US Nutritional supplementation regulations imposed by collegiate

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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 it’s 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 didn’t 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 won’t 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 it’s 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 we’re 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 can’t 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 it’s 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, they’re 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 NGB’s 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 substances—notably 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 we’ve 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 it’s 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 it’s 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 team’s 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 there’s 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.
We’ve 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 athletes—it’s 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 they’ve 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. It’s 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
alike–so this is no joking matter. Allied health professionals working with drugtested populations better be safe or they’ll 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 Supplements—Regulatory 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: What’s 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 - President’s 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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