The Proof Is In the Testing (NAD Case No. 7067): NAD recommended that Dakota Nutrition, Inc., discontinue a broad range of claims relating to the presence of elderberry in the company’s Elderberry Capsules and Elderberry Gummies products, including claims that the products even contain elderberry or provide benefits commonly associated with elderberry. NAD also recommended that Dakota Nutrition discontinue use of the term “elderberry” in the product name given that Dakota Nutrition was unable to provide a reasonable basis that its products contain elderberry, based on HPLC and HPTLC testing provided by the advertiser. This case is a reminder of the importance of robust ingredient and finished product testing, particularly as many companies have shifted to alternate suppliers during the pandemic to meet consumer demands.

Mmmm…Chicle (NAD Case No. 7077): NAD also went deep into ingredient testing in a challenge filed by global confectioner Perfetti Van Melle USA, Inc., against Mazee, LLC, maker of Glee Gum. Mazee advertised Glee Gum as, among other things, an all-natural, eco-friendly chewing gum made from chicle, a tree sap that Mazee claimed is sustainably harvested from the rainforests of Central America. To support its claims that Glee Gum contained chicle, Mazee provided information from its supplier stating that the gum base is 94% chicle tree sap (the other 6% consists of candelilla wax and natural citrus acid), along with the results of Carbon-14 testing by Beta Analytic.

Perfetti rebutted that the supplier information did not show that chicle is an ingredient because the CAS Registry Number it listed to identify “Chicle Tree Sap” is not the CAS Registry Number of chicle or any other known chemical substance. Further, the challenger argued that the results of Mazee’s Carbon-14 tests do not provide any information as to whether the gum base in Glee Gum contains chicle, but only purport to provide information regarding whether the carbon in Glee Gum is plant or fossil-based. Perfetti further attacked Mazee’s claims with analysis from two experts who concluded that Glee Gum did not exhibit typical chicle-related characteristics and, instead, their analysis suggested the presence of synthetic materials. Based on this, NAD recommended that the advertiser discontinue claims that the gum base of Glee Gum is “made with chicle.”

Lack of Blinding and Placebo Doom Establishment and Efficacy Claims for IBS Medical Food (NAD Case No. 7080): NAD recommended that i-Health discontinue “clinically shown” claims as well as efficacy claims relating to treatment of IBS symptoms on the company’s Culturelle IBS Complete Support product. Despite i-Health supporting the claims with the first large-scale trial to show that adult patients with IBS (irritable bowel syndrome) can achieve an improvement of IBS symptoms with supplementation of HMOs (human milk oligosaccharides) – a 317-person multicenter, open-label, single-arm clinical trial involving IBS patients from 17 sites across the United States – NAD found that the failure to blind the product and the lack of placebo caused the study to fall short of meeting the “competent and reliable scientific evidence” standard. Given these weaknesses and the emerging nature of the evidence supporting use of HMOs to manage IBS symptoms, NAD recommended that i-Health discontinue the challenged establishment (“clinically shown”) claims, the product efficacy claims, and the use of “Complete Support” in the product name. Further, NAD declined to issue a recommendation on whether the product was properly categorized as a medical food but recommended discontinuation of medical food-related claims that addressed product efficacy. In addition to being a thorough discussion of the “competent and reliable scientific evidence” standard, this opinion is a cautionary tale both of the importance of placebo and blinding as well as the need to consider qualified claims for emerging evidence.

Good Goli (NAD Case No. 7059): NAD also flexed its clinical study analysis muscles in a challenge filed by Church & Dwight against Goli Nutrition regarding weight loss and sexual health claims that Goli was making on its Goli Ashwagandha Gummies. In that matter, despite producing blinded, placebo-controlled ingredient (not finished product) studies to support its claims, NAD found the studies to be unreliable because of small sample sizes, sample populations that either did not represent the U.S. population or did not represent a healthy population, inadequate directions to study participants, lack of statistical significance, or lack of consumer relevance.

