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The FDA's loophole to stop you purchasing L-Glutamine and other Supps. Take Action!

Carl

Senior Member
Messages
362
Location
United Kingdom
If this is allowed to continue, a drug company could ask the FDA to remove all L-Glutamine from sale and the only option would be a $40,000 a year drug as a substitute. By comparison L-Glutamine costs very little.

Therefore I would urge anyone in the USA to forward the article to everyone that may be willing to send an objection and make their views known about this situation.

This does not directly affect me because I am not in the USA. However the drug companies are up to similar tricks around the world. The THMPD in the EU happened after several hundred people suffered kidney failure from being prescribed a herbal medicine by doctors which is never traditionally used for weight loss. This was used to convince EU MEP's when the THMPD was made law in the EU.

The THMPD was passed in the EU and now drug companies can remove from sale any herbal product they see fit. They were given control on any herbs that they saw as having medicinal properties ie those which threatened their drug sales. The EU did investigate this but behind closed doors and found no one liable. The drug companies were allowed to get away with it.
http://www.anh-usa.org/action-alert-close-the-fda-back-channel/
Note: There is a form on the anh website to contact your representative and voice your opinion.
Taken from the ANH website:
Tell Congress: Close the FDA Back-Channel
For years, consumers have benefited from access to cheap, safe, and effective CBD oil and L-glutamine supplements. But now the FDA says that CBD is a drug, not a supplement--a drug which will be sold for $32,500 a year. Legally the FDA could at any time remove all CBD supplements from the market, on its own volition, or if the drug company who holds drug market exclusivity requests FDA do so. A newly approved drug means L-glutamine faces a similar threat.

This is happening because of a back-channel that allows natural supplements to be turned into drugs by the FDA. It works like this: if a company is investigating a substance as a drug, FDA rules give the company market exclusivity on that substance--even if it is currently being sold as a supplement. There are only a few exceptions to this rule.

This means that, at any time, GW Pharmaceuticals, the manufacturer of the CBD drug, can ask the FDA to remove cheap CBD oil supplements from the market, and the only option consumers will have is their new drug that costs $32,500 a year. This hasn't happened yet, but GW could simply be waiting for the market for CBD oil to grow--which it is. When it reaches a tipping point, then GW can ask the FDA to remove all the CBD supplements, and wait for the cash to roll in from consumers who don't have any other choice.

The same goes for L-glutamine, a supplement that can be bought for $10 a bottle; the drug, Endari, will reportedly cost $40,000 a year.

We need legislation that protects CBD oil, L-glutamine, and other natural substances from being turned into drugs by eliminating the market exclusivity that drug companies get when a new drug investigation is on a dietary ingredient currently being sold in the market as a dietary supplement. These rules should apply retroactively to protect CBD oil and other substances like pyridoxamine that have already (or are likely to be) removed before this legislation becomes law.

Until we close this loophole, we will see drug companies continue to turn our natural dietary supplements into drugs. News headlines are filled with Phase II or Phase III drug trials failing; Big Pharma is in search of a sure thing, and what could be better than supplements that have demonstrated health benefits? The FDA will not protect us--they're in on it! More drugs mean more user fees--more money--for the agency, so don't expect the FDA to defend our access to supplements.

Write to the FDA and Congress and tell them that they must protect consumer access to cheap CBD oil, and should champion efforts to change the rules so supplements can't be turned into drugs.

We just need few pieces of information to connect you with representatives.
 
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Carl

Senior Member
Messages
362
Location
United Kingdom
I actually have a friend who is a drug developer and is going to a conference next week on this subject I will keep you all informed with what on what I hear.
I would be interested in reading about this when you have any information.

The problem is most people think things like this will never happen......until they do. This happened in Europe with the THMPD. Now drug companies have been given the power to decide whether any herbs have pharmaceutical properties and can ban their sale. This happened with Milk Thistle extract which can be helpful for CFS. I purchased some of this and when I attempted to order more from the same company they told me that they could not see if to people in the EU. I had to find other sources, one of which has since stopped selling it. I am now left with only one place to purchase from.
 

pamojja

Senior Member
Messages
2,384
Location
Austria
This happened with Milk Thistle extract which can be helpful for CFS.

https://www.lifeextensioneurope.com...s/milk-thistle?SID=esmq56hqe9o30b7pjoc185dbl7
https://swansoneurope.com/en/swanson-Milk-Thistle-(Standardized).html
https://www.healthmonthly.co.uk/products_search.php?search_string=milk thistle
https://www.indigo-herbs.co.uk/shop/buy/milk-thistle-extract

Funny, just got Milk Thistly extract from bulkpowders.at, but seems https://www.bulkpowders.co.uk doesn't carry it anymore.

But yes, it is very scary what can happen anytime, with the majority of the population totally unconcerned.


PS: As long we can find sources within the EU we're still ok. However, we already have that abstruse situation, that for example Austrian customs checks if any ingredient of a imported supplement is found in a prescription medicine. If it is, they declare it as illegal medicine import - practically as private person it's almost impossible to do so legally - and could fine it € 260,-, on repeat up to € 2600,-!

If the custom officer considers it a minor case, one gets fined € 50,- and the item confiscated. Happened to me already 3 times because of sillimarin, alpha-lipoic acid and nattokinase. In only one case I was indeed fined € 260,- for a bottle of NOW TMG worth 10 bucks. Did repeal and since they couldn't process the repeal in the required time of 15 month the charge was dropped. It is scary, because I never suspected such harmless supplements considered as prescription meds. Beside, all these are freely available in certain supermarket chains anyway here (but at ridiculously low doses and high prizes).
 
