Study: Over-the-counter “brain enhancement” supplements in the US found both to a) contain multiple unapproved drugs and b) lack some ingredients listed on the label

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Study: Your Brain Sup­ple­ments Could Con­tain Dan­ger­ous, Ille­gal Ingre­di­ents (Being Patient):

Brain sup­ple­ments that claim to boost cog­ni­tive func­tion are increas­ing­ly pop­u­lar, grow­ing from a $4 bil­lion indus­try of about 4,000 unique prod­ucts to a $40 bil­lion indus­try with as many as 80,000 dif­fer­ent prod­ucts on the market. 

… Fol­low­ing a recent study, clin­i­cians are warn­ing con­sumers that some of these cog­ni­tive enhance­ment sup­ple­ments may be dan­ger­ous for health, because they con­tain ille­gal ingre­di­ents with poten­tial­ly dan­ger­ous mix­tures and dos­es … Cohen and col­leagues searched the Nation­al Insti­tutes of Health Dietary Sup­ple­ment Label Data­base and the Nat­ur­al Med­i­cines Com­pre­hen­sive Data­base for brain health sup­ple­ments, ana­lyz­ing 10 over-the-counter sup­ple­ments sold in the Unit­ed States with eight explic­it­ly mar­ket­ed to enhance men­tal function.

The group found four ille­gal ingre­di­ents in the sup­ple­ments, and anoth­er known as vin­poce­tine that is a legal ingre­di­ent, Cohen said. Though the U.S. Food and Drug Admin­is­tra­tion (FDA) has pre­vi­ous­ly warned that vin­poce­tine, which is avail­able for use in some coun­tries as a drug to treat acute stroke and cog­ni­tive impair­ment, should not be con­sumed by women of child­bear­ing age … Mean­while, some drugs that were list­ed on the prod­ucts’ labels seemed to be absent as the researchers did not detect their pres­ence when test­ing the ingredients.

The Study:

Five unap­proved drugs found in cog­ni­tive enhance­ment sup­ple­ments (Neu­rol­o­gy). From the Abstract:

  • Objec­tive: To iden­ti­fy the pres­ence of unap­proved phar­ma­ceu­ti­cal drugs in over-the-counter dietary sup­ple­ments mar­ket­ed to improve mem­o­ry and cog­ni­tive function.
  • Meth­ods: Sup­ple­ments were iden­ti­fied by search­ing 2 sup­ple­ment data­bas­es for prod­ucts labeled as con­tain­ing either omber­ac­etam, anirac­etam, phenyl­rac­etam or oxirac­etam, 4 drugs not approved for human use in the US …
  • Results: In the 10 prod­ucts test­ed, omber­acteam and anirac­etam were detect­ed along with 3 addi­tion­al unap­proved drugs (i.e., phenibut, vin­poce­tine and picamilon). By con­sum­ing rec­om­mend­ed serv­ing sizes, con­sumers could be exposed to phar­ma­ceu­ti­cal-lev­el dosages of drugs … Sev­er­al detect­ed drugs were not declared on the label, and sev­er­al declared drugs were not detect­ed in the prod­ucts. For those prod­ucts with drug quan­ti­ties pro­vid­ed on the labels, 75% (9/12) of declared quan­ti­ties were inac­cu­rate. Con­sumers could be exposed to up to four-fold greater than phar­ma­ceu­ti­cal dosages and as many as 4 unap­proved drugs when using indi­vid­ual products.
  • Con­clu­sions: Over-the-counter cog­ni­tive enhance­ment sup­ple­ments may con­tain mul­ti­ple unap­proved drugs. The health effects of con­sum­ing untest­ed com­bi­na­tions of unap­proved drugs at unpre­dictable dosages with­out clin­i­cian over­sight in sup­ple­ments is unknown.

The Study in Context: