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Life Sciences Decoded

Life Sciences Decoded

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The new look of FDA food facility registration: Human and animal food companies beware

Diane Romza-Kutz Fredric Roth V November 11, 2016
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The food industry faces new registration requirements for food facilities under revamped FDA rules stemming from the FSMA. Facilities should no longer view facility registration as a minor requirement, as proper registration takes an enhanced role in inspections and enforcement actions. READ MORE

The updated face of food labels: The nutrition facts panel

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The original goal of both the NLEA and the underlying rules was to standardize food labels. That goal has been expanded under these two new FSMA rules to not only keep labels standardized but also to provide additional nutrition information to the food buying consumer. READ MORE

Protecting food industry whistleblowers: FDA, OSHA team up under FSMA

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Including the FDA, OSHA's Whistleblower Protection Program enforces the whistleblower provisions of more than 20 whistleblower statutes protecting employees who report violations of various workplace safety and health, airline, commercial motor carrier, consumer product, environmental, financial reform, food safety, health insurance reform, motor vehicle safety, nuclear, pipeline, public transportation agency, railroad, maritime, and securities laws. READ MORE

Move over GNC: Crackdown on dietary supplement makers continues

Diane Romza-Kutz May 10, 2016
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The FDA has renewed its outreach to consumers, educating them on important information and the process to report adverse events. In fact, as recently as March of this year, the FDA posted an updated page on how to spot health care fraud scams directed toward the supplement market. READ MORE

How the FDA’s new Sanitary Transport Rule affects food shipping

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The Sanitary Transport Rule is different from the others passed so far under the FSMA, as it is not focused on the manufacturing, packing, growing, labeling or other aspects of food creation. So what’s the scope of the Sanitary Transportation Rule? READ MORE

FDA creates new rigorous produce safety requirements

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Intending to address the safety of produce entering the human food chain, this new Rule establishes “science-based minimum standards for the safe growing, harvesting, packing and holding of produce.” READ MORE

FDA-regulated industries: Plan now for these changes in 2016

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Big changes are in store for the industries of animal health, drug, medical devices and tobacco. Among these, the FDA is expected to continue its scrutiny of animal food safety, ramp up its work in post-approval drug studies and keep a close watch on the evolution of mobile medical devices and e-cigarettes. READ MORE

FDA dishes out major regulatory challenges for food industry in 2016

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As the FDA continues to intensify its enforcement over its regulated industries, food companies should prepare now to manage their risk by developing and implementing a set of strict compliance programs to avoid enforcement action. READ MORE

New FDA rule places increased food safety responsibility on importers, foreign suppliers

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“Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” is the most recent Rule promulgated under the Food Safety and Modernization Act and places new responsibility on industry members to ensure that foreign suppliers follow the FDA’s HARPC requirements, that compliance is documented, and that importers include this new supply chain verification system in their HARPC food safety plans. READ MORE

DOJ continues crack down on dietary supplement industry

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The impact of DOJ actions to the dietary supplement industry is yet to be fully realized. However, it is clear that the supplement industry will continue to be the target of increased enforcement actions and government scrutiny. READ MORE

GNC lawsuit reflects FDA’s crackdown on dietary supplement industry

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The dietary supplement industry, through these FDA enforcement actions, is on notice that its products are under increased national scrutiny, and an internal review of ingredients, labels, and new dietary ingredient filings is well-warranted. READ MORE

FDA promotes safety, control by veterinarians in new Rule: Veterinary Feed Directive

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The FDA recently issued other updated regulations, including updating the Veterinary Feed Directive (VFD) regulations regarding VFDs and VFD Drugs (drugs intended for use in conjunction with animal feeds and pet foods). READ MORE

Long-awaited overhaul of FDA food safety rules arrives – Part III: Hazard Analysis and Risk-Based Preventive Controls

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The overall focus of this rule requires these plans to continue the FDA’s efforts to ensure the safety of the U.S. food supply and, therefore, each of these plans should be drafted with this in mind. READ MORE

Long-awaited overhaul of FDA food safety rules arrives – Part II: A roadmap for food manufacturers on FDA’s changes to cGMPs

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With the passage of the Food Safety and Modernization Act (FSMA), the FDA has created a new and updated set of cGMPs in conjunction with the new Hazard Analysis and Risk-Based Preventative Controls (HARPC) program to correct this lag. READ MORE

Long-awaited overhaul of FDA food safety rules arrives – Part I: Introducing HARPC, changes to cGMP

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Since the passage of the Food Safety Modernization Act in 2011, the FDA has promulgated proposed rules that overhaul the old Good Manufacturing Practice (cGMP) rule and create new Hazard Analysis and Risk-Based Preventative Controls (HARPC) for certain food. READ MORE

FDA Update: New guidance released on mobile medical devices, medical devices data systems

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Mobile devices, including cell phones and tablets, have had a major impact on the practice of medicine, how patients interact with their doctors, receive or implement treatments, as well as how software developers view the medical industry as a potential source of revenue. READ MORE

Animal supplements still in limbo, facing increased FDA scrutiny

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The thousands of food, agriculture and life sciences companies regulated by the federal government already face a barrage of complicated regulations. Add in significant regulatory uncertainty and a major reorganization of the governing agency and you see the current predicament of the animal supplement industry. READ MORE

Sifting sugar: FDA proposes rule requiring disclosure of added sugars on food labels

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After consideration of both certain recommendations by the Dietary Guidelines Advisory Committee as well as other scientific information, the FDA has proposed more rule changes that address the percent daily value of added sugars and a proposed footnote for the Nutrition Facts Panel explaining the percent daily value concept. READ MORE

Trans fat gets the axe: More changes to nutrition facts panel

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While there are several methods by which a product can be listed as safe, including a specific GRAS finding, products found not to be GRAS may not generally be used as an ingredient in food unless premarket review and approval is obtained from the FDA. READ MORE

FDA launches medical device database: AccessGUDID

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On May 4, 2015, the FDA launched the most recent component of its “Unique Device Identification System,” or “UDI System,” first created in September of 2013 and required by the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law in July of 2012. READ MORE