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Letters to the Editor Issue 118

by Letters(more info)

listed in letters to the editor, originally published in issue 118 - December 2005

Niacin (Vitamin B3) Lowers High Cholesterol Safely

There is a safe, inexpensive, non-prescription, convenient and effective way to reduce high cholesterol levels and reduce heart disease risk: niacin. Niacin is a water-soluble B-complex vitamin, vitamin B-3. One of niacin's unique properties is its ability to help you naturally relax and to fall asleep more rapidly at night. It is well established that niacin helps reduce harmful cholesterol levels in the bloodstream. Niacin is one of the best substances for elevating high density lipoprotein cholesterol (the 'good cholesterol'), and so decreases the ratio of the total cholesterol over high density cholesterol.

The finding that niacin lowered cholesterol was soon confirmed by Parsons, Achor, Berge, McKenzie and Barker (1956) and Parsons (1961, 1961a, 1962) at the Mayo Clinic, which launched niacin on its way as a hypocholesterolaemic substance. Since then it has been found to be a normalizing agent, meaning it elevates high density lipoprotein cholesterol, decreases low density and very low density lipoprotein cholesterol and lowers triglycerides. Grundy, Mok, Zechs and Berman (1981) found it lowered cholesterol by 22 percent and triglycerides by 52 percent and wrote, "To our knowledge, no other single agent has such potential for lowering both cholesterol and triglycerides."

Elevated cholesterol levels are associated with increased risk of developing coronary disease. In addition to niacin, a typical diet generally recommended by orthomolecular physicians will tend to keep cholesterol levels down in most people. This diet can be described as a high fibre, sugar-free diet which is rich in complex polysaccharides such as vegetables and whole grains.

With adequately high doses of niacin, it is possible to lower cholesterol levels even with no alteration in diet. E Boyle, then working with the National Institutes of Health in Washington, DC, quickly became interested in niacin. He began to follow a series of patients using 3 grams (3,000 milligrams) of niacin per day. He reported his conclusions in a document prepared for physicians involved in Alcoholics Anonymous by Bill W (1968). In this report, Boyle reported that he had kept 160 coronary patients on niacin for ten years. Only six died, against a statistical expectation that 62 would have died with conventional care. He stated, "From the strictly medical viewpoint I believe all patients taking niacin would survive longer and enjoy life much more." His prediction came true when the National Coronary Drug Study was evaluated by Canner recently. But Boyle's data spoke for itself. Continuous use of niacin will decrease mortality and prolong life.

Niacin Combined With Other Drugs Which Lower Cholesterol

Familial hypercholesterolaemia is an inherited disease in which plasma cholesterol levels are very high. Illingworth, Phillipson, Rapp and Connor (1981) described a series of 13 patients treated with Colestipol 10 grams twice daily and later 15 grams twice daily. Their cholesterol levels ranged from 345 to 524 and triglycerides from 70 to 232. When this drug plus diet did not decease cholesterol levels below 270 mg/100 ml they were given niacin, starting with 250 mg three times daily and increasing it every two to four weeks until a final dose of 3 to 8 grams per day was reached. To reduce the niacin 'flush', patients took aspirin (120 to 180 mg) with each dose for four to six weeks. At these dosage levels of niacin they found no abnormal liver function test results. This combination of drugs normalized blood cholesterol and lipid levels.

Fortunately, niacin does not decrease cholesterol to dangerously low levels. Cheraskin and Ringsdorf (1982) reviewed some of the evidence which links very low cholesterol levels to an increased incidence of cancer and greater mortality in general.

Niacin usually causes a flush when beginning treatment. The flush can be uncomfortable, but it is not dangerous. In order to slowly acclimate the body to niacin and minimize the flush, the following steps can be taken:

• One should expect to begin by taking 1000 mg of vitamin C and 50 mg of niacin three times a day, preferably after each meal. Niacin tablets are scored and a 100 mg tablet is easily broken along the score to produce two 50 mg half-tablets of niacin;
• After three or four days, the niacin dosage is increased to 100 mg three times a day. One might continue increasing the niacin by 50 mg or 100 mg every three or four days until the dosage of 1000 mg of niacin and 1000 mg of vitamin C are taken three times a day.
It normally takes about three months on the higher dosage of niacin and vitamin C for cholesterol levels to stabilize at lower levels.

Source and Further Information

The peer-reviewed Orthomolecular Medicine News Service is a non-profit and non-commercial informational resource. Andrew W Saul, OMNS Editor, Orthomolecular Medicine News Serviceomns@orthomolecular.org; www.othomolecular.org

Health Canada Regulations to put Organic Herb Company Out of Business

Letter from Faunus Herbs Inc.
Attn: Honourable Ujjal Dosanjh
Federal Minister of Health, Canada.

Dear Sir:
Our company, Faunus Herbs, is a small farm-based family enterprise, and has been in the business of growing herbs and producing formulae (both liquids and encapsulated) for over 25 years. We employ 12-15 full-time staff – good jobs with security and decent wages and benefits, in an economically depressed part of rural Ontario.

