FDA looking into safety of energy drinks

Consumer Reports News: November 29, 2012 11:08 AM

There's been a lot of buzz lately about the safety of energy drinks and shots. Following reports of harmful reactions and even deaths possibly associated with the products, two U.S. senators recently released a letter from the FDA stating that the agency is conducting a safety review of energy drinks and is considering requiring that labels disclose the amount of caffeine the products pack, limitations on use, and warnings about possible adverse effects. That makes sense, since our recent investigation found that the products sometimes have more caffeine than they claim.

"We support the FDA's investigation into the health effects of these products especially for vulnerable populations, including children, adolescents, those with heart problems and seniors," says Urvashi Rangan, Ph.D., director of consumer safety and sustainability at Consumer Reports. "We also believe that labeling is an important way to warn consumers of any potential dangers but that further action may be warranted based on FDA's findings."

Here's more news from the FDA's letter to U.S. Sens. Richard Blumenthal and Dick Durbin outlining the agency's actions and findings so far:

  • FDA is probing whether energy drinks may pose significant risks arising from direct toxic effects when consumed in excess or by vulnerable groups, including young people and those with pre-existing cardiac or other conditions. The FDA said its review would likely include consultation with the Institute of Medicine, an advisory committee or other public meeting.
  • FDA has yet to identify any safety studies that call into question the safety of combinations of various ingredients in energy drinks. However, it said that additive or synergistic effects of certain ingredients could be of concern. If stimulants, for instance, raise a significant safety question, FDA could require safety reviews.
  • FDA disclosed that an in-depth analysis of caffeine consumption in the U.S. completed in August 2010 found that on average about 300 mg of caffeine, per person, per day is consumed. That's within the 400 mg per day limit that FDA has said is not associated with adverse effects in healthy adults. The report found that teens and young adults, age 14 to 21, consume only about 100 mg of caffeine per person per day, mainly from soft drinks, coffee, or tea. However, it said the data may not reveal possible extremes of consumption which alone or in addition to other factors could pose health risks, and that some smaller individuals may be more sensitive to caffeine's effects.
  • FDA will consult with health profession groups about whether it is advisable for children and pregnant women to limit their caffeine consumption. It noted that the American Academy of Pediatrics recommends no more than 100 mg of caffeine per day for adolescents, but that the Institute of Medicine has said that stimulant-containing drinks and products have no place in the diets of children and adolescents because of the risk of physical dependence and withdrawal symptoms, such as sleepiness and irritability. The FDA noted that the United Kingdom's Food Standards Agency recommends that pregnant women consume no more than 200 mg of caffeine per day.

Bottom line: Reports of adverse effects and deaths possibly associated with some products by themselves don't prove the products caused the problems, the companies that responded to our requests for comment said, as did the FDA in a Nov. 16 press release. It's up to FDA investigators to assess the relationship, if any, between the products or ingredients and the reports, the agency said. But the FDA urged consumers thinking about taking energy drinks or shots to first consult a health care provider to ensure that they don't have an underlying or undiagnosed medical condition that could worsen as a result of their use. Consumers and health care providers should report adverse events they believe may be related to energy drinks and shots (or other FDA-regulated products) to the agency's MedWatch Adverse Event Reporting Program. Read our report in Consumer Reports.

Blumenthal, Durbin: FDA Reviewing Safety Of Caffeinated Energy Drinks And Their Additives [Press release]

Doug Podolsky

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