22 Sep Label Compliance: What you need to know
The Food and Drug Administration (FDA) and Occupational Safety and Health Administration (OSHA) along with several other federal administration organizations are proposing new regulations on the way we label food products, medical devices, and hazardous materials. If your business has not started to review the proposed changes and take the necessary steps to prepare – you may already be behind.
Food Label Compliance
The FDA Food Labeling regulations issued March 2014. Labeling on nutritional facts & ingredients must reflect the changes to regulations including allergen information, font size, origin of product, and more details on ingredients.
FDA Releases Supplemental Proposed Rule for Nutrition Facts Label – July 2015:
The look of nutritional labels are required to have adjustments made for more clarity and also for an ‘easy read’ which calls for larger and bolder fonts in some areas and things such as calories, fats, and saturated fats being presented first.
Allergens will also be included in the overhaul on the labels of food products. Food products containing allergens must be more prominently displayed in the ingredients list by some way such as being bolded or highlighted.
Font sizes on labels can be very small especially when you have a product that has a small container. There will now be guidelines based on the amount of space provided to ensure a legible font size.
The regulations on the origin have changed as well. Now it will be required to state where ingredients for the product came from in addition to the place the food was processed/manufactured.
More information on the proposed changes to the Nutrition Label
UDI (Unique Device Identification) Label Compliance
Unique Device Identification (UDI) is a system used to mark and identify medical devices within the healthcare supply chain.
UDI Compliance requires the following:
- All Applicable Systems and procedures must include the UDI
- Packaging and Devices must be accurately labeled
- A Device Identifier (DI) or unique numeric/alphanumeric value specific to the model device.
- Production Identifiers (PI) -optional- include information in Automatic Identification and Data Capture (AIDC) format such as lot number, serial number, manufacture date, and expiration date.
- All Device Identifier information must be loaded into the Global Unique Device Identification Database (GUDID).
Deadlines are here!
The UDI deadline for implantable, life-supporting, and life-sustaining devices is September.
The components of a UDI Label
Both device manufacturers and re-labelers must comply with UDI regulations.
For additional UDI compliance information click here or contact an AB&R® Label Specialist.