Best Hair Pickup Claims

Shark advertised that the Stratos vacuum offered “the best hair pickup of any upright vacuum in America.” There are a lot of upright vacuums in America, so a threshold question is how many vacuums need to be included in test to support this type of claim. The general rule is that if an advertiser makes an unqualified claim against an entire category of products, it must test against 85% of that category. Shark argued that the “85% rule” is a flexible standard that shouldn’t apply here.

Shark only tested 17 competing vacuums and defended its decision by saying it only had to test against vacuums that “specialize” in hair pickup. (Evidence in the record suggest that these models comprise only 2.3% of the upright market by unit share.) Both NAD and NARB rejected this argument, noting that Shark’s selection reflected “advertising strategies, not performance capabilities.” Accordingly, despite good test results, NARB determined that Shark’s tests were not sufficient to support its broad claims.

Dyson also took issue with other aspects of the test protocol. For example, although the infomercial showed the Stratos picking up a variety of hair from multiple surfaces, the test only measured pet hair pickup on one surface. Both NAD and NARB agreed this was a problem. NARB wrote that “different lengths of human hair should have also been used in the testing. This is especially the case here, given the prominent express reference to various types of hair in the infomercial.”

Odor Reduction (or Elimination) Claims

The infomercial stated that Shark had solved the problem of vacuum odor with breakthrough odor neutralizer technology that “interacts with odor-causing particles and transforms the bad odors into fresh-smelling air.” To support this claim (and other similar claims), Shark submitted a gas chromatograph mass spectrophotometry test, a sensory analysis testing conducted by an independent laboratory, and an in-home use testing conducted by Shark. The tests showed good results.

Although NAD and NARB both determined that Shark’s tests showed a reduction in odors, Dyson argued that the claims in the infomercial went further and suggested that that Shark’s odor neutralizer technology “eliminates” – not just reduces – odors. NAD and NARB agreed, finding that parts of the infomercial exaggerated the vacuum’s capabilities. While Shark’s tests could support a more narrow odor reduction claim, they weren’t enough to support the broader claims in the infomercial.

As with the “best hair pickup” claims, NAD and NARB also determined that there were certain visuals in the infomercial didn’t match up with the test protocol. For example, although the sensory analysis tests had trained panelists smelling the vacuums from several feet away, the infomercial showed actors with their noses inches from the vacuums. In addition, the odors used in the lab test didn’t match the odors used in the infomercial.

What to Pick Up from This Decision

Although a footnote in the NARB decision suggests there may be some flexibility in the application of the 85% rule, NARB determined that they didn’t need to address the boundaries, “given that Shark’s testing was easily determined to have been inadequate in scope.” Absent more guidance from NAD or NARB on this issue, advertisers should probably either follow the 85% rule or qualify their claims to reflect a more manageable category for testing purposes.

The decision also demonstrates that it’s important to ensure that whatever you show in your ads has to be closely tailored to your test protocol and the test results. There are a number of cases in which advertisers have been able to demonstrate superior performance in lab tests, but still lost advertising challenges when their ads exaggerated the results or depicted conditions that different from those that were tested.

In January 2023, Beiersdorf moved to dismiss the amended complaint. The company concedes that the formulas are the same. However, the company asserts, among other things, that the product claims are true and therefore the complaint fails because there is no deception. That is, Ms. Akes cannot succeed on her claims because the claims that she points to as the basis for her understanding that the product was specifically designed for facial use, i.e., the use of “FACE”, “oil free” and “won’t run into eyes” are, in fact, true. Beiersdorf points out that Akes does not allege that she looked at the regular version of Coppertone Sport Mineral prior to purchasing the “FACE” version and, therefore, her argument amounts to little more than regret over paying more than she would have liked. The court’s ruling is pending.

Courts have been skeptical of arguments that brands necessarily deceive consumers by packaging the same product at varying price points, e.g., rejecting arguments that infant acetaminophen is deceptively marketed when sold at a higher price as compared to children’s acetaminophen because there was nothing about the packaging that suggested that the products had different formulations. Here, had Akes looked at the 5 oz version, she presumably would have seen that the active ingredient in both was zinc oxide and would have also seen that the ingredient listings and Drug Facts were identical. But, courts are also skeptical of requiring consumers to actually read ingredient lists.

