Need advice regarding FDA Detained Herbal Import, due to 'misbranding' regarding!
Question:
Need advice regarding FDA Detained Herbal Import, due to 'misbranding' regarding sterility of item.?
Hello,
I have a shipment (from Hong Kong) of herbs that has cleared U.S. Customs, but has been detained by the FDA. I received a "Notice of FDA Action" letter, which says (paraphrased):
"The article appears misbranded because it's labeling fails to reveal material facts - namely, that the article is non-sterile - with respect to consequences from the use of the article according to labeling, advertising, or under conditions of customary or usual use. SUBMIT A COPY OF THE PRODUCT LABELING."
At first glance, it sounds like I just need to send them a copy of a label that simply says the article is non-sterile. But will they then counter that I can't sell a non-sterile item for consumption (as a "dietary supplement")?
Should I instead label it "Non-Sterile, Not for Human Consumption"?
Also, the article 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 own packaging for resale?
Thanks for any help!
Answers:
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.