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MitoQ confiscated in the mail by FDA and USDA

mitoq

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#1 geo12the

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Posted 22 December 2015 - 10:41 PM


My shipment of MitoQ was confiscated in the mail and I got a silly letter from the USDA and FDA that it was an UNAPPROVED NEW DRUG and that its prohibited by congress to purchase prescription drugs by mail blah blah blah. I think my name has been flagged because I ordered succulents from overseas once and they were confiscated so now I think all packages I get from overseas are inspected. Has anyone else had this issue with getting MitoQ? Is the FDA cracking down on it or is it just that my name is flagged?


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#2 Turnbuckle

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Posted 23 December 2015 - 12:13 AM

Don't mess with these people. They're like the mafia, protecting the profits of the drug industry, and they're serious. The USDA and the Post Office are both arming themselves--the USDA with 40 caliber submachine guns. Nobody wants MitoQ that bad.


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#3 niner

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Posted 23 December 2015 - 01:52 AM

Are you suggesting that the postman or someone from the Agriculture department are going to shoot us if we order MitoQ?  That seems unlikely.  I've been wondering how MitoQ could be sold here, given that it doesn't qualify under DSHEA94 as a supplement.  It is in fact an unapproved drug.  Not that I have a problem with unapproved drugs, but anyway I guess I don't have to wonder anymore.  We should probably expect the same treatment for any other research chemicals, nootropics, etc.  This raises a question regarding commercial c60oo.  It probably gets down to whether or not people are making health claims and how big their marketing effort is.  I think MitoQ probably went a little overboard in those areas.

 

@geo12the, I've never heard a report of a confiscation in the US, but I've never heard of a watch list of plant importers either.  Might just be a coincidence, but you could try having someone else order it.  Meanwhile, I guess you're out whatever it cost you, which sucks.  Is MitoQ shipping packages with their name on them?  If anyone was on a list, I'd expect it to be them rather than you.


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#4 Logic

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Posted 23 December 2015 - 10:28 AM

Are you suggesting that the postman or someone from the Agriculture department are going to shoot us if we order MitoQ?  That seems unlikely.  

 

No, but the fact that someone higher up feels it's necessary to arm them means that there are probably plans to start doing the kind of thing that will piss large crowds of people off a LOT..!?
I'm sure geo12 feels like ripping them a new asshole atm!  :)

Worrying.

Perhaps the National Institute of Aging's interest has put it on the radar?

http://www.longecity...lected-for-itp/

 



#5 Turnbuckle

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Posted 23 December 2015 - 05:26 PM

Are you suggesting that the postman or someone from the Agriculture department are going to shoot us if we order MitoQ?  That seems unlikely.  

 

 

The Homeland Security Act allowed many agencies to arm themselves, and so now we have EPA and Department of Education agents walking around with shotguns and the USDA with sub-machine guns. The USDA mostly kills animals--millions every year--but give it time. Agencies don't like to have tools and not use them.



#6 stefan_001

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Posted 23 December 2015 - 09:39 PM

 

Are you suggesting that the postman or someone from the Agriculture department are going to shoot us if we order MitoQ?  That seems unlikely.  

 

No, but the fact that someone higher up feels it's necessary to arm them means that there are probably plans to start doing the kind of thing that will piss large crowds of people off a LOT..!?
I'm sure geo12 feels like ripping them a new asshole atm!   :)

Worrying.

Perhaps the National Institute of Aging's interest has put it on the radar?

http://www.longecity...lected-for-itp/

 

 

 

I suspect they are monitoring this forum and hacking into our IDs to collect home adresses for a massive raid to wipe out the MitoQ community....Stuxnet II probably already attacking the mitoQ centrifuges...


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#7 niner

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Posted 23 December 2015 - 09:42 PM

Yeah, that's probably it.  I'm sure they've nothing better to do.


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#8 Turnbuckle

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Posted 23 December 2015 - 10:17 PM

Occasionally the USDA behaves like the early prohibitionists with their axes. From the Atlantic--

 

 

In Venice, California, the Rawesome raw food club was raided by armed federal and county agents who arrested a club volunteer and seized computers, files, cash, and $70,000 worth of perishable produce. James Stewart, 64, was charged on 13 counts, 12 of them related to the processing and sale of unpasteurized milk to club members. The other count involved unwashed, room-temperature eggs—a storage method Rawesome members prefer. The agents dumped gallons of raw milk and filled a large flatbed with seized food, including coconuts, watermelons, and frozen buffalo meat.

