by Marion Nestle
Nov 1 2012

Energy drinks: Why deregulation is not such a good idea

Concerns that highly caffeinated Monster Energy drinks might be responsible for the recent deaths of at least five young adults are, as I see it, a direct result of deregulation of food oversight.

Here’s my version of the history leading up to the present situation:

  • In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), which in essence deregulated dietary supplements, permitted them to be labeled and regulated as supplements, not foods, and removed much of FDA’s authority over their contents and health claims.
  • The dietary supplement industry, as I explain in Food Politics, wrote much of the key language of this law.
  • When the FDA tried to enforce its food rules for supplements, the courts ruled in favor of manufacturers on First Amendment grounds.
  • Because rules for supplements are less restrictive than those for foods, some manufacturers prefer labeling their products as supplements.
  • Monster Energy drinks are labeled as supplements, removing them from much of FDA’s authority.

The results of DSHEA, in this case, are explained by the New York Times:

But while the F.D.A. regularly makes adverse event reports about drugs and medical devices publicly available, it does not do so for dietary supplements like energy drinks. Because of that policy, consumers had no way of knowing of the complaints about Monster Energy drinks before incident reports were released by the F.D.A. in response to a formal Freedom of Information Act request.

Also, while supplement makers have been required since late 2007 to alert the F.D.A. to possible product-related deaths and injuries, Monster Beverage submitted just one such report to the agency over the last four years, agency officials said.

Most likely because of their high caffeine content, sales of energy drinks are rising rapidly, as shown in this graphic from the Times:

Booming sales means booming profits, and the makers of energy drinks are under pressure to cash in.  That sometimes means cutting corners or not always matching contents to labels.

For example, a Consumer Reports investigation of the caffeine content of energy drinks identified some discrepancies.

Caffeine levels per serving ranged from about 6 milligrams to 242 milligrams per serving—and some containers have more than one serving. The highest level was in 5-hour Energy Extra Strength; the lowest in the seemingly oxymoronic 5-hour Energy Decaf…By comparison, an 8-ounce cup of coffee has about 100 milligrams; a 16-ounce Starbucks Grande, 330 milligrams.

Five of the 16 products that list a specific amount of caffeine…had more than 20 percent above their labeled amount on average in the samples we tested. On the other hand, one…had caffeine about 70 percent below the labeled amount.

Consumer Reports noted one other key point: the FDA considers caffeine as GRAS (Generally Recognized As Safe) and does not require amounts to be listed on labels.

A representative of the Monster Beverage Corporation explained that his company does not list caffeine levels “because there is no legal or commercial business requirement to do so, and also because our products are completely safe, and the actual numbers are not meaningful to most consumers.”

Consumer Reports points out that Monster drinks—like those of 16 other products—warn against use by children, pregnant or nursing women, and people sensitive to caffeine, and recommend a daily limit.

Whether the Monster Energy drinks are really responsible for the reported deaths will not be easy to establish.  One victim, age 14, is said to have consumed two 24-ounce Monster drinks containing 240 mg caffeine each within a day or two.

That energy drinks are labeled as supplements ties the FDA’s hands in dealing with such products.

Here are some suggestions to consider:

  • Label energy drinks with standard Nutrition Facts panels.
  • Require amounts of caffeine to be stated on the label.
  • Limit the amount of caffeine that can be included in soft drinks.

Two Senators (Durban and Blumenthal)—not for the first time—are pushing the FDA to investigate.  Good idea.  I can only speculate about why the FDA isn’t responding, but I’m guessing that this issue, like so many others, is too controversial to take up during an election campaign.

Soon, please.

Comments

  • Steve
  • November 1, 2012
  • 2:55 pm

I am missing something here? A kid drinks the equivalent of a large coffee in consecutive days and dies tragically, and the blame lay with the deregulation of energy drinks? I’m sure he knew caffeine was in the drink and it the drink didn’t have a dangerous amount of caffeine in it. Regulation would not have changed anything.

