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Use qualified reference samples < Back Noncompliant Testing Methods Lead to Warning Letter Use qualified reference samples This company received 483s for GMP violations relating to testing methods and specifications. They were inspected in late 2021 and early 2022 and sent FDA five 483 responses last year. It seems these responses were not satisfactory, which led to this warning letter. There are numerous learning opportunities here. 🔷One of the violations was not having a strength test on a softgel product. It seems the company once had this, but it was removed 👉“at the request of the customer, as documented in your change control document.” A key learning lesson here is contract manufacturers should be flexible with their customers to a limit. Obviously, completely removing this test from the softgel specifications was a bad idea. Who knows, perhaps they could have found a more suitable strength test to satisfy GMP requirements and the customer. 🔷Unqualified reference standards are cited in this warning letter. The company was testing samples using FTIR, but the reference samples were not verified, which means they were likely from previous batches and not a purchased verified material. I will admit this is how I used to test identity circa 2010-ish. 👉From warning letter. “Identity testing using FTIR to compare the sample spectrum to an unverified reference sample is not an appropriate scientifically valid method” 🔷Identity testing in the finished product was brought up again, and this is a trend to watch. FDA requires the identity of each ingredient to be tested before blending and in the finished product. This is straightforward for some items but is costly and challenging if there are numerous botanical ingredients, as this requires developing expensive testing methods. I am unsure if this is the case in today’s #WarningLetterWednesday, but this is not the last time we will hear about this rigid pharmaceutical interpretation of supplement GMPs. I write about this here . 🔷Proving test method suitability is starting to appear in 483s and now in warning letters. This means that the FDA is asking why specific test methods are used. In the past, relying on a third-party lab for this was sufficient, but now, having suitability documentation on file for each method your lab uses is a good idea. Read the full letter . Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

< Back Presentation Tuesday Nov 15, 2022 Decoding the Regulations Around Cannabinoid Enforcement & Marketing Claims MJBizCon, Las Vegas, NV The FDA has not been shy about sending enforcement letters even with a lack of regulation and guidance. Operators in the hemp-CBD/cannabinoid marketplace can limit their risk, while still being truthful and not misleading. But what exactly is that magical line businesses cannot cross before getting a Dear John from the FDA? This session will identify high-risk marketing strategies and how to adapt accordingly. You will learn: - Recent enforcement trends across the industry - How to identify high-risk verbiage and example of lower-risk verbiage to communicate the same message - What is top of mind and what the FDA is looking for when reviewing claims in testimonials, hashtags influences and Tik Tok. - How to read enforcement actions (i.e. warning letters) and your next steps - Q&A at the end Session Date: Tuesday, November 15th, 2022 See the agenda here . Learn More Previous Next

Blogs on a commercial website are marketing claims < Back CBD Company Cited For Claims Made in Blogs and Socials Blogs on a commercial website are marketing claims This CBD #WarningLetterWednesday is a great teaching case as it cites many of the common mistakes we talk about each week. Here is what we can learn: Blogs on a commercial website are marketing claims. CBD is not allowed in OTC topicals. Hashtags, ingredient benefits, and product tags appear in more warning letters. Most of the cited claims in this warning letter are from blogs and social media. Here's one of several examples. From Warning Letter: "On the Blog post, "How to Use CBD to Combat Holiday Stress":.. "Reduced Anxiety and Depression" Blogs on a commercial website are "fair game" for enforcement and a key lesson from this WL. I write about best practices for blogs here. http://ow.ly/KMo250IYL43 High-risk words never belong on a commercial website, especially the "anxiety and depression" one-two punch. Here's my video about this. http://ow.ly/tuI350IYL48 From Warning Letter: "Although CBD is listed as an inactive ingredient in the labels of your .... "1000 mg Pain Relief Cream" products, the product labeling clearly represents CBD as an active ingredient" This product is labeled with drug facts and lists CBD as an inactive ingredient, but the label boldly lists "1000mg CBD". From Warning Letter: … "Even if CBD could be considered an inactive ingredient in your .... "1000 mg Pain Relief Cream" products, these products would still need an approved drug application to be legally marketed" The FDA's position is that CBD is not a suitable active or inactive ingredient in OTC topical drugs. Please read my article about this. http://ow.ly/N8rq50IYL3X From Warning Letter: "On your January 6, 2021 Instagram…"# CBDforArthritis # Anxiety” Hashtags are an enforcement trend to watch . Here's a video about this. From Warning Letter: “product_tag-dog-cancer-cbd” Product tags are mentioned in this warning letter . I wrote about this last week. From Warning Letter: "Orange Essential Oil [an ingredient in CBD Super Cider] may naturally relieve anxiety, . . . depression and inflammation of the body." Discussing ingredient benefits on a commercial website is a high risk . There's much more to talk about in this letter that I do not have room for. Read 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!

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!

