More specifically, the agencies’ goals related to reducing occurrence of foodborne illness are as follows:

• Increase uniformity, consistency, and capacity of state, tribal, local, and territorial (STLT) retail food protection programs;
• Promote industry’s active managerial control (AMC) of foodborne illness risk factors and promote a culture of food safety; and
• Maintain a strong FDA National Retail Food Team (NRFT) and CDC National Center for Environmental Health (NCEH) workforce to assist STLT partners.

• Improve STLT’s effectiveness in conducting risk-based inspections and foodborne illness investigations.
• Promote a culture of food safety and food safety management systems within retail and foodservice establishments (including facilities that serve highly susceptible populations (HSP) such as institutional foodservice, correctional facilities, schools, and healthcare facilities).
• Improve research in support of foodborne illness risk factor reduction.
• Improve the knowledge, skills, and abilities of FDA NRFT and CDC NCEH staff.

The FTC warned that the claims do not appear to be supported by competent and reliable scientific evidence, in violation of the FTC Act. The FDA warned that the products are being marketed as drugs that could cure, treat, mitigate, or prevent disease, but are not generally recognized as safe and effective for the marketed uses and not approved by the FDA. As such, the products are misbranded and illegal under the Food Drug and Cosmetic Act (FD&C Act). The letters demanded that the companies cease and desist from making unsubstantiated claims within 15 days.

Deceptive Claims under the FTC Act

To be sure, these letters are noteworthy for companies making diabetes-related claims, but their importance is not necessarily limited to that. Advertisers should pay attention more broadly to the FTC section of the letters, as it may signal the FTC testing its authority to seek penalties under Section 5(m)(1)(B).

In particular, in describing how and why the claims violate the FTC Act, the letters cite to cases holding that unsubstantiated disease claims of various types are unlawful, and appear to be styled as so-called Section (5)(m)(1)(b) letters laying the groundwork for civil penalties – similar to letters the FTC has sent companies making allegedly unsubstantiated claims that their products are made from bamboo. In general, the FTC has limited authority to obtain civil penalties. However, Section (5)(m)(1)(b) of the FTC Act authorizes the agency to seek penalties when the FTC has (1) previously determined in a litigated administrative proceeding that a practice is unfair or deceptive (2) issued a final cease and desist order with respect to such practice, and (3) put a company on notice of this fact (such that it has “actual knowledge) via warning letter.

It’s not clear yet whether the FTC will actually seek civil penalties based on these letters. But if it does, it would be testing the limit of its authority under Section 5(m)(1)(b). That’s because the law arguably contemplates that the “final cease and desist order” cited in a Section 5(m)(1)(b) letter be more specific to the practice being warned about than the potpourri of health cases cited in these current letters. Put another way, to confer “actual knowledge” on the companies, the cited cases should address unsubstantiated diabetes claims, not wholly different health claims about heart disease, cancer, erectile dysfunction, etc. Indeed, the language of Section (5)(m)(1)(m) and precedent from the bamboo cases support this narrower reading. Top FTC officials have called for more frequent and aggressive use of the FTC’s Section 5(m)(1)(b) authority, and this appears to be a move in that direction.

Misbranding Under the FD&C Act

The FDA section of the letters doesn’t break new ground, but it does provide a helpful gauge for risk and a reminder about the importance of context.

Companies marketing supplements and foods to people with diabetes or pre-diabetes should review the claims cited in the letters to help assess risk of their current marketing. For example, some letters cite to claims that clearly exceed the bounds of structure function claims, e.g., claiming that the ingredients or products produced quantifiable improvements in fasting blood sugar, A1C levels, and reduced blood pressure as well as risk of heart attacks. However, other letters cite to claims that many marketers may think fall more squarely on the structure-function side of the line, e.g., “promote healthy glycemic response” and “supports healthy glucose tolerance.” In addition to product labels and websites, the letters also cite to claims on social media – including testimonials dating as far back as 2018 – and to Amazon store fronts.

