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U.S. Food and Drug Administration (FDA) Regulations
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Has a mixture of all rac-α-tocopherol and RRR-α-tocopherol
(vitamin E).
•
Has a mixture of folic acid and folate.
Effective Date
Based on Food Safety Modernisation Act, on July 26, 2016, the new
regulations went into effect. It replaced the former regulations found
in the Code of Federal Regulations.
Compliance Dates
FDA allows industry time to incorporate the new rules into their
packaging. This is based upon the annual food sales of the
manufacturer as follows:
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Global sales > $10 Million : July 26, 2018
•
Global sales < $ 10 Million : July 26, 2019
IMPORT ALERTS
It is a notice to all entry ports that certain products from specific
areas or manufacturers may be violated. Import alerts are created
whenever FDA discovers a pattern of violation that creates a reason
to believe that future shipments may be similarly in violation. The
compliance officers will be instructed to detain these products.
Import Alerts is available on the FDA website. All alerts follow
the same format such as identifying information, reason for alert,
guidance, product description, charge, the list of countries and
products affected (if country specific) and the appropriate list of
facilities (red or green)
There are two types of import alerts:
a) Green List Import Alerts
•
Inherently risky products from anywhere in the world.
For example, puffer fish (Tetrodotoxin)
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