Nutritional Supplements and Other Substances Commonly Used in Sport CHAPTER 9 Overview • • • • Regulating dietary supplements Marketing dietary supplements Peer-reviewed scientific evidence Dietary supplement information specific to athletes • Common supplements in exercise and sport • Steroids and human growth hormone • Alcohol Popularity of Supplement Use in Sport • The prevalence of dietary supplement use among athletes is difficult to quantify because research data are limited. • Trying to determine prevalence is exacerbated by inconsistent methodology, poor research design, and a lack of homogeneity among studies. Regulation of Dietary Supplements • Dietary supplements regulated by the FDA • All issues regarding supplement labeling fall under the regulation of the FDA. • Advertising of supplemental products regulated by the Federal Trade Commission (FTC) Definition of Dietary Supplement • “A product taken by mouth that contains a ‘dietary ingredient’ intended to supplement the diet.” – The Dietary Supplement Health and Education Act of 1994 • Ingredients might include vitamins, minerals, herbs or other botanicals, amino acids, or substances such as enzymes, organ tissues, glandulars, or metabolites. Marketing Supplements and the FDA • If a manufacturer and distributor of a supplement intends to use a new ingredient, it is their responsibility to determine if the ingredient meets this definition. • They must demonstrate to the FDA that their proposed ingredient has a reasonable expectation of safety for use in their product (unless it has been recognized as a food substance and is present in the food supply). Dietary Supplements Regulation • Dietary supplements are not regulated as drugs—they are regulated as foods. • Drugs and food additives must be proven safe and effective for their intended use before marketing and sold to the public. • The FDA does not need to approve dietary supplements for safety or effectiveness before they reach the store shelves for purchase by the consumer. FDA and Supplement Labels • The FDA does not have the financial resources to analyze the contents of supplements before being sold to the public. • The manufacturer is responsible for ensuring that the Supplement Facts label and ingredient list are accurate, that the dietary ingredients are safe, and that the content matches the amount declared on the label. Eight Utah Residents Charged with $100 Million Worth of Fraud and Money Laundering Schemes Involving the Sale of Dietary Supplements Wednesday, December 14, 2022 For Immediate Release U.S. Attorney's Office, District of Utah SALT LAKE CITY, Utah – Multiple people were indicted by a federal grand jury in the District of Utah for their participation in a fraudulent online scheme through which they obtained more than $100 million of credit and debit card processing from financial institutions and payment processors. As charged in the indictment, the defendants allegedly committed 18 counts of criminal activity, including Conspiracy to Commit Wire Fraud, Conspiracy to Commit Bank Fraud, Conspiracy to Commit Money Laundering, Wire Fraud, Aggravated Identity Theft and Money Laundering Aiding and Abetting. FDA’s Responsibility for Restricted Use SEPTEMBER 15, 2023 Once a product is marketed and sold, it is the FDA’s responsibility to demonstrate that a dietary supplement is harmful or unsafe before it can take action to restrict the product's use or remove it from public purchase. Many popular cold medicines contain an ineffective ingredient; here's what to take instead The FDA said this week that phenylephrine, found in some Sudafed and Tylenol products, does not work as a decongestant BY KRISTIN HUNT PHILLYVOICE STAFF •HEALTH MediDAILY NEWS AND WICKED LOCAL STAFF PHOTO/ART ILLMAN / USA TODAY NETWORK Cold and cough medicines like Sudafed PE, NyQuil Severe Cold & Flu and Mucinex Sinus Max contain phenylephrine, a decongestant that an FDA panel says in ineffective. AU.S. Food and Drug Administration panel has concluded that a common decongestant does not effectively relieve cold and allergy symptoms, setting up a possible recall of many popular medicines. Phenylephrine is designed to constrict blood vessels in the nose to decrease congestion, and is found in products from Sudafed, Supplements—Adverse Reactions • Manufacturers and distributors of dietary supplements must record and investigate any reported adverse reactions from their product and forward these reports to the FDA. • The FDA reviews reported adverse reactions from manufacturer reports (or information reported by health care providers or consumers) to identify potential safety risks. Marketing Supplements for Sale • Once a product is ready for sale, it is the manufacturer’s and distributor’s responsibility to ensure that the product is safe. • Ads or claims should be backed by scientific evidence to show they are not false or misleading. • A manufacturer need not provide the FDA with the evidence used to substantiate the safety or efficacy of the product. • Not required to disclose to the FDA or inquiring