A Memphis-based company, HBB LLC, has been warned by the FDA that their popular product “Lazy Larry” (called “Lazy Cakes” until the company renamed the product in July) may not be safe for consumer use. The FDA may seize the product from store shelves.

The brownies, which feature a relaxed square of chocolate brownie cake on the packaging, are made with a hormone called melatonin that helps regulate a normal sleep-wake cycle. Melatonin occurs naturally in humans, but the FDA had not deemed it safe for consumption in food. Referring to medical research, Michael Roosevelt of the FDA expressed long-term health problems and concerns that may arise with the overuse of melatonin. According to the research Roosevelt cited, some of the concerns include neurological, cardiovascular and reproductive side-effects.

HBB LLC executives have not made an official statement regarding the FDA’s warning about their Lazy Larry brownies and are, according to a company spokeswoman, reviewing the information with lawyers at this time.

Melatonin is often sold as a “dietary supplement” in pill form. However, one of the concerns raised by the FDA is that adding the chemical to what is usually considered a “snack food” will lead to consumers eating too much of the hormone. Sen. Dick Durbin, D.-Ill, expressed his concern to the FDA in May.

“The sweet, chocolatey taste may encourage consumers to eat well over a recommended quantity of melatonin,” Dublin wrote, stating also that consumers should consult a doctor before eating the brownies due to concerns that it may not be appropriate for children, people with autoimmune diseases, or women who are pregnant or breast-feeding.”

Similar products, such as Kush Cakes, use similar ingredients but have not yet been approached by the FDA. These products claim to be 100% legal. It remains to be seen if the FDA will recall the sleepy brownies from store shelves.

FDA Says Sleepy Brownies Are Unsafe

Dannon has agreed to pay out $425,000 to the state of Idaho alone, as well as a sum to each of the other 38 states involved in the suit. The agreement was reached outside of the court room. Dannon had agreed several months ago that in addition to compensating consumers, the company would change their labeling of the product as well as how Activia is marketed. Although Dannon denies any wrong doing, the FTC has said that there is simply not enough evidence to back the claims that are made on the product’s label.

Dannon has agreed to pay out more than $21M to be divided between the states involved in the class-action lawsuit.

Activia Suit Settled for Millions

The agency says “Man Up Now,” an herbal compound that contains a variation of an active drug ingredient found in Viagra, can dangerously lower blood pressure.

Though no adverse side effects have been reported, the agency is concerned that companies that offer sexual enhancement products that claim to offer comparable results may contain harmful ingredients when consumed in large quantities.

Man Up Now is distributed by Synergy Distribution LLC, and is sold on various internet sites.

FDA Issues 'Man Up' Pills Recall

Both Alli and Xenical are sold over the counter. The FDA stated that there have been 13 total reported cases of liver damage linked to the weight loss drugs. The FDA has been staunch in their effort to alert users of Alli and Xenical to be cautious and aware of the liver damage findings. Glaxo Smith Kiine is the maker of Alli and Roche is the maufactuerer of Xenical. Both of these products have upwards of 10 million users and Glaxo is quick to point out that the liver damage cases are very minute compared to the other users.

Xenical has been around for over 10 years when the FDA approved it back in 1999. Statistics show that nearly 40 millions users have tried it. Alli was approved in 2007 and seen an increase in sales over the past two years. The FDA has been requesting liver toxicity results from both companies and through their research have come up with the liver damage results.

Their parent corporation is Johnson & Johnson. From the beginning of 2008, until the end of April, 2010, reports included 30 deaths,

The majority of those deaths were not connected to the Tylenol, Motrin, and Benadryl recall.
The FDA is examining reports of the hundreds of side effects and the 7 deaths that have occurred since the beginning of May.

This is when there was a voluntary recall by McNeil, of some 50 versions of over the counter medication for children because of the concerns of safety and quality.
When a customer reports a side effect that is serious in nature, it is referred to as an adverse event, according to the FDA. Because this is an ongoing investigation, the FDA declined to comment. On May 27, a committee in the House of Representatives, is holding a hearing to have an examination of the recall.
McNeil’s production facility, that manufactures the drugs for children, is located in Fort Washington, Pennsylvania. Production at this plant was halted following the last recall.
In the past seven months, McNeil has had four recalls. They insist that it was just precautionary.

