‘Smart drugs’ may contain unapproved pharmaceuticals, according to a new study

pharmafile | September 24, 2020 | News story | Sales and Marketing FDA, regulation, smart drugs 

Some supplements billed as ‘smart drugs’ may contain unapproved drugs in potentially dangerous combinations and doses, according to a new study.

This work was published in Neurology Clinical Practice. The team looked through the National Institute of Health’s Dietary Supplement Label Database and the Natural Medicines Database for products containing unapproved drugs. It tested 10 of these products, and found that through consuming recommended serving sizes, participants could be exposed to pharmaceutical-level dosages of drugs. These included unapproved drugs like omberacteam, aniracetam, phenubut, vinpocetine and picamilon. Several of the detected drugs were not listed on the label and several of the declared drugs were not actually present in the products. 

It found that 75% of declared quantities on labels were inaccurate, and consumers could be exposed to up to a four-fold greater dose than stated on the label. 

Dr Pieter Cohen, an associate professor at the Harvard School of Medicine and a general internist at Cambridge Health Alliance, said: “We don’t know how these drugs will affect human health. In some cases, there is a mixture of drugs combined in the same product that have never been tested together. The thing about every compound, regardless of where it comes from, is that too much can kill you. Even caffeine, one of the safest compounds, can kill you if the dose is high enough.

“With as many as four unapproved drugs in individual products, and in combinations never tested in humans, people who use these cognitive enhancement supplements could be exposing themselves to potentially serious health risks. The effects of consuming untested combinations of unapproved drugs at unpredictable dosages are simply unknown and people taking these supplements should be warned.”

These unapproved drugs slip through the regulatory process due to supplements not being strictly regulated by the FDA. The FDA may take action against a supplement maker after a product is on the market if it is mislabelled or contains unapproved drugs.

Conor Kavanagh

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