Contents

Page 1
Health Canada bans thermogenic supplements.
Low doses and bogus time limits.
Page 2
No caffeine allowed in ephedrine products.
Truthful speech banned!
Public citizen is pushing the same agenda.
Concluding remarks.

Interestingly, the Health Canada advisory calls this action a "voluntary recall" of products that are "marketed without approval." But it sounds about as "voluntary" as 'giving' your money to an armed robber:

"Health Canada is issuing letters to Canadian manufacturers, distributors and importers requesting that they discontinue sale of these products and that the products be recalled from all levels of the market, including retail. A customs lookout has also been issued, to ensure that these products are not imported into Canada . . . A random market survey will be undertaken within 6 months of the requested recall to determine whether these products have found their way back onto the Canadian market. Non-compliant products will be removed from the shelves " (1).

Voluntary? I guess politicians instinctively run from the truth in the same manner as cockroaches instinctively run for cover when you turn the lights on.

In a previous post, I detailed how the FDA uses scientifically worthless MedWatch adverse event reports to attack supplements. The Ephedra Education Council has correctly pointed out that the Canadian ban is based on the same type of scientifically fraudulent data used by the FDA to attack thermogenic supplements:

"Health Canada's voluntary recall is an over-reaction to unsubstantiated and unscientific adverse event reports (AERs). This action mirrors the mistakes that the U.S. Food and Drug Administration made five years ago in its attempt to restrict Ephedra products in the United States. In 1999, an investigation by the U.S. General Accounting Office (GAO) found the FDA at fault for using AERs as scientific data even though the reports contained no evidence of any causal link between Ephedra and the adverse reactions about which FDA said it was concerned. The GAOs findings forced the FDA to withdraw its proposed regulations and admit lack of scientific evidence" (4).

In startling contrast to the deceitful scare mongering of power hungry regulatory agencies, obesity scientists consider ephedrine/caffeine to be so safe that they have started to use it to treat obese adolescents! I kid you not. This study was published in the International Journal of Obesity and you can get the full text from Selma's Document Retrieval Service. In addition to finding that ephedrine/caffeine "spectacularly improves weight loss," the scientists found it to be so safe that it is well-tolerated by obese adolescents:

"The present study was performed to investigate the efficacy and safety of a caffeine/ephedrine (CE) mixture and obese adolescents . . . Adverse events were negligible and did not differ between the CE and PL [placebo] groups. Withdrawal symptoms were mild, transient and their frequency and severity were not different between the placebo and active groups. According to the present pilot study CE [caffeine/ephedrine] can be a safe and effective compound for the treatment of obesity in adolescents" (5).

Perhaps the most shocking contrast between the scientific evidence and the rubbish the regulators are feeding us concerns the effect of ephedrine/caffeine on your heart. The obesity scientists tested the adolescents and found that ephedrine/caffeine does NOT stress the heart. In addition, blood tests indicate that ephedrine/caffeine makes you less likely to have heart problems:

"Some of the well-known cardiovascular risk factors also improved in the active [caffeine/ephedrine] group. The plasma triglyceride and apolipoprotein B plasma concentrations in the active group were significantly lower than that of the placebo group at the 20th week . . . The cardiopulmonary responses of the subjects to stress testing were not affected by 20 weeks of treatment, supporting the observations of Stich et al made in adults after 3 days of CE [caffeine/ephedrine] treatment . . . Blood pressure and heart rate values showed no significant changes..." (5).

One reason why obesity is bad for your heart is because the abnormally low activity of the sympathetic nervous system causes a number of problems that predispose us to heart disease, diabetes, ect. Although many pay lip service to that notion that obesity is a real disease, this extremely important fact is rarely mentioned when  "obesity related diseases" are discussed. Thus, as the blood tests revealed, by helping to normalize the obese person's biochemistry, ephedrine/caffeine makes you less likely to have heart problems. Unless, of course, you actually think power hungry regulators know more than research scientists.

At the end of this page, there is a box that lets you email a link to this page. Why not contact reporters and see if they are willing to look into this scandalous situation. Selma's Document Retrieval Service will supply them with free copies of medical studies and I will answer technical questions. Are there any reporters out there with the guts to do an honest investigation?

Scientific Fraud

Health Canada's limitations are very similar to those originally recommended by the FDA. Thus, Health Canada's ban pertains to "Ephedra/ephedrine products having a dose unit of more than 8 mg of ephedrine or with a label recommending more than 8 mg/dose or 32 mg/day and/or are labelled or implied for use exceeding seven days."

So where does this seven day time limit come from? In 1997, the FDA proposed rules very similar to the rules that were recently adopted by Health Canada. The FDA's justification for their proposed rules was the single most fraudulent use of science that I have ever seen. They claimed that "ephedrine alkaloids, even at relatively low levels" can cause cardiomyopathy and myocardial necrosis, but most of the references they cited to support their claim didn't even have anything to do with ephedrine -- they were references to articles on cocaine and methamphetamine!

