The Regulatory Limits of Hemp and CBD Products for Drug Tested Athletes

Contributed by Guest Blogger Dave Ellis, RD, CSCS

   

Recently, the World Anti-Doping Agency (WADA) pulled cannabidiol (CBD) from the 2018 Prohibited Substance List. Previously, it was illegal for Olympic athletes to use hemp products and isolates from hemp-like CBDs (1).  Literally within 48 hours of WADA releasing the news of CBD’s new permissible status, some of the bigger players in the CBD supplement space began to target drug-tested athletes.  Many of these companies make claims that some of their CBD extracts are 100% THC-free, and in compliance with WADA testing standards for THC. Yet, studies show significant inaccuracies on label claims including the actual amount of CBD found in products, and the presence of THC (2,3).

We have no credible third-party certifying agencies that can currently ensure that every batch of a CBD extract is truly THC-free.  Skip lot testing (as often used for dietary supplements) on THC levels in CBD products is not going to be good enough for drug-tested athletes, and the folks doing the testing will have to be free of any conflicts of interest with the hemp industry. 

There are no federal guidelines that determine label claim qualifications for products promoted as being “THC free.”  One company making THC claims states that they are in compliance with WADA’s “strict testing regulations” for THC by not exceeding 0.3% THC in the product. 

Like caffeine, not everyone metabolizes cannabinoids the same (4).  Even in small amounts, increased frequency of use may well accumulate THC to the point of detection by a drug test. Athletes who are drawn to CBDs as an intervention for pain, concussions, sleep, immune health, etc., must proceed with caution. 

Some professional sports still consider CBD a prohibited substance. While most don’t specifically test for CBD, they do not fund or supply any hemp-based products to athletes, due to the lack of credible assurances or third-party verification that each batch of the product is truly THC-free.

Athletes are advised extreme caution when considering these unregulated and untested CBD products.

1. Summary of Major Modifications and Explanatory Notes – 2018 WADA Prohibited List. 

2. Bonn-Miller, MO, Mallory JE Loflin, Brian F Thomas, et al. “Labeling Accuracy of Cannabidiol Extracts Sold Online.” JAMA. 2017;318(17):1708-1709.

3. U.S. Food and Drug Administration. “Warning Letters and Test Results for Cannabidiol-Related Products.” 2015-2017. https://www.fda.gov/newsevents/publichealthfocus/ucm484109.htm. Updated Nov 2, 2017.

4. Hawks, Richard L. The analysis of cannabinoids in biological fluids. Vol. 42. Department of Health and Human Services, Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, National Institute on Drug Abuse, 1982.

Dave Ellis is a Veteran Sports RD who specializes in food and supplement security for drug tested athletes. His full bio and professional work can be found at daveellisbio.com. 

Anti-Doping Research: A Conversation with the Partnership for Clean Competition.

At Drug Free Sport, we believe that a balanced approach to sports drug testing and anti-doping involves testing and education. However, there are several elements that factor into the development of such testing and education, like proper research. With scientific advancements happening both for doping and anti-doping efforts, it’s important to be on top of developments to protect the integrity of sport. 

We recently exchanged with Jenna Celmer at the Partnership for Clean Competition about their work toward improving the detection of performance-enhancing drugs. Our organizations share the spirit of fair and safe sport. It was a great conversation that we’re proud to share with you. 

How did the Partnership for Clean Competition (PCC) come to be? 

Back in 2008, Major League Baseball, the National Football League, the United States Olympic Committee, and the United States Anti-Doping Agency came together to discuss how to better deter and detect performance-enhancing drugs (PEDs) and encourage a culture of clean sport.

These organizations understood that what the anti-doping movement needed was the collaboration and commitment of leading sport organizations willing to fund scientific breakthroughs which advance anti-doping policy. The initial (and subsequent) financial contributions of these four founding PCC members catalyzed the anti-doping research collaborative known as the Partnership for Clean Competition.

The decision was a vocal stand for sporting integrity, and an investment in clean sport and in the health of athletes worldwide.

Tell us more about your focus on “the science of doping.”

While a robust approach to anti-doping policy involves several aspects (such as the education that Drug Free Sport provides), the PCC focuses on advancing the science and technology surrounding anti-doping sample collection, detection, and analysis. Our science varies based on emerging priorities, but could involve the creation of new testing methods that are less invasive and expensive, reference materials for WADA-accredited labs, or innovative tests for new substances. With new doping agents and methods being created every day to try and evade current testing capabilities, it’s paramount that the PCC continues to fund the research that produces sound responses to imminent anti-doping challenges.

What is something that you’d like the public to know about the PCC? 