So, what’s a marketer to do? Beiersdorf rightly points out that “[t]here is nothing deceptive about emphasizing different but equally true aspects of a product to different market segments or pricing products differently when sold to different market segments or in different retail channels. This happens every day.” When confronting this issue, companies should keep in mind that differences in branding, packaging, merchandising (store and shelf placement) and other factors can help establish a valid legal basis to support an argument that, even if two products have the same formula, one rightly commands a higher price point.

State AGs began a multistate investigation after the Federal Drug Administration (FDA) warned the company about marketing its online vision tests without appropriate approval. The State AGs claim that their investigation revealed that Visibly deceived consumers, including by: (1) marketing and selling a device without the required clearance or approval from the FDA; (2) marketing unsubstantiated safety and effectiveness claims about its online vision test; and (3) falsely claiming to offer a 100% satisfaction or money back guarantee. Note that while the State AGs’ investigation was pending, Visibly began the process of seeking FDA approval, but they did not have this prior to the investigation.

To resolve these allegations, Visibly agreed to pay $500,000 combined to the participating states. Visibly must among other requirements do the following:

• Comply with consumer protection statutes, the Federal Food, Drug, & Cosmetics Act (FDCA), and FDA authority;
• Align all representations that its products can diagnose, cure, mitigate, treat, or prevent any disease or condition with the FDCA and FDA authority;
• Possess competent and reliable scientific evidence substantiating any claims that its products are comparable to the safety and effectiveness of products offered by doctors’ offices or other FDA approved devices;
• Clearly and conspicuously disclose any terms or conditions for eligibility for a satisfaction guarantee, money back guarantee or other offer of refund to consumers;
• Ensure all optometrists and ophthalmologists who contract with the company are in good standing with applicable states;
• Clearly disclose that providers in any “find a doctor” feature do not endorse its products (unless specifically obtained), and agree to remove doctors upon their request; and
• Provide a disclosure that Visibly’s online vision test is not a substitute for an in-person comprehensive eye examination and urge consumers to seek such exams to determine overall eye health.

Takeaway: Claims on telehealth platforms attract enforcers’ attention due to the sensitive nature of the services and the relative novelty of the technology involved. From the FTC, to the FDA, to State AGs, governmental entities are interested not only in protecting the privacy of telehealth consumers (as shown in the BetterHelp settlement), but also the substantiation of advertising claims. Companies should:

• Substantiate telehealth-related claims.
• Clearly describe any relationships with providers, and ensure providers comply with state licensing laws.
• Make appropriate disclosures regarding limitations of products and services where a failure to disclose may materially affect a consumer’s decision.

We’ve covered the FTC’s use of its long dormant Penalty Offense Authority extensively in prior posts (see here, here, here, here, and here). In those posts, we noted several unanswered questions regarding the FTC’s use of that authority, such as whether the FTC can use dated decisions from decades ago to justify civil penalties for first-time offenses occurring today; whether the facts and legal standards in place today are sufficiently similar to those present in these dated decisions to satisfy statutory requirements; and whether companies are afforded sufficient due process under an expansive use of this authority.

These questions remain outstanding today, as we have yet to see the FTC “put to its proof”’ by defending its interpretation of this authority in court. The only relevant activity we’ve seen so far has been in two recent settlements specifically referencing Penalty Offense Notices (DK Automation and WealthPress).

In today’s warning letters, the FTC outlined another broad array of purportedly deceptive practices that the FTC has determined to be unfair or deceptive in prior administrative cases, including:

• making an objective product claim without a reasonable basis consisting of competent and reliable evidence;
• making a health benefits or safety features claim without competent and reliable scientific evidence that has been conducted and evaluated in an objective manner by qualified persons and that is generally accepted in the profession to yield accurate and reliable results, to substantiate that the claim is true;
• claiming that a product is effective in the cure, mitigation, or treatment of any serious disease without possessing and relying upon at least one human clinical trial of the product that (1) is randomized, (2) is well controlled, (3) is double-blinded (unless the marketer can demonstrate that blinding cannot be effectively implemented given the nature of the intervention), (4) is conducted by persons qualified by training and experience to conduct such studies, (5) measures disease end points or validated surrogate markers, and (6) yields statistically significant results;
• misrepresenting the level or type of substantiation for a claim; and
• representing that a product claim has been scientifically or clinically proven without evidence sufficient to satisfy the relevant scientific community of the claim’s truth.

