Filed under: Risks
The Food and Drug Administration (FDA) sent warning letters to manufacturers and distributors of dietary supplements containing 1,3-dimethylamylamine (DMAA) due to lack of safety evidence provided before marketing. The FDA states that information about the safety of DMAA as a dietary supplement ingredient has not been identified. For more information, see the FDA News Release and HPRC’s latest on Dietary Supplement Products Containing DMAA.
The latest news on DMAA includes the New Zealand government’s ban just placed on DMAA-containing products. DMAA has already been declared a drug in Canada and is banned by the World Anti-Doping Agency, the United States Anti-doping Agency (USADA), collegiate sports teams, and most professional sports teams.
HPRC has again updated its list of DMAA-containing dietary supplements, including a number of additions as well as some products that have been discontinued or reformulated. The additions mostly represent lesser-known products that have been around a while, but surprisingly there are a couple new products too. And we have added two new “aliases” to the list of other names for DMAA. To download the list, click on this link to “Dietary Supplement Products Containing DMAA.”
HPRC has written about energy drinks and their possible adverse health effects; these drinks continue to be in the news following the death of a teenage girl due to caffeine toxicity from drinking two Monster energy drinks. Senator Dick Durbin has now urged the Food and Drug Administration (FDA) to investigate energy drinks, specifically to regulate caffeine in these drinks (caffeine content in colas is already regulated) and determine whether other ingredients contained in them are safe. Read the press release and Senator Durbin’s letter to FDA.
Do you buy dietary supplements when you want to lose weight, improve your performance, or give yourself a boost to get through a long day or hard workout? Then watch for this soon-to-be-released service-wide educational campaign by the Department of Defense in collaboration with the Human Performance Resource Center. Operation Supplement Safety (OPSS) will help Warfighters and their families make informed decisions when choosing dietary supplements. See HPRC’s new OPSS link for an introductory article on supplement safety.
Lately, HPRC has been receiving a lot of questions about banned supplements in the military, but the fact is, there isn’t a list of banned dietary supplements currently available. It isn’t always easy to determine whether a dietary supplement product is safe or not, so the Department of Defense (DoD) is working on an educational campaign to inform Warfighters and their families about potential health risks involved with taking dietary supplements and steps to take before choosing/using a dietary supplement. And although DoD currently has no formal policy on the use of dietary supplements, a committee is working to establish such a policy.
Some dietary supplements, including ones sold on military installations, may contain potentially harmful and problematic ingredients. HPRC has put together the resource Red Flags: What You Need to Know to Stay Safe and Avoid Fraud. Of particular note are problematic, potentially dangerous ingredients that could be red flags, including approved prescription drug ingredients and their analogs, drugs banned by the FDA for safety reasons, controlled substances (such as anabolic steroids), and untested/unstudied new active drug ingredients.
You can also learn more on how to make informed decisions about dietary supplements and natural products from the Natural Medicines Comprehensive Database (NMCD). HPRC has made this available to all active-duty personnel; a “.mil” email address is required to create an account. We encourage consumers of dietary supplements to consider only using products rated eight or above on their rating scale. These are in the green area of the scale and have evidence of safety. Items in the yellow range mean data are lacking, and the red area indicates well-known safety concerns and/or proven ineffectiveness. HPRC makes this user-friendly database readily available through links on its website for both Warfighters and healthcare professionals. Choose the appropriate version and follow the instructions to create an account.
Generally, if a supplement is not banned or recalled by the FDA, FTC, or DEA, then it is not banned by DoD. One way to ensure that a dietary supplement product is safe is to see if it is third-party verified. Third-party certification organizations have developed criteria for evaluating and authenticating the quality of a supplement—the ingredients, the dosage levels, the level of contaminants, the label claims, and whether the manufacturing facilities follow Good Manufacturing Practices (GMP). Currently, United States Pharmacopeia (USP) and NSF International conduct safety reviews, and NSF screens for substances banned by the World Anti-Doping Agency (WADA) or United States Anti-Doping Agency (USADA). Multiple professional sport/athletic organizations—including MLB, NHL, NBA, NFL, and NCAA—currently have policies requesting the use of NSF-certified products only. Shop for products with seals from USP and NSF International.
