DC Medical Malpractice & Patient Safety Blog

Red Bull. Rockstar. Monster.

They could be the names of ultimate fighters or black diamond ski runs, but as any American not living off the grid knows, they are the names of energy drinks, a food category that exploded into consumer consciousness in the late 1990s.

Basically, whether marketed as food or dietary supplements, they all sell caffeine. And while caffeine in moderation isn’t harmful for most people, there’s little guidance about the quantity of caffeine—which some sources define as a drug, others as a food additive and others as a stimulant chemical found in plants—in these drinks. There’s also a paucity of information about other ingredients in these drinks.

As noted in a recent story on NPR, there’s no consensus on exactly what an “energy drink” is. Today, you find canned coffee, tea and even fruit juice spiked with extra caffeine. There’s little research about their effects.

One researcher for the Center on Young Adult Health and Development at the University of Maryland School of Public Health called for better labeling of these products in an article published in the Journal of the American Medical Association (JAMA) titled “The ‘High’ Risk of Energy Drinks.”

The American Beverage Association drafted guidelines for energy drinks, but it’s up to manufacturers to include them on product labels. The guidelines call for caffeine quantity, warnings about mixing drinks with alcohol and noting that they are not intended to be consumed by children, pregnant or nursing women or people who are sensitive to caffeine. A few years ago, we wrote about energy drinks being linked to heart problems.

Still, what is an energy drink? According to Susan Carlson of the FDA’s Office of Food Additive Safety, “They range all over the place, from products that have probably no caffeine to products that do have caffeine and products that have ingredients that may contain caffeine. But there is no regulatory definition for energy drinks, per se.”

Regardless of whether an energy drink calls itself a food or a dietary supplement, the FDA has no regulatory limits for caffeine content. Those apply only to cola drinks. Red Bull has about twice as much caffeine per can than Coke.

By law, the FDA has the right to question a manufacturer's use of an ingredient and its safe use of an ingredient. The agency is concerned about conventional foods being marketed as dietary supplements, and, Carlson told NPR, it has taken public comment to draft industry guidelines.

If you’re sensitive to caffeine, or simply like to be informed about the contents of manufactured food products before you consume them, make your feelings about energy drinks known to the FDA.

In addition, visit product websites, where more information might be forthcoming. If not, let manufacturers know that you’re not likely to purchase their product unless you know what’s in it.

Now that even Minute Maid has introduced juice “enhanced” with caffeine, the energy drink craze really deserves scrutiny.

We’ve come to expect inflated or simplistic “news” offered by careless, undertrained and/or headline-hungry media covering medical and health topics. Now, even the people in charge of publicizing a recent scientific study published in BMJ (formerly called the British Medical Journal) are guilty of pandering at best and dumbing down at worst.

“It’s official – chocolate linked to heart health” read the headline on the journal’s news release announcing publication of the study. As noted by Kevin Lomangino, editor of Clinical Nutrition Insight and a reviewer for HealthNewsReview.org , “Intrigued by the headline …, I searched the release for an indication that some prestigious independent body -- the Institute of Medicine? a World Health Organization expert committee? -- had come together to evaluate the evidence on chocolate's cardiovascular effects. As unlikely as I found that prospect, I recognized that it could justify an ‘official’ declaration of an association between chocolate and heart disease outcomes.

“But no: the ‘official’ designation was apparently bestowed by a headline writer in the BMJ press office.”

It was just another attempt to suck you into a sexy story, not unlike the exuberant teaser by NBC news anchor Brian Williams: “The science that just might justify an American addiction.”

But the network reporting wasn’t done by a science or medicine reporter, and it made the same mistake so many such stories do: It claimed things not proved by the study, whose results invited further research, not categorical conclusions.

Although the BMJ news release did include the caveats to the study, much, if not most, of the popular reporting found them uninteresting. Irrelevant.

Yes, the study did find a correlation between high levels of chocolate intake and lower risk of cardiovascular disease and stroke. But if you value useful information over partial information, you need to know, as the researchers noted:

• the study had many important limitations;


• the available literature on this topic is “limited and novel";


• more studies are required "to confirm or refute the results";


• the results might be explained "by some other unmeasured (confounding) factor" besides chocolate.

As Lomangino reminds us, most of the chocolate we love has a lower concentration of cocoa flavonoids -- the plant molecules responsible for the salutary effects researchers confirmed -- and lots of sugar, fat and calories. The more you eat of the latter, the higher your risk of developing a cardiovascular problem. So we need to study the particular constituents of chocolate that confer health benefits, and how to consume more of them and fewer of their unhealthful partners.

That’s not a wild claim, that’s science.

In 2007, the FDA proposed guidelines for gluten-free labeling. The gluten component of foods is important to people with celiac disease, a disorder in which essential nutrients can’t be metabolized when gluten is consumed. Gluten is a constituent of many grains, such as wheat, barley and rye.

Now, the FDA-approved definition of "gluten-free" is up for review, and the agency is reopening the comment period. Rules for what can be deemed gluten-free were never adopted.

As reported in Food Safety News, last week Michael Taylor of the FDA said, "We want to get the most up-to-date information and data from affected consumers, from the food industry, researchers and others to ensure that we're making the right public health call in defining gluten-free."

Approximately 3 million Americans suffer from celiac disease. "We want to make sure that those suffering from celiac disease avoid adverse health consequences from being exposed to food that may trigger the symptoms and cause long-term health effects," said Taylor.

The proposed language requires any food with the gluten-free label to contain fewer than 20 parts per million of gluten -- the equivalent of, roughly, about 2 grains of salt in a piece of bread. That recommendation includes a peer-reviewed assessment of the existing literature on gluten safety.

Some people believe that any amount of gluten is unacceptable in a product labeled “gluten-free.”

The rules are expected to be finalized next year.

To view the FDA documents related to the discussion, link here and here. The proposed regulations for gluten-free labeling are in the Federal Register, docket no. FDA-2005-N-0404 at www.regulations.gov.