Sulbutiamine is a substance used as an ingredient in some dietary supplements. It is synthetic—created in a laboratory from thiamine (vitamin B1)—and can have mild stimulant effects. In some countries, it is sold as an over-the-counter drug, but it has not been approved as a drug for any use in the U.S. Instead, it is added to some dietary supplement products marketed to enhance cognitive function and improve memory, mood, and energy. It is also used in other dietary supplements, such as fat-burner and pre-workout products.

Sulbutiamine is on the FDA Dietary Supplement Ingredient Advisory List because it does not appear to be a lawful dietary ingredient. There is insufficient evidence to determine if it is safe or effective.

Sulbutiamine was developed in the 1960s as a drug to treat thiamine deficiency. Later, it was branded as a drug named Arcalion and used in some countries to treat symptoms of weakness or lack of energy. In 2019 the U.S. Food and Drug Administration (FDA) added sulbutiamine to its Dietary Supplement Ingredient Advisory List. At this time, it is unclear if sulbutiamine is suitable or legal for use in dietary supplements.

What does the science say?

Very little research exists on the effects of sulbutiamine. Early laboratory research indicated various effects on the brain. Very limited research has been done with humans to look at the use of sulbutiamine for conditions such as Alzheimer’s disease, chronic fatigue, and neuropathy. However, no positive or negative results from any studies have yet been replicated. As a result, insufficient evidence exists to say if sulbutiamine (as a drug) could be effective for any health-related outcome. No studies exist to confirm any claimed benefit for sulbutiamine as a dietary supplement ingredient.

Is it safe to take?

The few side effects reported with the use of up to 600 mg per day (for as long as 2 months) include nausea, headache, insomnia, diarrhea, tremor, agitation, palpitations, and cough. Long-term effects are unknown, and no safe amount has been established. However, some websites suggest using as much as 1000 mg sulbutiamine per day. Because sulbutiamine is currently on the FDA Advisory List, Military Service Members should avoid this ingredient.

How can I watch out for this ingredient?

If you read dietary supplement labels, you will often see sulbutiamine listed as part of a proprietary blend—that is, combined with other ingredients. The blends often include stimulants or other ingredients—some prohibited for Military Service Members, such vinpocetine, or others also on the FDA Dietary Supplement Ingredient Advisory List, such as higenamine, hordenine, and N-methyl tyramine. When you see combinations of stimulants listed on a product label, this should be a red flag. There is no evidence to suggest a cocktail of stimulants will be safe.

Other names for sulbutiamine you might find on a product label are:

  • sulbutiamina
  • sulbutiaminum
  • arcalion
  • bisibutiamin
  • O-isobutyroylthiamine disulfide

Bottom line

Sulbutiamine is currently on the FDA Dietary Supplement Ingredient Advisory List because it does not appear to be a lawful dietary supplement ingredient. It is unknown how products containing sulbutiamine might affect your readiness or health.

 

Posted 11 August 2021

References

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