Thursday, April 02, 2009

Health Canada Guidance on Food-like Natural Health Products

In Canada, natural health products and foods are regulated under the Food and Drugs Act (FDA) and its regulations. Products that meet the definition of a “natural health product” under the Natural Health Product Regulations (NHPR) are subject to the FDA. Products that are “food” as defined by the FDA are subject to regulation under the food requirements of the FDA and to Parts A, B and D of the Food and Drug Regulations (FDR).

Since implementing the Natural Health Product Regulations (NHPR) in 2004, Health Canada has received several hundred product license applications for products in food format (e.g., energy drinks, vitamin or mineral supplements in candy, and water with added vitamins or minerals). These products have characteristics of both natural health products (NHPs) and foods. There have been regulatory challenges in classifying these products. Are they food-like NHPs or NHPs in food form?

Health Canada provides a new guidance document that outlines the principles and consideration to be applied in determining if a product in a food format is a natural health product.

9 comments:

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Greg Mills said...

“She’s Mother Theresa meets MacGyver” says Doug Broeska President of the CliniCard while visiting Sassoon Hospital in Pune, India. “She should probably at least be nominated for the Nobel Prize in Medicine.”

That’s an impressive statement but also accurate when it comes to Dr. Aarti Kinikar, Head of Pediatrics at Sassoon Hospital in Pune, India (Pune is a city of nearly 10 million, just south of Mumbai, and Sassoon General Hospital is the biggest public hospital in the region). During the H1N1 Flu outbreak last year (2009-2010), Dr Kinikar was faced with a medical emergency seemingly out of all proportion to anyone’s ability to deal with it. Bodies were literally piling up outside of the hospital morgue and she feared that most of the young children and babies that were coming to Sassoon with severe breathing problems would be added to the growing pile. The hospital had only 4 working ventilators and was facing a steady flow of children to the pediatric ward that quickly swelled to a deluge of over 1200, all of whom were in severe respiratory crisis.

As the numbers of very sick children grew so did Dr. Kinikar’s resolve. There had to be way to create the bit of air flow needed to keep a child’s lungs breathing. “The best medication is sometimes oxygen, and even though the children had made it to the hospital, without it they might die right in front of you…that’s a helpless feeling for a doctor” said Kinikar. Motivated by equal parts of desperation and inspiration, Dr. Kinikar rigged a simple breathing tube device only with materials on hand. The PNC pressure device called a “nasal bubble CPAP device” (Continuous Positive Airway Pressure) miraculously worked for 85% of the children who were treated. Although bubble CPAP has been around for decades, the device she rigged was much less elaborate than the expensive tubing and valve configurations that are commercially available by the same name. “I was taking a risk,” Kinikar said. “I didn’t know whether people would back me using a technique which didn’t seem to have much scientific push.” As a result of her willingness to step outside of convention, an estimated 500 childrens’ lives were saved at Sassoon Hospital because her fast thinking in a time of extreme crisis. A few dollars worth of plastic tubing had taken the place of much more expensive devices which weren’t available to the hospital at the height of the emergency anyway. http://www.ccsviclinic.ca/ . Continued in the next comment.. Full Article also available here.. http://ccsviclinic.ca/?p=793

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Jessica Forester said...

After 6 months of offering stem cell therapy in combination with the venous angioplasty liberation procedure, patients of CCSVI Clinic have reported excellent health outcomes. Ms. Kasma Gianopoulos of Athens Greece, who was diagnosed with the Relapsing/Remitting form of MS in 1997 called the combination of treatments a “cure”. “I feel I am completely cured” says Ms. Gianopoulos, “my symptoms have disappeared and I have a recovery of many functions, notably my balance and my muscle strength is all coming (back). Even after six months, I feel like there are good changes happening almost every day. Before, my biggest fear was that the changes wouldn’t (hold). I don’t even worry about having a relapse anymore. I’m looking forward to a normal life with my family. I think I would call that a miracle.”
Other recent MS patients who have had Autologous Stem Cell Transplantation (ASCT), or stem cell therapy have posted videos and comments on YouTube. www.youtube.com/watch?v=jFQr2eqm3Cg.
Dr. Avneesh Gupte, the Neurosurgeon at Noble Hospital performing the procedure has been encouraged by results in Cerebral Palsy patients as well. “We are fortunate to be able to offer the treatment because not every hospital is able to perform these types of transplants. You must have the specialized medical equipment and specially trained doctors and nurses”. With regard to MS patients, “We are cautious, but nevertheless excited by what patients are telling us. Suffice to say that the few patients who have had the therapy through us are noticing recovery of neuro deficits beyond what the venous angioplasty only should account for”.
Dr. Unmesh of Noble continues: “These are early days and certainly all evidence that the combination of liberation and stem cell therapies working together at this point is anecdotal. However I am not aware of other medical facilities in the world that offer the synthesis of both to MS patients on an approved basis and it is indeed a rare opportunity for MS patients to take advantage of a treatment that is quite possibly unique in the world”.
Autologous stem cell transplantation is a procedure by which blood-forming stem cells are removed, and later injected back into the patient. All stem cells are taken from the patient themselves and cultured for later injection. In the case of a bone marrow transplant, the HSC are typically removed from the Pelvis through a large needle that can reach into the bone. The technique is referred to as a bone marrow harvest and is performed under a general anesthesia. The incidence of patients experiencing rejection is rare due to the donor and recipient being the same individual.This remains the only approved method of the SCT therapy.

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