One issue with particular relevance given the products gaining popularity as we emerge from the pandemic, with regard to claims that KSM-66 Ashwagandha could help promote weight loss and weight management, NAD rejected research based solely on overweight or obese individuals experiencing chronic stress to support the weight management claims because the products were not targeted solely to those populations and testimonials did not reflect those specific populations. It is always a challenge to square the reality that much dietary supplement research is conducted on a diseased population while the products are marketed primarily to a healthy population but, as NAD points out, this can be addressed in how the product is marketed to help ensure a solid fit between the substantiation and the claim.

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Litigation

Industry scored another win on the vanilla front when a New York federal judge tossed out a class action alleging that Oregon Chai misleads consumers into thinking that its tea mixes contain real vanilla, noting that there is little differentiating the plaintiff’s case from others that were dismissed on the basis that consumers see vanilla as a flavor but not necessarily as an ingredient. The judge also noted that there was nothing on packaging that suggested the predominant or exclusive use of vanilla as flavoring. This win didn’t stop plaintiff’s lawyers from scouring the aisles for new vanilla-labeled targets, though, including Starbucks and Trader Joe’s.

Post Foods settled a class action case involving allegations that the company misrepresented the nutritional value of its cereals by failing to disclose added sugar, thereby making the cereals seem healthier than they actually are. This settlement follows roughly five years of litigation and arguments by Post that the statements relating to the products’ nutritional content are pre-empted by food labeling laws and regulations, protected by the First Amendment, and truthful insofar as they do not make any claim about the healthiness of the cereals overall. The court rejected these arguments and ultimately certified a nationwide class of people who bought any of the Post cereal products at issue, including Raisin Bran, Honey Bunches of Oats, Honeycomb and Waffle Crisp between Aug. 29, 2012, and Nov. 2, 2020. Pursuant to the settlement, Post will establish a $15 Million fund to compensate the class and will make labeling changes to cereals if more than 10% of the calories come from added sugar. This settlement came on the heels of two similar “healthy” cereal lawsuits: one against General Mills, which was dismissed in 2019, and one against Kellogg for which settlement approval has been twice rejected, most recently in November of 2020 because of an overly broad release provision.

In a case involving certifications and animal welfare, Foster Farms scored a significant win on a preemption argument in California state appellate court. Plaintiff Carol Leining alleged that she purchased Foster Farms chicken, labeled as “American Humane Certified” because she “assumed the birds lived comfortably and were killed quickly and painlessly but claimed she discovered that the AHA certification doesn't require special treatment.” She also alleged that Foster Farms charges more for its chicken that bears the American Human Certified label but, since the AHA does not have humane treatment standards, the certification is meaningless.

The court disagreed, finding that the Poultry Products Inspection Act (PPIA) preempts Leining’s state law false advertising claims. Per the PPIA, Foster Farms’s labels were reviewed and approved by the USDA prior to use. The PPIA prohibits false and misleading labeling and, as such, the USDA could have prohibited use of the AHA seal, but it did not.

And for dessert…

A California federal judge dismissed a lawsuit against Hostess Brands alleging that the company’s carrot cake mini donuts were falsely advertised because plaintiff believed that they contained significant amounts of real carrot when, in fact, they did not contain any carrots. Hostess made a number of labeling arguments that undermined the plaintiff’s claims that she was misled by the label, including that the label did not display any pictures of carrots, did not list carrots in the ingredients declaration, and as of 2019 when plaintiff claims that she first started purchasing the product, the product was labeled as “naturally and artificially flavored carrot cake mini donuts.” This decision stands in contrast to a 2017 decision in which the N.D. Illinois permitted a similar claim to proceed with respect to Dunkin Donuts’ glazed blueberry doughnuts and other blueberry-flavored products.

(some links from Law360, subscription req’d.)

FDA

FDA enforcement on false COVID-19-related claims continued with joint warning letters issued with the FTC relating to tea products and supplements. FDA also issued several letters alleging failure to comply with the foreign supplier verification (FSVP) requirements.

