• FDA is in the process of updating its regulatory definition of the term “healthy” when it appears as an implied nutrient content claim on food labels. See FDA’s proposed rule published in September 2022. The current criteria for healthy claims (21 CFR 317.363) include limits for amounts of fat, saturated fat, cholesterol, and sodium, and also require foods to contain at least 10% of the daily value (DV) of one or more of vitamin A, vitamin C, calcium, protein, or fiber. The proposed criteria would establish a more complicated framework in which foods would be required to (1) contain at least one of the food groups or subgroups recommended by the 2020-2024 Dietary Guidelines for Americans (food group equivalents) and (2) would set limits for added sugars, saturated fats, and sodium. The required food group equivalents and the nutrient limitations would depend on product category.
  • The 2024 Consolidated Appropriations Act, which was signed into law in March 2024, includes provisions dealing with the effective date of any final rule FDA issues in connection with this proposal. Specifically, the Appropriations Act states that (1) food manufacturers may continue to comply with FDA’s current requirements regarding the term “healthy” on food labels throughout the compliance date FDA provides in the final rule establishing new criteria, and (2) any food products manufactured and labeled as “healthy” during the compliance period FDA provides in that final rule shall not be directly or indirectly subject to any state-law requirements that are not identical to either the current or updated FDA requirements. See Section 745. We read this language, particularly the words “directly or indirectly,” as being intended to preempt any lawsuits that might target “healthy” claims under state consumer protection laws.
  • We will continue to monitor and report on the updated healthy rule.  

Coca-Cola’s Juice Boxes Not Actually Healthy, Class Suit Says (subscription to Law360 required)

  • We have reported on FDA’s proposed rule for when foods can be labeled with the claim “healthy” on their packaging.  The proposed definition would permit the “healthy” claim on food products that contain a meaningful amount of fruit (or another specified food group) and adhere to specific limits for certain nutrients, including added sugars.  Under FDA’s proposed rule, the fruits group can include 100% fruit juice with no added sugars. 
  • On March 28, 2023, a proposed class action lawsuit was filed against Coca-Cola Co. over Minute Maid juice boxes bearing the statements “Good for You!” and “Part of a Healthy, Balanced Diet” and featuring images of whole fruit.  The plaintiff alleges that while a piece of whole fruit may be healthy, it is transformed into an unhealthy food when the natural food matrix is destroyed in producing juice, which concentrates and releases sugar from the fruit’s fiber.  The plaintiff asserts that Coca-Cola’s “health and wellness” messaging on these 100% juice products (e.g., Apple, Mixed Berry, et al.) preys on existing misconceptions that juice is healthy and the messages are false and misleading because scientific evidence (presented in the complaint) demonstrates that juice, like the Juice Boxes, increases risk of serious chronic diseases—such that authoritative bodies recommend avoiding or limiting its consumption.  The complaint also alleges that the juice box labeling violates FDA’s nutrient content regulations and fortification policy.
  • This new lawsuit involves complex issues, including the role of a single product in the total diet and whether sugar from fruits should be distinguished from “added sugars.”  In this regard, the Centers for Disease Control and Prevention (CDC), while recommending against juice for infants and stating that “juice after 12 months is not necessary,” also states that “4 ounces or less of 100% juice can be provided” for children over 12 months and recommends checking to be sure a juice product is 100% juice.  FDA’s proposed rule for “healthy” is in the early stages and some comments argue the definition should not apply to 100% juices that typically contain less dietary fiber than the whole fruit or vegetable. 
  • As we have previously blogged, last September FDA released a proposed rule with criteria for making “healthy” claims. In the proposed rule, FDA requested “comment on the eligibility of calorie-free beverages, coffee, and tea to bear the ‘healthy’ claim.”
  • Responding to this request for comment, various groups within the coffee industry, including the National Coffee Association, submitted comments to FDA which made the case for allowing healthy claims on coffee products. The comments cited a body of literature which indicates that coffee consumption is associated with many health benefits including reduced risk of cardiovascular disease and cancer, among others. The comments also note that the 2020-2025 Dietary Guidelines for Americans reference coffee consumption as part of a healthy dietary pattern when consumed with minimal sweeteners and/or creamers.
  • The American Heart Association also submitted comments which indicated its support for allowing coffee products to bear healthy claims provided that FDA is able to develop criteria which exclude coffee products which do not contribute to a healthy diet, such as those with added sugars or heavy creams.
  • We will continue to monitor and report on developments regarding the criteria for healthy claims.
  • On September 28, 2022, FDA announced that it had issued a proposed rule with criteria for when foods can be labeled with the claim “healthy” on their packaging. The proposed rule intends to align the definition of the “healthy” claim with the updated nutrition facts label, the current Dietary Guidelines for Americans, and current nutrition science.
  • The proposed definition would permit the “healthy” claim on food products that (1) contain a certain meaningful amount (determined using the daily recommended amount) of food from at least one of the food groups or subgroups recommended by the Dietary Guidelines (e.g., fruit, vegetable, dairy), and (2) adhere to specific limits for certain nutrients like saturated fats, sodium, and added sugars. The threshold for the limits is based on the percent of the Daily Value for the nutrient and varies depending on the food group.
  • With the proposed rule, FDA intends to empower consumers and help foster a healthier food supply by encouraging manufacturers to reformulate their food products to meet the updated definition. The agency is also considering the development of a symbol that manufacturers could use to demonstrate that their products meet the “healthy” claim criteria.
  • The proposed rule follows the White House Conference on Hunger, Nutrition, and Health as well as the release of the national strategy to end hunger and reduce diet-related diseases by 2030. FDA notes that it intends to continue taking steps to improve nutrition and health and that the agency’s future planned actions include developing a front-of-package labeling system, making nutrition information more easily available when grocery shopping online, and working to lower the sodium content of food in the food supply.
  • FDA is accepting comments on the proposed rule until December 28, 2022. Comments may be submitted by mail or electronically at regulations.gov (FDA Docket # FDA-2016-D-2335). Keller and Heckman will continue to monitor and report on any developments.
  •  We reported on FDA’s May 7, 2021 announcement of plans to conduct quantitative research studies to explore consumer responses to draft Front of Pack (FOP) symbols that manufacturers could voluntarily use on a food product as a graphic representation of the nutrient content claim ‘‘healthy.’’  FDA proposed an experimental study to be followed by two surveys.  FDA was required to collect comments on this proposal before submitting the plan for approval by the Office of Management and Budget (OMB) as required under the Paperwork Reduction Act (PRA).  The comment period on FDA’s plans closed July 6, 2021.
  • Today, March 28, 2022, FDA provided notice that plans to collect information have been submitted to OMB for approval of two consecutive quantitative research studies of consumer responses to the draft FOP symbols that companies could voluntarily use on packaged food as a graphic representation of the nutrient content claim “healthy.”  In response to comments on the plan put forth almost a year ago, FDA will reorder the research to perform the experimental study component first and will now conduct one survey with a larger sample size (instead of two surveys with smaller sample sizes).  FDA declined to make other changes in the experimental studies (suggested in 27 comments that were considered) including the use of images of real products, as opposed to mock images, and the use of online store settings or other naturalistic study environments.  FDA noted that later research may be necessary to address additional issues raised in the comments, such as the effect of other FOP symbols that may appear on the same package.
  • FDA maintains that the research proposal (OMB Control Number 0910-NEW) is not dependent on specific criteria for “healthy.”  Thus, while FDA’s Constituent Update promises that FDA intends to propose a revised definition “soon,” FDA contends there is no need to postpone the planned research on a “healthy” symbol until after the regulatory definition at 21 CFR 101.65(d) is updated.

