The Canadian regulator is continuing its campaign against the banned weight-loss herbal Ephedra and the anxiety-reliever Kava, yesterday issuing its latest warning to consumers not to use the substances.
The group is this time directly targeting two products sold under the Life Choice brand: Life Choice Ephedrine HCL and Life Choice Kava Kava.
Consumers have been told to immediately stop using these products, as Health Canada continues efforts to prevent the items from reaching the market.
This latest caution follows similar warnings against Ephedra in March this year, and also in 2006 and 2005, reminding consumers about the "serious, possibly fatal" hazards of using Ephedra or ephedrine, "either alone or in combination with caffeine and other stimulants, for purposes of weight loss, body building or increased energy."
Health Canada said potential Ephedra side-effects include dizziness, headache, decreased appetite, anxiety, restlessness or nervousness, gastrointestinal distress, irregular or fast heart beat, insomnia, flushing, sweating, hypertension, stroke, seizures, psychosis and death.
Over-the-counter nasal decongestants are the only form in which Ephedra and ephedrine are authorized for use in Canada and should be used only as directed, for short periods of time, Health Canada said.
The maximum allowable dosage for ephedrine is 8mg in a single dose or 32mg per day; for Ephedra 400mg in a single dose or 1,600mg per day.
Life Choice Ephedrine HCL is apparently still available, sold in 30mg capsules and packaged in bottles containing 60 capsules. However, the regulatory agency said the product contains “an excessive amount of ephedrine”. The agency also found the product to be contaminated with bacteria, and said it could cause “serious and irreversible adverse health effects, including death”.
Kava is a herbal which was previously used to treat anxiety symptoms. However, it was banned in Canada in 2002, after its use was associated with fatal liver toxicity.
The product has also been associated with adverse health effects that include an itchy, scaly skin condition, known as kava dermopathy, muscle weakness, and coordination problems, said Health Canada.
The agency said Life Choice Kava Kava is still sold in 150mg capsules, packaged in bottles containing 60 capsules.
Bans and appeals
Ephedra, in particular, has been a regulatory target following its high-profile ban in the US and Canada.
The product is a source of ephedrine alkaloids, which are adrenaline-like stimulants that can have potentially dangerous effects on the heart.
In the United States, an FDA ruling in 2004 banned the use of the ingredient in dietary supplement products, although the move sparked a debate that has played out in US courts as companies have appealed against the FDA position.
In April 2005, the ban was successfully challenged by Nutraceutical Corporation, since the 1994 Dietary Supplements Health and Education Act (DSHEA) does not make mention of risk-benefit balance in establishing whether a supplement presents an unreasonable risk. Rather, the FDA drew on the medical devices provisions of the Food Drug and Cosmetics Act, which does state that this is a determining factor.
However, this was then overturned by the federal appeals court decision in August of the same year.
Since then the pendulum has swung back and forth on appeal. The latest came in May last year when the US Court of Appeals rejected the Utah-based firm's challenge to the ban on the grounds that FDA's determination of "unreasonable risk" was itself unreasonable and meant virtually all dietary supplement ingredients stood the risk of being banned.
The court rejected the appeal without comment.
In April this year, nine Ephedra-containing supplement products marketed by Herbal Science International were recalled in the US. Industry backed the move, stressing the importance of abiding by good manufacturing practices.