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From Health Law Daily, May 11, 2018

Label claims regarding health effects of nutrients, not preempted

By Rebecca Mayo, J.D.

Scientific claims about the health effects of a particular nutrient on a product label are not considered nutrient content claims and therefore not preempted by federal regulations regarding nutrient content claims. A district court dismissed state law claims against Atkins Nutritionals, Inc. finding that federal law preempted claims that challenged statements on Atkins labels that set forth an amount of net carbs and explained how the net carbs are calculated. However, the court found that challenges to label statements that were not nutrient content claims were not preempted (Fernandez v. Atkins Nutritionals, Inc., May 9, 2018, Curiel, G.).

The label. On the labels of its snack products, Atkins includes a calculation of the net carbs contained in that particular product. On the back of the product label, a formula statement indicates that Atkins calculates the net carbs by subtracting the fiber and sugar alcohols from the total carbs. This formula statement contains an asterisk next to the term "Net Carbs" which leads the reader to an explanation statement that indicates that fiber and sugar alcohols should be subtracted from the total carbs since they minimally implant blood sugar.

The claim. A consumer brought a putative class action against Atkins claiming that the label statements are fraudulent, misleading, and omit material facts. The consumer argued that contrary to the statement on the label, sugar alcohols do impact blood sugar. Additionally, the labels conflict with the diet espoused by Dr. Atkins in his 2002 book where he claimed that only fiber should be subtracted from the total carbs to calculate the net carbs. Atkins filed motions to dismiss each of the claims based on preemption.

Formula statement. In a previous ruling, the court noted that the consumer’s state law claims escape preemption only if Atkin’s net carbs claims either are not nutrient content claims, or are nutrient content claims but violate the applicable regulations. Both courts concluded that Atkin’s net carbs claims are express nutrient content claims because they are statements about the amount of nutrients in a product and those nutrients were of the type required to be discussed in the regulations. Further, since the formula statements discuss the same type of the same nutrients in Atkin’s products, the formula statements also are express nutrient content claims. The court held that based on the allegations, Atkin’s net carbs claims and formula statements are not false or misleading in any respect and therefore the claims are preempted.

Explanation statement. The court noted that the explanation statements do not discuss the content of any nutrient, but instead make a scientific claim about the health effects of a particular nutrient. The provision Atkins relies on in its preemption argument operates to preempt any state law requirement regarding nutrient content claims. Because the explanation statements are not nutrient content claims, the provision does not apply and the preemption argument fails.

If the explanation statements could be considered an express nutrient content claim as Atkins asserted it still did not comply with the applicable regulations because taking the consumer’s allegation that sugar alcohols do impact blood sugar as true, the explanations statements asserting the opposite are false. The consumer thus stated a plausible claim that Atkin’s explanation statements are false or misleading in violation of the FDA’s regulations.

The case is No. 3:17-cv-01628-GPC-WVG.

Attorneys: Andrea B. Bierstein (Simmons Hanly Conroy LLC) for Cheryl Fernandez. Grant J. Ankrom (Dentons US LLP) for Atkins Nutritionals, Inc.

Companies: Atkins Nutritionals, Inc.

MainStory: TopStory CaseDecisions FDCActNews SupplementNews FoodNews FoodStandardsNews LabelingNews PreemptionNews CaliforniaNews

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