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  • Disease Claims Lead To Warning Letter

    Marketing in all languages should be compliant < Back Disease Claims Lead To Warning Letter Marketing in all languages should be compliant FDA issued a warning letter yesterday for Spanish language disease claims made on product labels and the company’s website. Examples of these claims include “cancer,” “antiviral,” and “arthritis.” Surprisingly, there have only been a small number of warning letters for dietary supplements issued by the FDA this year, which is why I was so excited to read this letter today. In April of this year, FDA purchased supplements from this company by calling the phone number listed on the website. Typically, FDA issues warning letters by simply flagging the online claims without purchasing products. I wonder if this is part of the continued adulterant testing of Spanish-language joint health products that are also making over-the-top disease claims such as thes e . This warning letter is a great example of claims to avoid, such as “diabetes,” “hypertension,” “antiviral,” and “prevent infections.” Read the full letter here . This letter shows that all products, even those in other languages, are fair game for scrutiny. This company’s website appears to be shut down, which seems to happen frequently when small companies get warning letters. Do you think this is enough to dissuade companies from making serious disease claims about their products? 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!

  • Pepsi Cited For Salmonella Contamination

    Food safety plans should be comprehensive < Back Pepsi Cited For Salmonella Contamination Food safety plans should be comprehensive This is a cautionary tale of how quality control, food safety oversight, and sanitation, even at one of the world's largest companies, can go wrong. Salmonella was discovered at one of Pepsi's granola bar manufacturing facilities. Here's the timeline. 11/25/23: Sample confirmed to have Salmonella. 12/12/23: Testing reconfirmed Salmonella after a suspected lab error investigation. The sample matched the same form of Salmonella that was previously found in the facility a few months before. ➡ Asa comments: Finding Salmonella in a facility is not uncommon, but not taking the proper steps to remove it from the facility with hazard analysis, cleaning, and testing is a concern. 12/14/23: Company notified FDA of the recall of some lots of granola products. In this warning letter, FDA reminds the company of its obligation to file with the Reportable Food Registry within 24 hours of determining the food should be reported. ➡ Asa comments: Not following FDA's reporting timeline is a good way to irritate the inspector. 12/19/23: FDA sent the "swab patrol," which usually does not happen so quickly after a recall. One of the samples was positive for Salmonella in a crack in the floor. ➡ Asa comments: Floor cracks are common hiding places for these pathogens, which shows the importance of not only cleaning but also facility maintenance. 1/3/24: From FDA: "We advised you of the whole genome sequencing (WGS) results via a conference call on January 3, 2024. You acknowledged that you had identified historical isolates of Salmonella Cubana in your facility since at least 2020. These findings may indicate that the same strain of Salmonella Cubana has survived since 2020." ➡ Asa comments: This unfortunately shows that this strain of Salmonella has been living in the facility for years. This likely could have been avoided. 1/11/24: Company testing shows the Salmonella had migrated to an area of a production line without a kill step, and they issued a recall for all products made at that facility. ➡ Asa Comments: Issuing a recall of this level is costly, and from my inference of the information in this letter, it could have been avoided. Who is to blame? Usually, the plant manager or the head of quality makes the call to "keep going" rather than stopping production and conducting a comprehensive cycle of repairing, cleaning, and swabbing until the pathogen has been eradicated, but it is impossible to know what the culture of compliance broke down. 4/3/24: The company decided to close manufacturing operations at this facility. FDA goes on to share that the hazard analysis conducted at the facility after finding Salmonella in 2022 and 2023 was insufficient. From FDA. "Furthermore, your corporate PEM program states that "repeat positive results typically indicate further deep dive," but you did not have any records indicating corrective actions beyond normal cleaning/sanitizing and maintenance (e.g., "deep dive" corrective actions) were taken at your facility." There is more to this warning letter , and I suggest all executives, food safety, and quality teams read the letter as a case study of what can go wrong. At my consulting company Supplement Advisory Group , we do not focus on these matters, but if you need food safety support or GMP auditing, I would be happy to share my preferred contacts. DATE ORIGINALLY POSTED: 7/10/24 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!

