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Asa is interviewed by a well-known influencer on the topic. This is applicable to the dietary supplement industry as well. Read here: https://www.letstalkhemp.com/hemp-influencers/ < Back Influencers and CBD: Be Careful What You Say Cait Curley and Asa Waldstein Interview Asa is interviewed by a well-known influencer on the topic. This is applicable to the dietary supplement industry as well. Read here: https://www.letstalkhemp.com/hemp-influencers/ Read More Previous Next

Batch records should be complete < Back Improper Written Specifications Lead To Warning Letter Batch records should be complete This warning letter is interesting as it details some of FDA's thinking on test methods. Upon my initial reading of this letter, it seemed like FDA had an issue with HPTLC, but the problem was actually how the specification was written. HPTLC is mentioned in this letter. Here FDA states that HPTLC is not a parameter that can be tested to. More information is needed, such as the plant’s genus, species, and the plant part. From warning letter. “HPTLC” is not a qualitative or quantitative parameter to which a test result can be compared to verify the identity of the component.” Thanks to my friends at Alkemist Labs for talking this through with me. Your expertise is very appreciated! This is a shortened version of Warning Letter Wednesday as I’m currently attending Supplyside West. If you are here and want to discuss consulting or Apex Compliance™ Compliance, let me know. There are also other GMP violations in the letter, such as incomplete batch records. This example FDA cites the company for not having cleaning records. When I was a manufacturer, we would attach cleaning records to each batch record. As FDA notes below, this is not needed, but cross-referencing this information is required. 👉 From warning letter. “Your batch production record fails to include the date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch or a cross-reference to records, such as individual equipment logs, where this information is retained.” I recommend reading the full warning letter , as there are other labeling and testing citations that provide good learning opportunities. 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!

Use caution when promoting blood sugar products. Remove claims on social media. < Back “Blood sugar” enforcement risks and review Use caution when promoting blood sugar products. Remove claims on social media. #WarningLetterWednesday; Blood sugar claims enforcement remains top of mind for the FDA. Since January 2021, there have been 36 blood sugar related warning letters. 🔷Blood sugar support is not a high-risk claim, but it becomes very high-risk when correlated with a disease such as diabetes. Not surprisingly, nearly 78% of the warning letters include the words diabetes or diabetic. The remaining eight that only mentioned "blood sugar" also contain high-risk words such as cancer and depression. These claims were made on Amazon, social media, testimonials, videos, and product tags. I expect to see more warning letters calling out claims on these platforms, especially with claims made in videos and testimonials. 🔷Testimonials: Claims made in testimonials were cited nearly 30% of the time, which is a strong enforcement trend to be aware of. Here is a video about why product reviews and testimonials can be considered marketing claims. 🔷Blogs: 22% of the warning letters include claims made in blogs. The line between "educational" and "product blogs" is thin. I talk about this here . 👉Here is a learning tool titled "Protect Your Company: Learn to read warning letters ." 🔷Social Media: Claims made on social media represent nearly 64% of these letters. The FDA is paying close attention to social media posts. I expect the number of social media related warning letters to increase, especially since the FDA is going back several years on company social media posts. They look at several year old posts in the same manner as current ones. Here is a video about reasons to clean up old social media posts. 🔷Hashtags: 25% of these letters include claims made in hashtags. This is a strong enforcement trend to watch. Here is a video about this. 🔷🔷Key Takeaways🔷🔷 👉Blood sugar marketing statements should be used with caution. 👉The word diabetes should be avoided. 👉Remove claims and high-risk words on all marketing platforms . 👉Blogs, hashtags, and social media are under increased scrutiny. What enforcement trends are interesting to you? 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!

Congress said to legalize it, and left it to FDA to figure out details. FDA's position: pound sand. < Back FDA ups the ante in its war against CBD Todd Runestad Interview Congress said to legalize it, and left it to FDA to figure out details. FDA's position: pound sand. Read More Previous Next

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.

