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Filed under: FDA

FDA warns: DMAA in dietary supplements now illegal

FDA urges consumers to check all dietary supplement product labels to ensure they do not contain the illegal stimulant DMAA.

The Food and Drug Administration (FDA) has issued a Consumer Update warning of the potential dangers of DMAA, which was announced illegal in dietary supplements on 11 April 2013. DMAA is also referred to as dimethylamylamine and other names. This dietary supplement product ingredient has been used in many weight-loss, bodybuilding, and performance-enhancement products. FDA received numerous reports of illnesses and death from the use of products containing DMAA; commonly reported reactions include heart and nervous system problems as well as psychiatric disorders. DMAA has been the focus of conflicting information regarding whether or not it is a natural extract from geranium. FDA has now found “the information insufficient to defend the use of DMAA as an ingredient in dietary supplements.” Online, FDA also stated, "Dietary supplements containing DMAA are illegal and FDA is doing everything within its authority to remove these products from the market."

For more information, read the FDA Q&A on DMAA here.

FDA Warns Consumers about DMAA

FDA urges consumers to check all dietary supplement product labels to ensure they do not contain the illegal stimulant DMAA.

The Food and Drug Administration (FDA) has issued a Consumer Update warning of the potential dangers of DMAA, which was announced illegal on 12 April 2013. DMAA is also referred to as dimethylamylamine and other names. This dietary supplement product ingredient has been used in many weight-loss, bodybuilding, and performance-enhancement products. FDA received numerous reports of illnesses and death from the use of products containing DMAA; commonly reported reactions include heart and nervous system problems as well as psychiatric disorders. DMAA has been the focus of conflicting information regarding whether or not it is a natural extract from geranium. FDA has now found “the information insufficient to defend the use of DMAA as an ingredient in dietary supplements.” Online, FDA also stated, "Dietary supplements containing DMAA are illegal and FDA is doing everything within its authority to remove these products from the market."

For more information, read the FDA Q&A on DMAA here.

Relaxation drinks: Problematic for teens?

Are relaxation drinks safe for children and adolescents? Recent reports highlight possible problems.

A number of relaxation beverages have been introduced into the market and are now available to consumers of any age from convenience stores, college campuses, and online vendors. There are recent reports of negative side effects in children and teens from the consumption of these drinks. There are two significant issues with relaxation drinks: First, some of their ingredients, particularly melatonin, have not gone through the Food and Drug Administration’s (FDA) process required for all food ingredients to be designated as safe or “generally recognized as safe” (GRAS). Second, other ingredients such as valerian and caffeine do not have established serving sizes or doses for this type of use. An additional concern is that it is unknown how ingredients might interact. Parents should be concerned about this.

It also may be hard to tell the difference between these drinks and those that have been recognized as safe because their bottles and labels are sometimes similar. A typical consumer may not realize which drinks contain ingredients that might have negative effects. Therefore it’s important to be aware what is in these drinks and to read all labels carefully. Many of these drinks have warnings on their labels that they are not intended for children. For more information about relaxation drinks, their ingredients, and their effects, check out HPRC’s article. Also, visit OPSS (Operation Supplement Safety) for more information about dietary supplement safety and specific ingredients.

Remember, there’s no magic beverage for relaxing or reducing stress. Instead, address those issues in order to get to the bottom of the stress you or your teen might be experiencing. There are strategies that you or your child can use to relax and de-stress in a healthy way. For even more ideas, visit the stress control section of HPRC’s website.

FDA investigating adverse events linked to energy drinks

Reports of adverse events —including five deaths—possibly linked to Monster Energy drinks are under investigation by the FDA.

The Food and Drug Administration (FDA) is investigating five deaths and a non-fatal heart attack that may be linked to Monster Energy drinks. The FDA has pointed out that while the investigation is going on, it does not mean that Monster Energy drinks caused these adverse events, which were reported to the FDA over a span of eight years. Other adverse event reports have been associated with consuming the energy drinks. Read the New York Times article here, as well as this one from NBC News.

Operation Supplement Safety (OPSS) has now been launched to answer many of your questions about Dietary Supplements. Visit the OPSS section of HPRC’s website now to learn more!

DMAA list update for October 2012

HPRC’s latest review of DMAA-containing products shows that 89 have been discontinued or reformulated since the list was first compiled nine months ago.

HPRC’s list of DMAA-containing dietary supplement products has been reformatted, revealing that many are no longer being manufactured or distributed. A number of manufacturers now indicate on their websites that products previously containing DMAA have been reformulated. DMAA-containing versions of discontinued or reformulated products are likely to be on the market until retail supplies have been exhausted, so check labels carefully for ingredients. However, the only way to be certain a product no longer contains DMAA is through laboratory testing.

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Two new dietary supplement reports

HPRC Fitness Arena: Dietary Supplements
Two reports released by the Inspector General of the Department of Health and Human Services show that some dietary supplement products have illegal claims on labels and don’t provide accurate company information to the FDA.

Two just-released government reports show that many supplements are illegally labeled and some companies are not including their phone number or address on the labels of products as the FDA requires. The first report explains that some of the structure/function claims on labels (such as “promotes weight loss” or “supports healthy immune function”) could not be backed up. The second report explained that 28% of companies tested did not register with FDA as required, and 72% of the companies whose products were examined did not provide the appropriate company information to the FDA. At both of the links above you also can listen to a podcast discussing the reports.

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.

Are you getting the protection your sunscreen promises?

HPRC Fitness Arena: Environment, Total Force Fitness
The U.S. Food and Drug Administration has given sunscreen manufacturers an additional six months to clean up their labeling on their products.

It’s always a good idea to replace old sunscreen, but next summer you’ll have even more reason to do so. Sunscreen companies have until December 2012 to revise their labels to abide by FDA’s new guidelines. The new labels will prevent manufacturers from false advertising with respect to the level of protection they provide. Sunscreens also will have to go through FDA’s testing to determine their effectiveness.

The new guidelines are summarized below:

Broad-spectrum designation: Sunscreens will have to pass FDA’s broad-spectrum test to be labeled as such. This confirms the sunscreen protects against both ultraviolet A and B rays, both of which contribute to skin cancer and early skin aging.

Use claim: Only broad-spectrum sunscreens with an SPF of 15 or higher can claim to reduce skin cancer risk and early skin aging if used as directed. Sunscreens with SPFs between 2 and 14 can claim only to help prevent sunburn.

Waterproof, sweatproof, and sunblock claims: Sunscreens will no longer be able to claim they are waterproof, sweat-proof, or “sunblock,” since those claims over-exaggerate their effectiveness. No sunscreen is waterproof or sweat-proof without the proper reapplication. Also, sunscreens do not “block” the sun; they reduce the penetration of the ultraviolet rays.

Water-resistance claims: Any sunscreen with a “water-resistant” label must indicate whether it is effective for 40 or 80 minutes while swimming or sweating.

Drug facts: All sunscreens must include standard drug-facts information on the label.

Stars and Stripes reports: Army study on DMAA will continue

The Army will continue its own study on the effects of DMAA even after the FDA sent warning letters to marketers and distributors of dietary supplement products with DMAA.

Following in the wake of the Food and Drug Administration’s warning letters to manufacturers and distributors of dietary supplements containing DMAA, the Army announced that its own study on the effects of DMAA on soldiers will continue. Read about the announcement and more in the recent Stars and Stripes article. For more information about the FDA’s action, you can read HPRC’s post, which also includes a link to the FDA news release.

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.

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