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jesse's mom

Senior Member
Messages
6,795
Location
Alabama USA
This is indeed awful!
I will report any information my friend relays from the conference.
He has developed drugs over his long career, and has been before the FDA many times.
He worked on nicorette gum, and antabuse.
He is in his 70's and is going before the FDA one more time, then he is retiring.
 

Carl

Senior Member
Messages
362
Location
United Kingdom
Unfortunately most of those are capsules which I avoid. I prefer 80% Silymarin extract powder. The Indigo Herbs is only 50g and I buy 250g (x5 times) when I purchase for less than 50% more on eBay. Indigo Herbs do tend to flout the rules when selling because they are not meant to sell alcohol based tinctures in the UK. I have purchased such things from them on multiple occasions but they are a bit expensive. I should try and order from a herbal product manufacturer which I used to order from but they did start asking whether I was a herbalist because they can only sell to registered herbalists. Difficult questions could trip me up but they need to do business so it is not really in their interests to do any more than the basics to assure they are only selling to who they are meant to.

But yes, it is very scary what can happen anytime, with the majority of the population totally unconcerned.


PS: As long we can find sources within the EU we're still ok. However, we already have that abstruse situation, that for example Austrian customs checks if any ingredient of a imported supplement is found in a prescription medicine. If it is, they declare it as illegal medicine import - practically as private person it's almost impossible to do so legally - and could fine it € 260,-, on repeat up to € 2600,-!

If the custom officer considers it a minor case, one gets fined € 50,- and the item confiscated. Happened to me already 3 times because of sillimarin, alpha-lipoic acid and nattokinase. In only one case I was indeed fined € 260,- for a bottle of NOW TMG worth 10 bucks. Did repeal and since they couldn't process the repeal in the required time of 15 month the charge was dropped. It is scary, because I never suspected such harmless supplements considered as prescription meds. Beside, all these are freely available in certain supermarket chains anyway here (but at ridiculously low doses and high prizes).
The EU is in the back pocket of the drug companies and tries to protect their profits while destroying human health at every opportunity. It is such a ####### organisation that I am glad that we are heading out, or at least should be if the EU remainers do not get their poorly considered way.
 
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Carl

Senior Member
Messages
362
Location
United Kingdom
PS: As long we can find sources within the EU we're still ok. However, we already have that abstruse situation, that for example Austrian customs checks if any ingredient of a imported supplement is found in a prescription medicine. If it is, they declare it as illegal medicine import - practically as private person it's almost impossible to do so legally - and could fine it € 260,-, on repeat up to € 2600,-!

If the custom officer considers it a minor case, one gets fined € 50,- and the item confiscated. Happened to me already 3 times because of sillimarin, alpha-lipoic acid and nattokinase. In only one case I was indeed fined € 260,- for a bottle of NOW TMG worth 10 bucks. Did repeal and since they couldn't process the repeal in the required time of 15 month the charge was dropped. It is scary, because I never suspected such harmless supplements considered as prescription meds. Beside, all these are freely available in certain supermarket chains anyway here (but at ridiculously low doses and high prizes).
https://www.bulkpowders.co.uk
do sell TMG powder because I purchase it from there myself. Serrapeptase/Nattokinase is available on ebay.co.uk or from their website
https://vitacure.co.uk/
If you can manage to get it imported into your country. I do not have any problems with Alpha Lipoic Acid which I usually get from healthmonthly.
 

pamojja

Senior Member
Messages
2,384
Location
Austria
The EU is in the back pocket of the drug companies and tries to protect their profits while destroying human health at every opportunity. It is such a corrupt organisation that I am glad that we are heading out, or at least should be if the EU remainers do not get their poorly considered way.

Actually I based my appeal mainly on this EU-high court decision: https://lexetius.com/2007,3165 (sorry, in German) according to which a medicine is clearly defined through EU laws by function and definition, ie. a clinically effective ingredient AND defined for treating a disease. Supplements differ in that they they still can contain an effective ingredient BUT with no declaration of treating a disease. According to EU ruling and high court decision.

Actually talked on the phone with the officer working on my legal case, and she agreed with my that this obviously not EU conform handling by Austrian customs seems very suspect of being just for the profit-protection of local pharmacies.

Therefore I feel Austria custom laws are even more protective than the EUs, which at least would give a clear legal distinction between supplements and medicine.
 
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Messages
97
Thanks for posting this link. I feel that it is extremely important for anyone who uses OTC supplements of any kind to take action on these type of issues. My fear is that the government is getting way too regulatory regarding alternative health options and at the same time, limiting our access to ‘real’ medical care by allowing insurance companies to dictate how doctors practice.
 

keenly

Senior Member
Messages
814
Location
UK
I warned about this years ago on here and was met with apathy. MOST supplements could be banned in the next decade.
 

pamojja

Senior Member
Messages
2,384
Location
Austria
But what can we do? Signing petitions or writing to representatives is one thing. Buying supplements an other. Since in the end it's an industry too. And the bigger of them will definitely defend their profit with all means.

One or the other thing will definitely be gone, like pyridoxamine which has been patented as drug in the US and since is accumulating dust on a shelf of the patent-office. Though paradoxically still available in the EU here.
 

jesse's mom

Senior Member
Messages
6,795
Location
Alabama USA
My friend went to the conference in DC and thinks we will not have a problem in the US with them changing the OTC supplements anytime in the foreseeable future. His daughter was mostly concerned about CBD oil and he again said no problem.