The FDA did, however, manage to dig up two medical articles and an abstract that actually mentioned ephedrine. I present them here, with quotes, so you can see for yourself that they have absolutely nothing to do with obese people who take moderate doses of ephedrine/caffeine. Here is the FDA's case against long-term use of thermogenic supplements and the references they used to support it:

FDA Proposed Rules: "The scientific literature establishes that use of ephedrine alkaloids for a period of several months or years can result in cardiomyopathy (Refs. 66 through 68)." [emphasis added]

66.) Van Mieghem W; Stevens E, and Cosemans J. "Ephedrine-induced cardiopathy." Br Med J, 1978 Apr 1; Vol: 1; Number: 6116; Page: 816; PMID: 638463.

"He had exercise-induced and hyperventilation asthma since the age of 14. In 1958 he began to take a cough mixture containing ephedrine that relieved his bronchial spasms. He progressively increased his ephedrine intake, until he was drinking more than a bottle a day, each of which contained 400 mg of ephedrine. He was also taking liberal doses of prednisolone intermittently, depending on how he felt. In 1972 and 1973 he was treated in another hospital for cardiac failure but continued to take the cough mixture." [emphasis added]

67.) To LB; Sangster JF; Rampling D, and Cammens I. "Ephedrine-induced cardiomyopathy." Med J Aust, 1980 Jul 12; Vol: 2; Number: 1; Page: 35-6; PMID: 7432264.

"Fourteen months after her initial presentation, she was referred for psychiatric treatment by her general practitioner. Her husband had overheard a telephone conversation during which his wife revealed the financial burden imposed by her drug taking habits. His unexpected support and acceptance enabled her to seek help. It emerged that she had been taking large quantities of ephedrine-containing compounds for 10 years because these gain her energy and a feeling of well-being, and counteracted chronic fatigue and depression. She had originally taken Ephedrobarbital, but had changed to Tabasan, as this was more easily available. She had ingested 10 to 30 tablets of Tabasan daily until the time of her admission to hospital for cardiac failure.  She had not resumed taking Tabasan after discharge, but, three months later, she started taking increasing amounts of Phensedyl elixir. At the time of psychiatric referral, she was consuming three bottles (375 mL) daily." [540 mg ephedrine daily!]

Ephedrobarbital: Each tablet contains ephedrine HCl 30 mg, phenobarbital 15 mg.
Tabasan: Each tablet contains ephedrine HCl 15 mg, theobromine 30 mg, and salicylamide 60 mg.
Phensedyl Elixir: Each 125-mL bottle contains promethazine HCl 90 mg, codeine phosphate 225 mg, and ephedrine HCL 180 mg.

68.) Gaultieri J, and Harris C. "Dilated Cardiomyopathy in a Heavy Ephedrine Abuser." Journal of Toxicology, Clinical Toxicology, 1996; Vol: 34; Page: 581-2 [Abstract - not on PubMed].

"We report a case of dilated cardiomyopathy in a heavy ephedrine abuser. Case: a 28 y [year old] 143 kg female presented with a 3 week history of progressing dyspnea, dry cough, fatigue, and orthopnea. She admitted to taking 25 mg ephedrine tablets for 8 y to lose weight but denied any other chronic drug or alcohol use except tobacco (1 ppd x 12 y) [1 pack per day x 12 years] . . . One week after the onset of her symptoms she reduced her daily intake from 80 tablets to three tablets." [emphasis added]

I fail to see how these examples of extremely reckless behavior can legitimately be used to establish an 8 mg dose limit and a seven day time limit. It is outrageous and morally criminal that government regulators would use science in such a fraudulent manner in an attempt to deny medicine to obese people. The FDA's propaganda about ephedrine causing heart damage is so ridiculous that it even drew fire from the U.S. Small Business Administration:

"The agency [FDA] states that its data shows that "long-term use of . . . ephedrine alkaloids, even at relatively low levels, is related to serious adverse events, including cardiomyopathy and myocardial necrosis. However, the presence of ephedrine alkaloids in the body is not dispositive of the fact that cardiomyopathy was the result. Reliance on AERs [Adverse Event Reports] to prove cardiomyopathy is inappropriate because of the prevalence of the disease in the general population. According to the Montgomery Heart Foundation for Cardiomyopathy, approximately one in 500 people carry an altered gene that can cause certain forms of the disease. Therefore, many who suffer or die from this disease, contracted it genetically. Others contract it through infection, endocrine disorders, metabolic disorders or other unknown causes. The agency has not identified any test or assay to prove dispositively that any reported incidents of cardiomyopathy truly are due to long-term use of ephedrine alkaloids. In fact, literature on the subject suggests that no such test exists" (9).

