The FDA has issued a warning for US consumers that “dietary supplements containing a stimulant called dimethylamylamine (DMAA) are no longer distributed and available for sale to consumers in the marketplace.”
Here is the warning in full:
“The Food and Drug Administration (FDA) is using all available tools at its disposal to ensure that dietary supplements containing a stimulant called dimethylamylamine (DMAA) are no longer distributed and available for sale to consumers in the marketplace.
The ingredient, DMAA, is most commonly used in supplements promising weight loss, muscle building and performance enhancement; it can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest. Given the known biological activity of DMAA, the ingredient may be particularly dangerous when used with caffeine.
As of April 11, 2013, FDA had received 86 reports of illnesses and death associated with supplements containing DMAA. The majority are voluntary reports from consumers and healthcare practitioners. The illnesses reported include heart problems and nervous system or psychiatric disorders. Note, however, that a report is not proof that the product actually caused the problem.
FDA has warned companies known to be using DMAA in dietary supplements that those products containing this ingredient are illegal. Such warnings offer the quickest way at FDA’s disposal to halt the further distribution of dietary supplements containing DMAA in the marketplace. In fact, all but one of the companies sent a Warning Letter have agreed to stop using DMAA as an ingredient in their dietary supplements. The one company that has yet to agree to such action, USPLabs, has responded to FDA’s warning by submitting published studies that purport to challenge FDA’s conclusions.
However, after reviewing the studies provided by USPLabs, FDA has found the information insufficient to defend the use of DMAA as an ingredient in dietary supplements. FDA is finalizing a formal response to the firm to reflect its findings, according to Daniel Fabricant, Ph.D., director of FDA’s Division of Dietary Supplement Program.
FDA’s authority over dietary supplements is very different from its authority over drugs and other medical products. FDA is required to undertake what are usually lengthy scientific and legal steps in order to force the removal of dietary supplements that may be unsafe or are otherwise illegal if companies don’t voluntarily comply.
As FDA continues the process needed to get DMAA off the market, the agency is urging consumers to check labels and avoid any dietary supplements containing DMAA, which is referred to on different product labels by 10 possible names. The alternatives are listed at FDA’s DMAA web page.”
Additional FDA information on DMAA:
“DMAA, also known as 1,3-dimethylamylamine, methylhexanamine or geranium extract, is an ingredient found illegally in some dietary supplements and often touted as a “natural” stimulant. DMAA, especially in combination with other ingredients such as caffeine, can be a health risk to consumers. Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems ranging from shortness of breath and tightening in the chest to heart attack. Dietary supplements containing DMAA are illegal and FDA is doing everything within its authority to remove these products from the market. FDA has issued warning letters to companies notifying them products with DMAA need to be taken off the market or reformulated to remove this substance. Most companies warned are no longer distributing products with DMAA. While FDA is working to get these products off the market, consumers should not buy or use any dietary supplement product containing DMAA.”
Questions & Answers
What is DMAA?
DMAA (1,3-dimethylamylamine) is an amphetamine derivative that has been widely used in sports supplements sold in the United States. Also known as methylhexanamine or geranium extract, DMAA is often touted as a “natural” stimulant, with many claimed functional uses including a body-building aid, an athletic performance enhancer, and a weight-loss aid. Although DMAA at one time was approved as a drug for nasal decongestion, no medical use of DMAA is recognized today. FDA is not aware of any reliable science indicating that DMAA exists naturally in plants.
DMAA-containing dietary supplements are illegal and their marketing violates the law. Based on the scientific information reviewed by FDA, DMAA is not a dietary ingredient.
Is it safe to consume DMAA?
No, FDA does not have any information to demonstrate that consuming DMAA is safe. FDA is very concerned about DMAA and we advise consumers not to purchase or use any dietary supplement containing DMAA. This substance narrows blood vessels and arteries, which can elevate blood pressure, and may lead to cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack, as well as seizures and other neurological and psychological conditions. FDA has received 86 reports of adverse events involving products containing DMAA. These events include psychiatric disorders, heart problems, nervous system disorders, and death.
