Search 2: DS Products Marketed for Performance Enhancement and Body Building
Before beginning a new search, click “Clear All” located on either the top or bottom right-hand side of the page. For our second search, we used a slightly different approach. From the “Advanced Search” function, we clicked on “Search by Ingredients.” For this search, we chose “must include” under “Select,” typed in “anabolic” under “Ingredient Name,” and chose “Supplement Facts Panel” under “Location.” We clicked on “Add,” chose “may include” under “Select,” typed “prohormone” under “Ingredient Name,” chose “Supplement Facts Panel” under “Location,” and clicked “Search.” This yielded 191 DSs so we further refined by clicking on “Revise search parameters” located at the top left-hand side of the page. We added 2 additional terms, “iol” with “must include” and “ione” with “may include,” both on the “Supplement Facts Panel.” For all search terms, nothing was added under “Amount Per Serving.” Finally, we clicked “Search” on the bottom right-hand side of the webpage to obtain the results of our search. Terms were derived from an Internet search on DS products marketed for body building. Table 3 displays the final search criteria for this approach.
Identifying Potentially Harmful DS Ingredients
Full label information for all DSs was downloaded as a single .xls file and imported into Microsoft Excel for analysis. Search results were further cross-referenced with the OPSS HRSL (http://www.opsshighrisksupplementlist.org/), the FDA Tainted Products Marketed as Dietary Supplements list (https://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=tainted_supplements_cder), the Natural Medicines database (https://naturalmedicines.therapeuticresearch.com/), and the NIH’s ODS Dietary Supplement Fact Sheets (https://ods.od.nih.gov/factsheets/list-all/) to identify ingredients that may pose a potential safety concern. The OPSS HRSL and FDA Tainted Products Marketed as Dietary Supplements list are tools to assist healthcare providers and consumers in identifying DS products that could pose a risk to health; both of them are open access. The OPSS HRSL and FDA Tainted Products Marketed as Dietary Supplements list also identify some DS products that have been found to contain undeclared DS ingredients, which can help healthcare providers identify possible adverse interactions. The Natural Medicines database is a subscription-based website that provides evidence-based information on the safety and efficacy of DS ingredients and alternative therapies. As part of a collaboration between the Natural Medicines database and OPSS, individuals with a .mil email address can sign up for free access to the Natural Medicines database via http://info.therapeuticresearch.com/dod. The NIH’s ODS Dietary Supplement Fact Sheets are available free of charge and are available as a consumer version as well as a more detailed healthcare professional version and include a variety of DS ingredients.
Cognitive Enhancement and Brain Health
Initial search results for DS products marketed for cognitive enhancement and brain health yielded 63 products. Thirteen were removed because of multiple flavors of the same product or duplicate entries, and 1 product was removed because it did not contain complete label information, which left 49 unique DSs. None of the 49 unique DSs appeared on the OPSS HRSL or the FDA Tainted Products Marketed as Dietary Supplements list. Further analyses revealed 5 common ingredients including phosphatidylserine (20/49), ginkgo biloba (13/49), acetyl-l-carnitine (12/49), huperzine A (10/49), and vinpocetine (9/49). One or more of these ingredients were present in 63% (31/49) of the supplements. Table 4 presents a brief overview of the 5 common ingredients. Each of the five was further cross-referenced with the Natural Medicines database and NIH’s ODS Dietary Supplement Fact Sheets.
Performance Enhancement and Body Building
The second search focused on performance-enhancing and body building supplements. Initial search results yielded 191 DS products; however, after refinement, including the addition of 2 more search terms (“must include” iol and “may include” ione), 25 DSs were identified. Seven products were removed because of multiple flavors of the same DS, which resulted in 18 unique DSs. None of the 18 unique products appeared on the OPSS HRSL or the FDA Tainted Products Marketed as Dietary Supplements list. Nearly all (17/18) supplements contained plant extracts claiming to be anabolic/prohormone products and included terms such as “Testosterone Support Complex,” “Male Performance Blend,” “Anabolic Blend,” “Anabol-5,” “Nonsteroidal Anabolic Stack,” “Muscle Stimulator Blend,” and other such blends or complexes (see Table 5 for common plant-derived ingredients reported on the labels for products marketed for performance enhancement and body building).
