1 / 30

Tuck’s Paralegal Services 6835 Hwy 62 North, Bldg 1, Suite 4 Belleville, ON K8N 4Z5

HOW TO SUCCESSFULLY OPERATE A TRADITIONAL NATURAL REMEDIES HEALTH CARE PRACTICE IN ONTARIO IN FULL COMPLIANCE WITH ALL APPLICABLE FOOD AND DRUG ACT PROVISIONS & PROSPER. Tuck’s Paralegal Services 6835 Hwy 62 North, Bldg 1, Suite 4 Belleville, ON K8N 4Z5 Phone: 613-968-3007 Fax: 613-968-3215

ian-chavez
Download Presentation

Tuck’s Paralegal Services 6835 Hwy 62 North, Bldg 1, Suite 4 Belleville, ON K8N 4Z5

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. HOW TO SUCCESSFULLY OPERATE A TRADITIONAL NATURAL REMEDIES HEALTH CARE PRACTICE IN ONTARIO IN FULL COMPLIANCE WITH ALL APPLICABLE FOOD AND DRUG ACTPROVISIONS & PROSPER Tuck’s Paralegal Services 6835 Hwy 62 North, Bldg 1, Suite 4 Belleville, ON K8N 4Z5 Phone: 613-968-3007 Fax: 613-968-3215 Presented by Trueman Tuck, Paralegal (LSUC #PO7521), Registered Lobbyist and Health Canada Regulatory Consultant

  2. INTRODUCTION Today, there is enormous confusion surrounding exactly what is Health Canada’s lawful areas of jurisdiction in regards to Traditional Natural Remedies/Dietary Food Supplements including Homeopathic Remedies. This is especially true for Provincially authorized practice of Medicine non-pharmaceutical Health Care Practitioners such as Homeopaths. Homeopathic Practitioners and their Traditional Homeopathic Remedies Have been subject to ridicule and harassment for decades in Canada.

  3. History of Practice of Medicine in Ontario The battle for control of our health system began long before confederation. Allopathic (Pharmaceutical) Medical Doctors began accruing power as early as 1759,when legislation was drafted to protect an unsuspecting public against quacks or "snake oil peddlers." Since many physicians sat on government benches, the precedent was set. Allopathic Medical Doctors set the rules. Unfortunately, lumped into the category of quacks along with the snake oil peddlers were bona fide non-pharmaceutical health practitioners such as herbalists and later, homeopaths. By 1839,the Ontario College of Physicians and Surgeons was well established in Canada. The College held the mandate to determine who could enter the profession, to establish the content of the curriculum, and to set standards of practice. Meanwhile in Europe another branch of medicine had established itself: Homeopathy.

  4. The Regulatory History of Homeopathy in Ontario Unlike allopathic/pharmaceutical medicine, which proposed the use of drugs [largely synthetic & toxic] to quell symptoms of disease, homeopathy used minute traces of natural substances to encourage the body to fight the disease using its own remarkable resources. To this day, homeopathy remains a major treatment modality in Europe and India. Its most celebrated adherents are the British Royal family, most of whom are well recognized for their good health and longevity. By 1859,Canadian homeopaths had their own board of examiners, and a training program. The profession was equal in every way to allopaths.

  5. Goodbye Homeopaths until 2014 But it was not to remain this way for long. Homeopaths and eclectics (similar to today 's naturopaths) had begun to make serious inroads to the allopaths ' earnings. Moreover, these nature-based practitioners were threatening their very business by advocating proper diet, fresh air and sunshine, plenty of rest and gentle medications to maintain good health. Allopathic doctors of the time were relying on bloodletting, blistering, cleansing bowels with large doses of mercurous chloride and tartrate of antimony (both of which are highly toxic), and prescribing arsenical compounds and opium as tonics. Unable to dismantle their competitors, the allopaths instead prevailed upon the government to encourage homeopaths to join them in one college with one board and one training facility. It was proposed that each modality have representation on the board, develop its own curriculum, and examine its own candidates.

  6. As logical as this may have appeared to the homeopaths, in entering this agreement, they had unwittingly signed themselves into oblivion. In a classic example of "Step into my parlour said the spider to the fly," the homeopaths and eclectics were gradually squeezed out of key positions and their treatments and theories dropped from the curriculum. By1928, it was illegal to practice homeopathy in Ontario. Osteopathy, a modality involving manipulation and massage, was also banished from Canada, although it flourishes today in the US, throughout Europe and in the UK. Only the chiropractors have managed to evade the many attempts made to discredit their profession.