 

 

 

 


Edited by Turnbuckle, 23 December 2015 - 10:18 PM.


#9 niner

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Posted 24 December 2015 - 06:04 AM

What is preventing people from changing the law so that raw milk is not illegal?  Are people afraid that if you did that, the next thing you know there'd be salmonella in the dairy case?  Could there be a carve-out for small operations like raw food clubs?  It doesn't do much good to complain about enforcement; we just need to get the laws changed.



#10 Turnbuckle

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Posted 24 December 2015 - 12:32 PM

What is preventing people from changing the law so that raw milk is not illegal?  Are people afraid that if you did that, the next thing you know there'd be salmonella in the dairy case?  Could there be a carve-out for small operations like raw food clubs?  It doesn't do much good to complain about enforcement; we just need to get the laws changed.

 

 

 

I'd never tasted raw milk until I spent some time in France, and I was astounded. It was so much better than what we call milk! Unfortunately, there are as many milk laws as there are states, and at the federal level, pasteurization isn't even a law but a regulation. More and more we are being regulated on everything by faceless, unelected bureaucrats.


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#11 stefan_001

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Posted 24 December 2015 - 08:46 PM

Occasionally the USDA behaves like the early prohibitionists with their axes. From the Atlantic--
 

 
In Venice, California, the Rawesome raw food club was raided by armed federal and county agents who arrested a club volunteer and seized computers, files, cash, and $70,000 worth of perishable produce. James Stewart, 64, was charged on 13 counts, 12 of them related to the processing and sale of unpasteurized milk to club members. The other count involved unwashed, room-temperature eggs—a storage method Rawesome members prefer. The agents dumped gallons of raw milk and filled a large flatbed with seized food, including coconuts, watermelons, and frozen buffalo meat.


Ok I admit, if they do that then a raid for substances qualified as unapproved drug is a real possibility.

#12 StephCThomp

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Posted 27 December 2015 - 10:05 PM

...um... dare I pipe in and suggest it's just a mistake?  :)  American weaponry obsession pathologies aside, perhaps the individual doing the checking got lazy or misunderstood something.  Just give them a call, have a chat, and they might send it on.

 

That happened to me years ago with Tocotrienols.  Not in America, granted.  The chap was unfamiliar with it.  All I did was call up, talk him through it being a relative of Vitamin E, he looked it up and then forwarded it to me.  Easy.  

 

Always worth a try explaining to them it's just a form of CoQ10, so a nutrient.

 

 



#13 niner

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Posted 27 December 2015 - 11:24 PM

Always worth a try explaining to them it's just a form of CoQ10, so a nutrient.

 

That's a good idea.  It might be possible to con them with this argument.  The more I think about it, I suspect that MitoQ went a little too far with the health claims and that's what set this off, but it's worth a try.  We might need to get someone outside the US to reship it in a plain brown wrapper.



#14 StephCThomp

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Posted 28 December 2015 - 12:33 AM

My point was not to "con" them, but to talk to them.  If MitoQ's health claims are excessive then yes the label might trigger that response, but if the (far less exciting) reality is that it's a nutrient in the CoQ10 family then it's correct to allow it through.  The giveaway is that MitoQ is available in the US from regular retailers.  It's not a prescription item.  I think the USDA/Customs staff quite likely just made an error or took a shortcut in the Christmas rush.



#15 pamojja

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Posted 28 December 2015 - 09:59 AM

My point was not to "con" them, but to talk to them.

 

Every country has different custom rules. As soon they find an ingredient of a shipment in any prescription medicine, it's declared an illegal medicine import and confiscated here. With small amounts (decided by the custom officer) fined right away with € 50,-, otherwise € 260,-. On repeat up to € 2600,-.

Payed already 50,- each for a bottle of Alpha-Lipoic acid and a trial bottle with 7 tabs of Inflama-Rest, because of Nattokinase and Silimarins in it. No matter that these would be available at low doses over the counter here too.

Once had to repeal a fine of 260,- for a bottle of TMG tablets. Only didn't had to pay because they didn't process it in the required time within 15 months.

 

 

Each time I did talk to the officers on phone, and they agreed that this regulation seems more to protect the local market, than the costumer. Nevertheless, they would have to comply to their rules..



