United States: FDA Is KIND About Healthy And Tasty

As the self-appointed protector of consumers' ability to understand product labels, the FDA has again attempted to demonstrate what Mel Brooks made famous in his movie The History of the World, it's "good to be the king." In a March 2015 Warning Letter, the FDA threatened KIND LLC with, among other things, an enforcement action based on

Following a growing industry trend, KIND challenged the FDA by responding with a maneuver of its own—filing a Citizen Petition. Other industry companies have resorted to suing the FDA to fight enforcement actions. In December 2015, KIND LLC filed its Citizen Petition urging the FDA to "align with modern science and federal guidelines" and update the regulatory requirements related to use of the term healthy. KIND LLC has pulled back the curtain revealing that when industry goes on the offensive, the great and powerful Wizard of Oz is not invincible.

As the KIND LLC saga drew to a close, on April 20, 2016, the FDA issued a closeout letter, concluding that KIND LLC "satisfactorily addressed the violations contained in the warning letter." But there is a sequel to the story. In its May 10, 2016 Constituent Update, the FDA responded to KIND's plea that it be permitted to use the phrase "healthy and tasty."  The FDA states that it evaluated the label as a whole and found that "in this instance it does not object" when the labeling clearly presents a "corporate philosophy" to be "healthy and tasty." The FDA stated the terms are "not represented as a nutrient content claim and [do] not appear on the same display panel as nutrient content claims or nutrition information." Why this change of heart? According to the FDA, "[i]n our discussions with KIND, we understood the company's position as wanting to use 'healthy and tasty' as part of its corporate philosophy, as opposed to using 'healthy' in the context of a nutrient content claim."

More importantly, and in addition to being kind to KIND, the FDA announced that "[i]n light of evolving nutrition research, forthcoming Nutrition Facts Labeling final rules and a citizen petition, we believe now is an opportune time to reevaluate regulations concerning nutrient content claims, generally, including the term 'healthy,' [and we] plan to solicit public comment on these issues in the near future." The FDA has recently extended a number of olive branches on labeling content to industry, suggesting it may be becoming more lenient and accommodating when it comes to promotional labeling enforcement. Nevertheless, as industry anticipates upcoming changes while the FDA reevaluates its stance concerning nutrient content claims, it should not forget that the FDA is a regulator with no mandate to concern itself with freedom of speech.

The term "healthy" is only one of the terms that industry must grapple with in promoting food products. The term "natural" has also produced a confounding hubbub of controversy and expensive litigation. Coincidentally, May 10, 2016, the day the FDA backtracked on its enforcement over "healthy," also marks the deadline for the public to weigh in on the FDA's docket entitled "Use of the Term 'Natural' in the Labeling of Human Food Products." The controversy over the term "natural" has been a long-running show—coming to a location near you for more than twenty years. Most recently, the FDA received a citizen petition from Consumers Union in October 2014 (FDA–2014–P–1650) requesting that the FDA prohibit use of the term ''natural'' on food labels altogether. In a March 2014 citizen petition (FDA–2014–P–0312), the Grocery Manufacturers Association requested that the FDA ''issue a regulation." The Sugar Association submitted an earlier citizen petition (FDA–2006–P–0206), asking that the FDA engage in rulemaking to define the term ''natural'' with respect to food and beverages and looking for consistency across Federal Agencies on the definition of the term ''natural'' based on the USDA's Food Standards and Labeling Policy Book definition. All the while, a Perfect Storm of litigation has been brewing in California where parties and courts have begged the FDA to define the term "Natural." Despite these pleas, the FDA continues to refuse. Finally, adding to the clamor, Congress has produced a number of proposed bills that would require the FDA to provide a definition. All this controversy over food label terminology has demonstrated that regulating product-labeling speech is becoming increasingly difficult for the FDA.

While litigating against the FDA is a risky, expensive and time-consuming undertaking, for those industries, companies and products where specific words matter, challenging the FDA is paying dividends and producing positive results. FDA-regulated industry has entered a new era where science and the Constitution are co-starring in an effort to usher in a new era in product labeling. With the aid of science, the courts are refocusing on the limitations placed on government in 1791 with the ratification of the First Amendment to the Constitution, making the FDA's task more difficult.

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