consumers the information they have about the safety or purported benefits of the product Why Vitamins and Other Dietary Supplements' Can Contain Anything Six former FDA commissioners regret inabilities to ensure safety and legitimacy of products. By James Hamblin Bottles of Ripped Fuel Metabolic Enchancer, which contained ephedra. The stimulant was banned after multiple deaths. (Ed Bailey / AP) JUNE 26, 2016 SAVED STORIES In a historic meeting in Aspen, Colorado, yesterday, the past six commissioners of the U.S. Food and Drug Administration gathered to critique the agency in charge of ensuring the safety of what we put into and on our bodies. At a time when $3 trillion in spending on health care is approaching 20 percent of the U.S. gross domestic product—much of that due to the exorbitant cost of medications and the consequences of poor diet—the FDA has a claim to being the most consequential agency in the country. Good Manufacturing Practices • The FDA has published comprehensive regulations for current Good Manufacturing Practices (GMPs) for those who manufacture, package, or distribute dietary supplement products. • Regulations focus on practices that ensure the identity, purity, quality, strength, and composition of dietary supplements. Consumer’s Responsibility • The FDA does not keep a list of dietary supplement manufacturers, distributors, or products sold. • It is the consumer’s responsibility to contact the manufacturer of the product if more information is desired. Supplement Facts Labels All supplement labels must include • a descriptive name of the product stating it is a “supplement;” • the name and place of business of the manufacturer, packer, or distributor; • a complete list of ingredients; and • net contents of the product. Supplement Facts Labels (continued) • The FDA requires most dietary supplements to have a Supplement Facts panel on each product. • This panel must list each dietary ingredient contained in the product. • Any ingredients not included on the panel must be listed under “other ingredients” printed beneath the panel. • Recommended serving size is determined by the manufacturer and does not require FDA approval. Nutrient Content Claims • Nutrient content claims were established under the Nutrition Labeling and Education Act of 1990. • These claims describe the quantity of a nutrient in a product and have been authorized for use by the FDA on foods and dietary supplements. • Detailed descriptions of FDA-approved nutrient content claims can be found on the FDA’s website. Health Claims • Health claims describe a relationship between a nutrient or ingredient (component of food or dietary supplement) and reduced risk of a health-related condition or disease. • In order to have the FDA approve a health claim for use on a food or supplement product, there must be significant scientific agreement supporting the proposed claim. • A limited number of claims are approved for use; the complete list can be found on the FDA’s website. Structure and Function Claims • Claims of general well-being • These claims may state how the product, nutrient, or ingredient intends to affect the normal structure or function within the body (e.g., calcium helps build strong bones) or how it acts to maintain a particular structure or function (e.g., fiber helps keep you regular, antioxidant nutrients help maintain cell integrity). • Claims cannot explicitly or implicitly link or associate the claimed effect of the nutrient, component, or dietary ingredient to a specific disease or state of health leading to a disease. Red Flags • Determine if the product is made by a national seller or is from a manufacturer that only produces items for specific populations or purposes (e.g., weight loss, body building, sexual enhancement). • National brands tend to have good manufacturing practices in place and want to keep a sound reputation. • Be concerned if a product claims to have the same effect as a prescription drug. It might be a false claim or be contaminated with a drug substance. • Don’t be fooled by the term “natural.” This is not a welldefined term and does not indicate a product is safe. Resources Regarding Quality and Banned Substances • A few well-established resources can minimize chances of purchasing a supplement that is adulterated or contaminated. • The FDA's Medication Health Fraud website lists a small fraction of the potentially hazardous products with hidden ingredients marketed and sold to consumers. • The National Sanitation Foundation (NSF) provides third-party certification, which is an independent analysis of a manufacturer’s product with standards for safety, quality, and performance. Informed-Choice • A quality assurance program designed for sports nutrition products and their manufacturers and suppliers • Products that carry the Informed-Choice logo certify that the nutritional supplements and ingredients in the product have been tested for banned substances by LGC, a world-class sports anti-doping lab. Dietary Supplement Information Specific to Athletes • Supplements