BakerHostetler FDA and Pharmacy Weekly Digest - February 12, 2019

Alerts / February 12, 2019
Food/Dietary Supplements

Commissioner Gottlieb Announces Plan to Enhance Dietary Supplement Regulation – The FDA Commissioner Scott Gottlieb issued a press release outlining the FDA’s plan to modernize the regulation and oversight of dietary supplements. Enhancements include “communicating to the public as soon as possible when there is a concern about a dietary supplement on the market, ensuring that our regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation, continuing to work closely with our industry partners, developing new enforcement strategies and continuing to engage in a public dialogue to get valuable feedback from dietary supplement stakeholders.”

FDA Issues Letters to Multiple Companies With Products Claiming to Treat Alzheimer’s – The FDA issued 12 warning letters and five advisory letters to companies selling dietary supplement products claiming to treat Alzheimer’s disease. The products at issue have not been reviewed by the FDA and the majority of the products are being sold online.

FDA Announces Enhancements to Recall Public Warning and Notification Process – The FDA issued an announcement and a final guidance to address when a company should issue public warnings about its voluntary recalls. The guidance covers when warnings should be made, the time frame in which the warnings should be issued and the information that should be included in the warnings.


FDA Seeks to Enhance Drug Supply Chain Security – The FDA announced the launch of a pilot program where members of the drug supply chain “can pilot the use of innovative and emerging approaches for enhanced tracing and verification of prescription drugs in the U.S. to ensure suspect and illegitimate products do not enter the supply chain.” The program will provide information to the FDA for the development of the track-and-trace system that will go into effect in 2023 per the Drug Supply Chain Security Act.

Laboratory Recalls Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL – A drug facility announced the continuation of a voluntary recall of levetiracetam in 0.54% sodium chloride injection, 1,500 mg/100 mL infusion bags due to mislabeling.

Medical Devices

FDA Issues Guidance Exempting Certain Products From Premarket Notification – The FDA released an updated guidance titled “Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements.” The guidance outlines its intent to exempt a number of product codes in the following product categories from the premarket notification requirements: Ear, Nose and Throat Devices; Gastroenterology-Urology Devices; General and Plastic Surgical Devices; Neurological Devices; Obstetrical and Gynecological Devices; and Physical Medicine Devices.

FDA Continues to Educate Patients About the Risk of Breast Implants – The FDA issued an update on its continuing efforts to keep patients informed about the risk of lymphoma associated with breast implants. The FDA noted that it received 660 medical device reports regarding breast implant-associated large cell lymphoma since 2010.


FDA Targets Specific Retailers Related to Youth Tobacco Use – The FDA announced enforcement actions against two retailers “for repeated violations of restrictions on the sale and distribution of tobacco products, including sales of cigars and menthol cigarettes to minors.” The FDA is seeking a No-Tobacco-Sale-Order, which prohibits the sale of tobacco products for 30 days at specific locations, against each retailer.

FDA Posts Warning Letters Targeting Vape Companies – The FDA posted six warning letters issued to vape companies. Several of the letters allege that certain e-liquid products are misbranded because the products have been sold to a person younger than 18. Others allege that certain products are misbranded because their advertising is false or misleading.


Court Enters Permanent Injunction Against Compounding Facility – The FDA announced that the U.S. District Court entered a consent decree of permanent injunction against a compounding laboratory and the pharmacist owner of the facility. The consent order alleges that the facility produced sterile compounded products under unsanitary conditions. The consent decree prohibits the facility and pharmacist from manufacturing and distributing sterile compounded products.

Authorship Credit: Lindsay P. Holmes

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