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Question by NeedHelp2Day: Need advice regarding FDA Detained Herbal Import, due to ‘misbranding’ regarding sterility of item.?
Hello there,
I have a shipment (from Hong Kong) of herbs that has cleared U.S. Customs, but has been detained by the FDA. I obtained a “Notice of FDA Action” letter, which states (paraphrased):
“The write-up appears misbranded simply because it can be labeling fails to reveal content facts – specifically, that the post is non-sterile – with respect to implications from the use of the article in accordance to labeling, advertising, or under conditions of customary or normal use. SUBMIT A Copy OF THE Merchandise LABELING.”
At first glance, it seems like I just require to send them a duplicate of a label that basically states the report is non-sterile. But will they then counter that I are unable to market a non-sterile merchandise for consumption (as a “dietary complement”)?
Should I instead label it “Non-Sterile, Not for Human Consumption”?
Also, the write-up is packaged in bulk, not ready for resale as shipped. So does the label the FDA is asking for refer to the original shipment, or my very own packaging for resale?
Many thanks for any support!
Best answer:
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Answer by commonsense2265
Very tricky!! Never cross the FDA. Have you brought this in before to the USA? Do you alter it or steralize it before use? I am betting it must be sterile before entering and you should talk to the manufacturer about this and have the correct label. The FDA isnot to be messed with. I would find someone who can answer these questions legally.
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Give your answer to this question below!
Good question. You might want to actually ask someone in the FDA on that one. Also, you would probably need some sort of evidence that the final product is sorted, inspected, and sterilized before it goes out.
Here’s a link to an FDA website. The information I found there would indicate that items that are intended as dietary supplements do have to meet standards for food, which means they must be kept sterile during shipping. If this is a first sample, the first supply you got from a certain source, I think I read something there about labelling it as a Quality Assurance sample not for consumption, but in that case, it still could not be used in a final product. I also found a flowchart on their site that may be useful to importers, also referenced below.
The last link in the list has several emails for contact that may be helpful. Remember, honesty is the best policy when dealing with the law.