Ontario Case Shows Potential Supplement Risk for Consumers

A woman’s quest to become pregnant resulted in lead poisoning from an Ayurvedic treatment. The case triggered the seizure of pills from an Ontario natural-products clinic and the issuance of government warnings about the risks of products from this business, according to a new report.

The case highlights the need for collaboration between clinicians and public health authorities to address the potential health risks of supplements, including the presence of lead and other metals in Ayurvedic products, according to the report.

“When consumer products may be contaminated with lead, or when lead exposure is linked to sources in the community, involving public health can facilitate broader actions to reduce and prevent exposures to other people at risk,” wrote report author Julian Gitelman, MD, MPH, a resident physician at the University of Toronto Dalla Lana School of Public Health, and colleagues.

Their case study was published August 8 in the Canadian Medical Association Journal.

The researchers detailed what happened after a 39-year-old woman sought medical care for abdominal pain, constipation, nausea, and vomiting. The woman underwent a series of tests, including colonoscopy, laparoscopy, and biopsies of bone marrow and ovarian cysts.

Only later did clinicians home in on the cause of her ailments: the Ayurvedic medications that the patient had been taking daily for more than a year for infertility. Her daily regimen had varied, ranging from a few pills to a dozen pills.

Heavy metals are sometimes intentionally added to Ayurvedic supplements for perceived healing properties, wrote the authors. They cited a previous study of a sample of Ayurvedic pills bought on the internet from manufacturers based in the United States and India that showed that 21% contained lead, mercury, or arsenic.

A case report published last year in German Medical Weekly raised the same issue.

Melatonin Gummies

Regulators in many countries struggle to help consumers understand the risks of natural health supplements, and the challenge extends well beyond Ayurvedic products.

There has been a “huge and very troubling increase” in US poison control calls associated with gummy-bear products containing melatonin, said Canadian Senator Stan Kutcher, MD, at a May 11 meeting of Canada’s Standing Senate Committee on Social Affairs, Science, and Technology.

In April, JAMA published a US analysis of melatonin gummy products, Kutcher noted. In this research letter, investigators reported that one product did not contain detectable levels of melatonin but did contain 31.3 mg of cannabidiol.

In other products, the quantity of melatonin ranged from 74% to 347% of the labeled quantity. A previous Canadian study of 16 melatonin brands found that the actual dose of melatonin ranged from 17% to 478% of the declared quantity, the letter noted.

The May 11 Senate meeting provided a forum for many of the recurring debates about supplements, which also are known as natural health products.

Barry Power, PharmD, editor in chief for the Canadian Pharmacists Association, said that his group was disappointed when Canada excluded natural health products from Vanessa’s Law, which was passed in 2014. This law sought to improve the reporting of adverse reactions to drugs.

“We’re glad this is being revisited now,” Power told the Senate committee. “Although natural health products are often seen as low risk, we need to keep in mind that ‘low risk’ does not mean ‘no risk,’ and ‘natural’ does not mean ‘safe.'”

In contrast, Aaron Skelton, chief executive of the Canadian Health Food Association, spoke against this bid to expand the reach of Vanessa’s Law into natural health products. Canadian lawmakers attached provisions regarding increased oversight of natural health products to a budget package instead of considering them as part of a stand-alone bill.

“Our concern is that the powers that are being discussed have not been reviewed and debated,” Skelton told Kutcher. “The potential for overreach and unnecessary regulation is significant, and that deserves debate.”

“Profits should not trump Canadians’ health,” answered Kutcher, who earlier served as head of the psychiatry department at Dalhousie University in Halifax, Nova Scotia.

By June, Vanessa’s Law had been expanded with provisions that address natural health products, including the reporting of products that present a serious risk to consumers.

Educating Consumers

Many consumers overestimate the level of government regulation of supplements, said Pieter A. Cohen, MD, leader of the Supplement Research Program at Cambridge Health Alliance in Massachusetts. Cohen was the lead author of the JAMA research letter about melatonin products.

Supplements often share shelves in pharmacies with medicines that are subject to more strict regulation, which causes confusion.

“It’s really hard to wrap your brain around [the fact] that a health product is being sold in pharmacies in the United States and it’s not being vetted by the FDA [US Food and Drug Administration]”, Cohen told Medscape Medical News.

The confusion extends across borders. Many consumers in other countries will assume that the FDA performed premarket screening of US-made supplements, but that is not the case, he said.

People who want to take supplements should look for reputable sources of information about them, such as the website of the National Institutes of Health’s Office of Dietary Supplements, Cohen said. This office and the FDA offer consumers the same advice about the use supplements: check with your physician or another medical professional involved in your care about these products.

But patients often forget or fail to do this, which can create medical puzzles, such as the case of the woman in the Ontario case study, said Peter Lurie, MD, MPH, executive director of the nonprofit Center for Science in the Public Interest, which has pressed for increased regulation of supplements.

Clinicians need to keep in mind that patients may need prodding to reveal what supplements they are taking, he said.

“They just think of them as different, somehow not the province of the doctor,” Lurie told Medscape. “For others, they are concerned that the doctors will disapprove. So, they hide it.”

CMAJ. Published online Aug. 8, 2023. Full text

Kerry Dooley Young is a freelance journalist based in Washington, DC. Follow her on Threads as @kerrydooleyyoung.

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