Part V - Understanding Alternative Approaches
Part V - Understanding Alternative Approaches
Supplements
FDA approval proving the safety or effectiveness of their products before they enter into the market, Sports nutrition and supplementation is a multi-bil- dietary supplements, like food, do not need to be lion dollar industry that continues to expand. Be- pre-approved by any part of the FDA before they cause of this tremendous growth, there is a need can enter the market.(1) for credible scientific information concerning the various ergogenic aids currently on the market ( The DSHEA gave the FDA the express responsiergogenic: a nutrient or supplement that enhances bility to regulate the manufacturing processes of exercise or athletic performance). The popularity dietary supplements, and the FDA issued its first of magazines such as Muscle and Fitness, Tes- proposed rule in 2003.(2) In June 2007 it issued tosterone.net and Planet Muscle demonstrate the its final rule,(3) which requires all dietary supplehigh demand for information in the field of fitness. ment manufacturers to ensure by June 2010 that It is not uncommon for these articles to be writ- production of dietary supplements complies with ten by someone of little or no actual training in the current good manufacturing practices, and be scientific method. As a FNC, you should never be manufactured with “controls that result in a consislimited by where you get your information. Even tent product free of contamination, with accurate though these tertiary journals mentioned above labeling.”(4) are not a definitive source, it is still wise to maintain an awareness of what is current in the state of In addition, the industry is now required to report to the FDA “all serious dietary supplement related our industry. adverse events.” The new rules have been critiIt is difficult to know who exactly you should listen cized, however, with skeptics arguing lack of FDA to and who you should avoid as it relates to how resources, loopholes, and an exception on quality you get your information regarding supplements. assurance for raw material suppliers (with the burThe pro athlete who is paid millions to endorse a den placed on manufacturers) will lead to continprotein shake? Or the celebrity doctor, who trans- ued quality problems.(5) There’s also concern that mits his beliefs to an unsuspecting public, willing to supplement manufacturers and retailers will hide behind the new regulations.(6). Prior to the rule believe anything. supplements have had major quality problems, The area of sport supplementation is dynamic, al- and the number of FDA investigators has declined ways changing. If you have ever had to read a (7). scientific journal, it is likely that you came upon the phrase ‘more study is needed in this....”. And while this is true, it takes many years to complete the kind of research work that results in a consensus. Therefore, it is prudent to move forward with what IS currently known for practical purposes and application to the client. Why are supplements controversial? Well, they are not regulated in the United States by any regulating agency in terms of the claims they make. As stated in wording of the DSHEA ( Dietary Supplement Health and Education Act), the Food and Drug Administration (FDA) regulates dietary supplements as foods, and not as drugs. While pharmaceutical companies are required to obtain
Dietary supplements are permitted to make structure/function claims. These are broad claims that the product can support the structure or function of the body (e.g., “glucosamine helps support healthy joints”, “the hormone melatonin helps to establish normal sleep patterns”). The FDA must be notified of these claims within 30 days of their first use, and
there is a requirement that these claims be proven or substantiated. But in reality, false claims about supplements have become common, particularly due to their proliferation on poorly-regulated commercial websites. 8 9
In 2009, Bodybuilding.com was predicted to earn 125 million from online supplement sales.
Should Your Client Use Supplements? Choosing whether or not to take a dietary supplement should not be taken lightly. It can be difficult to know which supplement, if any, are right for your client. Certain groups of individuals should definitely consider taking supplements: • Female clients who might become pregnant should take a supplement of folic acid to reduce the risk of birth defects • Some older or more mature clients are encouraged to take a supplement of vitamin D and calcium to reduce the risk of osteoporosis. • Clients who are lactose intolerant should take a calcium supplement containing vitamin D to prevent bone loss. • Vegetarian clients should take a vitamin B12 supplement to prevent anemia, which can result from the lack of meat sources in the diet. If your client is consuming a diet considered ‘balanced’, they will most likely get the nutrients they need. Despite this, multi-vitamins can be a healthy part of a balanced nutrition plan. For all other supplements, remember that only a few can make legitimate claims and have effects proven by sound scientific research. 10
Evaluation of Dietary Supplements Since the manufacture and sale of dietary supplements is about an $18 billion per year industry, sorting through the advertisements and associated claims for the 29,000-plus dietary supplements available could be both exhausting and confusing. But if a client is going to be ingesting something, it’s important to learn the facts about the item in question. Lets look at some guidelines and recommendations to evaluate dietary supplements and their claims. 1. Are there reasonable claims made to the actions of the supplement? Is it feasible? The purpose of a supplement or ergogenic aid is to enhance sports performance, whether it is to allow for increased work capacity, improve run times or impact endurance. To evaluate the product, ask yourself, “Is it possible for this item to enhance the performance of my client in the manner it is described?” As an example, creatine monohydrate is useful in energy reactions to regenerate ATP, the body’s energy systems. Next, consider whether the supplement is necessary for the desired outcome or reaction to occur, may improve the speed of the reaction, or will it do nothing to change normal bodily functions. 2. Does this product have any usefulness for the client and his or her sport of choice? Some supplements are meant to be used for highintensity, short-duration events, such as strength training or running. Others are developed to improve endurance. It depends on the sport or activity in question as in some cases, certain supplements should not even be considered. Using creatine monohydrate again as the example, it is not beneficial for long-duration, endurance-type activities, such as long distance running. In this evaluation, using creatine would seem to be contraindicated or at the very least, a waste of money for the client.
