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Using the Dietary Supplement Label Database to Identify Potentially Harmful Dietary Supplement Ingredients

Scott, Jonathan M., PhD; Lindsey, Andrea T., MS; Costello, Rebecca B., PhD; Deuster, Patricia A., PhD

doi: 10.1097/NT.0000000000000295
Clinical Nutrition

More than half of young adults, athletes, and Military Service members self-report using at least 1 dietary supplement (DS) 1 or more times per week. Dietary supplement may be consumed because users beige that they improve health, provide more energy, increase muscle strength, and/or enhance performance. The US Food and Drug Administration has raised concerns regarding adulteration, safety, and adverse events associated with DSs marketed for brain health and body building. Some DS products may compromise health as well as lead to a serious adverse event. The National Institutes of Health Dietary Supplement Label Database (DSLD), available at https://dsld.nlm.nih.gov/, can be freely accessed and used by researchers, providers, and consumers alike to screen for potentially harmful DSs. It was developed to serve the research community and as a resource for healthcare providers and the public. Herein, we provide 2 examples of how the database can be used to identify DS ingredients of concern in products marketed for brain health and body building. The search for DSs marketed for brain health returned 49 unique DSs, and the search for DSs marketed for body building returned 18 unique DSs. Search results were cross-referenced with the Operation Supplement Safety High-Risk Supplement List, the US Food and Drug Administration Tainted Products Marketed as Dietary Supplements list, the Natural Medicines database, and the National Institutes of Health Office of Dietary Supplements Fact Sheets. Three ingredients found in DSs marketed for brain health and 2 ingredients in DSs marketed for body building were identified as “of concern.” Educational tools, including the Dietary Supplement Label Database, can help consumers and providers make informed decisions regarding DSs.

Jonathan M. Scott, PhD, is an assistant professor at the Uniformed Services University.

Andrea T. Lindsey, MS, is the director of Operation Supplement Safety, a program of the Consortium for Health and Military Performance (CHAMP).

Rebecca B. Costello, PhD, is an adjunct assistant professor at the Uniformed Services University and a scientific consultant for the Office of Dietary Supplements at the National Institutes of Health.

Patricia A. Deuster, PhD, is a professor at the Uniformed Services University and director of the CHAMP.

Author Contributions: J.M.S., A.T.L., R.B.C., and P.A.D. designed the research; J.M.S. and A.T.L. conducted the research; J.M.S., A.T.L., R.B.C., and P.A.D. wrote the article; and all authors have read and approved the final manuscript.

This work was supported by a grant from the Center Alliance for Nutrition and Dietary Supplement Research, NB91FD.

The authors have no conflicts of interest to disclose.

The opinions or assertions contained herein are the private views of the authors and are not to be construed as official or as reflecting the views of the Uniformed Services University, Department of Defense, National Institutes of Health, or Department of Health and Human Services.

Correspondence: Jonathan Scott, PhD, RD, CSSD, LD, Department of Military and Emergency Medicine, Consortium for Health and Military Performance, Uniformed Services University, 4301 Jones Bridge Rd, Bethesda, MD 20814 (jonathan.scott@usuhs.edu)

More than half of young adults (66%), athletes (55%–64%), and Military Service members (55%–74%) self-report using dietary supplements (DSs).1–3 Individuals report using DSs for any number of reasons including to improve health, provide more energy, increase muscle strength, and/or enhance performance.1–3 Compared with nonusers, DS users are more likely to participate in physical activity to increase muscle mass.3,4 Since 2007, the US Food and Drug Administration (FDA) has found that more than 800 DS products, especially those marketed for weight loss, body building, and sexual enhancement, contain undeclared drug ingredients, steroids, steroidlike ingredients, and/or stimulants.5 Such DSs not only may compromise health and performance but also may lead to a serious adverse event and/or produce unwanted urinalysis test results for athletes, Military Service members, or individuals in public safety–related occupations (eg, law enforcement, truck driving). A new tool that can be used by researchers and providers to identify potentially harmful DS products is the National Institutes of Health’s (NIH’s) Dietary Supplement Label Database (DSLD; https://www.dsld.nlm.nih.gov/dsld/). The DSLD is an open-access website that provides full label information for many DSs marketed in the United States in a searchable format.

