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Learning from others' mistakes helps you be compliant < Back Celebrating 200 Weekly WLW Posts! Learning from others' mistakes helps you be compliant 200 weeks of writing this weekly post. Wow, what a journey it's been! Finding my voice on LinkedIn and beyond was not easy. I didn't want to create drama and be too inflammatory, as this is not my style. I also didn't want to misrepresent my level of knowledge in areas I am not an expert in, as this felt contrived. Also, I know that LinkedIn is not Instagram, and memes and viral cat videos were not my style either. I first started by liking and then commenting on others' LinkedIn posts and following my guiding principles of being kind and helpful. Then I came to realize I REALLY LOVE writing about enforcement trends, as they can help us "read between the lines" of where future enforcement will happen. This allows companies to adjust their marketing and learn from others' mistakes before serious regulatory or litigation occurs. I started posting more about interesting enforcement trends, and since FDA's weekly newsletter used to be sent on Wednesdays, I decided to call this post Warning Letter Wednesday . Thank you to Steven Yeager for helping with this name! Over the past 200 weeks, enforcement trends have come and gone. Here are some of the key enforcement trends since I started writing WLW. 🔹 Targeting Opioid Withdrawal: Supplements marketed for opioid addiction or withdrawal continue to see increased enforcement. Even though some companies are well-intentioned and trying to be helpful, making these claims has a high likelihood of attracting a warning letter. 🔹 Hangover Cures: Claims about preventing hangovers went from lower to high-risk in July 2020 when FDA issued seven warning letters to hangover supplement companies. FDA stated that claims to treat hangover symptoms are essentially disease treatment claims since being inebriated is the disease-state of alcoholism. These letters also included FDA's temporary battle with NAC, which has now subsided. I use this group of letters as an example of why following enforcement trend changes is a critical part of marketing compliance. 🔹 CBD Enforcement Surge and Decline: The cannabinoid sector experienced a boom-and-bust enforcement trend. From 2018 to 2021, dozens of CBD companies received warning letters for disease claims (e.g., cancer, Alzheimer's). Enforcement then started to drop in 2022 when the FDA issued 34 warning letters to CBD and delta-8 products, and then in 2023 that number dropped to 15 – a 56% year-over-year decrease. Now, CBD enforcement, other than some very risky delta-8 type letters, seems to be nearly non-existent. FDA has been issuing about one CBD warning letter about every 3-6 months. Follow my SupplySide Supplement Journal quarterly Warning Letter Roundup for more information on this. 🔹 COVID Enforcement: FDA and FTC crack down on COVID-19 claims. Several dietary supplement firms received joint FDA/FTC letters for COVID support claims. After this initial surge, COVID-related letters tapered off by late 2021 as the worst offenders were cited by regulatory action and updated their marketing. 🔹 Continued Reminders of GMP Compliance: FDA continues to focus on core compliance areas like labeling and GMPs. Since the beginning of WLW, a number of warning letters have cited the basics, such as products missing mandatory label elements, lack of allergen labeling, or specification-related GMP violations. These letters are a good reminder that FDA still enforces manufacturing and labeling accuracy. For example, one letter discussed in WLW described how a company's half-hearted recall and response on an undeclared allergen led to a warning letter, essentially for failing to follow through on promised corrective actions. 🔹 Rise of Biomarker Claims Scrutiny: In 2022 FDA sent out the "Big 7" warning letter, which was a group of letters citing biomarker claims related to heart disease. In the past, making biomarker claims like lowering cholesterol and lower LDLs was not "enough" to attract a warning letter unless higher risk words like hypertension were used. These letters signaled a more rigid shift in the FDA's enforcement of biomarker claims, which continues today. 🔹 Old Content Is "Active" Marketing: A theme over the past 200 weeks is that nothing on the internet or socials ever truly "expires" in FDA's eyes. Warning letters now routinely reference years-old Facebook posts, YouTube videos, or blog articles that companies may have forgotten to update. Here is a post where the FDA cited a 7+ year old re-tweet. 