Filed under: Dietary supplements
New York dietary supplement manufacturer Howard Sousa, of Artery Health Institute LLC and DeSousa LLC, has agreed to remove drug claims on his company’s website. Sousa’s Advanced EDTA Oral Chelation capsules were promoted on the website as drugs since the marketing language made disease treatment claims. More information is provided in the FDA News Release.
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.
Probiotic products were seized by U.S. Marshals after the Food and Drug Administration (FDA) complained that the products were marketed as drugs. The company who sells the probiotic products claims that the products will prevent or treat disease, which is in violation of the Federal Food, Drug, and Cosmetic Act. More information is provided in the FDA News Release.
The National Center for Complementary and Alternative Medicine (NCCAM) has produced a series of fact sheets on specific herbs and botanicals. Find information on common names, uses, potential side effects, and other information by choosing any of the 45 herbs or botanical fact sheets.
Food Safety News is reporting that Senator Dick Durbin (D-IL) has asked the FDA to clarify its regulatory position on dietary supplements and food additives on the back of widespread concerns about the marketing of melatonin-containing baked goods. A recent HPRC Performance News post notes that there have been questions raised on commercially available products such as Lazy Cakes and Lulla Pies that are marketed as "relaxation" brownies - which contain high doses of the sleep aid melatonin.
These products are being sold as dietary supplements to help people relax and fall asleep, rather than foods containing additives. Senator Durbin contends that these foods are being sold as dietary supplements but are really foods containing a dietary ingredient additive, which would require FDA approval. He has asked U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg to see if she has the authority "to oversee the safety of foods containing dietary supplement additives."
The vast array of dietary supplement products come in the form of tablets, capsules, powders, drinks, and energy bars. You can learn about dietary supplement labels, effectiveness, quality standards, safety and risks, and other important information about these products from the National Institute of Health’s Office of Dietary Supplements publication “Dietary Supplements: What You Need to Know.”
The Food and Drug Administration (FDA) is warning consumers to stop using dietary supplement products that claim to be antimicrobial (antibiotic, antifungal, or antiviral) drugs. These products are falsely promoted to treat upper respiratory infections, sinusitis, pneumonia, bronchitis, and colds, and they look like antimicrobial products sold in Mexico. More information, including product names, is provided in the FDA Press Release.