These cited administrative orders focus on a wide variety of product claims, including the biodegradability of certain plastics (ECM Biofilms), efficacy of add-on braking systems, auto fuel-savings devices, and gasoline additives (Auto. Breakthrough Scis., Brake Guard Products, Cliffdale Assocs.), efficacy of hair epilators (Removatron), superiority of microwave ovens (Litton Industries), efficacy of weight loss treatments (Porter & Dietsch), and health claims related to treatment of cancer, erectile dysfunction, heart disease, and other ailments (POM Wonderful, Daniel Chapter One, Thompson Medical, Bristol-Myers Comp., American Home Products).

The notices further encourage companies to reference the FTC’s recently released “Health Products Compliance Guidance,” which – as we noted here – constitutes a sweeping overhaul of the 1998 dietary supplement guidance and a departure from the agency’s prior, flexible interpretation of the “competent and reliable scientific evidence” standard.

We will be watching closely to see how the FTC uses these Penalty Offense Notices in future matters and settlements. In the meantime, we encourage all companies (not only the ones who received notices directly) to review claim substantiation and endorsement practices with an understanding that the FTC staff is continuing its efforts to impose a less-flexible substantiation standard and more stringent disclosure requirements.

1. Are you exaggerating what your AI product can do? It’s exciting to think about what may be possible, but it’s important to ensure that your claims are factually accurate, that you can support those claims, and that you disclose any material limitations.

2. Are you promising that your AI product does something better than a non-AI product? The post notes that “it’s not uncommon for advertisers to say that some new-fangled technology makes their product better.” “New-fangled” is arguably an old-fangled term to use when talking about AI, but that’s beside the point. The point is that “you need adequate proof for that kind of comparative claim.”

3. Are you aware of the risks? You should think about “reasonably foreseeable risks and impact of your AI product before putting it on the market.” For example, if you create an AI-powered cyborg and it starts wreaking havoc on humanity, that’s on you. (That may not be precisely what the FTC had in mind, but we’re reading between the lines. Anyway, see our warning about the dangers of cyborgs and bots here.)

4. Does the product actually use AI at all? Don’t think you can get away with saying that a product is AI-enabled if it isn’t. And remember that there’s a difference between using an AI tool to develop the product and having AI in the product. “FTC technologists and others can look under the hood and analyze other materials to see if what’s inside matches up with your claims.”

These messages aren’t new, but they are helpful reminders to companies as they consider their claims about AI. As the post concludes: “You don’t need a machine to predict what the FTC might do when those claims are unsupported.”

Although the settlement, which took the form of an Assurance of Voluntary Compliance (or “AVC”), is light on details, there is a lot to unpack from the underlying AG allegations. The C-Max vehicles in question were previously subject to multiple class action lawsuits alleging overstatements on fuel efficiency, and Ford previously provided payments to consumers when they acknowledged the overstated rating back in 2013. As for the Super Duty vehicles, the AGs alleged that the payload claims, which earned Ford a “Best-in-Class” status, were overstated because they were based on a hypothetical configuration that required the removal of several standard items such as a spare wheel, tire and jack, radio, and center console (a configuration only available to fleet customers).

So what are the broader lessons we can take away from these settlements?

• Claims must be substantiated – and not just technically. Ford arguably could support both its fuel economy claims (through historic practices of working with the EPA on generating ratings for different-but-related models), and its payload claims (through the configuration described above), but that wasn’t enough for the AGs. Rather, the focus was what the “real world” experience for a consumer would be – absent any other disclosure, the AGs are going to focus on what a typical consumer would expect.
• Attorneys General will pursue cases even without restitution. The $19 million payment can be used by the AGs for “any lawful purpose” – but cannot be characterized as a fine, penalty, or forfeiture. History tells us that while some offices may use their portion of the payment to repay consumers, most will use it for future consumer protection enforcement/education or have it revert to their general fund. Even though AGs make recovery for consumers a priority, in cases like this where identifying purchasers may be challenging and some consumers already received payment, the AGs’ priorities may shift.
• Attorneys General are especially focused on issues that impact consumers’ pocketbooks. While AGs focus their consumer protection efforts in a variety of areas, the recent wave on inflation has kept them specifically focused on matters that impact consumers’ out-of-pocket costs. Many of the press releases focused on rising gas prices and the significant impact fuel economy has on consumer choice. Businesses should be especially sensitive to disclosures made regarding overall costs.