The PCC funds PhD scientists all over the world (we currently have projects ongoing in 14 different countries), and we are always looking for additional investigators to contribute their unique acumen and scientific perspective to anti-doping challenges. A common misconception is that only dedicated ‘anti-doping scientists’ advance technology in this domain. The truth is, while there are certainly some incredible researchers who have devoted their careers to clean sport, many of the investigators we fund are taking the important work they develop or study in their scientific discipline and applying it to an anti-doping context. We have chemists, biologists, endocrinologists, pathologists, physiologists, food scientists, toxicologists, exercise scientists, and many others currently working on new and exciting developments. There are truly few areas of science that do not play a role, and we’re happy to talk through projects with scientists who aren’t certain if their work is a good fit.

What are some of the research-related findings that the PCC has contributed toward recently?

The PCC has granted over $18 million in research to 100+ investigators around the world; many recent advancements in PED detection and analysis are due to PCC funding. To understand how important this is, newly-found positives during reanalysis of samples from past Olympic games are possible, thanks to the more precise scientific methods developed by scientists.

While this type of research will always be a priority, the PCC has recently invested significant amounts of funding in alternative matrices – or new ways to collect and analyze samples. Currently, most drug testing is done on blood or urine, but two emerging technologies are on our radar:

      1. Breath testing. The PCC has invested in SensaBues breath tests as a quick, easy, and low-cost alternative to current in-competition testing. Athletes simply breathe into the device, which has been proven to detect not only drugs of abuse, but many classes of anti-doping substances, with lab analysis using existing WADA approved methods. PCC investment in the tests is ongoing, and we hope to do a pilot study in 2018.

      2. Dried Plasma Spot Card Testing. While current blood tests involves the use of phlebotomists to  draw blood (a process which may be perceived as invasive by athletes), the PCC has developed cards that require only a finger prick of blood to perform several different analyses. Not only is sample collection quick and easy, but the cards are easy to store, analyze, and transport, potentially providing a significant cost savings over blood testing.

We believe that developing lower-cost, less invasive sample collection methods may increase overall testing, thus enhancing overall deterrence. The PCC is investing in the scientific validation that would be required to protect clean athletes at the same level as blood and urine matrices currently used.

As an organization that funds research, you have a grant cycle deadline coming up. Care to talk about your grant processes and programs?

Absolutely! To begin a PCC grant, investigators must first fill out our 1 – 2 page “Pre-Application”, designed to gather high-level information about the intended project to ensure it fits the PCC mission and priorities. We do this so that investigators presenting research outside of our scope don’t spend time filling out our (lengthy) full application. For instance, the PCC does not currently fund social science research, even on the topic of anti-doping. We always encourage interested researchers to review our research priorities before submitting a pre-application. 

Pre-applications are due March 1^st, July 1^st, and November 1^st of each year.

As soon as pre-applications are approved (and most are), investigators are invited to submit the full PCC application, now available to them via their project site on our website. This application ranges in length from around 10 pages, to upwards of 75 pages, depending on the level of detail the investigators provide, the complexity of their research, and the amount of supplemental information they provide (for instance preliminary studies and data). Hint: the more experimental detail provided in an application, the more likely it is to be approved.

Full applications are due April 1^st, August 1^st, and December 1^st of each year (one month after the pre-application of that cycle).

Once full applications are received, they are reviewed by two members of our 10-member Scientific Advisory Board (SAB), which consists of scientific experts representing a diverse array of disciplines (from endocrinology to exercise physiology). The SAB meets every cycle to then collectively discuss the applications, and the feedback provided by each reviewer. As a unit, the SAB then makes funding recommendations for each application submitted during the cycle to our Board of Governors (consisting of a representative from each of our Founding Members) for final approval before successful investigators are notified.

At this point, the PCC will negotiate terms and conditions with the researcher’s host institution. Unsuccessful investigators will receive feedback on their application, and may be invited to re-submit their project with changes (often more detail is required). The entire process from pre-application to funding and/or feedback takes 3-5 months.

What has research shown that may be next, in terms of doping to gain an athletic advantage?

This is a difficult question to answer and one that is constantly changing. The PCC does get applications from scientists and lab directors who have concerns about specific substances and propose research on those substances. We also incorporate input from our sponsors, who are often on the front lines with regards to new perforamnce-enhancing substances. If researchers from labs, academia, or the private sector believe they have identified a need in the anti-doping community, we would encourage them to apply for a grant or micro-grant. 

Drug Free Sport Staff Weigh-in on Industry Trends Leading Into 2017

Contributed by Lara Gray, Director of Education

For this week’s blog, we interviewed a few of the staff at Drug Free Sport. We asked them to share insights from drug testing in 2016, and potential new (or repeating) trends in 2017.

