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Dangerous products will be cited even if they do not contain disease claims < Back Delta-8 Inhalable Product Dangerous products will be cited even if they do not contain disease claims Shocking warning letter! After writing this post for over 200 weeks, I am rarely surprised. However, this warning letter highlights some truly audacious and potentially extremely unsafe THC and mushroom vape products. FDA cited this company for selling an inhalable delta-8 THC product called “D9 Smashers Peach Mango Delta-8.” However, I found some even more over-the-top products on their website, such as these products. Some of these ingredients I’ve never heard of, and I doubt their inhalant safety has been verified. 👉From website (product contains):“ Mushroom Extract, THC-A Diamonds, THC-P D8 & D10 THC, CBD Live Resin” and “ Loaded with Delta 11, Delta 8 Live Resin, HHC., THC-P., & THC-JD.” There are also candy bars containing high amounts of THC and mushroom extracts in packaging that are considered “favorable to children.” Some of the product labels also contain cartoon characters with titles like “Darth Vapor.” Read about FDA/FTC’s thoughts on this and delta-8 safety. In previous FDA/FTC warning letters, the FTC used Section 5 as a rationale for deceptive marketing allegations when delta-8 was sold in formats favorable to children, like gummies. I find this approach fascinating and clever. 👉“Section 5 of the FTC Act prohibits unfair or deceptive acts or practices in or affecting commerce. This prohibition includes practices that present unwarranted health or safety risks….. preventing practices that present unwarranted health and safety risks, particularly to children, is one of the Commission’s highest priorities.” So, what can we learn other than the obvious takeaways? FDA reviewed this company’s website over a long period in May and December of 2024 and then again in January 2025. I assume if the company had “gotten its act together,” it could have avoided this letter. I am not an expert on FDA processes and resource allocations, but it seems this letter should have been issued long ago. I am curious what resources we can lobby for that will help FDA get these bad products off the market sooner. I ran Apex Compliance ® on their website and found disease claims that, surprisingly, were not mentioned in this warning letter. If you are interested in a copy of the scan, send me a note. Read the full FDA warning letter . DATE ORIGINALLY POSTED: 6/4/25 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!

Disclosing material connection is essential for compliance < Back Celebrity Endorsement Lessons Disclosing material connection is essential for compliance Lessons in endorsement guidelines. Celebrity Kevin Hart came under the scrutiny of the National Advertising Division’s (NAD) monitoring of endorsement disclosure compliance. These are interesting cases with some good learning opportunities. Here’s what went wrong. Kevin Hart is an equity owner of a clothing brand and commonly posts about it. Here, the company incorrectly believed that since Kevin Hart is a partial owner, then perhaps no additional disclosures were needed. While this may be true if the brand was called “Kevin Hart Clothing” or something like that, NAD’s comments show that it is not common knowledge he is an owner. 🔹From NAD case. “Fabletics asserted that a material connection disclosure might not be necessary given Hart’s prominent role and public association with the brand. However, as a significant segment of the audience might not be aware of Hart’s affiliation with Fabletics due to varying levels of engagement with athletic brands, comedians, or celebrity endorsements.” Disclosures need to be clear and conspicuous. For example, the updated posts include the hashtag “FableticsPartner” above the “more” button. As a general rule, disclosures made below the “more” button or buried in hashtags are not sufficient. They may appear different on some phones or devices, so ensuring compliance across different viewing platforms may be somewhat onerous to review, but it is an essential part of compliance. The previous disclosures that include tagging such @fableticsmen and/or “@fabletics” after the “more” button were not enough to disclose material connection clearly. Another NAD and Kevin Hart case, this time with JPMorgan Chase Bank, also includes disclosures. The hashtag “chasepartner” was positioned below the “more” section which as discussed above is unclear disclosure. What is fascinating is that Kevin Hart not only corrected the placement of the hashtag (this is good) but also changed hashtag “chasepartner” to “chase_partner,” which I am unsure was needed. What do you think? The moral of the story is when in doubt, disclose. I made this disclosure video from my daughter’s snowboard rail jam over the weekend as a fun way to educate about disclosures. This includes tips on when verbal disclosures are needed. Fabletics NAD case Chase NAD case DATE ORIGINALLY POSTED: 2/26/25 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!