At the most, 1.6 people die per year from drinking energy drinks. Meanwhile, 450 people die each year from falling out of their beds. Vending machines kill about 13 Americans per year. Buying an energy drink from a vending machine is literally much more dangerous than actually drinking it.

If all 5 of these reports are actually caused by energy drink consumption, then it’s no different than the other people who die due to being unaware of a rare allergy or health condition – sad, but unavoidable. You can’t regulate rare, accidental deaths out of the world.

Everyone focuses on the caffeine, but what about the fructose in these drinks?
Enough fructose to deplete liver ATP and elevate uric acid could slow the metabolism of caffeine and make it more harmful to circulation.

  • Fred
  • November 2, 2012
  • 4:18 am

Your 3 suggestions are good but I doubt they will convince teens (the main consumer group) not to buy such drink, simply because no teens look at labels! They just buy what’s cool, period.

  • Fred
  • November 2, 2012
  • 4:21 am

@The High Fat Hep C Diet I guess you meant HFCS? Because ‘fructose’ (sugars extracted from fruits) is a slow carbs that’s actually good. Your body needs such carbs.

  • SAO
  • November 2, 2012
  • 5:24 am

@Steve
My teenagers have never perceived energy drinks as anything other than slightly cooler soft drinks. They don’t know what’s in them.
And they don’t have an awareness of caffeine as an issue to watch. It’s not an issue that’s hit their health classes (which are highly repetitive and focused on food, drink and drugs)

I think if I haven’t hammered the issue, they’d have assumed that the “energy” part of “energy drink” was as meaningful as the “smile” part of “have a Coke and a smile” — advertising blather to be ignored.

What you’re actually asking them to do is to know when advertising is blather and to be aware of health issues that don’t get covered in school at a level that is well beyond “so energy drinks have caffeine and I shouldn’t drink too much, the same goes for Coke and coffee.”

  • joe
  • November 2, 2012
  • 7:14 am

It is well understood by most that teenagers have lemming-like qualities and follow what the crowd does. They will continue to do this despite regulations from the government.

I continue to have trouble understanding how the regulations of a government agency will eliminate risk. Health has been and is a matter of personal choice and responsibility. That may not be a popular sentiment here but it is none the less a fact.

Ugh. Once again another example of profits before people. I get we all make our own choices with what is presented to us, but I am so tired of companies putting out products that they know may cause harm. Where are the souls of these people?

  • TR
  • November 2, 2012
  • 9:19 am

Joe,
Maybe I can help you to understand how regulations can help reduce risk. Risk can’t be eliminated as you are assuming.

You point out that “Health has been and is a matter of personal choice and responsibility.” Let’s rephrase that statement to “buying a house has been and is a matter of personal choice and responsibility.” Sure, no one forces you to buy or not buy a house. You can try to buy a house that you cannot afford and you can buy a house that is inadequate for your needs. But, when you look at the plumbing coming up through the floor, you assume its attached to something on the other side and that when you turn on the faucet water will flow, and when you flush the toilet the sewage will go out through sewage pipes. Without government regulations and inspectors and all that bureaucracy, you cannot expect the plumbing to function in a safe and sanitary fashion. The pipes may just go down into the ground. You get no water and if you do your toilet just backs up or empties into the crawl space under the house. And, you wouldnt be able to hold anyone liable because there are no regulations.

This is the issue here: that producers are not required to be honest and accurate about the contents of their “supplements.” Consumers cannot know how much of what they are consuming regardless of whether they care. There are no regulations requiring the producers to do so. Does that make more sense?

  • Steve
  • November 2, 2012
  • 10:09 am

@SAO

I think you’re actually arguing against your point. Nobody’s told your kids to avoid caffeine, so labeling and regulating the amount of caffeine isn’t a solution.

Marion’s solutions assume that (1) caffeine is unusually harmful, (2) people don’t know there’s caffeine in energy drinks, and (3) the harm caused by this problem outweighs the costs of solving it. I think all of these assumptions are false; you need to prove each one true before you can agree with Marion’s suggestions.

