FDA Approves First COVID-19 Drug: Veklury

The Food and Drug Administration (FDA) approved the first drug for the treatment of COVID-19. The antiviral drug Veklury (remdesivir), manufactured by Gilead Sciences Inc., is approved for use in hospitalized adult and pediatric patients 12 years of age and older. Veklury was previously issued as an emergency use authorization (EUA) in May 2020 following the National Institutes of Health’s clinical trial, which showed promising results in battling COVID-19. Under the Federal Food, Drug, and Cosmetic Act, approval of a new drug product requires substantial…
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FDA Issues Warning Letter for Off-Label Promotion of Drug to Treat COVID-19

The Food and Drug Administration (FDA) recently issued a warning letter to the manufacturer of an approved prescription drug for an off-label use to treat COVID-19 symptoms. Off-label use is defined as an approved prescription drug for unapproved conditions, patient groups, or dosages. While the FDA has previously pursued hundreds of fraudulent COVID-19 products, this appears to be the first warning letter addressing the unapproved use of an FDA-approved drug to treat patients with COVID-19. Currently, there are no FDA-approved COVID-19 products on the…
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FDA Announces Laboratory Testing Method for Hand Sanitizers

We have written before on some of the issues relating to hand sanitizers, including troubling information about how some people misuse hand sanitizers in dangerous ways and the FDA’s efforts to publicize information about various hand sanitizers identified by the FDA as being hazardous to users. The FDA has warned consumers not to use those hand sanitizers and has warned importers, consignees, distributors, retailers, and others not to distribute or sell those hand sanitizers, even if the corresponding manufacturers have not recalled them. Earlier this…
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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 with the help of an injury lawyer from https://www.braininjurylawyersorangecounty.com/ appears to have had the last laugh. The plaintiff filed a personal injury claim with the help of a personal injury attorney from www.kwdllp.com/workplace-accidents/ against the defendant in California state court for products liability and pursued theories of strict liability, negligence and breach of an express written…
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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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