The FDA cited Lone Star Botanicals, Inc. after a facility inspection in the spring of 2023. The company manufactures seasoning blends as well as dry superfoods under the name Dr. Botanical Health. The warning letter listed several infractions, but we are going to focus on the misbranding of Dr Botanical Health superfoods as conventional foods when the claims are in violation of that classification.
more “Lone Star Botanicals warned of misbranding violations”
MoCRA has granted the FDA greater authority to the industry than ever before. The FDA will now have the authority to inspect facilities, access records, request voluntary recalls, as well as order mandatory recalls. Due to the new regulations set to go into effect July 2024 the interactions and oversight for the FDA in the industry will drastically increase.
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:
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.
We live in a constantly evolving world and today more than ever customers are combing through labels and scrutinizing the foods they are consuming. Companies are now listening with ears wide open to what the concerns are. In the food industry over the past few years there has been two driving forces behind changes in the industry, one is the consumers movement for “clean labels” and the other is the over 20 years in the making labeling reform. Both changes underline the same key concept, transparency. One of the important aspects of transparency is it simply builds trust and gives the food industry more motive than ever to meet consumer demand.
In 2011, the Food Safety Modernization Act (FSMA) was enacted into law, much of which created statutes to improve not only the capacity to detect but also the capacity to prevent food safety hazards. As 2017 marks the first year of full compliance food manufactures to importers are all impacted by its’ goal of preventing the contamination of all food products. Several additions to the law will focus on food suppliers having both backward and forward traceability.
more “Expanding the Requirements of Packaging Within the Food Supply Chain”
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.
The two final rules that the FDA issued pertain to food and supplement labeling as well as a rule that will amend reference amounts customarily consumed (RACCs) and regulations around serving sizes. These changes are made to help consumers make better informed decisions about the food they eat. more “New Serving Sizes”
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?