  7. NOW LET US TALK ABOUT THE SITUATION TODAY Sadly this tradition of slamming practitioners of Traditional Natural Remedies persists to this day. But one thing has changed: Today consumers and practitioners are far better educated and better informed. We read, we think, we challenge. We are capable of making decisions for ourselves and for our families. We no longer need the government to protect us from charlatans and snake oil peddlers. AND, most important of all, we get all together as we are doing here today to share our expertise in order to develop the best possible Health Care options not only for our clients, but also for ourselves and those we care for!

  8. HOW CAN TRUEMAN HELP & WHAT IS THE TRUEMAN STORY? • My journey into Holistic Health and related Rights Advocacy started while I was attending Carleton University studying four years for a Science degree in the late 1960’s. • I became interested in oriental cooking and began to explore the Japanese and Chinese grocery stores in downtown Ottawa near where I lived with a number of other students off campus.

  9. This exploration lead me into the spiritual and historical background of the cooking practices of these two eastern cultures. From there I became involved in the Traditional Natural Remedies from all corners of the Globe and my journey in the Traditional Natural Remedies industry not only in Canada but globally began.I worked in the Federal government during University in the summers and after University full time. While developing an excellent government career I bought into a Hamilton Whole Food store in the early 1970’s.

  10. As a result of lifestyle changes and my part time involvement in self-employment, in the rapidly growing Traditional Natural Health Industry in Ontario and Canada I decided in 1975 to resign from my Federal Career and immersed myself in our industry. My interest was educating individuals about their risks and benefits of the two primary health care systems in the world. DID YOU KNOW that we are not The Complementary or Alternative Health Care system? WE are and always have been the number one [1] primary Health Care System by percentage use based upon global population!

  11. UNDERSTANDING THAT MODERN PHARMACEUTICAL MEDICINE IS THE COMPLEMENTARY/ALTERNATIVE MEDICINE NOT OURS The pharmaceutical Medical system is the Number two [2] primary Health Care system in the World! In my passionate pursuit of good health and well-being for myself and my Health Food Store customers I discovered early on that most major Health Challenges being faced by Canadian could be prevented, treated and/or cured using Traditional Natural Remedies. I do not use prescription pharmaceutical Drugs/Medicines. I see Allopathic/Pharmaceutical Doctors usually most of my life for insurance reason or something infrequently. I rely upon over a dozen different Dietary Food Supplements on a regular basis for my good health and well-being.

  12. As I became involved in assisting individuals in Self Health Care for major Health Challenges such as cancer in the mid 1970’s I first began to have serious differences of opinion with Health Canada bureaucrats. It was not too long after that in the late 1970’s and early 1980’s that it became clear that the double digit marketplace growth of our industry in Ontario, Canada and the USA was upsetting the pharmaceutical Cartels and their allies. This lead to increasing escalation of Health Canada’s criminal investigations and related regulatory interventions into both my rights of choice as a consumer and as a self-employed professional in the Traditional Natural Remedies industry.

  13. Having worked as a researcher and legal services employee of the Federal Government for some seven [7] years I had been taught not only how the government functions, but also how to research its records and legally interpret their meaning. Over my 40 years of dealing with Health Canada my research revealed that the Food and Drugs Act wasactually first consolidated in 1884 and then titled The Adulteration and Fraud Act and contained approximately 10 pages. I then researched the entire legislative history of the Food and Drugs Act [FDA] which is the sole source of federal jurisdiction for Health Canada bureaucrats in our Dietary Food Supplements and other Traditional Natural Remedies industry in Canada. I DISCOVERED A NUMBER OF THINGS THAT EVERY ONE OF YOU IN THIS ROOM NEEDS TO KNOW IN ORDER TO PROSPER IN YOUR CHOSEN PROFESSION.

  14. ALL ABOUT THE FOOD AND DRUGS ACT [FDA] & HEALTH CANADA. The FDA has four areas of potential jurisdiction and is solely about protecting Canadians from dangers relating to adulteration and fraud/misrepresentations; They are; [1] Drugs, [2] Foods, [3] Cosmetics, And, [4] Devices. Also, the FDA has two different Ministers responsible for administration of the FDA – the Minister of Health and the Minister of Agriculture. The Adulteration and Fraud Act 1884 was amended in 1920 at the prompting of the Pharmaceutical investment interests to change its name to the Food and Drugs Act and to create a use-based definition, which is the source of most of our issues today with the Health Canada bureaucrats.

