Category Archives: FDA

FDA Offers Guidance for Mandatory Food Recalls

The U.S. Food and Drug Administration (FDA) recently issued guidance to the “industry” and FDA staff as to mandatory food recalls and providing integral information on how to handle and/or implement such food recalls when necessary. This guidance expands upon the FDA’s mandatory food recall authority that was first enacted under Section 423 of the Federal Food, Drug and Cosmetic Act (FD&C Act), which was added by Section 206 of the FDA Food Safety Modernization Act of 2011 (FSMA).  The FDA’s mandatory food recall authority…

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FDA Issues New Produce Handling Guidelines for Farmers and Food Processors

Two new draft guidance documents were released this week with the aim of helping US farmers and food producers comply with rules for the safe handling of produce. The guidance document for farmers, entitled ” Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Guidance for Industry,” provides farmers with examples and approaches for complying with the Produce Safety Rule.  The Produce Safety Rule establishes science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables…

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FDA Alert Concerning Consumption of Certain Food Products Infused with Liquid Nitrogen

The U.S. Food and Drug Administration (FDA) has recently issued an advisory about the potential harmful effects of a new food trend – the consumption of food and/or beverages infused with liquid nitrogen when the infusion is performed at the point of sale.  According to the FDA, examples include infused solid food products, such as cheese puffs, and beverages.  The infused products emit a smoke-like vapor or fog effect.   The liquid nitrogen is infused just before they are served and are often available at food…

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Seven Deadly(?) Substances: FDA Removes Seven Food Additives from Approved List Due to Cancer Risk

The FDA has revised its food additive regulations to block the use of seven synthetic flavoring substances in food products that may increase cancer risk in humans. Evidence submitted to the FDA by the Breast Cancer Fund, the Center for Environmental Health, the Center for Food Safety, and others, demonstrated that six of the synthetic substances caused cancer in lab animals under study conditions. The seventh flavor, styrene,  is being removed from the food additive list because it is no longer widely used by the…

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A Big Week of Changes in Cannabis Law

Despite continued animosity by U.S. Department of Justice regarding marijuana and marijuana-based products, at least one branch of the federal government decided that the time was right to approve the use of a drug made from cannabidiol. As many of you know from our earlier posts, U.K. company GW Pharmaceuticals Plc, created a drug to treat seizures associated with two types of epilepsy that typically affect children. After providing substantial evidence to the Food and Drug Administration (FDA), on Monday, June 25, 2018, the FDA…

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Federal Law Preempts State Law Product Liability Claims Involving “Hybrid” Medical Devices

On an issue of first impression in the federal Circuit Courts of Appeals, the Third Circuit held that federal law preempts state law claims involving hybrid medical devices where any part of the device requires FDA pre-approval of the device’s safety and effectiveness. The 1976 Medical Device Amendments to the Food, Drug and Cosmetics Act brought medical devices under the regulatory authority of the Food and Drug Administration. The Amendments established a system whereby certain types of devices, termed Class 3 devices, require approval by…

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FDA Clarifies Trading Partners Under the Drug Supply Chain Security Act

The Federal Food and Drug Administration (FDA) recently published several draft guidelines to aid industry and State and Local governments in understanding how to define entities in the drug-supply chain in accordance with the Drug Supply Chain Security Act (DSCSA). DSCSA — enacted as part of the Drug Quality and Security Act of 2013 — delineates the steps manufacturers, re-packagers, wholesale distributors, dispensers (i.e. pharmacies), and third-party logistics providers need to take to develop an electronic, interoperable system that tracks a drug at a unit…

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The FTC has its Eyes on Biotech for Antitrust Enforcement

On July 27, 2017, representatives of the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) gave coordinated testimony to Congress that ought to raise alarm bells for pharmaceutical companies. Scott Gottlieb, Commissioner of the FDA, and Markus Meier, Acting Director of the Bureau of Competition at the FTC, both testified before the House Judiciary Committee’s Subcommittee on Regulatory Reform Commercial and Antitrust Law. Their statements announced a renewed coordination between the respective agencies with a goal to increase competition in the pharmaceuticals market…

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Lobbying is not Conspiracy

Plaintiffs often seek to demonize corporate defendants, and one way they try to do so is by asserting that defendants engaged in a “conspiracy.”  For a plaintiff in one of the many talc/ovarian cancer cases pending in California state court, that tactic was unsuccessful as she failed to convince the court that she could proceed with such a claim. The plaintiff, Eva Echevarria, sought to convince Los Angeles Superior Court Judge Maren E. Nelson that she had sufficient proof that defendants Johnson & Johnson and…

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Shifting Regulatory Landscape for Off-Label Promotion Continues

On Wednesday, July 12, 2017, the Health Subcommittee of the Energy and Commerce Committee held a hearing to discuss proposed legislation that would impact the regulation of off-label use and promotion for drug products. There were representatives from all facets of the industry discussing the potential impact of decreasing regulation of off-label use of drugs and how it could affect patients, the public, manufacturers, and the economy. The FDA last solicited public comment on the issue of off-label use over six years ago, and the…

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