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Ten nutrients consumers can buy over-the-counter again

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by Dr. Eldon Dahl, ND

Vitamin pills in a leaf• Ever wondered if you could bottle that sleepy feeling you get after eating a big turkey dinner, for future use on one of those long, restless nights? Well, last December, the Canadian health food industry was overjoyed when L-tryptophan, along with nine other products, was released from *Schedule F restriction. Until then, all these ingredients were only available to Canadians via expensive prescriptions. According to clinical studies in the Natural Standard clinical database, these nutrients have been clinically reviewed and used with life-changing improvements. Despite their proven effectiveness, however, Canadians are only now able to obtain these products legally without a prescription.

Last year, Health Canada, with the help of its Drug Schedule Status Committee, undertook a review of the science assessment for these 10 naturally sourced medicinal ingredients and decided that none of the reasons for restricting them in Schedule F were found to apply. The committee recommended these medicinal ingredients could be regulated as non-prescription status under the Natural Health Products Regulations.

So why has tryptophan been so controversial? It is best known as a natural relaxant. It helps improve sleep patterns and aids the body in the metabolization of carbohydrates, proteins and fats. The controversy surrounding L-tryptophan is best explained in the book The Healing Nutrients Within by Dr. Eric R. Braverman, M.D. In 1989, a fatal outbreak of the rare autoimmune disease Eosinophilia-myalgia syndrome (EMS) cropped up. The disease causes fever, numbness and rashes. It also affects the muscles, arms and legs. In severe cases, EMS can cause death.

According to an article by William E. Crist entitled **Toxic L-tryptophan: Shedding Light on a Mysterious Epidemic, the outbreak was traced back to the Japanese engineering firm Showa Denko. Instead of fermenting its tryptophan normally, it introduced a new strain of bacteria into the fermentation and decreased the amount of activated carbon powder used in the purification process. These seemingly small manufacturing decisions, which were probably meant to be beneficial, instead proved to be catastrophic. Previously, tryptophan users had never reported any EMS-related symptoms. However, those who were unfortunate enough to receive the “bad batch” from 1989 reported major health issues. Several of those who developed EMS from the contaminated tryptophan sued the Japanese manufacturer. Although a settlement of $2 billion was eventually reached, this uproar resulted in a FDA mandate banning the sale of tryptophan in the US. Before discovering all the manufacturing facts, some of the media published the “health risks” of taking tryptophan, fuelling the fires of panic.

In time, however, the FDA’s Center for Food Safety and Applied Nutrition studied amino acid supplementation and concluded it was safe after all. And in 1996, L-tryptophan could be obtained in the US via prescription. Canada similarly followed suit with prescription use only. Health Canada finally released L-tryptophan from Schedule F in December of 2011. As Dr. Braverman and his colleagues state, “In our opinion, if there is any risk at all to amino acid therapy, it is taking imbalanced amino acids that do not contain tryptophan.”

L-Tryptophan has earned non-prescription status when sold as an oral dosage of no more than 220 mg daily. (It has prescription status when sold for human or veterinary use as a single ingredient intended for any route of administration other than oral.)

Another highly anticipated nutrient, L-carnitine (Levocarnitine), is now available to Canadians when sold for the treatment of its primary or secondary deficiency. An amino acid found in meat, this product helps reduce oxidized LDL-cholesterol levels in men and women, as well as circulating LDL-cholesterol and triglyceride levels for both genders. It also enhances exercise performance by facilitating glycogen storage during low-intensity aerobic exercise, as well as by balancing fuel utilization during high-intensity aerobic exercise. Basically stated, L-carnitine is good for many things, including mental clarity, energy, heart health and weight control.

The remaining list of released Schedule F products includes:

Apiol oil: Found in celery, parsley seed oil, dill, fennel seed, sassafras root bark, etc., it has been used in the treatment of liver, spleen and prostate diseases, as well as arthritis, anaemia and microbial infections. It has also been found useful as a laxative and diuretic.

Centella asiatica: Also known as gotu kola, this is a mild adaptogenic herb that is anti-inflammatory, anti-viral, anti-bacterial and diuretic. It can also aid in the treatment of anxiety and hypertension. Its ability to help heal wounds is responsible for its traditional use for leprosy.