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SEARCHING DS ON DSLD

The FDA estimates that more than 85 000 DSs are currently available on the market in the United States, of which approximately 76 000 are cataloged in the DSLD. The end goal of the DSLD is to consolidate information on all DSs sold in the United States into a single Web-based repository accessible to consumers and researchers at no charge. Consumers, including young adults, athletes, Military Service members, and healthcare providers, can use several features on the DLSD to risk stratify DS. The “Search” feature on the homepage allows users to search for any text on a DS label. Search results are sorted in an alphabetical order based on where the search term appears on the label under the following label elements: Product(s), Ingredient(s), Brand(s), Manufacturers, Distributors or Packagers, and Anywhere. Consumers can also cross-reference search results from the DSLD with the Operation Supplement Safety High-Risk Supplement List (OPSS HRSL) and the FDA Tainted Products Marketed as Dietary Supplements list to identify DSs of concern. Furthermore, providers may use results from the “Search” function to identify DS ingredients that may interact with medications, laboratory results, and/or other DSs. Researchers will likely find the “Advanced Search” feature more useful than the general “Search” function. The “Advanced Search” feature enables users to search keywords under the following 6 headings: Ingredients, Ingredient Category, Product Names, Category Codes (LanguaLCodes*), Label Statements or Health Claims, and Manufacturer, Distributor, or Packager. With the exception of Ingredient Categories and Category Codes, up to 5 search fields may be included within each of the other headings. Search results can be downloaded as either a Microsoft Excel data (.xls) or comma-separated value file to aid in analysis. The DLSD offers many features that consumers can use to risk stratify DS.

The objective of the study was to demonstrate the use of the DSLD. This was accomplished by conducting 2 separate searches by using the DSLD to identify ingredients in DSs that may pose a safety concern. The first search was conducted to identify DS products marketed for cognitive enhancement and brain health. The second search was conducted to identify DS products marketed for performance enhancement and body building. Subsequent search results were cross-referenced with the OPSS HRSL; FDA Tainted Products Marketed as Dietary Supplements list; Natural Medicines database, a commercial database that also includes assessments not only of safety but efficacy; and the NIH’s Office of Dietary Supplements (ODS) Dietary Supplement Fact Sheets to identify ingredients that may pose a safety concern. The resources used to cross-reference the results were selected because they all provide evidence-based information regarding DSs.

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METHODS

Search 1: DS Products Marketed for Cognitive Enhancement and Brain Health

We performed 2 separate searches in the DLSD (https://www.dsld.nlm.nih.gov/dsld/). The first search included terms commonly associated with cognitive enhancement and DSs marketed for brain health. Terms were derived from an Internet search on DSs touted to improve cognitive health. Within the DSLD, the “Advanced Search” function is accessed by clicking “Search” on the menu bar located on the top left-hand side of the page. A drop-down menu will appear that allows users to search across a maximum of 6 search fields at one time: Table 1 provides an overview of the advanced search options. We started by clicking on “Search by Label Statement or Health Claims.” This yields a screen with 2 options—“Select” and “Label Statement or Health Claims contains”—with the ability to add up to 5 different search terms. We sequentially typed in 4 search terms—“neuro,” “brain,” “cognitive,” and “omega”—into the “Label Statement or Health Claims contains” field, clicking “Add” after each search term, with “must include” for the first three “Select” options and “exclude” for omega. Finally, we clicked “Search” on the bottom right-hand side of the webpage to obtain the results of our search. Table 2 presents the final search criteria.

TABLE 1

TABLE 1

TABLE 2

TABLE 2

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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.

TABLE 3

TABLE 3

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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.

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RESULTS

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.

TABLE 4

TABLE 4

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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).

TABLE 5

TABLE 5

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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.

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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.

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CONCLUSION

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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REFERENCES

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5. US Food and Drug Administration. Tainted products marketed as dietary supplements. https://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=tainted_supplements_cder&displayAll=false&page=6. Updated April 16, 2018. Accessed April 19, 2018.
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*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
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