The U.S. energy supplement market represents big dollars for the companies involved not only from a manufacturing and distribution perspective but for the suppliers of the ingredients for their respective formulations. We are all familiar with the seemingly constant stream of commercials and late-night TV infomercials on these energy products.
The rapid success of some of these products is driven by the large scale marketing campaigns to create demand among a range of American consumer groups. Some of the promotional activity in the energy supplement market focuses on the “clinical trial data” and might feature a sound bite from a doctor or someone in the medical community endorsing the effectiveness of the product.
Oregon’s energy supplement battle
The State of Oregon has been involved in legal action against the makers of the energy supplement 5 Hour Energy due to a mounting number of adverse events allegedly linked to the consumption of the product.
The FDA has reports of such adverse events as spontaneous abortions, heart attacks, and 11 fatalities which involve people who regularly used the energy supplement. The State of Oregon decided that they needed to take legal action against the manufacturer of the product, and during the course of the process they requested data on the ingredients in 5 Hour Energy.
The manufacturer of the product responded by sending a list of ingredients with the specific amounts redacted from the documents. A judge recently ordered the manufacturer of this supplement to produce the documents with the specific amounts of the ingredients disclosed for the Oregon Department of Justice by February 15th.
The main issue here is that the regulatory process on a vitamin or energy supplement is much different than the regulations on a food or a drink. The FDA has a far more stringent policy for the submission of a new food product than the process which exists for vitamin or energy supplements. The energy beverages such as 5 Hour Energy are considered dietary supplements and are not held to the more stringent standards of a traditional beverage product.
In light of the alleged case against 5 Hour Energy and other similar supplements the testing and approval process for these products needs to be revamped. The increased pressure from the court of American public opinion could accelerate those changes in 2014.
Across the spectrum
The use of energy drinks and energy supplements is prevalent across the spectrum of ages and demographics. In a study by The Journal of Nutrition it was noted that of all the sugary drinks consumed by teens and children, 8.8% of those beverages consumed were energy drinks.
In a related report from Packaged Facts, the consumption of energy beverages by ‘’Baby Boomers” was correlated based on sales data which indicated a sharp increase in sales of 5 Hour Energy to that demographic. The report continued by noting that “Baby Boomers” represent 2/3 of the U.S. population, have enormous spending power, and are seeking energy boosts to maintain an active lifestyle.
The potentially dangerous effects of consuming these energy beverages or supplements has resulted in increasingly high incidences of health related adverse events. In fact, a study by the Department of Health & Human Services (H.H.S.) reported that hospital emergency room visits concerning the consumption of energy drinks doubled from 10,000 to 20,000 from 2007 to 2011 (www.hhs.gov).
In fair balance, it is also largely unknown how many cases regarding these medical incidents may be caused by misuse of the supplement or overconsumption of the energy drinks in question. In that case, then the labels of the products need to have clearer directions listed for the safe use of the product, and warnings should be more explicit on the potentially harmful effects caused by overindulgence in the product.
However, in either case, a resolution needs to be formulated to address this situation before the incidences increase in proportion to the consumer population involved.
The dangers stemming from the consumption of energy beverages or similar energy supplement products are becoming too big to ignore. Some of the companies involved are reportedly concerned that the continued stream of negative news regarding these products could threaten to damper the growth of this industry segment.
The solution, given my experience in the food industry, should be a multi-faceted approach where the F.D.A. as well as Congress and other entities work together to increase awareness of the potential adverse effects associated with these energy supplements.
The F.D.A. should continue to issue warnings to the manufacturers of these types of energy products. Congress should work to find a way to close the loophole and provide the F.D.A. with the proper pathways to exert better oversight over the regulations to better safeguard the manufacturing of these products.
The judicial system can get involved on the state level to advocate for the consumer regarding the ingredients involved in these energy supplements, and the case in Oregon will go a long way in determining how these matters will be addressed by the courts in the future.
A public service campaign geared toward all demographics is needed to raise awareness of the potential side effects from these types of products.
Finally, the manufacturers themselves could help their own cause by being forthright with the data requested, and by being more transparent. If all of these entities worked together, and the right level of awareness about the consumption and correct use of these products was communicated, then these types of medical events could be potentially avoided in the future.