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May 10 — The Food and Drug Administration says it will take a new look at regulations governing when a company may use the word “healthy” on food labels.
“In 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,' ” the FDA said in e-mail sent to Bloomberg BNA May 10.
Nutrient content claims generally are statements that characterize nutrient levels in a product.
Kind LLC, the maker of several types of popular snack bars, filed a citizen's petition with the FDA in December 2015 asking the agency to look into the use of the term on food and beverage packaging.
The petition followed a March 2015 warning letter saying some bars had too much fat to be called “healthy” under relevant regulations .
Nuts, a significant ingredient in Kind Bars, pushed some varieties over the regulatory labeling limit for saturated fat, FDA said.
Justin Mervis, Kind's vice president and general counsel, said he is pleased the agency is acting on the company's petition.
“We're thrilled,” Mervis told Bloomberg BNA in an interview May 10. “We're happy the FDA is recognizing this is the thing to do.”
“We are hoping they will start to get the thinking together to engage in rulemaking” he said.
No word yet from the agency on when the next steps might happen.
“So far we have established our intent to revisit Nutrient Content claims including ‘healthy' after completing the Nutrition Facts label rule,” an FDA spokesperson said May 10. There is “no timeline.”
But, the agency said, “We plan to solicit public comment on these issues in the near future.”
Kind received some other good news from the agency recently.
In April, the FDA said Kind could use the word “healthy” on its products as long as it didn't appear on the same label panel as any other nutrition-related statement.
Wording on the Kind Bar wrapper, which the company has since removed, included the phrase “Healthy and Tasty” in an “About Kind” statement that also described the company's products as “convenient and wholesome, economically sustainable and socially impactful.”
The agency's actions potentially could affect food labeling litigation over use of the word “healthy,” defense attorneys representing food and beverage makers said
Justin Prochnow told Bloomberg BNA May 10 in an interview he thinks the agency's actions will stave off some suits challenging “healthy” on food labels.
Prochnow, of Greenberg Traurig in Denver, also said companies now may be able to make an argument that the word “healthy” on the label isn't tied to a nutrient content claim, following the FDA's April notice to Kind that it could use the term in certain contexts.
Another defense attorney agreed the FDA's show of interest could potentially put civil litigation on hold.
“Given pending citizen petitions on the issue—and FDA’s clear indication that it is going to seek out comments regarding its healthy regulations and conform the regulations to current nutrition science—litigation challenging healthy labeling should stand down in favor of FDA’s primary jurisdiction,” defense attorney Dale Giali told Bloomberg BNA May 10.
Giali, of Mayer Brown, represents Kind in some related suits filed against the company.
Under primary jurisdiction theory, a court may stay or dismiss a civil suit pending an agency's disposition of the matter at issue.
In the context of food labeling litigation, many suits were stayed after the FDA sought public input on use of the word “natural” on food and beverage labels.
Recently, the U.S. Court of Appeals for the Ninth Circuit stayed a suit challenging yogurt labels, saying resolution must await the FDA's determinations regarding the meaning of “natural” and whether “evaporated cane juice” could be used to describe a sweetener(17 CLASS 339, 4/8/16).
In Kind's case, more than a dozen consumer suits followed the FDA's warning letter.
Those lawsuits, alleging the bars were labeled deceptively, were consolidated in the Southern District of New York (16 CLASS 871, 8/14/15).
Kind's December citizen petition asked the FDA to update its regulations to bring use of the term “healthy” in line with current nutrition science and federal dietary guidelines.
Current thinking emphasizes the importance of eating certain foods, including vegetables, fruits, whole grains, seafood, nuts and seeds, the company's petition said.
“We had to have two conversations,” Mervis said at a recent conference: one about the warning letter and one about the broader policy conversation. “We filed the petition to open that dialog.”
Prior federal guidance placed greater emphasis on the specific nutrient levels in the diet rather than the overall contribution of recommended foods, the petition said.
“Many current federal labeling regulations are based upon this past thinking, preventing foods that contain beneficial whole ingredients and are recommended for consumption—like nuts, avocados, olives, and salmon—from bearing the word ‘healthy' in their labeling,” Kind said.
Sugary cereal, low-fat pudding and low-fat toaster pastries, on the other hand, could be called “healthy” because the regulation doesn't address sugar, Mervis said.
“To have a regulation governing nutrients” but not food sources “didn't make sense,” Mevis told Bloomberg BNA May 10.
The revamped Nutrition Facts Panel, proposed in 2014, includes new serving sizes that will require other nutrient content claims to be adjusted because of the math, Mervis said.
“But to change the principles behind this, we'd like to think we made them focus on ‘healthy,' ” he said. It's about knowing “what's good to eat and what's not,” he said.
In April 2016, the agency confirmed in a closure letter that Kind had satisfactorily addressed the issues raised in the FDA's warning letter through its label modifications.
Although Kind changed its labeling, including removal of the “About Kind” statement, the company maintained that the phrase “healthy and tasty” described the company philosophy but wasn't a nutrient content claim governed by the regulations.
Kind also believed its use of “healthy” didn't implicate nutrient content regulations because it wasn't being used in connection with a nutrient statement, the company told FDA.
Kind sought further guidance from the FDA after receiving the closure letter.
In a separate correspondence April 22, the FDA said it “does not object” to the “About Kind” statement Kind wanted to place on bar wrappers, “on the condition that there will be no other nutrition-related statement” on the same label panel.
The FDA's action prompted a May 10 court filing, supporting Kind's motion for dismissal of the consumer suits.
There's no basis for the would-be class suits challenging Kind's “healthy” labeling statement, because the FDA now says the company may use the word, the company said (In re Kind LLC “Healthy and All Natural” Litig., S.D.N.Y., No. 15-02645, Notice of Material Development 5/10/16).
Tina Wolfson, who represents the plaintiffs, said May 10 she couldn't comment specifically on the aspects of the litigation related to “healthy” representations. However, she said the litigation also involves other labeling challenges, including non-GMO representations.
Meanwhile, Kind asked the court to take judicial notice of the correspondence with the FDA.
With the specific regulatory action on Kind's label, the plaintiffs' claim in the litigation evaporates, Mervis told Bloomberg BNA.
But the bigger policy question is the agency's response that it will look into the definition of “healthy,” he said.
Finkelstein, Blankinship, Frei-Pearson & Garber LLP and Ahdoot & Wolfson P.C. represent the plaintiffs.
Mayer Brown represents Kind LLC.
To contact the reporter on this story: Julie A. Steinberg in Washington at firstname.lastname@example.org
To contact the editor responsible for this story: Steven Patrick at email@example.com
Notice of material development is available at http://www.bloomberglaw.com/public/document/IN_RE_KIND_LLC_HEALTHY_AND_ALL_NATURAL_LITIGATION_Docket_No_115md/1.
The FDA's Warning letter is at http://www.bloomberglaw.com/public/document/IN_RE_KIND_LLC_HEALTHY_AND_ALL_NATURAL_LITIGATION_Docket_No_115md/2.
Letter to FDA from Kind's general counsel is at http://www.bloomberglaw.com/public/document/IN_RE_KIND_LLC_HEALTHY_AND_ALL_NATURAL_LITIGATION_Docket_No_115md/3.
Kind's Motion to dismiss is at http://www.bloomberglaw.com/public/document/IN_RE_KIND_LLC_HEALTHY_AND_ALL_NATURAL_LITIGATION_Docket_No_115md/5.
The citizen petition is at http://src.bna.com/eRD.
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