Tuesday, January 13, 2009

Why is L-Carnitine Restricted in Canada?

A controlled substance is "any type of drug that the federal government has categorized as having a higher-than-average potential for abuse or addiction. Such drugs are divided into categories based on their potential for abuse or addiction. Controlled substances range from illegal street drugs to prescription medications."

Carnitine is a nitrogen amide or quaternary ammonium compound synthesized by the human body from amino acids or ingested primarily through meat eating. Vegetarians, needless to say, consume very little carnitine, and vegans none.

Carnitine is essential for transporting fatty acids into mitochondria where the fatty acids are used as fuel to create energy. Those born without the enzyme that allows carnitine to work its magic have to consume carbohydrates, only carbohydrates, as their energy source and if they go too long without eating carbohydrates they will become weak. There is also some work that shows dogs who do not get L-carnitine in their diet may develop dilated cardiomyopathy. In other words, carnitine is essential for healthy muscle function, including healthy hearts.

Now Canada has a Natural Health Product Act (which Harper wants to tighten) that governs what can or cannot be considered a natural product. It has two Schedules. Schedule 1 lists all the "in" products, the ones Health Canada considers kosher. Schedule 2* lists the "baddies," the substances banned for various reasons that are not always logical, scientific, or based on anything other than who knows whom. Schedule 2 products are:
  1. A substance set out in Schedule C to the Act (this is lawyer speak for flip around, you have to work for your information). Turns out these are radiopharmaceuticals.
  2. A substance set out in Schedule D (biologics) to the Act, except for the following: a drug that is prepared from any of the following micro-organisms, namely, an alga, a bacterium or a fungus; and any substance set out on Schedule D when it is prepared in accordance with the practices of homeopathic pharmacy
  3. A substance regulated under the Tobacco Act
  4. A substance set out in any of Schedules I to V of the Controlled Drugs and Substances Act
  5. A substance that is administered by puncturing the dermis
  6. An antibiotic prepared from an alga, a bacterium or a fungus or a synthetic duplicate of that antibiotic
*Update 02-05-2011: Health Canada seems to have gotten rid of Schedule 2 and replaced it with Schedule F, and Schedule F is under review. This is what they are considering for L-carnitine (aka levocarnitine):



Levocarnitine - The current listing for levocarnitine (also called L-carnitine) would be revised to retain prescription status for levocarnitine and its salts and derivatives when sold for the treatment of primary or secondary levocarnitine deficiencies. Levocarnitine and its salts and derivatives for any other uses at any strength, dosage form or route of administration would be exempt from prescription status. Levocarnitine occurs naturally in animal products and in small amounts in most plants.

Overall, levocarnitine functions in the body mainly in optimal fat utilization for energy production. Absorption of levocarnitine is high from dietary sources but if dietary intake is low then the body can maintain a balanced level by synthesizing or reducing elimination of levocarnitine. In most people, sufficient quantities of levocarnitine are obtained from the diet or synthesized in order to meet human requirements.

Primary levocarnitine deficiency is a genetically inherited condition related to the processing of levocarnitine in the body and can lead to muscle weakness and death from heart failure. Secondary levocarnitine deficiency syndromes are numerous, and include genetic defects of metabolism. Treatment of these conditions with levocarnitine requires the supervision of a practitioner and routine laboratory monitoring.
End update. Back to original blog post:
    It is interesting to note that Schedule 1, which lists those products that can be used in natural health products, includes:
    1. Non-human animal material
    2. An extract or isolate of a substance described in item 1, the primary molecular structure of which is identical to that which it had prior to its extraction or isolation
    I do believe that L-carnitine fits the bill. But wait. Not so fast.

    Carnitine and its stereoisomers, including its biologically active form L-carnitine, are not a radiopharmaceutical, micro-organism, tobacco product, skin puncturing product, or an antibiotic, yet the Natural Health Product Act states that L-carnitine is a Schedule 2 product. L-carnitine is a "prohibited substance" and any product that contains it will not be considered for licensure as a natural health product. So that must mean it's listed in the Controlled Drugs and Substances Act. I actually couldn't find it listed in any of that Act's Schedules.

    However, Health Canada states also that L-carnitine is a Schedule F product. What is Schedule F? (Does your heard hurt yet?) It's a Schedule in the Food and Drugs Act that covers drugs that can only be prescribed and that cannot be sold to a consumer without a prescription (there are a whole slew of ifs, ands, buts covering how, when, where, to whom it can be prescribed).