🔹 Major Retailers and Marketplace Enforcement : FDA is holding platforms like Amazon accountable for the products they distribute. Amazon has received several warning letters , including three in 2023. FDA stated that by fulfilling orders, Amazon "introduced" an unapproved new drug into interstate commerce by distributing. 👉 Here are SOME of my more notable and favorite posts. 🔹 MLM Company Cited For Claims Made By Their Affiliates : Marking the one-year anniversary of WLW, this post highlighted an FDA warning letter to a direct selling company for disease claims made by its independent consultants. It was the first time I could remember when a company was cited for its affiliates' claims, showing that brands can be held responsible for influencer/affiliate content. Key takeaway: Train and monitor all affiliates to avoid unapproved disease claims. 🔹 Product Tags and Meta Tags : This post revealed how even website tags can trigger enforcement. An FDA/FTC joint warning letter to a CBD company cited the use of a "COVID-19" category tag linking to a blog post about fighting COVID. 🔹 Unauthorized NDI Leads to Warning Letter: This post spotlighted the enforcement of the New Dietary Ingredient (NDI) rules. A company received a warning letter for using N-Methyltyramine even though the product made no disease claims. FDA rarely issued letters solely for unapproved ingredients unless other violations existed. Here, the absence of any disease or GMP violations "should give companies pause" about using ingredients lacking NDI notifications. 🔹 GLP-1 Product Receives Warning Letter: This is one of the "cringiest" cases I've seen. This recent post detailed a company marketing a purported supplement as a natural alternative to Ozempic. The firm claimed their product was "FDA approved," better than the prescription GLP-1 drug, had "no side effects," and was proven in clinical trials. It was the first warning letter involving a GLP-1 weight-loss "supplement" and came alongside letters to several vendors selling actual semaglutide (the active ingredient in Ozempic) as research chemicals. 🔹 Influencer Material Connection Disclosure: This recent post shifted focus to advertising compliance, using Kevin Hart as a case study. The comedian had promoted a sportswear brand and a bank on social media without obvious disclosure that he was a paid partner or owner, leading to an inquiry by NAD. The motto, " when in doubt, disclose," is a key takeaway here. Free Warning Letter Wednesday stickers for you all! Learn more here . I've written WLW while sick with COVID, while on family vacations in eight countries, including Tanzania, New Zealand, and my current travels in Laos and Thailand, and this has been a labor of regulatory love. Thank you to all my readers and supporters! You are very appreciated! DATE ORIGINALLY POSTED: 5/7/25 Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

A weekly exploration of FDA warning letters and enforcement trends A weekly exploration of FDA warning letters and enforcement trends Get Warning Letter Wednesday in your Inbox Sign-Up Now! Select category Reset Celebrating 200 Weekly WLW Posts! Learning from others' mistakes helps you be compliant 5/7/25 Read More OTC Topical “Inactive” Ingredient Marketing Claims “Extra” claims are often non-compliant 4/16/25 Read More Influencers Must Disclose Free Product Brands should monitor influencer posts for compliance 3/26/25 Read More Heavy Metal Contamination Leads to Recall Following specifications prevents greater issues 3/5/25 Read More Environmental Claims Increase Scrutiny Ensure ESG claims are substantiated 2/12/25 Read More Incomplete Batch Records & Ingredient Specifications Ensure 483 responses are complete 1/22/25 Read More Product Review Engagement Trustpilot reviews can be “marketing” 1/1/25 Read More Basics of GMP’s Cited Functional mushroom products under increased scrutiny 12/11/24 Read More Best Practices When Making Competitor Comparison Claims Ensure statements are not disparaging 4/30/25 Read More Best Practices When Making Biomarker and Implied Claims Use FDA’s helpful resource (Criterion 2) 4/9/25 Read More Injectable CBD Warning Letter Curated testimonials are marketing claims 3/19/25 Read More Celebrity Endorsement Lessons Disclosing material connection is essential for compliance 2/26/25 Read More GMP Labeling Lessons Small issues signify deeper noncompliance 2/5/25 Read More “Non-Toxic” Claims Require Extensive Substantiation Safety related product claims attract scrutiny 1/15/25 Read More Refusing FDA Inspection Access Be nice to FDA investigators & follow inspection SOPs 12/26/24 Read More Fruit Snack Wars NAD challenge cases explored 12/4/24 Read More Navigating the Risks of Therapy-Adjacent Health Claims Use FDA's helpful resource (Criterion 7) 4/23/25 Read More In-Process Quality Testing A