  15. This use-based definition of Pharmaceutical Drug has allowed the Canadian Allopathic/Pharmaceutical Cartels to assert exclusive control over all Modalities of the practice of medicine and related medicinal products and services for almost a hundred years in Ontario and the rest of Canada. To most, it made no sense why in 1920 the Medical Doctors and related Health Professionals would change their scope of practice key reference point from the definition of Drug being whatever was listed in their pharmacopeias, either US or British to a vague use-based definition that had never used before. This happened in the US and Canada in similar timing BUT IS DOES MAKE SENSE – ORTHOMOLECULAR MEDICINE HAD BEGUN TO GROW IN POPULARITY AS HAD CONSUMER MEDICAL SELF-CARE. It was as usual all about the money and who controlled medicines of all types.

  16. THE MEDICAL DOCTORS AND THEIR INVESTMENT ALLIES RIGGED THE GAME IN THE 1920, 1927 and 1934 AMENDMENTS TO THE FOOD AND DRUGS ACT THEY further amended the Food and Drugs Act as it was now called to strengthen the use-based definition in 1927 and to add the censorship provisions in section 3 relating to schedule A in 1934. IT IS VERY IMPORTANT FOR EACH OF YOU TO FULLY UNDERSTAND YOUR HEALTH CANADA COMPLIANCE OBLIGATIONS AND OPPORTUNITIES. YOUR ABILITY TO FINANCIALLY PROSPER WILL BE SIGNIFICANTLY INFLUENCED, LIKE ALL HIGHLY REGULATED BUSINESSES, BY YOUR ABILITY TO EFFECTIVELY NAVIGATE REGULATORY BARRIERS!

  17. WHAT TUCK’S PARALEGAL SERVICES CAN DO FOR YOUR BUSINESS Effective January 1, 2004 Health Canada hoodwinked the Traditional Natural Remedies industry including related Health Care practitioners into consenting to change the federal regulatory classification of Traditional Natural Remedies into pharmaceutical Drugs/Medicines. What is not generally understood or known is that the legislation, being the Food and Drugs Act DID NOT CHANGE! Legally Health Canada bureaucrats CANNOT amend or expand the FDA by using policies or regulations. The Courts have determined that under the FDA due to the use-based definition where you make Health Representations/Health Claims for a product you trigger the use-based definition of pharmaceutical drug/Medicine. A classic example was the Wrigley’s anti-cavity gum. Gum is defined in the FDA specifically as a Food, But can also be a Drug if claims are made.

  18. Understanding that within your one on one relationship with your patient Health Canada does not have jurisdiction There is a key legal entity that is critical for you to understand – the Food and Drugs Act ONLY applies to sale and promotion of the four category of products to the GENERAL PUBLIC, being Drugs, Foods, Cosmetics and Devices. You, as Provincially authorized Health Care Professionals, are not without this definition when you are in your practice of medicine dealing one on one with your patients! Tuck’s Paralegal Services can assist you and your supplier in ensuring that any product covered by the FDA, that you wish to access, to sell one on one to your patient, you can legally do so and ignore Health Canada. The condition is that it must be a product approved within your scope of practice for you to use on your patients.

  19. WHERE HEALTH CANADA’S JURISDICTION WIOULD EXIST In your practice, if you sell to the General Public either on the internet or in a retail store setting then Health Canada would acquire jurisdiction under the FDA. As you are aware there are currently three pharmaceutical designations for Drugs in Canada where Health Canada has jurisdiction under the FDA. These are DINs, Natural Health Products and Homeopathic DINS. There has been considerable internal controversy within the Canadian Homeopathic industry about what is the best pathway to follow in order for the industry to grow and prosper and became a credible mainstream Health Care provider.

  20. WHAT ARE YOUR OPTIONS FOR HEALTH CANADA REGULATORY COMPLIANCE IN YOUR PRACTICE? • Consent to Health Canada having full product jurisdiction over homeopathic products key to your ability to practice in accordance with your full options as traditional homeopaths and only carry Health Canada licensed products. • Refuse to consent and only deal one on one with your patients and develop supply lines to provide all required products without Health Canada licensed products. • Or, do a combination of both. The Trueman Story is, that I provide as a Law Society of Upper Canada licensed Legal Services provider a unique Health Canada Compliance Consulting service.

