Another Shipment Detained by FDA

[Kava Time]

Hi Everyone

I would just like to inform you guys that we are facing major issues with FDA and will be out of stock on our kava indefinitely. For some reason we have come under their radar and they are marking down our shipments like crazy. Another shipment has been detained and we are clueless as to why. Our shipper (DHL) isn't helping either and I have no idea how to get in touch with the relevant people at FDA who can help clarify things. There may be a major delay to us restocking until we figure out whats going on.

We only have a few pounds of Ovalau's Heritage remaining in stock. After that's gone we will be out of stock on everything until further notice.

Neil

 

[kasa_balavu]

I'm sorry to hear that, Neil.

When you registered your facility with the FDA, you were required to provide the address of a US agent. This address should have received a notice from the FDA every time they detained a shipment explaining why the shipment was detained and providing steps you can take to convince them that the shipment should be allowed in.

If you don't have an agent, you can buy that service from registrarcorp.com or fdaimports.com, but it will cost quite a bit.

As your agent, they will reach out to the FDA to find out what the hold up is, and help you navigate that process.

Hope you can sort this out bro. Good luck!

 

[Kava Time]

I'm sorry to hear that, Neil.

When you registered your facility with the FDA, you were required to provide the address of a US agent. This address should have received a notice from the FDA every time they detained a shipment explaining why the shipment was detained and providing steps you can take to convince them that the shipment should be allowed in.

If you don't have an agent, you can buy that service from registrarcorp.com or fdaimports.com, but it will cost quite a bit.

As your agent, they will reach out to the FDA to find out what the hold up is, and help you navigate that process.

Hope you can sort this out bro. Good luck!

Nothing was sent to the US agent address either. I managed to get hold of a contact person waiting for midnight to give her a call in Ohio when FDA office opens there at 8

 

[Zaphod]

Are any other vendors who import on a regular basis having any issues?

 

[verticity]

There is a database of import refusals by the FDA by date and country here
https://www.accessdata.fda.gov/scripts/importrefusals/
There were a couple kava refusals from Fiji in February, that I don't think are yours, but the reasons are things like the label doesn't say "nutritional supplement", etc.

But they should send you a notice before refusing the import; however if you haven't received it that's a problem because I think there is a limited time to appeal. (The site mentions 10 days after the notice?)

 

[The Kap'n]

I've had a look at the link posted by @verticity and I can see your Feb shipment there. The explanation given by the FDA is basically that the items were misbranded and/or that the labels did not contain all of the required information. you can read more when you go to the website.

Yep, I see it too.

LACKS FIRM 403(e)(1), 801(a)(3); MISBRANDING The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor [Misbranded, Section 403 (e)(1)].

LACKS N/C 403(e)(2), 801(a)(3); MISBRANDING The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

PLANT PART 403(s)(2)(C), 801(a)(3); MISBRANDING The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(C) of the FD&C Act in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived.

USUAL NAME 403(i)(1), 801(a)(3); MISBRANDING The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.

 

[Kava Time]

Yeah i have seen that and corrected it but still they got detained. I called the relevant FDA compliance Officer after numerous calls to FDA to get his contact and he said that the metric weight on the packaging needs to be in Oz or Pounds where we have put them in grams
He says that it can be released to be re-labeled at consignees address but DHL will not release it and will send it back. It seems either DHL is double dipping on shipping for such issues or the guys at the port don't know what they are doing when it comes to clearance with FDA. Trying to get hold of them now.

 

[Kava Time]

FDA sent a notice of detention which never reached our fulfillment center. This copy was also sent to DHL but they never informed us about it. When i called to ask they said its with FDA and beyond their control when they as our shippers are responsible to inform the shipper or consignee of everything that happens with the consignment. The FDA officer suggested that i change my shipping partner which now i am determined to do. For such a big company, DHL offers the worst customer service.

 

[verticity]

Yeah i have seen that and corrected it but still they got detained. I called the relevant FDA compliance Officer after numerous calls to FDA to get his contact and he said that the metric weight on the packaging needs to be in Oz or Pounds where we have put them in grams
He says that it can be released to be re-labeled at consignees address but DHL will not release it and will send it back. It seems either DHL is double dipping on shipping for such issues or the guys at the port don't know what they are doing when it comes to clearance with FDA. Trying to get hold of them now.

