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US Nutritional supplementation regulations imposed by collegiate, Olympic, professional and military organizations Dave Ellis, RD, CSCS As evidenced

by the warnings from multiple Sports Medicine and Regulatory groups (1), health and doping concerns over the cavalier use of dietary supplements have long troubled health professionals, especially those who work with drug tested populations. So much so that at each level of sports you can usually find some limitation of what can be funded or supplied by teams to their athletes here in the U.S., and who is authorized to speak on the topic. Yes, we are now seeing organizational designation of someone on the team who speaks to the topic of dietary supplements (MLB and NCAA) so that athletes do not get conflicting messages about permissibility that could lead to organizational liability. This is typically the Sports RD (registered dietitian), Athletic Trainer or Strength Coach. In this article we will examine the current landscape of permissible dietary supplements in the collegiate, profession, Olympic and tactical/military ranks, where Sports RDs in particular play a critical role in managing the safety of what is now a global supply chain for food and dietary supplements. In the collegiate ranks you had a significant change in the limitations of what could be supplied back in 2001 with the passing of NCAA Division I Bylaw 16.5.2.g Nutritional Supplements. A 10-year retrospective on the intent of the proposal that led to the legislation being passed can be accessed online (2). As one of the early full-timers in this field who lived through the entire process, I can assure you it had everything to do with leveling the playing field between the schools that could afford dietary supplements and the widespread use of creatine by football teams at the time (cost containment). The muscle building focus of the legislation speaks to this and I will never forget getting a call from my conference rep that had a vote on the topic. This rep glowed as he proudly reported to me: The legislation was passed and creatine went down in a ball of flames.

There were two major goals behind the original legislation. The official language behind the goals of the legislation read as follows: a) to end the growing practice of institutions providing so-called musclebuilding supplements (e.g., creatine); and b) to decrease student-athlete exposure to dietary supplement products that are not well regulated. The reality was that the way the legislation was written before Bylaw 16.5.2.g, we were told by our NCAA compliance officers that using food as a between

meal snack was an "extra benefit" but if we used a supplement we were okay. Thus 16.5.2 dramatically narrowed what we could fund or supply to teams from the following four classes of permissible nutritional supplements: 1) Carbohydrate Boosters (beverages) 2) Electrolyte Drinks 3) Energy Bars (i.e., carbohydrate as an energy source) 4) Vitamins and Minerals And for years to follow there was one interpretation after another on questions as to permissibility of products that seemed to fall into these four categories, but that possibly contained impermissible ingredients. So its been a moving target of permissibility based on concerns from a health perspective or concern of a possible positive doping outcome, or just where a product maybe in conflict with the intent of 16.5.2 (3). The interpretations of 16.5.2 have always been the challenging part of practice in the collegiate ranks. Those interpretations are very hard to track and when it comes to issues like the ceiling on 30% of total calories from protein part of 16.5.2 (only intact peptides, no amino acids or hydrolysates), it gets very sticky. You can walk into any training table and find foods that by nature are higher in protein than 30%, which is where the line was drawn based on where the Zone products drew their line on protein yield (4). So along the way interpretations have surfaced that even having an ingredient around that might be a food such as powdered eggs, milk or whey protein, those foods might not be permissible even if they were put into products that yielded no more than 30% of total calories. Of course no one from the NCAA is running around training table kitchens policing any such protein food ingredients, but they would come down on any smoothie bar that had ingredients that were that high in protein. So you will see all NCAA recovery shakes and bars using products that yield 70% or more of their calories from sugar, starch and fat which, for post workout, is probably not the end of the world, but obviously didnt do much to help us deal with weight loss populations at the collegiate ranks, or to supply a source of soy protein for vegan athletes. The good news is that in 2009 the NCAA did take the handcuffs off our ability to use food between meals to fuel athletes without fear that it would be considered an extra benefit, but confined the foods to fruits, nuts and bagels, and for the sake of keeping this article reasonably brief, I wont go into all the challenges that have come with interpretations on nuts vs. peanut butter. Officially it reads as follows: NCAA Bylaw 16.5.2.h. (Fruits, Nuts and Bagels) became effective August 2009, making it permissible for a Division I institution to provide fruits, nuts and bagels

