Scarinci Hollenbeck, LLC
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201-896-4100 info@sh-law.comFirm Insights
Author: Scarinci Hollenbeck, LLC
Date: July 7, 2022
The Firm
201-896-4100 info@sh-law.comNestle Healthcare Nutrition, Inc. (Nestle) is facing a class-action lawsuit over claims that its Boost Glucose Control drinks help diabetic consumers manage their blood sugar levels. The case, Owen v. Nestle Healthcare Nutrition, Inc., was filed in New Jersey District Court. The suit alleges that Nestle makes druglike claims about the drinks, which have not been tested or approved by the Food and Drug Administration (FDA), and that the products mislead consumers into believing that the drinks help control blood glucose levels when in fact Nestle’s own study revealed they do not.
Plaintiff Steven Owen’s lawsuit involves Nestle’s BOOST-brand Glucose Control over-the-counter drinks with the name “Glucose Control.” As described in his complaint, the products are labeled “Glucose Control” and prominently state in bold, capitalized font that they “HELP MANAGE BLOOD SUGAR” and/or that they are “DESIGNED FOR PEOPLE WITH DIABETES.”
Plaintiff, a diagnosed diabetic, purchased a 24-pack of BOOST Glucose Control in or around April 2022 from Amazon for $38.99. He claims that the products did not “control” his Glucose or “manage his blood sugar” as he expected it would in light of the product’s labeling. “Defendant’s prominent and systematic mislabeling of the Products and its false and deceptive advertising form a pattern of unlawful and unfair business practices that harms the public and, if unstopped, could continue to lead to substantial harm,” his complaint states. His proposed class-action suit includes claims for breach of warranty, breach of implied warranty, unjust enrichment, and violations of New Jersey consumer protection laws.
In his complaint, Owens specifically maintains that Nestle’s Boost products make unproven health claims. “Critically, Nestle’s marketing and labeling are tantamount to express and/or implied disease claims relating to the prevention and control of diabetes,” the suit alleges. “Such claims made on dietary supplements are prohibited as a matter of law and further render the claims misleading and deceptive.”
Under 21 C.F.R. § 101.14(a)(1), a health claim is “any claim made on the label or in labeling of a food, including a dietary supplement, that expressly or by implication . . . characterizes the relationship of any substance to a disease or health-related condition.” Thus, claims on food labels are governed by FDA’s health claims regulations if they include either express or implied references to both a substance and a disease. Pursuant to 21 C.F.R. § 101.14(e), health claims may not be made unless such claims are expressly reviewed and preauthorized by the FDA. A product that makes unauthorized health claims is considered misbranded pursuant to 21 U.S.C. § 343(r).
In his complaint, Owens contends that consumers could understand Nestle’s representations to mean that they can use the products to effectively control glucose levels and manage blood sugar. For instance, he alleges that the name of the Product, “BOOST Glucose Control,” is an implicit or express health claim because it purports to control a health-related condition, namely the inability to control glucose. He further maintains that Nestle’s statement that the products are “DESIGNED FOR PEOPLE WITH DIABETES” is an implicit or expressed health claim because it denotes a relationship between the drink and diabetes.
Owens’ complaint further alleges that Nestle’s product deceptively represents that they control and manage glucose. “Representations that the products control glucose and ‘help manage blood sugar’ conveys to the consumer that the products affirmatively do something to control blood sugar: that whatever one’s blood glucose is at the time they take the products, drinking the products will make it better,” the complaint states. “But this is false, as demonstrated by the clinical study that Nestle discusses on a part of its website.”
According to the complaint, Nestle’s own clinical trial found that the products were associated with a lesser rise in glucose levels as compared to a standard nutritional drink in people with type 2 diabetes. However, they did not show that they controlled blood sugar. “Shockingly, the Products do not control glucose at all, but rather only produce a slightly favorable response to glucose levels as compared to one other unidentified product,” the complaint states.
Given the rise in lawsuits alleging false advertising and mislabeling, food and drink manufacturers must be particularly cautious when making statements that may be construed as “health claims.” Such claims are highly regulated by the FDA and must meet stringent legal requirements. To avoid unintended liability, we encourage manufacturers to consult with experienced counsel.
If you have any questions or if you would like to discuss the matter further, please contact me, Pat McNamara, or the Scarinci Hollenbeck attorney with whom you work, at 201-896-4100.
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