look at the manufacturing and quality process 4/3/25 Read More Amazon & Others Cited for Selling Injectables Distributors are responsible for the products they distribute 3/12/25 Read More Records Refusal Leads To Warning Letter Take FDA inquiries seriously 2/19/25 Read More "Promotes Brain Health” Claim Challenged Small words can drastically increase claim risk 1/29/25 Read More FDA Crackdown on Animal Product Seizure Claims Amazon compliance still needs improving 1/9/25 Read More GLP-1 Product Receives Warning Letter Marketing strategies should consider “reasonable consumer expectations” to avoid issues 12/18/24 Read More Lack of Allergen Labeling Leads to Potential Death Nutrition fact panels must be in a compliant format 11/27/24 Read More 1 2 3 ... 8 1 ... 1 2 3 4 5 6 7 8 ... 8

Distributors are responsible for products they sell < Back Amazon Receives 3rd Warning Letter This Year Distributors are responsible for products they sell Amazon just received its third warning letter this year and the fifth in the last 15 months! All of these letters are for selling adulterated or unallowable products. What makes this warning letter interesting is that it’s for a sexual enhancement product that was adulterated with sildenafil (Viagra). Amazon requires some mandatory third-party tests for products in this high-risk category, but I wonder why the drug-spiked ingredients were not found here. Perhaps after the initial batch tests, a subsequent non-tested batch contained the drug-spiked ingredients? ❗️Warning Letter Wednesday is available as a free weekly email. Sign up here . 🔷When we look at other Amazon warning letters, FDA seems to “follow the breadcrumbs” from other warning letters, recalls, or issues to Amazon. For example, this warning letter references products that were part of a drug-spiked recall in August. I would think that Amazon has the technological capability to find and remove recalled products from its platform. These types of warning letters come in groups so if companies were selling any of the adulterated brands cited in this warning letter, removing them from commerce now can help to avoid a letter. 🔷Amazon warning letters state that Amazon handles the products as opposed to them being dropped-shipped by the vendors. In my opinion, this “handling” is important to designate Amazon’s responsibility. I wonder if this means that marketplace sites that don’t actually touch the products have a lower risk of distributor scrutiny. 👉From warning letter. “Amazon distributed each of the products directly to individual U.S. consumers on behalf of third parties. Each of the products was “fulfilled” by Amazon; your website states, “Fulfillment by Amazon (FBA) is a service that allows you to outsource order fulfillment to Amazon. Sign up for Amazon FBA to send products to Amazon’s global network of fulfillment centers and offer customers free, two-day shipping through Prime. When a customer makes a purchase, Amazon fulfillment specialists can pick, pack, and ship the order. We can also provide customer service and process returns for those orders.” 🔷Other recent Amazon warning letters were for ophthalmic (eye), homeopathic products for molluscum contagiosum, Diclofenac spiked products and disease claims, and skin tag removal products. Read the full warning letter . DATE ORIGINALLY POSTED: 12/27/23 Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Ingredient research can be considered a marketing claim < Back Product “Tags” With Disease Claims Elevate Risk Ingredient research can be considered a marketing claim Ingredient research on a commercial website can be considered a marketing claim, which continues to be cited in warning letters. The key point that turns “research” into a marketing claim is when the ingredient is in a product sold on the site. This is when “education” crosses the line into marketing. Here is a post about seven CBD companies that were cited for this earlier in the year. Today’s #WarningLetterWednesday is another example of this, but it also has some new learning opportunities. Products or category “tags” help Google and customers find specific posts, but they are also considered marketing. These tags demonstrate the content’s intended marketing use and should be used carefully. I suggest against using disease “tags” on any supplement marketing, and this warning letter cites a very high-risk category tag. From warning letter: Your website ….. also includes various “Category” tags, including “COVID-19,” that link to the blog post “How Does CBD Help to Fight Against COVID-19?.” The blog post has links to CannaAid products available for purchase. I write more about product tags and meta tags here . This letter also references a call to action