caused lead poisoning, impotence, lethargy and “unarousable” sleep, nausea, vomiting, diarrhea, and abnormal heart rhythms in users who are trying to self-treat diverse ailments or improve physical function 11 It may be considered a best-practice to coach your client so that he or she understands the safety concerns associated with supplement usage. 5. Where does the information come from? Is it from a coach or Athletic Trainer? A physician? A lot of supplement information is available to anyone online. A vast amount of this information is anecdotal. Therefore, it makes more sense to think about the source of the information or the research study being presented. If an article on Vitamin D and calcium in milk is funded by the Dairy Board, then that may have an influencing factor on the research. Similarly, if a creatine study is funded by the manufacturer of said product, it is also useful to know of this type of possible relationship to the information, data or conclusions being presented about the supplement. Bias also factors in, as a lot of products are only tested within certain populations (people who are physically active) or in cases where a high profile endorsement is involved. Remember that some fitness magazines have relationships with supplement companies and some are known to be owned and managed by them too! 6. What are the legal definitions for use of this supplement? Some supplements are illegal. As an example, ephedra has become a banned substance in the United States - the FDA banned the sale of ephedra-containing supplements on April 12,
2004. Other ergogenic aids need to be evaluated further before they can be viewed as safe, and as stated before, this is a slow process. It is recommended that coaches remain cautious during conversations with clients about usage of certain supplements, especially if they may be the type that are controlled or not permitted for casual use. Your local laws will also influence your approach.
have different reactions, based on a host of variables.
The FNC should stay focused on mastering the basic concepts of nutrition before expanding into research for specific supplements; learning these basic concepts can then be applied to the study and understanding of dietary supplements at the appropriate time, but not before fundaThese are just some of the concerns or issues tied mentals of nutrition are well known. to supplement usage. A FNC should be prepared to answer questions on supplements from the client as it is most likely that you will experience scenarios where supplements are needed, used or sold. Essentially, dietary supplements should only be used if necessary, safe and legal. Whether or not the supplement is beneficial or not is not enough of a predictor to determine its use, as everyone will
References 1.McArdle, William, Katch, Frank, Katch, Victor, Sports and Exercise Nutrition, 9:258. Lippincott, Williams and Wilkins. 2005. 2. Goldman P (2001). "Herbal medicines today and the roots of modern pharmacology". Ann. Intern. Med. 135 (8 Pt 1): 594–600. PMID 11601931. 3. CFSAN. (2007). FDA Issues Dietary Supplements Final Rule. FDA. 4. FDA. (2007). Final Rules: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Federal Register. 5. U.S. Food and Drug Administration (2007-06-22). "FDA Issues Dietary Supplements Final Rule". Press release. Retrieved 2008-09-10. 6. Liva R. (2007). New FDA cGMPs for Supplements: Smoke or Substance?. Integrative Medicine Journal. 7. O’Connell J. (2007). The untold dietary-supplement scandal. Men’s Health. 8. Nutritional Supplements: Your Questions Answered. From Consumer Reports magazine, published 14 June 2006. Accessed 2 February 2007. 9. Beyond Ephedra”, by Leon Jaroff. Published in Time magazine 10 February 2004. Accessed 2 February 2007. 10. Carpenter, Ruth Ann, Finley, Carrie. Healthy Eating Every Day. 13:149. Human Kinetics, Champaign, Il (2005) 11. .McArdle, William, Katch, Frank, Katch, Victor, Sports and Exercise Nutrition, 9:259. Lippincott, Williams and Wilkins. 2005.
