dave ellis nutritional supplement regulations

7/29/2019 Dave Ellis Nutritional Supplement Regulations

1/14

US Nutritional supplementation regulations imposed bycollegiate, Olympic, professional and military organizations

Dave Ellis, RD, CSCS

As evidenced by the warnings from multiple Sports Medicine and Regulatorygroups (1), health and doping concerns over the cavalier use of dietarysupplements have long troubled health professionals, especially those who workwith drug tested populations. So much so that at each level of sports you canusually find some limitation of what can be funded or supplied by teams to theirathletes here in the U.S., and who is authorized to speak on the topic. Yes, weare now seeing organizational designation of someone on the team who speaks tothe topic of dietary supplements (MLB and NCAA) so that athletes do notget conflicting messages about permissibility that could leadto organizational liability. This is typically the Sports RD (registered dietitian),Athletic Trainer or Strength Coach. In this article we will examine the currentlandscape of permissible dietary supplements in the collegiate,profession, Olympic and tactical/military ranks, where Sports RDs in particularplay a critical role in managing the safety of what is now a global supply chainfor food and dietary supplements.

In the collegiate ranks you had a significant change in the limitations of whatcould be supplied back in 2001 with the passing of NCAA Division I Bylaw16.5.2.g Nutritional Supplements. A 10-year retrospective on the intent of theproposal that led to the legislation being passed can be accessed online (2). Asone of the early full-timers in this field who lived through the entire process, I canassure you it had everything to do with leveling the playing field between theschools that could afford dietary supplements and the widespread use of creatine

by football teams at the time (cost containment). The muscle building focus ofthe legislation speaks to this and I will never forget getting a call from myconference rep that had a vote on the topic. This rep glowed as he proudlyreported to me: The legislation was passed and creatine went down in a ballof flames.

There were two major goals behind the original legislation. The official languagebehind the goals of the legislation read as follows:

a) to end the growing practice of institutions providing so-called muscle-building supplements (e.g., creatine); and

b) to decrease student-athlete exposure to dietary supplement products that arenot well regulated.

The reality was that the way the legislation was written before Bylaw 16.5.2.g, wewere told by our NCAA compliance officers that using food as a between


2/14

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 fromthe 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 asto permissibility of products that seemed to fall into these four categories, butthat possibly contained impermissible ingredients. So its been a moving targetof permissibility based on concerns from a health perspective or concern of apossible positive doping outcome, or just where a product maybe in conflict withthe intent of 16.5.2 (3).

The interpretations of 16.5.2 have always been the challenging part of practice inthe collegiate ranks. Those interpretations are very hard to track and whenit comes to issues like the ceiling on 30% of total calories from protein part of16.5.2 (only intact peptides, no amino acids or hydrolysates), it gets verysticky. You can walk into any training table and find foods that by natureare higher in protein than 30%, which is where the line was drawn based onwhere the Zone products drew their line on protein yield (4). So along the wayinterpretations have surfaced that even having an ingredient around that mightbe 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% oftotal calories. Of course no one from the NCAA is running around training tablekitchens policing any such protein food ingredients, but they would come downon any smoothie bar that had ingredients that were that high in protein. So youwill see all NCAA recovery shakes and bars using products that yield 70% or moreof their calories from sugar, starch and fat which, for post workout, is probablynot the end of the world, but obviously didnt do much to help us deal with weightloss populations at the collegiate ranks, or to supply a source of soy protein forvegan 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 consideredan extra benefit, but confined the foods to fruits, nuts and bagels, and for thesake of keeping this article reasonably brief, I wont go into all the challenges thathave come with interpretations on nuts vs. peanut butter. Officially it reads asfollows:

