FDA | Caffeine and You

Guarana Profile

January 2, 2013 By Kate Heyhoe

Scan the label on an energy drink or energy shot, and you’ll likely see guarana: an ingredient twice as caffeinated as coffee, and a natural product of the Amazon. For centuries, natives there have used it medicinally, to suppress appetite, and for extending physical endurance.

What is guarana? The substance hails from the seeds of the guaraná plant, hence the name. Guaranine is the term for the caffeinated element in guarana, which is chemically identical to caffeine in coffee, tea and chocolate.

Where does guarana come from? Native to the Amazon basin, guaraná vines bear clumps of grape-size, Christmas-red berries and can climb as tall as 35 to 40 feet. When the three-sided guaraná fruits ripen, the capsule splits to reveal a black seed poking out of a white aril – they look like arm-length clusters of Muppet eyes. (Native legends say that the first guaraná plant sprouted from the eye of an infant god.) Native tribes have harvested guarana for centuries. The seeds are dried, ground, and brewed into tea or processed into an extract. Brazil is the leading supplier of guarana extract and powder, which are added to foods and beverages as a caffeine-boost.

How much caffeine does guarana yield? Guarana seeds are twice as caffeinated as coffee beans, about 4% caffeine by weight (coffee has 1-2% caffeine). But it’s difficult to know how much guarana a product contains. Like coffee and tea, guarana is naturally caffeinated, so U.S. regulations do not require the amount of guarana to be listed. If caffeine is listed separately, it typically does not include the extra caffeine that comes from guarana or guaranine.

What else does guarana contain? Guarana also contains the caffeine-related stimulants theobromine and theophylline. Some studies show guarana yields antioxidant effects. It’s classified as GRAS, generally recognized as safe, by the U.S. Food and Drug Administration (FDA).

For more about guarana, check out:

Children of Guarana: Tribe, Legend, Plant

Guarana Soda: Brazil’s National Buzz

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Mate or Yerba Mate Profile

January 2, 2013 By Kate Heyhoe

For a caffeine boost, some people drink a tea made from mate, also known as yerba mate. Mate’s bitter flavor is an acquired taste, especially when brewed alone, without tempering by other flavorings. It’s often a natural ingredient in energy drinks and energy shots.

What is mate or yerba mate? The mate plant, Ilex paraguariensis, is a type of tropical evergreen in the holly family. The word maté refers to the tea, which is traditionally drunk scalding hot through a straw; and also to the richly decorated, hollowed out gourd used by natives as a vessel for brewing and drinking.

Where does mate come from? Maté hails from rainforests in Paraguay, and is also found in Argentina and Brazil. Native tribes discovered its properties by brewing a tea from the smoke-dried leaves and twigs.

How much caffeine does mate yield? As a stimulating beverage, maté’s buzz is fairly low, with caffeine levels comparable to weak or very strong tea: between .7 and 1.7 percent (tea typically contains .4 to .9 percent caffeine). Maté’s caffeine is sometimes called mateine.

What else does mate contain? Maté’s theobromine content ranges from a low .3 to .9 percent; it may contain a tiny amount of theophylline or none at all (depending on the species).

Is mate safe? Studies have indicated that frequent, large consumption over prolonged periods may increase the risk of cancers of the mouth, lungs, and esophagus; but evidence suggests that in the subjects tested, drinking mate at high temperature, heavy consumption, and tobacco smoking are responsible for the carcinogenic results. Like guarana, mate is classified as GRAS, generally recognized as safe, by the U.S. Food and Drug Administration (FDA). Most experts also consider it safe in moderate amounts, though research has been sparse.

Caffeine Basics: Table of Contents

5. Wacky Regulations and Misguided Marketing

January 5, 2013 By Kate Heyhoe

The FDA does not require warning labels on highly caffeinated products, but this may change.

Sometimes caffeine amounts are listed on a label – and sometimes they’re not.

FDA and Energy Products Face Scrutiny

Even though caffeine is a drug, the U.S. Food and Drug Administration treats it differently depending on the type of product it’s in – such as medicines, dietary supplements, or food – which makes for a world of consumer confusion.

