Under the radar ingredient raises warning flags in Canada

07-Dec-2017 - Last updated on 16-Aug-2019 at 13:58 GMT

Related tags Food and drug administration Health canada

Products containing lithium orotate—a salt of a mineral that has been used to treat psychiatric disorders—have been the subject of two Health Canada warnings this year. Yet similar products are freely for sale south of the border, and don’t seem to be a concern for the US Food and Drug Administration.

On Dec. 1, 2017, Health Canada issued a warning on a specific product called Smart Brain Formulations Serotonin Support. In addition to the questionable ingredient, Health Canada said the product lot was also contaminated. The agency said the product “[M]ay pose serious health risks. The product is labelled to contain lithium orotate, which is a prescription drug and should be used only under the supervision of a health care professional. Health Canada testing also found bacterial contamination with E. coli, which can cause serious health problems.”

The notice also said that the company, Robert Lamberton Consulting, was not in compliance with Canadian regulations in that it did not have a site license or any product licenses for operation within the country. According to Canadian law, a dietary supplement manufacturer is supposed to register its facility and apply for premarket approval for products, which are then issued with a unique Natural Product Number (NPN) that goes on the label.

The SmartBrain Formulations product also contained tryptophan, which is another ingredient of concern for Health Canada. On May 30, 2017, the agency issued a warning that said the widespread availability of these products on Amazon posed a health risk.

“Health Canada is advising Canadians that multiple unauthorized products labelled to contain L‑tryptophan or lithium orotate were being sold on amazon.ca, and may pose serious health risks. L‑tryptophan (at doses higher than 220 mg per day) and lithium orotate are prescription drugs in Canada and should be used only under the supervision of a health care professional,” the warning said.

Freely sold, but not a big seller

But these products are of less concern in the US. Improperly manufactured L-tryptophan—an amino acid used in mood support products—was associated with 37 deaths and as many as 1,500 serious injuries in 1989. But properly manufactured versions of the ingredient have been on the market for years since without issues. Similarly, while some lithium formulations have been and to some extent still are prescribed as drugs to treat bipolar disorder, lithium orotate has also been marketed apparently without adverse events as a dietary ingredient in supplements sold in the US.

By all accounts the ingredient has not been a big seller nor has it been much researched. Many mentions of the scientific backing for this ingredient point to a paper published by German medical doctor Hans Nieper in 1973. Nieper, who died in 1998, reportedly was an advocate of orotates, which are salts of orotic acid, as a way to deliver trace minerals like magnesium and lithium for the treatment of various conditions. In addition to Nieper’s publication, there are only seven other mentions of the ingredient on the PubMed database, only one of which is a human clincal study. That was a 1986 study in Japan that looked at the use of the ingredient for treating alcoholism.

In 2014, FDA issued a warning letter to a company selling a lithium orotate dietary supplement. But the warning letter focused on the claims the company was making about the product (as well as GMP failures), not the presence of lithium per se.