Tag Archives: FDA

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FDA Draft Guidance for Postmarket Management of Cybersecurity in Medical Devices Puts Manufacturers on Notice of Potential Cybersecurity Risks

On January 22, 2016, citing cybersecurity threats to medical devices as a growing concern, the United States Food and Drug Administration issued draft guidance for industry and FDA administration staff for postmarket management of cybersecurity in medical devices. Public comments on the draft guidance will be open for 90 days. According to the FDA release, a growing number of medical devices are designed to be networked to improve and facilitate patient care. However, the FDA notes that networked medical devices incorporate software that may be…

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MedDevices

21st Century Cures Bill Indicates Congressional Desire for Medical Device “Unique Device Identifiers” to be Documented in Electronic Health Records

On July 10, 2015, the U.S. House of Representatives passed H.R. 6, commonly known as the 21st Century Cures Bill. While the broad scope of the bill deals with accelerating the discovery, development and delivery of 21st century medical cures, an amendment to the bill signals Congressional intent that Unique Device Identifiers, currently required on most medical devices used in patient care, be documented in the patients electronic medical records. House Amendment 661 to H.R. 6 states that the purpose of the amendment…

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No GMO.

Local Governments Can’t Stop GMOs

In the November election cycle last year, the voters of Maui County, Hawaii passed an initiative that banned most genetically engineered food and plant products from being grown within the county’s borders.  The measure passed by a slim 51% majority, and immediately faced legal action by agricultural companies seeking to enjoin the county from enforcing the ordinance.  Simultaneously, some county residents filed an action seeking a declaratory judgment that the ordinance was valid and needed to be certified and implemented. Last week, the United States…

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Defeating “Unnatural” Class Actions

On June 12, 2015 a plaintiff filed a class action lawsuit against Kraft Foods claiming that its Capri Sun beverages are not “all natural” because they contain citric acid and flavorings. “Simply put,” the plaintiff alleges in Osborne v. Kraft Foods Group, Inc., “they contain unnatural ingredients.” These allegations have become commonplace in beverage labeling class actions. Snapple, AriZona, Skinnygirl Margarita mix, and Pure Leaf Iced Tea have all faced similar accusations. The Pure Leaf class action complaint, Laboon v. Unilever U.S., Inc. filed…

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Is BPA still a bad word?

The continuing controversy over bisphenol A — better known as BPA — took an interesting turn on December 5, 2014, when the FDA announced that BPA is safe at the current levels that occur in foods due to their packaging. This announcement follows the completion of a four-year review of more than 300 scientific studies by FDA experts specializing in toxicology, analytical chemistry, endocrinology, epidemiology, and other fields. Consumer and environmental groups have been critical of BPA use in food containers for years. Twelve states…

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Food Technology: Charting Unknown Territories

The ever-changing industry of food products is one that is hard to keep up with. Much like electronics, or cars, or even toys, the industry is consistently innovating and creating new technologies and applying them to the food that we eat. Engineering our food products is not new – it has been around for decades on a large scale. In previous posts on this blog, we have addressed some of the legal implications of genetically modified foods and labeling claims related to organic or all-natural…

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Unsure What “Natural” Means? That’s Natural…

As anyone who has entered a grocery store in recent years has noticed, there has been a proliferation of foods and beverages claiming to be “natural.” This is not surprising, as according to market research, there is a large percentage of Americans who seek out and buy these types of products. Unfortunately, the FDA has not provided a clear statutory definition of what “natural” means. However, despite this regulatory uncertainty, manufacturers, suppliers, marketers, and retailers of such “natural” foods and beverages can glean some guidance…

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Proposed FDA Rule Changes Leading Food Companies to Take Proactive Measures

In December 2013, the FDA proposed comprehensive changes to the Food Safety and Modernization Act of 2008, with the intention of standardizing the processes for growing, harvesting, packing, and holding foods for human consumption. A summary of the proposals can be found on the FDA’s website. Food companies may have significant internal changes ahead in order to achieve compliance, should the proposed rules be adopted. In anticipation of that, some companies are already taking action – and it may prove to be a wise…

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FDA Issues Guidance on Gluten–Free Labeling Requirements

As American consumers become increasingly more heath conscious, many more of them now read the labels on food packages to determine the overall fat content, percent of calories from carbohydrates, the presence of trans fats, and generally to ascertain the ingredients in prepared foods. One of the growing concerns is the presence of gluten in many prepared foods. Gluten is a protein found in wheat, barley, and rye. Gluten also shows up in many whole grain foods related to wheat, including bulgur, farro, kamut, spelt,…

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FDA Assistance in Meeting New Food Safety Guidelines

In a practical effort to help companies meet the requirements of the recent Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration released the “Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA)” strategy guide on May 2, 2014.  The guide provides an overview of the FDA’s changing role in food and feed safety assurance under the FSMA and then suggests operational guidelines for actual food and feed facilities in how to work within the FDA guidelines and implement the act.…

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