FDA and Pharmacy Weekly Digest - October 29

Alerts / October 29, 2019
Food/Dietary Supplements

FDA Releases Final Rule on Calorie Labeling for Products in Vending Machines – The FDA stated, “The rule issued today finalizes the 2018 proposed rule and requires that the FOP calorie declaration type size be at least 150 percent (one and one-half times) the minimum required size of the net weight declaration on the package of the food item. The FDA previously required that the type size for calorie information be at least 50 percent of the size of the largest printed item on the label for items being sold in glass-front vending machines with FOP labeling to convey calorie information to consumers.”


FDA Withdraws Homeopathic Drug Compliance Policy Guide (CPG) – The FDA announced the withdrawal of CPG 400.400, which was issued in 1988. FDA stated that the CPG “is inconsistent with our risk-based approach to regulatory and enforcement action generally and therefore does not reflect our current thinking.”

FDA Issues Statement on SUPPORT Act – The FDA reviewed the actions it took in the past year related to the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act. Actions include clarifying the FDA regulation of nonaddictive pain products, prescribing guidelines related to evidence-based opioid analgesics, coordinating with U.S. Customs and Border Protection, and curbing the entrance of illicit drugs.

FDA Publishes Guidance on Type V DMFs – The FDA release a draft guidance titled “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Industry.” The guidance identifies “the types of DMFs that may be submitted. A Type V DMF is intended for the submission of FDA-accepted reference information and supporting data that are not covered by DMF Types II–IV.”

Medical Devices

FDA Addresses Breast Implant Safety – The FDA issued a statement about its continued effort to protect women’s health. As part of this commitment, the FDA issued a draft guidance titled “Breast Implants – Certain Labeling Recommendations to Improve Patient Communication.” The guidance addresses “the content and format for certain labeling information for saline and silicone gel-filled breast implants.” The FDA issued the “draft guidance to help ensure that a patient receives and understands the benefits and risks of these devices.”

FDA Issues Statement on Concerns About Medical Device Sterilization – The FDA addressed the closure and potential closures of facilities that use ethylene oxide to sterilize medical devices. FDA stated, “This is why today we are urging medical device manufacturers that use ethylene oxide facilities to assess their inventory for any potential downstream impacts of sterilization facility closures on their product distribution. We are committed to working with manufacturers to look for alternative sterilization options. When manufacturers keep the FDA apprised of progress and obstacles encountered, it helps ensure that everyone’s best efforts are being made to mitigate any shortages and prevent potential shortages. When U.S. manufacturers are not able to resolve a shortage and it involves a critical device needed for U.S. patients, the FDA may look for a firm that is willing and able to redirect safe and effective product into the U.S. market to address a shortage.”


FDA Tells Company to Remove Almost 100 ENDS Products From the Market – The FDA notified “the company that nearly 100 flavored electronic nicotine delivery system (ENDS) products do not have the required marketing authorization, and thus cannot be legally sold in the United States, among other violations…the FDA notes in its warning letter today that [the company] violated the Federal Food, Drug and Cosmetic Act (FD&C Act) by marketing new tobacco products without authorization, including e-liquids in flavors such as mango, cotton candy, sour gummy worm and others.”


Organization Settles Federal Inquires Related to Co-Pay Assistance Programs – The organization stated that it “settled federal inquiries regarding allegations that pharmaceutical manufacturers previously engaged with charitable co-pay assistance programs in violation of the federal Anti-Kickback Statute. The settlement reflects the organization’s desire to move forward and concentrate on providing assistance to people in need of life-saving and life-extending treatments.”

Massachusetts Holds Hearing on Healthcare Cost Trends – The Massachusetts Health Policy Commission held a hearing on the healthcare cost trends of 2019. The hearing covered pharmacy benefits managers and strategies to address healthcare spending growth.

Authorship Credit: Lindsay P. Holmes

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