HEALTH

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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Robinson Pharma preps launch of new probiotic

BY Michael Johnsen

SANTA ANA, Calif. — Robinson Pharma last week introduced its Unique IS-2 Probiotic Softgel in collaboration with B&D Nutritional Ingredients and Unique Biotech USA. The new product is a shelf-stable, guaranteed-yield probiotic softgel that delivers the Unique IS-2 Bacillus coagulans strain, a trademarked bacterium which has demonstrated high resistance to extreme temperature and humidity.

Probiotics are a hot business, Robinson Pharma stated in a release. "Probiotics are, and will continue to be, one of the most exciting categories in the supplement and foods industries," the company stated. "The massive growth in category sales and well developed consumer awareness is driven by a strong pedigree of clinical research supporting manifold benefits. RPI recognized more than a year ago that the category lacked an easy to swallow, soft gelatin capsule of a documented and researched strain offering a guaranteed shelf life. Filling this key market niche’ was the goal of our program."  

B&D Nutritional Ingredients, the exclusive U.S. distributor of Unique IS-2 and Robinson Pharma signed an exclusive agreement for the production and sale of soft gelatin capsules containing this strain. Robinson Pharma has initiated marketing of the product and forecasts a market introduction later this year.


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