to a student-athlete at any time. This legislation addresses the provision of food as opposed to the provision of nutritional supplement products, and, along with other meal legislation, should not be confused with 16.5.2.g. So anyone who has worked around sports on the fueling front knows that athletes like to eat and they soon tire of pills and powders over the course of their career, so its all about using food first with athletes. That is at the fabric of what Sports RDs do in their day-to-day practice. We create real value behind the power of food with athletes and operate within the financial and legislative limits of what were permitted to provide to teams (5). The real challenges that exist are with the frequency we can feed at the collegiate ranks (only one meal per day in a training table setting) and how the value of meals are calculated for athletes (based on watered down dorm prices). At the end of the day, scholarship athletes who move off campus immediately find that they cant afford to feed themselves. As a result we see athletes binge-eating at the training table meal when it is provided, and even that varies by conferences (some just feed inseason for two or three revenue sports). The reality is that the general public is under the impression that all collegiate athletes are being fed (scholarship and walk-ons alike), which of course is not the case. So we give athletes what we can when we can at the collegiate ranks and its typically never enough to meet the demands of activity and growth that these student athletes routinely require. They might be "part time" athletes, but when combining their demands of maintaining academic eligibility with the physical and mental demands of keeping their spot on the college roster, theyre faced with full-time recovery needs. I blog on this subject often and you can get into the details if you like (6). You can be assured that Sports RDs are heavily engaged in the deregulating rules that limit our ability to feed athletes like we do at the Olympic, Professional and Military ranks, which we will move onto at this point. When it comes to feeding athletes after college (assuming they went to college at all), we confronted primarily by budget, and not by legislation. However, when it comes to dietary supplements, we have varying degrees of regulation that must be navigated by those engaged with fueling. Olympic is the easiest to outline. They have no rules on what dietary supplements can be funded or supplied as long as the product is not labeled to contain banned substances or that metabolize into any banned substances (7). We do have a number of National Governing Bodies of Sport (NGBs) that are considering some kind of filter on products that are supplied where a third-party banned substance certification is used to limit the pool of dietary supplements. Because there is no policy between all USA NGBs on such a program, it creates some confusion with athletes as they move from one Olympic training venue to the other, where they sometimes get inconsistent advice that leaves them confused and, ultimately, vulnerable. Unfortunately the three most credible certification agencies for testing dietary supplements for banned substances are not regulated and are very hard for coaches and athletes to objectively compare. A set of specifications on what will constitute a comprehensive banned substances certification program will soon be published on the U.S. Anti-Doping Agency's new supplement web

site (8). Quite frankly, this topic deserves its own article to help health professionals improve their objective assessment skills when it comes to heavily fortified foods (functional foods) and dietary supplements. Reviewer Note: Waiting for USADA URL on new site referenced (8)

Our global food supply had set the stage for some sub-standard raw materials to enter the U.S. for fortification and formulation purposes, with up to 60% of them coming from China alone (9,10). Right now I consider the collegiate and Olympic policies on funding and supplying dietary supplements to be the most vulnerable to positive doping outcomes because they DO NOT MANDATE that dietary supplements be certified free of banned substances. The reasons for NOT validating any list of banned substance certified products stems from the notion that there is no complete list of banned substancesnotably no complete list of designer drugs that sometimes enter the marketplace under the radar--so why take on the liability. If you sit in a room full of attorneys and risk managers this is the road you would take. If you sit in a room full of coaches you would find that they would want a list because they live with the reality that dietary supplements are something you get at the grocery store now, and they are not going away anytime soon, so why not help athlete and health professionals find a safe pool of certified products to select from? The typical "liability" solution has been listing banned substances on posters and in policy handbooks, but at the end of the day, you would be banking on dietary supplements being accurately labeled and 100% interpretable, and that is just not the case. Proprietary Blends on labels alone make it impossible to rule out the inclusion of banned substances based on visual inspection, along with the very sketchy track record of intentional mislabeling, such as weve seen with Methlyhexaneamine over the last two years, which has led to positive doping outcomes (11). My hat goes off to organizations that have drawn hard lines on funding and supplying dietary supplements to drug tested populations only when they are certified to be free of banned substances, and that use certification programs that are both comprehensive and routinely audited. Anything less leaves all involved in the procurement and distribution of dietary supplements vulnerable to lawsuits that may require substantial settlements (12, 13). That is a career-ender in sports for all involved, and its the reason why athletes are being held responsible for what they put in their bodies. Reviewers Note: Waiting for NFL details on CBA to play out on Health & Safety, which will impact the content of this paragraph.... In the professional ranks we currently have two major sports leagues that have led the way to help ensure a safe pool of certified dietary supplements free

