In This Chapter
- Dietary supplements and the law
- Adverse events
- How to evaluate products
- Ingredients and products of concern
- DS and overall health
- Where to go for more information
- Energy drinks
- Dietary supplements, including those sold on military installations, are not always safe, effective, or legal.
- Manufacturers of dietary supplements are responsible for ensuring products are properly labeled and safe.
- The Food and Drug Administration (FDA) must be able to prove a dietary supplement is unsafe before it can be taken off the market.
- If you use dietary supplements, select high-quality products with third-party certification seals.
- Energy drinks can contain caffeine that is not disclosed on the label; the combinations of ingredients commonly found in energy drinks have unknown effects.
The most common reasons active-duty Military Service Members use dietary supplements (DS) include promoting general health, losing weight, improving performance1, increasing muscle mass, enhancing energy levels, and increasing strength. More than 65% of Americans take some type of DS. Sales of vitamins, minerals, herbs, meal supplements, sports-nutrition supplements, and specialty supplements exceeded $43 billion in 2017.2 The purpose of this chapter is to provide an overview of dietary supplements, their regulatory framework, how to spot red flags, adverse events associated with some DS, and information about some ingredients and products of concern. This chapter is not all-inclusive; more information can be found at Operation Supplement Safety (OPSS), the DoD-wide effort that provides up-to-date, evidence-based information on dietary supplements.
Dietary supplements and the law
Regulation and oversight
In 1994 Congress passed the Dietary Supplement Health and Education Act (DSHEA) to amend the Food, Drug, and Cosmetic Act of 1938. DSHEA changed the regulation and labeling of dietary supplements. It gave the U.S. Food and Drug Administration (FDA) regulatory control over DS. The law also requires that the label of a DS provide the name and quantity of each ingredient or proprietary blend. The manufacturer must provide this information, and most consumers assume that the information on labels is truthful and not misleading. However, this is not always the case.
What is a dietary supplement?
DSHEA defines a dietary supplement as a product taken by mouth (other than tobacco) intended to supplement the diet by increasing the total dietary intake3 and containing one or more of the following dietary ingredients: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Under DSHEA, DS can be extracts or concentrates and may come as tablets, capsules, softgels, gelcaps, liquids, or powders.
New dietary ingredients
FDA also regulates whether new ingredients are permitted. Technically, almost any ingredient that occurs “naturally” can be sold in the U.S. as a DS, but Federal rules don’t require makers of DS to test all their ingredients. Instead, the law states that supplement ingredients in the food supply or sold as DS in the U.S. before 15 October 1994 are presumed to be safe and are not subject to FDA review for safety. However, any dietary ingredient not marketed in the U.S. before 15 October 1994 is considered a “new dietary ingredient” (NDI) and must undergo FDA review for safety. But no list of dietary ingredients in DS marketed before 15 October 1994 exists, so manufacturers and distributors are responsible to determine if an ingredient is NDI.4
Rules for manufacturing5
Facilities in which DS products are manufactured and packaged must comply with Current Good Manufacturing Practices (CGMPs). In June 2007, FDA announced new Federal regulations that require DS to be produced in a manner that ensures certain quality standards, such that they do not contain contaminants or impurities and are accurately labeled. Manufacturers are now required to test all of the ingredients in their products to make sure they are neither adulterated nor contaminated.6
The Food Safety Modernization Act (FSMA) of 2011 clarified and expanded this to include registration and inspection of facilities that manufacture, process, package, or hold dietary supplements for U.S. consumption.
Supplement Facts labeling requirements
FDA requires a “Supplement Facts” label on every DS product. Read the OPSS article on labeling of dietary supplement products to learn more.
FDA also regulates what claims may (or may not) be made, while the Federal Trade Commission (FTC) enforces unproven, misleading, or deceptive advertising claims. Some DS products contain undisclosed ingredients such as prescription and/or over-the-counter drugs, steroids, steroid-like ingredients, and stimulants. Products marketed for bodybuilding, weight loss, and sexual enhancement are more likely than others to contain undisclosed ingredients.
DSHEA regulations contain many gaps, including:
- The manufacturer is responsible to ensure that products are properly labeled.
- Supplement ingredients sold in the United States before 15 October 1994 are presumed to be safe and are not subject to FDA review for safety.
- The manufacturer is responsible for providing evidence of safety.
- Before a product can be removed from the market, FDA must prove it is not safe.
- Government resources to monitor DS quality and safety are limited.
“Adverse events” are unfavorable or unusual reactions/effects/illnesses that can occur with the use of DS.
Examples of adverse events include anxiety, headaches, increased blood pressure, vision problems, stroke, heart arrhythmia, and death. Such adverse events might be due to one DS taken alone, combinations of DS, or interactions between drugs and DS.
