By Todd Harrison, Partner; Richard Starr, Associate; and Olisa Onyiuke, Associate, Venable06.02.22
If you are a marketer or manufacturer of dietary supplements, the specter of being sued in a class action over label and advertising claims is always present. This is especially true when making structure/function claims.
Recent court cases, however, cast doubt on whether a plaintiff can successfully sue a company over basic structure/function claims. A case out of the U.S. District Court of Massachusetts highlights this issue, but cases out of the 9th Circuit of Appeals also add more credence to the trend.
In Ferrari v. Vitamin Shoppe, Inc., No. CV 17-10475-GAO, 2022 WL 974048 (D. Mass. Mar. 31, 2022), a federal judge found that proposed class action allegations that Vitamin Shoppe, Inc. violated state statutes for false advertising and deceptive business practices were preempted by the Federal Food, Drug, and Cosmetic Act (FDCA) as amended by the Dietary Supplement Health and Education Act. While the opinion appears to present a unique perspective on the FDCA’s preemptive power for dietary supplement structure/function claims, the case can also be read to be consistent with “lack of substantiation” cases.
The added twist in Ferrari is the court found the plaintiff’s claims preempted because Vitamin Shoppe’s claims met the requirements of §403(r)(6) of the FDCA, which specifically allows dietary supplement companies to make structure/function claims if they have substantiation to support the claim.
The plaintiffs, Richard Ferrari and William Bohr, alleged that Vitamin Shoppe’s product labeling contained statements that induced them to buy the products, only to find out that the products did not yield the results they were promised. Vitamin Shoppe promoted its products by highlighting glutamine, the products’ major ingredient, as one that “has been shown to possess anti-catabolic properties to help preserve muscle,” “helps support muscle growth and recovery as well as immune health,” and “is involved in regulating protein synthesis.”
The plaintiffs alleged that they did not experience improved muscle growth after consuming the product, and that Vitamin Shoppe’s claims are unsubstantiated because the company disregarded several studies stating that glutamine had not been shown to promote muscle growth when abiding by the product’s intended use.
The District Court granted summary judgment in favor of Vitamin Shoppe on the premise that the plaintiff’s state law claims were preempted by the FDCA. The court specifically found that the FDCA creates statutory requirements for a structure/function claim and if those requirements are met, then the plaintiff’s false advertising cause of action is precluded.
In this regard, a structure/function claim must describe the general effects of a nutrient or dietary ingredient by which it may affect the structure/function of the body (and the claim does not apply to the finished product). This latter issue is of importance and is consistent with the trend to require a structure/function claim be tied to the ingredient as opposed to the whole product. (The logic of this position has always been nonsensical and should apply to the finished product, not just an ingredient claim. With that said, it has long been the position of FDA, the FTC, and NAD that the claim should be tied to the ingredient as opposed to the product.)
A company must have substantiating evidence and the product must include a disclaimer that the claim has not been evaluated by FDA. Lastly, the claim cannot expressly or implicitly imply that the ingredient diagnoses, treats, cures, or prevents a specific disease (i.e., not disease claim). (See 21 U.S.C.A. § 403(r)(6); 21 CFR 101.93(f).)
The court further reasoned that the FDCA prohibits states from creating any labeling requirement for dietary supplements that is “not identical to” the requirements articulated in § 403(r)(6). This means that any cause of action arising under a state law cannot create a different labeling standard than those of § 403(r)(6), and is preempted by the FDCA.
The court emphasized that a properly stated structure/function claim is neither inherently false nor misleading because the substantiation requirement is baked into the § 403(r)(6) requirements. The court then indicated that agreeing with the plaintiff’s argument would add additional requirements that are not included in § 403(r)(6). To state it differently, the court found that it was unnecessary for Vitamin Shoppe to overcome negative evidence as the claims properly described the role glutamine plays in the body.
The emphasis on glutamine as an ingredient as opposed to the product in general cannot be ignored. More specifically, the court is strongly suggesting if the claim relates to the established role a nutrient or dietary ingredient plays in the body then it, in essence, creates a safe harbor for companies even if there is evidence the dose level is not sufficient to support the claim.
Indeed, this makes sense as nutrients and dietary ingredients are supportive in nature. Absent a performance claim (e.g., “gain 10 pounds of muscle in 30-days”), the defendant properly described the role of glutamine. And there would be no desire on anyone’s part to conduct a clinical study to see if something is simply supportive when its role is already established and known.
