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NAD challenge cases explored < Back Fruit Snack Wars NAD challenge cases explored The fruit snack wars are on! A few months ago, I wrote about General Mills challenging television commercials by Welch's Fruit Snacks (PIM's). In the commercials, chef Gordon Ramsay throws away "Fruit Flavored Snacks" by tossing them out of a window. That post includes information on "ash canning," an advertising term that describes the practice of portraying competing products as so inferior that they might as well be discarded like ashes. Read that post here . In this case, Welch's Fruit Snacks (PIM's), who was previously on the defense, challenged several claims made by the Mott's brand of General Mills. This shows that bringing NAD cases can have the added ramification of reciprocal action. 👉From NAD. Although these seem minor, they will likely lead to plaintiff lawsuits and demand letters, which are the biggest"impacts" of NAD decisions. "NAD found that General Mills failed to support these implied claims through challenged social media posts and by reviews reposted by General Mills, including: 🔹"These are great. Way [sic] to get my kids to eat fruits and vegetables. They have [had] a package each night after dinner for years and years." 🔹"My kids love eating these and I love the fact that it's made with real fruits and vegetables and no artificial colors. It helps with trying to show them how to eat mindfully and healthy." You may be asking yourself what the big deal is with fruit snacks. I looked this up. Apparently, this is a $4 billion industry in the US. Also, as a complete aside, every time I hear the name Mott's, I think about this 1987 commercial . Read the NAD case here . DATE ORIGINALLY POSTED: 12/4/24 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!

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 . 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 marketing CBD products should avoid making disease claims < Back 300%+ Increase in CBD Warning Letters This Year Companies marketing CBD products should avoid making disease claims This year there have been 26 CBD-related warning letters. This is up from just seven in all of 2021. That is over a 300% increase, and we are only in August! This shows the FDA's growing intolerance for CBD products that make marketing disease claims. It is important to note all the CBD warning letters included high-risk disease claims such as Alzheimer's, depression, cancer, and PTSD. You may be saying, "of course, companies shouldn't make these claims," which I agree with. However, some of the 26 companies may not have known they were making disease claims, as forgotten several-year-old social media and blogs may have disease claims lurking in them. Here is a post about several-year-old social media posts being called out in a warning letter. CBD for animal products is mentioned in 30% of these 2022 warning letters. It is important to note that the FDA seems to have a lower "tolerance" for claims made about animal products. For example, mentions of "anxiety" and "inflammation" may be enough to attract an animal product warning letter. Still, some higher-risk words such as "depression" are usually present in the human letters. Some of the letters also include bizarre mentions, such as this example of a wrist band that was labeled as a supplement. The issue with this, of course, is that supplements must be ingested. Marketing products like this clearly show the FDA that the company does not understand the basics of dietary supplement regulations. From warning letter: "your website shows Supplement Facts panels for the "Tanka T-FLEX Band ….. your products' labeling states that the products are intended to be worn on the wrist. For example, your website describes how the "patented macromolecular technology works through direct contact with the skin to provide timed controlled-release of up to 30 days." 45% of the warning letters include the disease claim one-two punch "anxiety" and "depression." It should come as no surprise these two disease words continue to be called out in letters. Here is a video about this. Other Common high-risk words are "insomnia," “fibromyalgia,” and “Alzheimer's.” See this post and video for a deeper discussion. From warning letter “post on Instagram states, “What can #CBD do for #animals and our #furbabies ~ #anxiety #inflammation #arthritis #pain #seizures #cancer #cbdoil #health #dogs #cats #horses #cows #freestateoils ->> freestateoils.com/hemp-cbdpellets-for-farm-animals.” The post includes a graphic with photographs of several farm animals and pets, and includes statements such as, “Anti-ANXIETY || Anti - INFLAMMATORY || Anti – ARTHRITIC” The learning target here is the authorities look at the totality of the advertisement. This post is on a social media site that links back to a shopping cart; this is the material connection. The disease hashtags are claims and when a company adds its name in a hashtag, it further elevates the risk. The image with the animals and therapeutic claims such as "anti-anxiety" further demonstrate the intended use of animal disease prevention. Several of the warning letters include study citations. Even mentioning CBD studies on a commercial site is enough to attract a warning letter. Here is an example from one FDA warning letter. "Israeli researchers have launched three clinical trials that utilize CBD's anti-inflammatory properties as potential COVID-19." Here is a post about several CBD companies that received warning letters for similar infractions. More than half of these warning letters include claims made on social media. Here is a post about this. 47% of the warning letters include claims made in blogs. This is a continued enforcement trend, and several letters this year include claims made in old blogs that contained disease words. It is possible the companies didn't realize their several-year-old blogs contained high-risk words. A good reminder for a compliance "tune-up." Here is a post about this. 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!

