Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Thursday, May 30, 2013

Dietary Supplements: Energy Drinks

The most popular dietary supplement outside of a multi-vitamins are energy drinks.  Red Bull.  Monster. 5-Hour Energy. NOS. Full Throttle and many others.  According to some research there are over 500 different energy drinks on the market.  I bring up the topic of energy drinks because they are particularly popular among teens and young people and some research has shown that energy drink companies are marketing to this group.  The biggest concern connected with energy drinks is the potential for caffeine intoxication and other side effects including seizures, mania and even sudden death.  To understand the popularity of these beverages in the United States you only need to know that in 2012 the energy drink market was valued at $12.5 billion and young adults are considered the core market. 



WHAT IS AN ENERGY DRINK?
Energy drinks typically contain caffeine, taurine, sugars and sweeteners and herbal ingredients that are combined to give an “energy boost”.  These drinks are distinctly different from sports drinks and vitamin waters.  According to the National Federation of State High School Association (NFHS) Position Statement and Recommendations for the Use of Energy Drinks by Young Athletes, “An energy drink is a beverage marketed to both athletes and the general public as a quick and easy means of relieving fatigue and improving performance” usually using very high concentrations of caffeine and carbohydrates.  Energy drinks differ from sports drinks because sports drinks are designed to provide rehydration (and basic carbohydrate replacement) during or after athletic activity, containing a 6% - 8% carbohydrate solution and a combination of electrolytes formulated for maximum absorption.

Caffeine is typically the main active ingredient in any energy drink, containing 70-80mg per 8 ounce serving; energy shots can be even more concentrated.   To give you an idea, a typical energy drink contains about 3 times as much caffeine as a cola-based soft drink. The concern with energy drinks is that although the amount of caffeine (added as pure caffeine) may be listed on the ingredient label, the actual amount of caffeine in any given drink is hard to calculate. This calculation is difficult because most of these drinks include additional ingredients that contain caffeine, not reflected on the ingredient label.  Some typical additives are guarana, kola nut, yerba mate, cocoa, green tea, synephrine, and yohimbine among others.

The International Society of Sports Nutrition (ISSN) Position Stand:  Energy Drinks (2013) has published several tables that can easily help you understand the ingredient list of several common energy drinks in the United States as well as the purported effect of many of the ingredients found in energy drinks.



TEEN AND ADOLESCENT CONSUMPTION OF ENERGY DRINKS
According to some study data teens consume 60 – 70 mg/day of caffeine, mostly from soft drinks.  Caffeine consumption has ranged as high as 800 mg/day in some studies and energy drinks are becoming more and more popular.  Some research shows that drink makers are even marketing to younger consumers.  These companies are savvy and use sporting events and athlete sponsorships, along with key product placement on social media sites and in video games to connect with your kids.  Consumption rates vary, with one study finding that 28% - 34% of 12 to 24 year-olds regularly consume energy drinks,  College students were particularly prone to consuming energy drinks habitually to improve energy (usually due to a lack of sleep). 


HEALTH CONCERNS RELATED TO ENERGY DRINKS
Energy drinks can pose a risk to anyone who consumes them, with the most commonly reported symptoms centering around caffeine toxicity.  Energy drinks are not regulated by the FDA because they are considered dietary supplements (unlike soda which is limited to 71 mg caffeine per 12 oz. soda).  The FDA is currently responsible for investigating “Adverse Event” reports related to energy drinks and energy shots.  Currently there are reports regarding Monster, Rockstar, Red Bull, and 5-Hour Energy that you can view HERE.

The top 10 side effects associated with energy drinks according to a study by the Medical Journal of Australia are listed below.  These results are based on analysis of 7 years of phone calls to their poison control center.
  1. Palpitations/tachycardia (rapid heart rate)
  2. Tremor/shaking
  3. Agitation/restlessness
  4. Gastrointestional upset
  5. Chest pan/ischemia
  6. Dizziness/syncope (fainting)
  7. Paraesthesia (altered sensation)
  8. Insomnia
  9. Respiratory distress
  10. Headache

Of these, the most concerning are the cardiac symptoms.  There is a concern that caffeine toxicity in children with a cardiac condition (known or unknown) could ultimately lead to death due to sudden cardiac arrest.  Cardiac events could be especially of concern in children with ADHD, an eating disorder or those with diabetes.  There is some research (although controversial) that suggests calcium deposition in the bone is decreased in adolescents because caffeine interferes with intestinal calcium absorption. I bring this up because the adolescent years are the period of the most significant bone development

An additional concern, particularly for college age adults is the combination of alcohol and energy drinks.  Doing so often gives individuals a false sense of sobriety, leading to poor decision-making.  This topic is beyond the scope of this post, but if you’d like more information check out this article to learn more about the warning issued by the American Medical Association.