  • NAD Case: Influencer Material Disclosure

    Ensure material connection is disclosed properly < Back NAD Case: Influencer Material Disclosure Ensure material connection is disclosed properly This NAD case is a good reminder of the importance of influencers properly disclosing material connections in the same manner that endorsement is made. For example, suppose there is an image and no video/audio. In that case, then simply using hashtag#Ad or #(Company)Ambassador is sufficient, as long as these disclosures are not buried in a string of hashtags or below the “Read More” button. Now, according to the updated FTC guidelines, if an endorsement is made verbally, then the disclosure must also be made verbally. This kind of makes sense to me, but it becomes complicated when endorsements are made in Reels and Stories. Last year, FTC sent warning letters to several influencers and some sugar trade groups for not disclosing material connections in videos. I write about this here . Aside from that group of FTC letters, there hasn’t been much action with this new guidance, which is why this NAD case is so interesting. From NAD case stating what the company has agreed to do. "Requiring its influencers to include a verbal notice of their partnership with ... in any video influencer material." These rules ensure that consumers are not misled, which is important as we count on the honesty of reviews to make purchasing decisions. These disclosure requirements also apply to ambassadors, investors, and family members of companies. In this case, actor Demi Moore seemed to cross this line. From NAC case. "... challenged a social media post by Demi Moore in which she stated that her promotion of ... was "not an ad" and failed to disclose that she is an investor in the brand. The Demi Moore example is pretty over the top, but the likelihood that the other claims would have been cited in warning letter or agency action seems relatively low. This shows that “poking the bear,” which in this case is a very large company in the antacid space, can lead to increased challenger scrutiny. When in doubt, be very careful when disrupting category leader incumbents. Wondering what the National Advertising Division (NAD) is? Check out this post . There are some more interesting items in this case. Please read it here . 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!

  • FDA Issues Five CBD-Related Warning Letters

    CBD enforcement is top of mind for FDA < Back FDA Issues Five CBD-Related Warning Letters CBD enforcement is top of mind for FDA CBD-related FDA warning letters are up over 420% this year, and this recent batch of five warning letters has some excellent learning opportunities. The biggest news is one of these letters does not include disease claims. There may have been one or two CBD letters ever that did not include risky claims. The products cited are beverages that contain some caffeine and hemp extract. FDA's concern is related to CBD posing delayed caffeine metabolism. If you sell CBD and caffeine products, I would remove them from the market asap. This warning letter confirms that the labeled "hemp extract" is CBD by testing, citing a COA on the website, and citing blogs on the website. It's interesting to see how FDA "ties it all together." I ask, "If there was no caffeine in the product, would the company have been issued a warning letter?" Here is the letter . Many of these letters include CBD in food products such as lollipops, cookies, and infused sugar. This is a problem for FDA because these food formats are favorable to children who may consume too much CBD resulting in a possible health concern. These are not form factors used in the supplement industry; they seem unnecessary and poor formats for delivering CBD. FDA purchased and tested products from all five companies that received warning letters. I have not seen a reference to the FDA purchasing and testing products in any 2022 warning letters. What are your thoughts on this? Two of these warning letters reference five-year-old social media posts. Here's a post about this. One warning letter mentions Delta-8. Here's a video about Delta-8 enforcement. More YouTube claims are cited, including a 3-year-old video in this letter . When social media and YouTube claims are mentioned in letters, FDA demonstrates the commercial bridge with statements like this "which direct consumers to your website to purchase your products." Here is a post about this. From one of the warning letters. "From your YouTube social media" "July 16, 2019 video – "CBD has been shown to help with a lot of different things like anxiety, stress, pain, and inflammation, and even help with seizures." 40% of this year's CBD warning letters involve CBD and animal products, which continue to attract increased scrutiny. The FDA seems to have a lower "allowance" for claims about CBD and animal products. For example, "anxious feelings" for pets may be enough to attract a warning letter, whereas it's unlikely this statement would trigger a human product warning letter on its own. Here's a post and video about animal and CBD claims enforcement. Two of the letters include references to OTC drugs, including one involving sunscreen and CBD. This letter cites CBD as an active ingredient in the sunscreen product, a huge error. Anyone who has been paying attention knows FDA takes an unfavorable stance on CBD as an active or an inactive ingredient in OTCs. I write more about this here . Here's the warning letter that mentions sunscreen. Here's FDA's constituent update on these warning letters. 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!

