Search Results

Homeopathic products under increased scrutiny < Back Amazon and Walmart Cited For Distributing Homeopathic “Drug” Products Homeopathic products under increased scrutiny Amazon, Walmart, and four other companies were issued warning letters for distributing homeopathic products used to treat molluscum contagiosum, a viral skin condition most commonly occurring in children. This is the second warning letter Amazon and Walmart have received in the past year. The other letters were for distributing drug-spiked products with disease claims. Sign up for Warning Letter Wednesday. 🔷 Why did FDA choose to select products marketed for the skin ailment molluscum contagiosum? It seems FDA is concerned about the self-diagnosis of this skin infection when it could potentially be skin cancer. They also are concerned about products marketed as being “child safe.” 👉From warning letter. “A healthcare professional is needed to rule out the possibility of a more serious condition, such as, skin cancer…… FDA is concerned that people are forgoing or delaying proper diagnosis and treatment of a potentially serious, undiagnosed health condition by purchasing and using an unapproved drug product claiming to treat molluscum contagiosum.” 🔷We all know that Amazon dislikes this type of attention, and I wonder if this means the end of homeopathic sales on their platform. 🔷I am always interested when distributors actually get in trouble for selling products on their marketplace. We recently saw delta 8 distributors cited for this as well. According to regulations, companies are responsible for the products they distribute. 🔷The footnotes in the warning letter are worth reading and show that both Walmart and Amazon touched the products. If they did not physically handle the products, would they have been cited? 👉 From warning letter. “Each of the products was “fulfilled” by Amazon; your website states, “Fulfillment by Amazon (FBA) is a service that allows businesses to outsource order fulfillment to Amazon. .....when a customer makes a purchase, we pick, pack, and ship the order.” 🔷The warning letter footnotes also include FDA’s position on homeopathics. Several recent FDA letters have cited homeopathic claims, and I expect more in the future. Here is the Homeopathic Drug Products: Guidance . Reading this guidance and the warning letter footnotes shed light on where FDA’s thinking lies when it comes to homeopathic enforcement priorities and “discretion.” 👉Read the full Walmart letter 👉Amazon warning letter DATE ORIGINALLY POSTED: 8/23/23 Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Webinars are “fair game” for enforcement < Back MLM Distributors Cited in FTC Lawsuits Webinars are “fair game” for enforcement Warning Letter Wednesday primarily focuses on FDA-related enforcement, but occasionally I review interesting FTC actions. Today's #WarningLetterWednesday highlights three FTC cases against distributors of doTerra essential oils and supplements. doTerra is a network marketing company. This differs from last year's Young Living FDA warning letter, where the MLM parent company received the letter for claims largely made by its distributors (affiliates). Read more about this letter here . The claims in these three complaints were made in webinars in early 2022. FTC states they are "former healthcare practitioners who touted their expertise in recommending the products." Interestingly, FTC points out that the distributors named in these lawsuits use their medical background to market supplements. I'm sometimes asked if doctors can make statements about supplements they sell that non-doctors can't make. The answer is, of course, no, but in these cases, the distributor's medical background seems to be mentioned as another way they potentially misled consumers. Some of the cited claims imply products can support the immune system, and they dance around the idea they can protect or help with COVID. Since COVID claims are very high risk, even lightly implying protection is enough to attract agency action like a warning letter, administrative complaint, or lawsuit. Here is one example. From Lauren Busch FTC lawsuit. "LLV should be part of your daily routine, DDR Prime should be a nonnegotiable, especially with all the exposures we have in this world beyond just what's going on with COVID." A key takeaway is that all secondary marketing will be heavily scrutinized if any COVID claims are present. doTerra, the parent company from today's Warning Letter Wednesday, seems to do a good job at compliance. I ran my Apex Compliance program on their website and found just a few concerns. I'm happy to run a sample keyword check on your website; just let me know. The FTC complaint includes a permanent injunction against each defendant, stopping them from making unsubstantiated claims and also pay a $15,000 fine each. In my opinion, this monetary amount seems low, but it does send a cautionary tale that MLM distributors can be liable for the claims they make. COVID claims are likely why these distributors were targeted. "Brain fog" is also cited in one of the complaints. Do you consider this to be a disease claim? According to HHS, brain fog can be a symptom of long-haul COVID, a recognized disability under the Americans for Disabilities Act (ADA). My take is brain fog related to COVID symptoms is undoubtedly a disease claim, but brain fog not related to Covid isn't high risk. I feel "occasional brain fog" from time to time. I write about brain fog claims here . From FTC complaints: "The webinar was organized and promoted by doTERRA distributors …. and the registration link for the webinar was distributed on publicly accessible social media accounts." Interestingly, FTC references that access to the webinar is publicly available. If the webinar was closed to the public or invite-only, do you think it would have been cited in this complaint? Also, it seems the webinar recording may have been posted on YouTube, which, if true, maybe how the FTC found it. Companies and company representatives frequently record webinars and podcasts. Claims enforcement made in these formats are rare unless they are posted on YouTube, or the transcripts are hosted on a commercial website. My SaaS Apex Compliance program scans YouTube videos as well as websites and documents for risky keywords. Learn more here . Citing research is also mentioned in one of the complaints. From FTC lawsuit "slide displayed the abstract from an article titled "Computational evaluation of major components from plant essential oils as potent inhibitors of SARS-CoV-2 spike protein." We have previously discussed how citing COVID research to sell products can lead to warning letters. Read my comments on last year's FTC's 4.2 million dollar fine against Fashion Nova for allegedly hiding unfavorable product reviews here . Read about the FTC action 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!