As is standard, the letters cite to specific claims, but it’s important to also consider the broader context. When marketing diabetes-related products, it’s risky to position any product as the fix for a condition that likely requires medication along with constant dietary discipline and monitoring. Even if the product claims are substantiated and within structure-function limitations, the context of positioning the product as one part of an overall diabetes management plan is key to managing risk.

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We will closely monitor developments in these matters, as well as the agencies’ future use of warning letters and sources of legal authority, and post updates as they occur.

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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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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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Earlier this week, federal regulators continued their efforts to combat the spread of products featuring allegedly false and misleading claims that products can diagnose, treat, cure, or prevent COVID-19. In warning letters issued to CBD Gaze, Alternavita, Musthavemom.com, and Careful Cents LLC, the agencies identify the respective recipients as participants in the Amazon Affiliate program. Amazon Affiliates are marketers who earn commissions by promoting products sold on Amazon. The letters state that the products at issue, which include essential oils, grapefruit seed extracts, cod liver oil, and others, feature false treatment and prevention claims such as the following:

• CBD Gaze: “Find the best CBD Oil to help fight Coronavirus.”
• Alternavita: “4 Proven Ways To Protect Yourself Against Coronavirus,” you represent that “Everyone is concerned about Coronavirus and looking for ways to protect themselves,” and then state the following:

“Grapefruit Seed Extract If you want a little extra daily protection GSE is a safe antibiotic . . . [Amazon associate link].”

• Musthavemom.com: “NATURAL REMEDIES FOR CORONAVIRUS. . .There are plenty of things you can do to boost your immune system and fight off any virus including coronavirus. Here are a few!” … “2. Vitamin D . . . This important vitamin plays a crucial role in immune health. Being deficient in Vitamin D can increase your risk of infection. I recommend this brand of Vitamin D [Amazon associates link] and starting at a minimum dose of 5,000 IU.” [from your website https://musthavemom.com/coronavirus-prevention-treatment-plan/]
• Careful Cents LLC: “How to Boost Your Immune System Naturally With Essential Oils to Fight Coronavirus” you state: “Can you use essential oils to boost your immune system and fight coronavirus? Yes! Essential oils are one of the best tools to strengthen your immune system naturally . . .”

The letters state that the products are unapproved new drugs and misbranded pursuant to the Food Drug and Cosmetic Act. Causing the introduction or delivery for introduction of these products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d). The letters also state that “it is unlawful under the FTC Act, 15 U.S.C. 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. For COVID-19, no such study is currently known to exist for the product identified above. Thus, any coronavirus-related prevention or treatment claims regarding such product are not supported by competent and reliable scientific evidence.”

What’s the lesson? The difference between these letters and the warning letters that FDA and the FTC issued earlier this year is that these are targeted not to the company making the product or even the retail platform on which they are sold. They were sent to the middleman marketer, who likely does not produce or possess the product, but who is promoting and profiting from its sale. This is consistent with the FTC’s letters to product influencers in other marketing contexts but is a departure from FDA’s typical enforcement approach. Although we have seen FDA pursue retailers (particularly online ones), FDA has not made pursuit of marketing affiliates a priority. Clearly, regulators want affiliate marketers (Amazon or otherwise) to understand that they are not immune from enforcement if they are making aggressive or unsubstantiated health claims.

As business people, airport management, and event hosts everywhere try to figure out how they can return to business as usual, many are considering telethermographic device systems. These are cameras that can detect human temperature in comparison to their surroundings to help identify fevers. Reuters reported last week that Amazon implemented thermal cameras at its warehouses to scan for feverish employees. This has prompted many to wonder how telethermographic devices are regulated.

FDA helped answer this question last Friday. In its “Enforcement Policy For Telethermographic Systems During the COVID-19 Public Health Emergency,” FDA explains that use of such cameras to detect human temperature – even when used outside of a medical facility such as in an airport – may render the systems medical devices typically subject to pre-market clearance, registration, listing, and quality regulations. However, during the current pandemic, FDA is relaxing those regulations provided that the systems meet performance and labeling criteria.