See what clients and colleagues say about Asa Waldstein & Supplement Advisory Group. Christine Bardsley Manager of Regulatory, R&D and Knowledge Management MegaFood I had the pleasure of attending Asa's presentation on the latest AI tools for dietary supplements at MegaFood's Technical Innovation Day, and it was truly a game-changer. Asa's deep understanding of both the dietary supplement industry and the potential of AI was immediately evident. He highlighted the ways in which AI can revolutionize everything from product development to regulatory compliance, making processes more efficient, accurate, and scalable. One of the key highlights was his demonstration of Apex Compliance, his cutting-edge AI-powered platform designed specifically for the dietary supplement industry. Asa's ability to walk us through how Apex streamlines compliance processes, ensuring that products meet ever-evolving regulatory requirements, was impressive. Asa's presentation was both informative and engaging, breaking down complex AI concepts into actionable insights. I left the session feeling excited about the future of AI in our industry and motivated to leverage these technologies to improve compliance, innovation, and overall business performance. I look forward to exploring more of his work and the impact of AI on our industry. Jim Duquesnel Sonoran University of Health Sciences We at Sonoran University of Health Sciences recently had the pleasure of meeting with Asa Waldstein, who expertly guided us through the intricate regulatory framework required for different types of botanical products, such as topicals, supplements, and OTCs. His expertise in identifying risks and outlining best practices for both clinical studies and commercialization was invaluable. Thanks to his guidance, we have a broader perspective on how to navigate these complexities successfully, setting a solid foundation for compliance and market success. Emma Kindsvatter Director of Content and Experience Momentum Events Thanks to Asa Waldstein, who rocked the house with his talk on regulatory and marketing best practices. He managed to make the complex stuff about marketing compliance super approachable and engaging for everyone in the room, asking questions and engaging the crowd as he presented. It's rare to see someone explain tough topics in such an excellent, clear way that actually resonates with the crowd. Honestly, Asa nailed it, making the session not just informative but also really enjoyable for the 200 attendees. Big thanks for bringing such great vibes and valuable insights to our summit! Dr. Bhodi Tims Director Herbal Product Design and Cannabis Science Programs Maryland University of Integrative Health Asa has been a wonderful resource for our students in the Herbal Product Design Master program. He created a wonderful lecture video for our new "Business of Herbal Products" course. His expertise on avoiding and handling FDA warning letters and inspection was vital. The students were grateful for his information-packed and down-to-earth teaching style. Spencer Lynn, MBA Northeast Regional Manager KOS We recently used Asa to vet all of our product labels, website pages, social media posts, and marketing material. He came back to us with an extremely thorough list of recommendations which we promptly implemented. Asa also gave the entire company an hour long block of instruction on best practices for making claims and marketing our products. All of this proved to be incredibly useful and insightful. We're happy we made the changes Asa recommended and everyone benefited from his learning session and guidance. Not only is Asa extremely knowledgeable, professional, and experienced, but he's also a great person and passionate for making the industry better! Rhiannon Lewis Industry Consultant I suggest following Asa Waldstein when it comes to compliance and claims about the herbal products you sell via your website. You might find it illuminating to do so! Knowing how to market what you sell without falling into the trap of claims is a legal minefield! Jordan Gledhill Quality Assurance WB Blends Asa’s extensive knowledge of supplement regulations is invaluable. He is always happy and willing to share his knowledge and expertise to anyone who asks. Whether we have had questions about labeling regulations, ingredient concerns, or risk assessment, Asa’s advice is always sound, well reasoned, and extremely helpful. Additionally, his educational series and updates are exceptionally useful for keeping tabs on industry and FDA trends. We look forward to continuing to work with Asa! Laura Williams CEO Insync Media We hire Asa Waldstein as needed to review our web copy for compliance risks. He understands the nuances of marketing risk on platforms such as social media, blogs, and product pages. His risk level-based approach helps us determine what is high risk and what may be acceptable. We highly recommend his services! Sarah Burden (Former) VP of Education and Communication LifeSeasons Asa conducted a personalized company regulatory training for LifeSeasons. Having seen Asa’s online presence, I felt sure that our team would receive thorough and expert training. Even coming in with high expectations, I was still amazed by how much