    But wait.

    Carnitine is a nutrient used by the body, is essential to the body, and is not high inducing nor addictive; it's also found plentifully in food and synthesized by our own bodies, and excess carnitine is excreted by the kidneys, meaning it's safe. We know a controlled substance is one that is subject to abuse or addiction something like opium, and prescribed drugs are ones whose dosages require the expertise of a doctor to calculate and to guard against side effects, toxicity, and drug interactions. But unlike heroin, carnitine or L-carnitine is not addictive, and unlike so many prescription drugs, it's well tolerated and safe. So why does it need to be prescribed?

    Puzzled?

    Then consider this. Sigma-Tau, an Italian pharmaceutical company, is the sole owner of a plethora of patents for L-carnitine products. My search of the Canadian Patents Database resulted in 141 patents. Furthermore, according to Whistleblower2004, "former health minister David Dingwall did get a substantial campaign donation from the pharmaceutical company Sigma-Tau in the 1993 election." Only Sigma-Tau can sell L-carnitine.

    This is known as power. One company holds a bunch of patents on all sorts of products containing L-carnitine. Furthermore, these products can only be sold to consumers with a prescription. And finally, pharmacies can only order L-carnitine-containing products from one seller, the same company that holds the patents: Sigma-Tau. What a lock, eh!

    Our patent laws governing prescription drugs means a company holding a patent on a prescription drug has a lock on the sale of that drug, that is, no generic manufacturer can duplicate that drug, for 20 years from the date of patent. With no competition, the patent-holder can set any price it chooses for 20 years, and no one else can enter the market. Now over-the-counter (OTC) products have no such protections. If L-carnitine was sold OTC, then there would be no restriction to competitors coming in and selling their L-carnitine natural health products. But Sigma-Tau would lose a lot of bucks.

    To summarize: L-carnitine is a nutrient found in food and us. It is not a narcotic. It's not prone to toxicity as our kidneys excrete any excess amounts ingested. It makes no logical sense for carnitine to be a prescription-only, controlled drug.

    And the nail in the coffin as to why restricting the sale of L-carnitine is bogus and not based on science, is the fact that in the US it's available as an OTC product.

    Do I smell the whiff of corruption? Or is this part of a bigger, international industry-created-Canada-approved problem called "Codex Alimentarius"?

    35 comments:

    life insurance Canada said...

    Very interesting article. Bodybuilding is my big hobby and I know L-carnitine is very popular supplement in the world and it's really strange our authorities decided to act in such way...
    Regards,
    Lorne

    John M said...

    Thank you for this very interesting explanation. I ordered some L-Carnitine powder from iHerb.com and it has been held up at Canadian Customs. Today, they told me that they will not let me import it (4 oz). I have a book by reknowned nutritionist Robert Crayhon called "The Carnitine Miracle". Check it out on Amazon.com. Also, check out Ron Rosdale's book "The Rosedale Diet". He recommends L-Carnitine as a supplement twice a day. Both these guys are experts in their field. Why is Health Canada trying to protect me from getting healthy? Smells fishy to me. Your explanation clarifies this very cloudy logic. Thanks.

    talk talk talk / Shireen said...

    Lorne and John, thank you for commenting! I didn't realise all the different uses L-carnitine has -- beyond its beneficial effect on the heart -- until I started researching this and now hearing from you.

    Why is Health Canada trying to protect us from getting healthy, is a very good question. The media really ought to do a better job of exposing this kind of activity because L-carnitine isn't the only nutrient, non-narcotic, on that prohibited substances list. I have to wonder how theobromine got on there too!

    freeworkoutguides said...

    Thank you for this blog post!

    I've been trying to order some supplements with L-Carnitine in it and no-one is shipping to Canada.

    Someone did tell me that it's not illegal to be in possession of the product though so I might try going down to the states and getting some then brining it back across.

    Try to get the media in on this, it shouldn't be banned here OTC.

    Anonymous said...

    I have used L-Carnitine bought in the USA and it works great. You have more energy and you don't get any ups and downs like with coffee. The only reason it is restricted in Canada is because somebody is making lots of money of it. Try bring in a Canada cheese or wine from Europe and you will fine that only the chosen are allowed. I guess the same applies to L-Carnitine too. If it is not regulated then you will not have monopoly on the market.

