Filed under: FDA
The Food and Drug Administration (FDA) has issued warning letters to 15 companies regarding illegally marketed diabetes products that are in violation of federal law. These products are either dietary supplement products or unapproved prescription drugs with claims that they “prevent and treat diabetes” and “can replace medicine in the treatment of diabetes.”
FDA is warning consumers to stop using these products since they may harmful, and their use may interfere with receiving the necessary medical treatment for diabetes. More information is provided in FDA’s “Illegally Sold Diabetes Treatments,” which includes the news release, warning letters issued, and a consumer update.
Cheeba Chews are marketed as chocolate taffy, but they actually contain an illegal substance. Read the Operation Supplement Safety (OPSS) FAQ to find out more about these products and whether they are legal for members of the military community to consume. Be sure to check back often as we add answers to other questions and topics in the OPSS section of HPRC’s website.
Since we first posted our list of DMAA-containing dietary supplement products in December 2011, and especially since FDA’s announcement in April 2013, the number of products being manufactured with this ingredient has continued to decline. Our search does still occasionally turn up products with DMAA that were not on our previous lists: just six new products have been added since our last update in April 2013. Despite these additions, this update shows that about 80 dietary supplement products are apparently still being manufactured with DMAA, but note that many are by non-U.S. sources. Over the lifetime of this list 125 products have been discontinued or reformulated to exclude DMAA, including some of the most well-known ones. To the best of our knowledge and searching, 68 of these no longer appear for sale, even from distributor stock. You'll find our updated list of products containing DMAA here.
The trend of adding caffeine to new food products has led the FDA to take another look at caffeine regulations. In particular, they have decided to look into caffeine being added to foods, as reported in this Consumer Update. The FDA approved the addition of caffeine to colas (specifically) in the 1950s, but the addition of caffeine to foods and beverages popular with children and adolescents, such as waffles, chewing gum, and energy drinks, has prompted them to take a fresh look at the possible impact of caffeine on children and adolescents’ health.
Currently, the FDA has not set a safe amount of daily caffeine consumption for children. Medical professionals discourage any caffeine consumption and state that children and teens should take in no more than 100 mg of caffeine per day. To put that in perspective, an eight-ounce cup of coffee typically contains about 100 mg (or more), and the most popular caffeine-containing sodas contain around 30 to 55 mg in a 12-ounce can (a 12-ounce soda cannot contain more than 68 mg of caffeine). Not knowing how much caffeine and other stimulants are contained in the drinks and foods children eat is a concern. In the meantime, for a better understanding of the effects of caffeine, read this article from the American Academy of Pediatrics.
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.
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.
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.
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!
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.
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.