Federal Circuit reads "literal falsity" way too narrowly

BPI Sports, LLC v. Thermolife Int’l LLC, Nos. 2023-1068, 2023-1625, 2023-1112, 2025 WL 1683234 (Fed. Cir. Jun. 16, 2025)

This is a false advertising case involving allegedly false patent marking. Creatine nitrate is an amino-acid nitrate used in dietary supplements. At the time of the trial, ThermoLife owned several patents covering creatine nitrate, which it licensed to manufacturers. BPI sells supplements that compete with licensees of ThermoLife; it sued for false advertising under the Lanham Act and unfair competition under state law in connection with ThermoLife’s CRTN-3, as well as false patent marking under the Patent Act. A jury found that BPI showed false advertising and unfair competition but awarded zero damage, and found in favor of the defendants as to the false patent marking claim. In the cross-appeals, the court found that ThermoLife should have gotten judgment as a matter of law.

“JMOL should be granted only when the [moving party] presents no legally sufficient evidentiary basis for a reasonable jury to find for him on a material element of his cause of action.” Adopting a perjury-like standard, the court of appeals found that no reasonable jury could have found in favor of BPI under the falsity element of a false advertising claim: that CRTN-3 label’s statement of “increase vasodilation” was literally false. (BPI didn’t preserve misleadingness as an alternative ground, and there was no survey or other evidence of consumer reaction in the record.)

The claim was literally true because BPI’s own evidence shows that the dosage disclosed in CRTN-3’s label would “cause vasodilation” for people weighing 113 pounds or less. However, the dosage amount of creatine nitrate needed for “an average adult in the U.S. weighing 177 pounds” is more than the amount disclosed in CRTN-3. But the label didn’t claim to increase vasodilation for average people.

Once again, a court ignores ordinary rules of implicature. Other cases have (in my view correctly) held that a product that self-evidently won’t work for most people can’t claim to “work” in general. Under the Federal Circuit’s view, apparently, an advertiser could claim that its product “treats hair loss” if it could help the small percentage of people whose hair loss stems from a specific vitamin deficiency. That's a mistake, and it's one that thinking about "what would the true message look like?" could help.

"abortion reversal" promoter engaged in inherently and potentially misleading commercial speech, court rules

Culture of Life Family Services, Inc. v. Bonta, 2025 WL 1677783, No. 3:24-cv-01338-GPC-KSC (S.D. Cal. Jun. 13, 2025)

In two opinions on the same day, the court didn’t give much comfort to an “abortion reversal” provider.

COLFS sought to enjoin AG Bonta’s pending state court false advertising proceeding against its “abortion reversal” claims. APR is touted for pregnant women who have started the chemical abortion process by ingesting mifepristone, the first pill out of two; it involves taking the hormone progesterone in order to counteract mifepristone’s blocking of the body’s natural supply of progesterone. The main proponent, COLFS’s medical director, has done small human case studies, claiming an overall fetal survival rate was 48%, higher for the subgroup that received progesterone intramuscularly (64%) and the subgroup that received a high dose of oral progesterone followed by daily oral progesterone until the end of the first trimester (68%).  

The state enforcement action under California’s UCL and FAL challenged as unsupported by credible scientific evidence: the use of the terms “reverse” and “reversal”; claims that APR “has been shown to increase the chances of allowing the pregnancy to continue”; claims that APR has a success rate of 64-68%; claims that the rate of birth defects following APR is “less or equal to the rate in the general population”; claims that “thousands of lives have been saved” through APR; claims that APR may be effective at longer time ranges and following administration of misoprostol and methotrexate; and claims that APR can cause only non-life-threatening side effects, even though it can cause severe bleeding.

The court found the UCL and FAL to be content-neutral, because they were laws of general applicability that prohibit false and misleading statements. (This is probably not consistent with Reed, but Reed doesn’t make a ton of sense, especially applied to commercial speech—the underlying conclusion that strict scrutiny doesn’t apply is correct.)