Learn from other’s mistakes < Back Arthritis Claims Enforcement Learn from other’s mistakes Since the beginning of 2023, 11 warning letters have been issued for arthritis-related supplements and topical product claims. Here, I explore these warning letters, look at common trends, and share key takeaways. Higher-risk disease claims : I have always wondered if making arthritis claims alone is enough to trigger a warning letter. The answer is surprisingly “not really.” All warning letters since the beginning of 2023 have included high-risk words like cancer, depression, and fibromyalgia, except one. This warning letter accompanied GMP citations and included arthritis claims that were part of an out-of-compliance OTC drug that did not follow the official monograph. Social media and YouTube : 45% (5 out of 11) mention claims on social media and YouTube. This is not a surprising number, and it shows FDA’s continued focus on social media marketing claims. Some of the cited social posts were a couple of years old, which is a reminder to ensure even those old posts are “clean” of disease claims. Are you interested in finding the high-risk statements on your website, videos, and content before publishing? My software product, Apex Compliance, can help you identify and replace these high-risk phrases before they lead to warning letters and lawsuits. Our AI has been custom-trained on compliance principles, including warning letters, and it helps you understand what compliant language looks like. Learn more and set up a free demo here . Blogs : 18% include claims made in blogs. I’ve written a lot of this before, such as in this post . GMP Inspections Lead to Marketing Review : 27% of letters started with a GMP inspection, which led to a marketing review. I write more about this here . Drug-spiked ingredients were mentioned in 18% of these letters . The moral of the story is to keep disease words like arthritis out of marketing, and they will signal to authorities to look deeper for other high-risk marketing phrases. 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 ESG claims are substantiated < Back Environmental Claims Increase Scrutiny Ensure ESG claims are substantiated We love the environment, but companies making broad sustainability claims are asking for increased scrutiny. This is because statements like “environmentally friendly” and “sustainably sourced” can be interpreted in many ways, and providing the required substantiation is very difficult. A leading meat stick brand faced a challenge at the National Advertising Division (NAD) over its environmental and sourcing claims. In NAD cases, companies typically provide substantiating data to support their claims for review. However, rather than defending its claims, the company chose to remove the challenged environmental statements, including references to the product being “carbon neutral” and “sustainable.” 👉 From NAD. “(NAD) will treat the claims, for compliance purposes, as though NAD recommended they be discontinued.” Here are a few comments and best practices when making “eco” type claims. Provide measurable outcomes: For example, “Our packaging uses 30% post-consumer recycled content” is less likely to be challenged than “Our packaging is recyclable and sustainable.” Stay Away from Broad Claims: Statements like “No carbon footprint” are well-intentioned but are difficult to support without an offset program or verified calculation on all products. Specific vs. Broad Claims Example 🔹Broad Claim (Risky): “Our protein powder is eco-friendly and helps save the planet.” 🔹Specific Claim (Less Risky): “Our protein powder uses 25% less plastic per container compared to our 2021 packaging, reducing material waste.” Read the NAD decision here . DATE ORIGINALLY POSTED: 2/12/25 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!

Review old social posts for regulatory “landmines” < Back Seven-Year-Old Facebook Post Leads To Warning Letter Review old social posts for regulatory “landmines” This company received a warning letter for claims made on its website and old social media posts. The oldest post cited in this letter is from 2016, which shows that even old and potentially “forgotten” social posts are active marketing in the eyes of the authorities. Many companies now have “clean” marketing, but they may have inadvertently overlooked the regulatory landmines in their old socials. Now is the time to review and update these old posts (and old blogs). Sign up for this weekly email ! 🔷 Some very high-risk language on Facebook is cited in the letter. 👉 From warning letter.” In a July 29, 2017 post: “Can Plaquex® help prevent cancer?...When I linked the facts of these three independent information sources, the thought came to me, that Plaquex® – Phosphatidylcholine – may be able to prevent cancer.” 🔷 Following the “breadcrumbs” in warning letters is always fun. For example, in this letter, FDA notes that the Facebook page links to a website (book-selling site) that links to another website where customers can order supplements. FDA rarely references anything over “two clicks,” which is what makes this so interesting. FYI, the two-click rule is an urban legend and, as demonstrated in this letter, does not protect from disease claim enforcement. This “commercial bridge” is important, as it’s often cited in warning letters. 🔷 Unfortunately, this warning letter has not stopped the company from continuing to make very high-risk claims, such as statements about ingredients being antidepressant and antiarthritic. 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!