#16 Turnbuckle

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Posted 28 December 2015 - 11:15 AM

 

My point was not to "con" them, but to talk to them.

 

Every country has different custom rules. As soon they find an ingredient of a shipment in any prescription medicine, it's declared an illegal medicine import and confiscated here. With small amounts (decided by the custom officer) fined right away with € 50,-, otherwise € 260,-. On repeat up to € 2600,-.

Payed already 50,- each for a bottle of Alpha-Lipoic acid and a trial bottle with 7 tabs of Inflama-Rest, because of Nattokinase and Silimarins in it. No matter that these would be available at low doses over the counter here too.

Once had to repeal a fine of 260,- for a bottle of TMG tablets. Only didn't had to pay because they didn't process it in the required time within 15 months.

 

 

Each time I did talk to the officers on phone, and they agreed that this regulation seems more to protect the local market, than the costumer. Nevertheless, they would have to comply to their rules..

 

 

The West is losing its freedoms to a rising tide of Kafkaesque bureaucracy. In the US there is legalized highway robbery by federal and state agents that can seize money, cars, and any other property they deem might have some connection to drug trafficking, terrorism, or any other crime. Civil asset forfeiture is often used against minorities not charged with any crime whatsoever, and there is no administrative recourse. You have to sue them to get your property back, which can take years, cost thousands, and invite retaliation.

 

As for the case in the OP, bureaucracies respect those who know their rules (and treat them with the respect due to kings). On the FDA website, one will find the following--

 

 

Is it legal for me to personally import drugs?
 
In most circumstances, it is illegal for individuals to import drugs into the United States for personal use. This is because drugs from other countries that are available for purchase by individuals often have not been approved by FDA for use and sale in the United States. For example, if a drug is approved by Health Canada (FDA’s counterpart in Canada) but has not been approved by FDA, it is an unapproved drug in the United States and, therefore, illegal to import. FDA cannot ensure the safety and effectiveness of drugs that it has not approved.
 
FDA, however, has a policy explaining that it typically does not object to personal imports of drugs that FDA has not approved under certain circumstances, including the following situation:
 
The drug is for use for a serious condition for which effective treatment is not available in the United States;
There is no commercialization or promotion of the drug to U.S. residents;
The drug is considered not to represent an unreasonable risk;
The individual importing the drug verifies in writing that it is for his or her own use, and provides contact information for the doctor providing treatment or shows the product is for the continuation of treatment begun in a foreign country; and
Generally, not more than a 3-month supply of the drug is imported.
 

 

 

 
This FDA example provides a very tiny loophole, and is probably exaggerated to make it seem impossible. For MitoQ I would argue that it isn't a drug at all, but a supplement sold in the US, but perhaps not of the quality or form you need. (The only hit on the FDA website is a report that mitoquinone/MitoQ is a pro-oxidant that, in the case of cancer cells, "causes the upregulation of autophagy, and autophagy acts as an antioxidant feedback response triggered by cytotoxic levels of MitoQ." So probably it isn't on any list for confiscation...and probably not something you'd want to take unless you had cancer.)

Edited by Turnbuckle, 28 December 2015 - 11:36 AM.


#17 niner

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Posted 29 December 2015 - 05:20 AM

Some drugs are based on natural products, but they have been modified in some way, so they are no longer a natural product.  MitoQ falls into this class.  MitoQ contains ubiquinone, bound to a very unnatural triphenylphosphonium group.  In CoQ10, ubiquinone is bound to a long isoprenoid tail.   Once you've chopped up a molecule and bonded it to something else, it's not the same molecule.  MitoQ doesn't exist in nature and isn't a part of our diet or our physiology.   I'm pretty sure that it fits the FDA's definition of "drug", and not "dietary supplement".

 



#18 Turnbuckle

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Posted 29 December 2015 - 11:15 AM

Some drugs are based on natural products, but they have been modified in some way, so they are no longer a natural product.  MitoQ falls into this class.  MitoQ contains ubiquinone, bound to a very unnatural triphenylphosphonium group.  In CoQ10, ubiquinone is bound to a long isoprenoid tail.   Once you've chopped up a molecule and bonded it to something else, it's not the same molecule.  MitoQ doesn't exist in nature and isn't a part of our diet or our physiology.   I'm pretty sure that it fits the FDA's definition of "drug", and not "dietary supplement".

