Posts Tagged ‘FDA’

A Rough Ride Despite Saxenda’s Success

October 31, 2016 — Over the last four years, four new obesity meds gained approval and only one lived up to expectations in the marketplace – the Saxenda brand of liraglutide 3 mg from Novo Nordisk. The company reported quarterly results last week. Saxenda sales, growing impressively, are on track to surpass $200 million for the year. Net profit for […]

Unacceptable Liver Toxicity from Dietary Supplements

October 20, 2016 — To understand the potential for harm from herbal and dietary supplements (HDS) for weight loss, consider this observation recently published in Hepatology: HDS-induced liver injury now accounts for 20% of cases of hepatotoxicity in the United States based on research data. The major implicated agents include anabolic steroids, green tea extract, and multi-ingredient nutritional supplements (MINS). This observation […]

Healthy Labels, Healthy Food Sales, Healthy People?

October 5, 2016 — FDA wants to know what it means to call a food product “healthy.” They have a definition that dates back to 1992. Based on that definition, fat-free, high carb foods counted as healthy. Foods with beneficial fats, like avocados and almonds, didn’t meet the definition. FDA Director Nutrition and Food Labeling Douglas Balentine knows that change […]

Targeting Obesity: Win Some, Lose Some

July 22, 2016 — Targeting obesity with new treatments presents remarkable challenges. For evidence of this harsh reality, look at the sharply contrasting news this week for two potential new drugs: beloranib and setmelanotide. All work on beloranib was canceled by its developer, Zafgen. Almost simultaneously, Rhythm Pharmaceuticals published breakthrough results in the New England Journal of Medicine (NEJM) […]

Once-Daily Lorcaserin Approved. Now What?

July 21, 2016 — Eisai and Arena Pharmaceuticals announced this week that they received final approval from FDA for once-daily lorcaserin, which will be sold as Belviq XR for long-term obesity treatment. The real question is: what will this mean for the product, the patients who can benefit from it, and for obesity care more broadly? This approval will […]

Searching for Healthy Food

July 10, 2016 — Americans are searching for healthy food. The FDA is working on its guidelines for what foods can claim to be “healthy” since it had to backtrack with the makers of Kind Bars. Delving into this issue, the New York Times reports some significant gaps between what nutrition experts think is healthy and what the public thinks. Number […]

Obesity Drain Device Approved by FDA

June 16, 2016 — FDA has just approved a new gastric drain device for the treatment of severe obesity and it’s easy to find people with strong opinions about it. The AspireAssist system consists of a small tube placed through the skin and into the stomach. It connects to a port on the surface of the skin outside the […]

New Nutrition Facts Label, Now Final, Targets Sugar

May 21, 2016 — At the PHA Summit yesterday, First Lady Michelle Obama announced that the new nutrition facts label is now final, putting added sugar in the crosshairs for consumers who are paying attention. FDA notes eight changes to the label, but the real action has been focused on sugar all along. Companies have up to three years to make […]

Will FDA Save Us from Unhealthy and Unnatural Food?

May 13, 2016 — If you want a glimpse of how people feel about natural and unnatural food, just browse through many thousands of comments that FDA recently received on the matter. And this is just a prelude. The agency hasn’t proposed any rules yet. It hasn’t even decided if it will. FDA just asked for comments on putting the word “natural” on food […]

Give Me the All-Natural Fat, Sugar, and Salt

April 24, 2016 — Diet soda? No thanks. Slow-churned, low-fat ice cream? Give us the full-fat stuff. Bacon? Please. Himalayan pink sea salt? Sprinkle generously. More and more, American consumers are looking for all-natural fat, sugar, and salt in their foods. No more diet factory food for us. Edy’s Grand full fat ice cream is up 10%, while their […]