In a recently-filed lawsuit, Patrick J. Vital, a resident of the state of Florida, filed a class action complaint against One World Company, LLC (also known as One Natural Experience and doing business as One World Enterprises, LLC) for providing false information on the nutritional labels of their products, One Natural Experience Coconut Water (O.N.E.).
Coconut water has recently become popular, especially with athletes, due to it high potassium content, as well as other nutrients such as sodium, magnesium, phosphorus and vitamin C. According to the label on the packaging of O.N.E., this brand of coconut water is a "good source of electrolytes", which makes the drink appealing for rehydration after exercise.
Staying hydrated is an essential requirement for athletes. Water and other fluids help the body maintain proper body temperatures. As individuals sweat, their bodies lose water, which is necessary to help keep the body cool. Therefore, individuals must drink plenty of water before, during and after exercising.
Individuals should also be careful not to drink too much water, because it may lead to overhydration, or hyponatremia, which may be life threatening. This occurs when the body consumes more water than it loses. When there is too much water in the body, there are low levels of salt in the blood. As a result, people may experience swelling in the legs, shortness of breath and enlarged organs and veins.
In addition to losing water when exercising, the body also loses electrolytes, including sodium and potassium. These electrolytes are needed to regulate bodily functions. Individuals who are participating in strenuous exercise that lasts longer than a couple hours may benefit from sports drinks that contain electrolytes to help replace the ones lost during exercise.
Several sports drinks, including Gatorade®, may be a good source of these electrolytes. However, according to the U.S. Food and Drug Administration (FDA) regulation 21 C.F.R. 101.54(c), a product cannot claim to be a "good source" of any nutrient unless it provides 10-19 percent of the recommended daily value (DV). For instance, a product claiming to be a "good source" of sodium would need to contain at least 240 milligrams of this nutrient, since the recommended DV for sodium is 2400 milligrams.
Mr. Vital has filed a complaint against One World Company, LLC, because, despite its label claims, O.N.E. contains only 0.5 percent of the recommended DV for sodium and 5 percent of the recommended DV for magnesium. By not labeling its product according to the FDA regulations, Mr. Vital's lawsuit claims that One World Company, LLC has violated section 17200 of the Business and Professions Code, a part of California's Unlawful, Unfair, and Fraudulent Business Acts and Practices. According to this section of the Business and Professions Code, One World Company practiced "unfair, deceptive, untrue, or misleading advertising" by marketing O.N.E. as a "good source of electrolytes".
In addition, because O.N.E. does not contain a "good source of electrolytes" according to FDA regulations, Mr. Vital's lawsuit also claims that the product violated section 110620 of the Health and Safety Code of the California Food, Drug and Cosmetic Act, as well as section 17500 of the California Business and Professions Code. Both regulations do not allow misbranded food products to be sold to consumers.
Lawsuits such as this filed against manufacturers of dietary supplements or food products stress the need for these companies to follow certain FDA regulations. Although these products may not be evaluated by the FDA to the same degree as drugs, certain FDA guidelines apply to any product that is ingested, including dietary supplements. Consequently, this lawsuit highlights the fact that advertising claims made on labels, websites or other marketing strategies for dietary supplements must follow any necessary FDA rules or risk legal consequences.
For more information about integrative therapies with evidence of benefit for dehydration, please visit Natural Standard's Comparative Effectiveness Database.