Filed under: Dietary supplements
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.
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.
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.
The Food and Drug Administration (FDA) has issued a press release to consumers warning them about a counterfeit product being represented as the dietary supplement "ExtenZe.” The counterfeit product has hidden ingredients, including tadalafil or a combination of tadalafil and sildenafil, which are active ingredients of FDA-approved drugs, making these products unapproved drugs. Taking these products with prescription medications containing nitrates could lower blood pressure to dangerous levels. More information, including the lot numbers on the counterfeit packages, is provided in the FDA Press Release.
Lazy Cakes, Kush Cakes, and Lulla Pies are the names of melatonin-laced snacks that have been in the news lately as an antidote to the trend of energy/caffeinated powered beverages and products. But there is no research available on whether they are safe, or whether they actually work.
The New York Times reported on the sale of these products and others that are being sold online and in convenience stores and smoke shops. Some claim melatonin has a relaxing effect and can be used to alleviate jet lag or simply help induce sleep. But the Food and Drug Administration hasn't approved melatonin as a food additive or confirmed its safety when used as a sleep aid.
The HPRC began encountering stories of melatonin-laced brownie products back in March 2011, and we posted a Healthy Tip then that focused on the emergence of Lazy Cakes.