HEALTH

Doctors, public health experts want more FDA regulation of energy drinks

BY Alaric DeArment

NEW YORK — A group of doctors and public health professors are hoping the Food and Drug Administration will place stronger regulations on energy drinks to protect children and adolescents from what they call the harmful effects of high caffeine consumption.

The group, which includes 18 doctors and public health experts from around the country, delivered the letter to FDA commissioner Margaret Hamburg Tuesday, citing research indicating that consuming energy drinks — which have a high caffeine content — is leading to emergency room visits and even deaths among children.

"Children and adolescents are particularly vulnerable to the serious health risks of these drinks," University of California Berkeley public health professor and signatory Patricia Crawford said. "They have no place in the diets of young people."

The letter noted that energy drinks are projected to reach $19.7 billion in sales this year and that, according to an FDA-commissioned study from 2010, 65% of the people consuming them are ages 13 years to 35 years, while according to recent reports, between 30% and 50% of adolescents and young adults consume energy drinks. At the same time, according to the Drug Abuse Warning NEtwork, emergency room visits related to energy drinks more than doubled between 2007 and 2011, from 10,068 to 20,783.

On Tuesday, the New York Times reported that Monster Beverage, the largest maker of energy drinks, plans to change the labeling on its Monster Energy drink and sell it as a beverage rather than a dietary supplement, as it has for a decade. The Times reported that the change would mean the company would no longer required to inform regulators about reports that may link its drinks to injuries and deaths. The company also plans to list Monster Energy’s caffeine content on the can. Another energy drink line, Rockstar Energy, underwent a similar change to its packaging.


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GAO pushes FDA for final NDI guidance to improve enforcement efforts

BY Michael Johnsen

WASHINGTON — The U.S. Government Accountability Office on Monday advised the Food and Drug Administration to establish a time frame on New Dietary Ingredient guidance, as well as guidance clarifying whether a liquid product may be labeled and marketed as a dietary supplement or as a conventional food with added ingredients. Those two guidelines will help the agency use adverse event reports in overseeing dietary supplement products, the GAO stated. "With final guidance in place, firms may be able to make more informed product development and marketing decisions, which could ultimately reduce FDA’s enforcement burden in these areas," the GAO reported

“We believe that the recommendations from the GAO report are reasonable and open the door for further dialogue with FDA as to how industry and government can continue to work together," stated Steve Mister, president and CEO for the Council for Responsible Nutrition. "Our association has engaged in industry education since the law was passed, and most recently, CRN — along with the American Herbal Products Association, the Consumer Healthcare Products Association, the Natural Products Association and the United Natural Products Alliance — partnered on an educational webinar for the supplement industry with participation from [the] FDA, to further advise the industry on complying with serious adverse event reporting." 

"From 2008 through 2011, the Department of Health and Human Services’ Food and Drug Administration received 6,307 reports of health problems — adverse event reports — for dietary supplements," the GAO reported. As many as 71% of these were serious adverse events reported by the industry as required by law, and most of these AERs were linked with supplements containing a combination of ingredients, such as vitamins and minerals or were otherwise not classified within FDA’s product categories. 

However, the GAO cautioned the FDA that it may not be receiving information on all adverse events because consumers and others may not be voluntarily reporting these events, though they may be contacting poison centers about some of them. From 2008 to 2010, poison control centers received more than 1,000 more reports of adverse events linked to dietary supplements than the FDA did for the same period. 

With that disparity, the FDA had stepped up inspections of supplement firms to help ensure compliance with AER reporting requirements. Specifically, the FDA increased firm inspections from 120 in 2008 to 410 from Jan. 1 to Sept. 30, 2012. Over this period, the FDA took the following actions: three warning letters, one injunction and 15 import refusals related to AER violations, such as not including contact information on the product label or submitting a serious AER.

The industry supports the increased scrutiny. "We certainly support transparency for consumers with regard to adverse event reporting to the extent that consumers will benefit from that transparency and that industry will not be made the victim of frivolous lawsuits because of it," Mister said. "However, along with transparency, there must be context and education so that consumers are not misled and clearly understand that just because a consumer may have taken a product at the same time they experience an adverse symptom, it may not translate into a causal relationship between a product and the adverse event itself." 

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Perrigo launches store-brand guaifenesin 600-mg extended-release tablets

BY Michael Johnsen

ALLEGAN, Mich. — Perrigo on Monday announced that it has begun shipments of guaifenesin 600-mg extended-release tablets. It’s the first product that is generically equivalent to Reckitt Benckiser’s Mucinex 600-mg extended-release tablets. 

"This launch is representative of the Perrigo team’s abilities to overcome challenging circumstances as evidenced by this product’s complex formulation and patent challenges," noted Perrigo chairman and CEO Joseph Papa. "The team worked diligently to formulate the product, prove the product’s non-infringement to existing patents, validate and achieve commercial production and bring the product to market."

Sales of Mucinex 600mg Extended-Release tablets, an expectorant indicated to relieve chest congestion and make coughs more productive, reached approximately $135 million through food, drug and mass merchandisers for the last 12 months, Perrigo reported. 


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