From July 8-11, 2019, the FDA performed an inspection at California Cereal Products’ dry cereal manufacturing facility in Macon, GA. The inspection resulted in the Agency issuing a Warning Letter to the company. Although there were no label compliance issues to highlight from this one, the serious cGMP violations were almost TNTC (too numerous to count).
Four major observations of violations made it into the Warning Letter:
more “FDA Warns California Cereal Products”
There has been significant buzz in the industry around cannabidiol (CBD), however, the US Food and Drug Administration (FDA) has sent a firm reminder on the compound’s non-legal status. This past month the agency sent 15 warning letters to companies illegally selling products containing CBD. The companies were cited for marketing unapproved new human and animal drugs, selling CBD products as dietary supplements, and adding CBD to foods.
more “Is CBD Legal? – No”
Often found on packaging are claims that describe directly or imply the level of a nutrient in a serving. These claims are limited to those nutrients which are authorized by the FDA, and have established Daily Values. These types of claims can be used without direct review by the FDA, however there is still compliance based on the Code of Federal Regulations that must be adhered to. more “What are Nutrient Content Claims?”
Since the new regulations came out in 2016 one of the most talked about changes deals with the added definition for dietary fiber. Prior to 2016 the FDA did not have an “official” definition which allowed suppliers to base their total dietary fiber amount solely on analytical testing. Since then there have been dramatic updates to the regulations.
more “New Dietary Fiber Regulations”
In 2016, the FDA announced that it has finalized new rules that will make significant changes to nutrition labeling for the first time in more than 20 years, so what are these key changes?
- Removing the mandatory declaration of “Calories from fat” because research is showing that the type of fat consumed is more important than the amount.
more “Final Rule”