How does FDA regulate ingredients in dietary supplements like DMAA?
The law requires companies to notify FDA when they intend to market a dietary supplement containing a New Dietary Ingredient (NDI) in the United States, if the NDI has not been used in the food supply in the same chemical form. An NDI is a dietary ingredient that was not marketed in a dietary supplement prior to October 15, 1994. Unlike drugs, dietary supplements do not have pre-market approval for safety or effectiveness. If a safety issue arises post-market, FDA can investigate and take steps to remove products that may be unsafe from the market. However, in order for FDA to ban a compound in a dietary supplement, FDA is required under the statute to undertake a series of lengthy scientific and legal steps. In the interim, FDA can take direct action by issuing warning letters to industry to obtain removal of ingredients in dietary supplements and protect the public from potentially harmful products. FDA can also take a seizure action to remove products from the market or obtain an injunction against a company to prevent it from manufacturing and distributing illegal products.
What is FDA doing to remove DMAA-containing dietary supplements from the market?
FDA sent warning letters to a total of 11 companies advising them that DMAA-containing products marketed as dietary supplements are illegal and must be taken off the market or reformulated to remove DMAA. These 11 companies account for most of the DMAA products sold in the United States. This action was taken to protect consumers and get these products off the shelves as quickly as possible. To date, all but one of the companies warned by FDA have agreed to stop marketing products with DMAA. FDA is in communication with the one remaining company to bring the issue to closure. FDA is also sending its investigators to the companies that agreed to reformulate or remove DMAA to verify that they have taken the appropriate action. Six companies have been visited so far. Five of the companies were in compliance and the sixth company, which was not in compliance, agreed to recall their product after discussions with FDA.
Why hasn’t the FDA banned this ingredient, especially after the U.S. military took it off their shelves?
The U.S. military initiated a temporary hold on the sale of DMAA-containing products in military exchanges. The law requires FDA to follow certain lengthy steps before the agency can ban dietary supplements containing DMAA. FDA has been working to remove dietary supplements containing DMAA from the marketplace and we will continue to look at all regulatory and legal options to bring companies into compliance and protect consumers.
How do consumers know if a dietary supplement contains DMAA?
Consumers should look for DMAA listed on the product label. It may also be listed as:
- 4-methyl- (9CI)
Some products also will list Pelargonium graveolens extract or Geranium extract, which may indicate that the product contains DMAA.
What should consumers do if they believe they’ve been harmed by consuming DMAA?
Consumers can report incidents directly to FDA. See Dietary Supplements – Report an Adverse Event2.
Consumers can also report these adverse events to the company whose name and contact information is on the product label.
In addition, consumers should contact their health care practitioner if they have suffered or are still being affected by an adverse event.”
For decades, we believed that we were doing the healthy thing by taking calcium supplements to help prevent osteoporosis in our old age. Then a published report in the
British Medical Journal stated that calcium supplements do more harm than good. The researchers concluded that calcium supplements cause more heart attacks than it prevents in broken bones from osteoporosis.
Does this mean that we should dump our calcium tablets and reduce our calcium intake in the foods that we eat? Well, not so fast!
The real story behind osteoporosis, calcium intake and heart disease is a little more complicated than what many in the medical field are indicating. The real problem is not calcium supplements, but taking calcium supplements by themselves. Consuming calcium by itself can have bad health consequences, but taking calcium with its essential co-factors has many beneficial health results.
Vitamins and Minerals Require Co-factors.
As it turns out, calcium requires many other vitamins and minerals to allow it to build up our skeletal system without calcifying our muscles, arteries, joints, heart and kidneys. Take calcium without its co-factors and you start solidifying your body with hardened calcium deposits, and risk having a heart attack. But take calcium with its co-factors, and you provide your body with an essential mineral for optimum health as you age.
What are calcium’s co-factors?