  21. WHAT HEALTH CANADA COMPLIANCES SERVICES CAN TRUEMAN PROVIDE TO ME? I am a licensed Lobbyist in Canada, Ontario and Washington, as well a Licensed Paralegal in Ontario. I provide full regulatory assistance to Medical Doctors, Pharmacists, and anyone else either interested in fully complying and obtaining site licenses and product licenses from Health Canada or refusing to comply and ignoring Health Canada or wishing to do a bit of both. I have been dealing directly and indirectly with Health Canada now for some 40 years. Since 1995 when I cofounded Friends of Freedom International [FOFI]. I have dealt directly with every Minister of Health since that time and our Canadian Health Freedom Movement has been a major grassroots advocacy champion for Informed Freedom of Choice for individual Canadians.

  22. WHAT HAS TRUEMAN BEEN INVOLVED WITH IN REGARDS TO NATURAL HEALTH PRODUCT LICENCING OF HOMEPATHIC PRODUCTS I have applied for both single and multiple ingredient homeopathic product licenses. As everyone who has been involved in homeopathic licence applications knows, Health Canada had a prejudice towards Homeopathic single ingredient products. Due to my multiple discipline training and experience and connections, I never accept Health Canada nonsense. Health Canada gave me a hard time about Health Claims on single ingredient homeopathic remedies and I refused to accept their nonsense. I ended up in the Minister’s office and beat Health Canada’s nonsense and got the licenses done my way.

  23. TUCK’S REFERENCES: Cobramed Pharmaceuticals Limited • November 1, 2010 • To Whom It May Concern: • Re: Professional Reference of Trueman Tuck and Tuck’s Professional Services • I am a licensed pharmacist under the College of Pharmacists of Ontario since 1984. I currently operate a number of pharmacies in Ontario including two in Oshawa, ON. • Last year, I decided to introduce an extensive line of homeopathic medicines to be imported into the Canadian market. In order to import my products into the Canadian market, I spoke with my lawyer for advice on handling my federal applications. He advised me that this was a highly specialized and complex regulatory procedure. He recommended Mr. Tuck, of Tuck’s Professional Services in Belleville, ON, to assist me in these matters as he was knowledgeable and experienced. • I immediately contacted Mr. Tuck and arranged a preliminary meeting with him. I was impressed with his proposals and retained him in June 2009 pertaining to my proposed homeopathic import, export, manufacture and wholesale operations. Mr. Tuck would be providing his expertise in my business development, strategic planning and if required, his lobbying skills and crisis management services. • My experience with Mr. Tuck has shown him to be a competent, honest, hard working and creative business professional. When experiencing glitches in the regulatory process, he arranged many key meetings with elected and appointed government officials in Ottawa through his federal lobbying. I attended a number of these meetings and can attest that Mr. Tuck was well prepared and successful at assisting me and my company in achieving my goals. It was also apparent that during these technical meetings with senior level officials, that Mr. Tuck was articulate, intelligent and highly respected. Mr. Tuck is passionate, firm, polite and courteous in all of his dealings with government and bureaucratic officials, which includes conflict resolution meetings. • If you require any further information, please do not hesitate to contact me. • Yours truly,Rajni KassettCEO/Pharmacist

  24. TUCK’S REFERENCES CONTINUED: The Results Company • November 4, 2010 • To Whom It May Concern: • Re: Professional Reference of Trueman Tuck and Tuck’s Professional Services • I have known Mr. Tuck in a professional and personally for the last 15 years. During that time, we have worked together in our Canadian Health Freedom Movement advocating for “Informed Freedom of Choice” in regards to Traditional Holistic Health Care. Together, we defend individuals and small family businesses from the over zealous federal Public Servants and others bureaucracies in Canada. • Not only have we developed an ongoing professional relationship but also a strong friendship. I consider him to be one of the most moral, intelligent, competent, dedicated and honorable individuals I know in his roles as a professional businessman and personal friend. He is a person of high integrity. • In his professional capacity, as a businessman, he has always developed successful strategies, provided regular updates, seeking approvals when required and has sufficiently served my business interests. With his assistance, Trueman has saved me hundreds of thousands of dollars, still continuing to do so. If I ever have any concerns, he investigates the details and responds with excellent customer service. • In private and public, he always conducts himself in a polite, respectful and professional manner. He meets my needs in the agreed upon timelines. I would not hesitate to recommend Trueman in his professional services as a business developer, strategic planner, lobbyist and/or crisis management service provider. • If you have any questions concerning the aforementioned, please do not hesitate to contact me. • Yours truly,David W. Rowland, BComm., MBA., PhD.

