Key legal and regulatory developments driving and shaping M&A
The US Food and Drug Administration does not have much of a sense of humor when it comes to the mandatory ingredient list on packaged food products. Last month, the FDA issued a Warning Letter to the Nashoba Brook Bakery in Concord, Massachusetts, for, among other violations, listing “love” as an ingredient in its granola and whole wheat bread, in violation of 21 C.F.R. § 101.4(a)(1), which requires the label or labelling of a food to display a list of ingredients, “listed by common or usual name in descending order of predominance by weight on either the principal display panel or the information panel.” According to the FDA:
“‘Love’ is not a common or usual name of an ingredient, and is considered to be intervening material because it is not part of the common or usual name of the ingredient.”
Accordingly, it concluded that the products were misbranded under 21 U.S.C. § 343(i)(2), which sets forth the ingredient listing requirement.
It does not appear, however, that the FDA targeted this bakery solely for its creative labelling: an FDA inspection earlier this year found numerous serious violations of the Current Good Manufacturing Practice regulations, including failure to clean and sanitize equipment, staff wearing jewelry while working in direct contact with food, and “[o]ne approximately one inch long crawling insect underneath exposed ready-to-eat foods in the pastry area,” as well as other labelling violations. After being issued a listing of the FDA’s inspectional observations (FDA Form 483), the bakery provided no formal response to the FDA, triggering the Warning Letter.
This case serves as a warning that food companies should avoid creative license with ingredient lists, even when the reasonable consumer would clearly not expect the “ingredient”—in this case, love—to be in the product.
In this issue, we cover a broad spectrum of ‘hot button issues’ for boards and companies operating internationally.
© Norton Rose Fulbright LLP 2021