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Filed under: Dietary supplements

FDA seeks to remove Lazy Cakes from shelves

HPRC Fitness Arena: Nutrition, Total Force Fitness
Lazy Cakes, the melatonin-laced brownies that have caused some controversy in the past several months, have been deemed unsafe by the Food and Drug Administration.

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.

FDA warning to Muscle Milk manufacturer

HPRC Fitness Arena: Dietary Supplements, Nutrition
FDA sent a warning letter to the makers of Muscle Milk products, Cytosport, Inc., for making claims that are in violation of federal law.

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.

FDA News Release: Illegal drug claims banned for chelation products

HPRC Fitness Arena: Dietary Supplements, Nutrition
New York dietary supplement manufacturer agrees to remove drug claims from his website.

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.

Herbal products: Important information to know

HPRC Fitness Arena: Dietary Supplements
Herbal products are advertised as “natural," but are they safe? The American Academy of Family Physicians has some answers to important questions.

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.

Do you really need to take a multivitamin?

HPRC Fitness Arena:
Do you really need to take a multivitamin? How can you be sure that you’re taking the right one, or if you even need to take one at all?

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.


The lure of Jack3d

HPRC Fitness Arena: Dietary Supplements
This relatively recent supplement targeting the exercise performance market has been growing in popularity, but the limited information about its “recipe” and the severe warnings on its label and website should make potential users think twice.

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,
  • caffeine,
  • 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 FDA cracks down on a Minnesota company making unproven claims

HPRC Fitness Arena:
The FDA seizes probiotic products from Minnesota company that makes unproven disease claims.

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.

Zinc: Some Facts

HPRC Fitness Arena:
Your body needs zinc for a number of essential functions, so make sure your diet includes foods that provide this nutrient.

Zinc, an essential trace element, is found in cells throughout the body and helps the immune system by fighting off bacteria and viruses. It is also involved in making proteins and DNA and helps wounds heal, among other functions. Oysters are the richest source of zinc, and other good sources include red meat, poultry, crab, lobsters, and fortified cereals. For more information, including the average daily recommended amounts, see the Office of Dietary Supplements’ Fact Sheet.

Herbs at a glance

HPRC Fitness Arena:
Visit the website of the National Center for Complementary and Alternative Medicine for information on many of the herbs used as and in dietary supplements.

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.

Durbin raises concerns over melatonin baked goods

HPRC Fitness Arena:
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.

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."

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