The systems must be tested and labeled consistent with the following:

1) IEC 80601-2-59:2017: Medical electrical equipment – Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening; OR

2) Alternative performance specifications that provide similar results to IEC 80601-2-59:2017. The guidance lists several alternative standards.

FDA recommends labeling that includes the following:

1) A prominent notice that the measurement should not be solely or primarily relied upon to diagnose or exclude a diagnosis of COVID-19, or any other disease;

2) A clear statement that:

1. a) Elevated body temperature in the context of use should be confirmed with secondary evaluation methods (e.g., an NCIT or clinical grade contact thermometer);
2. b) Public health officials, through their experience with the device in the particular environment of use, should determine the significance of any fever or elevated temperature based on the skin telethermographic temperature measurement;
3. c) The technology should be used to measure only one subject’s temperature at a time; and
4. d) Visible thermal patterns are only intended for locating the points from which to extract the thermal measurement.

FDA also recommends labeling that explains the performance specifications, proper use, installation, and related technical considerations listed in the guidance.

Companies considering using these devices will want to keep in mind that FDA is likely to reinstate the regulatory requirements post-pandemic. When screening vendors, companies should consider whether the vendor will be able and willing to comply with the medical device standards once the economy has re-opened to a significant degree.

In addition, this technology raises employee and consumer privacy issues. Prior to using it, companies should consider applicable laws and policies around notice to the public or employees, capturing such data, potentially storing or sharing it.

Not anymore.

The public is rightly concerned about coronavirus and how to avoid catching it. And where the public has questions, marketers will have answers. Here are a couple things to think about before rushing that next campaign out the door.

State and Local Laws Prohibit Price Gouging

As hand sanitizer has become scarce, some who have it have sought to capitalize on consumer demand and no small amount of fear. We noticed this story about Amazon cracking down on third-party merchants selling coronavirus products at inflated prices.

Many states have laws governing price gouging. New York’s law prohibits merchants from taking unfair advantage of consumers by selling goods or services that are “vital to the health, safety or welfare of consumers” for an "unconscionably excessive price" during an abnormal disruption of the market place or state of emergency.

New York's price gouging law does not specifically define what constitutes an "unconscionably excessive price." However, per the NY AG, the statute provides that a price may be "unconscionably excessive" if: the amount charged represents a “gross disparity” from the price such goods or services were sold or offered for sale immediately prior to the onset of the abnormal disruption of the market. Merchants may provide evidence that justifies their higher prices were justified by increased costs beyond their control.

California’s law is more prescriptive. California’s anti-price gouging statute, Penal Code Section 396, prohibits raising the price of many consumer goods and services by more than 10% after an emergency has been declared. There may also be local laws that prohibit price gouging.

State attorneys general and CA district attorneys have reported receiving price gouging complaints. Companies that fail to comply will risk being enforcement targets.

Be Careful Not To Oversell

The FTC and FDA issued warning letters to seven companies allegedly selling unapproved products that may violate federal law by making deceptive or scientifically unsupported claims about their ability to treat coronavirus. Both agencies issued statements indicating that they are prepared to take further enforcement action to prevent the public from being misled.

An equally concerning scenario is the marketer who sees an opportunity to market around coronavirus with a product that has value but not to the degree that it would be an effective prevention tool. For example, dust masks are not the same as N95 face masks. Hand wipes without alcohol will not kill the same germs as those with alcohol. Tito’s Handmade Vodka is not hand sanitizer. It would be potentially misleading and deceptive to market dust masks, hand wipes without an effective sanitizer, or even Tito’s Handmade Vodka hand sanitizer as effective coronavirus prevention tools. It’s also a waste of good vodka. But, we digress.

The lesson is this: The rush to meet consumer demand should not overcome the legal clearance process or common sense. Rules still apply even in – and maybe especially in – times of public health emergency.

Stay tuned. We’ll update this post as the situation evolves.