The Ninth Circuit Court of Appeals has been grappling with this particular issue. In Dachauer v. NBTY, Inc., the Ninth Circuit held that FDCA, as amended by the Nutrition Labeling and Education Act, contains an express preemption provision that directly applied to structure/function claims (913 F.3d 844 (9th Cir. 2019)).
The plaintiff in Dachauer claimed that the defendant’s vitamin E supplements were misleading because the supplements did not prevent cardiovascular disease even though the labeling stated it promotes and supports cardiovascular, circulatory, and heart health.
Like the plaintiff’s argument in Ferrari, the plaintiff’s expert in Dachauer offered evidence that vitamin E supplements taken at the recommended dosage did not prevent cardiovascular disease. The court found that the FDCA preempted the state law claim so long as the structure/function claim was substantiated and met all of FDCA’s narrow requirements.
The court stated unequivocally that “manufacturers need not also have evidence that [vitamin E] structural or functional effects reduce the risk of developing a certain disease.” The court emphasized that this distinction is the whole point of the § 403(r)(6) structure/function claim carveout: to distinguish between the role a nutrient or dietary ingredient plays in supporting the structure/function of the body without requiring FDA-approval.
For example, in this case, preventing cardiovascular disease is an impermissible disease claim while supporting cardiovascular health is a permissible structure/function claim for a dietary supplement.
Similarly, the Ninth Circuit addressed another structure/function preemption case in Kroessler v. CVS Health Corp. The court held that the plaintiff’s claims were not preempted by FDCA’s standard (977 F.3d 803 (9th Cir. 2020)). The plaintiff alleged the defendant’s statements “supports flexibility” and “helps support and maintain the structure of joints” on its glucosamine supplements were false and misleading because it is known that glucosamine does not have those effects, and the defendant lacked substantiation for these structure/function claims.
The major difference here is that the defendant’s marketing stated that its glucosamine-based supplements as a finished product maintain or support joint health. The Ninth Circuit held that there was no preemption because a plaintiff can bring claims if alleging that the requirements of a structure/function claim have not been met, such as improper substantiation.
The court elaborated that the FDCA does not preempt state law (in this instance, California state law) because the challenged statement is a proper structure/function claim; but rather, preemption exists only if a “plaintiff’s legal claims and factual allegations would hold a defendant to a different substantiation standard than the FDCA.”
With that said, the 9th Circuit decision in Greenberg v. Target Corp. (985 F.3d 650 (9th Cir. 2021)) makes it clear there is no requirement that consumers derive health benefits from the supplement in line with the structure/function claims. Rather, the 9th Circuit held “[t]o substantiate [a structure/function] claim, supplement manufacturers need only show evidence that an ingredient has an effect on small aspect of the [specified bodily] structure/function.” (See Greenberg, 985 F.3d at 653.)
Similar to Ferrari , experts for both sides in Greenberg agreed that the nutrient biotin is known for its “cellular and biochemical role in the support of healthy hair and skin.” Furthermore, the defendant fulfilled all the FDCA structure/function requirements for its biotin supplements. Thus, the 9th Circuit ruled against the plaintiff and for the defendant because the claims were preempted.
More specifically, if the claim specifically describes the accepted role a nutrient or dietary ingredient plays in supporting the structure/function of the body, the claim should be dismissed since the claim is clearly permitted under the law and it accurately describes the known role the nutrient or dietary ingredient plays in the body. Stated differently, the emerging case law indicates that if the claim describes the known role a nutrient or dietary ingredient plays in the body and there is substantiation to support this role, the plaintiff cannot survive a motion for
summary judgment.
From a practical perspective, a company should consider tying the structure/function claim to specific nutrients whose mechanism of action or role it plays in the body is established. This places the company in the best possible position to defend against potential class action lawsuits for false advertising. That said, dietary supplement companies should remain vigilant about structure/function regulatory compliance to ensure they remain under the preemptive protection of the FDCA.
About the Author: Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com.
Recent court cases, however, cast doubt on whether a plaintiff can successfully sue a company over basic structure/function claims. A case out of the U.S. District Court of Massachusetts highlights this issue, but cases out of the 9th Circuit of Appeals also add more credence to the trend.
In Ferrari v. Vitamin Shoppe, Inc., No. CV 17-10475-GAO, 2022 WL 974048 (D. Mass. Mar. 31, 2022), a federal judge found that proposed class action allegations that Vitamin Shoppe, Inc. violated state statutes for false advertising and deceptive business practices were preempted by the Federal Food, Drug, and Cosmetic Act (FDCA) as amended by the Dietary Supplement Health and Education Act. While the opinion appears to present a unique perspective on the FDCA’s preemptive power for dietary supplement structure/function claims, the case can also be read to be consistent with “lack of substantiation” cases.
