Tag: dietary supplement
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Industry Groups Criticize JAMA Study Questioning Benefits of Omega-3
After JAMA Cardiology published a meta-analysis purporting to find “no significant association” between consumption of omega-3 fatty acids and “fatal or nonfatal coronary heart disease or any major vascular events,” industry groups reportedly criticized the conclusion, arguing that other meta-analyses find statistically significant reductions in cardiac death risks. The JAMA meta-analysis examined 10 randomized trials that…
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EFSA Launches Web-Based Botanicals Compendium
The European Food Safety Authority (EFSA) has released a searchable database of botanicals that contain naturally occurring substances of potential concern to human health. The compendium is intended for use as a safety assessment tool for food and dietary supplement manufacturers. The compendium will reportedly be expanded to include non-European botanical species and is expected…
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EC Issues Report on Sports Food Regulations
The European Commission (EC) has published a report finding that foods intended for sportspeople do not require special provisions under the regulation on food for specific groups (FSG Regulation), which will replace the framework on foodstuffs intended for particular nutritional uses (PARNUTs) on July 20, 2016. Based on the results of an external study commissioned…
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Federal Agencies Target Dietary Supplement Manufacturers and Distributors
The U.S. Department of Justice (DOJ) and U.S. Food and Drug Administration (FDA) have announced the latest developments in civil and criminal actions taken against 117 dietary supplement manufacturers and distributors as the result of a year-long investigation into allegedly tainted products. According to a November 17, 2015, DOJ press release, an 11-count indictment alleges…
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FDA Cracks Down on Sales of Pure Powdered Caffeine
The U.S. Food and Drug Administration (FDA) has issued five warning letters to the distributors of pure powdered caffeine, citing two fatalities linked to caffeine toxicity as evidence that the products “are dangerous and present a significant or unreasonable risk of illness or injury to consumers.” Equating 1 teaspoon of pure caffeine to 25 cups…
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Teen’s Family Sues Amazon for Wrongful Death After Caffeine Overdose
The estate of Logan Stiner, an Ohio teenager who died in May 2014 after ingesting pure caffeine powder purchased from Amazon, has filed a lawsuit against the online retailer and the companies that manufacture and market the powder. Stiner v. Amazon.com Inc., No. 15CV185837 (C.P. Lorain Cty., filed March 6, 2015). According to the complaint,…
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Shook Attorneys Discuss False Labeling Claims Based on Alleged Product Testing in Law360
In a recent article for Law360, Shook, Hardy & Bacon Class Actions & Complex Litigation Co-Chair Jim Muehlberger and Agribusiness & Food Safety Associate Jeff Lingwall discuss the new wave of putative class action litigation against food and nutraceutical companies brought by plaintiffs bearing product test results that allegedly indicate deviations from labeled amounts. They…
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FDA Extends Deadline for Comments on Expanding the Redbook
The U.S. Food and Drug Administration (FDA) has extended the deadline for public comments about whether to expand the products included in its guidance titled “Toxicological Principles for the Safety Assessment of Food Ingredients”—also known as the “Redbook.” The agency is apparently considering this expansion “to include chemical safety assessments for all products over which…