    Steveo said...

    I don't think this as insidious as the writer implies. I don't know of many doctors that are prescribing L-Carnitine; perhaps some naturopaths are, but I haven't seen or heard of MDs prescribing it.

    I personally have got a variety of carnitines from the US (ALCAR, PLCAR, LCLT) and have been quite impressed with them. It almost makes me want to try and change things in Canada, but I don't really think it's worth the effort.

    talk talk talk / Shireen said...

    Steveo, The principle of banning something to profit a single company is not something one ought to be complacent about. And if they do that with l-carnitine, what other products do they restrict for monetary not health reasons?

    Also, l-carnitine's value isn't just by itself but also as part of formulas that greatly help people with health problems like heart failure. And most doctors know little to nothing about basic nutrition so they won't know about how food or food components affect health positively or negatively.

    Suz said...

    I sometimes wonder who is running the show here in Canada. The government will allow us to take as many poisonous drugs as we can get prescriptions for. As long as an acceptable number of deaths occur they allow a drug to be released for the "greater good". How many people have died from consuming L-Carnitine? How many have even gotten ill??? I wish they would start regulating processed food and prescription drugs as diligently as they regulate natural health products. Perhaps our health care costs as a country would not be headed to 70% of the budget and would no longer be a threat to our economic wellness! Ah but then they would have to battle big business instead of the poor health seeking individual.

    hunter said...

    how do we change this? Is there any hope at all the law will change regarding this supplement?

    talk talk talk / Shireen said...

    hunter: I don't know. Maybe ask your MP about why Health Canada has some capricious rules...

    L-Carnitin said...

    i thought that L-carnitine doesnt had any side effects. it is very popular here!

    Anonymous said...

    In just bought it in Canada. I was told that it should be on the shelves regularly by march 2011.

    talk talk talk / Shireen said...

    That's good to hear. Thank you for sharing!

    supplement canada said...

    Fine clarification. Not getting enough protein in the diet is rare in the developed world, but if you're concerned about it.

    canada supplements

    Anonymous said...

    tried bringing some into Canada and was told by border agency that it is considered worse than cocaine and could have been doing jail time(10 YEARS)

    it was confiscated and no fine or jail time incurred

    talk talk talk / Shireen said...

    That's nuts! The border agent doesn't know what s/he's talking about, it being worse than cocaine. But that's the problem when the government restricts products based on grease-the-wheel reasons, yet won't protect us from products that really do endanger our health.

    Glad you weren't fined or sent to jail!

    Anonymous said...

    Thank you for that explanation. My vet recommended it for supporting my dog with neurological issues - due to aging. They have had good results with it.

    Now, the issue is finding it. :-(

    Anonymous said...

    Good article,
    I've always thought that Canada's government was not corrupt, or at least much less corrupt than other placess. It seems however, more and more that Health Canada's seal of Approval is available to highest bidder, with the health of Canadians being a much lower priority.
    I voted for Harper, but this crap is making me reconsider what I will do in the next election.

    Anonymous said...

    It is still not possible to bring this into Canada - just had my two bottles of L-Carnitine seized on the border, did not understood whay ban this product hee, but inthe light of this post I think I understand now - pork and more pork that's what counts for politicians!

    Jeanette said...

    I just purchased a bottle of L-Carnitine at a Health food store.
    I live and Breath in Canada.
    So how did this happen if its a banned substance.

    Holly M said...

    Hi
    I just found out today how difficult it will be to get LCarnitine. I saw it on Dr Oz and called Kardish specialty foods, who said they aren't allowed to sell it. Have you heard anything else about it being deregulated?
    I suspect the person at the health food store is fed up with the calls since Dr Oz got on the bandwagon about a number of products that aren't available here. I wasn't the first person she had to turn down.

    talk talk talk / Shireen said...

    Hi Holly and Jeanette: From the Health Canada website, it looks like unauthorized l-carnitine products pop up in health stores in various parts of Canada, but that sometimes HC finds and seizes them. That may be why occasionally someone can find it here.

    Health Canada is reviewing the status of l-carnitine. But it'll probably be awhile before Canadians can buy it, given how slowly government works.

    Anonymous said...

    I'm glad to hear that comment.

    However, I sent an email to Stephen Harper and health canada two elections ago and received a written response from Dr. Supriya Sharma, Director General,
    Therapeutic Products Directorate.