Please join us for State Attorneys General 101, a webinar covering the basics of State AG consumer protection powers, what to expect if you find yourself a target of attorneys general investigation, how to look to state attorneys general to stop improper actions of competitors, and more. RSVP here.

Need Help Talking To Dad About Milk?

The UK’s Advertising Standards Authority (ASA) recently investigated advertising by Oatly for advertisements that allegedly overstated the environmental benefits of the popular oat-based beverage. Here’s an example:

The first TV ad, seen on January 16 2021, featured a man sneaking into his home and putting a bottle of milk in the fridge. He was interrupted by his son who said, “What have we here? Cow’s milk? Really?” Large, on-screen text stated “NEED HELP TALKING TO DAD ABOUT MILK?”. Smaller text at the bottom of the screen stated “Oatly generates 73% less CO2e vs. milk, calculated from grower to grocer. To verify see www.oatly.com/helpdad”.

The ASA found the “Need Help Talking to Dad About Milk” ad to be misleading not because the life cycle assessment conducted to support the claims was not sufficiently robust to support a benefit. Rather, the substantiation was limited to Oatly’s Barista Edition but the ad and the disclosure could reasonably be understood to apply to all Oatly products. Because of this gap, the ASA found the ads misleading.

What’s the takeaway? The ASA’s decision, which also covers four other ads, is worth a read by any food company considering how to substantiate environmental claims. There are valuable insights from a technical perspective, including detailed discussion of life cycle analyses for Oatly’s product as well as the dairy, meat, and transportation industries.

There is also a focus on less complex but equally important features for food marketers – such as the consumer understanding of what is included in references to the “meat industry” or the “dairy industry”. Because consumers could interpret “dairy and meat” more narrowly than how Oatly did, the ASA found the claim "Today, more than 25% of the world's greenhouse gases are generated by the food industry, and meat and dairy account for more than half of that" to be misleading.

Stepping back, the biggest issue with Oatly’s advertising wasn’t that the company didn’t have robust substantiation for some claims. It appears that they did. The claims reasonably conveyed didn’t match the limitations and definitions in their substantiation, though, and this wasn’t made clear to consumers.

Recently lobbying group PoliticallyInFashion partnered with 40 organizations and individuals to submit a letter to the FTC asking the agency to conduct a comprehensive review of the Green Guides. Citing “an exponential growth in sustainability claims by businesses,” the group has asked the FTC to provide more guidance on use of the terms “organic” and “sustainable.” The Commission declined to provide specific definitions for either term when the agency last updated the Guides in 2012. PoliticallyInFashion suggests that retailers’ increased focus on sustainability claims, and consumers’ increased interest in retailers’ environmental commitments, warrants additional guidance on the terms. The FTC is scheduled to undertake a review of the Green Guides in 2022.

The U.S., however, is not the only country where sustainability claims are in the spotlight. Regulators across the globe are closely scrutinizing clothing retailers’ sustainability claims. In March, the Netherlands Authority for Consumers and Markets (“ACM”) sent letters to more than 70 clothing companies flagging potentially misleading claims. As one example, ACM advised a retailer that offers consumers the online option to filter items by “sustainability” to explain what makes the clothing sustainable. Director Edwin van Houten explained the importance of action in the clothing industry “because, for consumers, the aspect of sustainability plays a major role in their purchase decisions.”

As sustainability continues to influence consumers’ purchasing decisions, consumer protection regulators will seek to ensure that these claims are truthful. Especially because the FTC has yet to define the term “sustainable,” if your marketing team wants to make claims about product sustainability, having accurate and up-to-date substantiation that provides a reasonable basis for the claim is essential. For more information about sustainability claims, or other green marketing issues, see our blog archives or visit our Advertising and Privacy Law Resource Center.

* * *

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October 13 Futureproofing Privacy Programs Building a successful privacy program requires much more than compliance with data protection laws. To thrive in today’s global, data-driven environment, companies also need to understand the political environment and public attitudes surrounding privacy in the countries in which they operate. Of course, companies must anticipate and adapt to changing privacy regulations as well.

In conjunction with Canadian firm nNovation LLP, Privacy and Information Security practice chair Alysa Hutnik and partner Aaron Burstein will present strategies to help meet these challenges, with a focus on setting up structures to join local awareness with global compliance approaches.