 

 

I believe this is a simplistic view, as the regulations do not use the word "natural". (Nor do they exclude drugs from being natural). From the FDA website--

 

 

What is a dietary supplement?
Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement.
 
What is a "new dietary ingredient" in a dietary supplement?
 
The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined both of the terms "dietary ingredient" and "new dietary ingredient" as components of dietary supplements. In order for an ingredient of a dietary supplement to be a "dietary ingredient," it must be one or any combination of the following substances:
 
a vitamin,
a mineral,
an herb or other botanical,
an amino acid,
a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or
a concentrate, metabolite, constituent or extract.
A "new dietary ingredient" is one that meets the above definition for a "dietary ingredient" and was not sold in the U.S. in a dietary supplement before October 15, 1994.

 

 

So if CoQ10 qualifies as a dietary supplement, then MitoQ is simply "any combination"--a "ubiquinone conjugate," to use the FDA's language. And as MitoQ is already being sold in the US as a dietary supplement without interference from the FDA*, it isn't the place of a customs inspector to make this sort of decision and confiscate a package on that basis.

 

*According to the FDA--"Manufacturers and distributors do not need FDA approval to sell their dietary supplements."


Edited by Turnbuckle, 29 December 2015 - 11:35 AM.


#19 niner

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Posted 29 December 2015 - 10:12 PM

 

Some drugs are based on natural products, but they have been modified in some way, so they are no longer a natural product.  MitoQ falls into this class.  MitoQ contains ubiquinone, bound to a very unnatural triphenylphosphonium group.  In CoQ10, ubiquinone is bound to a long isoprenoid tail.   Once you've chopped up a molecule and bonded it to something else, it's not the same molecule.  MitoQ doesn't exist in nature and isn't a part of our diet or our physiology.   I'm pretty sure that it fits the FDA's definition of "drug", and not "dietary supplement".

 
I believe this is a simplistic view, as the regulations do not use the word "natural". (Nor do they exclude drugs from being natural). From the FDA website--

 

When I say "natural product", I'm not invoking some sort of naturalistic fallacy, I'm using it as a Medicinal Chemist defines the term, which is any compound found in nature. 

All the substances described in DSHEA94 are natural products.  Since triphenylphosphonium is not a component of human diets, or as far as I'm aware, found in nature, I think it falls outside of DSHEA94.
 

 

What is a "new dietary ingredient" in a dietary supplement?
 
The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined both of the terms "dietary ingredient" and "new dietary ingredient" as components of dietary supplements. In order for an ingredient of a dietary supplement to be a "dietary ingredient," it must be one or any combination of the following substances:
 
a vitamin,
a mineral,
an herb or other botanical,
an amino acid,
a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or
a concentrate, metabolite, constituent or extract.
A "new dietary ingredient" is one that meets the above definition for a "dietary ingredient" and was not sold in the U.S. in a dietary supplement before October 15, 1994.

 
So if CoQ10 qualifies as a dietary supplement, then MitoQ is simply "any combination"--a "ubiquinone conjugate," to use the FDA's language. And as MitoQ is already being sold in the US as a dietary supplement without interference from the FDA*, it isn't the place of a customs inspector to make this sort of decision and confiscate a package on that basis.
 
*According to the FDA--"Manufacturers and distributors do not need FDA approval to sell their dietary supplements."

 

Perhaps I'm misinterpreting it, but I read "any combination" as a mixture.   However, even if it were intended to include covalently bonded combinations of the substances on the list, it doesn't allow substances not on the list, so a triphenylphosphonium group would make the compound non-qualifying.
 



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#20 Turnbuckle

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Posted 29 December 2015 - 11:11 PM

I don't see TPP on the FDA's gras list, but the situation with supplements is political and thus not black and white. The main thing is they are not being consistent--if the FDA is treating domestic sales as unregulated supplements, how can a customs inspector declare it a regulated drug? Possibly the bottle has some claims not allowed for supplements in the US, but whatever the bureaucratic problem, that shouldn't be an issue for the buyer. So the steps could be these--

 

(1) Contact the vendor and ask that the item be reshipped or money refunded.

(2) Buy domestically from now on. 

 

Amazo n carries it, so getting it delivered shouldn't be a problem. 


Edited by Turnbuckle, 29 December 2015 - 11:12 PM.






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