Recalls Due to Undeclared Allergens Can Be Prevented

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)]

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Lone Star Botanicals warned of misbranding violations

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.

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Vanlaw Food Products Inc. cited for multiple recalls

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!

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FDA States Ben Heggy Candy Company is Lacking Control

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.

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Medina’s Inc. Warned for Misbranding and Missing Allergens

The FDA conducted an inspection at Medina’s Baking and Powder Products Inc. from August 31st, 2021 thru September 14th, 2021.  The inspections focused mainly on the liquid flavors and found serious violations at the food manufacturing facility.  The two main violations were around preventative control violations and misbranding, both of which is discussed in the warning letter released.

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Cedar’s Cited for Misbranding

From October 25th,2021 Cedars Mediterranean Foods Inc. a ready-to-eat (RTE) food manufacturing facility was notified by a consignee of a misbranded product. The item in question, Cedar’s Organic Mediterranean Hommus, was labeled with the ingredient declaration for Organic Everything Hommus and a voluntary recall was initiated.  The FDA determined that the recalled product was misbranded within the meaning of section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(w)], in that the finished product labels did not declare a major food allergen–tree nuts (i.e., Pine Nut).

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Dutch Letter Warning Letter

From September 13-15th, 2021 the FDA inspected a ready-to-eat (RTE) food manufacturing facility located in Iowa, called Picket Fence Creamery. The inspection resulted in the FDA issuing of a Warning Letter to the company.  During inspection FDA investigators found that twelve ice creams and three cheese curds were misbranded by having undeclared ingredients, sub-ingredients, allergens, as well as many packaging errors.

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Sassy Cow Gets Warned

From May 22nd – June 4th the FDA inspected a ready-to-eat (RTE) ice cream manufacturing facility in Wisconsin, called Sassy Cow Creamery. The inspection was initiated in response to a recall of mislabeled ice cream and resulted in the FDA issuing of a Warning Letter to the company.  During inspection FDA investigators found numerous severe violations which led them to determine that the products manufactured at the facility were held in unsanitary conditions and were deemed adulterated.

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