we all learned, how engaged everyone was, and how quickly the time flew by as the team had lightbulb after lightbulb go off in their heads! It takes a special skill to connect with a group with such varying levels of understanding—from new hires who heard the word DSHEA for the first time today, to industry veterans with 35+ years of supplement experience, and all of the team found value in the workshop today. Highly, highly recommended! Ellen Kamhi PhD, RN, AHG-RH, AHN-BC Natural Regulatory Nurse Natural Alternatives Health Education & Multimedia Services I would like to support Asa Waldstein in his service to the Natural Products industry, with an emphasis on his work in the regulatory arena. He offers a high level of understanding and offers free classes and blogs, to raise the knowledge about compliance in the supplements and hemp industry. He also has the ability to bring a complicated discussion into an easy to understand step by step game plan that a company can use to bring their offerings into compliance. Important if you want to stay in the game! Lou Tutino Nutraceutical / Cosmeceutical Industry Recruiter The Mattran Group One of the biggest challenges nutraceutical brands face these days is ensuring that the labeling and narrative used for its marketing are fully compliant with the latest regulations. Good news, help is out there! Asa's company, Supplement Advisory Group, specializes in helping companies navigate the ever-changing world of FDA regulations while remaining true to their marketing vision. Jesse Miller Director of Innovation Neogen Corporation Working with Asa as the AHPA cannabis committee chair has been great. Every meeting is well run by him and Jane Wilson and we have a diverse team that is able to address the issues facing the industry. Asa is always positive, respectful, a good listener and a great contributor. That is evidenced by his organization of the Colorado Hemp meetups he has organized. I'm excited to keep working together to make this industry a great one. Sarah Sykes Founder Sarah Rose Botanicals Asa set's a wonderful example in the compliance community and his initiative and leadership are highly impactful. I love that Asa makes regulatory information more accessible and that he empowers others with his expertise. Nate Call President & CEO Timor Solutions Asa's knowledge of the supplement industry is second to none. He creates excellent educational resources for industry professionals that you know you can trust. Whenever I have a regulatory or industry question, I look to Asa and his content and almost always find the answers I'm looking for. I highly recommend Asa for any role in the supplement industry. Gillian Neimark Content Writer Supplement Industry Asa Waldstein is a walking encyclopedia of nuanced knowledge and insight into FDA dietary supplement laws, and FDA compliant marketing and regulatory expertise. His interests span medicine, pharmacology, herbalism, nutrition and more. He loves what he does and is an inspiring and fun person to work with and learn from. Lisa Mahoney Director B2B Sales at Anthology Brands / Pure Hemp Botanicals I have worked closely with Asa and am always impressed by his vast experience in this field. Whether you need advice on supplements with cannabinoids, or any other kind of supplements and ingredients, he will help you navigate FDA and state requirements fast. Save yourself the brain damage of trying to figure the rules out yourself and use Asa as a consultant. You'll end up saving money as well as your valuable time. Karen Steuer Owner Tangled Roots Herbal & Hemlock Springs Soaps I never imagined marketing regulation or compliance would be interesting much less riveting - I was blown away by the content in the GMP & Marketing Claims Demystified 3-hour class. I am in the beginning stages of expanding my business and this info was exactly what I was looking for - practical, engaging, humorous and 100% on point. I appreciate Asa (and Steven) for sharing their experiences and demystifying FDA regulations on both sides of the regulatory coin (GMP and Marketing Compliance). Tim Gordon Global Industry Strategist and Visionary Asa has the knowledge and experience in the dietary supplements and CBD industry that makes him a sought after speaker, regulator, and advisor. His longtime operational skills shine at any position he enters. Asa is a kind professional has the professional background to support the hemp and CBD industry. Lynn Wells Enrichment Program Director University of Denver Asa came well-prepared to speak to students at the University of Denver’s Enrichment Program and is a true professional. He is adept at staying focused on the audience while juggling the technical aspects of delivering an online lecture, and he brought his enthusiasm and “A” game to the two-hour presentation. Asa delivered an informative lecture to our older students and dispelled the mysteries and myths around hemp. Even typically shy students felt comfortable, and actively engaged in discussion. Clair (Whiteman) Dainard MS, CN Vice President Deseret Biologicals, Inc I worked with Asa for nearly six years. He is extensively knowledgeable in all elements of the supplement industry and is committed to staying up to speed with the