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.

Given our propensity to pop an antibiotic at the first sign of a sniffle—and much of the medical establishment’s willingness to gratify this often unwise habit—it’s hard to believe that the use of antibiotics to fight infection has been common practice for only a couple of generations.

Like all medications, they come with risks of side effects, but in the right circumstances, antibiotics are truly wonder drugs. They’re so wonderful, however, that we overuse them. The problem then becomes not just one of risky and/or unpleasant side effects, but of reduced efficacy.

The more frequently antibiotics are used, the better bacteria become at resisting them. It’s simple evolution—survival of the fittest bacteria. The fitter (stronger) the bacteria, the more compromised the antibiotics. In order to keep up with the demand of increasingly resistant bacteria, new compounds must constantly be developed. The old ones simply don’t work anymore.

Antibiotic resistance occurs when humans ingest the drugs more frequently and for disorders they are not meant to address. But one contributor to this diminishing-effects scenario is not the direct result of human behavior—it results from the routine use of antibiotics in agriculture. They’re given to livestock to prevent disease and promote growth. That practice has been called into question often in recent years.

As explained in the Los Angeles Times, last year, the American Medical Association (AMA), the World Health Organization (WHO) and other medical groups warned that “the misuse of antibiotics in food animal production may be creating a serious problem for human health by fostering development of drug-resistant bacteria."

Further, some studies showed that taking antibiotics out of animal feed "made antibiotic-resistant bacteria less prevalent in both animals and people with no ill effects for animals or ranchers."

Earlier this month, the FDA put its foot down on some unapproved uses of antibiotics for livestock. The agency prohibited use in certain animals of one class of antibiotics called cephalosporins, and prohibited using the drugs for purposes other than their original intent (called “off-label” or “extra-label” use) except for animals that are rarely consumed by humans.

It wasn’t the first time the FDA attempted to curb the use of antibiotics in animals. In 2008, the FDA made a move to limit off-label antibiotic use in livestock, but wussed out in the face of opposition by agricultural interests.

Congressional Rep. Louise Slaughter (D-N.Y.) is a microbiologist who has written legislation addressing antibiotic overuse. In a statement about the latest action, she said, "We need to start acting with the swiftness and decisiveness this problem deserves. With over 1 million Salmonella cases in the U.S. each year, at least 30,000 Americans will contract cephalosporin-resistant bacteria every year. I'm glad the FDA is finally acting but how many Americans have needlessly been sickened in the meantime?"

The new rules take effect April 5, but as in 2008, there’s a comment period in the interim. Comments received last time helped sway the FDA against enforcing the restrictions. So if you care about antibiotic resistance, you might want to weigh in about the latest proposal. Link here to read a Q&A about general antibiotic use in animals and specifically this action. To submit comments, link here and include the docket number FDA-2008-N-0326.

According to a report by the Department of Health and Human Services, every year 128,000 Americans are hospitalized and 3,000 die from food poisoning. The FDA is responsible for safeguarding the food supply and for inspecting food facilities. A recent study addressed concerns about the rigor of these inspections.

As reported on the FDA Law Blog, the report enumerated several “significant weaknesses” in oversight of food facilities inspected by state agencies under contract to the FDA.

They include:

• failure to ensure that the number of required inspections was completed;


• payment for incomplete inspections;


• failure to ensure that all state inspections were properly classified and that all violations were remedied;


• failure to complete the required number of audits for one-third of the states and inconsistent follow-up on systemic problems.

The findings are important because in recent years state contractors have conducted most food facility inspections. Questions about the reliability of inspections and audits conducted by an agency other than the FDA have come from many quarters. Third-party auditors have taken the heat for several recent outbreaks of food-borne illness, such as the 2009 salmonella outbreak in a peanut processing facility.

Some such outbreaks have resulted in wrongful death lawsuits, including the listeriosis found in cantaloupes last year from which 30 people died.

As dire as the HHS report seems, the long-term effect on food safety is rosier once the FDA implements an accreditation system for third-party auditors authorized by the Food Safety Modernization Act (FSMA) enacted last year. That system focuses on imported food, but the FDA is interested in recognizing third-party certification programs generally.

As the report suggests, ultimate success is a matter of the FDA stepping up to answer the question “Who guards the guards?”

At the end of last week, the Centers for Disease Control and Prevention reported that 15 people had died and 84 were ill from eating listeria-contaminated cantaloupes.

It’s the deadliest food-borne outbreak in 13 years.

Listeria is a bacteria that causes listeriosis, a kind of food poisoning. Every year, according to WebMd, approximately 2,500 people become seriously ill with listeriosis. Most people recover on their own, but the outbreak is particulary dangerous for pregnant women, newborns, the elderly and people with compromised immune systems. Once diagnosed, they are given antibiotics.

Listeria can infect a variety of foods, and it’s more insidious than some other food-borne microbes because it thrives under refrigeration and can incubate for weeks before a person exhibits symptoms. The latter makes it difficult to identify the origin, and therefore stop the supply line of germs.

Here’s a primer on listeriosis.

Symptoms include one or more of:

• fever


• muscle aches


• nausea


• diarrhea


• headache


• stiff neck

Prevention involves practicing safe food handling:

• While shopping, bag raw meat, poulty and fish separately from other food items.


• Store food as soon as possible after shopping.


• Wash your hands before and after handling food.


• Wash fresh produce by rinsing well under running water.


• Use two cutting boards, one for fresh produce and one for raw meat, poultry and seafood.


• Wash knives and cutting boards in the dishwasher to disinfect them.


• Cook, refrigerate or freeze meat, poultry, eggs, fish and prepared foods within two hours of preparation.


• Refrigerators should be 40 degrees or colder. But because listeria grows in the cold, clean refrigerator spills promptly.


• Reheat leftovers to at least 165 degrees; don’t eat undercooked hamburger and beware the risk of eating raw fish.


• If in doubt, throw it out.

If you’re pregnant, do not eat:

• hot dogs, lunch or deli meats unless steaming hot;


• soft cheese unless the label says they’re made from pasteurized milk;


• refrigerated pate or meat spreads;


• raw milk;


• store-prepared salads, such as ham, chicken, egg, tuna or seafood.