Energy Drinks and Supplements: Investigations of Adverse Event Reports*
FDA: U.S. Food and Drug Administration
November 16, 2012
FDA takes every adverse event report seriously, and investigates and evaluates other possible causes before deciding whether a product actually caused a medical problem. An adverse event report does not necessarily mean the product identified in the report actually caused the event. The FDA assesses the relationship, if any, between a product or ingredient and the reported adverse event.
Energy products are relatively new to the market. Manufacturers of these products have labeled some as dietary supplements and others as conventional foods. FDA regulates both dietary supplements and conventional foods under the Federal Food, Drug, and Cosmetic Act (the FFDCA), but the requirements for them are different.
A food additive cannot be used in a conventional food unless it has been approved for that use by FDA. However, substances generally recognized as safe by qualified experts are not considered food additives, and can therefore be added to conventional foods without preapproval from the FDA.
Dietary ingredients (the active ingredients in dietary supplements) require no FDA preapproval. The FFDCA requires the FDA to prove a product is unsafe (under the suggested conditions of use) to take the product off the market.
Manufacturers, packers, and distributors of dietary supplements are required by law to report any serious adverse events to the FDA within 15 business days. They must also provide (within 15 business days) any additional medical information they obtain within a year of the adverse event report. However, the FFDCA does not require manufacturers, packers, or distributors of conventional foods to report serious adverse events to the FDA. Therefore, all adverse event reports the FDA receives are voluntary.
Further, those who voluntarily report an illness or injury typically identify the product they believe may have caused the injury or illness. As a result, the FDA, as a scientific public health agency, must carefully investigate and evaluate other possible causes before concluding the product actually caused the medical problem.
While FDA investigates all reports to the best of its ability, it does not always have access to all the information needed to determine the cause of the event. Challenges include the following:
incorrect, incomplete reports, often lacking contact information, which make following up with the complainant difficult or impossible;
variability among the completeness of the reports (Some reports may consist only of a single sentence with little detail.);
reports that list the brand, but do not identify the specific product;
absence of or lack of FDA access to other information related to the report, such as medical records and medical histories.(In fact, some state medical privacy laws prevent FDA from obtaining medical records related to the adverse event report.)
Complicating factors in determining the cause of a medical problem can include
use of other supplements or medications at the same time;
pre-existing or undiagnosed medical conditions;
improper use of the product.
The FDA cautions consumers that products marketed as energy shots or energy drinks are not alternatives to rest or sleep. Consumers should realize that, while stimulants such as caffeine may make one feel more alert and awake, judgment and reaction time can still be impaired by insufficient rest or sleep. If you are thinking about taking one of these products, please consult your health care provider to ensure that you don't have an underlying or undiagnosed medical condition that could worsen as a result of using them.
*Edited for clarity
U.S. Food and Drug Administration: http://www.fda.gov/Food/NewsEvents/ucm328536.htm
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