-ray equipment, cabinet x-ray systems (such as baggage x-rays at airports), laser products,
  • Ultrasonic therapy equipment, mercury vapor lamps, and sunlamps
  • Accrediting and inspecting mammography facilities

Veterinary Products

  • Livestock feeds
  • Pet foods
  • Veterinary drugs and devices

 Source: ComplianceOnline