Canada Recalls Products Containing Ephedra

Canada Recalls Products Containing Ephedra

OTTAWA--In early January, Health Canada requested a voluntary recall of certain products containing either ephedra or ephedrine. This comes after the agency conducted a risk assessment and found these products posed a serious health risk and may lead to strokes, heart attacks, heart rate irregularities, seizures, psychoses and possible death.

Products affected by the voluntary recall include those that have recommended doses exceeding 8 mg per serving and/or 32 mg/day; combination products containing stimulants (e.g., caffeine); and products promoted for weight loss, bodybuilders or increased energy. Products not affected include nasal decongestants and those used in traditional medicine. However, they must not contain caffeine nor can they exceed the 8 mg/dose and/or 32 mg/day recommendations. The recall does not affect products dispensed by practitioners.

In the meantime, Health Canada is issuing letters to Canadian manufacturers, distributors and importers requesting they discontinue selling these products, and regulatory letters will be issued to manufacturers of products that exceed the agency's recommended dosage. Ephedra products already on store shelves will be recalled. In addition, customs has been informed to halt the import of ephedra products affected by this recall.

Health Canada first issued an ephedra/ephedrine public advisory in 1997, and in June 2001, a similar advisory was issued. Now, the government body has taken a more decisive action. "The manufacturers and importers are the ones who are legally responsible to ensure that the product they have is safe and effective," said Ryan Baker, a spokesperson for Health Canada. "All recalls are voluntary when it comes to drugs, and 99 percent of the time, manufacturers and importers comply." He added that those who do not comply will have their products seized by the government. (Editor's note: In Canada, natural health products are regulated as either foods or drugs. In the case of ephedra/ephedrine, they are regulated as drugs.)

Since 1994, industry associations and companies in the United States proposed a dosage max of 25 mg/dose and 100 mg/day of ephedra alkaloids. "The science shows that ephedra is safe and effective when used according to labeled directions by those for whom it is intended," reported JudyBlatman, vice president of communications for the Council for Responsible Nutrition (www.crnusa.org). "All regulations, including those from Canada, should line up with sound science."

Natural products manufacturers are also speaking up about this latest development. "We fully support the actions of Health Canada to ensure the safety of consumers," remarked Nancy Baines, vice president of consumer health care at Boehringer Ingelheim (Canada) Ltd. The company added that it is important that consumers are provided with accurate and up-to-date information about health products that are effective and safe.

According to the agency, a random market survey will be undertaken within six months to determine if non-compliant products are still being sold. For more information, visit Health Canada's Web site(www.hc-sc.gc.ca/english/index.html).