Bonta argued that COLFS’s APR statements were commercial speech, used to advertise the treatment, and that fundraising provided an economic motivation for the APR claims. The court noted that many of the disputed statements appeared on COLFS’s website, and appeared more informational and educational than client-soliciting. Statements about APR in fundraising weren’t as clear as in a previous case, where a “majority” of fundraising communications involved the advertising language at issue, nor did COLFS anywhere claim to compete with abortion providers. However, in exchange for its APR services, COLFS accepts insurance and/or payment from women who have insurance or the means to pay; it also provides free treatment. On a motion to dismiss, COLFS sufficiently pled that its statements weren’t commercial speech.

However, the Free Exercise claim failed. A Free Exercise claim requires that a government entity has “burdened [a plaintiff’s] sincere religious practice pursuant to a policy that is not ‘neutral’ or ‘generally applicable.’ ” But the UCL and FAL “protect consumers by prohibiting false and misleading advertisements – because of the stated interest in consumer protection, not because of any sort of motivations underlying those advertisements – and as such these laws are neutral.” There were no exceptions to the UCL and FAL that could discriminate against religious conduct, nor did they treat “any comparable secular activity more favorably than religious exercise.” The AG “regularly enforces” these laws against secular entities. Although the UCL and FAL don’t apply to public entities or political speech, that wasn’t required to make them “generally applicable” laws. Instead, laws of general application treat religious and secular speech comparably. “Whether secular and religious activity are ‘comparable’ is evaluated ‘against the asserted government interest that justifies the regulation at issue’ and requires looking at the risks posed, not the reasons for the conduct.” The risks posed by public entity and political speech were different. Public entities are exempted because the state is a “sovereign entity representing the people,” and can have sovereign immunity. Political speech is exempted because “false and misleading political speech is protected while inherently false and misleading commercial speech is not.”

Although COLFS claimed that allowing progesterone to be prescribed for everything except APR treatment was not neutral and generally applicable, “laws do not need to cure every problem or aspect of a problem.” Seems like the correct result for the wrong reason—it might not be false or misleading to proscribe progesterone for something else! Plus, the claim here isn’t against the prescription, it’s against the advertising. The court gets there: “AG Bonta is not banning APR treatment, but is enforcing consumer protection laws against specific advertisements of APR treatment.”

COLFS argued selective enforcement against COLFS, but not Planned Parenthood. But “COLFS’s statements refer to a medical treatment that has only undergone studies for efficacy and safety since 2012, while Planned Parenthood’s statements speak to an FDA-approved medical procedure…. COLFS’s statements about APR treatment and Planned Parenthood’s statements about the abortion pill are not comparable.” There was no indication that Planned Parenthood had violated the UCL or FAL.

COLFS also didn’t have a valid “right to receive information” claim, which is cognizable “only where the listener has a concrete, specific connection to the speaker.” That wasn’t pled here, for statements outside a doctor-patient relationship.

The substantive due process claims for “COLFS’s patients’ rights to procreation, reproductive privacy, and to reject unwanted medical treatment” also failed.

 

Culture of Life Family Services, Inc. v. Bonta, 2025 WL 1687929, No. 3:24-cv-01338-GPC-KSC (S.D. Cal. Jun. 13, 2025)

The court denied a preliminary injunction against AG Bonta.

Continuing the First Amendment analysis: Content-neutral regulations like the FAL and UCL “are generally subject to heightened scrutiny: the government may impose reasonable restrictions on the time, place, or manner of protected speech, provided the restrictions ‘are justified without reference to the content of the regulated speech, that they are narrowly tailored to serve a significant governmental interest, and that they leave open ample alternative channels for communication of the information.’” This is weird framing because false advertising does assess content; the court thus turns to the commercial speech inquiry, which is the dispositive issue.

The court credited the AG’s evidence that COLFS uses the APR statements in advertisements that are directed towards, and solicit, women to become potential clients. The statements were “placed in a commercial context and are directed at the providing of services rather than toward an exchange of ideas.” COLFS’s use of the APR statements in its yearly fundraising gala and use of patient stories about APR to solicit donations also provided a “powerful economic motivation.” Plus, even though COLFS argued that it provided “numerous free services,” including “free APR treatment,” it still accepts insurance and payment for APR treatments from women who do have the ability to pay. That was an obvious economic motivation, which COLFS didn’t address.