Deanol and its salts and derivatives (also known as DMAE, precursor to choline) has been used for treating ADHD, autism, Alzheimer’s disease and tardive dyskinesia. It is also used for improving memory and mood, boosting thinking skills and intelligence, oxygen efficiency, athletic performance and muscle reflexes as well as for liver spots and improving red blood cell function.

Dimethyl sulfoxide (also known as DMSO) has non-prescription status, unless sold for the treatment of interstitial cystitis or scleroderma in humans or for veterinary use. DMSO is predominantly used as a topical analgesic, a vehicle for topical application of pharmaceuticals, as an anti-inflammatory and an antioxidant. Because DMSO increases the rate of absorption of some compounds through organic tissues, including skin, it can be used as a drug delivery system. It is frequently compounded with antifungal medications, enabling them to penetrate not just skin, but also toenails and fingernails.

Dopamine (and its salts) is a neurotransmitter that helps control the brain’s reward and pleasure centres. It also regulates movement and emotional responses. People with low dopamine activity may be more prone to addiction. Dopamine deficiency results in Parkinson’s disease. It now has non-prescription status unless sold for administration by injection.

Gold (and its salts and derivatives) now has non-prescription status unless sold for administration by injection. Gold can ease the pain of arthritis and inflammatory joint diseases.

Theobromine and its salts (found in chocolate, kola nuts, coffee and tea) is a stimulant similar to caffeine that helps open bronchial passageways for asthma and dilates blood vessels to aid circulatory problems.

Uracil and its salts has non-prescription status, unless sold for the treatment of cancer. It helps to carry out the synthesis of many enzymes necessary for cell function through bonding with riboses and phosphates.

In the US, these products have been sold over-the-counter and are protected by the Congress-defined term “dietary supplement,” as coined 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. Such supplements fall under the general umbrella of “foods,” not drugs.

Since these products have been sold in the US, they have not had any related safety concerns. In fact, they have attributed to better health and noticeable improvements for athletes. Yet until last December, free access to these supplements and their benefits was not available to Canadians because Health Canada had not yet fully reviewed and assessed them for safety, efficacy and quality, as required by the Food and Drugs Act and the Food and Drug Regulations.

Many in the health industry are elated to see these products legally available for sale; it is like a dream come true. The products work, but consumers have not had the opportunity to see the results for themselves. Canadians can now enjoy the same benefits that our US counterparts have enjoyed for decades: the freedom of choice. Canadians can use natural alternatives that provide great results without harmful pharmaceutical side effects and finally, as a bonus, no prescription is required. Another benefit to those seeking better health through prevention is that supplementation with a product such as L-carnitine may help avoid heart disease all together, saving millions in potential surgeries and prescription medication. To be frank, lives can ultimately be saved because of this Schedule F decision.

This milestone for the health industry should be celebrated, although, in retrospect, it is unfortunate it took so many years to recognize the healing potential of these products. Realistically, we still have a long way to go. There are more products that could benefit Canadians that are currently inaccessible under current regulations. Still, organizations such as the Canadian Health Food Association, the Natural Health Protection Association and Health Action Network are seeking to bridge the gap between the natural health industry and Health Canada. Steps such as this provide encouragement as better education brings enlightenment.

Proactively, in the spirit of cooperation, the natural health industry, the provinces and Health Canada can work together for the optimal health of all Canadians. Learn more about the organizations mentioned: CHFA www.chfa.ca/en-us/home.aspx NHPA http://nhppa.org HAN www.healthactionnetwork.com/

*Schedule F refers to Sections C.01.041 to C.01.049 of the Food and Drug Regulations, controlling the sale of medicinal ingredients. These ingredients require a prescription for both human and veterinary use, unless the veterinary use it is labelled for is in a form unsuitable for human use. In 2004, the Natural Health Products Regulations came into force and all naturally sourced ingredients of a natural health product became governed by these regulations.

**Toxic L-tryptophan: Shedding Light on a Mysterious Epidemic: www.seedsofdeception.com/Public/L-tryptophan/2BackgroundInformation/index.cfm

Dr. Eldon Dahl, ND, is the founder and director of the Life Choice™ nutraceutical product line. Its L-Typtophan product has earned an EN# from Health Canada (www.life-choice.net)

photo © Alita Bobrov

 

 

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