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Fetched from Food and Drug Administration Press Releases

The FDA released a statement regarding safety concerns with Total Body Formula and Total Body Mega Formula, manufactured by Total Body Essential Nutrition:

The U.S. Food and Drug Administration is advising consumers not to purchase or consume Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.

FDA laboratories are analyzing samples of the products to identify the cause of the reactions, including the possibility that the products contain excessive amounts of selenium, which is known to cause symptoms such as those described in the adverse events reported to the agency. Selenium, a trace mineral, is needed only in small amounts for good health.

The products have been distributed in Alabama, California, Florida, Georgia, Kentucky, Louisiana, Michigan, Missouri, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia.

Read the entire report for more information.

To their credit, Total Body Essential Nutrition has voluntarily recalled affected products, and appears convinced selenium is to blame. This warning appears on their websites totalbodyformula.com/ and totalbodyteam.com/:

IF YOU ARE TAKING TOTAL BODY FORMULA, LOT # 4016801, 4016802, 4024801, 4024802, 4031801, 4031802 or 4031803 PLEASE STOP TAKING IT NOW AND CONSULT YOUR PHYSICIAN. THERE IS EXCESSIVE SELENIUM IN THE PRODUCT THAT CAN CAUSE SERIOUS HEALTH PROBLEMS.

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photo credit: luvi

Fetched from Food and Drug Administration Consumer Updates

The FDA released an article today about lactose intolerance. According to the FDA release, lactose intolerance relates to a deficiency in lactase, the enzyme that breaks down milk sugar (lactose). A couple of interesting statistics the FDA includes:

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) estimates that 30 to 50 million Americans are lactose intolerant.

Lactose intolerance is more common in some ethnic groups than others. NIDDK estimates that up to 75% of all adult African Americans and Native Americans and 90% of Asian Americans are lactose intolerant.

The FDA release also mentions what foods are most likely to contain lactose. While most are obviously milk-related products, like ice cream, butter, cheese and yogurt, some are not so obvious. Least obvious is a particular ingredient the FDA specifically mentions:

Beware of foods labeled “non-dairy,” such as powdered coffee creamers and whipped toppings. Some of these foods may contain an ingredient called caseinate, which comes from milk and contains lactose. Look for “caseinate” or “milk derivative” on the label if you are trying to avoid milk products.

See the full article for more information.

photo credit: Gary Thomson

Fetched from Food and Drug Administration Consumer Updates

FDA has received at least 73 reports of adverse reactions, including at least one death, related to the use of denture cleansers. Problems have occurred with both proper and improper use of these products.

FDA is asking manufacturers of denture cleansers to include a warning in the label about persulfates, which are known to cause allergic reactions in some people. Persulfates are used in most denture cleansers as part of the cleaning and bleaching process. The agency is also recommending that manufacturers consider appropriate alternatives to persulfates.

An allergic reaction to persulfates may not occur after the first use or even until after many years of use. Symptoms of an allergic reaction may not appear for several minutes or even hours after actual use. Symptoms may include irritation, tissue damage, rash, hives, gum tenderness, breathing problems, and low blood pressure.

Other reactions may be due to misuse of denture cleansers. For example, some cleansers may list mouthwash as an ingredient, but consumers should never chew, swallow, or gargle with denture cleansers.

To reduce misuse of denture cleansers, FDA is also recommending that manufacturers improve the directions on the label. Labeling revisions are needed to make it clear that these products are meant to clean dentures in a container, not while still in the mouth. Some patients have gargled or swallowed denture cleansers, resulting in abdominal pain, vomiting, seizures, breathing problems, and low blood pressure. Dentures should be thoroughly rinsed with water before they are placed in the mouth.

For more information, read the rest of the story.

Fetched from Food and Drug Administration Press Releases

The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies marketing unapproved injectable colchicine, a drug used to treat gout. Colchicine is a highly toxic drug that can easily be administered in excessive doses, especially when given intravenously. There is a narrow margin between an effective dose of the drug and a toxic dose that can result in serious health risks, including death. The FDA is aware of 50 reports of adverse events associated with the use of intravenous colchicine, including 23 deaths. Potentially fatal effects include low blood cell counts, cardiac events, and organ failure.

Read more here: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01791.html

Fetched from Food and Drug Administration Press Releases

The U.S. Food and Drug Administration today announced that Brownwood Acres Foods Inc., Cherry Capital Services Inc. (doing business as Flavonoid Sciences) and two of their top executives have signed a consent decree that effectively prohibits the companies and their executives from manufacturing and distributing any products with claims in the label or labeling to cure, treat, mitigate or prevent diseases.

The consent decree of permanent injunction is a result of the companies and their executives making unapproved drug claims and unauthorized health claims about their products, such as “Chemicals found in Cherries may help fight diabetes.” The companies are prevented from making these claims until the products are approved by the FDA as new drugs, exempt from approval as investigational new drugs, or until the claims on the products’ label and labeling comply with the law.

Brownwood Acres Foods Inc. and Cherry Capital Services Inc. manufacture and distribute various products including juice concentrates, soft fruit gel capsules, fruit bars, dried fruits, liquid glucosamine, and salmon oil capsules.

The companies have a history of promoting unapproved claims on their product labels, brochures, and Web sites, stating that the products cure, treat, mitigate, or prevent various diseases. Most recently, the companies’ Web sites referred customers to an apparently independent Web site, which was actually controlled by Brownwood Acres’ president and contained similar unproven statements claiming benefits for their products.

The FDA can order the companies to stop manufacturing and distributing any product if they fail to comply with any provision of the consent decree, the federal Food, Drug, and Cosmetic Act or FDA regulations. The companies are also required to pay $1,000 per violation per day in the event they fail to comply with the consent decree.