of banned substances: the National Football League and Major League Baseball. Historically the use of banned substance certification programs had the strongest support from the players associations (NFLPA and MLBPA) to help ensure the athletes were not left to sort out supplement issues with the advice of the expert down the street. The NFL was first to implement such a policy in 2004, followed a year later by MLB. At the time this article was published both banned substance supplement certification programs were being administered by the same non-profit organization (NSF International), but were on two separate sets of tracks, in that companies had to submit their products through two separate application processes, and the products were listed if they passed on two separate permissible lists that teams conformed to when purchasing dietary supplements. As part of the Collective Bargaining Agreement (CBA) of 2011 between the NFL and NFLPA, they have decided to merge these two programs, which is called NSF Certified For Sport (<http://www.nsfsport.com>www.nsfsport.com). The NFL will still have some special categories of products that they want to exclude that have been certified (such as creatine), but its a huge step in the right direction. The PGA and LPGA use the same NSF program to limit what is funded and supplied to their athletes, and as this is written, more professional leagues are weighing in on participation in these types of certification programs to minimize risk and liability.

You should also be able to distinguish dietary supplements that are permissible to fund or supply" from products that have sideline exclusivity (what the public sees), which is usually something negotiated in a teams marketing department. Marketing folks from the team and, at times, from the sponsoring brands themselves (such as sports drink companies owned by global soft drink corporations) vigilantly police the sidelines of televised sports events, not only to properly position products, but to remove intruders that sometimes find their way to the field. Prominent sponsors have in some cases even leveraged the right to influence what team employees can endorse and recommend. This is the way of major college and professional sports today, and theres little that Sports RDs, athletic trainers or strength coaches can do about it retrospectively, even if it limits supplying something as fundamental as a Vitamin D or Omega3 supplement. The Mitchell Reports was a catalyst for MLBPA to collectively bargained for the right of MLB teams to fund and supply a pool of NSF certified pool of dietary supplements that are not at the whims of those who would put sponsor revenue ahead of the athletes health and welfare. The marketing forces are always in play so make sure you survey the landscape here before attempting to make any policy changes involving dietary supplements.

On the other side of the equation, we must cope with moving goalposts pertaining to what should be standardized recommendations for dietary

supplements. Certainly most sports organizations DO NOT want health professionals selling dietary supplements to their athletes, even if they are passing them along at a discount. In NCAA Bylaw 16.5.2 states " It is not permissible for an institution or an institutional staff member to sell or arrange the sale of muscle-building supplements to student-athletes." The American Dietetics Association and American Medical Association have policies on "disclosure" of any financial gain when RDs and MDs recommend any dietary supplements to clients (14, 15). As mentioned earlier, expect to see far fewer people having the authority to even speak to athletes about dietary supplements unless designated to be that support service expert. MLB has even employed a full time quality assurance position to work with each team to unify their advice on dietary supplements and ensure compliance with the established policies.