NAD

NAD did not issue any food-specific decisions in February 2021, but see select dietary supplement highlights here.

FTC

The FTC did not announce any food-specific settlements or litigation in February 2021 but see above the joint warning letters issued with FDA relating to allegedly false COVID-19 claims. The FTC now has civil penalty authority relative to deceptive COVID-19-related advertising.

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NAD

Health claim substantiation was front and center before NAD in a monitoring case involving Pendulum Therapeutics and a “medical probiotic” product featuring claims such as “The only medical probiotic clinically shown to lower A1C & blood glucose spikes for the dietary management of T2D*” (*Consult your physician as part of your total diabetes management plan. Results may vary from person to person.”)

The advertiser submitted a 12-week multi-center, randomized, double-blind, placebo-controlled study (the “Perraudeau Study”) to assess Pendulum Glucose Control’s safety and effectiveness in improving glycemic control in Type 2 diabetics and, ultimately, their dietary management of the disease – specifically, the role of certain probiotic strains found in prior research to be associated with the promotion of a healthy gut microbiome through the production of short-chain fatty acids (SCFAs).

The advertiser also provided clinical studies and research articles demonstrating the roles of A1C, fasting glucose and postprandial glucose levels in managing Type 2 diabetes. The advertiser also referred to the FDA’s Guidance document (Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention) to demonstrate what level of reduction in HbA1c was clinically meaningful.

While NAD expressed some concerns about the evidence, ultimately, NAD determined that the Perraudeau Study was a good fit for the challenged claim “The only medical probiotic clinically shown to lower A1C & blood glucose spikes for the dietary management of T2D*” (*Consult your physician as part of your total diabetes management plan. Results may vary from person to person.”) but recommended the following modifications: (1) limiting the claim to individuals who are taking metformin; (2) modifying the claim to clarify that the product can be used as part of the dietary management of type 2 diabetes; and (3) removing the references to percent reductions in blood glucose spikes in the absence of evidence in the record demonstrating that the reductions were clinically relevant.

This decision is a helpful discussion of the competent and reliable scientific evidence standard. Anyone seeking to understand health claims substantiation better should check it out.

FTC

Continuing with the diabetes management theme, the FTC announced a settlement with Agora Financial, LLC, a Baltimore-based company that the FTC charged tricked seniors into buying pamphlets, newsletters, and other publications that falsely promised a cure for type 2 diabetes or promoted a phony plan to help them cash in on a government-affiliated check program. In addition to the monetary judgment, which will be used to provide refunds to defrauded consumers, the proposed settlement also bars Agora and the other defendants from making such false or unsupported claims.

FDA

FDA’s pandemic-related enforcement took a new turn in February, with the issuance of warning letters to 10 companies selling dietary supplements that feature depression, anxiety, and mood-related claims. Examples of claims identified in the warning letters include the following:

• A treatment for depression, anxiety and stress
• Reduces anxiety
• Effective for mild to moderate depression
• the ONLY prebiotic that's been proven to help with anxiety
• "Constantly struggling with symptoms of anxiety and depression can have an incredibly detrimental impact on your life. . . . Our vision for the future of mental health is that we reach for probiotics as a first line of defense and even prevention for mental health issues.”
• A new natural supplement is providing relief to people across America suffering with severe anxiety and stress!’”
• “Enlifta is the only natural remedy depression supplement designed & created by a Psychiatrist.”
• For the relief of temporary depression or occasional feelings of sadness and melancholy.
• Reduce Anxiety by Affecting Serotonin

The pandemic has changed many things, but it has not changed the rules around marketing dietary supplements. If anything, companies selling in this space will want to be extra mindful of the pandemic context when crafting marketing copy.

In addition to that enforcement, FDA continued its prior COVID-related enforcement with warning letters related to subpotent and adulterated hand santizer primarily from Mexico.

