Legislation to consider when exporting
Your U.S. Importers who establish and verify compliance with pre-existing Dietary Supplement Current Good Manufacturing Practices (CGMP) regulation will not be required to comply with most of the standard Foreign Supplier Verification Program (FSVP) requirements.
Certain U.S. importers would not have to conduct hazard analyses and would be able to verify their foreign suppliers by obtaining written assurances from their supplier.
U.S. importers are required to identify and evaluate illness data, scientific reports and other known or reasonably foreseeable hazards for each type of food they import to determine if there are any hazards requiring a control. These include:
* Biological hazards, including parasites and disease-causing bacteria
* Chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins, food decomposition, unapproved food or color additives, and food allergens
* Physical hazards, such as glass.
In compliance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), the United States Food and Drug Administration (FDA) established new regulations:
- Domestic and foreign facilities that manufacture or process, pack, hold food 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.
- Unless registration was completed, any food product shipped to the United States will be DENIED ENTRY.
The FDA Food Safety Modernization Act (FSMA), signed into law on January 4 2011, enables the FDA to better protect public health by strengthening the food safety system. The FSMA amended section 415 of the Federal Food Drug and Cosmetic Act (FD&C Act), 21 U.S.C. § 350d, which requires domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to register with the FDA.
Under FSMA, all food facilities that are required to register with the FDA under section 415 of the FD&C Act must renew their registration with the FDA, every other year, during the period of time beginning on October 1 and ending on December 31 of each even-numbered year.
If your facility handles any of the included foods, it must be registered with the FDA:
- 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 and frozen foods
- Bakery goods, snack food, and candy (including chewing gum)
- Live animals
- Food for animals.
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