Published research results on rats show that the least amount of bone loss occurs when rats are fed sufficient amounts of calcium along with vitamins K2 and D during their entire life span. But we also know that magnesium is required to activate vitamin D. So the major co-factors of calcium are
- Vitamin D3
- And Vitamin K2
Science is still trying to determine the role of vitamin K2 in bone health, but we know for sure that vitamin D is required for proper calcium utilization, and magnesium is required to activate vitamin D. We also know that magnesium plays an important role in making sure that calcium doesn’t calcify the tissues and organs throughout our body.
Other studies also have shown that manganese, vanadium, boron, silica, zinc, and copper in trace amounts are also important for bone health.
Taking calcium supplements without its essential co-factors can have negative health consequences. But with its essential co-factors (especially magnesium), calcium supplements can play an important role in preventing osteoporosis.
Is There a Problem With Calcium Supplements or Is It Magnesium Deficiency?
The big problem occurs when we take vitamin D with calcium supplements. It’s true that vitamin D is needed for proper absorption of calcium, but vitamin D also depletes our body of magnesium. That’s because vitamin D uses magnesium to transform itself into a usable form. So the more vitamin D we take, the faster we deplete our bodies of magnesium.
Then as we deplete our bodies of magnesium, calcium starts to calcify our muscles, tissues and joints, which in turn increases our risks of arthritis and heart attacks. And that’s because magnesium is needed to prevent calcium from forming plagues throughout our body. It’s becoming more obvious that magnesium is the real key to preventing calcium from causing medical problems. It’s important for the activation of vitamin D to absorb calcium, and it’s important to prevent calcium from forming health threatening plagues.
Are Calcium Supplements Safe?
Taking calcium supplements without magnesium and other co-factors is not safe. It can lead to calcification of muscles, joints, and organs, which in turn can lead to kidney and heart problems. But with sufficient amounts of magnesium and other co-factors, calcium supplements can maintain bone health and prevent osteoporosis.
So instead of throwing away your calcium supplements, make sure that you also are getting sufficient amounts of magnesium and vitamin D3 to properly utilize calcium. You should also consider taking vitamin K2 supplements to minimize bone loss as you age. The other minerals that are needed in trace amounts for good bone health can be found in most multi-vitamins, mineral water and raw sea salt.
All minerals and vitamins can’t function properly in our bodies alone. They all need co-factors to be properly utilized. Calcium is no exception. For calcium to do its job of maintaining bone health and preventing disease like osteoporosis, it needs magnesium, vitamin D3 and vitamin K2 at the very least.
But most of all, never take calcium or vitamin D supplements without sufficient amounts of magnesium to accompany them. Magnesium takes calcium out of the blood and soft tissues and puts it back into our bones. By putting calcium back into our bones where it belongs, magnesium prevents calcium from forming hard, calcified plagues in our circulatory system and tissues that can lead to arthritis, heart attacks and kidney stones. We should try to get at least 500 mg of elemental magnesium in our diet daily to properly utilize calcium in our bodies.
Of course, you can also get natural magnesium from foods. According to the
Office of Dietary Supplements, some selected foods that are high in magnesium content are wheat bran and germ, almonds, spinach, cashews, legumes, nuts, oatmeal, peanuts and peanut butter, brown rice, bananas, avocados and yogurt and milk.
Magnesium Is Crucial for Bones
Vitamin D Council:
Vitamin D Cofactors
University of Maryland:
University of Maryland:
Harvard Medical School:
High Calcium Intake From Supplements Linked to Heart Disease in Men
Effects of Vitamin K2, Vitamin D, and calcium on the bone metabolism of rats in the growth phase
I remember my older relatives not sleeping well when I was young. They easily woke early. Rustled in bed often. Now that I’m that older relative, I understand why they had a hard time sleeping. It’s easy to wake 2 or 3 in the morning with your mind worrying about something. Perhaps you just don’t feel well, or you’re just not very tired. Not very tired, that is, until the next afternoon. Then I can hardly keep my eyes open.