Prop 65

Related to the need to kill germs, our sister blog, Kelley Green Law, featured two articles relating to EPA enforcement on disinfectant claims. One of the few areas of EPA policy continuity between the Biden and Trump eras is the aggressive enforcement attention being paid to products that claim to fight the SARS-CoV-2 coronavirus. EPA has issued “stop sale” orders to Amazon directing the company to take steps to prevent the continued sale “of potentially dangerous or ineffective unregistered pesticides and pesticide devices making illegal and misleading claims, including multiple products that claimed to protect against viruses.”

Class Action Litigation

A California federal judge tossed a proposed class action alleging the label on Walgreens' Infants' Pain & Fever Acetaminophen is false and misleading and violates California consumer protection statutes, ruling that the product's "undisputed" labeling would not be likely to confuse reasonable consumers. The plaintiff alleged that the labeling was misleading because the packaging and marketing on the infants' product misleads consumers into thinking it is specially formulated and therefore deceives them into paying more than the cost of the children's version, even though they have the exact same level of the active ingredient. In dismissing the case, the judge noted that the packaging was clearly labeled with the milligrams contained and also included a special dosing cup and syringe for use with children and infants.

Just as marketers are exploring immune system claims as of late, the plaintiffs’ bar is as well, with elderberry and immunity being challenged in California.

Dandruff brand Selsun Blue is the subject of an ingredient-related attack in the Northern District of Illinois relating to allegations that its active ingredient, selenium sulfide, causes scalp irritation and hair loss and another ingredient, preservative DMDM hydantoin, is known to slowly release formaldehyde.

Online cosmetics company Dermaset allegedly engaged in false advertising for failing to adequately disclose that consumers who pay $4.95 for shipping and handling for a 30-day free trial of cosmetics and a two-ounce free trial of cream will be enrolled in an automatic renewal offer resulting in consumers being charged recurring fees without their consent.

And if that isn’t enough for you…..

State Legislation

A California legislator introduced a bill that would restrict sale of certain weight loss supplements to anyone under age 18. Similar legislation has been considered in New York and Massachusetts.

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Litigation

Vanilla, vanilla, and more vanilla….The plaintiff’s bar remains skeptical of any product labeled as vanilla. Among the many vanilla-related lawsuits filed, McDonald’s, Whole Foods and Trader Joe’s defended suits alleging that their vanilla ice cream, vanilla almond milk, and vanilla almond cereal respectively were falsely labeled as vanilla. However, in a win for industry, a NY federal judge found that Topco did not improperly label its vanilla almond milk, ruling that although the product is not exclusively flavored with real vanilla, the suit failed to allege that a reasonable consumer would believe that a vanilla milk’s flavor was solely sourced from vanilla.

Other flavorings haven’t been immune from scrutiny, though. Frito-Lay appears to have settled a case involving allegations that the company's cheddar and sour cream chips are misleadingly labeled. The plaintiff alleged that the images of cheddar cheese and sour cream on the front of Ruffles-brand and Baked Lays Cheddar + Sour Cream Flavor potato chips, reasonable buyers would think that those ingredients flavor the chips. In fact, plantiff claimed that Frito Lay used synthetic diacetyl to provide the sour cream flavor in the chips, but did not disclose the artificial flavor on the front of the packaging, as required per the FDCA regulations.

Consumers were also dismayed to find out that 7-Eleven’s Yumions may not, in fact, be made from real onions and, separately, that the Keebler elves allegedly may not be making their cookies with “real fudge”.

The lesson from these cases and others is that flavor and ingredient-related representations continue to face considerable scrutiny. If businesses are updating labels or branding for the new year, it’s worth the time to review flavor descriptions and consider the arguments that these plaintiffs are asserting to help understand and assess risk.

(links from Law360, subscription req’d.)

FDA

FDA warning letters focused on claims that cause products to be considered unapproved new drugs, including claims featured on an aloe product relating to joint mobility, inflammation, and acid reflux. In other enforcement, a Washington-state federal judge entered a consent decree against a juice processor accused of distributing adulterated juice products.

FDA published findings of its leafy greens e. coli outbreak investigation, identifying cattle grazing upslope from the growing area as the likely source of contamination.

