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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• Specify that “internet sales” include purchases through mobile device applications;

• Clarify that the option to provide a warning “by electronic device or process” is intended to apply to in-store product purchases at a physical retail location, and that this provision is unrelated to the requirements for warnings provided online for internet purchases;

• Make clear that the tailored warnings provided in the regulations for specific products (such as for food, alcoholic beverages, and furniture) apply to internet and catalog sales; and

• Expressly state that the requirement to provide warnings in alternate/foreign languages applies to the tailored product-specific warnings.

In September 2020, after reviewing feedback on the rulemaking, OEHHA announced that it intended to withdraw the proposed clarifications. Now, the agency has released its final determination and response to comments document in which it explains that the withdrawal was precipitated by stakeholder comments that the supposed “clarifications” in fact represented a “wholesale change” to “the existing safe harbor warning for almost every consumer product.” OEHHA objected to commenters’ characterization of the proposed revisions, particularly the contention that the “current safe harbor regulations do not require businesses selling online to provide both a website warning and a warning on or with the same product.” In OEHHA’s view:

Websites and smart phones can be a part of a safe harbor warning method, but neither are a standalone safe harbor warning method.

With regard to alcohol sales, OEHHA finalized a series of changes intended to codify the terms of a settlement stemming from the California Attorney General’s enforcement action against online sellers of alcoholic beverages. The new provisions include a requirement that Prop 65 warnings provided on-line or in catalogs also must be “provided to the purchaser or delivery recipient prior to or contemporaneously with the delivery of the product.” Such warnings “must be readable and conspicuous to the recipient prior to consumption of the alcoholic beverages,” and must be provided (1) on or in the shipping container or delivery package, or (2) delivered by email or text message as part of the electronic receipt or confirmation of the purchase. These regulations go into effect April 1, 2021.

It is important to remember that the “safe harbor” warning regulations are not mandatory, but, rather, prescribe warning text and methods that are considered de facto compliant. Businesses can use other means of communicating a warning, or different text, but, if so, they run the risk of a plaintiff challenging the sufficiency of the warning as “clear and reasonable.”

Further information is available at OEHHA’s website.

Find out more on Prop 65 on our Kelley Green blog.