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


3/14

to a student-athlete at any time. This legislation addresses the provision of foodas opposed to the provision of nutritional supplement products, and, along withother 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 theircareer, so its all about using food first with athletes. That is at the fabricof what Sports RDs do in their day-to-day practice. We create real value behindthe power of food with athletes and operate within the financial and legislativelimits of what were permitted to provide to teams (5). The real challenges thatexist are with the frequency we can feed at the collegiate ranks (only one meal perday in a training table setting) and how the value of meals are calculated forathletes (based on watered down dorm prices). At the end of the day,scholarship athletes who move off campus immediately find that they cant affordto feed themselves. As a result we see athletes binge-eating at the training tablemeal when it is provided, and even that varies by conferences (some just feed in-season for two or three revenue sports). The reality is that the general public isunder the impression that all collegiate athletes are being fed (scholarship andwalk-ons alike), which of course is not the case. So we give athletes what we canwhen we can at the collegiate ranks and its typically never enough to meet thedemands of activity and growth that these student athletes routinelyrequire. They might be "part time" athletes, but when combining their demandsof maintaining academic eligibility with the physical and mental demands ofkeeping their spot on the college roster, theyre faced with full-time recoveryneeds. 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 deregulatingrules that limit our ability to feed athletes like we do at the Olympic, Professionaland Military ranks, which we will move onto at this point.

When it comes to feeding athletes after college (assuming they went to college atall), we confronted primarily by budget, and not by legislation. However, whenit comes to dietary supplements, we have varying degrees of regulation that mustbe navigated by those engaged with fueling. Olympic is the easiest tooutline. They have no rules on what dietary supplements can be funded orsupplied as long as the product is not labeled to contain banned substances orthat metabolize into any banned substances (7). We do have a number ofNational Governing Bodies of Sport (NGBs) that are considering some kind offilter on products that are supplied where a third-party banned substancecertification 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 withathletes as they move from one Olympic training venue to the other, where theysometimes get inconsistent advice that leaves them confused and, ultimately,vulnerable. Unfortunately the three most credible certification agencies fortesting dietary supplements for banned substances are not regulated and are veryhard for coaches and athletes to objectively compare. A set of specifications onwhat will constitute a comprehensive banned substances certification programwill soon be published on the U.S. Anti-Doping Agency's new supplement web


4/14

site (8). Quite frankly, this topic deserves its own article to help healthprofessionals improve their objective assessment skills when it comes to heavilyfortified 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 toenter the U.S. for fortification and formulation purposes, with up to 60% ofthem coming from China alone (9,10). Right now I consider the collegiate andOlympic policies on funding and supplying dietary supplements to be the mostvulnerable to positive doping outcomes because they DO NOT MANDATE thatdietary supplements be certified free of banned substances. The reasons forNOT validating any list of banned substance certified products stems fromthe notion that there is no complete list of banned substancesnotably nocomplete list of designer drugs that sometimes enter the marketplace under theradar--so why take on the liability. If you sit in a room full of attorneys and riskmanagers this is the road you would take. If you sit in a room full of coaches youwould find that they would want a list because they live with the reality thatdietary supplements are something you get at the grocery store now, and they arenot going away anytime soon, so why not help athlete and health professionalsfind a safe pool of certified products to select from?

The typical "liability" solution has been listing banned substances on posters andin policy handbooks, but at the end of the day, you would be banking ondietary supplements being accurately labeled and 100% interpretable, and that isjust 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 thevery sketchy track record of intentional mislabeling, such as weve seenwith Methlyhexaneamine over the last two years, which has led to positive dopingoutcomes (11).

My hat goes off to organizations that have drawn hard lines on funding andsupplying dietary supplements to drug tested populations only when they arecertified to be free of banned substances, and that use certification programs thatare both comprehensive and routinely audited. Anything less leaves all involvedin the procurement and distribution of dietary supplements vulnerable tolawsuits 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 heldresponsible 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 haveled the way to help ensure a safe pool of certified dietary supplements free


5/14

of banned substances: the National Football League and Major LeagueBaseball. Historically the use of banned substance certification programs had thestrongest support from the players associations (NFLPA and MLBPA) to helpensure the athletes were not left to sort out supplement issues with the advice ofthe 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 bothbanned substance supplement certification programs were being administered bythe same non-profit organization (NSF International), but were on two separatesets of tracks, in that companies had to submit their products through twoseparate application processes, and the products were listed if they passed on twoseparate permissible lists that teams conformed to when purchasing dietarysupplements. As part of the Collective Bargaining Agreement (CBA) of 2011between the NFL and NFLPA, they have decided to merge these two programs,which is called NSF Certified For Sport(www.nsfsport.com). The NFL will still have somespecial 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 LPGAuse 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 onparticipation in these types of certification programs to minimize risk andliability.