Weve recently heard of situations where even law enforcement officers and members of the military have taken dietary supplements that rendered positive tests and, as in sports, those tests have cost them money with suspensions and/or possible discharge (17). As a result, organizations like the National Tactical Officers Association (NTOA), International Association of Chiefs of Police (IACP) and Police Executive Research Forum (PERF) are exploring position statements and issuing warnings to their respective membership. Some of the products our military athletes run into when deployed are the biggest problem where mission demands compromise sleep patterns. The good news is we are seeing Special Operation Forces (SOF) being treated like athletesits where some of the most experienced Sports RDs and Strength and Conditioning Coaches are finding new and exciting career opportunities. This certainly is helping the military with recruiting and retaining highly trained military athletes. All US Warfighters are getting advice on strength training, nutrition and dietary supplement topics like theyve never had before, via their Human Performance Resource Center (18). Along with these improved support services are improved feeding programs that mirror what is happening in athletic training table settings throughout the country. While no mandates have yet been made for certifying dietary supplements for military athletes, the Sports RDs that have been engaged with Special Operation Forces are moving in that direction. Expect the same in law enforcement, where over time SWAT and other rapid-response teams will lead the movement toward dietary supplement safety.

Chronically under-rested athletes looking for a solution and a poorly regulated global supply chain for food and supplement ingredient has set the stage for a great deal volatility for health professional. Its easy to get caught between the "liability / cost containment camp" and the "performance / keep the athletes close camp". Careers are on the line for many people athletes and advisors alikeso this is no joking matter. Allied health professionals working with drugtested populations better be safe or theyll most certainly be sorry. Sports RDs

distinguish themselves by staying on top of dietary supplement and anti-doping issues, while meeting the performance demands of highly competitive athletes. They are a critical part of the circle of care around athletes who advocate for food as a first line of defense in our efforts to support anti-doping initiatives. A visible drug testing program and a commitment to feeding are fundamentals that can not be compromised in athletics if you hope to keep athletes focused on credible team resources. To learn more about Sports RDs, visit the Collegiate & Professional Sports Dietitians Association at <http://www.sportsrd.org>www.sportsrd.org and to learn more about antidoping education for coaches go to <http://www.usantidoping.org/coach>www.usantidoping.org/coach.

1) AACE - American Association of Clinical Endocrinologists <https://www.aace.com/sites/default/files/Nutraceuticals2003.pdf>https://ww w.aace.com/sites/default/files/Nutraceuticals2003.pdf ADA Position of the American Dietetic Association: nutrient supplementation. http://www.eatright.org/About/Content.aspx?id=8409&terms=Position%3a+nu trient+supplementation

ADA-SCAN/DC/ACSM - Position Stands: Nutrition and Athletic Performance http://journals.lww.com/acsmmsse/Fulltext/2009/03000/Nutrition_and_Athletic_Performance.27.aspx AHRQ - Agency for Healthcare Research and Quality. U.S. Department of Health and Human Services <http://www.ahrq.gov/downloads/pub/evidence/pdf/multivit/multivit.pdf>ww w.ahrq.gov/downloads/pub/evidence/pdf/multivit/multivit.pdf AIS - Australian Institute Of Sports http://www.ausport.gov.au/ais/nutrition/supplements AMA - Dietary SupplementsRegulatory Issues and Implications for Public Health http://jama.ama-assn.org/content/early/2011/06/30/jama.2011.982.extract ATLAS - Athletes Training & Learning to Avoid Steroids

http://www.ohsu.edu/xd/education/schools/school-ofmedicine/departments/clinicaldepartments/medicine/divisions/hpsm/research/atlas.cfm CCES - Canadian Centre for Ethics in Sport http://www.cces.ca/en/taskforcereport CR - Consumer Reports: Whats behind our dietary supplements coverage http://www.consumerreports.org/health/natural-health/dietary-supplementscoverage/overview/index.htm CRN - The Council for Responsible Nutrition http://www.crnusa.org/CRN_HSA.html DAWN/SAMHSA - Drug Abuse Warning Network (DAWN)/Substance Abuse and Mental Health Services Administration's (SAMHSA) http://www.oas.samhsa.gov/2k10/DAWN016/OpioidED.htm DEA - US Drug Enforcement Administration http://www.justice.gov/dea/pubs/pressrel/pr092909.html DOD - Department of Defense - Commission on Dietary Supplement Labels http://humanperformanceresourcecenter.org/dietary-supplements/policiesstandards-and-reports http://www.health.gov/dietsupp/cover.htm http://www.health.gov/dietsupp/ch3.htm#safety DHHS - Agency for Healthcare Research and Quality (AHRQ) of the U.S. Department of Health and Human Services http://www.nap.edu/openbook.php?record_id=10456&page=106 EHT - Environmental Health & Toxicology http://sis.nlm.nih.gov/enviro/dietarysupplements.html FDA - http://www.fda.gov/food/dietarysupplements/default.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm2 36967.htm http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm246744.htm

