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 involved at least 500 participants and a treatment duration of at least one year. “The U.S. Food and Drug Administration would seem to disagree with the conclusion of this study, as it has already approved at least one prescription medication for fish oil that provides benefits for people with cardiovascular issues,” the president of the Natural Products Association was quoted as saying.
Tag Archives dietary supplement
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 to be finalized in early 2017. See EFSA News Release, July 5, 2016. Issue 610
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 by the EC Directorate General for Health and Food Safety, the report explains that the FSG Regulation covers foods targeting vulnerable population groups— such as food for infants and young children, food for special medical purposes, and total diet replacement for weight control—but does not extend to sports foods intended for either (i) sportspeople who practice sport more than once a week, or (ii) lifestyle users who practice sport less than once a week or not at all. “Thus, since a categorization as foodstuff intended for particular nutritional uses will no longer be available to…
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 that weight-loss and workout supplement manufacturer USPlabs LLC “engaged in a conspiracy to import ingredients from China using false certificates of analysis and false labeling and then lied about the source and nature of those ingredients.” The indictment claims the products in question were sold to retailers across the nation, with USPlabs asserting that it used natural plant extracts “when in fact it was using a synthetic stimulant manufactured in a Chinese chemical factory.” “The joint agency effort is a testament to our commitment to protecting consumers from potentially unsafe dietary supplements and products falsely…
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 of coffee, FDA also warns consumers not to purchase or use powdered caffeine as “it is nearly impossible to accurately measure pure powdered caffeine with common kitchen measuring tools and you can easily consume a lethal amount.” In particular, the agency plans to “aggressively monitor the marketplace” for pure powered caffeine being sold as a dietary supplement. The warning letters not only find the products adulterated under the Federal Food, Drug, and Cosmetic Act, but argue that labeling directs consumers to use difficult measurements such as one-sixteenth of a teaspoon. “Consumers are unlikely to have…
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, “pure caffeine is a drug” under Ohio law, but the powder manufacturers have “successfully avoided meaningful regulation of [the] product by the U.S. Food and Drug Administration (FDA) by classifying their product as a ‘dietary supplement,’” which leaves them “responsible for determining that pure caffeine powder is safe.” The companies “failed to alert users of the known risks and side effects of ingesting caffeine powder, including the risk of cardiac arrhythmia and cardiac arrest,” the reaction that killed Stiner, the complaint says. The estate also alleges that the companies did not conduct adequate testing of…
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 explain U.S. Food and Drug Administration (FDA) standards for evaluating nutrition labeling and attendant provisions of the Federal Food, Drug, and Cosmetic Act/Nutrition Labeling and Education Act, advocating anticipatory measures by companies, given the advent of product testing websites, crowdfunded research and the increased scrutiny of the dietary supplement industry. Such measures, they say, include ensuring that (i) production processes (and those of any contract manufacturers) produce FDA-compliant test results and (ii) performing regular product testing to assure compliance with nutrition labeling per FDA-testing procedures. Issue 557
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 FDA’s Center for Food Safety and Applied Nutrition (CFSAN) has statutory authority including regulatory contexts such as food additives, food contact substances, dietary supplement ingredients, food contaminants, and cosmetics.” According to FDA, “The Redbook would describe toxicological principles which apply across regulatory categories while still providing specific guidance for applying these principles within each particular context. The safety of foods containing microbial contaminants will continue to remain outside of the scope of the Redbook.” Comments may now be submitted until May 11, 2015. See Federal Register, February 2, 2015.
A group of consumers has filed a putative class action against Cytosport Inc., maker of Muscle Milk, alleging that its powdered and ready-to-drink protein supplements do not contain the ingredients and characteristics advertised on its packaging. Clay v. Cytosport Inc., 15-165 (S.D. Cal., filed January 23, 2015). The plaintiffs argue that independent scientific testing shows that Muscle Milk products contain substantially less protein than the amount represented in the Nutrition Facts panel. They also allege that Muscle Milk labels list L-glutamine amino acids separately from the protein content to falsely imply that the products have additional L-glutamine beyond the content inherent in the protein mix. The complaint further argues that Muscle Milk labels cannot feature the word “lean” because the product does not contain less fat than its competitors. Alleging deceptive advertising, misrepresentation and breach of warranties, the putative class seeks certification, damages, an injunction, and attorney’s fees. Issue…
The U.S. Food and Drug Administration (FDA) will host a public meeting and is soliciting public input on 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 FDA’s Center for Food Safety and Applied Nutrition (CFSAN) has statutory authority including regulatory contexts such as food additives, food contact substances, dietary supplement ingredients, food contaminants, and cosmetics.” According to FDA, “The Redbook would describe toxicological principles which apply across regulatory categories while still providing specific guidance for applying these principles within each particular context. The safety of foods containing microbial contaminants will continue to remain outside of the scope of the Redbook.” The meeting will take place December 9, 2014, in College Park, Maryland, and those wishing to participate in…
