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

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

In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. < Back Q3 2024 warning letter roundup with Asa Waldstein Asa Waldstein Guest Article In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. At a Glance Minor label violations, such as fact panel line thickness, continue to be cited in warning letters. A NAD case involving a popular children's YouTube channel highlighted the complexities and need for material disclosure. FDA warning letters underscore that elaborating on studies or posting about them on social media can be problematic. Read More Previous Next

< Back Meet-Up Group Tuesday Feb 11, 2020 Founder's Night: Iconic CEO's share their stories Boulder Hemp-CBD Group Meet-Up Boulder Hemp-CBD Group Meet-Up hosted by Asa (In-person) A special Founders Night, a Fireside Chat format with two CEOs sharing their personal journeys, visions of where the market is going, and the host of decisions they need to make--business and regulatory both-as their companies grow. How do their companies deal with ever-changing regulations? How much budget and staff do they allocate for Regulatory compliance? Do venture capitalists take compliance into consideration when investing, both budget and company attitude? I am joined by special guests: Nancy Whiteman , well-known CEO of Wana Brands. Patrick Rea , CEO, and Co-Founder of Canopy Boulder See Pictures Previous Next

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

Re-review online marketing if inspected by FDA < Back TCM Company Cited for Claims & GMP Violations Re-review online marketing if inspected by FDA This Traditional Chinese Medicine (TCM) product company was cited for GMP violations and disease claims. This warning letter contains critical GMP and marketing lessons such as labeling, testing, and marketing essentials. Here, we unpack some critical takeaways as a learning opportunity to help keep you out of trouble. This company was inspected by FDA and received some 483s, which led to their website being reviewed for disease claims months after the inspection. As we've spoken about many times here on Warning Letter Wednesday, it is imperative for companies that are inspected by FDA to ensure their websites are "clear" of risky claims. This is one of the reasons I developed Apex Compliance . To learn more about Apex Compliance, contact me. Here are some key labeling takeaways. The botanical ingredients are not in the standardized common name as noted in AHPA's Herbs of Commerce. They appear to be the TCM names, which is fine, but the common or Latin names are also required. If a label lists information in another language than English, all required information must also be listed in that secondary language. Admittedly, I've never thought about this, but it makes sense from a consumer protection standpoint. The plant parts were missing from a label. Many of the GMP violations cited here have to do with specifications. Specifications are integral to GMPs, and each raw material and finished product must have specifications for identity, purity, strength, and composition. I suggest reading through the warning letter to review FDA's comments. Master Manufacturing Records (MMRs) are the recipe telling the staff how to make a product. Here are several missing items that were cited in this letter. Description of packaging and a representative label. A complete list of components. The weight or measure of each component. Any intentional overage amount. This is to accommodate for shelf life testing and manufacturing variance. A statement of theoretical yield. This is so the company can find problems before the product gets to the next stage of production. For example, if too much of an ingredient was added, the weight should potentially be over the theoretical yield. In the past, my team accidentally added one kilo rather than 0.1 kilo, and calculating the yield caught the error. Specifications are needed for each point, step, or stage in the manufacturing process where control is necessary One person weighs or measures a component, and another person verifies the weight or measure. This is known as the doer/checker system to ensure weighing issues are prevented. This can be difficult to achieve in small companies. And many more items. Unqualified reference standards continue to be called out in warning letters. This company was cited for not using a validated reference standard for FT-IR identity tests. This essentially means if you are testing for something like chamomile powder, you must purchase a qualified sample and test against this standard. Yes, I know GMPs can be burdensome. There has never been a more challenging time than now to be a supplement manufacturer. I feel your pain. From warning letter. "You do not have an adequate identity specification because you are not conducting identity testing against a qualified reference standard." An Out Of Specification (OOS) was cited in this letter. An ingredient or product was OOS for zinc, but the company retested using a different method. FDA took issue with this, which is a learning lesson to ensure retests use the same method. This seems obvious, but in the heat of the pressure to release products, these items can sometimes be inadvertently overlooked. From warning letter. "The investigation testing was performed using a different methodology and by a different laboratory than the laboratory which conducted the original analysis, thus making it difficult to compare the results and to verify accuracy." The website states that products can only be purchased by a practitioner and that no retail sale is available. This is very interesting from a "material connection" point of view. If there is a material connection (e.g., commerce on the website), this is what FDA uses to connect marketing disease claims to commerce. If there is no commerce on the website or linked websites, FDA seems to rarely call out disease claims, which makes this example a rarity. Full disclosure: I have no way to verify if this was a recent change since the warning letter. If anyone knows, please let me know. There are so many GMP learning opportunities 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!