latest research and changes within the regulatory environment. He passes this expertise onto his clients and I can feel confident that any project we collaborate on is innovative and will meet industry safety standards. He has continued to support my business with an exceptional level of customer service. Yalda Shokooh Director of Science and Nutrition Now Foods Asa Waldstein recently conducted a two-day comprehensive training on dietary supplement labeling regulations for a group at our company. Asa was very informative, presenting a detailed review of the essential information necessary for dietary supplement label compliance. He kept the group engaged and interested by using examples and getting the group involved in exercises to help us assess our comprehension and skills. The presentation stimulated a great deal of productive discussion not only around the regulations but also about risk assessment with respect to labeling and marketing materials. Asa’s commitment to answering follow-up questions and providing continued guidance was especially valuable for ensuring we stayed on track. The training concluded with clear, actionable steps for the team to ensure ongoing compliance and avoid common pitfalls. Asa customized the content to our company’s specific needs, which made the training even more relevant and actionable. It was a pleasure to work with Asa, who is a consummate professional, as well as an expert on all things related to the regulations of dietary supplement labeling. We will definitely be calling on him in the future when we are in need of consultation. Charlie Frohman Senior Director, Scientific & Regulatory Affairs, Innovation & Claims The Coca-Cola Company The Coca-Cola North America Scientific & Regulatory Affairs Team recently had the pleasure of hosting a training session with Asa Waldstein, who generously provided us with insights into the latest enforcement trends in dietary supplement marketing. Asa skillfully answered our tough questions and clarified the intricacies of real-world marketing risks. We greatly appreciate the expertise shared and are excited to continue consulting Asa as a go-to expert on complex marketing and enforcement challenges. Dr. Mika Gupta CEO & Founder Best Nest Wellness I highly recommend Asa Waldstein and his product, Apex Compliance, to anyone seeking expert guidance in the fields of compliance and marketing. Working with Asa has been an invaluable asset for our business, particularly in navigating the complex areas of labeling, advertising, and messaging. His service, Apex Compliance, stands out for its exceptional blend of comprehensive compliance and risk management expertise coupled with a deep understanding of marketing strategies. Asa’s proficiency ensures that our marketing efforts are not only effective but also fully compliant with industry standards. This unique combination of skills has been instrumental in enhancing our brand's integrity and success. John George C Suite Executive Physician's Choice In light of the FTC 2023 Health Products Compliance update, we asked Asa Waldstein, principal and founder of the Supplements Advisory Group, to design a regulatory compliance training program to ensure we stayed current. Asa brings 20+ years of experience in this space, and his ability to translate between Regulatory and Marketing provided us with a clear roadmap to ensure we continue to operate in lock-step with the updated FTC compliance guidelines. Thank you, Asa, and we would highly recommend Asa to all companies in the supplement category. David Ghiyam Co-Founder & President MaryRuth Organics Asa is an expert in marketing compliance and has been critical in helping us understand risk. He brings a practical approach to marketing risk analysis and often has lower-risk suggestions to help us truthfully and effectively communicate with our customers. He was integral in supporting our regulatory department training and compliance turnaround. Asa helped our compliance department move in the right direction, which can be challenging at a rapidly growing company like ours. I look forward to continuing to work with Asa. Max Pelli Consultant and Technical Writer Asa Waldstein shares the most insightful information on regulatory and compliance topics. I love his videos, and I tell everyone to follow his content! Lana Dvorkin Camiel, PharmD Professor Massachusetts College of Pharmacy and Health Sciences Asa Waldstein shared his knowledge of Cannabis marketing trends and regulatory compliance with pharmacy students in an elective course I co-coordinate. I enjoyed his enthusiasm and passion for the subject and was especially impressed by his preparation and attention to detail. I am looking forward to inviting Asa back next year. Ashton Collard Vice President Choq, LLC We met Asa during a compliance seminar at Supply Side, where he first impressed us with his knowledge and engagement in the course. Since then, we have relied on Asa's expertise to take our label compliance to the next level. We value his ability to analyze risk and provide lower-risk alternatives that help us avoid trouble, and help our customers understand our products' benefits. Additionally, Asa has been extremely personable and easy to work with. I would strongly