| Chopra played a major role, which detailed the scientific basis for the Gaps Report. health canada finally responded by requesting the Royal College of Physicians and Surgeons to investigate these concerns. The College responded with a report largely focused on the toxic veterinary effects of rBGH, with less recognition of human concerns. In this connection, it should be noted that, unlike the U.S., Canada has a code of practice for the care and handling of dairy cows that includes the prevention of injury and disease. |
| On the basis of this report, health canada had no option but to ban the continued use of rBGH.
Author's Petition Seeking The Withdrawal Of The New Animal Drug Application Approval For Posilac - rBGH Food and Drug Administration Center for Food Safety Rockville, MD 20852
March 16,2000
I would like to submit the following documentation in support of the above Petition.
1. Epstein, S.S. Letter and Report on "Potential Public Health Hazards of Biosynthetic Milk Hormones" to FDA Commissioner Young, July 19, 1989.
2. Epstein, S.S. "Potential Public Health Hazards of Biosynthetic Milk Hormones. |
| February, 1999: FDA admitted to previously suppressed evidence of induction of specific antibodies following oral administration of rBGH to rats, as disclosed in the 1998 "GAPS ANALYSIS" report to health canada, while attempting to trivialize its significance.
March, 1999: The European Commission released reports by two independent international scientific committees on the adverse veterinary and public health effects of rBGH, with particular reference to human cancer risks. |
Mike Adams, the Health Ranger
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 Some were sudden deaths and others were heart complications, and a total of 20 to 30 such reports lead health canada to take Adderall off the market.
Mike: Now these records are through the voluntary MedWatch system, correct?
Dr. Baughman: Exactly, which the FDA explains in a booklet about the mechanics of MedWatch and other similar voluntary reporting schemes. They confessed that such schemes ordinarily identify no more than one percent of actual occurrences. |
Kelly Patricia O'Meara
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 In February 2005, health canada, the Canadian equivalent of the FDA, announced that it was withdrawing the ADHD "treatment" Adderall from its market due to "safety information concerning the association of sudden deaths, heart-related deaths and strokes in children and adults taking the usual recommended doses of Adderall and Adderall XR."30 The FDA followed up the Canadian decision by releasing a Feb. |
| Statement on Adderall," which effectively referred to the Canadian decision to withdraw the drug, but added the "FDA does not feel that any immediate changes are warranted in the FDA labeling or approved use of this drug based upon its preliminary understanding of Health Canada's analyses of adverse event reports..."31
The FDA further reported in a Feb. |
James F. Balch, M.D. and Mark Stengler, N.D.
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 These new values are the collaborative work of the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes of the Food and Nutrition Board, the Institute of Medicine, the National Academy of Sciences, and health canada. Unlike the RDAs, which establish the minimal amounts of nutrients required to protect against possible deficiencies, the new DRIs are designed to reflect a more modern understanding of nutrient requirements, to optimize health in people and groups of people.
The DRIs are comprised of four reference values. |
Samuel S. Epstein, M.D.
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 The report also disclosed a confidential 1989 study by Searle, under contract to Monsanto, showing that, contrary to long-standing claims by Monsanto, FDA and health canada, rBGH is absorbed intact following feeding to rats, inducing specific immunoglobulins. Evidence of gross regulatory misconduct, suppression of data and conflicts of interest among Canadian Bureau of Veterinary Drugs reviewers was also detailed. |
Kaayla T. Daniel, PhD, CCN
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 Nutrition Research Division, health canada, Ottawa, has found that as lysinoalanines are formed, 19 to 20 percent of the essential amino acid lysine is lost. At the same time, heat and alkaline treatments destroy 73 to 77 percent of cystine, 35-45 percent threonine, and 18-30 percent serine. Furthermore, the natural forms of amino acid-isomers may be converted to the less usable or unusable analogues, resulting in a dramatic loss in protein digestibility and protein quality.28 (See Chapter 13.)
Alkaline processing also compromises mineral status. |
Dr. Timothy Scott
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 By 2000 half a dozen articles had appeared whose titles were blunt and pointed such as "Nefazodone-induced acute liver failure"18 and "Acute liver failure ascribed to nefazodone."19 health canada warned its nation's physicians that Serzone could cause liver failure in 2001. They removed the drug from the Canadian market in 2003. The Dutch Medicines Evaluation Board (CBG) announced in 2002 that because of the danger of liver failure Serzone was going to be removed from the Dutch market.20 Other European countries followed suit, but the FDA never removed Serzone from the U.S. market. |
Paula Begoun
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 Flick, 2001, William Andrew Publishing/Noyes; health canada, www.ec.gc.ca/nopp/DOCS/consult/voc-cov/cons-2003/en/dp5.cfm; and Drug & Cosmetic Industry, April 1, 1997).
