Filed under: Dietary supplements
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.
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.
HPRC recently wrote about “The Lure of Jack3d” and answered a “Question from the Field” about . 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.
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.
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.
According to an Associated Press article from August 2, 2011, the Food and Drug Administration (FDA) has warned the manufacturer of the melatonin-laced brownies known as "Lazy Cakes" that the government considers them unsafe and could seize them from store shelves. The brownies were originally sold under the name Lazy Cakes, but the manufacturer of the product has changed the product name to Lazy Larry.
The FDA said that melatonin has not been found to be safe for use in conventional foods. “On the contrary, reports in the scientific literature have raised safety concerns about the use of melatonin,” said the letter, sent last Thursday by the agency’s acting director for the Office of Compliance. Melatonin is not approved for use in any food, the FDA said.
HBB, LCC, the Memphis-based company that makes Lazy Cakes/Lazy Larry, was given 15 days to respond to the FDA with details on specific steps it would take to correct its violation of the ban against melatonin use in food.
It should be noted that the HPRC has been covering Lazy Cakes since they first became available.
There are many herbal products available to consumers, yet it is difficult to determine if they are safe. The American Academy of Family Physicians provides answers to questions about herbal product use, potential dangers with specific health problems, and possible drug interactions. A helpful chart about interactions between herbal products and supplements is also available.
A recent Wall Street Journal article reported on multivitamin use, the issue of what one actually needs to take, and understanding what is on the labels. The article asks the basic question: Do you really need a multivitamin? And what exactly should a person be looking for in a multivitmin?
According to the article, there is no generic, one-size-fits-all multivitamin that is capable of meeting every nutritional need, and factors such as age, gender, diet and health determine what vitamins a person should take, if any. Adding to the confusion is inconsistent vitamin labeling for consumers as well as the manufacturers who tailor product brands for different population segments.
Jack3d (sometimes known as “Jacked”) is, according to the bottle, a “powerful pre-workout supplement that increases your capacity to perform.” HPRC did an extensive search for evidence-based information on Jack3d and found that all the apparently scientific literature on the product led to its promotional website, where they offer their own reviews. Anyone taking supplements should know that there have been reports about “tainted” dietary supplements containing active ingredients of FDA-approved drugs or other compounds that are not classified as dietary supplements. But there are still testimonials, blog entries, and bodybuilding forums touting the effects of Jack3d. It’s important to know exactly what is in Jack3d and that there isn’t any information on how much of each individual ingredient is in a serving.
The label of Jack3d says that it contains 4145 mg of a “Proprietary Blend” in one scoop, with 45 servings per container. In that blend are the ingredients:
- arginine alpha-ketoglutarate,
- creatine monohydrate,
- beta alanine,
- 1,3-dimethylamylamine (geranium [stem]), and
- schizandrol A,
- as well as some flavoring and color additives.
So, what does this all mean to a consumer? There have been individual studies conducted on each of the ingredients in Jack3d. Some are more effective than others for potentially enhancing athletic performance and building muscle mass. For example, creatine may increase muscle mass and enhance exercise performance during short, high-intensity repeated exercise bouts. For more information about creatine, see HPRC’s research brief. We know that 1,3-dimethylamylamine (DMAA), a chemical from the geranium plant and also synthetically made, is used in supplements promoted for weight loss, bodybuilding, and enhanced athletic performance. According to the Natural Medicines Comprehensive Database, it’s thought to have stimulant effects. Its chemical structure is similar to that of amphetamine, and it is on the World Anti-Doping Agency’s banned substance list. No scientific literature exists on the effectiveness of DMAA for weight loss, bodybuilding, or enhanced athletic performance. Caution is advised on the use of DMAA with caffeine, since both have stimulant effects and could increase the chance of increased heart rate and blood pressure.
The amount of caffeine per scoop of Jack3d has not been released, although it has been estimated that there is less than 150 mg of caffeine/scoop. Caffeine is included on the FDA’s list as a substance “generally recognized as safe.” However, the FDA has established a maximum concentration for caffeine in cola beverages: 32.4 mg per 6 oz or 71 mg per 12 oz. Other than colas, the caffeine content of food and beverages is not regulated. The label of Jack3d states: “Do not use in combination with caffeine or any stimulants from other sources whatsoever, including but not limited to, coffee, tea, soda and other dietary supplements or medications.” Caffeine seems to increase physical endurance, but it does not seem to affect activities that require high exertion over a short period of time, such as lifting.
The main issue with Jack3d is the same one that exists with many bodybuilding products on the market. There is no way to judge the interaction between the ingredients, especially when the consumer is unable to determine how much of each ingredient is in the product. This product contains multiple ingredients and, potentially, additional and potent ingredients not listed. It also could be contaminated, as has been seen with many other supplements. The FDA has put together information on tainted products promoted for bodybuilding.
It is important to mention that Jack3d comes with serious warnings on its label. As with any supplement, be educated, be advised, and consider all the unknowns before you decide whether the possible benefits are worth risking your health.