recommend retaining his services! Seth Ninger Chief Operating Officer Portfolio Beverages, Inc. Asa Waldstein is considered by people in the know to be one of the leading Regulatory and Governmental Affairs experts in the country with regard to the supplement and cannabis spaces. It's always a surprise to each of us when we find out truths that contradict commonly held beliefs. Asa's videos have every bit of that shock value but additionally have the ability to save time, heartache, investment dollars, and potentially entire businesses as well. If you operate a health and wellness business, a vitamin business, or a cannabis industry business, do yourself a favor. Watch the educational videos and content Asa makes for us to protect your company. Neil Butterfield CEO Mineralife Asa's knowledge of the supplement industry is second to none. I have worked with Asa for years and continue to benefit from his skill set and knowledge of the industry and in particular, regulatory compliance matters. I currently have Asa on speed dial and I am glad to have him as a resource and friend in this industry! Lex Pelger Scientist @ CV Sciences & Host of 'The Lex Files' podcast I can attest that Asa is one of the top experts in the field. Plus, he's genial & well-spoken. I'd recommend him for any company looking to enhance their regulatory compliance, whether it be their bottles, their site, or their staff. Alex Seleznov (Former) President Advanced Extraction LLC Asa has an energizing personality. He loves to discuss regulatory matters and is passionate about keeping product producers and their investors safe from legal exposure. Knowledgeable and socially aware with a kind non-reactive approach, he seeks to provide transformative value to any organization. Environmentally conscious and an expert herbalist, I enjoy talking and interacting with Asa in addition to working with him! Eileen McBain Owner Whole Body Health Solutions Building a hemp or supplement distribution company in the US? Looking for someone to help ensure the marketing you do is legally rock solid and doesn’t mislead potential and current customers/clients and bring regulatory boards down on you? Or maybe you are a consumer (in or outside the US) and want to know what to look for in order to protect yourself from getting bamboozled by illegitimate supplement health claims. Asa Waldstein is absolutely your man. His experience covers decades and he is passionate about compliance and getting it right. Mike Hennesy VP of Innovation Wana Brands Asa is not only a terrific individual to work with, but also an excellent human! He saw the development of a partnership between two major brands in the cannabis space through many challenges, problem solving, connecting the right individuals, and having a great understanding of the space. I would look forward to working with Asa on any future projects and would recommend him to others. Vardan Ter-Antonyan Chief Science Officer Green Compass Global, Ltd Asa is one of the best experts and specialists of Regulatory Affairs in the dietary supplement and hemp space. If you are in need of any regulatory services when it comes to your labels, your operation, or anything else, contact Asa and he’ll make sure you are well equipped to face any regulatory inspection including the notorious FDA. Dr. Constance DiNatale DVM Owner Veterinary Acupuncture & Complementary Therapy Clinic I just want to say that you (and Steven) took a rather dry subject and made it very interesting and clear. It held my interest and was very well done. Thank you for an informative thought-provoking lecture! (3-hour GMP & Marketing Claims Workshop attendee) Patrick McCarthy CEO ValidCare Asa and I met on an industry panel to discuss regulatory compliance issues. Never seen someone so excited and professional about regulatory compliance! Asa is highly professional senior executive, a bridge builder and a problem solver. And within the regulatory world, he is able to take complex issues, simply them and provide easy and fun ways to integrate "best practices" into a business. Hannah Lasorsa Owner Herbal Content Cottage Asa is such a wealth of information! Compliance language can be complicated and a bit overwhelming if you’re new to it, but he makes it fun and straightforward. After a few mentoring sessions with Asa, I now feel much more confident creating marketing materials that are both inspirational AND compliant! Asa is generous with his knowledge, and it’s clear that he’s truly passionate about this topic. I would definitely recommend a mentoring call with Asa to any marketers or social media managers in the health and wellness industry! Feather Jones Registered Herbalist, AHG Botanical Field Guide and Instructor Asa Waldstein is a graduate of the Rocky Mountain Center for Botanical Studies. He was always self motivated to journey deeper into botanical medicine and has studied with various professional herbalists around the country. His level of knowledge and expertise is widely known in the herbal products and natural supplements field. With an attention to detail and an ability to bridge complicated and scientific information, he speaks with clarity and a down to earth style. He would be an asset to any organization or company.