Ensure substantiation is suitable for each claim < Back Learning Lessons From NAD Ensure substantiation is suitable for each claim I usually write about FDA warning letters, but today I will highlight a recent National Advertising Division (NAD) decision. NAD is a self-regulatory body under Better Business Bureau (BBB) programs, and I enjoy reading NAD cases to look for clues about claims substantiation and enforcement. Here are some marketing pieces NAD took issue with in this case. 👉From NAD complaint. "posts referenced the … Health Start Study, communicating that children taking …. visited the doctor less, missed fewer days of school, took fewer over-the-counter or prescription drugs and consumed less fast food/prescription drugs. DSSRC determined that the … Health Start Study was not the type of competent, reliable scientific evidence required for such claims and recommended that the claims be discontinued in the context in which they were communicated." Asa commentary: This shows that statements like "missing fewer days of school" are considered marketing claims and that these types of studies are insufficient substantiation. 👉From NAD complaint. "For the long-form videos shared on …., which include doctors making broad health claims related to use of the product, DSSRC determined that they may conflate certain health-related messages and that claims communicated in the videos are not supported by evidence in the record. DSSRC recommended that …. remove these videos or redact the portions of the video that make reference to the unsupported claims." Asa commentary: This shows that long-form videos will be scrutinized for marketing claims. These can be difficult to control because conversational discussions about product claims can easily cross the line. 🔷A little more about NAD. 🔹NAD reviews advertising disputes between competitors and other claims it becomes aware of. It is where companies can challenge each other's claims they feel are affecting their sales. NAD evaluates the truthfulness and accuracy of advertising and offers a streamlined resolution process to address advertising disputes. However, unlike a regulatory court, NAD cannot enforce its decisions, but if a company doesn't comply with NAD's recommendations, NAD can refer the case to the appropriate governmental regulatory authority, such as the Federal Trade Commission (FTC). This can also alert plaintiff attorneys. 🔹Interestingly, this complaint was not brought by a competitor but by a non-governmental advocacy group (NGO). The company in this complaint is an MLM which seems to attract more NAD scrutiny than other traditional supplement marketing channels. Read more about the 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!

Key GMP learning opportunities explored < Back Incomplete 483 Responses Lead to Warning Letter Key GMP learning opportunities explored We can learn a lot from warning letters. This manufacturer was inspected in April 2022, where they received some 483s. The company subsequently responded to some 483s, but according to the warning letter, “Not all of the items on the issued Form 483 were addressed in your response.” In my experience, most 483s can be addressed before they become warning letters. I talk about improper 483 responses here. Here is an example from the warning letter. From warning letter. “We have reviewed your June 23, 2022 response to the form FDA 483. We are unable to evaluate the adequacy of your response because you did not provide documentation demonstrating you have established specifications… You provide documents you describe as revised finished product specifications for the … product. We note that these documents do not demonstrate that you have established specifications that provide standards to confirm the identity, purity, strength, and composition of the finished batch of your dietary supplements. For example, the finished product specification for … product lists an “identification” specification of “Conforms to Standard” with a test method of “Eurofins or eq.” and a frequency of “Rotational.” “Conforms to standard” does not specify the extent to which the component must conform. “Eurofins or eq.” is not a test method, and “Rotational” does not describe the frequency of when testing is to occur. Let’s break this down. 🔹Identification: The company lists the type of identification as “conforms to standard” but does not provide information on what that standard is. The company is close but, unfortunately, falls short of GMP requirements. Here is howI think about GMP documents, such as this specification sheet. Will someone unfamiliar with your process be able to step in and understand how to test the product if there is no “institutional knowledge?” It is the "recipe" for staff to follow. 🔹Test method: The company lists “Eurofins or eq” which is the name of the laboratory, not the name of the method, such as “AOAC 121804.” 🔹Frequency of testing is listed as “Rotational,” which is not sufficient. It should state “Test all” or refer to an SOP on skip lot testing. Incorrect reference samples are also cited. 👉From warning letter. "You failed to establish and follow laboratory control processes that are reviewed and approved by quality control personnel to use criteria for selecting standard reference materials used in performing tests and examinations… Specifically, the FTIR analysis performed by your third-party laboratory uses previous shipments of components as the reference for testing and they do not own a reference library for the FTIR tests. Testing components against previous shipments of the component may confirm receipt of the same component but this does not ensure the identity, purity, quality, and strength of the component is thoroughly characterized.” I admit this is how I tested identity around 2010 until I realized that having a qualified reference sample was essential. In this example, the third-party lab should have handled this rather than just depending on previously provided reference samples, and the quality personnel should not have allowed this. One more learning opportunity. 🔹Theoretical yield calculation helps “error-proof” manufacturing. Let’s use the example of a capsule product. First, the powder needs to be blended. If the theoretical yield is off, this will signify too much or too little of an ingredient was added and, therefore, should not “pass” to the encapsulation process. 🔹The same Is true for encapsulation. If a company has substantially more capsules than the theoretical yield, this signifies the capsules are underweight and not at label claim. The production should be stopped for evaluation here. 🔹If the yield is too high in bottling, this shows there are likely not enough capsules in each bottle. This lily-pad approach to quality is designed to stop problems before they happen. From warning letter: "A statement of the theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process and the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary." Interested in learning more about GMPs? Here are a few webinars you may enjoy. 🔹Distributor requirements for supplements . 🔹Getting ready for FDA inspections . There are so many learning lessons. Read the full letter 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!