We Sleep Less And Less Well With Age
We tend to believe that sleeping less and less well is just a part of growing older.
It is true that as we age, we may need less sleep. Older adults tend to function just fine with 7 to 8 hours of sleep, while younger adults need closer to 9 hours. It is also true that we experience more fragmented sleep as we age, and we have poor regulation of sleep patterns due to the decrease in natural melatonin levels in our bodies. Many times this means that we seniors get less deep, restorative REM sleep. We get lower quality sleep.
It is the reduction in the quality of sleep, however, that can develop into serious health problems.
Consequences of Poor Sleep
Sleep problems at any age shouldn’t be taken lightly. There are health and safety consequences of poor quality sleep.
Insufficient sleep can lead to disease risks. According to the Division of Sleep Medicine at Harvard Medical School, consistently getting inadequate sleep can increase your risk of developing chronic diseases.
- Sleeping less than 6 hours each night produces hormonal changes in your body that increases your risk of becoming obese. Less sleep increases your level of insulin, which is associated with weight gain. Your body also produce less leptin, which suppresses your appetite, while making more ghrelin, which stimulates your appetite. This results in increased food cravings even though you’ve had adequate amounts of calories to sustain life and health.
- Inadequate sleep increases your risk of developing type 2 diabetes.
- Sleep less than you should, and you increase your chances of developing hypertension and heart disease.
- People who sleep less than the recommended amount have a more difficult time fighting off common diseases, like colds and flu.
- Sleep 5 hours or less each night, and you increase your risks of death by 15%.
Then there is the safety risks of poor quality sleep. Did you know that investigators claim that sleep deprivation played significant roles in the 1979 Three Mile Island and 1986 Chernobyl nuclear accidents? They also believe that sleep deprivation played important roles in the Exxon Valdez accident in Alaska, and the 1986 Challenger space shuttle explosion.
If you don’t get enough quality sleep, you’ll not function mentally as well as you should. And sometimes, lives are lost.
Is Prescription Medication The Answer To Poor Quality Sleep?
You’ve probably heard the sleepwalking, sleepdriving stories concerning Ambien. The most famous being Kerry and Patrick Kennedy having driving mishaps while under the influence of that drug. They’re not alone. There are many stories of people eating, talking on the phone, walking and driving while on Ambien, and not remembering doing any of those things.
And there is the potential of these drugs to have addictive properties. Even though Ambien is not considered addictive if taken as prescribed, people are starting to overuse the drug. Unfortunately, people take more of the drug than they should to relieve rebounds in anxiety as the drug wears off. This often leads to abuse.
Even though these drugs are good at making you unconscious, acting on a subconscious level without remembering it, drug abuse and side effects are good reasons to stay away from prescriptions drugs as sleep aids.
Are There Natural Sleep Aids?
An ideal solution to obtain better sleep is to find something that is a natural sleep aid without the dangerous side effects of manufactured drugs. Not only natural, but perhaps a chemical that is manufactured by your own body to help you sleep.
GABA may be that ideal and natural sleeping aid. In fact, one of the primary causes of poor quality sleep could very well be a GABA deficiency.
What is GABA?
GABA is an inhibitory neurotransmitter in your brain that counteracts other brain chemicals that keep your brain alert. Called gamma-aminobutyric acid, it helps your brain relax. It is an important ingredient in your sleep cycle that allows you to go into deep REM sleep. Without it, you may experience fragmented, restless sleep. It is possible that age related sleep problems may be associated with a deficiency in GABA.
Your brain produces its own supply of GABA. In the early stages of sleep, GABA is normally released to shut your brain down. Without it, you’ll be deprived of deep, restful sleep. And as we age, our brains may be producing less of this neurotransmitter that is essential for high quality sleep.