Be sure to listen to your body, pay attention to how you feel, and keep a written list of all prescription drugs, DS products, and over-the-counter medications you are taking. Tell your healthcare provider about all DS you are taking and any changes in your health status, particularly if you start to feel symptoms you did not experience prior to taking the DS. It is always best to talk to a healthcare provider before taking any dietary supplement.
To report an adverse event, or even if you suspect one, you can fill out a form through the Safety Reporting Portal.
How to evaluate products
Shop Smart: Look for products that are third-party certified
Third-party certification seals confirm independent testing and evaluation of dietary supplements and their ingredients and ensure that manufacturing and storage facilities comply with GMP (or similar) requirements. The companies that conduct such reviews vary widely in terms of how they approach the certification process and how they test products. Certification programs confirm that a product contains the ingredients listed on the label. They do not ensure a product’s effectiveness or safety.
The seals of 3 of the most common organizations (BSCG, LGC, and NSF) also ensure a product has been tested for and does not contain ingredients banned by the World Anti-Doping Agency (WADA). Another (USP) does not test for substances banned in sport, but it does verify the ingredients and their amounts in products. Note: All such testing is essentially a snapshot in time of a particular product and is no guarantee that future batches will have the same test results.
If you choose to use dietary supplements, look for products that are third-party certified.
Dietary supplement red flags
Despite growing popularity among military personnel, some DS on the market are tainted and unsafe. OPSS has an article about how to spot red flags. Ask yourself the red-flag questions to minimize your risk of consuming potentially harmful products. If you can answer “Yes” to any of the questions, you might want to reconsider taking that product.
DS companies often put a seal or stamp on their website or their product labels with words such as “Certified GMP,” “FDA Approved Facility,” or “CGMP Inspected Facility.” There is no “official” seal or stamp, and misuse of FDA’s logo is illegal. FDA does not approve or certify facilities or DS products. FDA does have the authority to inspect facilities and ensure they comply with CGMP regulations.
Ingredients and products of concern
Some DS products contain ingredients that are not legitimate dietary ingredients, including steroids, steroid-like substances, and other ingredients. FDA has found that bodybuilding, weight-loss, and sexual-enhancement products are the most common types of DS that contain undeclared drugs, which could cause issues with drug screening.
OPSS has a web page about DoD-prohibited substances that FDA, the Drug Enforcement Agency, and/or the U.S. Armed Forces have disallowed, including a list prepared by OPSS of prohibited ingredients sometimes found in products labeled as DS.
In general, stimulants are substances that affect the chemicals that convey messages between your brain and the rest of your body in a way that makes you more alert. But they also can increase your heart rate and blood pressure. In some cases, stimulants also can make you feel euphoric. And some stimulants are more powerful than others.
Please read the OPSS articles about the following stimulants found in DS:
The OPSS article about stimulants in dietary supplements has a more extensive list.
Steroids, steroid-like ingredients, testosterone boosters, and SARMs
Anabolic steroids have been linked to liver toxicity, testicular shrinkage, breast enlargement in males, adverse effects on lipid levels, and increased risk of heart attack and stroke. Anabolic steroids are classified as “controlled substances” and are illegal to purchase, use, or possess without a prescription, as well as banned by most athletic associations. They are not DS, although they can be found in some products sold as DS, sometimes listed on the labels and other times not disclosed. For more information about anabolic steroids, please read the OPSS article about steroids and visit the National Institute on Drug Abuse.
Some DS products contain synthetic anabolic androgenic steroids sometimes referred to as “designer steroids,” “prohormones,” or “testosterone boosters.” For more information about these, read the OPSS articles about testosterone boosters and designer steroids. There is no reliable scientific evidence that prohormones and testosterone boosters are effective to improve performance or increase testosterone levels, and there isn’t enough research as to their safety.
Also of concern are SARMs—selective androgen receptor modulators. They are synthetic drugs and are not allowed for use as ingredients in DS or, currently, for any use other than research. For more information, please read the OPSS web page about SARMs.
Other ingredients of concern
Peptide hormones, including information about IGF-1 and HGH
DS and overall health
In certain situations, some DS can benefit your health. Chapter 4 addresses vitamin and mineral supplements. You might need a fish-oil supplement, as discussed in Chapter 16, if foods high in omega-3s are not available. However, they should only be taken under the supervision of a healthcare provider. Chapter 16 also addresses joint supplements.
For women who are pregnant or of childbearing age, read the OPSS article about dietary supplements while pregnant.