  • Noncompliant Testing Methods Lead to Warning Letter

    Use qualified reference samples < Back Noncompliant Testing Methods Lead to Warning Letter Use qualified reference samples This company received 483s for GMP violations relating to testing methods and specifications. They were inspected in late 2021 and early 2022 and sent FDA five 483 responses last year. It seems these responses were not satisfactory, which led to this warning letter. There are numerous learning opportunities here. 🔷One of the violations was not having a strength test on a softgel product. It seems the company once had this, but it was removed 👉“at the request of the customer, as documented in your change control document.” A key learning lesson here is contract manufacturers should be flexible with their customers to a limit. Obviously, completely removing this test from the softgel specifications was a bad idea. Who knows, perhaps they could have found a more suitable strength test to satisfy GMP requirements and the customer. 🔷Unqualified reference standards are cited in this warning letter. The company was testing samples using FTIR, but the reference samples were not verified, which means they were likely from previous batches and not a purchased verified material. I will admit this is how I used to test identity circa 2010-ish. 👉From warning letter. “Identity testing using FTIR to compare the sample spectrum to an unverified reference sample is not an appropriate scientifically valid method” 🔷Identity testing in the finished product was brought up again, and this is a trend to watch. FDA requires the identity of each ingredient to be tested before blending and in the finished product. This is straightforward for some items but is costly and challenging if there are numerous botanical ingredients, as this requires developing expensive testing methods. I am unsure if this is the case in today’s #WarningLetterWednesday, but this is not the last time we will hear about this rigid pharmaceutical interpretation of supplement GMPs. I write about this here . 🔷Proving test method suitability is starting to appear in 483s and now in warning letters. This means that the FDA is asking why specific test methods are used. In the past, relying on a third-party lab for this was sufficient, but now, having suitability documentation on file for each method your lab uses is a good idea. Read the full letter . 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!

  • FDA/FTC Cites Six Companies For Selling Delta 8 Products

    Product formats & packaging should not appeal to children < Back FDA/FTC Cites Six Companies For Selling Delta 8 Products Product formats & packaging should not appeal to children FDA and FTC recently sent six joint warning letters to companies selling delta 8 products that were favorable to children. Thank you, FDA and FTC! These warning letters highlight some of the most over-the-top examples of products going too far, and I applaud the authorities for taking action. Here are some of the highlights: 🔷 More than disease claims: All of these warning letters do not include disease claims. This shows the agency is starting to think differently about enforcing cannabinoid products, and if they feel there is a safety issue, they will take action. Last year FDA shocked everyone by sending this letter to a company that was not making disease claims but was adding CBD to a caffeine-containing beverage. 🔷 Unfair or deceptive marketing is cited in these letters, which is where FTC comes in. Delta 8 poses dangers, especially to children, in favorable formats like gummies which are considered deceptive marketing. I find this approach fascinating and clever. 👉 From warning letter “Section 5 of the FTC Act prohibits unfair or deceptive acts or practices in or affecting commerce. This prohibition includes practices that present unwarranted health or safety risks….. preventing practices that present unwarranted health and safety risks, particularly to children, is one of the Commission’s highest priorities.” 🔷 Some of the most egregious products are Cheetos Crunchy Flamin’ Hot THC Infused Chips and Doritos Nacho Cheese THC Infused Chips. Wow, in addition to trademark issues, this company took it way too far. 🔷 Safety is cited as a primary reason for some of these letters, such as this example where similar products resulted in adverse event reports. 👉 From warning letter : “Ten of the reports specifically mention the edible product to be a copycat of popular foods. Your Sour Worms” 🔷 Some of these letters were issued to marketplace sites where numerous third-party products were sold. This shows that companies are responsible for the products they sell, as exemplified by last year’s Amazon and Walmart warning letters . 🔷 We are all aware of FDA’s unfavorable position on CBD, but they really do not care for delta 8 with good reason, as exemplified in last year’s consumer update . Delta 8 can be dangerous, and according to data from National poison control centers, 2,362 delta 8 exposure cases had been reported, including “One pediatric case was coded with a medical outcome of death.” This report warns consumers that delta 8 products are widely available in forms favorable to children, such as chocolates and candies. This should have given the delta 8 industry pause, but these products have unfortunately continued to proliferate. 🔷 Although most of the products cited in this letter have been removed, there are still some brazen products being sold, such as a carton of cookies that contains 30mg delta 9 THC per cookie. OMG! There is much more to read in the FDA news release . 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!