We encourage you to talk with your healthcare provider or dietitian before using dietary supplements to avoid potential problems. Also, see FDA’s list of tainted body building products, which includes important public notifications.
HPRC recently posted a list of dietary supplement products containing DMAA. Since we originally posted this list at the end of December, some changes have occurred that deserve note. Some products are no longer available on the manufacturer’s websites, while others appear to have been reformulated to eliminate DMAA from their recipes. To download the updated list, go to the Dietary Supplements Resources page under the “Resources” tab, or just click on this link to directly access “Dietary Supplement Products Containing DMAA.”
The Food and Drug Administration (FDA) is advising consumers to stop using multiple weight-loss products that contain the undeclared drug ingredient sibutramine, which was removed from the market in 2010 for safety reasons and may present significant risks for those with coronary artery disease and other heart issues. The following 18 products have received FDA Public Notifications advising consumers not to purchase or use any of them:
- Lose Weight Coffee
- Dream Body Slimming Capsule
- Pai You Guo Slim Tea
- Botanical Slimming
- Fruit Plant Lossing Fat Capsule
- Sheng Yuan Fang
- Acai Berry Soft Gel ABC
- PhentraBurn Slimming Capsules
- Magic Slim Tea
- Magic Slim Weight Reduction Capsule
- P57 Hoodia
- Leisure 18 Slimming Coffee
- A-Slim 100% Natural Slimming Capsule
- Advanced Slim 5
- Ja Dera 100% Natural Weight Loss Supplement
- Slender Slim 11
For more information, see the FDA Tainted Weight Loss Products page, and click on a product name under “Public Notifications.”
Dietary supplement products containing DMAA have been temporarily removed from military stores by the AAFES, but they are still available on the public retail market. HPRC has prepared a list of many of these products to help you watch for them if you are considering the purchase of dietary supplements. DMAA is found most commonly in products sold for bodybuilding or weight loss, but it can also be found in other performance-enhancing products, as well as in recreational party pills. The list also includes other names for DMAA that may be found on product labels. To download the list, go to the Dietary Supplements Resources page under the “Resources” tab, or just
Due to concerns about possible serious adverse health effects, the Department of Defense (DoD) has put a medical hold on the sale of weight-loss and bodybuilding products containing 1,3-dimethylamylamine (DMAA), also referred to as methylhexanamine, Geranamine, and geranium oil, extract, or stems and leaves, from military exchanges.
An extensive investigation will take place to determine the safety of DMAA in dietary supplement products, as well as an educational campaign to assist Warfighters and their families in making informed choices.
For more information, please see the Question and Answers fact sheet by the Directorate of Strategic Communications, Office of the Surgeon General.
The Army and Air Force Exchange Service (AAFES) has temporarily removed products containing 1,3-dimethylamylamine (DMAA), also referred to as methylhexanamine, Geranamine, and geranium oil, extract, or stems and leaves from its stores. DMAA is increasingly being associated with serious adverse events. For additional information about the recent AAFES decision, read the Stars and Stripes article. We have also put together a list of products containing DMAA carried by AAFES for your information.
A list of products containing DMAA carried by AAFES (to include GNC) includes:
USPlabs Jack3d (Tropical Fruit and Lemon Lime)
USPlabs OxyELITE Pro
Nutrex Research Lipo-6 Black (his and hers)
Nutrex Research Lipo-6 Black Ultra Concentrate (his and hers)
Nutrex Research Hemo-Rage Black Powder, Punch, Berry
Fahrenheit Nutrition Lean EFX
Muscle Warfare Napalm
SNI Nitric Blast
BIORhythm SSIN Juice
MuscleMeds Code Red
SEI MethylHex 4,2
Gaspari Nutrition Spirodex