FDA

The long goodbye: FDA ruling will eliminate trans fats from U.S. foods


Former Executive Editor, Harvard Health

Partially hydrogenated oils, once a workhorse of the food industry, have gotten an official heave-ho from the U.S. food supply. In a long-awaited decision, the FDA ruled yesterday that partially hydrogenated oils, which are the main source of harmful trans fats, are no longer “generally recognized as safe.” That means any food company wanting to use partially hydrogenated oils must get the FDA’s approval to do so. Companies have until 2018 to stop using partially hydrogenated oils or to petition the FDA for approval. The move is a good one for individual and public health. Trans fats have been a favorite of the food industry because they increase the shelf life of liquid oils and make margarine easier to spread. But trans fats are bad for arteries. Removing them from the U.S. food supply would prevent between 72,000 and 228,000 heart attacks each year.

FDA approves weight-loss drug Contrave

Howard LeWine, M.D.

Chief Medical Editor, Harvard Health Publishing

For the third time in two years, the FDA has approved a drug to help people lose weight. The new drug, Contrave, combines two generic drugs, naltrexone and bupropion. Naltrexone is used to help kick an addiction to alcohol or narcotics. Bupropion is used to treat depression and seasonal affective disorder. Many people also take bupropion to stop smoking. Neither naltrexone nor bupropion by itself has been approved for weight loss. Specifically, Contrave was approved for use by adults who are obese (meaning a body-mass index of 30 or higher) and by overweight adults (body-mass index between 27 and 30) who have at least one other weight-related condition or illness, such as high blood pressure or type 2 diabetes. Across the clinical trials on which the FDA based its approval, some people lost more than 5% of their body weight. But it’s important to note that more than 50% had minimal or no weight loss. Side effects ranging from seizures and high blood pressure to diarrhea and constipation were reported.

FDA’s proposed changes to the Nutrition Facts label are good, but could be better

Every day, millions of Americans use the Nutrition Facts labels on food packages to make healthy choices. The U.S. Food and Drug Administration has recently proposed changes to make the labels even more useful. It’s an important move that could help curb the skyrocketing number of Americans with type 2 diabetes, osteoarthritis, and other weight-related conditions. The proposed new label will list information about added sugars, update daily values for sodium and dietary fiber, list the amount of potassium and vitamin D, and remove the “Calories from Fat” category while continuing to list types of fat. For foods that come in larger packages but could be consumed in one sitting, manufacturers would have to use a two-column label showing calorie and nutrition information for both a single serving and the entire package. These changes are a step in the right direction, but don’t go far enough with sugar, ingredient listing, and nutrient claims.

Teen suicide tries increased after FDA toughened antidepressant warning

Howard LeWine, M.D.

Chief Medical Editor, Harvard Health Publishing

A few years ago, the U.S. Food and Drug Administration issued warnings that children and teens who took a common kind of antidepressant might experience suicidal thoughts. The point of the warning was to make sure that parents and doctors paid closer attention to kids taking these medications. But the plan may have backfired. A national team of researchers tracked antidepressant use among 2.5 million young people between 2000 and 2010. After the FDA’s warnings in 2003 and 2004, use of commonly prescribed antidepressants fell by 30% in teenagers while suicide attempts rose by 22%. The researchers concluded that the decrease in antidepressant use, sparked by worries over suicidal thoughts, may have left many depressed young people without appropriate treatment and that may have boosted the increase in suicide attempts.