The U.S. Food and Drug Administration issued a warning last month not to use homeopathic teething products linked to 10 deaths and hundreds of illnesses because they could contain toxic amounts of belladonna, also known as deadly nightshade. The company that sells the products, Standard Homeopathic Co., did not agree to issue a product recall despite the FDA's concerns.
The potentially dangerous teething products are still available for sale to Canadians. But you may not have heard about it because so far, the federal government has not taken action – a situation that highlights problems with the regulation of natural health products that could put consumers at risk.
The controversy started in 2010, when the FDA, Health Canada and Standard Homeopathic, which manufactures Hyland brand teething products, issued a voluntary recall of teething tablets after FDA tests showed they contained inconsistent amounts of belladonna. At the time, the company said it would address manufacturing issues to prevent the problem. Belladonna is a poisonous plant often used in herbal remedies and ointments that can be toxic, particularly when ingested.
Last September, the FDA issued a new warning not to use Hyland's homeopathic teething tablets because it had received new reports of seizures and other serious side effects in infants and children who had used them. Last month, the agency issued another warning after laboratory tests confirmed "inconsistent levels" of belladonna in Hyland's teething tablets, "sometimes far exceeding the amount claimed on the label." In the past six years, the FDA says it received more than 400 reports of seizures, fever, shortness of breath, tremors, vomiting and other serious side effects linked to the products, including 10 deaths. It's unclear if the teething tablets were the definitive cause of the adverse events and the FDA says it is continuing its investigation.
"The body's response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement. The agency added that homeopathic teething products "have not been evaluated or approved by the FDA for safety and effectiveness" and that it's "unaware of any proven health benefits of the products."
But unlike the 2010 incident, Standard Homeopathic now says it doesn't want to conduct a product recall and says the products are safe. The company decided to stop selling teething tablets and teething gel in the United States, blaming the FDA for creating an unnecessary problem.
"This warning has created confusion among parents and limited access to the medicines," a statement on the Hylands.com website said. Standard Homeopathic did not respond to requests for comment.
In September, Health Canada issued a vague public advisory about homeopathic teething products that did not mention the product or company name involved in the FDA investigation. The department said there "is no indication of a similar safety concern in Canada" but did not say whether any of the products have been tested here or what other steps have been taken.
Michael Kruse, executive director of Bad Science Watch, a science-based advocacy group, said Health Canada needs to address this issue.
"This is a clear danger to children. You'd think they'd want to at least have a precautionary approach," he said.
Health Canada declined an interview request. In an e-mail statement last Friday, a spokesperson said the department "continues to work actively on this file" and is "assessing the new information" from the FDA.
According to the department's adverse reaction database, there have been three reports of infant seizures and vomiting linked to teething tablets since 2013. The database does not indicate which brands were involved. Natural health product manufacturers are not required to report side effects to Health Canada.
A regulatory system rife with problems
The response from Health Canada highlights problems with regulation of natural health products. They must be approved before they're sold. But unlike prescription drugs, Health Canada will approve a natural health product even if there is little evidence it works or is safe. For instance, products can be approved if a manufacturer can show that they have been used in traditional medicine.
As a result, products end up on store shelves, sometimes with bold health claims on the label, even though they have been subject to little scrutiny.
This regulatory system has long been a thorn in the side of evidence-based medicine advocates who say it allows the natural health industry to profit from ineffective and even potentially dangerous products. They also point to other flaws in the regulatory framework, such as the fact Health Canada does not have the legal power to order dangerous products off store shelves. So even if Health Canada decided to take action on Hyland's homeopathic teething tablets, it couldn't force the products off the market (troubling, considering the company has refused to conduct a recall in the U.S.).
Change on the horizon?
The good news is the current regulations may soon be a thing of the past. In September, Health Canada detailed plans to overhaul the regulatory framework for natural health products, cosmetics and non-prescription drugs. Experts say the proposed changes would likely affect natural health products the most. Under the proposed new framework, products in those three categories would be assessed based on risk. A product designed to aid heart health would be treated as high risk and subject to rigorous scrutiny. Vitamins and homeopathic products would be considered low risk. The changes would also prohibit natural health product manufacturers from making most health claims on product labels, and they would no longer be licensed by Health Canada.
It's a major departure from the current system, under which natural health products can make health claims and boast the approval from Health Canada. The industry has struck back against the proposed changes, saying it would unfairly restrict access and treat natural health products like drugs.
Others say this is a long overdue move that will protect consumers from misleading claims or potentially dangerous products. But Mr. Kruse noted that Canada's multi-billion-dollar natural health products industry successfully fought off previous governments' attempts to change the regulatory framework. It remains to be seen whether Health Canada will follow through this time.