Supplements
FDA approval proving the safety or effectiveness of their products before they enter into the market, Sports nutrition and supplementation is a multi-bil- dietary supplements, like food, do not need to be lion dollar industry that continues to expand. Be- pre-approved by any part of the FDA before they cause of this tremendous growth, there is a need can enter the market.(1) for credible scientific information concerning the various ergogenic aids currently on the market ( The DSHEA gave the FDA the express responsiergogenic: a nutrient or supplement that enhances bility to regulate the manufacturing processes of exercise or athletic performance). The popularity dietary supplements, and the FDA issued its first of magazines such as Muscle and Fitness, Tes- proposed rule in 2003.(2) In June 2007 it issued tosterone.net and Planet Muscle demonstrate the its final rule,(3) which requires all dietary supplehigh demand for information in the field of fitness. ment manufacturers to ensure by June 2010 that It is not uncommon for these articles to be writ- production of dietary supplements complies with ten by someone of little or no actual training in the current good manufacturing practices, and be scientific method. As a FNC, you should never be manufactured with “controls that result in a consislimited by where you get your information. Even tent product free of contamination, with accurate though these tertiary journals mentioned above labeling.”(4) are not a definitive source, it is still wise to maintain an awareness of what is current in the state of In addition, the industry is now required to report to the FDA “all serious dietary supplement related our industry. adverse events.” The new rules have been critiIt is difficult to know who exactly you should listen cized, however, with skeptics arguing lack of FDA to and who you should avoid as it relates to how resources, loopholes, and an exception on quality you get your information regarding supplements. assurance for raw material suppliers (with the burThe pro athlete who is paid millions to endorse a den placed on manufacturers) will lead to continprotein shake? Or the celebrity doctor, who trans- ued quality problems.(5) There’s also concern that mits his beliefs to an unsuspecting public, willing to supplement manufacturers and retailers will hide behind the new regulations.(6). Prior to the rule believe anything. supplements have had major quality problems, The area of sport supplementation is dynamic, al- and the number of FDA investigators has declined ways changing. If you have ever had to read a (7). scientific journal, it is likely that you came upon the phrase ‘more study is needed in this....”. And while this is true, it takes many years to complete the kind of research work that results in a consensus. Therefore, it is prudent to move forward with what IS currently known for practical purposes and application to the client. Why are supplements controversial? Well, they are not regulated in the United States by any regulating agency in terms of the claims they make. As stated in wording of the DSHEA ( Dietary Supplement Health and Education Act), the Food and Drug Administration (FDA) regulates dietary supplements as foods, and not as drugs. While pharmaceutical companies are required to obtain
Dietary supplements are permitted to make structure/function claims. These are broad claims that the product can support the structure or function of the body (e.g., “glucosamine helps support healthy joints”, “the hormone melatonin helps to establish normal sleep patterns”). The FDA must be notified of these claims within 30 days of their first use, and
there is a requirement that these claims be proven or substantiated. But in reality, false claims about supplements have become common, particularly due to their proliferation on poorly-regulated commercial websites. 8 9
In 2009, Bodybuilding.com was predicted to earn 125 million from online supplement sales.
Should Your Client Use Supplements? Choosing whether or not to take a dietary supplement should not be taken lightly. It can be difficult to know which supplement, if any, are right for your client. Certain groups of individuals should definitely consider taking supplements: • Female clients who might become pregnant should take a supplement of folic acid to reduce the risk of birth defects • Some older or more mature clients are encouraged to take a supplement of vitamin D and calcium to reduce the risk of osteoporosis. • Clients who are lactose intolerant should take a calcium supplement containing vitamin D to prevent bone loss. • Vegetarian clients should take a vitamin B12 supplement to prevent anemia, which can result from the lack of meat sources in the diet. If your client is consuming a diet considered ‘balanced’, they will most likely get the nutrients they need. Despite this, multi-vitamins can be a healthy part of a balanced nutrition plan. For all other supplements, remember that only a few can make legitimate claims and have effects proven by sound scientific research. 10
Evaluation of Dietary Supplements Since the manufacture and sale of dietary supplements is about an $18 billion per year industry, sorting through the advertisements and associated claims for the 29,000-plus dietary supplements available could be both exhausting and confusing. But if a client is going to be ingesting something, it’s important to learn the facts about the item in question. Lets look at some guidelines and recommendations to evaluate dietary supplements and their claims. 1. Are there reasonable claims made to the actions of the supplement? Is it feasible? The purpose of a supplement or ergogenic aid is to enhance sports performance, whether it is to allow for increased work capacity, improve run times or impact endurance. To evaluate the product, ask yourself, “Is it possible for this item to enhance the performance of my client in the manner it is described?” As an example, creatine monohydrate is useful in energy reactions to regenerate ATP, the body’s energy systems. Next, consider whether the supplement is necessary for the desired outcome or reaction to occur, may improve the speed of the reaction, or will it do nothing to change normal bodily functions. 2. Does this product have any usefulness for the client and his or her sport of choice? Some supplements are meant to be used for highintensity, short-duration events, such as strength training or running. Others are developed to improve endurance. It depends on the sport or activity in question as in some cases, certain supplements should not even be considered. Using creatine monohydrate again as the example, it is not beneficial for long-duration, endurance-type activities, such as long distance running. In this evaluation, using creatine would seem to be contraindicated or at the very least, a waste of money for the client.