The added twist in Ferrari is the court found the plaintiff’s claims preempted because Vitamin Shoppe’s claims met the requirements of §403(r)(6) of the FDCA, which specifically allows dietary supplement companies to make structure/function claims if they have substantiation to support the claim.
The Ferrari v. Vitamin Shoppe View of FDCA Preemption
On Mar. 31, the U.S. District Court for the District of Massachusetts ruled on a class action lawsuit against Vitamin Shoppe involving structure/function ingredient claims for dietary supplements.The plaintiffs, Richard Ferrari and William Bohr, alleged that Vitamin Shoppe’s product labeling contained statements that induced them to buy the products, only to find out that the products did not yield the results they were promised. Vitamin Shoppe promoted its products by highlighting glutamine, the products’ major ingredient, as one that “has been shown to possess anti-catabolic properties to help preserve muscle,” “helps support muscle growth and recovery as well as immune health,” and “is involved in regulating protein synthesis.”
The plaintiffs alleged that they did not experience improved muscle growth after consuming the product, and that Vitamin Shoppe’s claims are unsubstantiated because the company disregarded several studies stating that glutamine had not been shown to promote muscle growth when abiding by the product’s intended use.
The District Court granted summary judgment in favor of Vitamin Shoppe on the premise that the plaintiff’s state law claims were preempted by the FDCA. The court specifically found that the FDCA creates statutory requirements for a structure/function claim and if those requirements are met, then the plaintiff’s false advertising cause of action is precluded.
In this regard, a structure/function claim must describe the general effects of a nutrient or dietary ingredient by which it may affect the structure/function of the body (and the claim does not apply to the finished product). This latter issue is of importance and is consistent with the trend to require a structure/function claim be tied to the ingredient as opposed to the whole product. (The logic of this position has always been nonsensical and should apply to the finished product, not just an ingredient claim. With that said, it has long been the position of FDA, the FTC, and NAD that the claim should be tied to the ingredient as opposed to the product.)
A company must have substantiating evidence and the product must include a disclaimer that the claim has not been evaluated by FDA. Lastly, the claim cannot expressly or implicitly imply that the ingredient diagnoses, treats, cures, or prevents a specific disease (i.e., not disease claim). (See 21 U.S.C.A. § 403(r)(6); 21 CFR 101.93(f).)
The court further reasoned that the FDCA prohibits states from creating any labeling requirement for dietary supplements that is “not identical to” the requirements articulated in § 403(r)(6). This means that any cause of action arising under a state law cannot create a different labeling standard than those of § 403(r)(6), and is preempted by the FDCA.
Properly Stated and Requisite Substantiation
In Ferrari, the court ruled that the plaintiff’s state law misbranding allegation was preempted by the FDCA, as Vitamin Shoppe had the requisite substantiation to support glutamine’s anti-catabolic properties. The court further noted that all the other requisite requirements of the FDCA were met. The court found the plaintiff’s contrary evidence was irrelevant when the plaintiff’s expert agreed that the structure/function claim was consistent with the known role that glutamine plays in the body. In fact, the plaintiff’s expert agreed on glutamine’s basic properties, including that it generally supports muscle growth.The court emphasized that a properly stated structure/function claim is neither inherently false nor misleading because the substantiation requirement is baked into the § 403(r)(6) requirements. The court then indicated that agreeing with the plaintiff’s argument would add additional requirements that are not included in § 403(r)(6). To state it differently, the court found that it was unnecessary for Vitamin Shoppe to overcome negative evidence as the claims properly described the role glutamine plays in the body.
The emphasis on glutamine as an ingredient as opposed to the product in general cannot be ignored. More specifically, the court is strongly suggesting if the claim relates to the established role a nutrient or dietary ingredient plays in the body then it, in essence, creates a safe harbor for companies even if there is evidence the dose level is not sufficient to support the claim.
Indeed, this makes sense as nutrients and dietary ingredients are supportive in nature. Absent a performance claim (e.g., “gain 10 pounds of muscle in 30-days”), the defendant properly described the role of glutamine. And there would be no desire on anyone’s part to conduct a clinical study to see if something is simply supportive when its role is already established and known.
