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FDA reports dietary supplement manufacturing violations

About half of those dietary supplement manufacturers inspected by FDA found to have manufacturing violations.

The U.S. Food and Drug Administration (FDA) has found violations in manufacturing practices in half of almost 450 dietary supplement companies it has inspected over the last four years, according to a Chicago Tribune article. The implications of these findings can have serious health problems for consumers. Since dietary supplement manufacturers are the ones responsible for ensuring a product is safe before it is marketed, the FDA inspects companies to check for compliance and takes action only if a product is deemed unsafe after it has been marketed. For more information, see the FDA website’s Dietary Supplements section.

Operation Supplement Safety (OPSS) will launch this summer, with answers to many of the questions you may have about Dietary Supplements. Watch for HPRC’s announcement coming soon.

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Alert: Dendrobium for performance?

A new dietary ingredient—a stimulant—has emerged in dietary supplement products marketed to boost athletic performance.

A new dietary supplement ingredient, dendrobium, is appearing rapidly in dietary supplement products promoted to boost athletic performance. According to the Natural Medicines Comprehensive Database, manufacturers claim that dendrobium is a natural source of the stimulant phenylethylamine, but some researchers say that phenylethylamine doesn’t occur naturally in dendrobium. Phenylethylamine is a stimulant, with effects similar to those of amphetamines. At this time, the safety of dendrobium is unknown, so users should be aware that products containing this ingredient might be unsafe, particularly when used in combination with exercise.

Operation Supplement Safety (OPSS) is about to launch this summer and will answer many of your questions about Dietary Supplements. Watch for HPRC’s announcement coming soon.

 

Tainted products widget

Alerts and health information about tainted products marketed as dietary supplements are now automatically displayed on HPRC’s Dietary Supplement page via FDA’s “widget.”

Up-to-date information on tainted products marketed as dietary supplements are now provided on HPRC’s Dietary Supplement domain page via a “widget” from the Food and Drug Administration (FDA). Recent product alerts and health information on products marketed for weight loss, sexual enhancement, and bodybuilding are automatically displayed and updated as the FDA adds new notifications. Please see this new feature by visiting HPRC’s Dietary Supplements section.

FDA Warns Companies about DMAA Safety

Marketers and distributors of products containing DMAA warned by FDA.

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.

DMAA list updates

HPRC has again updated its list of DMAA containing products. The latest news includes New Zealand’s ban on DMAA-containing products.

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.

Senator Durbin urges FDA to investigate energy drinks

Senator Dick Durbin has asked the FDA to investigate the caffeine content and other ingredients in energy drinks due to serious concerns about their safety.

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.

Introducing OPSS: Operation Supplement Safety

Watch for new educational materials about how to determine if a dietary supplement is relatively safe or not.

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.

FDA Alert: Multiple “tainted’ weight-loss products

Consumers are advised not to purchase or use these 18 weight-loss products, which contain the undeclared drug ingredient sibutramine.

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
  • Tengda
  • PhentraBurn Slimming Capsules
  • Magic Slim Tea
  • Magic Slim Weight Reduction Capsule
  • P57 Hoodia
  • Leisure 18 Slimming Coffee
  • Lishou
  • 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.”

DMAA-containing products in question

HPRC offers a list of products containing DMAA to help you make informed decisions in buying dietary supplements.

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 click on this link to directly access “Dietary Supplement Products Containing DMAA.”

Marines address boot camp injuries

Reducing injuries during boot camp is a priority for the Marine Corps; athletic trainers keep watch over recruits to ensure the 13-week training is as injury-free as possible.

The Los Angeles Times is reporting on how the Marine Corps has hired 27 certified athletic trainers—most with experience tending professional and college athletes—to oversee training for enlisted recruits and officer candidates at sites throughout the United States. According to the article, this is a new direction for the Corps: Not that long ago, the drill instructors might have dismissed recruits who complained of being injured and ordered them back into action.

To learn more about military recommendations for prevention of injuries related to physical training related, visit the HPRC’s Injury Management page and click on the link to read Recommendations for Prevention of Physical Training (PT)-Related Injuries.

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