In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. < Back Q1 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. Read More Previous Next

Asa Waldstein, Principal, Supplement Advisory Group, discussed the most recent info on FDA and FTC’s thinking regarding immune support in Communicating in-store and online—where are we now? “FDA is going back many years and citing multi-year-old social media posts in warning letters,” he shared. “One cited a social media post from 2014, and they treat those the same way as new posts. Hashtags are also claims. ‘Liking’ a post is a claim. Replying to or reposting a customer comment on social media, that’s a claim. All marketing is considered ‘labeling’.” That includes, he said, product reviews and testimonials; infographics; citing studies; blogs; and more. < Back #NaturallyInformed Event Looks at Immune Health from All Angles Julia Peterman Press Mention Asa Waldstein, Principal, Supplement Advisory Group, discussed the most recent info on FDA and FTC’s thinking regarding immune support in Communicating in-store and online—where are we now? “FDA is going back many years and citing multi-year-old social media posts in warning letters,” he shared. “One cited a social media post from 2014, and they treat those the same way as new posts. Hashtags are also claims. ‘Liking’ a post is a claim. Replying to or reposting a customer comment on social media, that’s a claim. All marketing is considered ‘labeling’.” That includes, he said, product reviews and testimonials; infographics; citing studies; blogs; and more. Read More Previous Next

Asa Waldstein is principal of Supplement Advisory Group, chair of the AHPA Cannabis Committee, and undisputed AHPA superfan – championing the association and contributing to AHPA initiatives every chance he gets. With a background in herbalism, Asa has 20 years of experience developing and implementing compliant marketing and cGMP manufacturing processes, and he is widely respected for his dietary supplement and hemp regulatory expertise and creative outreach. His dedication to supporting the market for safe, high quality dietary supplements and herbal products is outstanding and his commitment to advancing AHPA's efforts is inspiring. Asa Waldstein is the recipient of the 2023 AHPA Herbal Hero Award. “When I started studying clinical herbalism in the late 90s and followed my passion for herbs into the supplement industry, I had no idea how much fun and opportunity it would bring me. This award signifies that anything is possible if you follow your passions, work hard, and find a supportive community like AHPA. I have been an AHPA member for almost half of my life, and I attribute much of my professional success to the connections and education from being an active AHPA member. I thank the AHPA community for this prestigious award. It's genuinely one of the pinnacles of my professional career, and I am so thankful!” -Asa Waldstein < Back Asa Waldstein wins AHPA Herbal Hero Award AHPA Press Mention Asa Waldstein is principal of Supplement Advisory Group, chair of the AHPA Cannabis Committee, and undisputed AHPA superfan – championing the association and contributing to AHPA initiatives every chance he gets. With a background in herbalism, Asa has 20 years of experience developing and implementing compliant marketing and cGMP manufacturing processes, and he is widely respected for his dietary supplement and hemp regulatory expertise and creative outreach. His dedication to supporting the market for safe, high quality dietary supplements and herbal products is outstanding and his commitment to advancing AHPA's efforts is inspiring. Asa Waldstein is the recipient of the 2023 AHPA Herbal Hero Award. “When I started studying clinical herbalism in the late 90s and followed my passion for herbs into the supplement industry, I had no idea how much fun and opportunity it would bring me. This award signifies that anything is possible if you follow your passions, work hard, and find a supportive community like AHPA. I have been an AHPA member for almost half of my life, and I attribute much of my professional success to the connections and education from being an active AHPA member. I thank the AHPA community for this prestigious award. It's genuinely one of the pinnacles of my professional career, and I am so thankful!” -Asa Waldstein Read More Previous Next

This edition talks about labeling essentials and best practices. < Back Compliance Essentials for Hemp-CBD Companies Part 2 of 3 Asa Waldstein Guest Article This edition talks about labeling essentials and best practices. Read More Previous Next

Remove high-risk claims in all marketing materials < Back Product catalogs are considered extensions of the label Remove high-risk claims in all marketing materials #WarningLetterWednesday Claims made in product catalogs are considered marketing. This warning letter includes claims made on product labels, catalogs, newsletters, and brochures. This is a good reminder that anything used to sell a product is considered an extension of the label and, therefore, should be compliant. Here is a video about this . 🔷This timeline is interesting here. The company was inspected in June 2021, before, during, and after a recall for undeclared soy allergens. FDA then reviewed this company's website in February 2022, which is the basis for most of the items in this warning letter. This is a trend, as last week's WLW also talks about an FDA inspection that leads to a website review and a warning letter . 👉This is a good reminder for companies to clean up their websites before/during/after GMP inspections, as a complete website compliance clean-up may have prevented this letter. From the warning letter. ➡️From the product catalog on your website, On page 13: “Enzymes Plus: … This formula uses specialized enzymes that helps the body break down excess protein on scar tissue and fibrin in the blood vessels and internal organs. It also seems to help remove the protective protein coating on tumors, cancers, and parasites, helping the body render viruses and bacteria inert. This blend is combined with Magnesium (a natural blood thinner) and B-6 that the body uses to help lower Blood Pressure and dissolve blood clots.” 👉Read the full warning letter here . 👉👉Join my Warning Letter Wednesday group . 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!