What about falsity/misleadingness? “Three district courts have struck down state laws that required abortion providers, under threat of criminal sanction, to inform patients about supplemental progesterone therapy in language providers objected to for being untruthful or misleading.” Plus, district courts have split on this situation: “a pro-life organization asking for a preliminary injunction that would disallow an attorney general from pursuing a hypothetical enforcement action against them based on APR-related speech.”

Use of the terms “reverse” and “reversal”: These statements are based on a theory that supplemental progesterone can “outcompete” mifepristone to counteract or “reverse” the effects of mifepristone. Typically, mifepristone acts as a “competitive binder of the progesterone receptor – it binds to progesterone receptors at twice the avidity of progesterone itself, thus blocking endogenous progesterone from acting to support a pregnancy.” But, given high amounts of progesterone in pregnancy, mifepristone is still able to work; adding more progesterone would be like “rain on a swimmer in a pool – the swimmer cannot get more wet.” Rat studies were unhelpful because “there are significant differences between rat and human pregnancies and progesterone’s actions in each” and “[p]rogesterone receptors also vary widely between species in their responsiveness to different molecules...”

A recent placebo-controlled study on nine people was designed to examine the effects of progesterone supplementation, after mifepristone administration, on the endometrium (the inner lining of the uterus where implantation occurs) on nonpregnant persons, but the endometrial lining, uterus, and hormonal milieu of a pregnant person are all “vastly different” from those of a nonpregnant person.

Given that the science was “unclear on how exactly supplemental progesterone reacts with mifepristone,” the court turned to the common understanding of the word “reverse” to determine whether it accurately captures what we do know about the effects of supplemental progesterone. According to dictionary definitions, “reverse” means “to change the direction, order, position, result, etc. of something to its opposite.” Or, “to turn completely about in position or direction” or “to undo or negate the effect of (something, such as a condition or surgical operation).” “Reversal” was the wrong way to describe the evidence here. It was also plausible that “failing to continue taking the second drug in the medication abortion regimen, misoprostol, may result in continued pregnancy in some percentage of women who take mifepristone[.]” (The court notes that there is no agreement on the baseline here. In studies, continuing pregnancy rates ranged from 8% to 46%, depending on the mifepristone regimen used, making it hard to conclude that supplemental progesterone did any better than simply not taking the second medication.) Without better evidence, “it would be at the very least potentially misleading to state that supplemental progesterone can ‘reverse’ an abortion.”

Effectiveness statements: COLFS’s principal’s study purportedly showed that progesterone increases the chances of a pregnancy continuing after taking mifepristone. But some patients were screened by ultrasound for viable pregnancies before joining the study, which biased the data towards pregnancies already likely to continue. It also did not record how far along in her pregnancy each patient was or how much progesterone each patient took – even though mifepristone is less effective at terminating pregnancies as they progress. And there were no controls in the study, despite treatment by 325 different medical providers. Thus, the study didn’t support the statement that APR is “effective” in continuing pregnancies. [Reminder: the AG can go after advertising for lack of substantiation.] “The Court finds that given the lack of robust scientific study on this issue, statements on the effectiveness of APR are potentially misleading.”

Likewise, there wasn’t enough evidence to conclude that the side effects were limited/that APR was safe. “No study offered or used by COLFS appears to track health or safety outcomes for the pregnant individual.” The first and only randomized clinical study to attempt to test the safety and efficacy of APR had to stop because of the serious “safety concerns” after 3 of the 12 participants experienced “severe bleeding” after taking mifepristone without misoprostol. Two of those three received a placebo; the third person had been given progesterone. The “dearth” of evidence made it potentially misleading to say that APR can only cause non-life-threatening side effects.

Birth defects: Again, the evidence was limited and tiny. “Given the lack of scientific evidence on this specific question, the Court finds the statements on birth defects following APR to be potentially false and misleading.”

That APR has a 64-68% success rate was also inherently false and misleading, given the defects in the supporting studies and the lack of clarity about what percentage of COLFS patients would use which methods of administration.

“Thousands of lives saved” statement: This claim was based on the number of pregnant people who used APR and were confirmed by Heartbeat International to remain pregnant at 13 weeks, plus the number of those who started APR (but Heartbeat cannot confirm remained pregnant) multiplied by a 64% success rate. But there was no reason to generalize this statistic to all women who started APR. These were potentially false and misleading.

