FDA’s Opinion: CBD You in April…Maybe.

On Wednesday, February 27, 2019, FDA Commissioner Scott Gottlieb, MD, testified before Congress. He testified that the agency planned a public meeting in April to begin a rule making procedure on CBD. The goal is to create “an appropriately efficient and predictable regulatory framework for regulating CBD products,” he said. This is good news for those in the hemp and cannabis market. Unfortunately, the statement also means that CBD infused products are still illegal in the U.S. Dr. Gottlieb’s testimony is further evidence of the…
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Hydroponic Operations Fight for Organic Certification Amidst Disapproval from Traditionalists

Hydroponic agriculture is a cutting edge method of growing plants and produce in nutrients which have been dissolved into flowing water. Hydroponic operations have historically fought an uphill battle in their quest to achieve organic certification. In most other developed nations, hydroponic crops cannot be certified as organic, as they are not grown in soil. Between 2001 and 2010, this issue was repeatedly raised to the National Organic Standards Board, which continually held that soil-less systems were inconsistent with organic status, even if they use…
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Litigation is the Pits – Claim Dismissed for Injuries Caused by Natural Food Substance

“A lady bit down on a pit in an olive …” may sound like the opening line to a bad joke, but the defendant she sued for her injuries appears to have had the last laugh. The plaintiff filed a personal injury claim against the defendant in California state court for products liability and pursued theories of strict liability, negligence and breach of an express written warranty.  This claims arises from plaintiff’s purchase of several cans of “Lindsay’s Large Pitted Olives” that she planned to…
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Gingerbread House of Horrors: FDA Issues Warning Regarding Raw Cookie Dough

This week, the FDA and CDC issued a warning reminding holiday bakers to lay off the raw cookie dough. While most are aware that raw eggs used to make cookie dough or cake batter can contain salmonella, the FDA also noted that flour is a raw food product that has not been treated to kill germs such as E.Coli. Earlier this year, boxes of Duncan Hines cake mix were recalled after salmonella was detected in a box of Classic White Cake Mix in Oregon. It…
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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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