< Back Virtual Fireside Chat Friday Jan 19, 2024 Radicle Perspectives: Elevating the supplement industry Radicle Science There was no shortage of dietary supplement regulation and compliance talk in 2023. From FTC guidance and FDA’s response to NAC and NMN, to the Dietary Supplements Access Act, continued market disruption due to supply chains and inflation, not to mention authenticity issues continuing to plague major online retailers, what can we anticipate in 2024? Tune in to another insightful episode of Radicle Perspectives as we welcome our esteemed guest, Asa Waldstein, as we prognosticate about what 2024 has in store for dietary supplement regulations and compliance. Key Topics: Recap major industry news from 2023. Anticipate how these headlines from 2023 will impact regulations and compliance in 2024. Learn about other dietary supplement regulations and compliance issues beginning to percolate already. Register Previous Next

Regulatory consultant Asa Waldstein previews a SupplySide West education session on substantiating claims and clinical trials. Waldstein is moderating the Oct. 28 session that features two attorneys and two experts from contract research organizations. < Back Join me for SupplySide West workshop on nutritional ingredient claims, legal flames Asa Waldstein Guest Article Regulatory consultant Asa Waldstein previews a SupplySide West education session on substantiating claims and clinical trials. Waldstein is moderating the Oct. 28 session that features two attorneys and two experts from contract research organizations. Read More Previous Next

Everything used to market products must be compliant < Back Product Tags & Metatags Attract FDA Attention Everything used to market products must be compliant Website product tags and metatags continue to attract FDA attention in warning letters. #WarningLetterWednesday This year three warning letters mention product tags or “category” tags. These tags help people find products when they search for things on Google or a website, and they are considered marketing in the eyes of the FDA and FTC. Although these tags are an “extension of the label,” they are not likely to attract a warning letter on their own. However, they signal intended use, which can lead authorities to a commercial website to keep digging for claims once there. Here are some examples involving product tags and metatags with disease claims. It's worth noting that additional high-risk website and social media claims are also present in each warning letter. This is an important reminder that compliance is not done in a vacuum, and all online content must be free of high-risk claims to avoid warning letters. From Warning Letter: “From the product webpage at …. Tags: anxiety, . . . memory, mental performance, natural depression remedy” Read this warning letter From Warning Letter: “Tags: anti-viral, COVID, COVID-19, Cure ” Read this warning letter From Warning Letter: “The above noted website claims are supplemented by metatags used to bring consumers to your website ….. through Internet searches. The metatags are: • “Take Altitude RX for altitude sickness prevention…” Read this warning letter here: Here is my “All Marketing is Labeling ” video. 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!

