Health Protection Branch

Health Protection Branch, Department of National Health and Welfare, Tunney s Pasture, Ottawa, Ontario KIA 0L2, Canada... 

Canadian Health Protection Board Canadian Health Protection Branch... 

The capsules contained a mean of 82 mg feverfew and thus the level of activity calculated as parthenolide can be estimated as 0.67%. Other studies quote 0.87% sesquiterpene lactones calculated as parthenolide [27] and 0.25-0.30% of active (antimicrobial) material [33]. Bohlmann s extraction of individual components from the dried plant yielded 116 mg sesquiterpene lactones/kg dried feverfew which amounts to less than 0.01 % [17]. Another extraction yielded 330 mg endoperoxides/kg and 56 mg canin/kg alone [19] which would amount to a level of sesquiterpene lactones of at least 0.04%. Thus, the level of sesquiterpene lactones appears to vary with different sources of the plant and this could have been due to a number of factors including the conditions in which feverfew was grown, the season in which it was picked and the way in which it was stored. Another important determinant of the parthenolide content of feverfew appears to be the geographical location. A recent survey of commercial preparations found that all the North American commercial products tested contained less that 0.1% parthenolide, wheras much higher values were obtained for British products. A minimum level of 0.2% parthenolide in commercial products has been proposed by the Health Protection Branch of Health and Welfare Canada [71]. 

The decision to approve a new drug is made by a national regulatory body (Food Drug Administration in the U.S.A., the Health Protection Branch Drugs Directorate in Canada, UK Europe, Australia) to which manufacturers are required to submit their appUca-tions. AppUcants must document by means of appropriate test data (from predinical and clinical trials) that the criteria of efficacy and safety have been met and that product forms (tablet, capsule, etc.) satisfy general standards of quality control. 

The main players at ICH are now the European Commission/EMEA, EEPIA, Japanese Ministry of Health Labour and Welfare (MHLW), Japanese Pharmaceutical Manufacturers Association (JPMA), US FDA and Pharmaceutical Research and Manufacturers of America (PhRMA). The WHO, Canadian Health Protection Branch and the European Free Trade Area (BETA) countries enjoy an observer status at ICH meetings. 

Drugs Directorate Guidelines, Acceptable Methods, Health Protection Branch -Health and Welfare Canada, 1992,20-22. 

Di(2-ethylhexyl) phthalate was found in both the packaging and in a number of contacted foods sampled in a 1985-89 survey as part of the Canadian Health Protection Branch Total Diet Program. Low levels (65 lg/kg [L] average in beverages and 29 ig/kg average in foods) associated with the use of di(2-ethylhexyl) phthalate-plasticized cap or lid seals were found in a variety of glass-packaged foods. It was... 

Drugs Directorate Guidelines Health Protection Branch, Health Canada, Acceptable Methods, Ottawa, Ontario, Canada, 1994. 

In Canada, the Health Protection Branch (HPB), Health and Welfare, fulfills the responsibilities by establishing MRLs for pesticides in foods and by establishing programs to ensure compliance with these MRLs (30). 

B. Stavric. Internal communication, Health Protection Branch, Ottawa (1980). 

Subterranean parts, powder, extract, and tincture are permitted as traditional tranquilizers The Health Protection Branch of Health Canada allows products containing valerian as a single medicinal ingredient in the form of crude dried root in tablets, capsules, powders, extracts, tinctures, drops, or tea bags intended to be used as sleeping aids/sedatives... 

Corbet RL, Worobey BL, Webster GRB. 1981. Preliminary analysis and confirmation of the presence of polychlorinated dibenzo-p-dioxin (PCDD) and polychlorinated biphenyls (PCB) in lake sediment. In Muir DC, ed. Sixteenth Annual Workshop on pesticide residue analysis and ninth annual workshop on the chemistry and biochemistry of herbicides, Winnepeg, Manitoba, Canada Department of National Health and Welfare, Health Protection Branch, 111-116. 

Ryan JJ. 1987. Personal telephone communication between DK Basu and JJ Ryan Food Research Division, Health Protection Branch, Ottawa, Canada. Syracuse Research Corporation, N.Y., September 2, 1987. 

Source Reprinted from Health Canada, Health Protection Branch consultative document on draft proposals-sub-jects (1) fortification of flour and pasta with folic acid, (2) harmonization of flour enrichment with the United States of America, (3) optional enrichment of flour. 

The authors appreciate the help of Dr. R. Mongeau, Nutrition Research Division, Health Protection Branch, in the fibre analysis of the cereals. They also thank Mr. S. Malcolm, Food Statistics and Operational Planning, for statistical analysis of the data. 

F. W. Scott and N. S. Lee, Report of the Bureau of Nutritional Science Committee on Functional Foods, Food Directorate, Health Protection Branch, Ottawa, Canada (1996). 

Health Canada is the responsible Ministry for the enforcement of the Food and Drugs Act and for the formulation of and amendments to the Drugs Regulations. The former Drugs Directorate and the Medical Devices Bureau of the Health Protection Branch (HPB) have been combined to form a new agency, the Therapeutic Products Programme (TPP). 

In Canada, the Health Protection branch allows sale of tablets and capsules made from feverfew crude dried leaves for decreasing the frequency and severity of migraine headaches. The products should be standardized to contain no less than 0.2% parthenolide. In France, feverfew has traditional use in the treatment of heavy menstrual flow and prevention of migraine headache (4). 

A survey for natural benzoic acid was carried out by Nagayama et al [28] and further surveys for benzene in fruits, retail fruit juices, fruit drinks and soft drinks were carried out by the Canadian Health Protection Branch [29] and by the FDA in foods [30]. Decarboxylation of benzoic acid in the presence of ascorbic acid and a transition metal catalyst has been reported to yield benzene [31]. Studies on benzene formation in beverages at the National Laboratory of Food Drugs in China [32] showed that ascorbic, sodium benzoate and hydrogen peroxide increase benzene formation initially, but when a certain concentration was reached, the effect was reversed ethanol and Fe " ions inhibited benzene formation. 

Environment Canada and Health and Welfare Canada (1993) Guidelines for the Notification and Testing of New Substances Chemicals and Polymers. Pursuant to the New Substances Notification Regulations of Canadian Environmental Protection Act. Environment Canada, Conservation and Protection, and Health and Welfare Canada, Health Protection Branch, Ottawa, Ontario. 

Some organizations, including the Canadian Health Protection Branch and the United States Pharmacopeia (USP), act as observers to the conference working committees, and their input is also influential in the guideline-setting process. In addition, the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) acts as an umbrella organization and provides the ICH secretariat to coordinate the preparation of documentation. 

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