FDA and Pharmacy Weekly Digest - August 13

Alerts / August 13, 2019
Food/Dietary Supplements

States Enact Laws to Limit Use of the Term ‘Meat’ – A number of states have passed laws limiting the use of certain terms like meat, burger, etc., to describe plant-based foods, because such names mislead the consumer. Most recently, the states of Mississippi and Arkansas have been sued by plant-based food producers over these laws. 


Acting Commissioner Discusses Safe Importation – Acting FDA Commissioner Dr. Ned Sharpless announced, “[The] Safe Importation Action Plan we’re describing today is the result of the hard work by the dedicated staff of the FDA, in close collaboration with HHS and the White House, to identify potential pathways we can pursue to support the safe importation of certain prescription drugs. We’ve been keenly focused on ensuring the importation approaches we’ve outlined would pose no additional risk to the public’s health and safety. Specifically, the Safe Importation Action Plan outlines the government’s intention to pursue two pathways to allow safe importation of drugs originally intended for foreign markets.”

FDA Warns Consumers About Ingesting Certain Drink Products – The FDA issued a warning to consumers not to ingest specific drink products that “when mixed, develop into a dangerous bleach, which has caused serious and potentially life-threatening side effects

FDA to Hold Meeting About Allergenic Products – The FDA announced that it will hold a meeting “to discuss and make recommendations on the safety and efficacy of Peanut [Arachis hypogaea] Allergen Powder … indicated for treatment to reduce the risk of anaphylaxis after accidental exposure to peanut in patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy.”

FDA Issues Guidance on Fabry Disease – The FDA published a draft guidance titled “Fabry Disease: Developing Drugs for Treatment Guidance for Industry.” The guidance outlines “recommendations to sponsors regarding clinical trial design features that can support approval of drugs and biological products intended for the treatment of Fabry disease (FD).”

Medical Devices

FDA Holds Webinar to Address Sterilization Alternatives – The FDA announced a webinar “to spur the development of new approaches to device sterilization.”

FDA Provides Consumers Tips About Medical Devices During Hurricanes – The FDA set out a number of tips for the use of medical devices during hurricane disasters, including warnings about potential carbon monoxide problems when using generators to maintain power to medical devices.


FDA Asks Companies to Remove Certain Flavored Products – The FDA issued warning letters to four companies relating to 44 flavored e-liquids and hookah tobacco products. The FDA stated, “The products subject to the warning letters were introduced or modified after Aug. 8, 2016 – the effective date of the final rule that extended the FDA’s authority to all tobacco products. Any new tobacco product that does not meet the Federal Food, Drug, and Cosmetic Act’s (FD&C Act) premarket requirements is adulterated and/or misbranded and may not be legally marketed without authorization from the FDA.”


FDA Comments on Bulk Compounding Court Decision – The FDA commented that “the court agreed, finding that the agency’s method of determining whether there is a ‘clinical need’ for a bulk drug substance is consistent with the law.” The FDA reiterated its compounding work, noting that “compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product.”

Authorship Credit: Lindsay P. Holmes

Baker & Hostetler LLP publications are intended to inform our clients and other friends of the firm about current legal developments of general interest. They should not be construed as legal advice, and readers should not act upon the information contained in these publications without professional counsel. The hiring of a lawyer is an important decision that should not be based solely upon advertisements. Before you decide, ask us to send you written information about our qualifications and experience.