You should also be able to distinguish dietary supplements that are permissibleto fund or supply" from products that have sideline exclusivity (what thepublic sees), which is usually something negotiated in a teams marketingdepartment. Marketing folks from the team and, at times, from the sponsoring

brands themselves (such as sports drink companies owned by global soft drinkcorporations) vigilantly police the sidelines of televised sports events, not only toproperly position products, but to remove intruders that sometimes find theirway to the field. Prominent sponsors have in some cases even leveraged the rightto influence what team employees can endorse and recommend. This is the wayof major college and professional sports today, and theres little that Sports RDs,athletic trainers or strength coaches can do about it retrospectively, even if itlimits supplying something as fundamental as a Vitamin D or Omega-3 supplement. The Mitchell Reports was a catalyst for MLBPA to collectivelybargained for the right of MLB teams to fund and supply a pool of NSF certifiedpool 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 forcesare always in play so make sure you survey the landscape here before attemptingto make any policy changes involving dietary supplements.

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


6/14

supplements. Certainly most sports organizations DO NOT want healthprofessionals selling dietary supplements to their athletes, even if they arepassing them along at a discount. In NCAA Bylaw 16.5.2 states " It is notpermissible for an institution or an institutional staff member to sell or arrangethe 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 dietarysupplements to clients (14, 15). As mentioned earlier, expect to see far fewerpeople having the authority to even speak to athletes about dietary supplementsunless designated to be that support service expert. MLB has even employed afull time quality assurance position to work with each team to unify their adviceon dietary supplements and ensure compliance with the established policies.

Weve recently heard of situations where even law enforcement officers andmembers of the military have taken dietary supplements that rendered positivetests and, as in sports, those tests have cost them money with suspensions and/orpossible discharge (17). As a result, organizations like the National TacticalOfficers Association (NTOA), International Association of Chiefs of Police (IACP)and Police Executive Research Forum (PERF) are exploring position statementsand issuing warnings to their respective membership. Some of the products ourmilitary athletes run into when deployed are the biggest problem where missiondemands compromise sleep patterns. The good news is we are seeing SpecialOperation Forces (SOF) being treated like athletesits where some of the mostexperienced Sports RDs and Strength and Conditioning Coaches are finding newand exciting career opportunities. This certainly is helping the military withrecruiting and retaining highly trained military athletes. All US Warfighters

are getting advice on strength training, nutrition and dietary supplement topicslike theyve never had before, via their Human Performance ResourceCenter (18). Along with these improved support services are improved feedingprograms that mirror what is happening in athletic training table settingsthroughout the country. While no mandates have yet been made for certifyingdietary supplements for military athletes, the Sports RDs that have been engagedwith Special Operation Forces are moving in that direction. Expect the samein law enforcement, where over time SWAT and other rapid-response teams willlead the movement toward dietary supplement safety.

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


7/14

distinguish themselves by staying on top of dietary supplement and anti-dopingissues, while meeting the performance demands of highly competitive athletes.They are a critical part of the circle of care around athletes who advocate for foodas a first line of defense in our efforts to support anti-doping initiatives. A visibledrug testing program and a commitment to feeding are fundamentals that can

not be compromised in athletics if you hope to keep athletes focused on credibleteam resources. To learn more about Sports RDs, visit the Collegiate &Professional Sports Dietitians Associationat www.sportsrd.org and to learn more about anti-doping education for coaches goto www.usantidoping.org/coach.