Minor label issues signal deeper compliance issues < Back Labeling Lessons Minor label issues signal deeper compliance issues This warning letter has numerous examples of what not to do when labeling supplements. Here’s what we can learn. 🔹Incorrect statement of identity: The statement of identity is one of core required elements on supplement labels. “Dietary Supplement” is most common but if accurate terms like “Vitamin Supplement” or “Herbal Supplement” are allowed. In this warning letter, FDA cited “Nutritional Supplement” as not being a compliant statement of identity. You can see how “vitamin” is descriptive, whereas “nutritional” is not specific enough. 🔹Serving sizes: This product’s serving size is listed as 1 to 3 teaspoons twice a day, but the supplement fact panel lists the serving size as one teaspoon. A serving is the “maximum amount consumed per eating occasion,” which is three teaspoons in this example. The company could have kept the one-teaspoon serving size on the label by updating it to “one teaspoon up the 3x daily.” I review a lot of labels with my work at Supplement Advisory Group, and this issue is more common than you may think. 🔹Adverse event reporting: A full domestic address or domestic phone number is needed for adverse event reporting requirements. 🔹Supplement fact panel layout: 🔺From warning letter. “The statement “Daily Value Not Established” is not linked to a symbol linking it to the heading “%DV heading,” which is not in accordance with 21 CFR 101.36(b)(2)(iii)(F).” 🔺Servings per container: Did you know that the servings per container may be omitted when stated in the net quantity of contents declaration? 🔹Missing DSHEA disclaimer: From warning letter. “The labels make structure/function claims but fail to bear the required FDA disclaimer, in accordance with 21 CFR 101.93(b)-(e).” Are you interested in learning more about nutrient content claims? Here is my write-up . Here are more labeling citations from previous warning letters. Do you need support with labeling compliance? I love this stuff! Read the full warning letter . DATE ORIGINALLY POSTED: 6/11/25 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!

Specifications continue to be cited < Back GMP Manufacturing Lessons Specifications continue to be cited Manufacturing supplements is not easy. I was a supplement manufacturing & marketing executive for 15 years before starting my regulatory marketing compliance company , and implementing continuous improvement into our Quality Management System required several full-time jobs. Step one in GMP compliance is setting and following specifications, and this Warning Letter Wednesday highlights several GMP lessons, especially the importance of specifications. Heavy metal specifications. Here, FDA cites the company for not establishing heavy metal specifications for botanical ingredients, which are especially at risk of heavy metal contamination. FDA notes that a lack of ingredient specifications may lead to issues in the finished product. I like this example because it demonstrates that stopping potential problems before they get to the production line is best. From warning letter. “The investigator noted that you failed to establish limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch of the dietary supplement.” Interestingly, the company did have finished product heavy metals specifications, but it seems FDA pushed back on their arsenic limits, asking for clarification on why they were set so high. This reminds us that specifications must have a scientific rationale. As a good reference point, the American Herbal Products Association (AHPA ) is an excellent resource for this. From warning letter. We note that the (b)(4) finished product specification for Lead is < (b)(4) ppm and for Arsenic is < (b)(4) ppm. Your batch record for (b)(4) batch (b)(4) reports lead results of (b)(4) ppm. Under 21 CFR 111.70(e), you must establish specifications for limits on those types of contamination that may adulterate, or may lead to adulteration of, the finished batch of dietary supplement to ensure the quality of the dietary supplement. We request that your response address the scientific basis for setting a specification for Lead at < (b)(4) ppm as a level that will not adulterate the dietary supplement. Testing by input. Over the past two years, FDA has increasingly been citing companies for testing finished products by input rather than using qualified analytical methods. The company’s 483 response seems to show that instead of providing a specification sheet example with valid testing methods, they apparently listed “input” as the test method. This part of the warning letter could have been avoided with a proper 483 response. FDA’s response, “measuring input may be a useful process control, but it is not an appropriate test method for determining the strength specification,” should be an essential mantra written on the wall of every QA/QC department. From warning letter. We received and reviewed your December 5, 2023, written response and determined it inadequate. Your finished product specification sheet for your (b)(4) product is lacking adequate strength specifications. The method listed on the finished product specification sheet for determining the strength of (b)(4) and (b)(4) in the finished product is by “input.” While measuring input may be a useful process control, it is not an appropriate test method for determining the strength specification of these ingredients in the finished batch of dietary supplement. Also, the company was cited for selling a product with a disease claim in the product’s title. This name was redacted in the warning letter, so I reached out to the company that received the letter to ask what the product’s name was, but I have not heard back from them. I’m always intrigued when I see product names cited in warning letters, and I’ve previously written about this here . From warning letter. “Product name, (b)(4) : The product name implies the product is intended to cure, mitigate, treat, or prevent migraines.” Labeling issues are also mentioned in this letter. Check out last week’s post for best practices for labeling dietary supplements. Read the full warning letter here . DATE ORIGINALLY POSTED: 7/31/24 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!