Companies are responsible for co-manufactured products < Back Eye Care (Ophthalmic) Products Under Increased Scrutiny Companies are responsible for co-manufactured products This warning letter is interesting. This is an ophthalmic drug warning letter, but the supplement and cosmetic industries can glean helpful information here. Here, I review these learning opportunities. Claims on website and videos. Timeline: Could the company have avoided a warning letter? Ophthalmic (eye) drug products are under increased scrutiny. Manufacturer and distributor responsibilities Are you interested in a free discussion about high-risk claims on your website? I’ll run my compliance software and share the findings. Book your free session . ● Claims on website and videos. FDA has cited seven companies for claims in YouTube videos this year. What makes this interesting is the videos mentioned in this warning letter were embedded on the webpage rather than just on YouTube. This shows me that FDA is going the extra mile to review videos. Also, some of these videos are old, like this one from 2018. From warning letter. “From your March 16, 2018, YouTube video titled, “MSM Eye Massage (Eye Exercise)” on your… where you demonstrate an eye massage with one of your MSM eye drop products: “This MSM eye massage is great for inflammatory eye conditions, blepharitis, dry-eye, improving the lymph system, and stimulation of tears.” As a side note, Apex Compliance, my monthly compliance software, scans YouTube video transcripts for compliance issues in seconds. Learn more . ● Timeline . FDA tested one of the company’s products and found that it contained microbial contamination, which is very serious for products applied to the eyes. On August 21stof this year, FDA and the company had a virtual meeting, presumably to talk about the contaminated product. A few days later, the company issued a voluntary recall for this and some of their other products. At some point in August FDA reviewed the company’s website and found many drug claims. At some point in August FDA reviewed their website. If the company would have conducted a website compliance check when contacted by FDA, I wonder if they could have avoided a warning letter. ● Manufacturer and distributor responsibilities. This company was using contract manufacturers but apparently did not check their work. Here FDA reminds companies that they are responsible for the products they get made by co-manufacturers. If the company had conducted quality checks, they probably would have caught the microbial contamination before it led to a recall and subsequent warning letter. →From warning letter. “You are responsible for the quality of your drugs regardless of agreements in place with your contract facilities.” FDA also provides a link to this useful guidance document, Contract Manufacturing Arrangements for Drugs: Quality Agreements . ● Ophthalmic drug products are under increased scrutiny. There have been 21 ophthalmic FDA warning letters this year, compared with seven last year. This continued enforcement trend has involved some of the largest companies, such as Amazon. I write more about this . It sounds like the company did not follow the path of an OTC or other drugs. Anything added to the eyes has a high level of danger and should go through proper regulatory channels. →From warning letter. “new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect…. No FDA-approved application pursuant to section 505 of the FD&C Act, 21 USC 355, is in effect for these products.” 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!