FDA Safety Information and Adverse Event Reporting Program to find the latest safety alerts on any product. http://www.fda.gov/Safety/MedWatch/default.htm FTC - Federal Trade Commission http://www.ftc.gov/bcp/menus/consumer/health/drugs.shtm IOC IOC Consensus Statement on Sports Nutrition 2010 26 November 2010 http://www.olympic.org/ioc-commissions/documents-reports-studiespublications IOM Institute of Medicine, Dietary Supplements: A Framework for Evaluating Safety 2004 http://www.nap.edu/catalog.php?record_id=10456#toc MLB/MLBPA - NSF certifies products and inspects facilities for a range of substances identified by leading sports organizations, such as the National Football League (NFL), National Football League Players Association (NFLPA) Major League Baseball (MLB), Major League Baseball Players Association (MLBPA), Professional Golf Association (PGA), Ladies Professional Golf Association (LPGA), and Canadian Centre for Ethics in Sport (CCES). http://mlb.mlb.com/mlb/news/mitchell/report.jsp?p=2 http://www.nsfsport.com/ NASM - National Academy of Sports Medicine http://www.nasm.org/hfpnpreview/article.aspx?id=2342&terms=dietary+suppl ements NATA - Position Statement: Evaluation of Dietary Supplements for Performance Nutrition is currently in review. NAYS - National Alliance For Youth Sports http://www.nays.org/fullstory.cfm?articleid=10292 NIHDA - National Institute on Drug Abuse http://www.drugabuse.gov/ResearchReports/Steroids/anabolicsteroids5.html

NFSHSA - National Fed. Of State High School Assn. http://www.nfhs.org/WorkArea/DownloadAsset.aspx?id=3356) NCAA - http://www.ncaa.org/checkitout http://www.ncaapublications.com/p-4203-2010-2011-sports-medicinehandbook.aspx NCAM - National Center For Complementary and Alternative Medicine http://nccam.nih.gov/health/supplements/wiseuse.htm NCDFS/REC - National Center for Drug Free Sport Resource Exchange Center www.drugfreesport.com. NFL/NFLPA POLICY ON ANABOLIC STEROIDS AND RELATED SUBSTANCES 2010 (edits coming based on 2011 collective bargaining agreement) http://images.nflplayers.com/mediaResources/.../PDFs/.../.../2010%20Steroid %20Policy.pdf NIH/ODS - National Institute of Health - Office of Dietary Supplements http://ods.od.nih.gov/HealthInformation/DS_WhatYouNeedToKnow.aspx Conference on the Science and Policy of Performance-Enhancing Products http://www.crnusa.org/ODS_CRN_PEP_FinalReport.pdf NLM - National Library of Medicine http://dietarysupplements.nlm.nih.gov/dietary/index.jsp NSCA - No Position Stand On Dietary Supplements (seem to default to ISSN on these topics) http://www.nsca-lift.org/Publications/posstatements.shtml www.nsca-lift.org/HotTopic/download/Nutritional%20Supplements.pdf PADS - Professionals Against Doping In Sports http://www.nodope.org/ PINES - Professionals in Nutrition for Exercise and Sport (PINES) New web site in works, need new URL when available.