Sunscreen in Hair-Care products
No question about it, hair needs to be protected from the sun! Sun damage destroys hair by breaking down the bonds that keep hair's structure intact. Where brushing and combing chip away at the outer cuticle, energy from the sun destroys the interior of hair, which explains why hair color fades with sun exposure. |
| A letter has been circulating the Internet which claims that there is a link between cancer and sodium laureth (or lauryl) sulfate (SLS), an ingredient used in [cosmetics]. health canada has looked into the matter and has found no scientific evidence to suggest that SLS causes cancer. It has a history of safe use in Canada. Upon further investigation, it was discovered that this e-mail warning is a hoax. The letter is signed by a person at the University of Pennsylvania Health System and includes a phone number. |
Fred A. Baughman, Jr., M.D. and Craig Hovey
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 On February 9, 2005, health canada, the Canadian counterpart of the FDA, instructed Britain's Shire Pharmaceuticals Group Pic, manufacturer of Adderall and Adderall-XR (both a mixture of amphetamine salts), to withdraw Adderall-XR (the long-acting form—the only one sold in Canada) from the Canadian market. Their decision came after a review of 20 sudden deaths (14 in children) and 12 strokes (2 in children) in patients taking either Adderall or Adderall-XR. Nor were these occurrences associated with overdose, misuse or abuse—they were being taken as directed. |
Josef A. Brinckmann and Michael P. Lindenmaier
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 MygraFew™ (contains 12mg Partex™ per tablet, a dried extract of feverfew leaf standardized to 7% parthenolide); Mygracare® (100 mg dried feverfew flower and leaf per capsule standardized to 600 ug parthenolide).
The health canada Therapeutic Products Directorate published a Labelling Standard monograph in 1997 for Feverfew Leaf in the form of encapsulated or tabletized crude dried leaves, labeled as Traditional Herbal Medicines (THM), for migraine headache prophylaxis. The adult daily dosage must provide the equivalent of 250 ug to 1,000 ug parthe-nolide. |
Heather Boon, BScPhm, PhD and Michael Smith, BPharm, MRPharmS, ND
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 In response to public demand, the Federal Minister of Health created a new Federal Office of Natural Health Products (ONHP) in March 1999 as part of health canada. The mission of the new Office, now known as the Natural Health Products Directorate (NHPD), was to "ensure that all Canadians have ready access to natural health products [including herbs] that are safe, effective and of high quality, while respecting freedom of choice and philosophical and cultural diversity. |
Jeffrey M. Smith
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 Global Reactions to Canada's Revelations
Concerns about IGF-1, like many of the other issues raised in the Gaps Analysis Report, was a frustrating setback to many Senior health canada officials who were determined to get the rbGH on the market. Their original intention was to approve the drug without review, simply because the U.S. had. |
| While the FDA claimed that rats fed rbGH showed no effects, the short duration chosen for the study astounded critics. Health Canada's Chopra says, "In twenty-eight days, what can you find?"10 The second study was also short-term—ninety days.
According to the Canadian Gaps Analysis Report, since rbGH was a hormone, "its chemistry should have prompted more exhaustive and longer toxicological studies in laboratory animals." These are "usually required ... to ascertain human safety. |
Josef A. Brinckmann and Michael P. Lindenmaier
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| Canada by the FDA and health canada, respectively (though their use in Traditional Herbal Medicines in Canada is permitted). This measure taken by the FDA is remarkable in the sense that American calamus oil, as mentioned in the constituents section, is practically free of ot-isoasarone. Additionally, the German Commission B8 of the former BGA (Federal Health Office) gave calamus oil a negative evaluation as a bath additive. Even though the risk of acute toxicity may be low for drug material that contains not more than 0. |
| Health Canada Therapeutic Products Directorate. Labelling Standard: Echinacea Root. Ottawa (1997).
Willuhn
Echinaceae pallidae radix
USNF monograph is planned
Echinacea pallida root
1 cm
Fig. 1: Echinacea pallida root Description: The drug consists of the dried and sometimes twisted, cylindrical or slightly tapering, reddish brown to grayish brown and 5-10 mm long, longitudinally wrinkled roots, including the rhizome. |
Jeffrey M. Smith
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| On December 7, 1999, health canada scientists told a new Canadian Senate Committee how they were threatened, harassed, and denied promotions in retaliation for their testimony the previous year.37 When the committee learned that scientist Shiv Chopra had been suspended for testifying, they asked to see his boss, Andre Lachance. But Lachance disappeared a few days later. His attorney claimed he was sick and unable to appear before the committee. The department then replaced Lachance altogether and announced that he wouldn't be returning at all. |
Josef A. Brinckmann and Michael P. Lindenmaier
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| Health Canada, Labelling Standard: Valerian, 17. May 1996.
Wichtl
Verbasci flos
Mullein flowers
Ph. Eur.