In the U.S., the FDA considers caffeine safe enough to permit people of all ages to consume it. Regulations for some food and drinks do limit caffeine amounts, restrict marketing claims, and set up guidelines for consumer information. But in other cases, regulations are almost nonexistent.

Internationally, a few countries have taken the lead in establishing more rigorous consumer labels and guidelines, especially on energy drinks. Because several teen deaths have been claimed to be linked to energy drinks, the FDA is scrutinizing the entire caffeinated-product industry, but has yet to make any real policy changes. Some energy drinks have toned-down their marketing tactics to teens and kids, to avoid further scrutiny and public backlash.

Some beverage companies in the U.S. – like Monster Energy – are voluntarily changing their labels, or in some cases, their formulas, in responses to public pressure. They’re no longer dietary supplements, but instead are beverages, and this means different labeling, but with the same amount of caffeine.

Even the FDA admits the rules on caffeine are a little wacky. While the rules haven’t changed in decades, the products they regulate have changed, in ways no one would anticipate.

The following sections cover the basics on caffeine labeling, with tips every consumer should know.

Caffeine Basics: Table of Contents

Is Caffeine a Drug or a Food?

January 5, 2013 By Kate Heyhoe

Caffeine blocks adenosine receptors, and changes other processes in the brain

Technically, caffeine is a type of psychotropic drug (also called a psychoactive drug). That is, it affects the central nervous system and alters brain activities associated with mental processes, perception and behavior.

Caffeine: Listed or Hidden?

When caffeine occurs naturally (as in coffee, tea, or chocolate), the FDA does not require caffeine to be listed as a separate ingredient. So a Hershey’s Kiss or bottle of Starbuck’s Frappuccino doesn’t need to specify caffeine. Nor does an energy drink when the caffeine is part of a natural botanical source, like guarana or yerba mate.

But when caffeine is present as an additive, the FDA does require it to be listed as an ingredient; this applies to foods, beverages, over-the-counter and prescription medicines, and dietary supplements – which include energy drinks and energy shots – but not to soft drinks.

Sodas are not dietary supplements. Soft drink makers got a special pass from the FDA back in 1980, when they argued caffeine was added just as a flavor enhancer – a claim that appears to be more myth than fact. Consequently, they are not required by the FDA to list the amount of added caffeine they contain, though the amount must not exceed 71 mg per 12 ounces. Only recently do some soft drink makers voluntarily print caffeine amounts on their labels, which we’ll get into later.

A Monster Energy Example

In 2013, Monster Energy – and a few other energy drinks – switched from being classified as a dietary supplement to being classified as a food (or specifically, a beverage). Monster’s formula is the same, and it still loads the same amount of caffeine, but the information on the can is different.

The new Monster can sports a Nutrition Facts panel and adds “CAFFEINE FROM ALL SOURCES: 80 mg PER 8 FL. OZ.”

The old Monster wore a Supplement Facts label and the standard dietary supplement disclaimer that reads “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.” The old Monster also lists caffeine, but not the amount, and only as an ingredient in its proprietary “Energy Blend,” which also includes guarana, inositol, glucose and other substances.

Here’s what’s puzzling for consumers: Unlike sodas which are limited to 71 mg per 12 ounces, the recategorized new Monster contains much more than 71 mg per 12 ounces; an 8-ounce portion still delivers 80 mg of caffeine. Which points out the flaws in the FDA’s regulations. Many would argue that the fizzy sweet Monster Energy drink tastes and looks just like a soft drink.

Even the FDA’s deputy commissioner Michael R. Taylor says the rules on caffeinated products appear to be outdated, and the agency is looking at ways to revamp them.

Caffeine Confusion for Consumers

So, if it looks like a soda, and tastes like a soda, but it’s more caffeinated than a cup of coffee, it’s probably an energy drink. If the FDA classifies the energy drink as a type of dietary supplement, caffeine may be added in any amount as long as it’s not known to be harmful. (Terms like energy drink and energy shot are purely marketing terms, not FDA categories.)

