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Old posts are "active" marketing < Back "Forgotten" Old Social Media Posts Old posts are "active" marketing “Forgotten” social media posts from years ago are active marketing and are fair game for enforcement. Today, I’ll explore old social media warning letter citations that include retweeting, images, videos, LinkedIn, hashtags, and more. Retweeting: Retweeting (or is it called ReXing (smiles)) and reposting are considered endorsing the testimonial claim. For example, if a consumer wrote something nice about your product and you retweeted it, the information in the consumer tweet would now be your marketing. The risk increases if you add commentary such as “This is why we made the product.” → From warning letter. “You retweeted another user’s September 26, 2014 tweet, which said, “#lipoicacid [an ingredient in your …R-Lipoic Acid Vegcaps 100 mg] model treats autonomic neuropathy.” → Read this warning letter . LinkedIn: Warning letters that mention claims on LinkedIn are rare, and they usually cite issues on a company’s company page rather than individual posts or claims made in easily searchable disease hashtags like # Covid. In the past, it seemed like LinkedIn did not allow posts to be indexed for Google searches, but in the past couple of months this has seemed to change, meaning that old posts are more discoverable. Because of this, I expect more LinkedIn-related warning letters this year. Images and videos: FDA also cited claims made in images and videos. Here are some examples of 4.5-year-old Facebook and Twitter posts. ● IMAGES: This post shows that imagery, especially when added to the disease-word-containing text, can be considered marketing. Here’s a recent LinkedIn post about this. → From warning letter. February 9, 2019 Twitter post: An image of the “Vision Clarity Eye Drops” with the text, “Carnosine, a cataracts worst nightmare.” ● VIDEOS: This Facebook video also shows that even making implied claims can lead to a warning letter. → From warning letter. “July 11, 2019 Facebook video post. “We do not make any medical claims nor guarantees on any specific health issue, but we are very thankful that for over 10 years, people have been able to avoid having cataract surgery because they’ve used these drops.” → Read this letter . Hashtags: Here’s a 2019 post that includes hashtags. Hashtags are easily searchable and are easy targets for agencies looking for disease-containing posts. → From warning letter. “On your April 26, 2019 tweet: “Make Nutrovape Recover your best friend and say adios to a #hangover!” I am writing this from a beautiful beach overlook in Whangarei, New Zealand, where the birdsongs and water make an excellent place for concentration and relaxation. 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!

Small labeling issues increase warning letter risk < Back Labeling Violations & Web Claims Small labeling issues increase warning letter risk This company received several observations for minor labeling issues, but the GMP-related observations and the website disease claims likely tipped the scale into a warning letter. This warning letter is filled with important reminders about labeling format, and I review some key points here. Do you want Warning Letter Wednesday delivered to your inbox each week? 🔷Structure-function claims and the DSHEA disclaimer are required to link to each other with a symbol. This is rarely referenced in warning letters but may be a more common plaintiff lawsuit. 👉From warning letter. “Your … product labels each fail to bear a symbol next to all structure/function claims linking the claim to the disclaimer, in accordance with 21 CFR 101.93 and (d). For example, we note use of the term “wellness” is a structure function claim.” 🔷“Supplement Facts” should stretch the top length of the supplement fact panel. This is a minor but common label oversight. 👉From warning letter. “Your… products fail to set the “Supplement Facts” full width of the nutrition label.” 🔷Vitamins or minerals with less than 2% daily value must be listed in “Other Ingredients.” Admittedly, this is a new one for me. 👉From warning letter. “Any dietary … that is present in an amount that can be declared as zero in section 21 CFR 101.9(c), must not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals). The source of the ingredient, i.e., potassium citrate must be listed in the Other Ingredients list. “ 🔷Items without a percent daily values must be disclosed in grams rather than milligrams if over 1000mg. Again, this is a minor but common oversight. 👉From warning letter. “Your … products fail to declare the quantitative amount by weight of each dietary ingredient per serving using metric measures in appropriate units (i.e., 1000 units must be declared in the next higher set of units, e.g., 1,100mg must be expressed as 1.1 g)” 🔷“Dietary Supplement” should be in bold and in a large font size. 👉From warning letter. “The statement of identity “dietary supplement” on your … products must be presented in bold type on the principal display panel, in a size reasonably related to the most prominent printed matter on the panel” 🔷This warning letter is another example of an FDA inspection that led to a website review six months after the initial inspection. This is an important reminder that a compliance re-review of online marketing is essential if the FDA has recently visited your facility. I ran ApexCompliance on their website and found many risky statements. Learn more about this compliance program . There are many more learning lessons in this 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!