The mainstream media won't touch this with a ten foot pole, but one of the world's foremost obesity scientists, Arne Astrup, actually came out and publicly accused the FDA of misrepresenting his data in their quest to demonize ephedrine:

"Dr. Astrup also pointed to an FDA report on the published literature as misrepresenting data in his study on the safety of the two ingredients to instead support FDA's allegations concerning Ephedra. "I think our data and results are mischaracterized and the presentation is flawed and distorted," said Dr. Astrup. "It's giving a very negative picture of the safety profile of the combination of ephedrine/caffeine, which is not supported by our research" (10).

I challenge Health Canada to either produce some real science -- not this type of fraudulent propaganda -- or put an end to this ridiculous "voluntary recall" of thermogenic supplements.

Dennis Jones, Ph.D., of Bariatrix International provided additional insight into why Health Canada says ephedrine products should only be used for seven days:

"Jones pointed out that the Canadian label requirement cautioning users not to take ephedra products for more than seven days is often misunderstood. The caution does not imply that the products are unsafe if taken for more than seven days, but rather expressed the attitude of the Canadian government toward self-medication, according to Jones. He explained that this statement means that if an individual uses a self-treatment for seven days and sees no improvement, the individual should go to the doctor" (6).

So there it is. Isn't it, like, totally ridiculous to apply this time limit nonsense to a chronic condition like obesity? By the way, the 12 week limit that you currently see in the ephedrine warnings appears to be a compromise between the FDA's original seven-day limit and the supplement industry. I'm not aware of any real science to support any of this political BS. It's no wonder people are confused.

Personally, I am sick to death of the government's "attitude" toward self-medication. I get email from people who are scared and confused by these time limits. What can I say? I'm not a doctor and I can't tell anyone what they should do, but personally I believe the obesity scientists. In my opinion, the evidence indisputably proves that the bureaucrats cannot be trusted.

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Written
Jan 2002
Last Update
Jan 2002

1.) Health Canada requests recall of certain products containing Ephedra/ephedrine ( Jan 9, 2000).

2.) Astrup A and Toubro S "Thermogenic, metabolic, and cardiovascular responses to ephedrine and caffeine in man" Int J Obes Relat Metab Disord 1993, Vol 17 Suppl 1 Pg S41-3, PMID: 0008384179.

3.) Astrup A, Breum L, Toubro S, Hein P, Quaade F "The effect and safety of an ephedrine/caffeine compound compared to ephedrine, caffeine and placebo in obese subjects on an energy restricted diet. A double blind trial" Int J Obes Relat Metab Disord 1992, Vol 16 (4), Pg 269-77. PMID: 0001318281.

4.) The Ephedra Education Council Responds to Canada's Request for a Voluntary Recall of Ephedra Products (Jan 11, 2001).

5.) Molnar D; Torok K; Erhardt E, and Jeges S. "Safety and efficacy of treatment with an ephedrine/caffeine mixture. The first double-blind placebo-controlled pilot study in adolescents." Int J Obes Relat Metab Disord, 2000 Dec; Vol: 24; Number: 12; Page: 1573-8; PMID: 11126208.

6.) Jones, D "Highlights of the 1999 AHPA International Ephedra Symposium" Natural Products Industry Insider.

7.) Ardati, AK; Wolfe, SM. "Letter to American Medical Association urging their support of HRG petition to the FDA to ban dietary supplements containing ephedrine alkaloids (HRG Publication #1604)" Public Citizen Website, Jan 17, 2002.

8.) Federal Register: June 4, 1997 (Volume 62, Number 107) Proposed Rules, Page 30677-30724.

9.) Re: Initial Regulatory Flexibility Analysis of the Proposed Rule for Dietary Supplements Containing Ephedrine Alkaloids  U.S. Small Business Administration, 62 Fed. Reg. 30,678 (June 4, 1997); Docket No. 95N-0304.

10.) Ephedra Education Council "Ephedra's safety and benefits confirmed" September 14, 2000.

FDA References

66.) Van Mieghem W; Stevens E, and Cosemans J. "Ephedrine-induced cardiopathy." Br Med J, 1978 Apr 1; Vol: 1; Number: 6116; Page: 816; PMID: 638463.

67.) To LB; Sangster JF; Rampling D, and Cammens I. "Ephedrine-induced cardiomyopathy." Med J Aust, 1980 Jul 12; Vol: 2; Number: 1; Page: 35-6; PMID: 7432264.

68.) Gaultieri J, and Harris C. "Dilated Cardiomyopathy in a Heavy Ephedrine Abuser." Journal of Toxicology, Clinical Toxicology, 1996; Vol: 34; Page: 581-2 [Abstract - not on PubMed].