  • “Non-Toxic” Claims Require Extensive Substantiation

    Safety related product claims attract scrutiny < Back “Non-Toxic” Claims Require Extensive Substantiation Safety related product claims attract scrutiny Making a “Certified Non-Toxic” claim on a mouthwash triggered a competitor challenge. According to the National Advertising Division (NAD) comments, the substantiation provided by the company was not sufficient to support the claim. 👉From NAD. “In support of the “Certified Non-Toxic” claim, Oral Essentials submitted two cytotoxicity studies (one for its sensitivity mouthwash and one for its whitening mouthwash) and a certification statement from MADE SAFE, a third-party certification program that verifies ingredient safety and non-toxicity. Oral Essentials mouthwashes were certified by MADE SAFE at the time of manufacture.” 👉From NAD. “Strong evidence is needed for non-toxic claims due to potential health and environmental risks as well as the potential for consumers to misuse the product or take away a broader message about the product’s safety that is not supported by the claim.” 👉Apparently, the cytotoxicity studies did not exactly match the and did not address the “real-world” effects. From NAD. “NAD found Oral Essentials’ cytotoxicity studies did not support the challenged claims such studies do not reflect the real-world effects on humans and only address one form of toxicity. Additionally, the study formulations contained one less ingredient and differed from the current product ingredients.” It seems the position is that making a “Certified Non-Toxic” claim on a mouthwash label may give some consumers the idea that they can drink the whole bottle or put it in their eyes with no safety issues. I expect people to have more common sense than this, but I guess it is possible for a consumer to think that “Non-Toxic” means they can go nuts with it. I assume the same rationale would apply to toothpaste or any other product that is sparingly used internally. 🔹Don’t rely on certifications: The company also relied on a “MADE SAFE” certification, but this did not substantiate the claim because it was unclear to NAD which real-world factors were evaluated in the certification process, and the company's certification had expired in October 2024. At Supplement Advisory Group , my regulatory consulting company, I often share the “less-is-more” principle with clients. This means that every aspect of packaging will be scrutinized, and if it’s not necessary for marketing, removing it is a good idea. This is not always a popular opinion, but it is important to measure risk and reward while keeping substantiation in mind. Read more about the case here . DATE ORIGINALLY POSTED: 1/15/25 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!

  • Biomarker Claims Lead to Warning Letter

    Expect arterial health claims to be cited in the future < Back Biomarker Claims Lead to Warning Letter Expect arterial health claims to be cited in the future Blood sugar support claims continue to be cited in warning letters. This letter includes biomarker claims such as “improved blood sugar sensitivity and lower A1C.” Based on recent warning letters, listing these types of statements is now enough to attract a letter. I write more about this here . There are other biomarker claims cited in this letter, such as “increased levels of TT3 and TT4," "reduced mean fasting serum glucose," and "promotes arterial elasticity." Keep an eye on your marketing statements relating to arterial plaque and elasticity, as I predict we will see these cited in 2023. This is a warning to companies making similar biomarker claims, and now is the time to review marketing and find and replace these statements. In the past, biomarker claims were not typically enough for a warning letter, but the “Big 7” cardiovascular letters from November signal a change in FDA’s thinking. There are other commonly cited higher-risk claims, such as “diabetes” and “depression,” in this letter. The more of these words used in marketing, the higher the likelihood of receiving a warning letter. You may be saying, “these companies should know better,” and in many ways, I agree. However, they may not have understood that mentioning ingredients in blogs or citing ingredient research is considered marketing. These mistakes are all too common and are a sign of companies who don’t understand the nuanced rules of dietary supplement marketing. Educating on these topics is one of the reasons I write Warning Letter Wednesday. Blogs are mentioned in this warning letter. We are seeing blog titles like this mentioned in recent letters. They help bring traffic to the website but are also clear indications of intended marketing use. In this example, turmeric is in a product sold on the website, which is an implied claim. From warning letter. “Pain Support - Can Turmeric Relieve Arthritis, Joint Pain & Inflammation?” To round this letter out, there are statements such as “Reduce Chance of Catching A Cold.” Talking about reducing the duration of a cold, flu, or respiratory infection is off-limits and should be avoided. Read the full warning letter . 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!

  • MLM Company Cited For Claims Made By Their Affiliates

    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 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!

  • Digestive & Cholesterol Claims Cited in Warning Letter

    Remove testimonials with claims < Back Digestive & Cholesterol Claims Cited in Warning Letter Remove testimonials with claims Digestive system claims like Crohn's and IBS occasionally show up in warning. Diseases like Crohn's Disease or syndromes like Irritable Bowel Syndrome should be removed, or if accurate, replaced with statements about stomach and digestive health support. 👉From warning letter. "I used to have terrible knife-like sharp pains in my stomach from the Crohn's and IBS, and a great deal of discomfort from the acid reflux. Dr. Miller's Holy Tea has cleared all of this up…." I'm writing this from a Soulshine retreat in Bali, so today's Warning Letter Wednesday will be brief. Testimonials are also cited in this warning letter. I expect many product reviews and testimonials to be called out in warning letters this year. I talk about engaging with testimonials here. Blood pressure and cholesterol claims enforcement are not slowing down, and I expect this trend to continue. Here is a post about this. 👉From warning letter "Regular use of Youthin Fat Burners may help control High Blood Pressure and Cholesterol" Read the full post here . 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!