Opioid support claims are high risk < Back Kratom Claims Enforcement Increasing Opioid support claims are high risk There have been four kratom warning letters this year compared to just one last year, a 400% increase. This shows there has never been a riskier time than now to market kratom with disease claims. All kratom warning letters this year involve claims related to opioid withdrawal. Products marketed for opioid and substance withdrawals remain a high risk as those suffering from addiction are considered a “vulnerable population” and are top of mind for the FDA/FTC. Other vulnerable populations are the elderly, children, and those with mental illness. Now is a great time to ensure these high-risk statements are not inadvertently hiding on a company website or socials. The FDA does not have a favorable position on kratom and considers it a New Dietary Ingredient (NDI) according to this import alert . The FDA also sent out this kratom alert where several US Marshall kratom seizures are highlighted. There also have numerous kratom-related recalls because of salmonella contamination. The key learning lessons are that if a company must sell kratom, they should be very careful not to make opioid withdrawal support or other disease claims, including statements in blogs or citing clinical studies. Also, investing in safety studies and testing every lot for microbials is advisable. I think safe and responsible kratom commerce may someday have a place in dietary supplements. The 2022 kratom warning letters are joint FDA and FTC warning letters. Also, they include cease and desist demands requiring the companies to stop making unsubstantiated claims or face injunction, civil penalties of up to $46,517 per violation, and requirements to refund customers. 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!

Comparison to drugs is high risk < Back Ingredient Benefits, Clinical Studies, & Blogs Lead to Warning Letter Comparison to drugs is high risk Comparing a supplement product to a drug is a quick way to attract FDA attention. In this warning letter, the company compared turmeric, an ingredient in their product, to the effectiveness of NSAIDs (such as aspirin). Although, in many cases, it may be true that supplements can work better than drugs without side effects, these statements do not belong in compliant marketing. Below is the statement cited in the warning letter. The use of disease words like “inflammation” and “pain” and the reference to clinical studies added to the risk of scrutiny. Instead, sticking with statements about an ingredient’s soothing properties and quality of life statements such as “feel ready to go hiking” can be a lower-risk marketing strategy. 👉From warning letter. “….are a great option for those looking for a natural alternative to over-the-counter pain relievers. In fact, studies show that turmeric is just as – if not more – effective in reducing inflammation and joint pain than NSAIDs.” 🔷This company already received a warning letter last December, which I write about here . It seems FDA deleted the December warning letter and reissued it recently, as the person named in the original warning letter was not part of the company at that time. 🔷There are several references to clinical studies in this warning letter. Implying that an ingredient or product has supporting clinical data, such as “studies show” statements, can lead to increased scrutiny, especially from FTC and plaintiff attorneys. Here’s a post about “clinically proven” claims . 👉From warning letter. “2016 study showed that taking a high dose of 1000 mg of curcumin each day for an average of 8-12 weeks helped reduce inflammation and joint pain.” 🔷Blogs are commonly referenced in warning letters, and this company crossed the line from education to marketing by talking about ingredients they sell. Even if there is no cross-linking, simply mentioning an ingredient in a disease context, such as a “Thyme is a strong antimicrobial that can help promote relief,” can elevate warning letter and litigation risk. I see companies making this mistake all the time. There is a lot more to this warning letter, including numerous GMP violations. See my previous post about this, or read the 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!