Ingredient studies may support product claims < Back NAD Case: Supporting Substantiation Ingredient studies may support product claims Where is the line between needing an ingredient study or a full product study for substantiation? This National Advertising Division (NAD) case explores the nuances of reasonable consumer interpretation of labeling claims. It’s really interesting! Here are my extrapolations. Study population matters: NAD examined the ashwagandha Randomized Controlled Trials (RCTs) and determined that one of the trials was insufficient for substantiation, as the study group consisted of perimenopausal women, and the product is not specifically marketed toward women in this group. From NAD case. “NAD determined that one study did not adequately support the claimed sexual health benefits due to its focus on perimenopausal women and thus could not qualify as competent and reliable support for the challenged claims.” Attributing benefits to ingredients is a “safer” strategy. It’s “common-ish knowledge” in certain regulatory circles that attributing benefits to ingredients rather than to the entire product may lessen the need for a product RCT. This can also help reduce litigation risk. What is odd is that Example #37 in FTC’s Health Products Compliance Guide seems to suggest that ingredient studies may not be enough. This got me thinking about context and the reasonable consumer takeaway. The theme is CONTEXT MATTERS, so reviewing the entire advertisement rather than just a specific claim is essential. From NAD case. “Of the eight express claims, five specifically named ashwagandha as providing the expected benefit. The three remaining challenged claims did not specifically reference ashwagandha, but appear in contexts that make clear that ashwagandha is the source of the claimed benefits. NAD determined that in this context, reasonable consumers would interpret the claims as attributing the product benefits to ashwagandha.” This a big victory for KSM-66 whose ashwagandha extract studies were likely used for substantiation. Read the NAD case here . DATE ORIGINALLY POSTED: 7/9/25 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!

Product reviews are marketing claims < Back Warning Letter Issued for Eye Color Changing Drops Product reviews are marketing claims Do you ever see products and think to yourself, "This can't be safe" or "What regulatory category does that fall into?" After reading this recent warning letter that was issued to a company making ophthalmic (eyedrop) products designed to change people's eye color, I thought to myself, "Is this actually a product that people are putting in their eyes?" Sign up for this weekly newsletter and search three years of previous weekly posts here . According to FDA, making claims such as "Lighten & Brighten Dark Your Eye Color, Speed Up the Eye Color Changing Process" are unapproved drug claims. This is the 13th ophthalmic-related warning letter this year, which shows that if you make a product that goes into the eyes, use extreme caution in product marketing and cleanliness. Also, there's been a group of ophthalmic letters that involve MSM and other ingredients that generally should not be placed in the eyes. I write about this here . Also explore other homeopathic-related ophthalmic warning letters here . Product reviews are cited in this warning letter. This is a reminder that when reviews are curated on a "Reviews" page, FDA looks at them as being showcased, which means they are marketing and fair game for enforcement. There seems to be a fine line between third-party, non-curated reviews on a website and "marketing" reviews curated on a reviews page. I rarely call out companies by name on Warning Letter Wednesday, but looking at how the company formatted their reviews page is an example of what not to do, and avoiding this can help keep you out of trouble. From FDA letter. "On the webpage https://lnkd.in/gemFTh54 . Customer review from 05/17/2024: "I've had brown eyes for years, and they were blue when I was born! Now, after 5 months, I bought it hoping for green eyes, and it works well. It has changed my eyes, and now having green eyes is what I'm most excited about." This company appears to continue to sell the product, which means we can likely expect more decisive FDA action soon. What do you think? Read the full letter here . DATE ORIGINALLY POSTED: 11/13/24 Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Plan for FDA inspections by addressing common violations < Back GMP inspection leads to a warning letter for disease claims and GMP violations Plan for FDA inspections by addressing common violations GMP inspection leads to a warning letter for disease claims and GMP violations. #WarningLetterWednesday In this letter, common GMP violations such as setting specifications and the company’s inadequate 483 responses led to the warning letter. Most 483s can be addressed before they become a warning letter. Here’s a recent “GMP Violations & Unanswered 483s Lead to a Warning Letter” post and video about this. I wrote this very detailed post about GMP pitfalls as a training tool, and I hope you enjoy it. Learn about the differences between 483s and warning letters here . Disease claims from the product label and website are mentioned in this letter. From FDA warning letter. “On your product label: “Take if suffering from glaucoma or ocular hypertension.” This falls under the “treatment” part of diseases. Remember the DSHEA disclaimer “not intended to diagnose, treat, cure, or prevent disease.” From FDA warning letter. “Alereve was developed to better treat patients’ ocular allergies without exacerbating their dry eye component in fact, our initial study demonstrated that some patient’s Dry Eye Syndrome was significantly improved with Alereve treatment” In my opinion, this is added as a “pigpile” or” secondary claim” and would not attract a warning letter unless higher risk claims are present. The best way to avoid a warning letter is to remove claims made web and on social media, including blogs and old social media posts ! Read the 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!

Some of our favorite resources to help educate about Prop 65. Prop 65 Guidance / Proposition 65 Guidance These are common areas of enforcement and lawsuits.Here are some resources to help understand these regulations. AHPA expert Prop 65 webinar AHPA Prop 65 herbal products guidance AHPA Prop 65 cannabis guidance Back