5 Hour Energy - Potential Health Risk

5 Hour Energy® - Potential Health Risk
5 Hour Energy® is an energy drink in the form of a 2oz shot produced by ©Living Essentials, LLC. Since its introduction in 2004, 5 Hour Energy® has become one of the most popular brands available on the market by claiming 80% of the energy shot market with approximately 350-360 million bottles sold per year . This popularity and widespread use have not gone without controversy. Lawsuits and reports of adverse health reactions have resulted in a groundswell of cynisism regarding product safety as well as the short-term and long-term health of 5 Hour Energy® customers. One such lawsuit alleges that 5 Hour Energy® is directly responsible for the wrongful death of a heart attack victim. In the lawsuit, the victim’s wife alleges that the victim would have never used the product had he known the health consequences, risks, and adverse reactions that may be caused by the energy drink. Additionally, Health Canada and the U.S Food and Drug Administration have received numerous reports of adverse reactions. Regardless of the outcomes of pending lawsuits and adverse reaction cases, there is clearly a need to assess the possible health risks that may be associated with 5 Hour Energy® products.
Risk (by ingredient as listed on product labels)
Niacin (also known as Vitamin B3, niacinamide, nicotinic acid)
According to the product labels, 5 Hour Energy®Original contains 30mg of Niacin per serving, 5 Hour Energy®Extra Strength contains 40mg of Niacin per serving, and 5 Hour Energy®Decaf does not list Niacin as an ingredient. The Reference Daily Intake for Niacin is 20mg and the average daily dietary intake is 30mg for men and 20mg for women .
Niacin is important in metabolism and hormone production. One common side effect of Niacin intake is a burning, tingling sensation in the face and chest, and reddening of the skin referred to as “Niacin flush”. Niacin flush can occur at dosages around 30mg for men and 20 mg for women and, as a result, the Institute of Medicine set tolerable upper intake limits of 35 mg for adults (19 years and older) and 30mg for adolescents (14-18 years) .
Vitamin B6 (also known as pyridoxine)
According to the 5 Hour Energy® labels, there is 40mg of Vitamin B6 per serving in Original, Decaf, and Extra Strength. The Reference Daily Intake for Vitamin B6 is 2mg and the average daily dietary intake varies, but an upper intake level of 100mg/day for adults and 80mg/day for adolescents was established by the Institute of Medicine . Additional side effects include nausea, light sensitivity, abdominal pain, and loss of appetite. Pyridoxine also may interact with prescription drugs such as antibiotics, antidepressant medications, Amiodarone, chemotherapy drugs, Erythropoietin, Levodopa, and Phenytoin. Folic acid has potential to interact with prescription drugs similar to those listed for Vitamin B6 and Niacin.
Vitamin B12 (also known as cobalamin, cyanocobalamin)
According to the 5 Hour Energy®Original, Decaf, and Extra Strength labels, there is 500mcg of Vitamin B12 per serving. The Reference Daily Intake is 6mcg and there is no established upper intake level because only a small amount of Vitamin B12 is absorbed regardless of the dose when taken orally because Vitamin B12 is very soluble and any excess readily passess through the body. Vitamin B12 is instrumental in DNA replication and red blood cell production. There are no known toxic effects or adverse reactions known to be association with daily intake doses greater than the recommended daily dose, however, there are potential prescription drug interactions similar to those previously listed for Niacin, Vitamin B6, and Folic Acid.
Sodium
According to the 5 Hour Energy®Original, Decaf, and Extra Strength labels, there is 18mg of sodium per serving. The recommended daily intake for sodium is approximately 1.5g which is the estimated bodily requirement. Although dietary sodium intake is a problem in many populations, it is not deemed to be a health concern specific to 5 Hour Energy®.
Energy Blend
The ‘energy blend’ in 5 Hour Energy® is listed as a single ingredient even though the label lists taurine, glucuronic acid, malic acid, N-acetyl, L-tyrosine, L-phenylalanine, caffeine, and citicoline as constituents. The total amount per serving of this energy blend is 1870mg/serving for 5 Hour Energy®Original, 2009mg/serving for 5 Hour Energy®Decaf, and 2000mg/serving for 5 Hour Energy®Extra Strength but there is no specific dosage information or daily reference values given for individual energy blend ingredients. The side-effects of caffeine may vary greatly between individuals depending on body mass, metabolism, and tolerance but for every individual there is still a likely dose-response relationship. The controversy about using 5 Hour Energy® products is fueled in large part because the caffeine dosage per serving is not listed on the product label in a clear manner. Instead, it is listed ambiguously as an ingredient in the "energy blend" and the actual caffeine dosage could therefore range from 0-1870mg, 0-2000mg, 0-2009mg depending on the product being consumed. 5 Hour Energy®Original claims to contain as much caffeine as a cup of leading premium coffee. An 8-oz cup of premium Starbucks© coffee contains 180mg of caffeine. According to an analysis by Consumerlabs.com in October 2010, 5 Hour Energy® Original was determined to contain 207mg caffeine per serving. Again, if the product warning labels are taken under advisement and there is a two bottle per day maximum, it is possible by the information provided on the product labels that the caffeine intake could exceed 3700mg in a matter of seconds, or a matter of two "shots".
Regulation
The debate about the safety of 5 Hour Energy® products and the health consequences of these products on consumers truly lies in the legislation that outlines the regulation and oversight of these products. All of the ingredients in 5 Hour Energy® products have a biochemical impact in the human body to some degree, but that degree is very uncertain. Numerous public health professionals and consumer advocate groups have emphasized the need to more research. The real question is, who is responsible for doing the research, the companies selling the products or the regulatory agencies responsible for monitoring the companies products? Currently, 5 Hour Energy® is considered a “dietary supplement” as defined by Congress in the . According to the DSHEA, a dietary supplement is any product taken orally that contains vitamins, minerals, herbs or other botanicals, amino acids, enzymes, organ tissues, glandulars, and metabolites intended to supplement the diet. Dietary supplements, including 5 Hour Energy®, are regulated by the U.S. Food and Drug Administration (FDA) as a category of food. Under the DSHEA, products like 5 Hour Energy® do not need approval from the FDA to be sold on the open market. Supplements must simply be labeled as a “dietary supplement” and a product must not claim or be represented to diagnose, treat, prevent, or cure any disease. Additionally, unless dietary supplements contain a “new dietary ingredient”, they are not required to provide the FDA with any evidence supporting the safety or efficacy of their product. Manufacturers are expected to conform to standard production practices outlined by the Dietary Supplement Current Good Manufacturing Practices (cGMPS) and in some cases register with the FDA pursuant to the Bioterrorism Act. If passed into law, the Dietary Supplement Labeling Act of 2011 would require manufacturers to register their products with the FDA. Additionally, the Secretary and Institute of Medicine would compile a list and analyze dietary supplements, ingredients, and proprietary blends deemed to pose a health risk. If found to cause potentially adverse events, drug interactions, contraindications, or pose risks to subgroups, a mandatory warning label would be required on the supplement package. Propriety blends, such as the energy blend used in 5 Hour Energy®, may also be required to list the weight per serving of the ingredient in the proprietary blend on the supplement label.

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