    This was in the middle of 2008 and it essentially indicated that L-Carnitine and Acetyl-L-Carnitine are being "reviewed". Considering the time line it is likely that nothing is actually being done and that your hypothesis about the influence of big pharma in this case holds water.

    Perhaps it's time that natural health consumers, retailers and manufacturers created their own full time lobbying/watchdog group, in order to prevent the government from being misled and legislating on the basis of blatantly incorrect and/or biased information

    Anonymous said...

    I also bought some in the US along with some amino acids and cookies & cream gold whey protein, which i had to put in a zip lock bag because the container was too big for my luggage.

    The airline happened to misroute my luggage and they sent it for delivery the day after. Border services called me and asked me if I had had issues in the past with the customs or been to jail for that and then asked me if I knew i had illegal substances inside my luggage... I was like "what the heck" until he told me that amino acids are illegal in Canada and he even confiscated my 5 lbs of whey protein because he said i could not prove it was what i said it was... (all that over the phone)...
    Soo disgusted with Canadian customs... Soo people smoke marijuana all over the streets here and someone who is just health conscious is getting robbed? cost me 140 USD gone down the drain or to some agent's house... Sucks...

    Anonymous said...

    I used to buy L-Carnitine in the late 80's early 90's.. Then all of a sudden they banned the sale of it. It was about the same time they banned ephedrine. The government claimed it was harmful. Since then I have gone to special 'Health' stores, who will sell it secretly behind the counter.

    G said...

    I have asked for it a a couple of health supplement stores and both times they have told me they have told me they are not allowed to sell it here in canada, then after some chatting about other stuff / supplements they offer it to me if I pay cash... tripple price of course...

    I go to Buffalo every so often and I lways purchase a bottle or two and have never had a problem with it, I always declare it and show my GNC receipt (alog with a bunch others) and have never had any problem... That said, after reading here I'm a little scared I may have some throuble next time...

    Anonymous said...

    We got pulled over at the border because we had liquid L-Carnitine. The border officer said that it causes "heart problems." The lady that sold us the product told us it is very healthy for digesting fats and that it is safe. We knew L-Cartinine was banned but for some reason my dad still wanted to buy it... I personally don't think L-Carnitine should be banned but Canadian policies are a little too strict..

    Anonymous said...

    I am a doctor and I have prescribed L-carnitine in the past. It is one of the rare supplements that is actually useful and without much side effects (may cause nausea and vomiting at the begining). I agree with some of the comments that it should become over the counter in Canada. I think there should be a cmpaign and perhaps even a lawsuit against health canada over this.

    Josiah said...

    I was on supplementscanada.com, 5 minutes ago, and in the new product section Optimum Nutrition has their L-Carnitine product for sale. Has the regulations on the supplement changed?

    talk talk talk / Shireen said...

    Josiah: I had heard recently that they were changing, but hadn't realised that it was now freely available. Since it's an online site you went to, perhaps they're jumping the gun, knowing Health Canada is finally becoming sensible on this matter??

    Anonymous said...

    http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2011/2011_168-eng.php

    http://suppcanada.com/2012/l-carnitine-approved-by-health-canada-finally/

    Its ( L- Carnitin ) not banned in Canada any more :) ..Call your stores & let them know that ..as of Jan - 2012 its no longer banned :)

    talk talk talk / Shireen said...

    Awesome! And I see theobromine is on that list too.

    Thank you Anon for telling me and my readers!!

    Anonymous said...

    I buy l-carnitine from Vitacost in the States and get it delivered to Canada. The prices are unbelievable! I have no problems and it only takes a week to get delivery. Why are these things so much cheaper in the States?

    Anonymous said...

    When DHL delivers a package to Canada they send an envelope a week later asking for you to pay broker/administration fees usually $30 charge. So not a good deal.

    Anonymous said...

    Thanks Anonymous for bringing to our attention the border officer's comment that L-Carnitine causes "heart problems".

    I learned about L-Carnitine from a Dr. Oz TV show specially recommended for people with weight in upper body (chest & arms). I have been taking liquid L-Carnitine now for 3 weeks in addition to apple cider vinegar and water for my acid reflux problem every morning before breakfast as recommended. 2 days ago I experienced my heart beat going faster and felt dizzy something I never felt before. Overly, I am very healthy petite woman trying to loose 15lbs I gained since Christmas. The health food store owner told me it is safe to take but I have to check with my doctor.