 

Welch Inks $1.5M Deal To End Grape Juice False Ad Suit (Law360 Subscription Required)

  • Welch Foods Inc. (“Welch”) is seeking preliminary approval for a nationwide settlement of a class action lawsuit filed in US District Court for the Northern District of California by plaintiff Curtis Hansen in March of 2020.  Hansen alleged that the company falsely represented that its grape juice products, which contain a substantial amount of sugar, support heart health. The proposed settlement includes a $1.5M payout to class members who purchased the Welch’s grape juice products since March 23, 2016. In addition to the class payout, the settlement includes agreement for Welch’s to refrain from using heart healthy claims on some of its grape juice products for two years.
  • This is not the first time Welch’s has been the subject of litigation surrounding its heart health claims. A 2013 suit in the US District Court for the Central District of California challenged the company’s claim that its 100% grape juice “Helps support a healthy heart.”  Heart health claims made about cereal and snack products have been similarly targeted.
  • These and similar lawsuits challenge so-called structure function claims about the role of the advertised food in supporting or promoting heart health.  Unlike health claims, which associate a food or food ingredient with reduction of risk of a disease or health related condition, the Food and Drug Administration does not need to approve structure function claims, leaving them vulnerable to such class action challenges for their alleged false or misleading implications.
  • Keller and Heckman will continue to monitor and report on this and similar litigation outcomes.

 

  •  Since launching in 2018, the FDA Nutrition Innovation Strategy (NIS) has included the possibility of FDA introducing a new symbol that could be used to convey the nutrient content claim “healthy” on packaged foods, as well as related plans to update the regulatory definition of “healthy” at 21 CFR 101.65(d).  Currently, the term may be used as an implied nutrient content claim on the label or in labeling of a food that meets certain nutrient conditions, including specific criteria for nutrients to limit in the diet, such as saturated fat.  In the interim, while FDA works on the updated rule, as discussed here, FDA issued a guidance document stating that FDA does not intend to enforce the regulatory requirements for foods that use the implied nutrient content claim “healthy” on their labels which: (1) Are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or (2) contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.
  • On May 7, 2021, FDA announced the availability of a procedural notice regarding plans to conduct three consecutive quantitative research studies—an experimental study and two surveys—to explore consumer responses to draft Front of Pack (FOP) symbols that manufacturers could voluntarily use on a food product as a graphic representation of the nutrient content claim ‘‘healthy.’’  The first study will be a controlled, randomized experiment that will use a 15-minute web-based questionnaire to collect information from 5,000 U.S. adult members of an online consumer panel maintained by a contractor.  The second and third studies (surveys) will each utilize a 10-minute questionnaire to test sets of draft FOP symbols in a sample of 1,000 U.S. adult participants from an online consumer panel.
  • There is no news on any FDA progress in updating the regulatory definition of “Healthy.”  Comments on FDA’s proposed collection of information for the study, ‘‘Quantitative Research on a Voluntary Symbol Depicting the Nutrient Content Claim ‘Healthy’ on Packaged Foods,” are due by July 6, 2021.  After public comments are received, FDA’s consumer research plans will be submitted for approval from the Office of Management and Budget (OMB).