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!

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!

Investigating customer complaints is a cornerstone of supplement safety and compliance < Back Failure to Report Serious Adverse Events Investigating customer complaints is a cornerstone of supplement safety and compliance Investigating customer complaints and reporting serious adverse events (SAERs) is a cornerstone of dietary supplement safety and compliance. In this warning letter, a supplement company that makes products for young children was cited for not properly investigating customer complaints, quality issues related to a product market withdrawal, and reporting SAERs to the FDA. This is a shocking and dangerous lesson in how a supplement company that was not following GMP regulations and properly investigating safety concerns has led to potentially serious health risks for its consumers, including babies. Here is an example of one of the complaints that were not reported within 15 days to FDA. 👉From warning letter. "You received a complaint (#(b)(4)) in which the complainant described their six-week-old infant choked on Gripe Water Original. Per your complaint record, the complainant explained their infant "(b)(4)." Your complaint record further explains the complainant attempted cardiopulmonary resuscitation (CPR) multiple times until the infant began breathing again. The complainant also reported that paramedics were called and looked over their infant." Side note: Babies are considered a "vulnerable population," which means the FDA pays special attention to the safety and compliance of products marketed to them, and for good reason. The violations in this warning letter are noncompliant for people of any age, but are dangerous for babies who don't have fully formed immune systems. Also, I ran Apex Compliance ® on their website and found some crazy disease claims! This warning letter includes some interesting labeling items that likely would not have been mentioned if there had not been other serious violations. 👉From warning letter. "The product's inner bottle labels do not bear nutrition information, as required by 21 CFR 101.36. The unit container is exempted from these requirements if the unit container bears the statement "This Unit Not Labeled for Retail Sale." 🔺Asa Comments: I understand that safe usage instructions, warnings, and allergen disclosure should be on an inner label, but I've never seen this cited in a warning letter. 👉From warning letter. The dosage guide and/or directions for use are placed above the Supplement Facts label, which is not in accordance with 21 CFR 101.2(a) and (e). Nutrition information should appear on the principal display panel (PDP) or directly to the right of the PDP with no intervening material in between. 🔺Asa Comments: Wow, I've also never seen this in a warning letter, and it's a widespread labeling practice. This warning letter reads like a scary book that has all the plots, including disease claims, improper 483 responses, and the FDA giving lots of opportunities for improvement. I suggest everyone read it. DATE ORIGINALLY POSTED: 6/25/25 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!

< Back Panel Discussion Wednesday Sep 21, 2022 Building Brands in Cannabis Naturally Boulder Boulder, CO CBD, THC, and Cannabis are all over the news. Consumers see the products in stores, are starting to see limited advertising, and are hearing anecdotes from their friends. Everyone is talking about it, but people have very little information about it. And, the information they do have varies by the state or community they live in. This creates an interesting business opportunity for entrepreneurs! For current brands looking to incorporate cannabinoid-based benefits of sleep, pain relief or calm there is obvious opportunity, but also, complexity and risk. For new brands launching into the space, there is a steep and unique learning curve in navigating formulation, branding, and distribution that is like no other industry. If you’ve wanted to learn more about this continually emerging, high-growth industry, Naturally Boulder has assembled a panel of experts to discuss the state of the industry, what’s hot and new, and how you can develop and build a powerhouse brand in the space. Learn More Previous Next

< Back Presentation, Online Friday Nov 18, 2022 Naturally Informed: Living Longer, Stronger & Healthier Virtual Conference Registration Naturally Informed powdered by Wholefoods Magazine and Trust Transparency Center Asa Waldstein presents a regulatory and enforcement update on notable action happening in emerging categories such as brain health; bone, muscle, and joint health; libido; immunity; heart health; eye health; and more! On Demand Access Previous Next

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!

< Back Online, Presentation Monday Nov 7, 2022 Labeling and Marketing Hemp-CBD Products: Best Practices & Pitfalls to Avoid Smither's Hemp & CBD Workshop Asa Waldstein reviews best practices, and common mistakes companies make when marketing and labeling hemp-CBD products. Anatomy of a CBD supplement label. A detailed review of how to comply with state and federal regulations. Marketing insights: A review of recent regulatory trends, common marketing oversights, and best practices for compliance. This includes looking at the nuances of social media engagement, reposting, and infographics. Asa will also discuss other enforcement areas, such as influencer marketing and blogs. Learn More Previous Next

< Back Panel Discussion Thursday Jan 25, 2024 Amazon: Opportunities and Threats in 2024 and Beyond Organic & Natural Health Association Cape Coral, FL Asa Waldstein participates in a panel discussion on AI and Amazon with David Trosin ( NSF ), Ryan Sensenbrenner ( Enzymedica ), and moderated by Quality of Life , Dan Lifton . This discussion takes place at the Organic and Natural Health Association's annual conference. Learn More Previous Next