where the blog post links to a shopping cart. Although blogs with implied disease claims are cited in warning letters, this “commercial bridge” likely elevates the risk of scrutiny. This company would have received the warning letter without the “Covid” tags and without linking to a shopping cart, but this shows how authorities may consider these factors when deciding to issue a warning letter. Here is a post about discussing ingredient benefits. This joint FDA/FTC letter includes a cease and desist. Learn more about these here . Read the full letter here . DATE ORIGINALLY POSTED: 11/16/22 Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Only use permitted dietary ingredients or face regulatory issues < Back Unauthorized NDI Leads To Warning Letter Only use permitted dietary ingredients or face regulatory issues Warm greetings from 35,000 feet, as I am flying back from a 3-day whirlwind trip to participate in the Vitafoods Startup Award finals in Geneva. This company received a warning letter for using N-Methyltyramine, an unauthorized New Dietary Ingredient (NDI), in its products. This shows that FDA is getting serious about enforcing the unauthorized NDI requirement. FDA has sent warning letters for Hordenine (a similar molecule to N-Methyltyramine) in the past, but using these types of ingredients typically isn’t enough to attract a letter unless disease claims or GMP violations are present. In this instance, there were no disease claims or GMP violations present which should give companies pause before using certain NDI ingredients. Read this WLW post about hordenine warning letters. I predict this may be paving the way for more CBD and kratom letters, even if there are no disease claims present. A similar ingredient to N-Methyltyramine is listed in FDA’s Information on Select Dietary Supplement Ingredients and Other Substances document . This includes some “off limits” products such as DMAA but also includes commonly used dietary ingredients like biotin. I would like to see this list clarified to show what FDA considers lawful dietary ingredients, unauthorized new dietary ingredients, and unallowed ingredients such as DMAA. Read the letter here . DATE ORIGINALLY POSTED: 5/15/24 Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

The FDA/FTC look at old posts the same as current ones < Back Clean up old social media posts The FDA/FTC look at old posts the same as current ones #WarningLetterWednesday highlights very old social media posts called out in this warning letter. It is common for the FDA to look back a couple of years on social media posts, but this warning letter mentions a 2014 re-tweet and several three-year-old Facebook posts. This is an excellent reminder to clean up old social media posts, as the FDA/FTC looks at old posts similarly to current ones. I even made a video about this. Re-tweeting and re-posting can be seen as marketing claims, especially if a company adds commentary to the original post. This is the first time I have seen a re-tweet without company commentary called out in a warning letter. This is surprising and shows the viewpoint of the FDA's West Division 5 office, which has rarely issued marketing-only warning letters. It is interesting to see what online marketing claims each FDA division focuses on, and I will dig deeper into this fascinating aspect of enforcement at a later date. There are several high-risk disease words mentioned in this warning letter, such as Parkinson's, antidepressant, anti-tumor, and hashtag diabetes, which likely was why this company received a letter. Here's a video I made about removing and replacing high-risk "buzzwords" being the most crucial first step to becoming compliant. Claims made on Amazon are also referenced in the warning letter. It is no longer considered the "unholy grail" of disease claims, and I expect to see more Amazon warning letters in the future. Read the warning letter here . I've been writing about these enforcement trends for a while now. You may enjoy reading my regulatory blogs here . It can be challenging to find content on LinkedIn, so I started this Warning Letter Wednesday Group . Please check it out. DATE ORIGINALLY POSTED: 1/19/22 Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Companies that compensate influencers or affiliates may be responsible for claims they make < Back MLM Company Cited For Claims Made By Their Affiliates Companies that compensate influencers or affiliates may be responsible for claims they make This is the one-year anniversary of #WarningLetterWednesday. I have written this post every week, even when having Covid, on a tropical vacation, or under a massive work deadline. I love writing this post and hope you find as much joy in it as I