  • Steve
  • November 2, 2012
  • 10:31 am

@TR

I think you’re a bit confused. You don’t need regulations to sue somebody. If you commit fraud, you go to jail and pay restitution to the person you defrauded. You don’t need extensive home-building regulations to protect yourself from buying a house that doesn’t have plumbing.

  • TR
  • November 2, 2012
  • 11:02 am

No, I’m not confused nor am I hardheaded. If you commit fraud and go to jail for it, then there was a law or regulation saying you can’t commit fraud. If there isnt a law or regulation saying you can’t commit fraud, then you can fraud anyone and there’s nothing anyone can do about it. Remember the days of snake oil medicine?
Regulations are needed if you are to sue someone. Otherwise, its all up to consumer responsibility to research the product before they buy it. I dont think they’ll let you open the can to inspect it for caffeine content before you purchase it. Do you really expect a person to have to test the snake oil medicine to prove to themselves that it does what the salesman claims it will do before they purchase it? How is the average person going to do that?

  • Steve
  • November 2, 2012
  • 12:43 pm

You’re still confusing laws with regulations. They are totally different things. There’s no regulation that prevents someone from knocking and your door and stabbing you; instead, we have a law against murder to dissuade people from doing it. Likewise, a law against fraud is sufficient in this instance. You can’t pass a regulation for every infinitesimal risk in society.

You’re also imagining a problem that doesn’t exist. Despite a lack of regulation, caffeine content is within a safe range on all of these drinks and there has been, according to the numbers Marion presented, zero harm caused by a lack of regulation.

  • Joe
  • November 2, 2012
  • 12:51 pm

The free market is a much better regulator of bad products than is a government agency. If the energy drink is implicated in this case then many people will regulate the purchase of that beverage on the basis of not wanting to die. This will happen while the government is still trying to come up with the best wording for the final draft of the regulatory document.

  • Cathy Richards
  • November 2, 2012
  • 3:19 pm

Monster Energy claims to have 240 mg of caffeine, but I’ve never been able to find out if that is from added synthesized caffeine only, or if it includes the caffeine-related chemicial in the guarana seeds that are also in Monster Energy. Depending on growing conditions, guarana’s caffeine-related content can vary dramatically. Is it possible that some batches of Monster Energy have more caffeine-related content than others?

Regardless, these energy drinks specifically target young adults, and we all know how much children and teens want to emulate their slightly older ‘peers’. It’s criminal that regulators didn’t anticipate this tidal wave. They were warned by numerous dietitians, pediatricians, and other health professionals. Like cigarettes and alcohol, there needs to be an age restriction on purchasing these potentially dangerous substances.

  • Cathy Richards
  • November 2, 2012
  • 3:21 pm

Marion – do the current heads of FDA and Food Safety have any ties to the GMO corn industry? Because energy drinks tend to be very high in HFCS. In Canada the sugar content (grams) does not need to be declared on these “‘Natural’ ‘Health’ Products”. A great way to obfuscate the continued demand for HFCS and GMO corn.



Look, I’m not trying to minimize the issue here. Really. But you have to put this into perspective. For instance, in the report for just 2010 alone there were 130 deaths associated with acetaminophen, 66 with antihistamines, and 12 with antacids. That’s in one year. (Table 18 for those really interested). If I’m reading the tables correctly, energy drinks were associated with no deaths in 2010.

In 2010, battery ingestions killed 2 kids. (Table 17E)

It’s thought that the high dose of caffeine might have combined with an arrhythmia to result in a serious heart problem. But you can also get a lot of caffeine elsewhere. In fact, the Mayo Clinic reports that energy drinks have less caffeine than grande coffee drinks.

  • Tom Massey
  • November 3, 2012
  • 9:44 am

De-regulation does not mean NO-regulation. It means LESS regulation.

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