Filed under: Safety
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.
Apple juice containing arsenic has been a topic in the news recently. The Food and Drug Administration (FDA) has put together questions and answers to assist the public in sorting through the information. The FDA’s conclusion is that apple juice is safe to drink. More information is available in FDA: Apple Juice Safe To Drink.
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.
Agromod Produce, Inc., is recalling all papayas distributed nationwide and to Canada due to potential contamination with Salmonella Agona. For more information, read the Food and Drug Administration Press Release.
Cytosport, Inc. was cited for having false or misleading label and website claims in violation of several points of federal law for several products, including “Chocolate Muscle Milk Protein Nutrition Shake,” “Vanilla Crème Muscle Milk Light Nutritional Shake,” and “Chocolate Peanut Caramel Muscle Milk.” The company is in violation of the Federal Food, Drug, and Cosmetic Act and is required to take specific actions to correct the violations. More information is provided in the FDA Warning Letter.
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.
Warfighters are deployed to all kinds of environments, including hot and dry conditions where sun exposure is a concern. Choosing a "broad-spectrum" product that protects against sunburn, skin cancer, and premature skin aging is important, but product labeling can be confusing. Now, however, the Food and Drug Administration (FDA) is taking steps to regulate the labeling of sunscreen products in order to help consumers choose a product that will protect them from sun damage to the skin.
The new measures include a regulation, effective one year from now, that requires sunscreens to undergo a standard test if they want to be labeled as a “broad spectrum” product. Those that pass the test will be allowed to use “broad spectrum” on their packaging, which indicates a product that provides protection against both ultraviolet B radiation (UVB) and ultraviolet A radiation (UVA). UVB rays are primarily responsible for sunburn, but both UVA and UVB rays are harmful and can cause sunburn, skin cancer, and premature skin aging.
Other provisions in the FDA regulation include:
- A warning about the risk of skin cancer and early skin aging on the labels of sunscreen products that are not broad spectrum.
- The amount of time the consumer can expect protection from a product with water resistance claims must be stated on the front label. The FDA, based on standard testing, will allow either a 40-minute or 80-minute timeframe on labels.
- Products will no longer be allowed make a claim of “waterproof” or “sweatproof” or use the term “sunblock,” nor can they make the claim of immediate or instant protection or protection for more than two hours without reapplication.
Additional measures regarding the labeling of sunscreen products have been proposed. To learn more, view the FDA’s full article.
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.