Free speech protections go away when there is marketing material connection < Back Affiliate Marketing Content Must Be Compliant Free speech protections go away when there is marketing material connection Affiliate marketers continue to be scrutinized for making claims. #WarningLetterWednesday A few years ago, affiliate warning letters were nearly nonexistent. Now regulators are savvy and are no longer tolerating claims where there is material connection. Affiliates develop content in hopes of bringing consumers to their site which then hyperlinks to a shopping cart for purchasing the mentioned product. Affiliates get a cut of sales which can be 30%, so you can see the incentive for sensationalized content. Affiliate relationships should also be disclosed clearly and conspicuously. Affiliates are responsible for the accuracy and compliance of their statements. The difference between "Average Jane" and affiliates is the material connection. If there is no material connection, including free product and employee/family relationships, consumers can say pretty much anything about products they like. Original Q&A published 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!

Uncompliant hashtags attract FDA attention < Back 6-Year-Old Social Media Posts & Hashtags in Warning Letter Uncompliant hashtags attract FDA attention Today's #WarningLetterWednesday reminds us that the FDA considers old social media posts and hashtags marketing claims. Six-year-old social media posts, uncompliant hashtags, and product tags are mentioned in this warning letter. We have spoken about the importance of cleaning old non-compliant social media posts many times. Today's WLW is another reminder. Here is a post and video about this from a few months back. From FDA warning letter On your June 2, (Facebook) 2016 post: “Phenibut is known as a GABA analogue. Outside the US many countries around the world use phenibut clinically for symptoms of PTSD, anxiety, depression and insomnia.” Hashtags on a social media page that link to a product shopping cart are considered marketing claims. It is important to remember the “linking to a shopping cart” portion is the material connection that turns a general statement into a marketing statement. Here is a “Hashtags Are Claims ” video you may enjoy. From FDA warning letter On your February 27, 2017(Instagram) post: “#anxietyrelief” Here is a post and video about identifying and replacing high-risk “buzzwords. ” This is the first step in making online marketing compliant. Interestingly, product tags are mentioned in this letter. Product tags, like metatags, are not likely to attract warning letters on their own. They do, however, signal intended use to the FDA/FTC, showing the authorities. From FDA warning letter “Tags: anxiety, . . natural depression remedy” “Medical studies indicate that L-theanine is neuroprotective and can improve symptoms of depression, anxiety, insomnia, and cognitive impairment. . . . Here is a WLW post from July 2021 where metatags are mentioned . 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!