do. Today’s post is unique. It involves an MLM company that was cited for claims made by company “consultants,” which is very similar to influencers or affiliates that receive compensation for referral sales to a company website. This is the first time I have seen a company cited for claims made by its affiliates, and this is a trend to watch. From warning letter: “Consumers interested in your products are then redirected by your consultants to your websites www.youngliving.com and www.naturesultra.com to purchase your products.” One of the affiliate Instagram pages mentioned in this letter only has 627 followers, a good reminder there is no such thing as being too small to attract FDA scrutiny. Most claims cited in the warning letters are from the “consultants,” with a few exceptions such as this. From warning letter: “On your website, https://naturesultra.com ....Some studies suggest [t]he most common illnesses caused by an improperly functioning ECS are depression, Alzheimer[’]s, IBS, fibromyalgia, and even migraines” The Denver office issued this warning letter, which seems to be more rigid with online claims enforcement than other divisions or the national offices. Key takeaways are companies should remove risky words from company websites and train and monitor affiliates and influencers to ensure no disease claims are present. I look forward to hearing your comments on this very fascinating warning letter! Full warning letter DATE ORIGINALLY POSTED: 7/20/22 Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Advisory labeling is not a replacement for allergen control program < Back Undeclared Allergens Lead To Recalls Advisory labeling is not a replacement for allergen control program Is major allergen labeling complicated? The answer is maybe sometimes, but it doesn’t have to be. Here, I review recent allergen labeling-related recalls and provide some helpful resource links. It seems like recall alerts for undeclared allergens happen every week, but even though recalls for undeclared allergens are common, allergen-related warning letters are uncommon, which makes this week’s Warning Letter Wednesday interesting (to me at least). One company has had four recalls related to undeclared major allergens since 2019, and here’s how the recent mix-up happened. This is, unfortunately, a common mistake and is the reason why GMPs and process control exist. · From warning letter. “You indicated that you were scheduled to run “Hamburger Cheeseburger Macaroni Skillet Meal”; however, the line supplier mistakenly brought the incorrect cartons to the production line, and the lab tech failed to verify that the correct cartons were used.” Read this warning letter here . Another company received a warning letter because of an inadequate FDA communications request response. They are also a conventional food company that had an undeclared allergen recall, which was apparently due to a formulation change without changing the label. The purpose of Warning Letter Wednesday is to educate, and this is a perfect example of a half-hearted response and no follow-through that led to an avoidable warning letter. Yikes! · From warning letter. “Your proposed action to prevent reoccurrence indicated that there would be no formulation changes without the signatures of the buyers and the owners.” ….” FDA sent you an email giving you an opportunity to provide FDA additional corrective actions to address the root cause of the undeclared major food allergen involved in your recall; however, you did not respond.” Read this warning letter here . Here are FDA’s comments on major allergen disclosure (from warning letters). The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act [21 USC § 343(w)(1)(A)]; or The common or usual name of the major food allergen in the list of ingredients is followed in parenthesis by the name of the food source from which the major food allergen is derived (e.g., “Whey (Milk)”), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 USC § 343(w)(1)(B)].” So how about allergen advisory statements like “This product was manufactured in a facility that handles peanuts, soy, and milk?” According to this FDA guidance document, “Advisory labeling, such as “may contain [allergen],” is not a substitute for adherence to current good manufacturing practices and, when used by a facility, food allergen preventive controls.” Read this FDA’s “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry” document here . Here’s how you sign up for FDA recall alerts . DATE ORIGINALLY POSTED: 3/13/24 Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Do not engage with customer “disease” testimonials < Back Saying “Thanks” on a Social Post Leads to Warning Letter Do not engage with customer “disease” testimonials If a company engages with a post on its social media wall, this is considered “endorsing the testimonial” and is marketing. It has been quite a while since we have seen a company cited for this, and honestly, I thought FDA had stopped enforcing this until the recent warning letter . Sign up for weekly Warning Letter Wednesday posts here . There are a few interesting aspects to this warning letter. Even saying “thanks for commenting” or “liking” a post is an “endorsement.” Based on this, I guess that smiley face emojis should also be avoided when posts have a disease or disease-treatment claims. The lesson here is that any engagement turns a customer comment into a marketing claim. Companies should review old social posts to ensure there is no engagement on customer comments with disease-type claims. FDA may look back several years on a company’s social media page. Claims made on Amazon and Walmart are cited in this letter. Companies commonly focus on website compliance but often overlook “old” marketing statements on these platforms. FDA is paying close attention to these platforms. This was part of the “Big 7” cardiovascular-related warning letters from a few weeks ago, which show that even talking about diagnostics related to heart disease, such as “lowers LDLs” can lead to a warning letter. I write about this in detail here . From warning letter. “You also endorsed the following responses to your post by liking them: “I just got my blood test back my total cholesterol went down 56 points and my bad cholesterol went down 82 points.” FDA cited claims made on a company testimonials page. The authorities have been “hands off” with non-curated, non-compensated, third-party product reviews. These cross the line into marketing if they are showcased on banners or, in this case, on a specific testimonials page. DATE ORIGINALLY POSTED: 12/14/22 Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Old blogs & posts are “active” marketing < Back 15 CBD & Delta-9 Warning Letters in 2023 Old blogs & posts are “active” marketing Two weeks ago, FDA sent its 15th CBD and delta-8 warning letter of 2023. Although this seems like a high number, it was down from 34 last year. So why the dramatic reduction in enforcement action? One reason is many CBD companies were started by people not familiar with the nuanced rules of marketing ingestible products. These businesses and the inexperienced operators that were making risky marketing claims have moved to other industries, and there are simply no longer thousands of noncompliant CBD companies. 💡 I've been writing this weekly post for ~2.5 years (yes, EVERY week). Sign up for the email newsletter and see old posts here . There still are however, some companies selling CBD, and today’s Warning Letter Wednesday has good learning opportunities for the supplement and cannabinoid industries. 🔷Old blog posts are marketing. The days of 2020 are thankfully behind us, but all of the content produced back then is still active marketing in the eyes of the FDA. This warning letter cited several posts, including this one from November 2020. The lesson here is going back and reviewing old social media and blog posts is an essential part of compliance as these “forgotten” posts continue to be cited in marketing. 👉From warning letter. “A November 12, 2020 blog post titled “CBD, COVID-19, And The Novel Coronavirus” which contains claims such as “On the more promising side of research, a research team based out of Augusta University (GA) found a potential protective role for CBD as part of the treatment of COVID-19” 🔷Social media Here is a post where the company makes high-risk statements on their Facebook and Instagram. 👉From warning letter. “Experimental evidence is limited, and more research is needed, but studies on pain and inflammation, breast cancer, epilepsy, and other conditions have found a greater therapeutic effectiveness of whole-plant or full-spectrum cannabis products than isolated cannabinoids.” Read the full letter . DATE ORIGINALLY POSTED: 1/10/24 Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Ensure statements are not disparaging < Back Best Practices When Making Competitor Comparison Claims Ensure statements are not disparaging Calling out the differences between your product and competitor products is permitted, but "poking the bear" often leads to competitor challenges. This NAD case involves a well-known mattress company challenging another competitor's claims as disparaging. The challenged claims in social media posts made statements such as the other mattress was "just a glorified air mattress." According to NAD, the advertisements created a "misleading impression, suggesting Sleep Number beds are comparable to temporary air mattresses that consumers would not use for their regular sleeping needs." Here is one example . So, where is the line between truthful comparison and being disparaging? Here are some tips. Truthful comparison : Keep the scope narrow and ensure you have supporting data while being careful with implied claims in imagery. 