Opinion ID: 867071
Heading Depth: 2
Heading Rank: 2

Heading: Cholesterol Claims

Text: Young contends that the FDCA does not preempt his action with respect to the Cholesterol Claims because he seeks to enforce state law requirements that are identical to regulations prohibiting false and misleading health claims. Young argues that the District Court failed to distinguish between “Defendant’s false claim that Benecol as a whole is ‘Proven to Reduce Cholesterol’ [and] the FDA-approved claim that plant sterol/stanol esters are ‘Proven to Reduce Cholesterol.’” (Appellant’s Opening Br. at 26.) Two interrelated FDA regulations, 21 C.F.R. §§ 101.14 and 101.83, govern the Benecol Cholesterol Claims. J&J’s claim that the product is “Proven to Reduce Cholesterol” is a “health claim” subject to 21 C.F.R. § 101.14 because it is based on the fact that the product includes particular amounts of plant stanol esters, and therefore “characterizes the relationship of a[] substance to a disease or health-related condition.” Id. § 101.14(a). Food labeling may not include a health claim, whether express or implied, unless the claim is “specifically provided for” in 21 C.F.R. §§ 101.70-83, and the claim “conforms to all general provisions of [§ 101.14].” Id. § 101.14(e)(1), (e)(2). The general provisions of § 101.14 require, inter alia, that health claims must be “complete, truthful, and not misleading.” Id. § 101.14(d)(2)(iii). The Benecol Cholesterol Claims also come under 21 C.F.R. § 101.83, which specifically provides for health claims “which summarize the relationship between diets that include plant 8 sterol/stanol esters and the risk of [heart disease] and the significance of the relationship.” Id. § 101.83(d)(3). Young argues that J&J’s claim that its product (rather than the plant stanol esters the product contains) is “Proven to Reduce Cholesterol” is not “specifically provided for” in §§ 101.70-101.83 (as required by § 101.14(e)), and that it violates § 101.14(d) because it is false and misleading. The first argument is directly contradicted by § 101.83, which permits a food product to make a health claim based on plant stanol esters if “the food product ... contain[s] ... [a]t least 1.7 g of plant stanol esters ... per reference amount customarily consumed of the food products eligible to bear the health claims, specifically spreads ... .” 21 C.F.R. § 101.83(c)(2)(iii)(A)(2) (emphasis added).6 Thus, “[t]he regulations state the minimum amount of plant stanol esters that a product must contain before it can bear health claims, but[] ... do not require that products show that they effectively reduce cholesterol as formulated.” Reid v. Johnson & Johnson, No. 11-cv01310-L-BLM, 2012 WL 4108114, at  (S.D. Cal. Sept. 18, 2012) (internal quotation marks omitted). Young’s second argument, that the “Proven to Reduce Cholesterol” claim is false and misleading, rests on the assertion that the claim is expressed with reference to the product itself rather than to the plant stanol esters it contains, and that the product 6 In 2003, the FDA reduced the amount of plant stanol esters required for a food to make the health claims listed in 21 C.F.R. § 101.83 to 0.4 grams per serving, and a total daily intake of 0.8 grams, but the regulation was not revised to reflect that change. Benecol contains more than those required amounts, and Young does not appear to challenge Benecol’s ability to make cholesterol-lowering claims based on the amount of plant stanol esters it contains. 9 contains harmful trans fats. Both of those facts are irrelevant. It is of no consequence that the claim may be read as referring to the product rather than to the plant stanol esters it contains because the regulations expressly authorize the product to make the health claim. See 21 C.F.R. § 101.83(c)(2)(iii)(A) (describing the “[n]ature of the food eligible to bear the claim” in terms of the amount of plant stanol esters that the “food product shall contain”). Also, the regulations set forth a “model health claim” that speaks in terms of “[f]oods containing” and “servings of foods containing” the specified amounts of plant stanol esters. Id. § 101.83(e)(2)(i), (e)(2)(ii). Likewise, the fact that Benecol contains small amounts of trans fats does not render its Cholesterol Claims false and misleading because the Cholesterol Claims are authorized by the regulations based solely on the product’s plant stanol ester content, without reference to other nutrients such as trans fats. Id. § 101.83(c)(2)(iii)(A)(2). In summary, J&J is permitted to make heart health claims that relate to Benecol based on the product’s plant stanol esters content. The Cholesterol Claims are authorized by FDA regulations and are not false or misleading. Because Young’s state law action seeks to impose standards that are not identical to those set forth in the regulations, it is expressly preempted by the NLEA as it relates to those claims. 10