Faunus Herbs has been a leading edge innovator in Canada, and we were the very first annually inspected and regulated Certified Organic herb farm and manufacturer of herbal products in North America. For many years we were the only local producers of many products that are now considered industry and consumer standards. Our farm and facilities have been inspected regularly and frequently by international regulatory agencies and were used as a model for successful farm/rural vertical integration in the US Canada and Central and South America.

During all of our years in business, we have always done everything possible to comply with every regulation – labeling or QC. The Canadian Food Directorate staff visited us several times – and never came by again. We have been inspected by local authorities, workplace safety officials, etc., who all commented on our integrity and our commitment to quality and safety. In accordance with federal regulations, health claims have never been made for any product that we have manufactured and sold.

I personally worked with the Canadian Health Food Association (CHFA) for four years during the mid to late 1990s, developing their data management, membership, regulatory and accounting systems – even producing their marketing and promotional materials in direct daily consultation with their Executive Director.

We are a small farm business – and we have deliberately chosen to remain small. In our local rural community we are respected and admired for our commitment to employee safety and personal development. Most of our staff have been with us for years… some for over a decade.

Our small farm business has generated of millions of dollars in tax revenue for Canadians over the years. As primary producers, we are well aware that for every job we create, at least 7-10 jobs are produced 'down the line'. At the retail level, our annual production of products is worth more than four million dollars. Our customers are predominately medical practitioners (MDs, Naturopaths, Chiropractors, Herbalists, etc.) and we do some contract manufacturing for a few retail distributors. We have always believed that we were an asset to our community, and by extension to Canada. Yet we are now being told by Health Canada, that unless we apply for a 'site license' and register all our individual products, we will have to close our business, or be forcibly closed by Health Canada directly!

Faunus Herbs manufactures and sells single and combination formulae that potentially involve the registration of over a thousand products. Many of these formulae are produced 'on demand' according to practitioner/client request. Herbs are grown, produced and collected, according to established, Hermetic and Eclectic principles. Products are manufactured first and foremost for effectiveness and quality, using herbs that are not always readily available. We work with dozens of farmers and growers, wild herb gatherers. Herbs are collected for us here in Canada and all over the world. Our manufacturing and growing processes do not fall into, and are incompatible with, a rigid and formal drug-based regulatory model, that is designed specifically for inherently toxic products that are synthetically derived.

As well as conflicting with our traditional growing and production practices, implementing the proposed regulatory regime according to Health Canada's own figures) will cost us well in excess of one hundred thousand dollars – even to begin site licensing and product registration!

It is my understanding that, according to Health Canada, there are more than 2500 businesses in Canada that require site licenses, involving over 50,000 food based products. Currently only 300 site licenses are approved, and only a tiny percentage of the products have been given a 'permit' for sale in Canada. At the current rate of regulatory implementation it will take over one hundred years to regulate just the current products sold in Canada!

Again, the only way for you and your staff to even begin to understand the issues outlined in this letter, is for you to visit our farm and processing facilities.

It is clear to me that these new regulations will mostly help Health Canada to increase its budget (more bureaucrats), and to deliver more of the marketplace to the larger drug and vitamin companies, who can afford to implement these new proposed 'drug' regulations. In fact, these companies are already 'drug"'regulated – therefore implementation will cost them nothing. When you consider that more that 80% of the businesses in our industry are small (under $5,000,000 in sales annually) the consequences are clear – and dire. The low level of applications and registrations of products to date speak quite clearly to this.

For goodness sake, small business is the backbone of the Canadian economy – it employs more persons per dollar invested than any other segment of the economy – by far. Yet it appears that this new excessive regulation and site licensing is merely going to open up our industry to the large pharmaceutical companies (very few jobs, government subsidies, profits sent offshore etc.) and result in a considerable reduction in the number of quality products available to Canadians.

The food-based medicine products that we grow and produce help prevent, treat, and in some cases cure, many of the chronic diseases and health problems that currently afflict Canadians. Food-based medicines, on a global basis, are in fact the primary health care choice for more than 50% of the world's population. The current allopathic medical model has clearly failed in Canada, and our sole reliance on toxic and synthetic drugs has not delivered improved health to Canadians, and is in fact in the process of bankrupting our nation. A recent study indicated that for every dollar of cost that governments added to our manufactured, food based medicine products, publicly funded health care costs increased by approximately 400%.

And let us be very clear – these products that we manufacture are demonstrably among the safest food products available in the world today. Every statistical analysis obtainable indicates very plainly that the vast majority of the products that we grow and manufacture are perfectly safe. Consumers are statistically more than 100 times more likely to be killed or injured by eating a beef burger at home or in a restaurant, than suffering injury or harm from consuming the products we produce. Consuming Health Canada's currently approved toxic and synthetic drug 'medicines' will increase your risk of death or injury more than 20,000 times, and is the number one cause of death in Canada.