Register Here

October 20 New Frontiers of the Intersection Between Privacy Laws, Antitrust and Misleading Advertising Enforcement Canadian Bar Association (CBA) 2020 Fall Competition Law Conference The Bureau is pushing the boundaries of the intersection between competition and privacy laws, and the pandemic has accelerated pre-existing trends in digital enforcement. The FTC is similarly continuing to pursue robust enforcement in cutting-edge areas such as data privacy and fintech. Join Alysa Hutnik and a host of others for this session for a conversation on misleading advertising priorities in Canada and the U.S. in the digital economy.

Register Here

November 10 Nuts and Bolts of Basic Advertising: Substantiation, Disclosures and Social Media 2020 ANA/BAA Marketing Law Conference: A Virtual Experience

Join partner Gonzalo Mon for this session, which will cover important principles of advertising law, including prerequisites to prove your claims, the type of proof required, how to make disclosures, and application of these principles to social media. In addition, it will cover options for challenging competitors. Whether new or experienced to advertising, this session will give you down-to-earth information you need to put later sessions into context. This presentation will put a great new spin on important topics.

Register Here

October 21 2020 Election Outlook: An In-Depth Analysis of the Race for the White House and Congress Please join Kelley Drye's Government Relations and Public Policy Group as we present a bipartisan assessment of the upcoming 2020 elections. Election analysts Greg Speed and Jim Ellis will provide a detailed and data-packed assessment of the current state of play in the race for the White House. In addition, they will cover key Senate and House races and the prospects for control of both chambers in the upcoming 117th Congress.

Register Here

November 10, 2020 The Future of Consumer Protection and Privacy - What to Expect from the FTC As the election approaches, our government prepares for a transition – either to the second term under President Trump or to the Biden Administration. As this is occurring, consumer protection law also finds itself in transition. Partners Christie Grymes Thompson and John Villafranco will focus on what this means, in terms of recent enforcement activities and priorities related to privacy, data security, marketing, advertising, and other areas of consumer protection.

Register Here

For on-demand webinar replays and other content organized around Advertising and Marketing Standards, Privacy and Data Security and Consumer Product Safety, visit the Advertising and Privacy Law Resource Center microsite. Available via www.KelleyDrye.com, the site provides practical, relevant information to help in-house counsel answer the questions and solve the problems that they face on a daily basis.

While Missouri is generally a plaintiff-friendly jurisdiction in the class action arena, United States District Judge John A. Ross found that a majority of Plaintiffs’ claims (breach of warranty, breach of contract, and claim for injunctive relief) could not stand and dismissed them without prejudice. The Court dismissed the breach of warranty claim because Plaintiffs failed to provide the requisite pre-suit notice to Colgate. Judge Ross rejected Plaintiffs’ argument that the filing of the original complaint should suffice as notice as “interesting,” but “unconvincing and not rooted in any analogous caselaw.” The Court also dismissed the contract claim because Plaintiffs failed to respond to Colgate’s arguments, and the standalone claim for injunctive relief both because Plaintiffs did not allege an intent to continue purchasing Speed Stick in the future and because “injunctive relief is a remedy and not an independent cause of action.”

However, the Court permitted the MMPA and unjust enrichment claims to proceed into discovery, rejecting Colgate’s argument that the challenged advertising would not deceive a reasonable consumer because it is “common sense” that a product that claims to fight stains does not mean that it would prevent stains altogether. Judge Ross was “unpersuaded, at this early stage of the proceeding,” and found Plaintiffs’ allegations that they believed that stains would be prevented was sufficient.

Finally, the Court denied Colgate’s motion to strike the nationwide class allegations in connection with the unjust enrichment claim, finding that while “it has serious doubts as to whether Plaintiffs will be able to satisfy [Rule 23’s] predominance requirement” based on the variations in state law, that decision should be made after affording the parties time to conduct discovery.

While Colgate will be required to proceed with discovery on two claims, this decision shows that motions to dismiss in Missouri are not a lost cause, and should be considered when there is an opportunity to narrow the scope of the case.

COVID-19 has brought a proliferation of products claiming to kill or otherwise inhibit viruses, bacteria and other germs. These products, before they can be legally sold, are heavily regulated by the U.S. Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and sometimes both. Major enforcement actions are pending against companies making illegal claims or selling unregistered products. Meanwhile, the FTC regulates advertising of many sanitizing products and the agency has pursued enforcement on companies that overstate their products’ germ-killing performance.

Please join us for a webinar covering the basics of germ killing and related product claims.

