dietary supplement | Caffeine and You

Supplements in Energy Drinks

January 3, 2013 By Kate Heyhoe

The “energy” in energy drinks and energy shots comes from two sources: caffeine (including the caffeine in guarana, yerba mate, and kola nut) and glucose, or sugar. The following ingredients are also common in energy drinks and “dietary supplement” products.

Taurine

Taurine is an amino acid, obtained in meats and fish, and helps regulate water and mineral salt levels in the blood. Studies on rats suggest caffeine and taurine have a synergy, enhancing caffeine’s stimulant properties, but not enough research on humans has been done. European nations once banned Red Bull out of concern over taurine’s safety, but continued research has not shown any ill effects. Taurine is not included on the FDA’s GRAS list (generally regarded as safe). At best, taurine’s impact in energy drinks is unknown.

Ginseng

Ginseng is an herb. Traditional herbalists say it enhances mental wellbeing, boosts the immune system, and improves stamina. In energy drinks, ginseng probably won’t improve athletic performance. One study did show 200 mg of ginseng gave cognitive test-takers a mental boost, but only at that dose. Ginseng is shown to lower blood glucose and may interact with blood-thinning drugs like wayfarin, so consumers should consult their doctor before use.

Inositol

Inositol is a nutrient found in plants and animals that plays a role in brain, heart, muscle, and nerve cell functions. Insufficient evidence exists to support functional claims in dietary supplements, and quantities in energy drinks are too small to make an impact. The FDA lists it as “generally regarded as safe.”

B Vitamins

B vitamins help regulate metabolism, convert food to energy, and include thiamin, niacin, riboflavin, and cobalamin among others. They’re also believed to help maintain mental function. People get plenty of B vitamins in a normal diet, and excess is usually flushed from the system. But some amounts can be unsafe. B-6 is known to cause numbness and nerve damage in hands and feet when taken in large quantities over time. The FDA recommends 1.3 mg per day for most adults, and sets the tolerable upper limit for B-6 at 100 mg per day, but supplements often exceed that amount. (A 5-Hour ENERGY shot contains 40 mg of B-6.)

Ginkgo Biloba

Ginkgo biloba has been a favorite traditional herbal medicine for thousands of years, even though it’s not on the FDA’s GRAS list of safe ingredients. It’s taken to enhance memory and improve circulation. It can interact with other drugs and cause unwanted side effects, especially with anti-depressant medications and blood thinners. Energy drinks generally contain too small an amount to be of benefit.

L-Carnitine

L-Carnitine, a nutrient synthesized by amino acids in the body, converts food into energy, and helps move fat into cells to burn as energy. Some studies suggest it boosts metabolism, energy levels, and athletic endurance, but research is not conclusive. Most people on a normal diet produce adequate amounts, but physical stress may reduce available L-carnitine. It may cause gastrointestinal distress in some people.

Bottom line: Some of these ingredients may provide health or performance benefits, but probably not in the amounts found in energy drinks. People with health conditions or on medications should consult a doctor before consuming these substances.

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…

Caffeine Basics: Table of Contents

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

Energy Drinks Change Marketing, Not Caffeine

January 5, 2013 By Kate Heyhoe

Full Throttle has reached teens as a sponsor of the National Hot Rod Association

To recap: Energy drinks as Dietary Supplements must list caffeine as an ingredient, but not its amount, according to FDA rules. Soft drinks are not required to list caffeine at all, but the amount of caffeine cannot exceed 71 mg per 12 fluid ounces, or .02 percent.

Voluntary Caffeine Labels Deter Regulation

Caffeine amounts now appear on many soft drinks. It’s part of a voluntary, industry-wide action by the American Beverage Association. The ABA is a trade group whose members include Coke, Pepsi and manufacturers of non-alcoholic beverages, including energy drinks and tea.

By volunteering to list caffeine amounts, the beverage industry creates a win-win situation. With this information, people looking to limit caffeine consumption can choose their products, as can people seeking to increase their caffeine consumption. At the same time, beverage companies have successfully prevented mandatory government regulation.

So, the amount of caffeine in energy drinks remains unlimited, and existing regulations on cola drinks are also unchanged. The only difference is that North American consumers can now see in real numbers the amount of caffeine per serving. (The ABA move applies mainly to beverages in the U.S. and Canada, and not necessarily to other nations.) But the decision to list caffeine on a soft drink label remains entirely voluntary.

In 2o13, many energy drinks (including Full Throttle, made by Coca-Cola) switched their FDA category to food, instead of being a Dietary Supplement. As a food, these drinks now bear a Nutrition Label (not a Supplement label), which means they don’t have to list their caffeine amount.

But for some unexplained reason, these energy drinks aren’t affected by the soft drink rule, which limits caffeine to 71 mg per 12 ounces. Energy drinks with a Nutrition Facts label appear to be just as abundant in caffeine as they were when they were Dietary Supplements. And most are more caffeinated than soft drinks.

The ABA Says Caffeine Is Not a Drug. Really?

In a 2011 news release, the American Beverage Association (ABA) actually claimed “caffeine is not a drug.”

The ABA also says caffeine is a stimulant.

Conflicting statements don’t do much for credibility, and misleading statements chip away at consumer safety. Caffeine is classified as a drug, a type of central nervous system stimulant; the FDA considers it both a drug and a food additive. Naturally, the ABA has a mission to boost profits for its members. But by making caffeine confusing, beverage makers undermine the public’s ability to consume caffeine safely and responsibly.

Energy Drinks Tweek Marketing Practices

In further response to Congressional pressure and to stave off mandatory regulations, the American Beverage Association adopted other voluntarily policies specifically for energy drinks. Labels, they advise their members, should list total caffeine content, and a warning that energy drinks are not recommended for children, pregnant or nursing women and people sensitive to caffeine.

The ABA guidelines recommend:

“Labels and marketing of energy drinks should not promote the mixing with alcohol or make any claims that consumption of alcohol together with energy drinks counteracts the effects of alcohol. Energy drinks are functional beverages, which differ from sports drinks and therefore should not be marketed as sport drinks. Energy drinks should not be sold nor marketed in schools (K-12), or to children.”

A good way to see if an energy drink is marketing itself to teens, sports fans, or other groups is to visit the brand’s website. That way you can decide for yourself who the brand is targeting and whether the pitch is appropriate.

Read the Report: Congress Looks into Energy Drinks

In April 2013, three members of Congress tried to make sense of the current FDA rules on caffeinated products. To address growing concerns over energy drinks and their the marketing to children, Representative Edward J. Markey (D-MA) and Senators Richard J. Durbin (D-IL) and Richard Blumenthal (D-CT) launched an investigation into the practices of fourteen commonly sold energy drink brands. You can get this report as a PDF at this link:

Report: What’s All the Buzz About?

A Survey of Popular Energy Drinks Finds Inconsistent Labeling, Questionable Ingredients and Targeted Marketing to Adolescents
By the staffs of Congressman Edward J. Markey (D-MA), Senator Richard J. Durbin (D-IL) and Senator Richard Blumenthal (D-CT)

Caffeine Basics: Table of Contents