LG: What, if anything, is changing in sport drug testing and analysis?

Staff: More and more, we are seeing professional sport leagues test blood samples as well as urine to ensure fair play. Amateur and institutional clients are beginning to look into oral fluid testing and other matrices as complementary features of their current drug testing program.

LG: Specific to the blood testing, what’s changing?

Staff: The World Anti-Doping Association (WADA) has validated Human Growth Hormone (hGH) biomarker analysis to compliement isoform testing for hGH. Essentially, they’re able to test for a greater detection window with the biomarker analysis that can show hGH up to two weeks after administration. Comparatively, isoform testing can detect hGH only within 24 – 48 hours of administration.

LG:  Is WADA validation important with new testing methods?

Staff: Of course. Many sport leagues look to the WADA Code and Prohibited Substances List as a gold standard. However, full implementation of WADA protocols can be difficult for clients that must also negotiate terms with their players unions through Collective Bargaining Agreements.

LG: What are sport organizations doing to work with the players unions and still provide effective drug testing programming?

Staff: “Smart” testing is becoming a new trend where we are seeing a shift to testing methodologies that efficiently and effectively use appropriate funds for deterrence testing. We are seeing this across the board for professional, amateur, and collegiate/institutional clients. Essentially, everyone is learning how to make the most of their drug-testing dollars and amplify the impact on deterrence.

LG: Are there any changes being made to the substances tested for in sport?

Staff: Nothing is changing dramatically in terms of the substances screened, even with marijuana which gets a lot of attention. We don’t anticipate any significant changes in marijuana testing as a result of the legislation efforts in several states across the country. Until there is a change from the Federal government, there likely won’t be a change in marijuana as a banned substance in sport. What has changed, however, is the conversation around marijuana—again, because of legalization in certain states.

LG: Can you elaborate? What has changed in the conversation?

Staff: There is a discussion targeting the social acceptability of marijuana—especially in the states where it is now legal for recreational use. We are providing more education on the different forms of marijuana use like edibles and concentrates, or that athletes may be using e-cigarettes or vape pens to mask their use on campus or within the sports facility. The potency of marijuana has changed dramatically over the last few years, which may be leading to higher dosages, longer lasting effects in the body, even addiction. For institutional collegiate clients, marijuana remains the largest concern on campuses.

LG: Are there other substances of concern looking ahead into 2017?

Staff: It’s hard to say what will be new in 2017, but there is growing concern over growth hormone releasing peptides (GHRPs) in professional sports, and the reemergence of anabolic steroids that were popular in the Eighties. SARMs, such as ostarine and LGD-4033, are also a concern as they are appearing in more supplement items and marketed as “legal”, which is absolutely false. Collegiately, there have been increasing requests for testing panels to include prescription narcotics and opiates. Prescription stimulants being used and abused without a prescription are also concerns on college campuses—we’ve even heard stories specific to athletes snorting amphetamines like Adderall.

LG: Sounds like there’s a lot going on! Are there any other trends you feel are important to share?

Staff: Probably the technology that surrounds drug-testing and third party administration of programs. For example, there are a number of researchers working on new technology that can detect certain drugs at lower specific gravity (or urine concentrations). Labs are also making strides to update machines that are “greener” in terms of efficiency. This helps decrease the turnaround time for receiving results which positively benefits the clients. We also know that there is a lot of work going into delivering appropriate protocols for testing transgender athletes. In January, we distributed our "Collection Procedures and Guidelines for Transgender Student-Athletes" to all of our collectors nationwide.

LG: Lastly, what impact (if any) do you feel the 2016 Russia doping issue has had on drug testing efforts in the US, or for Drug Free Sport specifically?

Staff: The impact is really just the importance of having independent administrators for drug-testing programs. A complete third-party that conducts athlete selection, administration of the program, conducts testing and works with WADA accredited labs, and provides accurate reports to the sport organization is critical. Their involvement must be completely separate and independently run. The Russia issues also increased the importance of consistency in communicating confidentiality and the code of ethics for drug testing to all of our certified collectors. Cyber security also becomes a larger concern in the wake of 2016.

LG: I think all of this is important to share and continue to discuss as we get further into 2017. Thanks for your time and insights!

For more information on any of the issues or topics discussed here, please email Lara Gray at lgray@drugfreesport.com.

Special thanks to the following staff members for their time and responses that made this blog possible: Ryan Willis, Sarah Ziegelmann, Allison Lathim, Ben Mosier, and Michaela Stemmons.