Discussion topics include:

• The regulatory landscape: Who regulates what – EPA, FDA and FTC jurisdiction and requirements
• What can you say and when can you say it
• Potential liability and enforcement considerations
• What to do if you receive a warning letter or other enforcement action

To view the presentation slides, click here.

To view the webinar recording, click here.

Subscribe to our Ad Law News and Views newsletter to receive information on our next round of webinars and to stay current on advertising and privacy matters.

Visit the Advertising and Privacy Law Resource Center for additional information for additional information, past webinars, and educational materials.

The FTC has recently sent warning letters to hundreds of companies for allegedly falsely implying that products can be used to treat, cure, mitigate, or prevent COVID-19. The FTC has also issued warning letters for implied earnings claims connected to the pandemic, alleging that some have overpromised on the financial opportunities available and misleadingly tied them to the pandemic. These announcements have made clear that any claim mentioning COVID-19, the pandemic, or even “these times” will be closely scrutinized.

To help ensure your company isn’t next, please watch the replay of our webinar covering the basics of advertising product and earnings claims, and how those should be applied during the pandemic. Discussion topics included:

• Claim Substantiation and Puffery • Express and Implied Product Claims • Express and Implied Earnings Claims • Enforcement Examples and Takeaways • Monitoring Third Parties Making Claims on Your Behalf (Endorsers, Independent Distributors) • What to do if you receive a warning letter or other enforcement action

To view the presentation slides, click here.

To view the webinar recording, click here.

Subscribe to our Ad Law News and Views newsletter to receive information on our next round of webinars and to stay current on advertising and privacy matters.

Visit the Advertising and Privacy Law Resource Center for additional information for additional information, past webinars, and educational materials.

NAD recently issued a decision involving a video by the owners Your Superfoods, promoting the company’s Immunity Bundle. But the claims in this video are a little different than the ones recently targeted by the federal agencies. Here’s the relevant part of the video:

With all that’s going on, with the coronavirus there is [sic] a lot of things you cannot control. However, there is a piece that we can control, and that is our own health and building our immune system because its depends on what we eat…. It’s super important to have a lot of micronutrients now, so Superfoods can help. We have this amazing immunity bundle – Super Greens to up your green, Mellow Yellow which really reduces your stress because stress actually reduces your immunity, and then we also have immunity boosting mushrooms in our Magic Mushroom mix.

Notice that the owners don’t actually say their products can treat or cure the coronavirus. (Not even their magical mushrooms.) Instead, the only reference to the coronavirus is the true statement in the first sentence. Here, NAD was likely concerned that following that sentence with other sentences about how the products can help consumers build immune systems could lead viewers to believe that the immunity extended to the coronavirus, itself.

Whether you are talking about health or something more mundane, this case should serve as a reminder that ads can be deemed misleading, even if the individual claims in the ads are literally true. What matters is how reasonable consumers will interpret the claims in context. Make sure you view your ads through their eyes and that you can substantiate all likely interpretations.

For some of these products, those claims have not been reviewed or accepted by EPA and, therefore, may present a risk to consumers, and healthcare providers in particular.

Earlier this year, EPA issued a list of disinfectants (“List N”) that meet the agency’s criteria for use against the coronavirus (SARS-CoV-2, the strain of coronavirus that causes COVID-19). While the surface disinfectant products on List N have not been tested specifically against SARS-CoV-2, they are expected to work against the virus because they demonstrate efficacy against other viruses that are deemed harder-to-kill or another similar strain of coronavirus.

Please note that just because the product label states that it kills “99.5% of viruses,” this does not necessarily mean that it will kill coronavirus.

See my prior post on EPA enforcement activity in this area, as well as a more detailed description of EPA’s approval policy for products deemed effective against SARS-CoV-2.

EPA’s advisory is available here. List N can be found at: www.epa.gov/ListN.

The latest episode of the Ad Law Access Podcast discusses three keys to making compliant health claims: determining the product regulatory classification, claim substantiation standards, and the importance of context. This episode is a prequel to her earlier Health Claims in the Context of COVID-19 episode which focused on recent FTC and FDA enforcement relating to false COVID-19 health claims and the importance of considering the current pandemic context in health-related marketing.

Listen on Apple, Spotify, Google Podcasts, SoundCloud or wherever you get your podcasts.