🔹 Truthful and supportable statements such as "Our foam conforms to your body shape while brand X's spring coils do not." 🔹 Comparisons based on objective tests or third-party data, such as "In lab testing, our mattress reduced pressure points by 30% versus air-chamber designs." 🔹 Puffery: I love this topic and have written more about it here . Disparaging claims : Implied claims like imagery matter! 🔹 Even if an actual statement is true, it can be disparaging if it infers negative connotations such as "basically an air mattress," which implies it is bad quality or uncomfortable unless there is undeniable and defensible supporting data. Read the NAD decision here . DATE ORIGINALLY POSTED: 4/30/25 Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Do's and don'ts of puffery < Back Puffery Claims Explored Do's and don'ts of puffery Puffery is one of my favorite advertising compliance discussions. Last week, I attended the ACI Substantiation Conference in NYC, where puffery was widely discussed. A recent National Advertising Division (NAD) case determined that a beef jerky company’s “the best” and “Clearly the best” statements were puffery. OK, I know I write about supplements, but we can learn from the beef jerky NAD case. Also, I go into more detail about what constitutes puffery below. According to NAD, puffery is “an exaggerated, blustering, or boastful statement or general claim that could only be understood to be an expression of opinion, not a statement of fact.” From NAD case. “Old Trapper’s “Clearly the Best Beef Jerky” slogan, when used on its product packaging and website, conveys a message of corporate pride, and the use of “best” is not comparative as no specific competitor or ingredient is identified. In these contexts, the challenged claims are unquantifiable and, therefore, puffery.” “The claim “The Best Ingredients Create the Best Beef Jerky” which appears prominently on the Old Trapper website landing page, did not convey a specific comparative superiority message.” “Old Trapper’s 15-second YouTube video that depicted a single bag of Old Trapper jerky while “Old Trapper is Clearly the Best Beef Jerky. Clearly More. Clearly Nothing to Hide. Clearly Fresh. Clearly the Best”, did not convey a comparative superiority message because the video only featured Old Trapper, did not tout attributes other than a single reference to “clearly fresh,” and did not refer to or depict any competitors or competitors’ products.” NAD did however find that the company’s “We use only the highest quality ingredients” is an objective claim that requires support. If they had stayed with the “Only the best ingredients make the best products” claim, this would have likely been considered puffery. NAD looks at whether a claim is provable, measurable, or is an opinion. Here are three parameters of puffery (with examples). Thanks for this, NAD! 1) Puffery as exaggeration: We all remember the movie Elf, where Will Ferrell declares the crummy coffee was, in fact, the “World’s best of coffee.” This statement is so exaggerated that no reasonable consumer would believe this to be accurate. If a company advertised “Best cup of coffee in Boulder,” then perhaps it would no longer be puffery. Adding quantifiable comments such as “#1 coffee choice in Boulder” would require substantiation. 2) Puffery as an opinion: “The best almonds make the best almond milk.” was considered to be proof of corporate pride in its product and was not a comparative claim. This would require substantiation if it could be quantified, such as “We only use the best California almonds.” 3) Puffery from depictions and imagery: This example shows how context matters and that even if a claim is puffery, the corresponding imagery can make it a claim requiring substantiation. a. A statement that may have been puffery in isolation but was presented in the context of other claims that made it NOT puffery. Many of us may remember the “Hefty, hefty, hefty. Wimpy, wimpy, wimpy.” advertisements. NAD found that in a radio advertisement, this line was puffery, but when used in a television commercial featuring John Cena, who is very large, and Rob Schneider (much smaller), the visual commercial made Glad Bags seem wimpy. NAD has a podcast about puffery. Learn more here . Read the beef jerky NAD case here . DATE ORIGINALLY POSTED: 2/14/24 Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!