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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.”

Get the latest scoop on multivitamins

New multivitamins/minerals fact sheets for consumers and health professionals are now available from the Office of Dietary Supplements.

The Office of Dietary Supplements has released new fact sheets on multivitamin/mineral supplements. The QuickFacts version was designed for consumers; health professionals and those who want to know more can get additional detailed information from the Fact Sheet.

What is Supplement Safety Now?

Supplement Safety Now is a public safety initiative to help consumers know if an OTC supplement is safe to use.

A myriad of dietary supplements make their way to the market labeled as “healthy” for the public. However, many contain dangerous substances, including steroids, and consumers have no idea they are taking harmful substances. Supplement Safety Now, a public protection initiative, was founded by the U.S. Anti-Doping Agency to make sure over-the-counter supplements are safe for consumers. For more information, read more about this initiative.

Omega-3 food sources

Find out what food sources contain omega-3 fatty acids.

Salmon is commonly touted for its omega-3 fatty acids. HPRC recently received a question about what foods other than salmon are the best sources of omega-3 fatty acids. For a complete answer, including the recommended intakes from the American Heart Association, please see HPRC’s answer.

Reporting adverse events associated with dietary supplement use

Reporting adverse events from dietary supplement use is essential for determining the safety of available products and ingredients.

Many adverse events associated with dietary supplement use go unreported. HPRC has developed one page information resources on how to report adverse events. Warfighters and their families can follow the directions for reporting adverse events to MedWatch (FDA) and Natural Medicines Watch. In addition to these sites, Health care providers can follow step by step directions for reporting via AHLTA.

Consider the side effects before using Apidexin.

Before trying to slim down with weight loss supplements, consider the potential side effects. Some could seriously impact your health.

Apidexin is a weight-loss supplement that contains vitamin B12, chromax (a form of chromium), and a proprietary blend of various ingredients. One of the ingredients is guggul, which has been associated with side effects such as headaches, nausea, vomiting, diarrhea, skin reactions, and more. Other ingredients in Apidexin with known side effects are Irvingia gabonensis and DiCaffeine Malate. Both been associated with headaches and difficulty sleeping, and the latter also can increase heart rate and raise blood pressure. And keep in mind that there’s no data on how all of these ingredients might act together. For more detailed information, read HPRC’s Answer to a recent question about the side effects of Apidexin.

More on Jack3d and OxyElite Pro

Jack3d and OxyElite Pro contain the ingredient DMAA, but recent findings do not support claims that it is a “natural” derivative from the geranium plant. It’s another story of “buyer beware.”

HPRC recently wrote about “The Lure of Jack3d” and answered a “Question from the Field” about OxyElite Pro. Jack3d is marketed as a pre-workout supplement and OxyElite Pro is marketed as a fat-burner product. Both contain the ingredient 1,3-dimethylamylamine (DMAA). Since we last wrote about both products, there have been new reports about DMAA.

Makers of Jack3d and OxyElite Pro claim that DMAA is a “natural constituent” of the geranium plant. DMAA was originally patented as a drug in the U.S. by Lilly in the 1940s. Since then, it has been identified on many product labels (especially on sport, energy, and weight-loss products) as being derived from geranium oil, stem, or extract, but review of the scientific literature has not substantiated this claim. To date, there is no credible scientific data that establishes the presence of methylhexanamine in geranium. Recently, the American Herbal Products Association announced that products containing DMAA (which can also be seen on labels as 1,3-dimethlypentlyamine, methylhexaneamine, or MHA, in addition to 1,3-dimethylamylamine) should be labeled as such and not as geranium oil or any part of the geranium plant. Health Canada has clarified that DMAA is a drug and must go through appropriate drug approval processes before it is used in any product. The United States Anti-Doping Agency (USADA) has long warned athletes about dietary supplements and more recently about the inclusion of methylhexaneamine in products under the guise of “geranium”; USADA has recently issued an advisory to athletes. There are questions about whether DMAA may be legally included in dietary supplements, since there is no credible evidence that it is present in geranium and it has not gone through the New Dietary Ingredient notification process with the Food and Drug Administration. Therefore, caution is advised when considering whether to use a product that contains this ingredient. Please be aware that such products may be sold in large retail nutrition outlets and on the Internet.

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USADA Athletic Advisory: Methylhexaneamine and dietary supplements

HPRC Fitness Arena: Dietary Supplements, Nutrition
Athletes are advised to avoid consuming supplements that contain the prohibited stimulant methylhexaneamine, also known as DMAA.

The United States Anti-Doping Agency (USADA) has issued an Athlete Advisory regarding methylhexaneamine, a prohibited stimulant. After reports that many athletes have tested positive for this stimulant, USADA is advising athletes to be cautious about taking supplements with methylhexaneamine, also referred to on labels as 1,3-dimethylamylamine (DMAA), dimethylpentylamine (DMP 4-methylhexan-2-amine), Geranamine, and geranium oil, extract, or stems and leaves. For more information, read the USADA Athletic Advisory.

Tools for the healthcare provider

Two new healthcare provider tools are available on HPRC’s website: a dietary supplement history questionnaire and a video of an effective way to ask about dietary supplement use.

If you are a healthcare provider, you may be interested in two new resources available on our website. One is “Guidelines for Taking a Comprehensive Dietary Supplement History” and the other is “How to Probe for Dietary Supplement Use and Report Adverse Events” [video]. Both of these helpful tools can be found on the website by clicking on the Dietary Supplements tab on the home page, then choosing Dietary Supplement Resources from the left-hand column, and then clicking on the Resources tab on the next window.

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