FDA Approved Meaning
FDA Approved Meaning
One of the most frequently asked questions by clients and the public alike is what FDA approved means. The difficulty is there is no single answer. Typically, what someone is trying to say or imply is that their
Foods or Dietary Supplements: The term FDA approved carries little significance for these products. There is no general process for the FDA to review each food or dietary supplement. Only products with new or novel ingredients, which is a very small group, would file a GRAS (Generally Recognized as Safe) or NDI (New Dietary Ingredient) submission for clearance to use a specific ingredient. No label for a food or dietary supplement can claim FDA approved.
Cosmetics: There is no process for the FDA to review cosmetics or ingredients in cosmetics. The one exception is certified color additives, those that begin with FD&C. No label for a cosmetic can claim FDA approved.
Medical Devices: Class I,
Drugs: Like
The term FDA approved has many means that should be carefully evaluated and approached with some caution.
What does FDA
Mean?
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Hello,
I am not sure if this is the correct place to ask but doesn’t hurt to ask. If a company is FDA approved and they ship into Australia do they need to register with the TGA?
Thank you for the comment, Elton. My firm only works on FDA regulations, a TGA consultant may be better able to assist you. Generally speaking, every nation has its own independent regulatory system.