might contain prohibited substances not declared on the label. • Product might be contaminated due to poor manufacturing practices or deliberate adulteration. • Most sports organizations with banned substances policies have strict liability. – This means that even if athletes innocently or unknowingly ingest a banned substance and then test positive, they lose ability to compete—or lose any awards if the competition has already occurred. (continued) Dietary Supplement Information (continued) • Credible organizations provide dietary supplement information specific to athletes. • The National Center for Drug Free Sport • The U.S. Anti-Doping Agency (USADA) – This organization manages the U.S. anti-doping program, including in-competition and out-ofcompetition testing, results-management processes, and drug reference resources. Common Supplements in Exercise and Sport • Hundreds—even thousands—of supplements are available on the market. • Some of the most common among athletes are products that contain carbohydrate and electrolytes. • Other popular supplements include caffeinated beverages and other energy drinks. Caffeine • Generally recognized as safe for consumption • Because caffeine is not a nutrient, its content is not required on a food label; exact quantities are variable and difficult to determine. • The ergogenic benefit of caffeine is most likely related to its role as a central nervous system stimulant. • The major dietary sources of caffeine are from coffee, tea, and soft drinks, which contain approximately 3 to 200 mg of caffeine per serving. – Chocolate is another common source of caffeine but content is significantly lower (usually less than 15 mg per ounce). Adenosine • • • • Found in all cells in the body Plays important role in energy metabolism Widens blood vessels to increase oxygen flow Caffeine and adenosine compete for the same receptors in the brain. • When levels of adenosine are reduced due to higher levels of caffeine competing for binding, the result is an increased feeling of alertness. (continued) Adenosine (continued) • Benefit in endurance performance is a heightened sense of awareness and decreased perception of effort. • Might cause gastrointestinal distress, jitteriness, mental confusion, problems concentrating or focusing, sleep disturbance Sodium Bicarbonate • Consumed in an attempt to neutralize hydrogen ions to extend the time of high-intensity activities before fatigue sets in • Side-effects: nausea, vomiting, stomach pain, and diarrhea. Glycerol • Triggers fluid retention, hyperhydration • Prolonging or preventing dehydration can have a significant positive effect on performance. • Glycerol might have a secondary benefit of aiding in the maintenance of blood glucose via gluconeogenesis in the liver. • Side-effects: gastrointestinal distress, bloating, nausea, diarrhea, lightheadedness Nitrate • Believed to have cardiovascular healthpromoting and performance-enhancing benefits • Consumed in foods, nitrate does not appear to have adverse health consequences in healthy persons. • Little is known about the safety of high doses in the supplemental form. Creatine • Creatine is used in the ATP-PC energy system where PCr is able to rapidly rephosphorylate adenosine diphosphate (ADP) to adenosine triphosphate (ATP). ATP is then used as the energy source for the contracting muscle. • Data support an ergogenic benefit for anaerobic performance. • Creatine is a widely researched sports supplement and the subject of many articles in peer-reviewed journals. Beta-alanine • Beta-alanine is a beta-amino acid, differing from the majority of alpha-amino acids found in the human diet. • Might enhance natural carnosine production and provide an ergogenic, buffering effect during anaerobic exercise • Potential side-effect is paresthesia (tingling in the skin) • More research is needed on the safety of this product. Beta-hydroxyl-beta-methylbutyrate • A metabolite of leucine reported to have therapeutic effects in individuals with atrophic conditions and cachexia. • Used by some athletes and bodybuilders in attempts to increase skeletal muscle protein strength and hypertrophy Dehydroepiandrosterone (DHEA) • Classified as a prohormone • Prohormones are androgenic precursors that become enzymatically converted to testosterone derivatives once ingested and metabolized. • Some athletes take DHEA in an attempt to improve muscle strength and hypertrophy with fewer side-effects than anabolic steroids. Green Tea • It is thought that the combination of the naturally occurring caffeine and EGCG may have stimulatory properties that enhance weight loss or fat loss. • Some studies demonstrate a significant effect on body weight or fat, but values are clinically insignificant. • No known adverse side-effects; no reason to recommend its discontinuation Garcinia Cambogia • Heavily marketed via media as a weight-loss miracle • Both weight reduction and satiety reported with HCA consumption in rat studies • Some human trials report desired effects on BMI, body weight, and satiety, yet a number of other