外贸中的问题:从中国向美国邮寄包裹被扣了怎么办?怎样跟美国食品药品监督管理局交涉?

2018-06-04 11:00

朋友从中国国内快递来美国十瓶猴头菌片,跟踪查询显示一直在芝加哥将近一个月,后来终于在美国收到一封从美国食品药品监督管理局邮寄来的信件,很是慌张,心想这下摊上大事了!



信件内容


"DETAINED– Subject to Refusal"



邮件说药品没有英文标识,看起来是未批准新药,不准进入美国。


第一页底部提示可以写信联系FDA官员申诉,请求释放包裹。

试着给指定的官员写了一封电子邮件,说猴头菌片是用来养胃的,提示是保健品。


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:

 

Houtoujun Pian 

"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.

Category: Gastritis

Info Source:https://www.amazon.com/box-LIONS-MANE-Hericium-Erinaceus/dp/B00GUEEMEK

Thepill is for my personal use, for 3 months.   

 Entry#:  0347271-0

————————————————————————————————

第二天就收到电邮回信,效率还真高。该官员也不是吃素的,不好蒙,反驳这个中药不是保健品。即使是保健品也不行。


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.

  

M*** Ph.D.

U.S. Food and Drug Administration


各种规定:要美国国内的医师的联系方式。引进药品的理由需要是:没有这个药就活不成(非原话)!


好吧,我算是尽力了。还好这个药每瓶5块钱,就是心疼这邮费了!


据说要让FDA取消其进口拒绝通知通常是很难的、并且非常罕见:

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.

Source:https://www.fdaimports.com/fda_requirements/imports/fda_refusals.php


来源:JHKTRANS