This advisory came as the result of a joint U.S./Canadian study that shows a link between the use of PPIs (proton pump inhibitors) and chronic fracture risk in adults. “There is a possible increased risk of fractures of the hip, wrist, and spine if you take certain drugs for heartburn, acid reflux, or ulcers,” the FDA announced in a release today. Five other smaller studies also showed this risk for bone fracture.

The people most at risk are those over the age of 50. The FDA will now require a warning label to be added to prescription and nonprescription versions of these antacids.

Each year there are 113.4 million perscriptions written for the drugs in question. The drugs do work for those with heartburn issues, but the FDA is advising that patients reduce the dosage they take and only take for 14-day treatment periods.

The study also claimed that excessive use of the heartburn drugs can lead to diarrhea.

The FDA had 6 U.S. companies and a Brazilian company notified that their claims are considered deceptive. The companies were claiming that the injections simply melt away fat and there were no chances of side-effects resulting. However, there were many side-effects reported to the FDA. Permanent blemishes and lumps under the skin, where the contents of the injection did not dissolve, are some of the ailments that led to complaints.

It is hopeful that this crackdown will be a warning to other facilities making claims that cannot be proven but instead cause painful side-effects. In addition, the drugs used by the companies were never cleared with federal scientists, which must occur before the product is used or declared to be effective.

Patients are spending thousands of dollars for these unproven methods. The FDA has just saved many people money that can be better used elsewhere. It is good to see the FDA on the job again looking out for the health of Americans.

93 companies were asked to attend a seminar about the medical devices and exposure to radiations. Officials decided to hold the seminar after 206 patients suffered illness because they were exposed to dangerous levels of radiation at the Cedars-Sinai Medical center in California. The 206 cases involved patients who had CT scans on the brain. Overexposure to radiation causes burns on the skin, eye cataracts. Extreme exposure can lead to illness and death.

The cases resulted from medical linear accelerators and radiation cure planning. Reports received by the FDA covered a ten-year period. The FDA hopes to discuss the problems with these common technologies and help the companies come up with solutions to the problems posed by these devices.

The Medical equipment companies that received the letters were only advised to send representatives to the proposed seminar. An earlier seminar was held with architects and engineers of radiation cure devices.

Amid evidence that the use of tanning beds, and exposure to ultra violet light, raises the risk of skin cancer, the FDA is very likely to raise regulations. According to Allan Halpern, who is the Vice President of the Skin Cancer Foundation, as many as one of four melanomas found in women could be linked to tanning bed use. Already, many tanning salons prevent their customers from using a tanning bed more than once in every 24 hour period.

Previous studies have shown that teenagers and children are far more likely to suffer from the effects of tanning beds than other people. While this could be because they will use tanning beds much more frequently throughout their lives than those who only tan as adults, teenagers that tan are 8 times more likely to suffer from skin cancer than someone that does not tan.

The U.S. Food Safety and Inspection Service announced that around fifty thousand pounds has been recalled because of problems relating to the importation rules.

A New Jersey based company named; Well Luck Co., Inc. is the importer of the brand and made the call to implement the recall of the brand based on import standards. We don’t have exact details on what inspection requirement wasn’t met but we have heard that the inspection requirements for pork, beef, and poultry products was part of the failed standards for products in the United States.

The Jin Mai Lang Brand noodles were sold throughout the entire country. So far the recall has been successful and there have not been reports of any health issues surrounding the noodles. Well Luck Co., Inc. has set up a help line for anyone to call in with questions regarding the recall and for those who would just like to know more about the issue.

The company has also provided specifications of the noodles that have been recalled so that customers are aware of the exact group of noodles and do not have a hard time identifying the recalled noodles.

Jin Mai Lang Brand Instant Noodles Recalled