In the U.S., whenever an energy drink, energy shot and energy gel or other caffeinated edible is approved by the FDA as a “dietary supplement,” it’s permitted to be sold without limits to the caffeine content, because the FDA does not consider them food. So even though caffeine is a stimulant drug, it’s not regulated as a drug by the FDA – when it’s an ingredient in a dietary supplement.

Things get especially murky when you realize that a Starbucks Doubleshot Energy drink is considered a food, while a Java Monster Loca Moca is a dietary supplement, yet both contain the same amount of caffeine in a 15-ounce can.

To the average consumer, they’re all just caffeinated beverages.

How to tell the difference? Look at the label:

Supplement Facts – appears on dietary supplements
Nutrition Facts – appears on foods (and beverages)

When a product is classified as a dietary supplement, it gets to play by different rules, as the next section explains…

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What Exactly Is a Dietary Supplement?

January 5, 2013 By Kate Heyhoe

Energy shots are regulated as dietary supplements

Energy shots, like energy drinks, are regulated as dietary supplements

Caffeinated energy drinks, energy shots, sports gels, weight-loss products, caffeinated gum, and other caffeine-added products are typically regulated as dietary supplements; though as the previous section explains, some energy drinks are now reclassifying themselves as beverages.

So what constitutes a dietary supplement, and how did FDA regulations get to be so loose?

The FDA defines a dietary supplement as a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet.

The “dietary ingredients” in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders.

At first, the FDA considered dietary supplements to only consist of such essential nutrients as vitamins, minerals, and proteins. In 1990, “herbs, or similar nutritional substances” were allowed.

In 1994, dietary supplement rules were expanded to allow non-essential nutrients, such as ginseng, garlic, enzymes, fish oil, and caffeine, for instance. Congress heeded to lobbyists and passed the Dietary Supplement Health and Education Act (DSHEA).

As long as makers of dietary supplements made no unsubstantiated claims that their products treated, prevented or cured diseases, FDA barriers were dropped.

Today, the FDA puts no limits on the serving sizes or amounts of ingredients in dietary supplements. Manufacturers are responsible for ensuring their products are safe, and if an ingredient is itself new, the FDA must first review the safety data on it. But otherwise, dietary supplements are pretty loosey-goosey; they don’t need FDA approval before marketing.

The Dietary Supplement Disclaimer

We’ve all seen labels that read:

“This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”

In the U.S., dietary supplements can’t promote themselves as cures. But dietary supplements can make three types of claims:

health claims – the link between food substance and disease or health condition
structure/function claims – the intended benefits of using the product
nutrient content claims – the amount of a nutrient or dietary substance in a product.

So the FDA allows for some pretty wide leeway on labels, and puts the onus of truthfulness on the manufacturer. According to the FDA:

“In general, these claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body. The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not approved by FDA.”

Dietary supplements must include a disclaimer that the FDA has not evaluated their claims, and must also state that the product is not intended to “diagnose, treat, cure or prevent any disease,” because only a drug can legally make such a claim. (Additionally, the Federal Trade Commission regulates marketing claims in advertising materials.)

How Is Caffeine Listed on a Dietary Supplement?

According to the FDA, the “Supplements Facts” panel must list all dietary ingredients, including caffeine. But caffeine comes in many forms, which may not be obvious on the label. Besides caffeine, a label may list guarana, maté, chocolate, cacao, tea, or coffee. These ingredients also deliver a caffeine buzz, but they don’t have to be specified as “caffeine.”

The “Other Ingredients” statement lists ingredients that the FDA says “could include the source of dietary ingredients, if not identified in the Supplement Facts panel (e.g., rose hips as the source of vitamin C), other food ingredients (e.g., water and sugar), and technical additives or processing aids (e.g., gelatin, starch, colors, stabilizers, preservatives, and flavors).”

You’ll often find guarana and yerba mate (or mate) listed as “Other Ingredients,” especially in energy drinks and shots.

Caffeine Basics: Table of Contents