Review videos for compliance concerns < Back YouTube Claims Lead To Warning Letters Review videos for compliance concerns There have been three YouTube-related supplement warning letters this year, which shows FDA is not slowing down with this enforcement trend. Since this is a US holiday, I will keep today’s Warning Letter Wednesday brief. All of the 2023 YouTube-related warning letters also cite claims from other platforms like websites and other social media platforms. This means that “where there’s smoke, there’s fire,” and if there are claims on videos, there are most likely disease claims elsewhere in a company’s marketing. I just launched Apex Compliance , a compliance software designed to find risky phrases on websites, YouTube videos, and uploaded content before it gets you in trouble. I developed this SaaS tool to help companies fix their marketing before it leads to a warning letter or lawsuit. Learn more here . Two letters link to a shopping cart, and the other one references a video embedded on the website. This is the material connection that correlates the video to commerce. I doubt these videos would have been cited if there were no links to where customers can order products. Only one FDA warning letter in FDA’s warning letter archives mentions claims on Vimeo (that I can find). Here are the three letters: 👉ByPro Nutrition LLC 👉PharmaCanna 👉Spartan Enterprises Inc. 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!

Inflammation + arthritis claims = warning letter < Back Lessons From Inflammation Warning Letters Inflammation + arthritis claims = warning letter Inflammation claims were cited in 17 supplement-related warning letters last year. Here, we’ll look at the lessons we can learn from these letters. Statements like “reduces inflammation” or “anti-inflammatory” are disease claims, but they are not likely to attract a warning letter on their own. 47% of the inflammation claim warning letters (8 of 17) cited in 2023 warning letters include the word arthritis. 53% of these warning letters (9 of 17) include the word “cancer.” Here are some key takeaways. All 17 warning letters include high-risk claims like arthritis, cancer, or Monkeypox, with one exception. This warning letter exception is animal-related and “only” makes inflammation and anti-viral statements. Although risky, this is typically not enough to tip the scale into warning letter category unless it’s an animal product, as FDA has a lower “tolerance” for claims made about animals compared to human products. Although making inflammation claims carries some risk, they are unlikely to be the sole reason for a warning letter. This includes claims made on posts or platforms different from the inflammation claim. This demonstrates how FDA looks at disease claim enforcement. They look at the 10,000-foot view of a company’s online persona and piece together claims from areas like blogs and socials for one big picture of non-compliance. This shows that compliance is not done in a vacuum, and taking a holistic approach to compliance is important. This is one of the approaches we take at my regulatory consulting company, Supplement Advisory Group. Contact me to talk about your consulting needs. 41% of these warning letters involve claims on social media. This is a friendly reminder that even very old social media posts are considered active marketing. 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!

Copackers & distributors must comply with GMPs < Back Incomplete 483 Responses Copackers & distributors must comply with GMPs This copacker didn't have most of the basic GMP structure required for handling and distributing dietary supplements, and based on my reading of the letter FDA gave them plenty of opportunity to address their 483 responses. Unfortunately, this company likely didn't seek professional help and has earned a warning letter for poor GMP compliance and insufficient 483 responses. Here is what we can learn. Product retentions: We don't often see this cited in warning letters, but it is an integral part of GMPs and product investigations. In my days as a manufacturer, I frequently used product retentions to conduct customer complaints and investigations. I also used these products to help substantiate shelf life expiration dating. From warning letter. "You must retain reserve samples for one year past the shelf-life date (if shelf-life dating is used), or for two years from the date of distribution of the last batch of dietary supplements." The reason product retentions are rarely mentioned in warning letters is that they are a pretty simple 483 response. The company needs to update its policies and show its work, meaning it should provide proof that product retentions will be collected and saved for the proper amount of time. This company fell short of proving this to FDA, which is why it was added to the warning letter. From warning letter. "(from company) [w]e corrected and labeled retention samples before the end of our inspection" and "[w]e have a special location for retention samples and hold for are [sic] required to hold for 2 years for the lot." (from FDA) However, you did not provide any supporting documentation demonstrating you made these corrections. Further, the inspector did not observe any corrections prior to the closeout of the inspection. Consequently, we cannot evaluate the adequacy of your corrections at this time." Subpart G: This involves receiving dietary supplements for packaging. You will see the company did not prove the corrective action to FDA, which, In this case, should be so simple. From warning letter. "During the inspection, you did not have any procedures in place for the dietary supplement products you receive for packaging and labeling. 483 response comments from warning letter. "Your "Inbound Policy" failed to provide written procedures regarding the examination of each immediate container or grouping of immediate containers in a shipment of product that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) for appropriate content label, container damage, or broken seals to determine whether the container condition may have resulted in contamination or deterioration of the received product." As a side comment, I love writing this weekly post. Please share with your community to help spread the word. You can sign up here for WLW and my monthly newsletter, and to learn more about my consulting company, Supplement Advisory Group , and my award-winning compliance software company, Apex Compliance . Your support means the world to me! Thank you! There are several other incomplete 483 responses cited in the letter. Read the full warning letter here . DATE ORIGINALLY POSTED: 8/14/24 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!