  25. TUCK’S REFERENCES CONTINUED: Nutraxis International Inc. • Mr. Trueman Tuck 06-10-2010 • Tuck’s professional services • Belleville Ontario • Mr. Tuck, • I would like to congratulate you and your team for the representation and diligence in working with Health Canada and various government agencies in the interest of getting our NPN numbers emitted. • I am relieved after close to four years in our part and 10 months in your part, that with your help we finally got our much needed NPN numbers for our flagship products. We now have the necessary tools for proper integration in the Canadian marked more specifically the pharmacy groups. • David enjoyed working with Dara with this ongoing process as it turned out to be a good learning experience I believe for both parties. • In any case Job well done, • Yours truly,Robert GauthierPresident & CEONutraxis International inc, • 19381 COUNTY ROAD 24 | DUNVEGAN | ONTARIO | CANADA | KOC 1J0TEL 613.527.5252 | SANS FRAIS 888.968.3592 | FAX 613.527.1084WWW.GSHPLUS.COM

  26. TUCK’S REFERENCES CONTINUED: Warm Buddy Company • In March, 2010, I came under the radar of Health Canada as a result of a consumer complaint. • This complaint was a result of gross misuse of our product and nobody was hurt. • Health Canada launched an immediate recall of our most popular product line, that had been sold safely for 15 years. Within one week, we were instructed to remove all products from 750 retail outlets. • This action was unfair and devastating to my business and I began trying to find a way to work with Health Canada. I hired 2 lawyers to help communicate with the government. Replies to our letters took months and produced no positive results. As my product is very safe and popular, I wanted to continue selling to my customers. • After months of trying to resolve my issue through business organizations, member of parliament etc., I realized that nobody was able to understand my situation or help me work with government officials. • After 6 months of no results, Trueman found out about my story and offered to help. His specialty is working through issues with Health Canada and he is in Ottawa for meetings several times per month. We met with several top ministers and mp’s in Ottawa to discuss my situation. Dealing with the local inspectors did not produce any results. • As a result of much hard work and intense communications with government officials, Trueman was able to find a way for us to sell our products and stay in business. • Trueman was extremely good at following up, sending correspondence and informing me of steps along the way that were necessary to resolve my situation. He is very knowledgeable re government procedures and was able to reassure me along the way. • I would not hesitate to recommend Trueman and his staff to anyone needing to understand and overcome regulatory issues. It is very reassuring to know that there is somebody who cares and can prevent destruction of business. • Karen L. McKeePresident, • Unit 4 – 801 West 1st StreetNorth Vancouver, BCV7P 1A4CanadaPhone: 604-984-3218Fax: 604-984-3212Toll Free: 1-888-649-0649Web: warmbuddy.com

  27. TUCK’S REFERENCES CONTINUED: Symbionature inc. • June 8, 2012 • To whom it may concern: • In 2009, ours small, natural products agricultural company was faced with unexpected and inappropriate restrictions from agriculture Canada which threatened our existence. Lawyers, in Montreal, familiar with natural products, advised us that $200,000 we could go to court and most certainly lose. We retained the services of Mr. Trueman Tuck after his having been recommended to us by a small supplement distributor near Quebec City. • His knowledge of the legal system in Canada and its regulations, his ease in approaching and working with members of Parliament and civil servants and his extraordinary strategizing made it possible for us to continue serving our clients. • Though we are not 100% out of the woods at this time, we are serving our clients and are more profitable than we were before this crisis. We know of no one else like him in Canada and are thankful that he is there as we continue to operate in the gray zone between unjust and inappropriate regulations and the desire to freely serve those who see the benefits of working with our products and services. • Sincerely yours • Michael BernardinPres. and technical director

  28. Tuck's Paralegal Services  Belleville6835 Highway 62 North, Building 1, Unit 4Belleville, OntarioCanada K8N 4Z5 Toll Free 1-888-611-5243Phone: (613) 968-3007Fax: 1-888-872-7035Fax: (613) 968-3215 trueman@tucksparalegalservices.ca www.theparalegallitigator.com

More Related