No Love from FDA

**FDA Warns Bakery it Cannot Label “Love” As An Ingredient **                                                                                                                                                                                                                                                                                                                                                                                                                     

A warning letter published by the Food & Drug Administration and issued to Massachusetts-based Nashoba Brook Bakery highlights that FDA has little tolerance for eccentricity when it comes to labelling compliance.  According to the letter, Nashoba sold granola with labeling that said that one of the ingredients was “love.”  Charming as that may be, FDA was not impressed,  writing that “Ingredients required to be declared on the label or labeling of food must be listed by their common or usual name . . . ‘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.”  It is not clear whether FDA was inspired by 2016 research that found that study participants rated identical food as superior in taste and flavor if they were told it was lovingly prepared using a family-favorite recipe.  We’ll see if there are any repercussions to the bakery from the FDA Love Letter – other than the free publicity it garnered.

For those who follow our blog, you’ll recall we have written in the past about KIND®, who was also on the receiving end of a not so kind letter asking the company to remove any mention of  “healthy” from its packaging and website.  Notably, later in 2016, the FDA had a change of heart – on April 22, 2016 emailing Kind  informing the company that it could return to its “healthy” language – as long as the use of “healthy” is in relation to its “corporate philosophy,” and not a “nutrient claim” (the latter being the statutory predicate under 21 C.F.R. § 101.65).  Unfortunately for Kind, the 2015 letter prompted a suite of lawsuits.  A number were filed in California: Kaufer v. Kind LLC., No. 2:15-cv-02878 (C.D. Cal), Galvez v. Kind LLC., No. 2:15-cv-03082 (C.D. Cal); Illinois and New York: Cavanagh v. Kind, LLC., 1:15-cv-03699-WHP (S.D.N.Y.), Short et al v. Kind LLC, 1:15-cv-02214 (E.D.N.Y).  Ultimately, a multi-district panel assigned the case to the Southern District of New York (In Re: Kind LLC “Healthy” and “All Natural” Litigation, 1:15-md-02645-WHP).  The cases in large part were voluntarily withdrawn after FDA sent its April 22, 2016 “change of heart” email.

That said, plaintiffs in the MDL case also made claims that Kind Bars are not “All Natural.”  The Court stayed the “All Natural” component of the action pending FDA’s consideration of the term under the primary jurisdiction doctrine.  Dkt. No. 83 (see also our previous post on primary jurisdiction “all natural cases.”)  Plaintiffs have recently sought to lift the stay, arguing that FDA is taking too long.  Dkt. No. 109.  Plaintiffs have also amended their “All Natural” claims to encompass the additional question of whether Kind’s “Non-GMO” statements comport with state GMO laws.  Kind responded by arguing that such state law claims are preempted by the National Bioengineered Food Disclosure Standard, Pub. L. 114-216 (“National GMO Standard”) (7 U.S.C. § 1639i).  Dkt. No. 101.  The Court has heard oral argument on the GMO preemption issue and the lifting of the stay, but is yet to rule on either.

 

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