Take FDA inquiries seriously < Back Records Refusal Leads To Warning Letter Take FDA inquiries seriously Being unresponsive to official FDA requests can lead to serious issues. A drug manufacturing facility in India received a records request from FDA. After several attempts, the company responded that they did not make the products FDA was inquiring about, which did not match the information provided by the customer. FDA continued to follow up with no reply. This led to a warning letter and an import alert. 👉From warning letter. "A contract manufacturing agreement provided by the (b)(4) owner and other records show that you are the manufacturer of (b)(4), which was shipped to the United States. These records include your registration file, your certificate of analysis, and a batch production record." All products from this company were placed on import alert, which means they may not be imported into the US. Learn more about import alerts here . Remote Regulatory Assessments (RRAs) are different and may be considered voluntary. I've heard that participating in voluntary RRA requests helps prioritize FDA inspections, which can lessen the frequency that FDA inspects and reinspects compliant companies. Learn more about RRAs here . This is a shorter Warning Letter Wednesday than normal as I am speaking at the NutraIngredients Weight Management Summit in San Diego and am still processing the passing of AHPA President Michael McGuffin. Michael, you will be missed with a warm, herbal heart. Read the full warning letter here . DATE ORIGINALLY POSTED: 2/19/25 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!

We can learn a lot from NAD cases < Back NAD Case: Sustainability & Clean Ingredient Substantiation We can learn a lot from NAD cases This company was making claims related to sustainability, “clean ingredients,” and efficacy. This is a really interesting case that we can learn a lot from! The National Advertising Division (NAD) is a great place to look for case law regarding substantiation requirements. Here, I review a recent NAD monitoring case against a cosmetic and flavor ingredient company. Clean Ingredients Here is the claim challenged by NAD. “Clean ingredients and clean formulas – we ban over 2000 ingredients that are known to be toxic to you and the environment.” NAD’s finding: “NAD found that it is not clear whether the over 2,000 ingredients … does not use in its products are associated with cosmetic products. Therefore, NAD recommended modifying the claim specifying banned ingredients typically used in cosmetic products.” Asa comments: This shows that if a product does not typically contain an ingredient, stating that the product is free of an unlikely ingredient may be misleading. Do you think this applies to labeling a product “no soy” if it’s very unlikely to contain soy? Sustainability Claims Here is the claim challenged by NAD. “Keeping 2 million sharks every year safe from liver harvesting.” To substantiate this claim, the company provided data regarding an estimated number of sharks killed and an estimate of the global demand for shark liver oil; however, this was insufficient to provide a reliable number. NAD’s finding: “NAD recommended that the claim be discontinued or modified to avoid referring to a numerical figure. NAD noted that nothing in its decision prevents …. from making a more general claim that sharks are not harvested for squalane found in (its) products.” Asa comments: Numerical claims require increased substantiation and should be avoided unless there is firm supporting data. Here is another numerical claim example. Challenged claim and NAD’s findings: “All of our ingredients are also ethically and sustainably sourced,” NAD determined that while … Supplier Code of Conduct might demonstrate its commitment to ensuring that ingredients are ethically and sustainably sourced, it does not demonstrate that all ingredients are, in fact, ethically and sustainably sourced. Asa comments: I wonder if the code of conduct would have substantiated a “some of our ingredients” statement. Efficacy Claim NAD challenged this efficacy claim: “(ingredient) locks in weightless moisture, calms and protects, and improves elasticity.” NAD’s findings: “(The company) relied on three studies that assessed the impact of squalane, in the form and range of the amount found in the … products, on these objectively measurable attributes.” Asa comments: This shows how important it is to have comparable studies. For example, if the studies were conducted using different forms and dosages, they may not have been sufficient for substantiation. This is a slightly shorter WLW than normal as I am celebrating my wife’s birthday Tuesday night, so no staying up late for me. 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!

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!