I
-v -j"
1 cm
Fig. 1: Mullein flowers
Description: The drug consists only of the corolla and stamens. The yellow 5-part corollas have two smaller upper and three larger lower petals, all with a white tomen-tum; fragments of the flowers are also present. |
Jeffrey M. Smith
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| His report, which went unanswered, outlined many of the key criticisms that the scientists at health canada were later to address. Epstein also received a box of secret FDA documents, sent to him anonymously. The information revealed that a high percentage of cows injected with rbGH had serious health problems and, according to Epstein, showed that Monsanto and the FDA were involved in a massive cover up.
In February 1996, the coalition tried to stop freelance writer Linda Weltner from including references to Epstein's concerns in her Boston Globe column. |
Doris J. Rapp, M.D.
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 Health Canada to Ban Some Deet Products," Pesticides and You, Summer 2002: 22 (2), 9.
30d "Chemical Watch Fact Sheet, DEET," Pesticides and You,
Summer 2002:22 (2) 9-10. 31a NCAMP, Tech. Report, December 2000:15 (12) 4. www.chem-tox.com.
31b "West Nile Moves Bird to Bird in Lab," USGS Researchers: October 25, 2000. 703.648.4732.
32 Edmon, Dr. John, Center for Vector-Borne Disease, Research School of Veterinary Medicine, U of Calif., Davis, CA 95616.
33 NCAMP, Tech. Report, December 2000:15 (12), 4. 34a www.usgs.gov.
34b www.unmesc.usgs.gov/http_data/nwhc/news/westnil2.html. |
Brenda Davis and Tom Barnard
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 Sucralose The FDA, the Joint Food and Agricultural Organization of the World Health Organization, the American Council on Science and Health, and the Health Protection Branch of health canada all vouch for the safety of sucralose. Prior to giving its approval, the FDA examined over one hundred safety studies and forty environmental studies conducted over a twenty-year period. Overall, sucralose has generated relatively little negative press. However, as with most products, we managed to find a few outspoken critics. |
| This is the view currently held by the FDA, health canada, and CSPI. Although there is no evidence of harm to people, some express concern that laboratory studies on animals suggest possible cancer and reproductive-health problems. The second school of thought declares that the FDA has been actively suppressing stevia for years, probably caving in to pressures from the politically powerful artificial sweeteners industry. Stevia would be a fearsome competitor—it is relatively cheap and it is natural—both features attractive to consumers. Who's right? |
Josef A. Brinckmann and Michael P. Lindenmaier
See book keywords and concepts |
| Health Canada Therapeutic Products Directorate. Labelling Standard: Echinacea Root. Ottawa (1997).
Willuhn
Eleutherococci radix Eleutherococcus
Ph. Eur., PPRC, a USNF monograph is planned
(Ph. Eur.),
Eleuthero
(USNF)
J i
Fig. 1: Eleuthero root
Description: The rhizomes are 1.5-4 cm wide, knotty and of irregular cylindrical shape. The surface is rough, longitudinally wrinkled and grayish brown to blackish brown. The bark, about 2 mm thick, closely adheres to the xylem. The fracture is coarsely fibrous, particularly in the internal part of the xylem, with short, thin fibers in the bark. |
Mark Blumenthal
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 Ottawa, Ontario: health canada Therapeutic Products Directorate. August 6, 1997; 1-3.
Heptinstall S, Awang D, Dawson B, Kindack D, Knight D, May J. Parthenolide content and bioactivity of feverfew (Tanacetum parthenium (L.) Schultz-Bip.). Estimation of commercial and authenticated feverfew products. / Pharm Pharmacol 1992;44:391-395.
Heptinstall S, Awang D. Feverfew: A review of its history, its biological and medicinal properties, and the status of commercial preparations of the herb. ACS Symposium Series 691. Phytomedicines of Europe-Chemistry and Biological Activity 1998; 158-75. |
Heather Boon, BScPhm, PhD and Michael Smith, BPharm, MRPharmS, ND
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| Constriction of the blood vessels in the mucosa of the respiratory system results in decreased mucous production, providing a decongestant action.14 health canada has published a labeling standard for ephedra-containing products as nasal decongestants,15 an indication for which approximately 20 ma huang products have been registered as non-prescription drugs. There are also 3 commercial products containing ma huang registered in Canada as vasoconstrictors, 7 as sympathomimetics, and 4 as homeopathic products. |
| Claims for use of ephedra-containing products as stimulants or diet aids for weight loss are not allowed by health canada under the Herbs and Natural Products drug category.16
ATHLETIC PERFORMANCE
In a review article, Clarkson and Thompson conclude that there is very little evidence to support the use of ephedrine or pseudoepherine to improve sporting performance. While some athletes may take ephedrine to reduce body fat and promote muscle mass, there is no evidence to support this indication in individuals who are not overweight. |
| In response to these concerns, health canada has warned consumers not to use products containing ma huang unless the product label carries a Drug Identification Number and the consumer follows strictly the dosage directions and precautions. |
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