Some more questions for you…

1. Why are you attempting to close our business of over 25 years? What have we done to deserve this? Is it your intent to wipe out hundreds of small, law abiding and tax paying businesses across Canada?

2. To meet the new proposed regulatory requirements would require us to invest hundreds of thousands of dollars that we do not have. We cannot increase prices; competition from big business and cheap imports makes this impossible. Will you provide us with the funding? Will you restrict imports?

3. Can you help us to obtain a site license? We need personnel and/or funding – will you provide one or the other?

4. Canadian consumers can purchase as many US sourced dietary food supplements as they wish over the internet. Will our borders be closed to consumers who purchase these products from the US? Will all personal mail and parcels be opened and inspected to prevent the entry of these products?

5. Herbal products are imported from China, India and other countries. Are these imported products (running into the thousands) now to be banned in Canada if they do not meet the new regulatory requirements? If not… why not?

6. Why do we need multiple site licenses (grower, manufacturer, distributor, product developer, etc. etc.)? In heaven's name we are just a small farm-based business!

7. We have never had any claims for any product that we have sold in over 25 years. These herbs/foods have been sold legally in Canada for hundreds of years. Will it now be illegal to sell an herb or food in a capsule or liquid form without an NHP number? Even without a medical/health claim?

8. If the answer to the above question is yes, would it be illegal to sell capsules containing coffee? Tea? Other food substances? Does having a food product, packaged in a capsule and/or liquid delivery form, automatically make that food a new drug in Canada? Does it then make GST tax free food products GST taxable? Please note that herbs are packaged into a capsule as a convenient method of use – not as a system of dosage.

9. I understand that the products produced and sold by our family farm business are defined as foods under existing legislation, because we make no health claims. Does this mean that if we do not voluntarily register, and make the mandatory health claims, then our products remain legislatively defined as foods, making it unnecessary for us to comply with the new sub category of drug regulations?

10. The new regulations are riddled with bizarre contradictions. What applies in a farm field outside our facility doors, compared to what applies inside the facility buildings is completely contradictory. On the farm side of the doors I can legally spray our herbs with banned neuro-toxins, coat them in diesel fumes, sprinkle them with used oil, grease and rubber, cover them with animal excrement, even urinate upon them, yet on the facility side of the door I must wear a hazmat suit and instigate strict drug industry quarantine rules, even to just pick up and handle the exact same herbs! Regulatory systems developed and intended for chemical drugs, manufactured from sterile chemicals in a sterile environ-ment, become nonsensical when applied to organic, farmed and wild-gathered herbs. Please explain to me how and why this is not bureaucracy and regulation gone mad?

Please understand that we have no problem with appropriate regulation. We are currently regulated locally, provincially and federally as a food producer. It is just that these new proposed regulations are outside of our current abilities to implement; they are simply too expensive and would destroy our traditional methods of production. Are my staff and I to be thrown on the scrap heap of welfare and poverty because we are not a large enough business? Are we to be penalized for being a farm based business? Are our questions to be ignored because we employ no lobbyists and make no monetary contributions to political parties?

The real tragedy of course, is that the food-based medicine industry, which has been built over the last hundred years in Canada, mostly by small family-owned farm businesses just like ours, is going to be destroyed.

Is this what you really intend to accomplish here in Canada, with these new proposed regulations?

The allopathic minded 'regulators' at Health Canada once threatened many of us with imprisonment for selling herbs and vitamins that are now considered mainstream. In fact, several of my more renowned peers once served prison time for promoting health and nutrition, and its role in preventing disease! And now, the very people that fought to destroy our industry over the years (big pharma, allopathic medical doctors and pharmacists, and their respective trade and lobby groups, and the mass market food sector) are poised to take it all over – with your help and my tax dollars!

I look forward to further communication with you, as time is quickly running out for my staff, and the farmers and others with whom we work.

Please respond as soon as possible.

Please note – I have already invested the time and money to attend as a witness before the federal Standing Committee on Health (May 11th 2005), to advise you and your colleagues of the damaging effects that the proposed federal regulatory initiatives are having on farms, and farm-based businesses like ours. Is anyone listening?

If you are not able to immediately visit our farm and facilities, due to understandable scheduling difficulties, we are willing to come to Ottawa to meet with you, and as soon as practically possible.

We all still have faith in the decency and fairness of our Canadian political, legal and regulatory system, and we depend on you to reaffirm our confidence in that system by meeting with us as soon as possible. We urgently need to find common ground for the benefit of our collective trade and economic security. I thank you in advance for your prompt response.

Sincerely
Nicholas Morcinek, Faunus Herbs Inc
nick@faunusherbs.com

Further Information

HPFB-DGPSA Deadline site.
Alliance of Natural Health Suppliers
Faunus Herbs
Health Canada English: www.healthcanada.ca/nhpd
Sante Canada Francais: www.santecanada.ca/dpsn

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