1) AACE - American Association of Clinical Endocrinologistshttps://www.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+nutrient+supplementation

ADA-SCAN/DC/ACSM - Position Stands: Nutrition and Athletic Performancehttp://journals.lww.com/acsm-

msse/Fulltext/2009/03000/Nutrition_and_Athletic_Performance.27.aspx

AHRQ - Agency for Healthcare Research and Quality. U.S. Department of Healthand Human Serviceswww.ahrq.gov/downloads/pub/evidence/pdf/multivit/multivit.pdf

AIS - Australian Institute Of Sportshttp://www.ausport.gov.au/ais/nutrition/supplements

AMA - Dietary SupplementsRegulatory Issues and Implications for PublicHealthhttp://jama.ama-assn.org/content/early/2011/06/30/jama.2011.982.extract

ATLAS - Athletes Training & Learning to Avoid Steroids


8/14

http://www.ohsu.edu/xd/education/schools/school-of-medicine/departments/clinical-departments/medicine/divisions/hpsm/research/atlas.cfm

CCES - Canadian Centre for Ethics in Sporthttp://www.cces.ca/en/taskforcereport

CR - Consumer Reports: Whats behind our dietary supplements coveragehttp://www.consumerreports.org/health/natural-health/dietary-supplements-coverage/overview/index.htm

CRN - The Council for Responsible Nutritionhttp://www.crnusa.org/CRN_HSA.html

DAWN/SAMHSA - Drug Abuse Warning Network (DAWN)/Substance Abuseand Mental Health Services Administration's (SAMHSA)http://www.oas.samhsa.gov/2k10/DAWN016/OpioidED.htm

DEA - US Drug Enforcement Administrationhttp://www.justice.gov/dea/pubs/pressrel/pr092909.html

DOD - Department of Defense - Commission on Dietary Supplement Labels

http://humanperformanceresourcecenter.org/dietary-supplements/policies-standards-and-reports

http://www.health.gov/dietsupp/cover.htmhttp://www.health.gov/dietsupp/ch3.htm#safety

DHHS - Agency for Healthcare Research and Quality (AHRQ) of the U.S.Department of Health and Human Serviceshttp://www.nap.edu/openbook.php?record_id=10456&page=106

EHT - Environmental Health & Toxicologyhttp://sis.nlm.nih.gov/enviro/dietarysupplements.html

FDA - http://www.fda.gov/food/dietarysupplements/default.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm236967.htmhttp://www.fda.gov/ForConsumers/ConsumerUpdates/ucm246744.htm


9/14

FDA Safety Information and Adverse Event Reporting Program to find the latestsafety alerts on any product.http://www.fda.gov/Safety/MedWatch/default.htm

FTC - Federal Trade Commissionhttp://www.ftc.gov/bcp/menus/consumer/health/drugs.shtm

IOC IOC Consensus Statement on Sports Nutrition 2010 26 November 2010http://www.olympic.org/ioc-commissions/documents-reports-studies-publications

IOM Institute of Medicine, Dietary Supplements: A Framework for EvaluatingSafety 2004http://www.nap.edu/catalog.php?record_id=10456#toc

MLB/MLBPA - NSF certifies products and inspects facilities for a range ofsubstances identified by leading sports organizations, such as the NationalFootball League (NFL), National Football League Players Association (NFLPA)Major League Baseball (MLB), Major League Baseball Players Association(MLBPA), Professional Golf Association (PGA), Ladies Professional GolfAssociation (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 Medicinehttp://www.nasm.org/hfpnpreview/article.aspx?id=2342&terms=dietary+supplements

NATA - Position Statement: Evaluation of Dietary Supplements forPerformance Nutrition is currently in review.

NAYS - National Alliance For Youth Sportshttp://www.nays.org/fullstory.cfm?articleid=10292

NIHDA - National Institute on Drug Abusehttp://www.drugabuse.gov/ResearchReports/Steroids/anabolicsteroids5.html


10/14

NFSHSA - National Fed. Of State High School Assn.http://www.nfhs.org/WorkArea/DownloadAsset.aspx?id=3356)

NCAA - http://www.ncaa.org/checkitouthttp://www.ncaapublications.com/p-4203-2010-2011-sports-medicine-handbook.aspx

NCAM - National Center For Complementary and Alternative Medicinehttp://nccam.nih.gov/health/supplements/wiseuse.htm

NCDFS/REC - National Center for Drug Free Sport Resource Exchange Centerwww.drugfreesport.com.