Warning letters show claims made in socials, blogs, testimonials & hashtags < Back A Review of 56 Diabetes Related Warning Letters Warning letters show claims made in socials, blogs, testimonials & hashtags I reviewed all diabetes and blood sugar related FDA warning letters since the beginning of last year and found some interesting results. These findings provide a snapshot of where the FDA is finding and perhaps looking for risky words. We can learn a lot from this, and it's an excellent reminder for companies to re-review these areas to ensure no risky statements are lurking on their website or social platforms. There have been 56 blood sugar and diabetes-related FDA warning letters since the beginning of 2021. This is a lot, demonstrating the FDA's continuing attention to this high-risk diabetes and blood sugar category. 62% of these warning letters include claims made on social media. This should come as no surprise but is an important reminder to scan for high-risk words on socials, including old posts. Here is a post and video about this. 26% of these letters include claims made in blogs. This is a strong enforcement trend to watch as the FDA looks at old blogs in the same manner as current blogs. I have found this to be a common oversight, as companies have learned about compliance over the years and their new blogs are compliant, while their forgotten older blogs are riddled with disease claims. Scanning these forgotten blogs is a great way to reduce risk, and this is a service we at Supplement Advisory Group are often hired to conduct. Here is a post about best practices for reducing risk in blogs. 23% of these warning letters include claims made in testimonials. The FDA and FTC are generally "hands off" with non-curated, honest, 3rd party generated product reviews. These cross the line into marketing claims when a company engages with them or showcases them in any way, such as copying an Amazon review onto social media or showing them on a product page. Here is a post that shows how engaging with product reviews led to a company warning letter. 25% of these letters include hashtags. Hashtags are easily searchable and can turn compliant posts into disease claims with an uncompliant hashtag. Here is a video about this. 👉Here is a learning tool titled "Protect Your Company: Learn to read warning letters." I hope you enjoyed reading the synopsis, and I welcome your thoughts! Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Key GMP learning opportunities explored < Back Incomplete 483 Responses Lead to Warning Letter Key GMP learning opportunities explored We can learn a lot from warning letters. This manufacturer was inspected in April 2022, where they received some 483s. The company subsequently responded to some 483s, but according to the warning letter, “Not all of the items on the issued Form 483 were addressed in your response.” In my experience, most 483s can be addressed before they become warning letters. I talk about improper 483 responses here. Here is an example from the warning letter. From warning letter. “We have reviewed your June 23, 2022 response to the form FDA 483. We are unable to evaluate the adequacy of your response because you did not provide documentation demonstrating you have established specifications… You provide documents you describe as revised finished product specifications for the … product. We note that these documents do not demonstrate that you have established specifications that provide standards to confirm the identity, purity, strength, and composition of the finished batch of your dietary supplements. For example, the finished product specification for … product lists an “identification” specification of “Conforms to Standard” with a test method of “Eurofins or eq.” and a frequency of “Rotational.” “Conforms to standard” does not specify the extent to which the component must conform. “Eurofins or eq.” is not a test method, and “Rotational” does not describe the frequency of when testing is to occur. Let’s break this down. 🔹Identification: The company lists the type of identification as “conforms to standard” but does not provide information on what that standard is. The company is close but, unfortunately, falls short of GMP requirements. Here is howI think about GMP documents, such as this specification sheet. Will someone unfamiliar with your process be able to step in and understand how to test the product if there is no “institutional knowledge?” It is the "recipe" for staff to follow. 🔹Test method: The company lists “Eurofins or eq” which is the name of the laboratory, not the name of the method, such as “AOAC 121804.” 🔹Frequency of testing is listed as “Rotational,” which is not sufficient. It should state “Test all” or refer to an SOP on skip lot testing. Incorrect reference samples are also cited. 👉From warning letter. "You failed to establish and follow laboratory control processes that are reviewed and approved by quality control personnel to use criteria for selecting standard reference materials used in performing tests and examinations… Specifically, the FTIR analysis performed by your third-party laboratory uses previous shipments of components as the reference for testing and they do not own a reference library for the FTIR tests. Testing components against previous shipments of the component may confirm receipt of the same component but this does not ensure the identity, purity, quality, and strength of the component is thoroughly characterized.” I admit this is how I tested identity around 2010 until I realized that having a qualified reference sample was essential. In this example, the third-party lab should have handled this rather than just depending on previously provided reference samples, and the quality personnel should not have allowed this. One more learning opportunity. 🔹Theoretical yield calculation helps “error-proof” manufacturing. Let’s use the example of a capsule product. First, the powder needs to be blended. If the theoretical yield is off, this will signify too much or too little of an ingredient was added and, therefore, should not “pass” to the encapsulation process. 🔹The same Is true for encapsulation. If a company has substantially more capsules than the theoretical yield, this signifies the capsules are underweight and not at label claim. The production should be stopped for evaluation here. 🔹If the yield is too high in bottling, this shows there are likely not enough capsules in each bottle. This lily-pad approach to quality is designed to stop problems before they happen. From warning letter: "A statement of the theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process and the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary." Interested in learning more about GMPs? Here are a few webinars you may enjoy. 🔹Distributor requirements for supplements . 🔹Getting ready for FDA inspections . There are so many learning lessons. Read the full letter here. Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Replace “insomnia” with lower-risk alternatives < Back Insomnia claims continue to attract FDA attention Replace “insomnia” with lower-risk alternatives #WarningLetterWednesday highlights insomnia claims that continue to attract FDA's attention. There were 22 FDA warning letters in 2021 with insomnia claims, dramatically up from 14 in 2020, 2019 (13), and 2018 (7). This is a clear indication of an FDA enforcement trend and a good reminder for marketers to remove the high-risk buzzword "insomnia" from their marketing. As many of you know I have an "Asa Risk Scale" where certain claims are rated on a 1-5 risk scale, with anything 3+ likely to attract a warning letter. Insomnia is rated as a solid 3.5+, which means it should never be used. If truthful and not misleading here are some possible alternatives for insomnia. *feeling refreshed in the morning *a restful night's sleep *healthy slumber support *sleep support *supports a healthy night's sleep *support rest 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!

