In the past year, FDA has made considerable progress (in most cases), fine-tuning the regulations on foods and dietary supplements, including the updates and changes to the Nutrition Facts Panel, the promulgation of the Generally Recognized As Safe (GRAS) final rule, release of the New Dietary Ingredient (NDI) draft guidance, etc. Though none of these listed above directly relates to claims, FDA has signaled its tightening stance on claims through warning letters and other ways, such as requesting public comments on certain claims (i.e. “healthy” and “natural” claims) appearing on product packages. Below is a synopsis of FDA’s position on regulating product claims in recent years and how it impacts food and dietary supplement manufacturers.
In March 2016, a court case which has lasted for eight years between POM Wonderful LLC v. The Coca-Cola Company finally closed with the court rejecting POM Wonderful’s allegations that Coca-Cola’s pomegranate-blueberry flavored drink had misleading label claims. Although this Minute Maid product only contains 0.3% pomegranate juice and 0.2% blueberry juice and is primarily comprised of apple and grape juices, according to the court’s decision, it is acceptable as “Enhanced Pomegranate Blueberry Flavored 100% Juice Blend”.(1) Interestingly, during this case, one argument from Coca-Cola was the assertion of an affirmative defense of unclean hands to POM, which involved how POM utilized “health claims” not supported by “substantial scientific evidence” to advertise and promote its pomegranate juice.(2) In early 2015, the DC Circuit affirmed, in response to an allegation from Federal Trade Commission (FTC) to POM, that many of POM’s ads contained false or misleading claims which indicate how POM products can reduce the risk of heart disease, prostate cancer and other disease and health conditions.(3,4)
This allegation of false and unsubstantiated claims dates back to 2010, when FTC took action against POM. In the same year, FDA issued a warning letter to POM stating that claims made on POM’s website promoted unsubstantiated drug claims that the product can cure, mitigate, treat or prevent diseases.(5) POM was not the only company having trouble with claims at that time. In March 2010, FDA notified 17 food companies, including both large brands such as General Mills and Nestle Nutrition Gerber and smaller brands, with warning letters on misleading claims.(6) If not handled appropriately, it could be very costly for a company to respond to such warning letters. Products may need to be recalled from the shelf and new labels might have to be generated. Costs to the company could include direct revenue losses due to consumer perceptions and mistrust which could be largely influenced and manipulated by social media. The damage could extend to the brand and even a company image, which may have taken years to establish and would need to be rebuilt after such media exposures. Even worse, litigation could be triggered, including class action lawsuits. From this POM claim case, manufacturers should be aware that a solid foundation of supporting data should be constructed prior to making product claims, which means either having a regulatory team to closely check for compliance of product claims with current FDA requirements or requesting professional help from third-party consultants for label compliance and claim support.
A recent example of how a company was put under the spotlight by FDA regarding claims is Hampton Creek, the manufacturer for Just Mayo spread. In August 2015, FDA warned Hampton Creek about its alleged misleading name and imagery used on the label, as well as an unsupported nutrient content claim and an unauthorized health claim.(7) According to the warning letter, Hampton Creek failed to meet the requirements for a nutrient content claim “cholesterol free” on the label. Based on the regulations, if the reference amount customarily consumed (RACC) is small, the level of total fat in a serving would have to be disclosed on the label, which Hampton Creek failed to do so.(8) In addition, the website contained an unauthorized implied health claim on the reduced risk of heart disease, but the product contained too much fat to qualify for such a claim.(8) After this warning letter, some attorneys commented that litigation could follow, just like the case with KIND, the nut bar manufacturer.(7)
In March 2015, FDA issued a warning letter to KIND which used the word “healthy” on some of its products not qualified for such claims. According to FDA, products that could be claimed as “healthy” need to meet a very specific definition and a list of other requirements, among which one requirement is to contain one gram or less saturated fat, and those KIND products picked by FDA in the warning letter failed to meet this specific requirement. Additionally, some of the KIND bars bear a plus sign on the labels, to indicate extra antioxidants, fiber, or protein. However, to be able to qualify for such signs, the product needs to contain 10% more of the nutrients than a product considered as representative of that category by FDA.(9) Within 10 days of the letter’s publication, three lawsuits were filed against KIND, alleging misleading marketing by the company.(10) After the warning letter, KIND filed a Citizen Petition in December 2015 which cited the current limitations of how FDA defines “healthy” as simply based on macronutrients, but precluding many whole foods that contain nutritious fats, such as nuts, avocado and salmon. In May 2016, after re-evaluation of the term “healthy”, FDA said that KIND can keep “healthy” label.(12) Now FDA has issued a draft guidance for industry regarding the use of “healthy” on labels for human food products and is still requesting public comments.(11) Although KIND may have had some bitter days after FDA’s warning letter, its strategy on reevaluating current labels versus FDA requirements, and how to best position and defend itself when interacting with FDA, is well deserved as learning examples for their peers.