For more information on health claims and other topics, visit:

• Kelley Drye's Advertising Law Practice Page
• Advertising and Privacy Law Resource Center
• Ad Law Access Blog
• Ad Law News and Views Newsletter

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.

The FTC recently sent warning letters to companies for falsely claiming that their products can treat or prevent COVID-19. The latest episode of the Ad Law Access Podcast discusses the importance of keeping the current pandemic context in mind when making health claims more generally.

Listen on Apple, Google Podcasts, SoundCloud, Spotify, or wherever you get your podcasts.

For more information on these and other topics, visit:

• COVID-19 Response Resource Center
• Advertising and Privacy Law Resource Center
• Ad Law Access Blog
• Food and Drug Law Access
• Advertising and Privacy Law Resource Center
• Ad Law News and Views Newsletter

• Substantiate all objective claims;
• Use clear and conspicuous disclosures;
• Specify how the claim applies (e.g., product, package, or service);
• Do not overstate environmental impact; and
• Clearly identify points of comparison.

• Qualify “Green,” “Eco-Friendly” and similar claims to identify the particular benefit and use those claims only if the benefit is significant.
• Use “Recycled Content” claims only for materials that have been recovered or diverted from the waste stream during the manufacturing process or after consumer use. Advertising for products made only partly from recycled content should include the percentage of recycled content (e.g., “Made from 30% recycled plastic bottles”).
• Avoid “Free-Of” claims (e.g., “free of dyes”) unless:
  • The product doesn’t have more than trace amounts or background levels of the substance;
  • The amount of substance present doesn’t cause harm that consumers typically associate with the substance;
  • The substance wasn’t added to the product intentionally; and
  • The product doesn’t include a different substance that poses a similar environmental risk.
• Qualify claims about “Renewable Material” to identify the material used and explain why it is renewable.

In late March, a proposed class action filed against One Brands LLC was dismissed with prejudice, with the court determining that the defendant did not deceive consumers about the sugar content in its energy bar products. In Melendez v. One Brands, LLC, 1:18-cv-06650 (E.D.N.Y.), the plaintiff contended that One Brands’ labeling and marketing of two of its nutrition bar product lines – ONE Bar and ONE Basix – was misleading because the front label contained the brand name “ONE,” which refers to the bars’ one gram of sugar.

Plaintiff asserted that independent laboratory testing determined that the bars actually contained 5.2 grams of sugar, rather than the advertised one gram. According to plaintiff, the misleading advertising was particularly important to consumers looking for healthier or diet-based options and also resulted in the bars being sold at a premium price.

The plaintiff asserted two different theories under New York state law: (1) the advertising was actually false, and (2) regardless of whether the “one” gram of sugar statement was actually false, it was still misleading as it deceived reasonable consumers into believing the bars offer lower calories and carbohydrates than competing brands.

U.S. District Judge Carol Bagley Amon rejected each of these arguments under NY General Business Law (GBL) §§ 349 and 350 and related common law theories.

The Court agreed with One Brands that the falsity claim was preempted by federal law. In order to escape federal preemption, the Court ruled that a plaintiff must comply with FDA’s procedures, which require that testing be based on 12 sub-samples of the product and analyzed by specific reliable and appropriate procedures. Plaintiff’s testing failed to comply with this methodology, and therefore his claims were preempted.

The Court also found that the “one gram sugar” statement on the ONE Bars’ front label was not likely to mislead a reasonable consumer into believing that the bars are lower in carbohydrates and calories than they actually are, because the back panel of the bars’ packaging serves to clarify any potential ambiguity on the front label. Because the products’ carbohydrate and caloric contents are contained in the mandatory nutrition facts panel – which is “exactly the spot consumers are trained to look” for such information –the court found that plaintiff failed to sufficiently plead the misleading claim under New York GBL §§ 349 and 350.

The Northern District of California recently reached a similar result in a case against General Mills, reasoning that consumers could not be deceived by the sugar content in Honey Nut Cheerios because “all truthful and required objective facts” were disclosed on the product’s side panel of ingredients, and that individual consumers must reach their own conclusions about how much sugar is “healthy” for them to consume.

Advertisers should remain keenly aware of the growing number of class action lawsuits involving health and nutrition claims, and remember that, while an accurate nutrition facts panel cannot “cure” a false or misleading claim found elsewhere on the package, it can contribute to a finding that the overall package is not misleading to reasonable consumers and can support dismissal – even at the pleadings stage – in appropriate cases.