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U.S., Canada: under-the-radar ingredient implications

Already the focus of two warning letters from Health Canada this year, Lithium orotate is a “questionable ingredient” used in some products for treating psychiatric disorders. However, NutraIngredients says that similar products are sold ‘south of the border’, and contain the salt mineral, but have not raised as high a concern for the U.S. Food and Drug Administration (FDA).

Advocates of orotates claim support of the salt’s ability (as an orotic acid) to deliver trace minerals like magnesium and lithium in treating various health conditions including alcoholism. However, in a Dec. 1 recall notice, Canadian officials warned people in Canada that “the unauthorized health product ‘Smart Brain Formulations Serotonin Support’ may pose serious health risks.” According to the recall, testing by Health Canada found bacterial contamination with E. coli and the company who sells the contaminated product “currently does not hold a site license or any product licenses with Health Canada.”

Under Canadian law, dietary supplement manufacturers must register their facility and apply for premarket approval in order to receive a Natural Product Number (NPN) for each product label.

Additionally, a May 30 ‘safety alert‘ by Health Canada warned consumers about The SmartBrain Formulations products; “multiple unauthorized products labelled to contain L‑tryptophan or lithium orotate” were for sale on amazon.ca, “and may pose serious health risks”, as “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 healthcare professional.”

This drug concerns people in the US as well. Specifically, in 1989, L-tryptophan (an amino acid ingredient for mood support products) contributed to 37 deaths and 1,500 serious injuries to people in the US. Since then, “properly manufactured” versions of the ingredient have been used with no issues, along with drugs that contain “lithium formulations” according to the NutraIngredients report. However, Canadian officials are concerned that “lithium orotate has also been marketed apparently without adverse events as a dietary ingredient in supplements sold in the US.”

Although there have been few accounts, one 2014 warning letter (issued to Bio-Recovery Inc. by the FDA) concerned a company that was selling a lithium orotate dietary supplement that warranted “significant violations” of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements. Additionally, the firm’s website also contained “evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment, or prevention of disease”, according to the website.

Vasilios Frankos, Ph.D., Director of FDA’s Division of Dietary Supplement Programs, advises the following information regarding supplements:

“Today’s dietary supplements are not only vitamins and minerals. They also include other less familiar substances such as herbals, botanicals, amino acids, and enzymes. Check with your health care providers before combining or substituting them with other foods or medicines. Do not self-diagnose any health condition. Work with your healthcare providers to determine how best to achieve optimal health.”

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