Not only do products claimed as “healthy” need to pay attention to FDA’s requirements on using this term, but those claimed as “natural” also have to watch closely as how FDA moves regarding this labeling term. In November 2015, FDA started to seek comments on use of the term “natural” on food labels. There had been citizen’s petitions requesting FDA to either clearly define or prohibit this term on food labels.(13) Issues related to natural claims have been centered on whether ingredients such as high fructose corn syrup, GMOs and others should belong in a product labeled as “all-natural”.(13) The comment period closed in May 2016, yet FDA has not released a guidance regarding this issue.(14)
In the updated Nutrition Facts Panel (NFP) announced in May 2016, not only have the format and content of the NFP been changed, more subtle changes come from the new recommended daily values for food ingredients such as salt and fiber. With a reduced recommended daily value for salt and an increased recommended daily value for fiber, product claims, especially nutrient content claims, and even health claims will be impacted.(15) Products that bear nutrient content claims such as “low in salt” or “high in fiber” based on previous standards may no longer be qualified for these claims in the new context. On the other hand, FDA continuously checks on products on the market that violate claim requirements and issues warning letters. The best advice for manufacturers today is to ensure regulatory compliance of products in the first place, and to build on that, always keep current with FDA’s moves and updates, either with the help of an in-house regulatory team, or professional regulatory consultants. In addition, manufacturers need to constantly check for any possible misinterpretations by FDA regarding the manufacturer’s current product claims and labeling, and new opportunities arising with regulation changes.
(1) Ikeda T, Blackburn JS. Coca-Cola defeats POM Wonderful’s misleading labeling claims: a key takeaway for food and beverage manufacturers. March 25, 2016; Available at: http://www.lexology.com/library/detail.aspx?g=e441f0dd-34eb-4183-864b-b7dee87f978f. Accessed December 27, 2016.
(2) Valkenaar L, Perloff S. Long legal battle ends with jury victory for Coca-Cola in pomegranate juice dispute. April 5, 2016; Available at: http://www.thebrandprotectionblog.com/long-legal-battle-ends-with-jury-victory-for-coca-cola-in-pomegranate-juice-dispute/. Accessed December 27, 2016.
(3) Lexology. Jury finds Coca Cola’s pomegranate beverage did not mislead consumers. March 25, 2016; Available at: http://www.lexology.com/library/detail.aspx?g=48d7695f-7663-4d79-b49f-c8d2e976a05b. Accessed December 27, 2016.
(4) Grant K. DC Circuit Court puts limits on FTC’s advertising substantiation requirements. February 3, 2015; Available at: http://www.thebrandprotectionblog.com/dc-circuit-court-puts-limits-on-ftcs-advertising-substantiation-requirements/. Accessed December 27, 2016.
(5) Starling S. FDA says POM Wonderful antioxidant claims not so wonderful. March 3, 2010; Available at: http://www.nutraingredients-usa.com/Regulation/FDA-says-Pom-Wonderful-antioxidant-claims-not-so-wonderful. Accessed December 27, 2016.
(6) Layton L. FDA warns 17 food companies of misleading claims on labels. March 4, 2010; Available at: http://www.washingtonpost.com/wp-dyn/content/article/2010/03/03/AR2010030303119.html. Accessed December 27, 2016.
(7) Watson E. FDA warning letter to Hampton Creek could trigger new wave of lawsuits, predict attorneys. August 25, 2015; Available at: http://www.foodnavigator-usa.com/Regulation/FDA-warning-letter-to-Hampton-Creek-could-trigger-lawsuits. Accessed December 27, 2016.
(8) FDA. Warning Letter to Hamton Creek Foods 8/12/15. August 12, 2015; Available at: http://www.fda.gov/iceci/enforcementactions/warningletters/2015/ucm458824.htm. Accessed December 27, 2016.
(9) Rutsch P. Nut so fast, kind bars: FDA smacks snacks on health claims. April 15, 2015; Available at: http://www.npr.org/sections/thesalt/2015/04/15/399851645/nut-so-fast-kind-bars-fda-smacks-snacks-on-health-claims. Accessed December 27, 2016.
(10) Shanker D. First the FDA said KIND bars weren’t “healthy”, and now people are suing. May 7, 2015; Available at: http://qz.com/398647/first-the-fda-said-kind-bars-werent-healthy-and-now-people-are-suing/. Accessed December 27, 2016.
(11) FDA. “Healthy” on food labeling. September 28, 2016; Available at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm520695.htm. Accessed December 27, 2016.
(12) Kowitt B. In reversal, the FDA says ‘Healthy’ can return to Kind bar packaging. May 10, 2016; Available at: http://fortune.com/2016/05/10/kind-bar-healthy-fda/. Accessed January 3, 2016.
(13) Watson E. FDA seeks comments on use of the term “natural” on food labels. November 10, 2015; Available at: http://www.foodnavigator-usa.com/Regulation/FDA-seeks-comments-on-use-of-the-term-natural-on-food-labels. Accessed December 27, 2016.
(14) FDA. “Natural” on food labeling. September 14, 2016; Available at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm456090.htm. Accessed December 27, 2016.
(15) Heneghan C. 4 food and beverage categories facing steep challenges from FDA’s Nutrition Facts overhaul. June 7, 2016; Available at: http://www.fooddive.com/news/4-food-and-beverage-categories-facing-steep-challenges-from-fdas-nutrition/420182/. Accessed December 27, 2016.Tags: claims, FDA, warning letters