The FDA/FTC look at old posts the same as current ones < Back Clean up old social media posts The FDA/FTC look at old posts the same as current ones #WarningLetterWednesday highlights very old social media posts called out in this warning letter. It is common for the FDA to look back a couple of years on social media posts, but this warning letter mentions a 2014 re-tweet and several three-year-old Facebook posts. This is an excellent reminder to clean up old social media posts, as the FDA/FTC looks at old posts similarly to current ones. I even made a video about this. Re-tweeting and re-posting can be seen as marketing claims, especially if a company adds commentary to the original post. This is the first time I have seen a re-tweet without company commentary called out in a warning letter. This is surprising and shows the viewpoint of the FDA's West Division 5 office, which has rarely issued marketing-only warning letters. It is interesting to see what online marketing claims each FDA division focuses on, and I will dig deeper into this fascinating aspect of enforcement at a later date. There are several high-risk disease words mentioned in this warning letter, such as Parkinson's, antidepressant, anti-tumor, and hashtag diabetes, which likely was why this company received a letter. Here's a video I made about removing and replacing high-risk "buzzwords" being the most crucial first step to becoming compliant. Claims made on Amazon are also referenced in the warning letter. It is no longer considered the "unholy grail" of disease claims, and I expect to see more Amazon warning letters in the future. Read the warning letter here . I've been writing about these enforcement trends for a while now. You may enjoy reading my regulatory blogs here . It can be challenging to find content on LinkedIn, so I started this Warning Letter Wednesday Group . Please check it out. DATE ORIGINALLY POSTED: 1/19/22 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!

Some of my favorite regulatory resources. If there are other resources I should list here please let me know. Helpful Resources Here are some of my favorite regulatory resources. If there are other resources I should list here please let me know. Marketing Guidance This section covers helpful marketing resources, View Resources Prop 65 Guidance Prop 65 can be confusing. Here are some of my favorite resources. View Resources cGMP Guidance This section covers helpful GMP resources, View Resources Made in the USA and All Natural These are common plaintiff lawsuit targets. View Resources Labeling Guidance This section covers helpful labeling resources, View Resources NDI and GRAS Guidance This section covers helpful NDI and GRAS resources, View Resources Influencer Marketing & Product Reviews This section covers helpful influencer marketing resources. View Resources Home About Warning Letter Wednesday Work With Me Testimonials Appearances Press Regulatory Blog Resources More

< Back Meet-Up Group Wednesday Jan 15, 2020 FDA and Class Action Enforcement Trends & Updates: Fireside Chat Asa's Regulatory Education Series Boulder Hemp-CBD Group Meet-Up hosted by Asa (In-person) In any rapidly emerging industry building a community to help support each other in education, compliance, and in developing best practices is always a good idea. This is a fireside chat format to discuss FDA and class action enforcement and trends. We expect an update from the FDA soon and we can likely guess there will be more lawsuits and perhaps more warning letters as well. I am joined by special guests: Garrett Graff , Managing Attorney of Hoban Law Group Dave Rodman , Founder of the Rodman Law Group Read more Previous Next