Where to go for more information
- FDA: Dietary Supplements
- Federal Trade Commission: Dietary Supplements
- National Center for Complementary and Integrative Health: Dietary and Herbal Supplements
- Office of Dietary Supplements (ODS)
- MedlinePlus: Drugs, Herbs and Supplements
Energy drinks are beverages designed to give a burst of energy. Some are classified as DS (these have a Supplement Facts label) and but nearly all are conventional foods (which carry a Nutrition Facts label). Typically, they contain a combination of sugars, caffeine, B vitamins, amino acids, and/or herbal ingredients. The long-term effects of the various energy-drink ingredient combinations are unknown. Potential side effects of energy drinks include an increase in heart rate and blood pressure, anxiety, and nervousness. Energy drinks should not be used while exercising, during training or missions, or with alcohol. FDA has issued warnings regarding the addition of caffeine to alcoholic beverages (including energy drinks with alcohol), because caffeine can mask the effects of alcohol.7 Manufacturers of such products were required to remove them from the market.
Read the OPSS article for more information about the ingredients found in energy drinks.
Nicotine, like caffeine, exerts potent effects on the human body.8 It is considered a psychoactive drug, which means it alters the normal functioning of the brain by stimulating the central nervous system. This results in a nicotine “buzz” or “high.” Some people use smokeless tobacco for performance enhancement. Smokeless alternatives can contain higher nicotine concentrations than cigarettes.8 When smokeless tobacco is placed in the mouth, the nicotine is readily taken up into the small blood vessels that line the mouth and gums, after which it travels through the bloodstream to the brain, where it exerts multiple effects.
Self-reported “benefits” of nicotine include:
- Decreased appetite
- Decreased pain
- Control or reduction of body weight
- Ability to focus attention
- Increased energy
The reported ability of nicotine to focus attention or “enhance mental state” is why users claim their reaction time and performance are enhanced. However, studies consistently find no differences in reaction times between users and nonusers of smokeless tobacco.
Some studies have examined the effects of nicotine (using forms that did not require smoking) on exercise performance.9 The results suggested that it might have some performance-enhancing benefits, but more studies are needed.
Nicotine has some very detrimental effects:10
- It increases blood pressure, heart rate, and rate of respiration.
- It constricts/tightens blood vessels, which leads to increases in blood pressure and heart rate.
- It stimulates the nervous system.
Although nicotine might have performance-enhancing benefits, they do not outweigh the negative effects of potential nicotine dependence and withdrawal. The Centers for Disease Control and Prevention has a fact sheet on the health effects of smokeless tobacco, including information about nicotine addiction.
- Austin, K. G., McLellan, T. M., Farina, E. K., McGraw, S. M., & Lieberman, H. R. (2016). Soldier use of dietary supplements, including protein and body building supplements, in a combat zone is different than use in garrison. Applied Physiology, Nutrition, and Metabolism, 41(1), 88–95. doi:10.1139/apnm-2015-0387
- Nutrition Business Journal. (2018). Supplement Business Report 2018. New Hope Network, http://images.info.newhope.com/Web/NewHopeNaturalMedia/%7Bd6521f56-fca7-448f-84bb-2b3911741c88%7D_Supplement_Business_Report-PREVIEW_2018.pdf
- U.S. Food & Drug Administration (FDA). (19 June 2018). Questions and Answers on Dietary Supplements. Retrieved 27 September 2017 from https://www.fda.gov/food/dietarysupplements/usingdietarysupplements/ucm480069.htm
- U.S. Food & Drug Administration (FDA). (29 November 2017). New Dietary Ingredients in Dietary Supplements – Background for Industry. Retrieved 29 November 2017 from https://www.fda.gov/Food/DietarySupplements/NewDietaryIngredientsNotificationProcess/ucm109764.htm
- U.S. Food & Drug Administration (FDA). (2010). Guidance for Industry: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Small Entity Compliance Guide. Retrieved 27 September 2017 from https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm238182.htm
- U.S. Food & Drug Administration (FDA). (2008). Guidance for Industry: Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk; Small Entity Compliance Guide. Retrieved 27 September 2017 from https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm072997.htm
- Centers for Disease Control and Prevention (CDC). Smokeless Tobacco: Health Effects. Retrieved 27 September 2017 from https://www.cdc.gov/tobacco/data_statistics/fact_sheets/smokeless/health_effects/index.htm
- Pesta, D. H., Angadi, S. S., Burtscher, M., & Roberts, C. K. (2013). The effects of caffeine, nicotine, ethanol, and tetrahydrocannabinol on exercise performance. Nutrition & Metabolism, 10(71), 1–15. doi:10.1186/1743-7075-10-71
- Johnston, R., Doma, K., & Crowe, M. (2018). Nicotine effects on exercise performance and physiological responses in nicotine-naïve individuals: A systematic review. Clinical Physiology and Functional Imaging, 38(4), 527–538. doi:10.1111/cpf.12443