The Food & Drug Administration (“FDA”) oversees the regulation and safety of prescription drugs, over-the-counter drugs, and medical devices. This agency also oversees the regulation and safety of many food items and cosmetic products. Below are recent notifications by the FDA concerning the safety of medical devices, drugs, and food products:
Device Safety Notification
Smartwatches to measure glucose levels: The FDA recently issued a safety communication regarding the risks of using smartwatches to measure blood sugar levels. The FDA warns that it has not evaluated the safety and effectiveness of these tests. Likewise, the FDA has not approved them.
Primarily, the notice affects people with diabetes who must measure their blood glucose levels. Glucose levels determine how to manage diabetes. Importantly, accurate glucose measurements are necessary to determine how much insulin or other medication to take. Taking the wrong dose can lead to serious injury, including coma or death.
Any device that claims to measure blood glucose levels without requiring a finger prick is subject to this warning. Multiple manufacturers sell the devices at issue and make the concerning claims. However, these devices are different from smartwatches that display glucose data after using an FDA approved device to measure glucose levels. The complete safety notification can be read here.
Dietary supplement recall
Vitamin D for infants: Nordic Naturals, the manufacturer of Nordic Naturals Baby’s Vitamin D3 Liquid, issued a recall of the dietary supplement. The recall was issued after the company realized a that some bottles contained elevated levels of vitamin D. Elevated levels of vitamin D are dangerous in small children.
The recalled vitamin D is used as a dietary supplement in children under 12 months of age. The bottles have a expiration dates of December 2025.
Food recall:
Cheese: Recent outbreaks of Listeria monocytogenes have been linked to Cotija and Queso Fresco cheese. As a result, the FDA has recalled these types of cheese. Not only are the cheese products recalled, but kits and meals that include the cheese are recalled.
Symptoms of Listeria monocytogenes include fever, muscle aches, and nausea. Sever symptoms include confusion, dizziness, and convulsions.
The affected products are sold at retailers across the country. A full list of recalled products can be found here.
If you have been injured by one of the aforementioned items, please contact the FDA.