caused lead poisoning, impotence, lethargy and “unarousable” sleep, nausea, vomiting, diarrhea, and abnormal heart rhythms in users who are trying to self-treat diverse ailments or improve physical function 11 It may be considered a best-practice to coach your client so that he or she understands the safety concerns associated with supplement usage. 5. Where does the information come from? Is it from a coach or Athletic Trainer? A physician? A lot of supplement information is available to anyone online. A vast amount of this information is anecdotal. Therefore, it makes more sense to think about the source of the information or the research study being presented. If an article on Vitamin D and calcium in milk is funded by the Dairy Board, then that may have an influencing factor on the research. Similarly, if a creatine study is funded by the manufacturer of said product, it is also useful to know of this type of possible relationship to the information, data or conclusions being presented about the supplement. Bias also factors in, as a lot of products are only tested within certain populations (people who are physically active) or in cases where a high profile endorsement is involved. Remember that some fitness magazines have relationships with supplement companies and some are known to be owned and managed by them too! 6. What are the legal definitions for use of this supplement? Some supplements are illegal. As an example, ephedra has become a banned substance in the United States - the FDA banned the sale of ephedra-containing supplements on April 12,
2004. Other ergogenic aids need to be evaluated further before they can be viewed as safe, and as stated before, this is a slow process. It is recommended that coaches remain cautious during conversations with clients about usage of certain supplements, especially if they may be the type that are controlled or not permitted for casual use. Your local laws will also influence your approach.
have different reactions, based on a host of variables.
The FNC should stay focused on mastering the basic concepts of nutrition before expanding into research for specific supplements; learning these basic concepts can then be applied to the study and understanding of dietary supplements at the appropriate time, but not before fundaThese are just some of the concerns or issues tied mentals of nutrition are well known. to supplement usage. A FNC should be prepared to answer questions on supplements from the client as it is most likely that you will experience scenarios where supplements are needed, used or sold. Essentially, dietary supplements should only be used if necessary, safe and legal. Whether or not the supplement is beneficial or not is not enough of a predictor to determine its use, as everyone will
References 1.McArdle, William, Katch, Frank, Katch, Victor, Sports and Exercise Nutrition, 9:258. Lippincott, Williams and Wilkins. 2005. 2. Goldman P (2001). "Herbal medicines today and the roots of modern pharmacology". Ann. Intern. Med. 135 (8 Pt 1): 594–600. PMID 11601931. 3. CFSAN. (2007). FDA Issues Dietary Supplements Final Rule. FDA. 4. FDA. (2007). Final Rules: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Federal Register. 5. U.S. Food and Drug Administration (2007-06-22). "FDA Issues Dietary Supplements Final Rule". Press release. Retrieved 2008-09-10. 6. Liva R. (2007). New FDA cGMPs for Supplements: Smoke or Substance?. Integrative Medicine Journal. 7. O’Connell J. (2007). The untold dietary-supplement scandal. Men’s Health. 8. Nutritional Supplements: Your Questions Answered. From Consumer Reports magazine, published 14 June 2006. Accessed 2 February 2007. 9. Beyond Ephedra”, by Leon Jaroff. Published in Time magazine 10 February 2004. Accessed 2 February 2007. 10. Carpenter, Ruth Ann, Finley, Carrie. Healthy Eating Every Day. 13:149. Human Kinetics, Champaign, Il (2005) 11. .McArdle, William, Katch, Frank, Katch, Victor, Sports and Exercise Nutrition, 9:259. Lippincott, Williams and Wilkins. 2005.