Don’t engage with risky reviews < Back Product Reviews Become Marketing Don’t engage with risky reviews In this warning letter, the company engaged with "third-party" reviews on its website, which turned them into marketing. If product reviews are collected and displayed on a website, the agencies are generally "hands-off" as long as they are: Third-party Honest: The honest experience with the product. Here's an FTC case concerning Google and I Heart Radio from a couple of years ago. Not solicited: Such as "a free product for a favorable review." Non-curated: Don't favor positive reviews. Also, conglomerating reviews on a "Reviews" page can be considered curation. Non-compensated: No paid influencers or free products unless disclosed. Not showcased: Such as those highlighted in a banner or a social media image. Not engaged with: These reviews become marketing when a company showcases them in a banner or social media post or engages with them on their website or social media. When in doubt, don't engage is a good rule for product reviews and testimonials. Not hidden negative reviews: FTC pays attention to companies hiding negative reviews, and, in some cases, hands down big fines, such as this $4.2 million case against Fashion Nova . Some companies go the extra mile and delete any reviews or testimonials that contain disease words. This is fine as long as you have a documented policy that treats positive and negative reviews the same. Here's an example from the warning letter. From warning letter. "January 24, 2023 customer review states, "I have been using this CBD for my pup who has seizures for some time, since starting CBD she has not had one. I like that there are no unnecessary ingredients, and she takes it with no problems." (company) replied, "Thank you for the review, (b)(6) That is amazing news - we are so glad to hear that your pup's seizures stopped!!!" There is so much more to this warning letter. Read it here . DATE ORIGINALLY POSTED: 10/23/24 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!

Small business learning lessons < Back Education vs Marketing Discussion Small business learning lessons Today's post highlights common mistakes made by a small herbal company. Looking at their mistakes can help show others what not to do. I am not picking on this company as they likely didn't know the rules of supplement marketing. One of the reasons I write Warning Letter Wednesday is to educate companies on the dos and don'ts of marketing. Please share to help get this knowledge to those who need it. Copying information for herbal texts can lead to trouble. Education is ok, but it crosses the line into marketing when used to sell products. This reference was likely copied from a book onto the company's website. I also see companies making this mistake when copying information from clinical studies to commercial websites or socials. The lesson here is that any statement used to sell products should be compliant. The "Asa rule" is that you shouldn't use it in secondary marketing pieces if you wouldn't put it on the label. 👉From warning letter. "Antispasmodic Tincture • To be used in cases of epilepsy, convulsions, lockjaw, delirium, tremors, fainting, cramps, hysteria, suspended animation, etc." Claims about "colds and flu" are high risk. This is obvious, but it is worth repeating. This phrase is in one of my "top 50" that comes preloaded in my Apex Compliance program. 👉From warning letter. "Echinacea's cold and flu fighting and healing ability alone has made it the #1 immune herb…" Product names are also cited as disease statements in this warning letter. Normally FDA does not normally reference product claims unless they are over the top. 👉From warning letter. "Insomnia Formula• Product name: The product name implies that the product is intended to cure, mitigate, treat, or prevent insomnia." Read the 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!