In a recall turned class action litigation story, Midwestern Pet Foods, Inc., initiated a recall of multiple pet foods on December 30, related to the presence of aflatoxin. Consumers whose pets perished after consuming the food recently filed suit alleging that the foods caused their pets’ deaths.

Undeclared allergens and potential presence of listeria monocytogenes and other contaminants were the most common reasons for food recall listed in FDA’s recall database.

Prop 65

Our sister blog, Kelley Green Law, featured two Prop 65 developments that may impact certain products, including Prop 65 warnings required on products that may expose consumers to THC and a proposal to minimize use of the short form warning format. Also, although not directly in the personal care space, given the proliferation of many products that feature disinfectant claims, companies may want to note this post regarding EPA enforcement on unregistered disinfectants.

FTC

The FTC did not announce any food-specific settlements or litigation in January 2021.

NAD

NAD did not issue any food-specific decisions in January 2021, but see select dietary supplement highlights here.

* * *

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NAD

NAD tackled substantiation for “#1 Dermatologist Recommended” claims in a challenge involving L’Oreal’s CeraVe moisturizer and use of syndicated survey data to support related claims.

Health claim substantiation was front and center in a Council for Responsible Nutrition-led challenge involving glutathione and the level of evidence required to support claims relating to low-glutathione levels.

FTC

Indirectly related to dietary supplements and consumer care, the FTC announced a settlement with app-maker Flo regarding allegations that the company shared the health information of users with outside data analytics providers after promising that such information would be kept private.

As we noted here, the FTC has new civil penalty authority relative to false COVID-related advertising claims and practices.

FDA

As it has since relaxing the regulatory standards relative to manufacturing of hand sanitizers in March 2020, FDA continued issuing warning letters related to hand sanitizer products that contain active ingredients other than those allowed per the hand sanitizer tentative final monograph, primarily methanol, and relative to hand sanitizers that are allegedly sub-potent.

The agency also continued its enforcement relative to COVID-related claims with warning letters issued to AusarHerbs and Allimax US (joint warning letter with the FTC), as well as non-COVID-related letters to companies whose products featured claims relating to joint health, hair loss, and inflammation, which caused the products to be considered unapproved new drugs. The letters rely heavily on evidence from social media posts, blog posts, and product websites.

Prop 65

Our sister blog, Kelley Green Law, featured two Prop 65 developments that may impact certain products, including Prop 65 warnings required on products that may expose consumers to THC and a proposal to minimize use of the short form warning format. Also, although not directly in the personal care space, given the proliferation of many products that feature disinfectant claims, companies may want to note this post regarding EPA enforcement on unregistered disinfectants.

Class Action Litigation

In a significant win for the dietary supplement industry, the Ninth Circuit Court of Appeals upheld the Northern District of California’s grant of summary judgment to Target Corp., ruling that state law false advertising challenges to permissible structure/function claims are preempted by the Federal Food, Drug and Cosmetic Act. See our blog post discussing the case here.

Other highlights from courtrooms around the country include…

Southern California skincare company Yes To Inc. agreed to pay $775,000 to a proposed class of consumers to resolve allegations it misrepresented the dangers of its Grapefruit Vitamin C Glow-Boosting Unicorn Paper Mask, which was recalled after a flood of consumers reported facial skin irritation and burning. (Law360 subs. req’d.)

A California federal judge has thrown out for the last time a proposed class action alleging that Johnson & Johnson Consumer Inc. and Bausch Health US LLC misled customers about the safety of their talc products, saying even after five chances to amend the complaint, the pleadings still fall short. (Law360 subs. req’d.)

Skincare company Murad LLC was hit with a proposed class action claiming the company deceived buyers by wrongly representing its moisturizer as "oil-free" when the product actually contains oils. (Law360 subs. req’d.)

A woman suing Charlotte's Web Holdings Inc. argued that the CBD company shouldn't be able to pause or escape her proposed class action over its labeling of products as dietary supplements, saying that identifying them as such violates state and federal laws. (Law360 subs. req’d.) There are several cases involving this issue. See a recent post on this issue on Cannabis Law Update.