That's nuts. Keeping us safe from the Metric system.

Some of the other vendors here might be able to offer some advice about better international shipping options.

 

[kasa_balavu]

Since your shipments are small, and these infractions of the labeling laws so minor, it seems to me that this is a real dick move by the FDA. A warning would have sufficed here.
At least it doesn't seem like you were singled out, as the other Fijian kava exporter got dinged for the same thing that month.

The FDA officer suggested that i change my shipping partner which now i am determined to do. For such a big company, DHL offers the worst customer service.

I got that impression when I asked DHL for a quote a few months ago. Their sales office probably has their most proactive people since... well... that's where they make their money, but I was less than impressed with their response time.

I guess the alternatives are UPS (Williams & Gosling), Fedex (Carpenters), and EMS.

 

[ThePiper]

Unbelievable

 

[recentreturn]

We want Kadavu! We want Kadavu!!!!

 

[SelfBiasResistor]

We want Kadavu! We want Kadavu!!!!

I only tried this last batch. It was very high quality, like Kavatime products typically are. It wasn't as uplifting as my normal heavy Vanuatu types but it was the best kava for long duration sleep I've had in a while.

 

[pythagoras51213]

So sorry to hear that, Neil. Horrible thing to do to a blissful business like yours. I will gladly wait for your wonderful kava, but how stressful for you as a business owner.

 

[Zaphod]

That's nuts. Keeping us safe from the Metric system.

“In metric, one milliliter of water occupies one cubic centimeter, weighs one gram, and requires one calorie of energy to heat up by one degree centigrade—which is 1 percent of the difference between its freezing point and its boiling point. An amount of hydrogen weighing the same amount has exactly one mole of atoms in it. Whereas in the American system, the answer to ‘How much energy does it take to boil a room-temperature gallon of water?’ is ‘Go fuck yourself,’ because you can’t directly relate any of those quantities.” Wild Thing by Josh Bazell.

 

[NAMBATU]

For such a big company, DHL offers the worst customer service.

I have never dealt with a courier whose customer service didn't suck. Good luck.

 

[Crunked]

FWIW, the only international shipper I have had customs problems with is DHL. For a while, if I used DHL, the item (not kava and not prohibited) would be detained for a customs inspection ($75) which was payable to DHL. This never happened with any other shipper or USPS. I couldn't help suspect that it was some sort of scam so I stopped using them. Surprise, within a few weeks DHL said they would 'cover' customs inspection charges.

 

[Edward]

That's nuts. Keeping us safe from the Metric system.

There's nothing wrong with the metric system... imperial is fine too... just use both as the mood takes you

FWIW, the only international shipper I have had customs problems with is DHL. For a while, if I used DHL, the item (not kava and not prohibited) would be detained for a customs inspection ($75) which was payable to DHL. This never happened with any other shipper or USPS. I couldn't help suspect that it was some sort of scam so I stopped using them. Surprise, within a few weeks DHL said they would 'cover' customs inspection charges.

I used to use DHL when I got my shipments from stackry. They were fast, like really fast, but quite often I would get a small charge for customs. Now I use the cheaper option and it's a bit slower but everything has always arrived and in a reasonable time (5 or 6 days instead of 3) and I've not had a charge since.

 

[Kava Time]

Good news! Finally managed to get the restock consignment cleared by FDA on condition that all packages are relabeled. This will be taken care of by the fulfillment center so we should be back in stock with some Savusavu, Taveuni, 8yr old single cultivar kadavu (Dokobana Loa) and all the flavored kavas by early next week

 

[SelfBiasResistor]

Good news! Finally managed to get the restock consignment cleared by FDA on condition that all packages are relabeled. This will be taken care of by the fulfillment center so we should be back in stock with some Savusavu, Taveuni, 8yr old single cultivar kadavu (Dokobana Loa) and all the flavored kavas by early next week

Definitely good news. How bad was your Kadavu farmer impacted from the cyclone?