softtrace - delivering traceability solutions


	Click here to find out more

The Food and Drug Administration is one of the oldest and most respected consumer protection agencies in the US.

Stated most simply, FDA's mission is:

To promote and protect the public health by helping safe and effective products search the market in a timely way,
To monitor products for continued safety after they are in use, and
To help the public get the accurate, science-based information needed to improve health.

Food

FDA safeguards the nation's food* supply by making sure that all ingredients used in foods are safe, and that food is free of contaminants -- like disease-causing organisms, chemicals, or other harmful substances.

The agency must approve new food additives before they can be used in foods.
FDA also monitors the safety of dietary supplements and the content of infant formulas and medical foods.
* Meat and poultry products, however, are regulated by the USDA.

FDA uses regulations and product standards as the "yardsticks" that define specific requirements manufacturers must follow to assure product safety and to provide accurate information to health professionals and consumers.

FDA works with foreign governments to encourage the safety and quality of imported products by making sure that foreign standards are equivalent to those enforced by FDA.

(Above excerpt taken from the FDA Overview Power Pont Presentation which can be found at http://www.fda.gov/oc/opacom/fda101/sld001.html)

Manufacturers - The Law:

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the FDA by December 12, 2003.

Who must register?

Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register the facility with the FDA.
Domestic facilities are required to register whether or not food from the facility enters interstate commerce.

Foreign facilities that manufacture/process, pack, or hold food also are required to register unless food from that facility undergoes further processing (including packaging) by another foreign facility before the food is exported to the United States. However, if the subsequent foreign facility performs only a minimal activity, such as putting on a label, both facilities are required to register.

Examples of FDA-regulated Foods

Food and food additives for man or animals
Dietary supplements and dietary ingredients
Infant formula
Beverages (including alcoholic beverages and bottled water)
Fruits and vegetables
Fish and seafood
Dairy products and shell eggs
Raw agricultural commodities for use as food or components of food
Canned foods
Live food animals
Bakery goods, snack food, and candy

What facilities are exempted from registration?

Exempt from registration are farms; retail food establishments; restaurants; non-profit establishments that prepare food for, or serve food directly to, consumers; fishing vessels not engaged in processing [as defined in 21 CFR 123.3 (k)]; and facilities regulated exclusively throughout the entire facility by the U.S. Department of Agriculture. More...

How long will this take?

FDA estimates that it will take one or two hours of a manager's time to read and understand the regulations. Filling out a registration form would take a total of one hour -- 45 minutes of an administrative worker's time and 15 minutes of an owner, operator, or agent-in-charge's time to certify the registration before submitting the form to FDA. More...

(Above excerpt taken from the Registration of Food Facilities page on the official FDA website – www.fda.gov)

softtrace delivers traceability solutions tailored to insure you facility complies with FDA regulations.

Download softtrace papers on FDA regulations and overviews: