If it looks like a duck and quacks like a duck ... : energy "shots" should be regulated as energy drinks in Canada.

Hammond, David ; Reid, Jessica L.

In 2012, Health Canada transitioned caffeinated energy drinks from Natural Health Product (NHP) to Food and Drug classification and regulations, based on product characteristics, consumer perceptions and use. Until food and drug regulations are issued for energy drinks, Health Canada is granting Temporary Marketing Authorizations to products that meet specific requirements, including limits on caffeine content, mandatory cautionary labelling, and restrictions on health claims. (1) Since 2012, more than 300 caffeinated energy drinks have been granted such authorizations. (2)

The current requirements for energy drinks in Canada do not apply to "energy shots," which remain classified as a "natural health product" and are thus subject to NHP regulations rather than the more comprehensive labelling and other requirements for energy drinks. The rationale given for energy shots remaining classified as NHPs is as follows: Caffeinated products that are not consumed or perceived as foods will continue to be classified as NHPs. For example, many products termed "Energy Shots" are distinguished from foods by their smaller volumes and product representation. Health Canada has set the upper limit for the volume of an energy shot at 90 mL; therefore, caffeinated products that are pre-packaged, ready-to-consume, containing 90 mL or less, and meant to be consumed in a single dose, shall be classified as NHPs (p. 6). (1)

Despite their smaller volume, the caffeine content of energy shots is often equivalent to larger energy drinks. For example, 5-hour Energy--the most popular energy shot in Canada--contains 190 mg of caffeine, (3) more than the maximum allowed for energy drinks. Indeed, Health Canada's maximum caffeine limit is higher for energy shots (200 mg per container) than for energy drinks (180 mg per container). (4) Energy shots have also been associated with a similar number of adverse health events as energy drinks. A search of Health Canada's Adverse Reaction database (5) as of May 2015, which includes voluntary reports from consumers and health professionals, indicates 16 adverse events for 5-hour Energy, more than any brand of energy drink other than Red Bull. A number of these are serious or life-threatening events. (5,6) In the United States, the FDA has received reports citing the possible involvement of 5-hour Energy shots with 13 deaths between late 2008 and 2012. (6,7) Since 2009, 5-hour Energy has been mentioned in approximately 90 filings with the FDA, including more than 30 serious or life-threatening injuries, such as heart attacks and convulsions. (7)

Health Canada's primary rationale for continuing to treat energy shots as NHPs rather than including them as foods with energy drinks is that they are "not consumed or perceived as foods" in the same way as energy drinks. We tested that assumption in a population-based study, conducted in October 2014 to examine the use and perceptions of energy drinks among youth and young adults in Canada.

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An online survey was conducted with respondents aged 12-24 in all provinces (N = 2040), recruited via email through Leger's consumer panel (which includes more than 400,000 active members, half of whom were sampled using probability-based methods). (8) Surveys were conducted in English (n = 1329) or French (n = 711) with youth aged 12-17 (n = 1013) and young adults aged 18-24 (n = 1027). Respondents received remuneration from Leger in accordance with their usual incentive structure. The study was reviewed by and received ethics clearance from the Office of Research Ethics at the University of Waterloo. A full description of the study methods is published elsewhere and can be found in the Technical Report. (8)

Respondents were shown an image of a popular energy shot brand (5-hour Energy; see Figure 1) and asked "Which of the following do you think best describes this product?" Participants were provided with six options that appeared in random order: "Energy drink", "Supplement", "Vitamin drink", "Natural health product", "Soft drink" and "Food product", as well as "Don't know" and "Refuse to answer". A total of 78.8% of respondents perceived the energy shot as an "energy drink", followed by 9.5% who viewed it as a supplement, 2.5% as a vitamin drink, 1.9% as a natural health product, 0.9% as a soft drink, 0.6% as a food product, and 5.5% selected "don't know" (a further 6 respondents refused to answer).

The results demonstrate that the vast majority of youth and young adults surveyed--the primary target group for energy drinks--perceive energy shots as an energy drink. This is consistent with evidence that they are used for similar reasons as energy drinks. (9) To our knowledge, this is the only evidence on how consumers perceive energy shots. In the absence of any other empirical evidence, and given the similarity in product constituents, there appears to be little basis for regulating energy shots differently from energy drinks. Indeed, given the alarming number of adverse events associated with energy shots, these products should be subject to similar labelling requirements and health warnings as energy drinks. To our knowledge, the distinction between energy shots and energy drinks is unique to Canada and not reflected in other jurisdictions that require labelling of high caffeine products, such as the European Union.

REFERENCES

(1.) Health Canada, Food Directorate, Health Products and Food Branch. Category Specific Guidance for Temporary Marketing Authorization--Caffeinated Energy Drinks, December 2013. Available at: http://www.hc-sc.gc.ca/fn-an/legislation/ guide-ld/guidance-caf-drink-boiss-tma-amt-eng.php (Accessed June 24, 2015).

(2.) Health Canada. Lists of Foods That Have Received Temporary Marketing Authorization Letters, Last updated March 31, 2015. Available at: http://www. hc-sc.gc.ca/fn-an/legislation/acts-lois/list-tmal-rpsn-eng.php (Accessed June 24, 2015).

(3.) Health Canada. Licensed Natural Health Products Database, 5-Hour Energy (NPN 80038715). Last modified February 27, 2014. Available at: http:// webprod5.hc-sc.gc.ca/lnhpd-bdpsnh/info.do?licence=80038715&lang=eng (Accessed May 16, 2016).

(4.) Mackrael K. New limits placed on caffeine in 'energy shots'. The Globe and Mail. Feb 5, 2013. Available at: http://www.theglobeandmail.com/ life/health-and-fitness/health/new-limits-placed-on-caffeine-in-energy-shots/ article8286575/ (Accessed June 24, 2015).

(5.) Health Canada. Canada Vigilance Adverse Reaction Online Database. Available at: http://www.hc-sc.gc.ca/dhp-mps/medeff/databasdon/index-eng. php (Accessed May 7, 2015).

(6.) Mackrael K. Health Canada okays 'energy shot' drinks while U.S. probes possible links to deaths. The Globe and Mail. Feb 5, 2013. Available at: http://www.theglobeandmail.com/life/health-and-fitness/health/healthcanada-okays-energy-shot-drinks-while-us- probes-possible-links-to-deaths/ article8236152/ (Accessed June 24, 2015).

(7.) Meier B. Caffeinated drink cited in reports of 13 deaths. New York Times. Nov 14, 2012. Available at: http://www.nytimes.com/2012/11/15/business/5hour-energy-is-cited-in-13-death- reports.html?_r=0 (Accessed June 24, 2015).

(8.) Reid JL, Hammond D. Evaluating the Impact of Canada's Caffeinated Energy Drink Policy Among Youth and Young Adults: Online Survey, Technical Report, December 2014. Available at: www.davidhammond.ca/projects/ energy-drinks/energy-drinks-national-survey/ (Accessed November 9, 2015).

(9.) Stephens MB, Attipoe S, Jones D, Ledford CJW, Deuster PA. Energy drink and energy shot use in the military. Nutr Rev 2014;72(S1):72-77. PMID: 25293546. doi: 10.1111/nure.12139.

Received: July 30, 2015

Accepted: November 14, 2015

David Hammond, PhD, [1] Jessica L. Reid, MSc [2]

Author Affiliations

[1.] School of Public Health and Health Systems, University of Waterloo, Waterloo, ON

[2.] Propel Centre for Population Health Impact, University of Waterloo, Waterloo, ON Correspondence: David Hammond, PhD, School of Public Health and Health Systems, University of Waterloo, 200 University Avenue West, Waterloo, ON N2L 3G1, Tel: 519-888-4567, ext. 36462, E-mail: dhammond@uwaterloo.ca

Financial Support: The project described in this report was funded by a Canadian Institutes of Health Research (CIHR) Operating Grant (Evaluating the impact of Canada's caffeinated energy drink policy among youth and young adults). DH is also supported by a CIHR New Investigator Award, and a Chair in Applied Public Health, funded by the Public Health Agency of Canada in partnership with the CIHR Institute of Neurosciences, Mental Health and Addiction (iNmHA) and Institute of Population and Public Health (IPPH).

Conflict of Interest: None to declare.