POSITION STATEMENTS AND OTHER RESOURCES REGARDING ENERGY DRINKS
Listed in this section are current position statements and other articles regarding the consumption of energy drinks with a particular focus on teen and adolescent consumption as sources allow.  I have used these sources to help inform this blog post, but I encourage you to read the full articles and position statements to gain a fuller understanding of the topic.


 Submitted by Heather L. Clemons, MS, MBA, ATC


Wednesday, May 15, 2013

Dietary Supplements 101


As the sporting landscape becomes more and more specialized and ultimately more competitive at a younger and younger age many athlete are looking to improve their performance in any way they can.  Often times this doesn’t mean just improving sports-specific skills and overall fitness through additional practice or training, it may mean considering dietary supplements as part of a daily regimen and diet.  While these supplements may be appropriate in some cases, it is important for parents to understand what their children may be taking.  The dietary supplement industry is a highly unregulated one, meaning choosing the right supplement that is proven effective can be challenging at best, in many cases.  Knowing this, what can parents do to learn more?   

As part of this post today I am going to point you to yet another position statement from the National Athletic Trainers Association:  Evaluation of Dietary Supplements for Performance Nutrition.  Obviously, the intended audience for this statement is athletic trainers who are often the first line of help with athletes who considering supplements, but much of the information is easily understood and appropriate for parents of young (high school) athletes who may be considering dietary supplements. 

According to the Federal Drug Administration (FDA) dietary supplements are defined as “products taken by mouth that contain a ‘dietary ingredient’ that include vitamins, minerals, amino acids, and herbs or botanicals as well as other substances that can be used to supplement the diet.”  These supplements can come in various forms:  tablets, capsules, powders, energy bars and liquids.  An important note regarding these supplements is that while the FDA regulates the definition of dietary supplements and labeling requirements, there is no requirement for third-party verification of the content of the supplements (meaning the purity is not guaranteed).

KEY MESSAGES:
The NATA Position Statement makes several key recommendations regarding dietary supplements.  I always encourage people to read the entire position statement, but in an effort to help you focus on what I believe to be most important, here are key messages parents should be aware of:

  • When helping your child improve their performance the first option should always be to adapt the daily diet through natural food intake rather than supplements.  The body can more effectively use naturally occurring ingredients as opposed to synthetic ones.  Nutritional recommendations are beyond the scope of this post, but finding a local sports nutritionist may useful in some situations.
  • Dietary supplements are not clearly regulated through third-party verification to assure purity.  Safety cannot be assumed because they are sold over-the-counter and in some cases athletes may risk unknowingly ingesting a banned substance.
  • Be aware of the resources available that can help you understand the actual dietary analysis of any dietary supplement that your child may use.  A list of resources is available in the appendix of the position statement.  Utilizing these resources will help ensure the safety, purity and efficacy of a given substance.
  •  If you are a parent that who likes to do research on your own be careful when looking at efficacy data regarding any given supplement since an overwhelming majority of it is done by the company who produces the supplement.  This potential conflict of interest may result in misleading efficacy information regarding that particular dietary supplement.



In the end, it is important that you gather as much information as you can before allowing your child to use a dietary supplement.  The position statement includes a decision-making algorithm that will walk you through all the important questions you should ask before making a final decision.  The appendix includes resources regarding:  1) food/nutrition, 2) regulatory information, 3) safety, 4) purity (third party verification), and 5) efficacy information and fact sheets.  Utilizing these resources should give you some comfort in your final decision.  I would always advocate that any dietary performance improvements be made through your daily food intake, but in some situations dietary supplements are a key addition.  If a dietary supplement is appropriate for your situation I encourage you to do the work to educate yourself to be sure you’re making the best choice for your specific need.

NOTE:  In a future post I will take the time to address the issue of supplement purity and the potential to test positive for a banned substance (particularly for college athletes) as I discuss performance enhancing drug (PEDs) use with athletes.  As a primer check out this information from the Taylor Hooten Foundation.

Submitted by Heather L. Clemons, MS, MBA, ATC

Wednesday, April 24, 2013

Protecting Yourself in the Summer: The Summer Sun

As summer approaches it is important to have a plan for maximizing both fun and safety.  One very important consideration is protecting your skin during all those outdoor sporting events (and days at the beach) to minimize your risk of skin cancer.  The American Academy of Dermatology (AAD) does a great job of delineating the things you can do to protect yourself from the sun, ultimately reducing your risk of skin cancer through an initiative called SPOT Skin Cancer.  The AAD uses the phrase, “Prevent. Detect. Live.” to highlight key components of how to successfully prevent skin cancer.  The purpose of this blog post today is use some of the resources provided by the AAD to familiarize you with some easy steps you can take to decrease your risk of getting a sunburn and/or skin cancer.