Statements on non-standard situations (after 72 hours have passed from the ingestion of mifepristone and t after taking the second pill of medication abortion): “From the Court’s review, nothing from the expert declarations submitted by COLFS even purports to support either of these statements.” These statements were inherently misleading.  

Where the statements were inherently misleading, the court’s analysis was done. Where they were only potentially misleading, the court proceeded to apply Central Hudson. (In my view, this is the wrong approach. The potentially misleading standard goes to the scope of a prohibition—if a statement is potentially misleading, the question is whether it can be communicated in a nonmisleading way, in which case the properly presented claim can’t be prohibited entirely. But the particular way in which a defendant is communicating a claim may be actionable/enjoinable even if the state would be required to allow a properly qualified claim. Given the posture of the case, I would expect this to be an issue for the state court.)

Under Central Hudson, the regulation of misleading advertising by medical professionals directly advances a substantial government interest (protecting medical consumers). And it directly advances the asserted government interest and was not more extensive than necessary to serve that interest. “AG Bonta is not aiming to limit the actual practice of APR. And reproductive choices are not apart from consumer choices: women, in exercising their reproductive rights, are also consumers who must be given the correct information to make knowledgeable decisions for themselves.”

 

it's plausibly deceptive to sell "Kids" gummies identical to adult gummies

Barrales v. New Chapter, Inc., 2025 WL 1584424, No. 2:25-cv-01171-HDV-KES (C.D. Cal. Jun. 4, 2025)

Plaintiff alleged that defendant’s Fiber Gummies were deceptively labeled (1) because the claim “with 4g of probiotic fiber” was false because it implies that each gummy contains that amount of fiber, when the serving size is 2 gummies; and (2) because the KIDS Organic Fiber Gummies falsely implies that the product is specifically formulated or uniquely suitable for kids. She brought the usual California claims (including common-law claims).

regular gummies

Kids gummies

Compared to the regular gummies, the front label of the Kids Gummies has the word “kids” with each letter a different color, but they have the exact same chemical composition and consumption method as the Fiber Gummies.

Defendant argued that the FDCA preempted the claim because it expressly allows claims made by serving size. FDCA regulations allow “direct statements about the level (or range) of a nutrient in the food” so long as they “do not in any way implicitly characterize the level of the nutrient in the food and are not false or misleading in any respect.” Here, the allegations were that the nutrient content claims were false or misleading; thus, plaintiff was seeking only to enforce a requirement identical to federal law and her claims weren’t preempted.

Defendant argued that “with 4g[rams] prebiotic fiber” was specifically allowed because it was based on the “reference amount customarily consumed,” i.e., serving size, FDA-defined as the “maximum amount recommended, as appropriate, on the label for consumption per eating occasion.” “But the Ninth Circuit differentiates between claims that challenge and seek to alter accurate statements about serving size and the nutrient content thereof, and claims that a defendant’s ‘omission of supplemental or clarifying language’ misleads consumers.” The plaintiff wasn’t seeking to alter how the serving size is calculated, nor how the fiber content of each serving is calculated.

Misleadingness was also plausible; a reasonable consumer might not consult the back label. Believing that each gummy contains four grams of fiber was “plausibly an unambiguous interpretation of the label based solely on the language used.”

Likewise, it was plausible for a reasonable consumer to be deceived by the “KIDS” label into thinking it was especially suitable for kids. Contrary cases involved factual differences, e.g. a medicine whose “infant” version came with a dropper for administration and its otherwise identical “children’s” version had a cup. “Here, there is nothing, pharmacologically or otherwise, that differentiates the Fiber Gummies from the Kids Gummies.”

 

"wholesome" not puffery in context, court finds

Levit v. Nature’s Bakery, LLC, 767 F.Supp.3d 955 (N.D. Cal. 2025)

Nature’s Bakery Products fig bars claim “Wholesome Baked In,” “equal parts wholesome and delicious,” “what we bake in is as important as what we leave out,” “simple snacks made with real ingredients,” and “the best fuel for active ... lives.” The packaging also includes a “ ‘heart’ vignette next to depictions of real, whole fruit, and also displays a ‘Whole Grains Council’ stamp.”

