FDA’s “Love”-Less Warning Letter to a Boston Bakery: Food GMP Overkill?
[Posted on: Thursday, October 12, 2017] Last month FDA sent a Warning Letter citing GMP and labeling violations to a bakery based in the suburbs of Boston which could be perceived by many to be an example of overkill by the Agency auditors, and is some ways it is. The most outrageous statement in the FDA letter was to ding the company for listing “love” as one the ingredients of its products. The Warning Letter highlights violations that may be common in many food manufacturing facilities, particularly small companies. The story of this bakery may sound familiar to many similar small food facilities spread across the nation. Nashoba Brook Bakery is a small bakery in the suburbs of Boston that sells baked bread products on wholesale across greater Boston, and also runs a small retail store at the location of its manufacturing facility. The bakery has one manufacturing site that has been operational for about 20 years. The GMP violations cited by the FDA include inadequate cleaning of utensils, lack of control of cross-contamination of different products to avoid mixing of products containing allergens from the non-allergen ones, facility maintenance issues, pests (the FDA auditor found 5 flies and one crawling insect), improper storage of manufacturing equipments, and workers wearing loose jewelry such as earrings, bracelets and nose-rings while working in food production operations with an apparent risk of the jewelry coming in contact with food or may fall into the food being manufactured. A video on the website of the bakery shows workers in the facility without gloves, hair covers, and other measures to maintain GMP level hygienic practices. All these violations can be easily addressed and it seems the facility accepted the auditor’s recommendations and promised to address them. But the facility failed to respond to the FDA 483 in writing leading to the Warning Letter. It is the labeling deficiencies listed in the Warning Letter than should get all food manufacturers worried. FDA objected to phrases such as “whole wheat bread” because the bread also contained corn meal and wheat flour, “Natural Sourdough Starter”, and “A hearty whole grain loaf.” FDA cited a guidance document from 2006 for whole grain labeling requirements that most small manufacturers may not be aware of. And of course, FDA objected to use of the word “love” in the list of ingredients. The Warning Letter contends that "Love is not a common or usual name of an ingredient or part of the name of an ingredient.” Hence the product was deemed “misbranded”. According to 21 CFR 101.18, misbranding is defined as use of terms “which is false or misleading” to the consumer. Now, it is hard to know what was going through the mind of the person who wrote the sentences regarding “love” in the Warning Letter. While the violation is technically true, it is fair to assume that no consumer would be misled by the word “love” in the ingredients of a given food. Food manufacturers use creative words to describe how their food is manufactured or what it contains to differentiate from competition. The intent of the law was clearly to regulate false advertisement and deception but expanding that definition to include terms such as “love”, and “hearty”, is overkill. The irony is that due to that one “word” rest of the important findings could get ignored by other companies who could heave use this Warning Letter as a learning experience. That one finding risks indicating that all findings were frivolous, which clearly was not the case. FDA should take an approach to truly represent the intent of the law, and focus on clear findings rather than allow its Warning Letters to be mocked by media. The food manufacturers should also take FDA 483s seriously and respond to FDA in writing describing how they have addressed the findings in a reasonable time so such Warning Letters can be avoided.
|
|