Potential Concerns Stemming From the Case Studies
From the current searches, DS ingredients of potential concern emerged. With regard to cognitive enhancement and brain health products, 3 ingredients—vinpocetine, huperzine A, and picamilon—are potentially problematic. According to the Natural Medicines database, vinpocetine and huperzine A “stretch the definition” of a DS because they are synthetic ingredients and have undergone extensive chemical purification with properties similar to purified drugs. Long-term studies (>12 weeks) to evaluate the safety of these dietary ingredients are also lacking.7 Subsequently, in 2016, the FDA tentatively concluded that vinpocetine does not meet the definition of a dietary ingredient, which would exclude it from being sold as a DS ingredient.8–10 Picamilon is used as a prescription drug in Russia to treat a variety of neurological conditions; however, it is not approved as a drug in the United States. According to the FDA, picamilon does not meet the statutory definition of a DS ingredient.11 As a result, products containing picamilon and marketed as DSs are considered misbranded.
According to the Natural Medicines database, 2 ingredients identified in the body building and performance enhancement analysis, 1,3-dimethylamylamine and yohimbe, pose a safety concern.7 1,3-Dimethylamylamine is a synthetically produced stimulant that has been linked to psychiatric disorders, cardiovascular problems, nervous system disorders, and death.12–14 In 2013, the FDA declared that DSs containing 1,3-dimethylamylamine are illegal.15 Yohimbe has been associated with serious adverse effects including cardiac arrhythmia, agitation, myocardial infarction, and seizure.7 For many of the other ingredients found in DSs marketed for body building and performance enhancement, little or no data are available on the safety and/or efficacy of these combinations of multiple ingredients.7 Furthermore, the FDA has urged consumers to avoid using DSs marketed for body building or claiming to contain steroid and steroidlike substances because of the risk of serious liver injury and other adverse health consequences.16 On the basis of previous work from our group and others, the label is not always accurate and any one of the products could have contained illegal anabolic steroid ingredients, drug analogs, and/or synthetic stimulants.17–19 Such information would not be captured by the DSLD.
Limitations of the DSLD
A limitation of the DSLD is a lack of integration with other databases. Currently, users must cross-reference search results with other databases to identify potential ingredients of concern. In addition, it is not known what proportion of DSs appearing on the FDA Tainted Products Marketed as Dietary Supplements list also appear in the DSLD. Although not a downloadable app, the 2008 DSLD was redesigned, reengineered, and rereleased in 2017 with an improved graphical user interface and improved search functionality and in a “mobile-friendly” format to better serve access from Tablets and phones. The DSLD fills a much needed. Consumers, health providers and researchers have free access to label-serviced information for many DS sold in the United States. Finally, many DSs sold over the Internet marketed for brain health and body building are still not captured in the DSLD.
Dietary supplements will continue to be popular with young adults, athletes, and Military Service members, especially among those seeking to enhance their health and fitness. Our objective was to demonstrate how the DSLD could be used to identify potential DS ingredients that may pose a safety concern. We successfully used the DLSD to rapidly search approximately 76 000 DS labels and identified 3 ingredients that pose a safety concern in DSs marketed for brain health and 2 ingredients in DSs marketed for body building.
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17. Attipoe S, Cohen PA, Eichner A, Deuster PA. Variability of stimulant levels in nine sports supplements over a 9-month period. Int J Sport Nutr Exerc Metab
18. Cohen PA, Avula B, Venhuis B, Travis JC, Wang YH, Khan IA. Pharmaceutical doses of the banned stimulant oxilofrine found in dietary supplements sold in the USA. Drug Test Anal
19. Cohen PA, Travis JC, Venhuis BJ. A synthetic stimulant never tested in humans, 1,3-dimethylbutylamine (DMBA), is identified in multiple dietary supplements. Drug Test Anal
*LanguaL stands for “Langua aLimentaria” or “language of food.” LanguaL is a structured, controlled vocabulary for describing foods in a systematic organization that simplifies retrieval of information for data analysis. It is based on the principle that items within a database (whether they are DS or conventional food products) can be described by a combination of uniform terms chosen from “facets” that characterize various mutually exclusive attributes of these products.6 Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.