Many believe that GABA supplements, however, are ineffective since this chemical can’t pass through the blood-brain barrier. This natural barrier allows beneficial components of blood to enter your brain, but not other components that nature deems unsafe. Your brain is thus protected from foreign substances, hormones and neurotransmitters.
Innovative chemists have developed GABA analogs, which are able to pass through the blood-brain barrier. Chemical analogs are molecules that are similar to the original, but slightly different to overcome some chemical obstacle. These analogs are thought to mimic GABA in your brain. Phenibut is one GABA analog that can be found in health supplement stores. I haven’t tried it myself, but many claim that it provides relaxation and restful sleep. Several drawbacks is that Phenibut is pricy and is still a manufactured drug.
Even though Phenibut may work well to provide high quality sleep, are there ways to naturally entice your own body to make more GABA?
How To Naturally Increase GABA Levels In Your Brain
Valerian root has been used for millennia as a remedy for anxiety and insomnia. It is not known how this root works, but scientist think it may increase GABA levels in your brain. It is slow acting, however. It probably will take 2 to 3 weeks for you to feel any beneficial effects. If you are patient, valerian root will probably improve your quality of sleep over time, as some scientific studies have shown.
Yoga exercises are another way to increase your brain’s level of GABA. A study published by the Boston University School of Medicine concluded that GABA levels increased by 27% following a 60-minute session of yoga. On top of that, yoga is a good form of exercise.
These methods of increasing GABA levels in your brain may not be as convenient as popping a pill. Both valerian and yoga also may not give you the instant gratification that you seek, since they both slowly increase GABA levels. However, you won’t experience dangerous side effects with these two methods, and the results may be longer lasting.
It is true that you need less sleep as you age. However, you still need at least 7 to 8 hours of sleep to stay physically and mentally healthy. Not just any sleep, but deep, high quality REM sleep.
Prescription drugs do put you to sleep, but come with a lot of unwanted side effects. Some of these side effects even involve sleepwalking, driving and eating while still under the influence of the drug. Not only that, but prescription drugs may not be putting you into that deep, high quality REM sleep that you need.
Many of you may be getting fragmented, poor quality sleep due to an deficiency of the inhibitory neurotransmitter GABA in your aging brain. Unfortunately, GABA supplements probably don’t work since GABA can’t pass through your blood-brain barrier – at least not easily. There is a chemical analog of GABA called Phenibut that may help you relax and get deep REM sleep. It’s a little pricey and is still a manufactured drug. If you’re a little patient, you can slowly increase your brain’s GABA levels with valerian root and yoga exercises. The good point of these last two options is that they are natural sleeping aids with few side effects.
But there is still another option that I find effective – glycine. For now, I will leave the discussion of that option to Part 2: Natural Sleep Aids – Glycine.
Harvard Medical School:
Consequences of Insufficient Sleep
GABA and Sleep
GABA Supplements that pass the blood-brain barrier
Kerry Kennedy Crash Raises Questions About Ambien Use
Can You Become Addicted to Ambien?
Ambien Sleep Walking Turned Me Into a Midnight Binge Eater
Are Sleep Problems Normal as We Get Older?
Neuroscience For Kids:
The Blood Brain Barrier
University of Maryland:
Yoga Asana sessions increase brain GABA Levels
The good news is that there is no connection between calcium supplement and heart disease in women, and there is no connection between calcium from food and heart disease.
The problem for men is when we take more than 1,000 mg of calcium in the form of a supplement. If we men do that, we are 20% more likely to suffer heart disease compared to men who don’t take calcium supplements. This is the conclusion of evidence that comes from the
NIH-AARP Diet and Health Study that has followed the health of almost 400,000 men and women since 1995.
This study was not a randomized study, which means that there could be other factors other than calcium supplements that may explain the increased risk of heart disease. However, there are also other studies being conducted that are showing a concern about calcium supplements and heart disease in men.
The bottom line is that it is much healthier for men to get our calcium from food rather than from supplements.
