Obesity | Global Professional Consultants

Remove Artificial Trans-Fat from Processed Foods

October 31, 2015 gproconsultants Clinical News, Industry News, Recruitment News, Social Awareness

Based on a thorough review of the scientific evidence, the U.S. Food and Drug Administration today finalized its determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” or GRAS for use in human food. Food manufacturers will have three years to remove PHOs from products.

“The FDA’s action on this major source of artificial trans fat demonstrates the agency’s commitment to the heart health of all Americans,” said FDA’s Acting Commissioner Stephen Ostroff, M.D. “This action is expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year.”

This determination will significantly reduce the use of PHOs, the major source of artificial trans fats, in the food supply. In 2013, the FDA made a tentative determination that PHOs could no longer be considered GRAS and is finalizing that determination after considering public comments.

Since 2006, manufacturers have been required to include trans fat content information on the Nutrition Facts label of foods. Between 2003 and 2012, the FDA estimates that consumer trans fat consumption decreased about 78 percent and that the labeling rule and industry reformulation of foods were key factors in informing healthier consumer choices and reducing trans fat in foods. While transfat intake has significantly decreased, the current intake remains a public health concern. The Institute of Medicine recommends that consumption of trans fat be as low as possible while consuming a nutritionally-adequate diet.

“Studies show that diet and nutrition play a key role in preventing chronic health problems, such as cardiovascular disease and today’s action goes hand in hand with other FDA initiatives to improve the health of Americans, including updating the nutrition facts label,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition. “This determination is based on extensive research into the effects of PHOs, as well as input from all stakeholders received during the public comment period.”

The FDA has set a compliance period of three years. This will allow companies to either reformulate products without PHOs and/or petition the FDA to permit specific uses of PHOs. Following the compliance period, no PHOs can be added to human food unless they are otherwise approved by the FDA.

The FDA encourages consumers seeking to reduce trans fat intake to check a food’s ingredient list for partially hydrogenated oils to determine whether or not a product contains PHOs. Currently, foods are allowed to be labeled as having “0” grams trans fat if they contain less than 0.5 grams of trans fat per serving, including PHOs, the primary dietary source of artificial trans fat in processed foods.

Many companies have already been working to remove PHOs from processed foods and the FDA anticipates that many may eliminate them ahead of the three-year compliance date.

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New, non-surgical temporary balloon to treat obesity

September 26, 2015 gproconsultants Clinical News, Industry News, Medication, Research

The U.S. Food and Drug Administration today approved a new balloon device to treat obesity without the need for invasive surgery. The ReShape Integrated Dual Balloon System (ReShape Dual Balloon) is intended to facilitate weight loss in obese adult patients. The device likely works by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not yet understood.

The ReShape Dual Balloon device is delivered into the stomach via the mouth through a minimally invasive endoscopic procedure. The outpatient procedure usually takes less than 30 minutes while a patient is under mild sedation. Once in place, the balloon device is inflated with a sterile solution, which takes up room in the stomach.

The device does not change or alter the stomach’s natural anatomy. Patients are advised to follow a medically supervised diet and exercise plan to augment their weight loss efforts while using the ReShape Dual Balloon and to maintain their weight loss following its removal. It is meant to be temporary and should be removed six months after it is inserted.

“For those with obesity, significant weight loss and maintenance of that weight loss often requires a combination of solutions including efforts to improve diet and exercise habits,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This new balloon device provides doctors and patients with a new non-surgical option that can be quickly implanted, is non-permanent, and can be easily removed.”

The ReShape Dual Balloon was studied in a clinical trial with 326 obese participants aged 22 to 60 (with a BMI of 30 kg/m² to 40 kg/m²) who had at least one obesity-related health condition. In the study, 187 individuals randomly selected to receive the ReShape Dual Balloon lost 14.3 pounds on average (6.8 percent of their total body weight) when the device was removed at six months, while the control group (who underwent an endoscopic procedure but were not given the device) lost an average of 7.2 pounds (3.3 percent of their total body weight).

Six months following the device removal, patients treated with the ReShape Dual Balloon device kept off an average of 9.9 pounds of the 14.3 pounds they lost.

Potential side effects for the procedure include headache, muscle pain, and nausea from the sedation and procedure; in rare cases, severe allergic reaction, heart attack, esophageal tear, infection, and breathing difficulties can occur. Once the device is placed in the stomach, patients may experience vomiting, nausea, abdominal pain, gastric ulcers, and feelings of indigestion.