 Some of you may have heard the phrase, “an ounce of prevention is worth a pound of cure” and that definitely holds true when enjoying the summer sun safely.  It’s much easier to prevent sunburns and other medical concerns than it is to treat them once they happen.  So, let’s focus on the things you can do to minimize your risk. 

 
According to the AAD the keys to prevention are:

·         Seek shade when appropriate
·         Wear protective clothing
·         Wear a broad-spectrum, water-resistant, sunscreen
·         Use extra care near water, snow and sand
·         Avoid tanning beds

For those of us who are athletes (and their parents) attending day-long tournaments and events, finding enough shade can be particularly challenging.  It can be a challenge for a few reasons, not the least of which is the rules of the sport or venue design may not be set up to allow for access to shade during the athletic event.  Additionally, athletic facilities may not offer shaded areas that athletes can utilize between games or matches.  Despite these difficulties it may not be impossible to create your own shade by bringing a tarp to put over an open dugout to create shade for the team when on the bench or consider bringing a portable tent so that you can at least create some shade between games/events.  Also, you should avoid being in the sun during its peak “shining hours” of 10a – 2p, if possible.

Another recommendation that may be potentially challenging for athletes to comply with is wearing appropriate protective clothing.  This clothing can be anything from long sleeve shirts, long pants, a hat and/or sunglasses.  While some activities have uniform requirements that may coincide with these recommendations, others may not.  The one positive in all this is that clothing technology as it relates to “heat gear” and “cold gear” is very common so that there are considerably more options for athletes than previously available.  If possible (since I’m aware some of this clothing can be more expensive), it may be worth investigating the viability of covering up more when spending long periods of time in the sun, especially if sunscreen isn’t as effective as you’d like or opportunities for shade are limited.

The final recommendation I am going to address today is the use of sunscreen.  The AAD recommends the use of a broad spectrum, water-resistant sunscreen with a minimum SPF of 30.  It is recommended that you reapply at least every 2 hours, even on cloudy day.  Before I go into a bit more detail about selecting a sunscreen it is important to know that because of a recent FDA requirement the labels on your sunscreen will be changing this summer (2013).  Look for the following on your sunscreen label:

·         It will state clearly whether the sunscreen prevents sunburn and skin cancer or sunburn only.  There are two tests it must pass to state it prevents skin cancer (see the above link).
 
·         It will carry the following warning if it does not provide broad spectrum coverage and at least an SPF of 15:  “This product has only been shown to prevent sunburn, not skin cancer or early aging.”

·         The FDA will ban companies from using the term, “waterproof” or “sweatproof”.  This is not possible and you will now see the term “water resistant”.

For more information you can also check out this press release, “American Academy of Dermatology Association Welcomes New FDA Sunscreen Rules”.


It is important to know that everyone should use sunscreen, no matter their natural complexion. It should take approximately 1 ounce of sunscreen to cover the exposed areas of the body (one shot glass). 

According to a handout developed by the AAD users should select a broad spectrum, water-resistant, SPF 30 or higher sunscreen, but what does this mean? 

·         A broad spectrum sunscreen means that is protects against both UVA and UVB rays, both of which can cause cancer. 

·         A water-resistant sunscreen means that when tested it provides protection for 40 – 80 minutes.  If you will be wearing sunscreen in the water, it is especially important to re-apply, likely every hour or so, instead of two hours. 

·         The Sun Protection Factor (SPF) 30 sunscreens will block approximately 97% of the sun’s harmful rays, higher sunscreens will block slightly more, but no sunscreen is 100% effective.  Higher SPF sunscreens should also be reapplied every 2 hours or as recommended on the label, the higher SPF does not mean you can go longer without reapplying. 

In the end, wearing sunscreen is one of the best defenses against sunburn and skin cancer but, it needs to be used appropriately.  That means applying it at least 15 minutes before you go outside so that it can dry.  Reapplying at regular intervals and using enough sunscreen to maximize its effect.  More people are wearing sunscreen but, many of them do not apply enough to exposed areas to make the sunscreen maximally effective.

 


So, go ahead, get ready to enjoy the summer sun, just do it safely!  If you have additional questions about sunscreens and how best to protect yourself check out these FAQs from the American Academy of Dermatology.
 
Submitted by Heather L Clemons, MS, MBA, ATC