I received a letter from you regarding my mail shipment of "Pill Labeled inForeign Language, 10 pieces" being Detained at the post office. I amrequesting that you release this detainment. The pill is:
"LION'S MANE Hericium Erinaceus 10:1 extract 100 Tablets Good for Stomach"
PharmaceuticalPacking : 100 tablet bottle
PharmaceuticalIngredients : Chinese Herbal
Usageand Dosage : Oral, take 3 - 4 tablets 3 times a day.
Thepill is for my personal use, for 3 months.
Dear Mr. **
The product does not appear to be releasable. It is being marketed to U.S. customers and does not have English labeling. Even as a dietary supplement the product is not releasable based on the product violation Federal Food Drug and Cosmetic Act402(y) [21 U.S.C. 343(y)] the products label does not contain a domestic address or Domestic phone number through which a the responsible person mayreport a serious adverse event. The detention stands since the productappears to be packaged as a drug.
U.S. Food and Drug Administration
Rescinding an FDA Import Refusal notice is difficult and usually a very rare event. Rescinding an FDA Import Refusal depends upon the facts related to the shipment and the product, the way FDA handled the entry (including how and when FDA issued its notices to the importer), whether the importer or customs broker supplied any information to FDA to try to resolve the detention, and whether FDA is correct in its application or interpretation of the law.