In This Issue:

• Initial Attempt at Pinning Presence of PFAS in Coca-Cola Juice Drink as False Advertising Fizzes Out
• NAD Nixes Claims That Competing Product Is Bad at Detecting Breast Cancer in Black Women
• Peer-Reviewed Ingredient Studies Do Not Equal Peer-Reviewed Formula Studies, NAD Tells Eye Health Supplement Maker

Initial Attempt at Pinning Presence of PFAS in Coca-Cola Juice Drink as False Advertising Fizzes Out

The U.S. District Court for the Southern District of New York dismissed a plaintiff's initial complaint against Coca-Cola for falsely advertising its juice drinks as "all natural," as the court found that the plaintiff's allegations were insufficient to confer standing to sue.

Plaintiff alleged that labeling touting Coca-Cola subsidiary The Simply Orange Juice Company's "Simply Tropical" juice drink as "All Natural" and made with "all-natural ingredients" is false because the drink contains PFAS — man-made "forever chemicals" that are harmful to the human body. Plaintiff further alleged that PFAS were present in the product in "concerning levels."

According to the complaint, the presence of PFAS is "entirely inconsistent" with Coca-Cola's "pervasive marketing representations" of the product as "All Natural," "simple," and made with "all-natural ingredients" with "nothing to hide."

Plaintiff's argument is that Coca-Cola's misrepresentations and false and misleading statements about the product caused him to suffer economic injuries because he paid a premium for the product that he would not have paid had he known that the beverage contained PFAS.

The court, however, found that plaintiff failed to support these claims with sufficient factual allegations. In particular, the court held that his reliance solely on his own testing of the product to allege that the products contain PFAS was insufficient to show that he suffered an injury sufficient to confer standing.

As the court noted, to properly allege injury under a price-premium theory of injury, plaintiff had to allege that he purchased a product that contained PFAS. However, plaintiff's inclusion of a single product test showing the presence of PFAS, based on a mere sample, was insufficient to allege an injury in fact, absent at least the inclusion of further studies or articles suggesting that the products contain PFAS.

Plaintiff failed to allege any connection between his own purchase of the juice and the presence of PFAS — i.e., he did not show any link that would suggest the product he purchased contained PFAS. The exception was a single "attempt to link the testing to the Product he purchased" by asserting that both occurred in the same month — but that allegation of temporal proximity was not enough. Alternately, plaintiff could have alleged that the presence of PFAS was so widespread as to "render it plausible" that he purchased the mislabeled products at least once. But plaintiff did not make such an argument.

These conclusory allegations of actual injury to plaintiff did not suffice to meet even the "lenient" pleading requirements at this stage, concluded the court.

Key Takeaways

Bottom line: The court gave the plaintiff a roadmap and the opportunity to file an amended complaint. Stay tuned.

NAD Nixes Claims That Competing Product Is Bad at Detecting Breast Cancer in Black Women

Was an advertiser's claim that its breast cancer diagnostic products are superior at providing a prognosis for breast cancer recurrence and chemotherapy benefit in Black women backed up by solid scientific evidence, or was it fearmongering to Black women at a vulnerable moment?

These are the questions the National Advertising Division (NAD) considered in order to resolve a challenge between competing providers of diagnostic testing which assesses the risk of breast cancer recurrence in early-stage breast cancer patients.

In the context of a large body of research showing that Black women suffer worse breast cancer outcomes than white women, Genomic Health Inc. (GHI) challenged multiple express and implied claims that Agendia's products are more accurate at detecting breast cancer in Black women than GHI's products, including that GHI's Oncotype DX is a biased test with inconsistent results and that it has a lower prognostic accuracy in Black women.

Agendia argued that its claims are supported by scientific evidence that shows that Black women are twice as likely as white women to have a type of cancer that Oncotype DX is not effective at detecting. GHI countered that Agendia doesn't have the scientific proof to back up these claims, and that based on relevant expert evidence the Oncotype DX is the preferred test for all races of women with breast cancer.

In a postcard distributed to medical professionals, Agendia promoted that it provides "EQUAL CARE FOR ALL" and that "Only MammaPrint & BluePrint results can identify higher risk ER+ tumors in black women" as well as that Agendia is "committed to addressing racial disparities in breast cancer." NAD recommended Agendia discontinue these claims because in its view at least one message conveyed by the claims was that GHI does not want equal care for all.

NAD found that given GHI's initiatives to improve health disparities in cancer healthcare, this message was not supported. Further, although Agendia submitted evidence of discordance between MammaPrint and Oncotype DX test results, NAD agreed with the challenger that the evidence did not support the message GHI had a "callous indifference towards providing care to black women," as Agendia's advertising potentially implied.

On this same postcard, Agendia also claimed that "Only MammaPrint & BluePrint results can identify higher risk ER+ tumors in black women." Here, NAD agreed with the advertiser that two studies the company provided in support of this claim did support the conclusion that there is a higher incidence of ER+ Basal high-risk cancers in Black women than in white women, that Agendia's BluePrint is the only test that identifies whether a cancer is a Basal-subtype cancer, and that this was an important and impactful benefit that Agendia provided.

