FDA Compliance, FDA Regulations and FDA Inspections

Overview of FDA Compliance, FDA Regulations, FDA Inspections, FDA Approval Process, 21 CFR Part 11 and FDA Legislation

FDA Compliance
Bankruptcy Alternatives
FDA Compliance

Home PageNot Regulated By FDA
FDA InspectionsApproval Process
21 CFR Part 11FDA Legislation

FDA Regulations Food and Drug Administration

What The Food and Drug Administration Doesn’t Regulate

The Food and Drug Administration'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. Contact information is given for agency headquarters offices, which are located in the Washington, D.C., area. Local offices, listed in the phone book under U.S. Government, may be available to provide assistance as well.

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. Consumers may write to FTC at 6th St. and Pennsylvania Ave., N.W., Washington, DC 20580; Telephone (202) 326-2222.

Alcohol

The labeling and quality of alcoholic beverages are regulated by the Department of Justice's Bureau of Alcohol, Tobacco, Firearms and Explosives, Consumers can write to: Bureau of Alcohol, Tobacco, Firearms and Explosives, 99 New York Avenue, NE, Washington, D.C. 20226;  Telephone 1-800-800-3855 (Toll Free) - 202-648-7777 (Local Number).

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. Consumers may send written inquiries to CPSC, Washington, DC 20207. CPSC operates a toll-free hot line at (800) 638-2772 or TTY (800) 638-8270 for consumers to report unsafe products or to obtain information regarding products and recalls.

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. Inquiries regarding DEA activities may be sent to the Drug Enforcement Administration, U.S. Department of Justice, Washington, DC 20537;  Telephone (202) 307-1000.

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.) Consumers with questions regarding meat or poultry, including safe handling and storage practices, should write or call the Food Safety Inspection Service's Meat and Poultry Hotline, Room 2925S, Washington, DC 20250;  Telephone (800) 535-4555.

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. Public inquiries regarding EPA should be mailed to U.S. Environmental Protection Agency, Office of Pesticide Programs Public Docket (7506C), 3404, 401M St., Washington, DC 20460;  Telephone (202) 260-2080.

Restaurants and Grocery Stores

Inspections and licensing of restaurants and grocery stores are typically handled by local county health departments.

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.

Click Here To Continue To The Next Page
Preparing For FDA Inspection: 5 Ways To Prepare



Check Out These Other Health and Wellness Websites

Medications   Weight Control   Nutrition   Cosmetics   Medical Devices   Diabetic Supplies  
Cosmetic Surgery   LASIK Vision   Arthritis   Hair Restoration   FDA Compliance   Clinical Trials  
Cancer Treatments   Chemotherapy   Imaging & Radiology   Biologics & Blood   Mesothelioma   Pet Care  

Free Debt Consultation — Deal Debt A Fatal Blow Today!

Call Now! 1800 DEBT.COM (that's 1800 332-8266) or Click Here



Valuable Resources For Your Financial Needs!

Credit & Financing   Mortgages   Credit Cards   Auto Loans   Student Loans   Cash Advances
Business Loans   Sub Prime Loans   Income Opportunities   Financial Resources   Payless Insurance

Debt Relief   Debt Settlement   Debt Management   Credit Counseling   Debt Consolidation Loan
Christian Debt Counseling   Tax Debt  Student Debt   Business Debt   Stop Foreclosure
Loan Modification   Bankruptcy Alternatives   Filing For Bankruptcy

Deep In Debt? Call 1800 DEBT.COM
For a FREE Debt Consultation
That's 1800 332-8266

Medical Devices and Home Medical Equipment
Medical Devices

Home Medical Equipment
Home Page
Custom Search
Main Site     Advertise With Us     Resources

Brought To You By: The Center For Health and Wellness

Information and Resources for Living Disease Free and Maintaining a Healthy Lifestyle