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Fast-Track Eligible Cases

Only certain single-issue cases are accepted for the fast-track review and include, for example:

• Influencer & Incentivized Reviews Disclosures;
• Native Advertising Disclosures; and
• Pricing & Sales Claims.

• Complex substantiation, including reviews of clinical studies;
• Complex legal analysis where the NAD can’t rely on past NAD decisions; or
• Multiple advertising issues.

Fast-track review streamlines the standard NAD procedure and condenses the timeline—with the intention of arriving at a final NAD decision within 20 days. Here is the timeline:

• The Challenger files a complaint, starting the clock.
• The Advertiser has four days to object to the fast-track process and/or NAD’s jurisdiction. NAD will decide on the objection within 10 days.
• The Advertiser has 15 days to reply to the complaint (the objection does not extend this time).
• Remote (telephone or video) party meetings are held within five days of the Advertiser’s reply.
• NAD will submit a final decision to the parties 20 days after Challenger files its complaint.
• The Advertiser has five days to submit a statement for inclusion in the published decision.

• The Advertiser has three days to inform the NAD, NARB, and the Challenger of an intent to appeal the decision.
• The Advertiser has eight days to submit the case file to the NAD, NARB, and the Challenger (with the appeal limited to 15 double-spaced pages).
• The Challenger has two days to object to the appeal (no cross-appeals allowed).
• NARB Chair has absolute discretion to choose which types of members (public, advertising agency, and/or advertiser) will comprise the review panel.
• NARB will issue a decision three days after the review panel hearing.

The fast-track review cost is $5,000 higher than the standard NAD review cost. For BBB National Partners, the filing cost is $30,000. For Challengers with gross annual revenue less than $250 million, the cost is $15,000. For Challengers with gross annual revenue less than $5 billion, the cost is $35,000. For Challengers with gross annual revenue more than $5 billion, the cost is $40,000. If the NAD determines a case is not eligible for fast-track review, it will only retain a $5,000 processing fee and the Challenger has the option of filing a standard NAD challenge.

This month, NAD announced a decision involving T-Mobile’s ads for its TVision service. The service currently allows subscribers to watch TV over a wired broadband connection, though T-Mobile plans to offer wireless technology in the future. The decision covers a lot of ground, but we’ll focus on some key points related to product and feature comparisons in this post.

A commercial opens with a shot of a couple flipping through channels, as a T-Mobile spokesperson describes cable TV as “a rat’s nest of devices and wires.” Shots of the couple’s messy entertainment system reinforce that message. In contrast, shots of T-Mobile’s TVision service only show one wire inconspicuously coming out of one device. The challenger argued that because TVision actually requires the same number of wires and pieces of equipment as cable TV service, the claims and images were misleading. NAD agreed.

The challenger also argued that the ad implies that TVision service is wireless, in part, because the single wire is barely noticeable in the shots. NAD shared the concern, noting that T-Mobile is primarily known as a wireless company. The disclosure that “home connectivity and connected set top box [is] required” didn’t help because it didn’t mention a wired connection. Moreover, it wasn’t clear or conspicuous. NAD suggested that T-Mobile could address the issue by showing the wires or more clearly disclosing that three wires are required.

The challenger also took issue with T-Mobile’s claims that cable offers “outdated technology” and a “crappy” interface, especially given that the challenger provides an industry standard interface and an app with additional capabilities. NAD noted that the advertiser provided no information about the interfaces of other companies. Under NAD precedent, claims that denigrate another product must be truthful, accurate, and narrowly drawn. Because that wasn’t the case here, NAD recommended that those claims be discontinued.

When comparing your product to a competitor’s, it’s important to ensure that you accurately describe the differences between the products and show the products in a realistic manner. Be careful about exaggerating the differences. Although there may be instances in which you can argue that consumers won’t take those exaggerations seriously, that can be a hard argument to win at the NAD.​