 9th Circ. Judge Doubts General Mills False Label Claims (subscription to Law360 required)

  • Proposed class action lawsuits against Kellogg, Post, and General Mills, with a common lead plaintiff in the Northern District of California federal courts, allege that “healthy” and other nutrition-related claims on various breakfast cereals are false and misleading because the cereals contain high amounts of sugar.
    • As we previously reported, the judge certified three classes of consumers in the case against Kellogg, and the case may be settled if an agreed upon deal is reworked to make it acceptable to the court.
    • A class was also certified in the lawsuit against Post, and the case is proceeding to trial after the judge found there is a material issue of fact as to whether the products are unhealthy given the amount of added sugar.
    • The case against General Mills was dismissed, however, with the judge finding that plaintiffs could not possibly have been misled because the amount of sugar in the cereals is clearly disclosed on the product labels.
  • On June 12, 2020, in a hearing by a three-judge panel of an appeal of the dismissal of the lawsuit against General Mills, a recently confirmed judge, Danielle J. Hunsaker, asked a line of questions regarding what amount of added sugar in a product makes the product unhealthy.  The judge reportedly was not swayed by the plaintiffs’ argument that a “healthy” claim is not appropriate on any product with added sugar.
  • While many consumers continue to be concerned about sugar in the diet, there are complex issues surrounding the impact on health of added sugars in a single product and a product’s role in the total diet.  Meanwhile, as it works on redefining the “healthy” nutrient content claim for food labeling, FDA has not indicated how it will act on a citizens petition (discussed here) requesting a regulation to establish disqualifying levels of added sugar that would prohibit the use of a “healthy” claim.
  • A group of seven CBD brands (Boulder Botanicals & Bioscience Labs, CBDistillery, CBD American Shaman, Charlotte’s Web Holdings, Columbia Care, HempFusion, and Kannaway) have committed to collectively sponsor ValidCare (a clinical trial outsourcing and market research company) in conducting observational research to evaluate the impact of daily CBD use (both full-spectrum, hemp-derived CBD and CBD isolate) on the liver function of healthy adults.
  • According to a press release issued by ValidCare on June 9, 2019, the liver study, the results of which will be provided to the U.S. Food and Drug Administration (FDA) for consideration in its efforts to regulate CBD, is scheduled to begin in July 2020 and expected to be completed by the end of this year.  The study intends to aggregate data from at least 700 consumers, which will be combined with information regarding personal history, blood tests, and product information.
  • Participants will be provided with oral CBD products from the study’s supporting brands for consumption in connection with the study.  Participants will be required to attest that they have used the products for at least 60 days prior to the start of the study, and continue consuming the products for the duration of the study.  Participants will document their CBD use and any observable effects for 30 days, and provide blood samples.  The study is observational (not a randomized double-blind placebo controlled human clinical study), and FDA’s treatment, consideration, and evaluation of these results has yet to be seen.  As previously reported here on this blog, FDA recently announced that it made “substantial progress” towards a goal of providing additional guidance on ingestible CBD products, but offered no specific details and continued to emphasize its ongoing questions and concerns about the science, safety, effectiveness, and quality of CBD products (which include concerns regarding liver toxicity).
  • We will continue to monitor the situation for any developments.
  • Consistent with similar efforts by FDA, USDA’s Food Safety and Inspection Service (FSIS) is initiating rulemaking to update its regulations on the term “healthy” in line with FDA’s 2016 updates to its nutrition labeling rules.  The rulemaking seeks to amend both 9 CFR 317.363(b) and 381.463(b).
  • FDA, in response to a Citizen Petition filed in December 2015 by KIND LLC, issued guidance in 2016 stating that it will exercise enforcement discretion for foods labeled as “healthy,” even though they do not comply with the definition under 21 CFR 101.65, when such foods (1) have a fat profile of predominantly mono- and polyunsaturated fats, but do not meet the regulatory definition of “low fat,” or (2) that contain at least 10 percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.
  • Both FDA’s and USDA’s initiatives seek to make its enforcement of the “healthy” definition more consistent with FDA’s 2016 changes to its nutrition labeling regulations.  Those changes refocused attention from lowering fat in the American diet to lowering sugar in the American diet.  The same changes replaced vitamins A and C with potassium and vitamin D as mandatory nutrients to be declared on food labels.
  • USDA is accepting comments until May 18, 2020.