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I'll first talk about the US Food and Drug Administration. I'll talk about some of the
other key regulatory agencies here in the U.S. I'll discuss the key regulations, the
main regulation, that is overseeing or regulates your products: the Food, Drug and Cosmetic
Act; discuss some of the common misconceptions that companies have when they are exporting
products regulated by the U.S. FDA; and then I'll talk about a new regulation, a new law
that has just come out and is effective now, called the Food Safety Modernization Act.
So, let's get started firstly with the US Food and Drug Administration. That is a federal
agency. It's not a state or local agency here in the United States. It is under our Department
of Health and Human Services, and it is organized into seven different centers. The parent organization,
the Office of the Commissioner, below that the various centers, the Center for Food Safety
and Applied Nutrition, Center for Veterinary Medicine, Center for Devices and Radiological
Health, Center for Drug Evaluation and Research, Center for Biologics, Center for Tobacco and
the Center for Toxicological Research.
Now, the center that we'll be most concerned with is the Center for Food Safety also known
as CFS which I'll get to in a couple of moments. The Food, Drug, and Cosmetic Act is the principal
regulation that oversees food, drugs, cosmetics, all of the types of products that you would
be exporting to the U.S.
If it's a food or beverage, or a dietary supplement, or a an ingredient that is going to be regulated
by the Drug and Cosmetic Act, which was established in 1938. That law today remains the principal
law regulating all products, food and beverages, whether they're produced here in the U.S.
or exported from abroad.
This regulation has been amended many times over the years, right up to the new food safety
modernization act. So, what products do, does the U.S. FDA regulate? They regulate again
food and beverages, health supplements, cosmetics, drugs, etc. Now the role of the FDA really
is two-fold. Firstly, they act as a gatekeeper.
In other words, they are the licensing body that decides what products, what ingredients
are appropriate for the marketplace. They set the standards, often with the public and
with industry input. But secondly, they are the police, in essence. They are the enforcer
of regulations. They are in the ports of entry.
They work with Customs and Border Protection, another U.S. agency, to oversee the importation
of food and beverages. Now the Food, Drug, and Cosmetic Act is detailed in what we call
the Code of Federal Regulations, and the Code of Federal Regulations, or CFR, are all the
rules published in what's called the Federal Register of the Executive Departments and
the agencies of our federal government, of which, FDA is a part.
Title 21, of the Code of Federal Regulations is reserved for the rules of the FDA. Now
as I said earlier, the Center for Food Safety, that is the within F.D.A. that oversees most
food products, with the exception of meat and poultry which is regulated by the U.S.
Department of Agriculture, and I'll get into that in a moment.
Agricultural foods, products, processed foods, canned foods, seafood, alcoholic beverages,
non-alcoholic beverages, bottled water, seafood, etcetera, these are all regulated by the Center
For Food Safety and Applied Nutrition.