Page 135 - JSOM Summer 2020

this definition and found in “brain health” products include Supplement Label Database, Natural Medicines, and pop-
B-complex vitamins, magnesium, omega 3 fatty acids, l-citrul- ular websites selling such products. Full details are reported
9
line, green tea extracts, Bacopa, Ginseng, and Ginkgo biloba. elsewhere. Overall, 650 unique products were identified as
marketed with claims for enhancing cognitive performance.
Nootropics are not exclusive to dietary supplements. In fact, We selected 24 products that had been asked about in an ATE
some nootropics are prescription drugs intended to treat (or query submitted to OPSS by Military Servicemembers in 2019.
manage) specific medical conditions, like attention-deficit/
hyperactivity disorder or Alzheimer disease ; others are ap- Each product was purchased and sent to National Center for
4,5
proved, over-the-counter drugs (e.g., NoDoz) and yet some Natural Products Research, University of Mississippi, MS, for
are drugs in other countries but have not gone through the analysis to verify whether the ingredients listed on the labels
US FDA drug approval process (unapproved drug). Neither were accurate. The specific methods for analysis are reported
prescription, over-the-counter, nor unapproved drugs are al- on elsewhere. 9,10 All products analyzed were also screened for
lowed in dietary supplements. Also, some nootropic ingredi- relative safety according to the OPSS scorecard, a tool de-
ents found in dietary supplements have not gone through the signed for consumers to identify potential red flags when read-
regulatory framework to be considered a dietary ingredient. ing the product label. 12
6,7
These ingredients fall into a gray zone: are they a drug or
potentially a new dietary ingredient? Unknowingly ingesting What We Found
these ingredients might not only jeopardize a career by pop-
ping positive on a drug test; they might pose a serious health Scientific Product Analysis: Label Claim Verification
risk to Operators. Of the 24 products analyzed, 17 (71%) had at least one in-
gredient (and up to six ingredients total) claimed on the Sup-
Do We Have to Question Supplements plement Facts label that was not detected through analysis.
Already on the Market? When one reviewed the ingredients on the labels, nine (38%)
Dietary supplements are regulated by the FDA but not in the products listed ingredients not meeting current regulations for
same way as prescription and over-the-counter drugs. The being in a dietary supplement according to the FDA. Table 1
various regulatory issues related to dietary supplements were presents these ingredients, some of which are on the OPSS pro-
described in detail in the 2018 Winter JSOM issue, but this hibited list and thus not allowed for use by any Servicemem-
13
was before nootropics became so popular. Importantly, di- ber; these include DMHA (octodrine), DMAA, piracetams
8
etary supplements cannot claim to “treat” any medical condi- (Noopept), and vinpocetine. DMHA and DMAA are not al-
tion, yet we see this regularly: products for concussions, pain, lowed by the FDA in any dietary supplement. Vinpocetine is
arthritis, Alzheimer disease, and the like are being marketed. a drug in other countries and FDA tentatively concluded in
As the brain health market booms exponentially, reports are September 2016 that vinpocetine does not meet the definition
uncovering unfounded claims and some unsafe products. 9–11 of a dietary ingredient; the FDA has also issued warnings that
Given the emerging interest in brain health and cognitive per- it could cause “a miscarriage or harm fetal development.”
14
formance coupled with the surge in nootropic dietary supple- Higenamine, hordenine, and sulbutiamine are currently on
ments, it is important to answer the questions – are dietary the FDA advisory list, which means they are being looked at
supplements promoted for cognitive enhancement safe? And, by the FDA and likely not dietary supplement ingredients.
15
what does the SOF community need to know? To that end, we Despite clear issues, these ingredients remain in many dietary
analyzed the content and label claims of various products Ser- supplement products marketed to the military community for
vicemembers had asked about and then we applied the OPSS performance and cognitive enhancement.
scorecard algorithm to identify the various potential red flags
and ascertain the relative safety of the various products. Other ingredients of concern, but commonly found on supple-
ments labels of products we tested, include Mucuna pruriens
extract “standardized for L-Dopa,” which is a drug used to
How We Addressed the Questions
treat Parkinson disease. To “standardize” means to make
16
A scoping review was performed to identify dietary supplement them all exactly the same, but it is unclear what “standardiza-
products marketed for brain health and cognitive performance tion” process the extract went through or how this was deter-
in otherwise healthy adults. The authors searched the Dietary mined. In addition, another common ingredient being tracked

TABLE 1 Products Where Red Flag Ingredients Are Found Listed on Supplement Facts Labels and Being Sold to US Consumers
Ingredient Found in Products Found
Dietary Supplement Product Safety Concern and Marketed, n
Stimulant drug, FDA notice, OPSS Prohibited list, World Anti-Doping
DMAA (1,3-dimethylamylamine) 268
Agency list
DMHA (1,5-dimethylhexylamine) or Octodrine Stimulant drug, FDA notice, OPSS Prohibited list 71
Noopept (Omberacetam) Stimulant drug, OPSS Prohibited list 9
Vinpocetine Stimulant drug, OPSS Prohibited list 678
Higenamine Stimulant, FDA advisory list, World Anti-Doping Agency list 139
Hordenine (N,N-dimethyltyramine) Stimulant, FDA advisory list 317
Sulbutiamine Stimulant drug, FDA advisory list 44
Halostachine (N-methylphenylethanolamine) Stimulant 44
β-Phenylethylamine (β-PEA) Stimulant 422

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