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"?