Nature's Bakery front panel

Levit alleged that the products are actually high in sugar, excessive consumption of which is “toxic to the human body.” Of 19 total grams of sugar, 14 grams are added sugars, representing 28% of the total calories. Levit brought the usual California statutory claims, as well as common law claims for breach of express warranty, breach of the implied warranty of merchantability, negligent and intentional misrepresentation, and unjust enrichment.

The court found most, but not all, of the challenged statements to be puffery: “what we bake in is as important as what we leave out” is an unmeasurable opinion, and, in full context, “Started by father and son bakers, we believe simple snacks made with real ingredients are the best fuel for active, joyful lives,” was a subjective statement of belief, as was the heart vignette in conjunction with the phrase “We ‘Heart’ Figs.” Likewise, though the “Whole Grains Council” stamp was falsifiable, Levit didn’t allege that it was false.

However, the statements using “wholesome” were potentially actionable.

“Wholesome Baked In” and “equal parts wholesome and delicious” were not phrases like “unbelievably wholesome” or “positively wholesome,” which converted the term to “exaggerated advertising, blustering, [or] boasting.”

And deception was plausibly alleged where a food label proclaims a product to be healthy but in fact allegedly contains unhealthful levels of sugar, despite the disclosures on the Nutrition Facts panel. There was no argument that “wholesome” was ambiguous such that a reasonable consumer would consult the label to determine its meaning. However, fraudulent omission-based claims failed because there needs to be a duty to disclose; although the complaint plausibly alleged that high levels of sugar mean the products are not wholesome, it didn’t plausibly allege that eating Nature’s Bakery’s fig bars in “customary” amounts would cause death or serious injury, or any other basis for a duty to disclose.

competitor's challenge to use of expired certification marks must go to trial

FireBlok IP Holdings v. Hilti, Inc., No. 19-cv-50122, 2025 WL 1557924 (N.D. Ill. Jun. 4, 2025)

FireBlok sued defendants, relevantly for false advertising and false association. The court denied FireBlok’s motion for summary judgment.

FireBlok alleged that defendants’ use of the UL certified mark and FM approved mark on their product, the Firestop Box Insert, was false advertising and false association. “According to UL’s website, a product with the UL certification mark is one that UL found to meet UL’s requirements by a representative sample. According to FM’s website, an FM approved mark denotes that a product has completed FM’s testing process.” FireBlok was never FM approved, and its UL certification was withdrawn in 2025. Defendants’ product has used the UL and FM marks since 2008 and 2009, respectively, but requested withdrawal of UL certification/sent an email to FM leading FM to withdraw its listing in 2008.

FireBlok was asserting false association claims on behalf of a third party as false advertising, which led to an “undifferentiated amalgam of a claim.”

 “A ‘literal’ falsehood is bald-faced, egregious, undeniable, over the top.” (This is a bad standard, risking a conflation of falsity with willfulness.)

The court found that it was not enough to get summary judgment on literal falsity that defendants withdrew their certifications with both certifying bodies. Defendants argued that the Firestop Box Insert was, in fact, UL certified as shown by UL’s continued listing of Hilti’s product as a UL certified product and UL’s lack of adverse actions against Defendants for their use of the UL certified mark, and that their use of the FM approved mark was not literally false because FM continued to conduct routine inspections of the manufacturing process, issued Certificates of Compliance, and continued listing the Firestop Box Insert as an FM Approved product. This was a genuine factual dispute over what the use of certification marks meant. A jury could find the use to mean that the Firestop Box Insert met the safety requirements set by UL and FM, “in which case the statement would be true.” But a jury could also reasonably interpret these statements to mean that defendants were authorized to use these marks on their product [though one has to wonder about materiality in that event].

The parties argued over the likely confusion factors, but false attribution isn’t enough: “a false advertising claim requires a showing of deception about the product itself.”

FireBlok also failed to show that there was no dispute about materiality. Nor was injury to FireBlok shown sufficiently to grant summary judgment; it wasn’t enough that the parties competed.

What about false association? (I would probably have held that there wasn’t standing under 43(a)(1)(A), only (B).) Doing conflating of its own, the court said that, without literal falsity, FireBlok had to show misleadingness with actual consumer confusion, and there was no evidence of that. The court would not presume likely confusion from literal falsity in a false association case.