The FDA warned two companies (Glister-Mary Lee Corp and Knickerbocker 365) for undeclared milk allergens on their finished product. The agency declared both companies’ products misbranded for failing to declare the allergens present in the product. The Act prohibits the introduction or delivery for introduction into interstate commerce of any food that is misbranded by section 301(a) of the Act [21 U.S.C. § 331(a)]
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.
The FDA cited Juicer Connections, Inc. after a facility inspection in late 2022. This warning letter highlights the labeling violations and the implications of those violations. The company was cited for HACCP monitoring, implementation, verification, and recordkeeping violations, but namely the misbranding label violations stood above all else. So, let’s dive into the warning letter!
more “Juicer Connections, Inc. warning letter doused with labeling infractions”
On April 13th, 2023, the FTC released warning letters to almost 700 companies stating that they can face penalties if they can’t substantiate health claims made. Although the list didn’t directly indicate wrongdoings, enforcement may be to come.
more “How to avoid the crosshairs-FTC Truth in Advertising Laws and the FDA coordination”
The FDA cited Vanlaw Food Products Inc. after three recalls over the course of 2022. This warning letter highlights the labeling violations and the implications of those violations. Far too often we see misbranding issues when it comes to allergen labeling, this can be problematic for companies not only from a logistical standpoint but from consumer trust as well. Let’s dive into the warning letter!
When a characterizing flavor is included in the product name or implied through a graphic, there are specifics that must accompany the flavor name in all locations on the package. It also must be presented in at least half the type size of the characterizing flavor name.
more “Flavor Qualifiers, creating the distinction with labeling”
Effective January 1st,2023 sesame will be added as the 9th major food allergen required to be labeled on packaging and monitored within manufacturing facilities under the regulations of FSMA and the FASTER Act.
more “Preventative Allergen Controls: How are manufacturers handling the requirements?”
If we could pick some of the most common issues companies face when it comes to FDA inspections and recalls, failure to control allergens and label misbranding are often at the top of the list. For this week’s warning letter highlight we are going to look at Ben Heggy Candy Co. which received a warning letter after a company inspection in the spring of 2022. There were numerous violations mentioned but sifting through the letter and highlighting the labeling violations we wanted to highlight certain infractions we see far too often.
more “FDA States Ben Heggy Candy Company is Lacking Control”
The FDA conducted an inspection of Amazon’s website and found several violations regarding claims, branding, and illegal products in the marketplace, all of which is discussed in the Warning Letter released.
more “Amazon Warned for Distribution of Unapproved Products”