Archives for January 2013

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

Flavor-Enhancer Myth: Colas Get a Pass

January 5, 2013 By Kate Heyhoe

Coke claimed caffeine was a flavor enhancer

The FDA almost banned caffeinated soft drinks in 1980. But Coca-Cola and its rivals successfully argued that caffeine was merely a flavor enhancer – not a drug. The FDA agreed to allow caffeine in soft-drinks if it didn’t exceed .02 percent, or 71 mg per 12 fluid ounces. In addition, caffeine was not required to be listed as an ingredient.

But does caffeine really enhance the flavor of soft drinks?

In 2011, researchers suspected that caffeine was being added to beverages for other reasons. “The majority of people cannot taste the difference between caffeinated and non-caffeinated soda,” said the author of the study, Dr. Jennifer Temple. The team tested whether over time, teens would prefer caffeinated beverages over comparable non-caffeinated ones.

Teens repeatedly sampled various unfamiliar soda drinks and rated their likings of each. The sodas contained different amounts of caffeine. Over time, participants increased their liking of soda with the highest caffeine levels. But there was no change in preference for soda with low or no caffeine. Plus, the amount of caffeine made a difference: the more caffeine a soda contained, the more teens liked the beverage. Dr. Temple concluded that caffeine in sugary carbonated beverages teaches adolescents to prefer those beverages.

So caffeine may be the secret ingredient that brings people back to a product – again and again and again – but not because it enhances flavor, as soda companies claim.

This raises the question of whether caffeine is addictive, or at the very least, habit-forming – a topic to come in Chapter 8: Your Pattern: Habit, Safety, and Addiction.

Caffeine Basics: Table of Contents

Future Regulations for Energy Drinks

January 5, 2013 By Kate Heyhoe

What if “energy drinks” were renamed “caffeinated beverages”?

Imagine this: You’re pushing your cart down the energy drink aisle, shopping for a can of Full Throttle Energy Drink. You almost walk right by it, before you realize, it’s there – but the label is completely different. In fact, all the energy drinks look different. They’re now called “caffeinated beverages” and you can’t find the word “energy” on any of them. Plus, they’ve got all sorts of new warnings on them:

Not recommended for children, pregnant or lactating women, persons sensitive to caffeine and sportspersons. Do not drink more than two cans per day. May not contain more than 320 mg of caffeine per liter.

You’re not dreaming. You’re also not in the U.S., or the western world. You’re in India.

International Warnings on Energy Drinks

In June 2012, India’s national health agency cracked down on “energy drinks.” Once the changes go through, energy drinks will be renamed “caffeinated beverages.” After deliberating for two years, the Food Safety and Standards Authority of India (FSSAI) took a stand on highly caffeinated drinks, stripping them of the “energy” tag, and adding safety warnings similar to ones on tobacco products. The products will also be banned from making any nutritional claims.

Energy drinks are causing a global regulatory stir. A handful of countries ban energy drinks, but most countries (including the U.S.) are still figuring out what to do. Policies are being reviewed and rewritten. The most common solution puts an upper limit on caffeine and adds warning labels to the can. In Australia, for instance, energy drinks must not contain more than 320mg/L of caffeine. Labels must disclose the amount of caffeine contained, with a statement that the product is not suitable for children, pregnant or lactating women.

The European Union stipulates that products containing more than 150 mg/liter of caffeine bear a warning of “high caffeine content” followed by the amount of caffeine contained.

France once banned Red Bull, but not because of caffeine. The safety of taurine, an added ingredient, was once considered questionable, but health-risks were never definitively proven. So today, Red Bull is sold in France and throughout the European Union.

Conclusion

What’s driving extreme caffeine consumption?

Marketing and new products. “Virgin” segments of consumers – ones that aren’t yet caffeine consumers – are prime targets. Additionally, FDA rules permit both extreme caffeine products and marketing to all age groups.

We tend to think that more is better, but that’s not the case with biphasic drugs. Caffeine is a biphasic drug; it has different effects at low doses than high ones, and adverse effects occur generally at higher doses. Most experts agree that caffeine is safe in moderate consumption for most people. Dietary supplement rules allow energy drinks, shots, and other extreme caffeinated products to push caffeine levels higher.

Caffeine is safe in low doses, but high doses are risky

Here’s the problem: People can’t tell how much caffeine they’re consuming if the label doesn’t list the amount. High doses of caffeine can be risky, even for healthy individuals. Kids are especially vulnerable, including teens with heart conditions. Today’s products make caffeine fashionable to young users; and the suggestion of danger makes extreme caffeine deliciously wicked to some kids.

Caffeine overdose happens. It’s not always lethal, but it has become more frequent since extreme caffeine products arrived. Emergency rooms treat young people with reactions triggered by caffeine or large amounts of alcohol and caffeine. The untamed market for energy drinks continues to grow, especially among young, new customers – but some countries are pushing back with consumer labeling and other restrictions.

In the U.S., the FDA prefers voluntary industry restraint over federally mandated laws. Especially when a substance like caffeine is widespread and also found naturally in coffee, tea, chocolate, and guarana.

But consumer complaints and lawsuits regarding energy drink safety are mounting rapidly. At the same time, the American Beverage Association is a powerful lobbying group, whose members make everything from soft drinks, to tea, to energy drinks. Ultimately, the FDA may have a long push-pull battle with the ABA over marketing tactics and labeling, rather than restricting the amount of caffeine in products themselves.

Chapters 10 and 11 explore what doctors say about caffeine in young people, children, and adults.

Caffeine Basics: Table of Contents

6. Making Caffeine Work for You

January 6, 2013 By Kate Heyhoe

Be the caffeine-consumer you want to be. The next six chapters explore caffeine’s effects – so you can decide just what sort of relationship you want to have with caffeine.

Should caffeine be a take-it-or-leave-it acquaintance? A team player? A friend with benefits? A marriage partner to wake up with every morning? Or is your relationship with caffeine doomed, a heart-breaker that will never work? Perhaps you keep caffeine’s number on emergency speed dial, like the AAA tow truck that only shows up when your car breaks down.

Outdated research studies have clouded people’s understanding of how caffeine works, so these chapters focus on clearing up myths and misconceptions. Caffeine can be a great friend, or for some, it can be a foe. But for most of us, caffeine offers safe and attractive features, when taken in low to moderate doses.

Much Depends on You

The intensity of caffeine’s effects largely depends on you: your chemistry, your age, your sex, how your brain is wired, and your genes – which help determine if you’re a slow or fast metabolizer.

Why do people respond so differently to caffeine? Or conversely, why do people respond so similarly? Given that 90 percent of the world now consumes caffeine every day, this chapter poses the questions: Why is caffeine so important to humans? Is it good or bad for us?

Chapter 7, which follows this chapter, covers caffeine’s half-life, the length of time caffeine stays in a person’s system, and its biphasic nature, meaning low and high doses produce drastically different effects (more is not better). So if you want you want to skip ahead and then return to this part, that’s fine. The information in both chapters goes hand-in-hand.

Coming up: Is caffeine an evolutionary tool in the human toolbox?