studies do not concur. • A meta-analysis concluded that HCA may be more effective for weight loss than placebo but tested on only a short-term basis with small subject numbers. • Clinical significance still to be determined; long-term effectiveness unknown; many scientists dubious Citrus Aurantium • Thought to decrease food intake as a result of reduced gastric motility and to increase energy expenditure • Demonstrated reduced food intake with citrus aurantium or synephrine intake (rodent studies) • Appetite suppression and weight loss not evident in humans Conjugated Linoleic Acid (CLA) • Animal research demonstrates that CLA delivers promising results for body fat loss, but results are not extended to studies on humans. • Human studies report mixed results; those that report positive effects on weight loss or body composition are not convincing and not clinically important. • Most studies used between 3 and 6 grams per day, which is a dosage that appears safe for consumption. • Long-term safety and efficacy still in question Chromium Picolinate • Stimulates the neurotransmitters that play a role in food cravings, mood, and eating behavior • Might result in appetite suppression and increased thermogenesis • Appears to be well tolerated, but reports of weakness, dizziness, headaches, nausea, and vomiting have been cited Chitosan • A polysaccharide thought to bind with dietary fat in the gastrointestinal tract and enhance weight loss • Research in mice demonstrated reduced food intake with chitosan supplementation. • Some human studies have reported greater weight loss, but other studies report no effect of chitosan consumption. Glucomannan • A water-soluble dietary fiber derived from konjac root that might act in the stomach and intestines by absorbing water • This increased bulk may provide a feeling of satiety and reduce energy intake. • Most research studies used a dose between 2 to 4 grams per day. • Studies don’t support statistically significant weight loss with supplementation. Glucosamine and Chondroitin • Popular supplement for treating osteoarthritis • 1,500 mg/day of glucosamine sulfate combined with 500 mg/day of chondroitin might help with symptoms of osteoarthritis pain and improve cartilage growth and joint maintenance. • Benefit not instant; can take months to see an effect Probiotics • Live microorganisms that confer a health benefit with proper dosage • Most common species: lactobacillus and bifidobacterium • Probiotics should be nonpathogenic (contain good, healthy bacteria, not harmful ones), be resistant to processing (gastric juices, bile), colonize intestinal epithelial tissue, and provide measurable benefit. Prebiotics • An ingredient that targets microbiota in the gut, acting as a “food” for the target microbes • Not digested until they reach the colon, where they become fermented • Might help athletes reduce risk of developing respiratory and gastrointestinal illnesses during periods of heavy training and psychological stress Stimulants • Most common prohibited stimulant-based drugs are amphetamine and its derivatives, Dmethamphetamine and methylphenidate. • Purportedly increase energy and concentration and enhance performance • Side-effects: tremor, tachycardia, jitteriness, insomnia, myocardial infarction, stroke, death Anabolic Androgenic Steroids • Generally taken in an attempt to gain skeletal muscle mass • Some athletes feel justified in using steroids to facilitate injury recovery, but research does not support a benefit. • Consumed doses tend to be well beyond the therapeutic level given to treat medical conditions. • Side-effects: gynecomastia, testicular atrophy, widespread acne, especially on the chest and back Human Growth Hormone (hGH) • hGH in its natural form requires a prescription. • It is intended to treat a number of conditions: short stature, Turner syndrome, Prader-Willi syndrome, muscle wasting from AIDS, and growth hormone deficiency. • Prescription and distribution of hGH is tightly regulated. • Use for nonlegitimate medical reasons (e.g., antiaging or to enhance performance) is illegal. (continued) Human Growth Hormone (hGH) (continued) • Side-effects: depression, fluid retention, acromegaly (elevated levels of hGH in the body) • Symptoms of acromegaly: swelling and subsequent abnormal growth of the hands and feet; overgrowth of bone in the face (protruding of the brow and lower jaw, enlargement of the nasal bone, spacing of the teeth); carpal tunnel syndrome; enlargement of body organs, including the heart Alcohol • Athletes use alcohol for many reasons: perception of “taking the edge off,” social acceptance, team building, etc. • Prevalence of alcohol consumption similar in the athletic and general populations. • Especially popular in the college setting due to weekend festivities and association with celebrations of success • The NCAA has cited alcohol as the most abused drug in college sport. • College athletes associate alcohol consumption with an enhanced sense of well-being and feel that social drinking helps build group identification.