Nonetheless, NAD found Agendia's claim was still too broad, and that the evidence, while compelling, did not support the claim that the Agendia products were the only ones that could identify higher-risk ER+ tumors in Black women. NAD recommended the company discontinue the claim and instead promote this product benefit in a "more specific and nuanced manner."

GHI also challenged several videos and social media posts questioning why anyone would rely on an Oncotype DX test, which Agendia depicted as being of lower accuracy and providing inconsistent results for Black women. For example, in one video shot from the perspective of a Black woman, Agendia makes the following claims: "WOMEN WITH BREAST CANCER THAT RECEIVED A LOW RECURRENCE SCORE" "WERE FOUND TO BE HIGH RISK WITH MAMMAPRINT" (citing to the Robinson Study25). "IMAGINE RELYING ON A TEST THAT HAS LOWER ACCURACY IN BLACK WOMEN."

NAD concluded that because of the reference to "recurrence score," an element of the Oncotype DX test, the video is overly comparative. Additionally, one reasonable takeaway from these claims was that Oncotype DX is less accurate at making a prognosis and provides less consistent results for Black women. This takeaway was not supported by the evidence, said NAD. One of the two studies that Agendia provided to support the claims did not compare the accuracy of the tests and instead simply examined whether the prognostic accuracy of GHI's Oncotype DX recurrence score varied by race/ethnicity. The other study showed that MammaPrint could "select patients who will not benefit from chemotherapy independently of their ancestry." But neither study supported a comparative superiority claim that MammaPrint delivers consistent results across ethnicities while Oncotype DX does not.

NAD also found that additional independent studies Agendia provided in support of its claim that Oncotype DX has lower prognostic accuracy in Black women did not support the claims. These studies reflected a "growing body of research that" "within a certain [recurrence score] range" in some cases there is a "discordance between the Oncotype DX and MammaPrint/BluePrint genomic tests for Black women with certain types of tumors," and that the recurrence score might have to be calibrated differently, but not enough to support the claim that Oncotype DX is generally worse at providing a prognosis for Black women.

Key Takeaways

FDA-regulated drugs and devices are increasingly coming under scrutiny by NAD — which considers prescription drug advertising (as distinct from FDA-approved labeling) within its jurisdiction. As with all health claims, advertisers should be careful to narrowly tailor the claim to reflect the evidence, however compelling that evidence may seem. This is especially true where, as here, the studies concern emerging science, where advertisers should be especially careful not to overstate findings.

Peer-Reviewed Ingredient Studies Do Not Equal Peer-Reviewed Formula Studies, NAD Tells Eye Health Supplement Maker

Also on the health claims front, NAD weighed in on a challenge featuring competing eye health supplements. MacuHealth challenged claims made by Vision Elements about the Early Defense eye health dietary supplement — including that it is "science driven," that it "helps maintain healthy eyesight and visual performance," and that it is shelf-stable.

The advertiser claimed that Early Defense is "Science Driven" with "[f]ormulas developed from peer-reviewed, published studies." This claim appeared beside the image of a beaker. MacuHealth argued that this claim alongside the image conveyed the message that Early Defense has the same formula and efficacy as a supplement that has been the subject of peer-reviewed studies. Vision Elements countered that the message is that the product is made with formulas developed from peer-reviewed studies related to the ingredients.

NAD agreed with the challenger. "The word 'formula' together with the image of a beaker and the claim 'Science Driven' can communicate to reasonable consumers that the product combines ingredients in both the amounts and formulation that have been tested to be effective. Consumers can reasonably take away the message that the product formula was tested with ingredients in both the amount and formulation in 'peer-reviewed published studies,' not that the ingredient amounts were tested." There was no evidence that the formula for the supplement had been peer-reviewed, so NAD recommended the claim be discontinued, though the advertiser could certainly promote the fact that the ingredients were developed from peer-reviewed studies.

Next NAD analyzed the performance claim that Early Defense "helps maintain healthy eyesight and visual performance." To support this claim, the advertiser submitted two studies regarding the effectiveness of Early Defense's two main ingredients. The problem was, neither study directly tested the performance of the product nor the interaction of the ingredients. The advertiser's evidence had to show that the product as sold was formulated to provide the claimed benefits.

On the "shelf-life stability" and safety claims, NAD sided with the advertiser. Vision Elements claimed that "purity content and shelf-life stability are proven over and again through extensive ongoing quality control testing." In support of this claim, Vision Elements provided standard operating procedures showing testing done on the product at multiple times, and also provided evidence of raw material testing and other assessments. NAD found that this evidence demonstrated that Vision Elements conducts multiple tests on Early Defense after the product hits the shelves, substantiating the claim that Vision Elements tests Early Defense multiple times to ensure product stability and potency.

NAD also found claims that the advertiser conducts multiple tests throughout production to ensure safety and potency substantiated. Vision Elements provided evidence of several tests showing the absence of metals and other harmful substances in several Early Defense lots, as well as evidence that, according to the FDA's Generally Recognized as Safe (GRAS) database, each ingredient in Early Defense is likely to be recognized as safe for human consumption. Taken together, the product testing on product shelves, the GRAS information, and the testing of the product for harmful substances was enough to substantiate the claim that "multiple tests are performed throughout the production process to ensure safety and potency."

Key Takeaways

NAD is steadfast in its careful review of health claims and will always parse the studies and the claims closely to assess and assure fit.

[View source.]