FDA tells KIND it can use term ‘healthy’ on pack: ‘Our regulations on nutrient content claims are due for a re-evaluation’
KIND's 'healthy' saga began in March 2015 when bosses received a warning letter from the FDA noting that selected KIND bars (which contain a lot of nuts) did “not meet the requirements for use of the nutrient content claim ‘healthy’” as they contained too much fat per serving.
A flurry of lawsuits quickly followed as plaintiff’s attorneys accused KIND of violating consumer protection laws, prompting KIND to lodge a citizen’s petition with the FDA urging it to update 'outdated' regulations governing the use of the term healthy on food labels.
FDA: We do not object to the specific statement that you would like to place on your bar wrappers
And it appears to have paid off.
In correspondence with Justin Mervis, VP and general counsel at KIND, dated April 22, seen by FoodNavigator-USA, 16, Dr. Susan Mayne, Director of the Center for Food Safety and Applied Nutrition at the FDA, said:
“We do not object to the specific statement that you would like to place on your bar wrappers, on the condition that there will be no other nutrition-related statement, such as express or implied nutrient content claims, on the same panel of the label.”
And more significantly for the industry as a whole, she went on to say that the FDA is now looking again at the criteria underpinning nutrient content claims in light of KIND’s experience:
"We agree with you that our regulations concerning nutrient content claims are due for a reevaluation in light of evolving nutrition research.”
"The current FDA definition of healthy is notably out of alignment with the recommendations of the 2015 Dietary Guidelines for Americans. It also doesn’t align with what most reasonable people, health experts or nutritionists would consider to be sound nutritional science or dietary advice. For example, sugary cereals, salty canned soups or highly processed albeit low fat TV dinners are allowed to be called 'healthy,' but nuts, salmon or avocado cannot since their fat content is too high.
"Though the enforcement discretion only applies to KIND, it means that other companies will likely begin to use 'healthy' on a broader range of products since FDA has to give similar treatment. We can expect to see the use of the word 'healthy' used more liberally by more aggressive marketers."
Melissa Musiker, director, global food, consumer products & retail practice lead, APCO Worldwide
Lawsuits should be dismissed, argue KIND’s attorneys
The FDA’s comments were immediately cited in court filings in the lawsuits over KIND’s labeling, with KIND’s attorneys calling for the cases to be dismissed in documents filed today: “FDA reversed its preliminary position as evidenced by Dr. Mayne’s response, and effectively declared that the way in which KIND had been using the word ‘healthy’ on its labels all along did not, and does not, violate 21 C.F.R. § 101.65, and is therefore permissible under the FDCA [Food, Drug & Cosmetic Act].
“Plaintiffs’ healthy claims should now be dismissed.”
What are the broader implications of this case?
Attorneys said it was good news for KIND, but too early to say what it meant for ‘healthy’ claims more generally.
One lawyer told FoodNavigator-USA: “FDA is now saying that the KIND statement it challenged in its March 2015 warning letter does not violate the regulations on ‘healthy so long as it is on a label panel in which there are no nutrient content claims – which was always the case. This is very significant, but it is specific to the KIND warning letter.
“As a separate issue, FDA is going to consider amending the healthy regulations to bring them up to date with current nutrition science.”
FDA: We’re going to look again at nutrient content claims
The FDA in turn, issued a statement clarifying the very specific nature of its apparent u-turn: “In our discussions with KIND, we understood the company’s position as wanting to use 'healthy and tasty' as part of its corporate philosophy [in a section called ‘About KIND’], as opposed to using 'healthy' in the context of a nutrient content claim. The FDA evaluates the label as a whole and has indicated that in this instance it does not object."
However, it added: “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.' We plan to solicit public comment on these issues in the near future.”
KIND CEO Daniel Lubetzky, meanwhile, said he felt vindicated, but added: “Our work remains far from done. A true success will come when the healthy standard is updated, empowering consumers to better identify the types of food recommended as part of a healthy diet.”
“FDA’s current regulatory approach for food labeling claims limits the ability of food producers to tell consumers that products containing certain foods—such as nuts, whole grains, seafood, fruits, and vegetables— are 'healthy' even though they are currently recommended as key components of a healthful diet.” Daniel Lubetzky, CEO, KIND
Good bad and ugly fats
The 2015 dietary guidelines advisory committee report does not recommend an upper limit for total fat and the FDA is itself proposing to ditch the ‘calories from fat’ requirement on the Nutrition Facts panel, because it is “not necessary to assist consumers in maintaining healthy dietary practices”.
Manufacturers should be allowed to make statements on pack (e.g. 'Nuts are part of a healthy diet') that are consistent with federal dietary recommendations and current scientific evidence, argues KIND.
However, food labeling regs still mandate that the term ‘healthy’ can only be used as a nutrient content claim to describe foods that contain 3g or less total fat and 1g or less of saturated fat per serving, with the exception of fish and meat (which are subject to slightly different criteria).
In other words, says Lubetzky, the regulations require that the majority of foods marketed as healthy must also meet the criteria for ‘low fat’ and ‘low saturated fat’ claims, “regardless of their nutrient density,” which means that fat-free puddings and sugary cereals can be labeled as ‘healthy’, while “nutrient-rich foods such as nuts, avocados, olives and salmon” cannot.
"For food companies – for whom a 'healthy' designation can mean millions of dollars in extra sales – the FDA’s new stance likely will reshape the marketplace. More immediately, the FDA’s move will likely lead to a pause in the extensive litigation against the food industry regarding allegedly deceptive 'healthy'labeling, as the courts wait for the FDA to take a position."
Chip Magid, partner at international law firm Dorsey & Whitney