Discussing ingredient benefits is a marketing claim < Back Ayurvedic Product Company Receives Covid Warning Letter Discussing ingredient benefits is a marketing claim This company was cited for making immunity and Covid support claims, which remain top of mind for the authorities. There is never a suitable time to discuss Covid support claims when selling products, so a good practice is to remove all references to Covid or Coronavirus from any marketing platform, including old social posts. Removing these "buzzwords" dramatically helps to mitigate risk. Do you want Warning Letter Wednesday delivered to your inbox each week? Sign up here . Authorities look at the 10,000-foot view of a company's online persona. Unless egregious, one "buzzword" will likely not attract a warning letter, but claims on social media, videos, blogs, product reviews, hashtags, and ingredient descriptions elevate risk. The authorities piece them together for one big picture of non-compliance—the more "buzzwords," the higher chance of scrutiny. I suggest removing or replacing them with truthful, accurate, and not misleading options. This company is an all-in-one Sri Lankan travel agent, web designer, and Ayurvedic product seller who probably didn't realize they were breaking the law by making high-risk Covid claims. This is one of the missions of Warning Letter Wednesday; to educate unknowing companies about the dos and don'ts of marketing compliance. Sadly, this company still doesn't get it, as they removed the Covid statements cited in the warning letter but left claims relating to preventing heart attacks and fighting the flu. This is a good lesson about the nuances of supplement and food marketing for companies entering these industries. If you know any of these companies, please feel free to share some of my regulatory hints videos . This company was cited for discussing the benefits of its tea ingredient. I talk about how discussing ingredient benefits can lead to a warning letter here . This is also a joint FDA/FTC warning letter. I discuss more about what this means here . Read the 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!

Playful ads can attract scrutiny < Back Bashing Competitors Can Lead to Challenges Playful ads can attract scrutiny Bashing competitors, even unnamed ones, can lead to competitor challenges. In this post, I review this National Advertising Division case where General Mills challenges television commercials by Welch's Fruit Snacks. In the commercials, celebrity chef Gordon Ramsay throws away generically labeled "Fruit Flavored Snacks" by tossing them out of a window and even spitting them out. In my opinion, the commercial is actually pretty good. It can be watched here . 🔹From NAD. "NAD determined that one reasonable takeaway from the commercials is that the whole fruit content of Welch's Fruit Snacks makes it a superior product for consumers." NAD also determined that the dramatic throwing away of the generic products was considered "ash canning," which depicts "competing products like General Mills' fruit snacks as lacking any positive value." The term "ash canning" in advertising refers to a practice of depicting competing products as having little or no value and implies that the competing product is so inferior that it might as well be discarded like ashes. Here's another NAD case involving "ash canning," where a beer company was asked to discontinue a commercial with imagery and a "Light beer shouldn't talk like water. It should taste like beer. "statement. In the beer case, NAD offers this information regarding the needed substantiation. 🔹 "NAD determined that tasting "like water" is a measurable attribute. Reliable sensory testing could demonstrate whether consumers detect a watery taste or the complete absence of taste. Consumers may also reasonably expect that the statement is supported by such evidence. Good resource here; I came across the ABC Television: Advertising Standards & Guidelines document , which has some helpful high level information on things like puffery, ash canning, and substantiation of performance and efficacy claims. The moral of this story is to use caution when bashing even anonymous products, especially the litigious ones with deep pockets, to initiate challenges. Read the case summary here . DATE ORIGINALLY POSTED: 10/16/24 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!

Replace “high risk” words with lower risk alternatives < Back Using words such as “inflammation” increase warning letter chances Replace “high risk” words with lower risk alternatives #WarningLetterWednesday High risk words should be avoided in all forms of marketing. The words "inflammation" or "anti-inflammatory" is being referenced in many warning letters. Read full warning letter here . If truthful and not misleading replacing "inflammation" with words such as discomfort, soothe, support-comfort, body-resilience can help convey a marketing message in a lower risk manner. 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!