NFL/NFLPA POLICY ON ANABOLIC STEROIDS AND RELATEDSUBSTANCES2010 (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 Supplementshttp://ods.od.nih.gov/HealthInformation/DS_WhatYouNeedToKnow.aspxConference on the Science and Policy of Performance-Enhancing Products

http://www.crnusa.org/ODS_CRN_PEP_FinalReport.pdf

NLM - National Library of Medicinehttp://dietarysupplements.nlm.nih.gov/dietary/index.jsp

NSCA - No Position Stand On Dietary Supplements (seem to default to ISSN onthese topics)http://www.nsca-lift.org/Publications/posstatements.shtmlwww.nsca-lift.org/HotTopic/download/Nutritional%20Supplements.pdf

PADS - Professionals Against Doping In Sportshttp://www.nodope.org/

PINES - Professionals in Nutrition for Exercise and Sport (PINES)New web site in works, need new URL when available.


11/14

PCPFSN - Presidents Council on Fitness, Sports and Nutritionhttp://www.fitness.gov/digest_jun1998.htm

UK Sport - supplements resource entitled ...... Prudent About Their dietarychoices.http://www.uksport.gov.uk/docLib/Publications/Annual-Review-2006.pdf

USA Triatholon - Supplement Savvyhttp://www.usatriathlon.org/resources/multisport-zone/fuel-station/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, theU.S. Olympic Committee, the National Basketball Association and the NationalHockey League.http://www.supplementsafetynow.com/issue-need/overview.aspx

USDA - USDA National Agricultural Libraryhttp://fnic.nal.usda.gov/nal_display/index.php?tax_level=1&info_center=4&tax_subject=274

USGAO - United States Government Accountability OfficeDietary Supplements: FDA Should Take Further Actions to Improve Oversightand Consumer Understandinghttp://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 ConsumerSafeguards"http://www.access.gpo.gov/congress/house/pdf/109hrg/27187.pdf

USP - United States Pharmacopeiawww.usp.org/pdf/EN/members/dietarySupplements.pdf

USSA - United States Ski and Snowboard Associationhttp://www.ussa.org/magnoliaPublic/ussa/en/formembers/sportscience/nutrition.html


12/14

WADA - http://www.wada-ama.org/en/Resources/Q-and-A/Dietary-Supplements/

2) NCAA - Nutritional Supplements 10 Years Afterhttp://www.ncaa.org/wps/portal/ncaa/ncaa/nutritional_supplements

3) NCAA Nutritional Supplementshttp://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 thathad a hand in the 30% of total calories from protein back when 16.5.2 wasbeing 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-matter-supplement-consumers


13/14

10) NBJ - Nutrition industry grows 6% to $117 billion in 2010 sales as growthrates for natural & organic foods nearly double those for functional foodsand supplements. A rising tide of consumer distrust over science in the foodsupply 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 $5.4Mhttp://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, 2005http://www.swimmingworldmagazine.com/lane9/news/9452.asp

14) ADA - Guidelines Regarding the Recommendation and Sale of DietarySupplementshttp://www.eatright.org/About/Content.aspx?id=8145

15) JAMA. 1998;280(11):967-968 - Physician Marketing of NutritionalSupplements

http://jama.ama-assn.org/content/280/11/967.2.extract

17) NYPD Ban On Legal Supplementshttp://www.myfoxny.com/dpp/news/local_news/nyc/nypd-ban-on-legal-supplements-20100302

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


14/14

2012 Abbott LaboratoriesThe EAS ACADEMY website and its content is owned by Abbott Nutrition, a division of AbbottLaboratories. All rights reserved.Any redistribution or reproduction of any part or all of the contents in any form is prohibited other than thefollowing:

1. you may print or download to a local hard disk extracts for your personal and non-commercial useonly;

2. you may copy the content to individual third parties for their personal use, but only if youacknowledge the website as the source of the material.

You may not, except with our express written permission, distribute or commercially exploit the content.

Nor may you transmit it or store it in any other website or other form of electronic retrieval system.

dave ellis nutritional supplement regulations

Documents