Learn from other’s marketing mistakes < Back Website Marketing Claims Lead To Warning Letter Learn from other’s marketing mistakes This company was cited for making high-risk claims related to colds, the flu, and viruses in product and ingredient descriptions. This warning letter is an excellent lesson on what not to do when marketing supplements. Learning from other’s mistakes can help inform compliant marketing, which is one of the reasons why I love writing Warning Letter Wednesday . Here are some high-risk “trigger words” from this letter that should always be avoided. These are some of the preloaded words Apex Compliance scans for when conducting website and content reviews. Antimicrobial, antiviral, and antifungal: Most words with “anti” should be avoided. Fight infection, viruses, influenza, cold and flu. Arthritis Diabetic support Even though the company removed the direct references in the warning letter, the rest of the website still contains product statements such as “Used for over 88 years as an alternative approach to treating cancer.” I’m always bewildered when I see companies only removing the statements called out in warning letters but leaving other high-risk claims elsewhere in their marketing. Perhaps we can support FDA to provide a more comprehensive warning letter list of violations or offer education to companies that do not understand the sometimes confusing world of supplement marketing. I volunteer to help, and my Apex Compliance product is also made for this. There are also lower-risk statements cited that are not likely to attract a warning letter on their own. These “secondary” claims are added when there are higher claims made, but they can help us understand what FDA considers a disease claim and what is an “allowable” structure-function claim. From warning letter. “a natural antihistamine that can help stop damaging particles in the body known as free radicals, which negatively impact how cells work. “ From warning letter. “Kudzu - an herb used in ancient medicine to ease an upset Stomach Ache.” I see companies making the mistake of overexplaining ingredients and products using widely available language such as “Garlic Bulb Extract - contains antimicrobial, antiviral and antifungal properties that assist in alleviating colds as well as other infections” all the time. This is an essential reminder that clinical studies, “educational” websites, and herbal texts do not always translate to compliant marketing. Marketing that focuses on quality-of-life statements such as “wellness support” and “help you feel like yourself” usually gets the message across without making disease claims. This is a shorter WLW than usual, as I’m writing this from the French Riviera on a family holiday. I invite you to 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!

Use caution when discussing ingredient benefits on a commercial webpage < Back Ingredient benefit discussions can be marketing claims Use caution when discussing ingredient benefits on a commercial webpage Ingredient descriptions are considered marketing claims when used to sell a product. Today's #WarningLetterWednesday highlights this common marketing mistake. This is an example of a well-intentioned writer and webpage designer not understanding the nuances of dietary supplement marketing. If the company would have separated the ingredient benefits discussion from the product page, removed high-risk words such as infection, and noted this education is not intended to sell products, they would not have received a warning letter in my opinion. From Warning Letter: "Copper product page: Infections: A lack of copper in the diet may lower the body’s immune system. Normal intakes may help to reduce the risk of infection.” Full warning letter 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!

Curated testimonials are marketing claims < Back Injectable CBD Warning Letter Curated testimonials are marketing claims Injectable CBD? The first CBD warning letter of the year is an odd one. The company was cited for selling injectable CBD products and making disease claims on its website and social media. Here are some key takeaways. 🔹Where is the commerce (sales) taking place? The company's website is designed for practitioners, and it looks like no actual commerce takes place on the website or social media. I even looked at archived website versions of the Wayback Machine. I didn't see anywhere to actually purchase the product unless I set up an appointment with a licensed therapy professional or provided professional credentials. Typically, these "gated" or "commerce-removed" websites do not attract FDA warning letter attention since no public commerce takes place. This type of situation is rare and is really interesting. 🔹Curated testimonials: The agencies are generally "hands off" with third-party, non-curated, non-compensated product reviews or testimonials. These become "marketing" when the company engages with them or curates them, such as adding them to a banner, product page, or social post. Also, FDA sometimes considers separate "testimonial" or "product review" pages as being curated, meaning they are fair game for enforcement. In this letter, the "testimonials" web page had many disease claims. This testimonial shows that making a "better than drugs" statement will increase the chance of a warning letter. 👉From warning letter. "I have now completed two PICO CBD infusions (each 14 days apart) and have had no need to take any Xanax. It's been years since I have been able to go 30+ days without an anti-anxiety pill." 🔹Products marketed as a dietary supplement. Even though the product image label does not appear to list a "supplement" statement of identity or fact panel, the FDA did some investigation work. 👉From warning letter. "You appear to be marketing your "Pico IV" as a dietary supplement. For example, marketing material found on your website states that "CBD, and other cannabinoids, are considered dietary supplements by the FDA . . . even if they're administered intravenously." 🔹Social media disease claims. FDA cited several disease claims in this letter. What's fascinating about this example is the company's use of "potentially." The softening words do not allow a company to make disease claims. 👉From warning letter. "CBD [p]otentially reduce anxiety and inflammation. CBG [c]an support bone health and neuroprotection" This letter came in a group of other injectable-related warning letters which shows that FDA wanted to make a statement about the dangers of IV therapeutics. Read the full letter here . DATE ORIGINALLY POSTED: 3/19/25 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!