  • Marketing Claims Turn Cosmetics Into Drugs

    Cosmetics are not "FDA-approved" < Back Marketing Claims Turn Cosmetics Into Drugs Cosmetics are not "FDA-approved" This warning letter shows us where the line is between allowable cosmetic claims, the "not really okay structure-function claims, and disease claims. In this letter, the disease claims tipped the scale to regulatory action. Cosmetics have a narrow definition of what types of marketing claims are allowed. First, let's start with FDA's cosmetic definition. "Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance." This is very narrow and leaves little room for bold marketing statements. Structure-function claims. Although not permitted for cosmetics FDA tends not to cite cosmetic companies for making lighter "supplement" structure-function claims such as "joint comfort" or "promotes skin elasticity." In this example, the company was making supplement-style claims about an ingredient in the formula. These types of statements, while not ultra-high risk, should still be avoided. From warning letter. "Magnesium Chloride helps with the normal functioning of cells, nerves, bones, and the heart." Disease claims. Here are some examples that cross the compliance line. From warning letter. "5 Benefits of Natural Progesterone Cream: Treats Fibroid Tumors . . . Helps Endometriosis" "Lower the risk of urinary tract infections (UTIs)" "May help relieve skin flares caused by Psoriasis & Eczema" GMP violations . This warning letter also includes GMP violations, such as the very common "you didn't test your glycerin for DEG" citation. I write more about this here . Cosmetics and supplements are not FDA-approved. I typically don't take pleasure in other company's misfortunes, but I rather enjoy seeing "FDA-approved" statements called out in warning letters. This serves as a reminder that cosmetics and supplements are not "FDA approved," which differs from "FDA registered." Interestingly, the website's "FDA approved" statement and the ambiguous website "FDA inspected and certified facility" claim were cited. I doubt the label claims would have been called out in this letter without the blatant "FDA-approved" website claims. I will add this to my Apex Compliance keyword lists, which helps companies find and replace risky statements before they lead to lawsuits or letters. ·From warning letter. "the website for Magnesium 50 mg Body Cream includes the image of a blue circle with the claim, "FDA * APPROVED * FACILITY." Further, the product labels and/or websites for the other seven before-listed products include statements that these products are made or manufactured in an "FDA inspected and Certified Facility," a "Certified FDA registered facility," I ran Apex Compliance on this company's website and found lots more very high-risk claims that can lead to additional warning letters or lawsuits. For example, "may help with depression" when promoting vitamin D ingredients. For just $500, I can provide a line-by-line report showing where risky phrases occur, a risk rating, notes, and more. Let me know if interested. There is a lot more to this letter. Read the full warning letter here . DATE ORIGINALLY POSTED: 8/28/24 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!

  • Clinically Proven Claims Lead To Scrutiny

    Study design must be correct < Back Clinically Proven Claims Lead To Scrutiny Study design must be correct This NAD case shows that making “clinically proven” claims attracts the highest level of scrutiny. The National Advertising Division (NAD) has been paying close attention to skincare marketing claims, and this monitoring case shows that this trend is continuing. A celebrity-supported skincare brand was making the following statement. “Clinically-proven to quickly and visibly lift, firm, and diminish the appearance of fine lines for a revitalized eye area.” Reading NAD’s comments on the clinical study design is interesting. The clinical study “included instrumental measurements of skin hydration and elasticity, digital photographs, and participant questionnaires,” but NAD determined the subjective portion of the study questionnaire could not support all of the ‘clinically proven to quickly and visibly lift’ statements but “NAD found that other portions of the claim were supported, therefore recommended the claim be modified to reflect that the “quick” and “visible” results pertain only to hydration and “the appearance of fine lines.” This shows how even small marketing statements may be picked apart and should be adequately substantiated. There are also some other items in this case which are worth reading. Full disclosure: I am a big Reese fan, but the folks in charge of her brand ambassador compliance can learn from this. From NAD. “The National Advertising Division (NAD) also recommended that actress Reese Witherspoon’s status as a … brand ambassador be clearly and conspicuously disclosed. NAD’s inquiry further focused on whether the format of the challenged advertising gives the impression of editorial content from InStyle and Hello! Magazines and Sephora when, in fact, they are advertisements.” The company also discontinued the “#1 best selling product at Sephora” claim. NAD cases continue to reference claims like “#1 best selling” and “#1 doctor recommended,” which should be avoided unless the company has solid substantiation. These types of claims should not be confused with puffery statements such as “world’s best cup of coffee,” which are permitted. I write more about puffery here . Read the NAD case here . 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!

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