USDA National Nutrient Database for Calcium provides an excellent list of foods that have naturally occurring calcium in real food. Excellent food sources of calcium are low fat milk and yogurt, soymilk, dark green leafy vegetables like spinach and sardines packed with their bones.
The problem with calcium is when it is not completely absorbed into the bloodstream, and starts to calcify organs (kidney stones), joints (arthritis) and arteries in the form of arterial plague. The medical community and the mineral supplement industry, unfortunately, does not stress enough that calcium must be balanced with magnesium. One of the functions of magnesium in our body is to keep calcium from calcifying our tissues, arteries and joints.
Again using the
USDA National Nutrient Database for Magnesium shows that buckwheat, oat bran, whole grain wheat, spinach, pumpkin seeds, black beans and nuts are excellent sources of magnesium. If you can’t get enough from foods, try a magnesium supplement. Magnesium chloride is considered by some to be the most bio-available. Dr. Carolyn Dean, MD – author of the book “The Magnesium Miracle” – takes magnesium in the form of magnesium citrate and magnesium taurate. Magnesium oxide is less absorbable, but is widely available and inexpensive.
For men, it is best to stay on the side of caution and try to get our daily calcium needs from food. And as an added caution, taking a magnesium supplement will help prevent even natural forms of calcium from causing medical problems with our heart, kidneys and bones.
Harvard Health Publications:
High Calcium Intake From Supplements Linked to Heart Disease in Men
Dr. Carolyn Dean, MD:
The Magnesium Miracle
When I was younger, I noticed that some of my older relatives did not sleep as much as the younger folk. After I turned 50, I too started to sleep fewer hours at night. As it turns out, this is not an uncommon problem with seniors.
According to the National Sleep Foundation, older people tend to have a more difficult time falling and staying asleep than younger people. In some cases, this problem can lead to sleep deprivation. And sleep deprivation can lead to other health problems like
- cardiovascular disease
- memory loss
- and depression.
Like most, I tried all types of concoctions to have a better night’s sleep. None really worked all that well. Melatonin did make me drowsy enough to fall asleep, but I still woke up in the middle of the night unable to get a full night’s rest. It is also a bad idea to overdose with melatonin. Some side effects of melatonin are daytime sleepiness, dizziness and headaches.
Then I heard on the Dr. Oz Show that the amino acid glycine helps careate positive changes in the brain wave patterns that are associated with deep non-REM sleep. It promotes a deeper and faster sleep without causing the foggy morning hangover feeling associated with most drugs and some other natural sleep aids.
According to a study by the Frontier Research Labs in Japan, test patients given glycine, showed significant reduction in fatigue and sleepiness during the day. The study on humans concluded that glycine improves sleep quality without negatively affecting daytime performance. It actually improved the symptoms of sleep deprivation.
So I gave it a try, and I’m a believer. I definitely sleep much better, and feel more refreshed and energetic during the day. I now take one serving of glycine powder about one hour before bedtime. I fall asleep quickly, and get a full night’s rest.
If you prefer, you can increase your blood’s glycine levels by drinking chamomile tea. Chamomile is an European flower in the daisy family. A study funded by Oxford Natural Products showed that chamomile tea increased the urinary levels of glycine. And glycine levels remained elevated for two weeks after test subjects stopped drinking the tea.
I think that chamomile is one of the better tasting herbal teas. I also like the aroma of the tea. Just like the glycine powder, drink some chamomile tea about one hour before going to bed. Sometimes I put a small amount of glycine in the chamomile tea, which gives it a sweet taste. I really get a good night’s sleep when I combine the two.
Give it a try like I did. Either take some glycine or drink the chamomile tea, and get a good night’s rest. You will feel much better the next day. I do.
Chamomile Tea: New Evidence Supports Health Benefits
US National Library of Medicine:
The effects of glycine on subjective daytime performance in partially sleep-restricted healthy volunteers
Dr. Oz Show:
Natural Prescription Alternatives
National Sleep Foundation:
Aging and Sleep
Is Melatonin a Helpful Sleep Aid