PCPFSN - Presidents Council on Fitness, Sports and Nutrition http://www.fitness.gov/digest_jun1998.htm UK Sport - supplements resource entitled ...... Prudent About Their dietary choices. http://www.uksport.gov.uk/docLib/Publications/Annual-Review-2006.pdf USA Triatholon - Supplement Savvy http://www.usatriathlon.org/resources/multisport-zone/fuelstation/supplement-savvy USADA -Supplement Safety Now was founded by the U.S. Anti-Doping Agency, with support from Major League Baseball, the National Football League, the U.S. Olympic Committee, the National Basketball Association and the National Hockey League. http://www.supplementsafetynow.com/issue-need/overview.aspx USDA - USDA National Agricultural Library http://fnic.nal.usda.gov/nal_display/index.php?tax_level=1&info_center=4&tax _subject=274 USGAO - United States Government Accountability Office Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding http://www.gao.gov/products/GAO-09-250 US House Of Representatives, Committee On Gov. Reform, March 9, 2006 "THE REGULATION OF DIETARY SUPPLEMENTS: A Review of Consumer Safeguards" http://www.access.gpo.gov/congress/house/pdf/109hrg/27187.pdf USP - United States Pharmacopeia www.usp.org/pdf/EN/members/dietarySupplements.pdf USSA - United States Ski and Snowboard Association http://www.ussa.org/magnoliaPublic/ussa/en/formembers/sportscience/nutriti on.html

WADA - http://www.wada-ama.org/en/Resources/Q-and-A/DietarySupplements/ 2) NCAA - Nutritional Supplements 10 Years After http://www.ncaa.org/wps/portal/ncaa/ncaa/nutritional_supplements

3) NCAA Nutritional Supplements http://www.ncaa.org/wps/portal/ncaahome?WCM_GLOBAL_CONTEXT=/ncaa /NCAA/Academics+and+Athletes/Personal+Welfare/Health+and+Safety/Drug+ Education+Programs/nutritional_supplements

4) Interview with a member of the NCAA Competitive Safeguards Committee that had a hand in the 30% of total calories from protein back when 16.5.2 was being drafted.

5) Training & Conditioning Article, Sports Nutrition: A Growing Field http://www.sportsrd.org/T_C_story_on_CPSDA.html 6) NCAA Walk-On Meal Proposal & Scholarship Values In Question http://www.daveellisbio.com/www.daveellisbio.com/Blog/Entries/2010/10/31_ NCAA_Walk-On_Meal_Proposal_%26_Scholarship_Value_In_Question.html 7) WADA Prohibited List http://www.wada-ama.org/en/Science-Medicine/Prohibited-List/ 8) Will get this URL ASAP from USADA 9) Does 'Made in China' matter to supplement consumers? http://newhope360.com/supply-chain-management/does-made-china-mattersupplement-consumers

10) NBJ - Nutrition industry grows 6% to $117 billion in 2010 sales as growth rates for natural & organic foods nearly double those for functional foods and supplements. A rising tide of consumer distrust over science in the food supply points toward segmentation within the industry. http://newhope360.com/nutrition-business-journal/2011-07-01 11) USADA Athlete Advisory On Methyhexaneamine http://www.usada.org/default.asp?uid=3423 12) David Vobora awarded $5.4M http://sports.espn.go.com/nfl/news/story?id=6680714

13) Kicker Vencill Wins Suit Against Nutrition Company, Awarded Almost $600K, Swimming Info & Swimming World Magazine, May 13, 2005 http://www.swimmingworldmagazine.com/lane9/news/9452.asp 14) ADA - Guidelines Regarding the Recommendation and Sale of Dietary Supplements http://www.eatright.org/About/Content.aspx?id=8145 15) JAMA. 1998;280(11):967-968 - Physician Marketing of Nutritional Supplements http://jama.ama-assn.org/content/280/11/967.2.extract 17) NYPD Ban On Legal Supplements http://www.myfoxny.com/dpp/news/local_news/nyc/nypd-ban-on-legalsupplements-20100302

18) The Human Performance Resource Center (HPRC) http://humanperformanceresourcecenter.org/dietary-supplements

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