Consistent with Ninth Circuit Confirmation
Importantly, the court’s reasoning in Ferrari is also consistent with the 9th Circuit Court of Appeals, the Circuit Court most willing, in earlier cases, to permit false advertising lawsuits. The decision in Vitamin Shoppe continues the trend of FDCA preemption of state advertising structure/function ingredient claims.The Ninth Circuit Court of Appeals has been grappling with this particular issue. In Dachauer v. NBTY, Inc., the Ninth Circuit held that FDCA, as amended by the Nutrition Labeling and Education Act, contains an express preemption provision that directly applied to structure/function claims (913 F.3d 844 (9th Cir. 2019)).
The plaintiff in Dachauer claimed that the defendant’s vitamin E supplements were misleading because the supplements did not prevent cardiovascular disease even though the labeling stated it promotes and supports cardiovascular, circulatory, and heart health.
Like the plaintiff’s argument in Ferrari, the plaintiff’s expert in Dachauer offered evidence that vitamin E supplements taken at the recommended dosage did not prevent cardiovascular disease. The court found that the FDCA preempted the state law claim so long as the structure/function claim was substantiated and met all of FDCA’s narrow requirements.
The court stated unequivocally that “manufacturers need not also have evidence that [vitamin E] structural or functional effects reduce the risk of developing a certain disease.” The court emphasized that this distinction is the whole point of the § 403(r)(6) structure/function claim carveout: to distinguish between the role a nutrient or dietary ingredient plays in supporting the structure/function of the body without requiring FDA-approval.
For example, in this case, preventing cardiovascular disease is an impermissible disease claim while supporting cardiovascular health is a permissible structure/function claim for a dietary supplement.
Similarly, the Ninth Circuit addressed another structure/function preemption case in Kroessler v. CVS Health Corp. The court held that the plaintiff’s claims were not preempted by FDCA’s standard (977 F.3d 803 (9th Cir. 2020)). The plaintiff alleged the defendant’s statements “supports flexibility” and “helps support and maintain the structure of joints” on its glucosamine supplements were false and misleading because it is known that glucosamine does not have those effects, and the defendant lacked substantiation for these structure/function claims.
The major difference here is that the defendant’s marketing stated that its glucosamine-based supplements as a finished product maintain or support joint health. The Ninth Circuit held that there was no preemption because a plaintiff can bring claims if alleging that the requirements of a structure/function claim have not been met, such as improper substantiation.
The court elaborated that the FDCA does not preempt state law (in this instance, California state law) because the challenged statement is a proper structure/function claim; but rather, preemption exists only if a “plaintiff’s legal claims and factual allegations would hold a defendant to a different substantiation standard than the FDCA.”
With that said, the 9th Circuit decision in Greenberg v. Target Corp. (985 F.3d 650 (9th Cir. 2021)) makes it clear there is no requirement that consumers derive health benefits from the supplement in line with the structure/function claims. Rather, the 9th Circuit held “[t]o substantiate [a structure/function] claim, supplement manufacturers need only show evidence that an ingredient has an effect on small aspect of the [specified bodily] structure/function.” (See Greenberg, 985 F.3d at 653.)
Similar to Ferrari , experts for both sides in Greenberg agreed that the nutrient biotin is known for its “cellular and biochemical role in the support of healthy hair and skin.” Furthermore, the defendant fulfilled all the FDCA structure/function requirements for its biotin supplements. Thus, the 9th Circuit ruled against the plaintiff and for the defendant because the claims were preempted.
Key Takeaways
The Ferrari decision and the decisions out of the 9th Circuit clearly show that false advertising class actions are not going away. However, these decisions as well as others regarding “lack of substantiation” clearly demonstrate the courts may finally be growing wary of these lawsuits when the defendant has complied with the requirements of § 403(r)(6) of the FDCA.More specifically, if the claim specifically describes the accepted role a nutrient or dietary ingredient plays in supporting the structure/function of the body, the claim should be dismissed since the claim is clearly permitted under the law and it accurately describes the known role the nutrient or dietary ingredient plays in the body. Stated differently, the emerging case law indicates that if the claim describes the known role a nutrient or dietary ingredient plays in the body and there is substantiation to support this role, the plaintiff cannot survive a motion for
summary judgment.
From a practical perspective, a company should consider tying the structure/function claim to specific nutrients whose mechanism of action or role it plays in the body is established. This places the company in the best possible position to defend against potential class action lawsuits for false advertising. That said, dietary supplement companies should remain vigilant about structure/function regulatory compliance to ensure they remain under the preemptive protection of the FDCA.
About the Author: Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com.