Companies that compensate influencers or affiliates may be responsible for claims they make < Back MLM Company Cited For Claims Made By Their Affiliates Companies that compensate influencers or affiliates may be responsible for claims they make This is the one-year anniversary of #WarningLetterWednesday. I have written this post every week, even when having Covid, on a tropical vacation, or under a massive work deadline. I love writing this post and hope you find as much joy in it as I do. Today’s post is unique. It involves an MLM company that was cited for claims made by company “consultants,” which is very similar to influencers or affiliates that receive compensation for referral sales to a company website. This is the first time I have seen a company cited for claims made by its affiliates, and this is a trend to watch. From warning letter: “Consumers interested in your products are then redirected by your consultants to your websites www.youngliving.com and www.naturesultra.com to purchase your products.” One of the affiliate Instagram pages mentioned in this letter only has 627 followers, a good reminder there is no such thing as being too small to attract FDA scrutiny. Most claims cited in the warning letters are from the “consultants,” with a few exceptions such as this. From warning letter: “On your website, https://naturesultra.com ....Some studies suggest [t]he most common illnesses caused by an improperly functioning ECS are depression, Alzheimer[’]s, IBS, fibromyalgia, and even migraines” The Denver office issued this warning letter, which seems to be more rigid with online claims enforcement than other divisions or the national offices. Key takeaways are companies should remove risky words from company websites and train and monitor affiliates and influencers to ensure no disease claims are present. I look forward to hearing your comments on this very fascinating warning letter! Full warning letter DATE ORIGINALLY POSTED: 7/20/22 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!

Do not over-explain clinical research < Back Best Practices For Using Clinical Study Citations Do not over-explain clinical research Using clinical study citations can be a crucial part of product marketing. If the study citations are from well-powered studies using competent and reliable scientific evidence, they can bolster the brand's scientifically supported position, which is important to many customers. I have heard this also helps boost Google's SEO rankings. There is, however, a fine line between compliantly using clinical study stations and making high-risk disease claims. When can clinical study citations be used? FDA addresses this question in the Small Entity Compliance Guide On Structure-Function Claims . From FDA. "Can I use citations of publications that relate to my product's intended use in labeling if the publication title or the journal name mentions a disease name? Yes, but some limitations apply. If the citation implies treatment or prevention of a disease, it is a disease claim. Thus, if in the context of the labeling as a whole, its presence suggests treatment or prevention of disease (for example, by placement on the immediate product label or packaging, inappropriate prominence, or lack of relationship to the product's express claims), the citation is a disease claim. If the citation is used in labeling, its context determines if it is a disease claim. A citation that is used in the bibliography section of labeling, is included in a balanced discussion of the scientific literature, is not excessively prominent relative to other citations, and provides legitimate support for a structure/function claim made for the product would not be a disease claim." Asa comments. Adding citations at the bottom of a scientific blog is not likely to attract a warning letter, but the keywords do attract attention. For example, words like Alzheimer's will be picked up by web crawlers and invite attention. This means if you are using clinical citations in product marketing, ensure these are not construed as marketing by showcasing them. Also, double-checking the rest of your web and social marketing is crucial, as extra attention will be paid to ALL marketing. Elaborating on the studies does cross the line into marketing, as we see with this recent warning letter . From warning letter. "In another recent study, correlations between CBD and blood pressure were examined. Two groups were evaluated, one being test subjects who were given CBD and the other being a control group with a placebo. All subjects were exposed to stressors that would induce a higher blood pressure. The study concluded that a dose of CBD was helpful to reducing blood pressure." FDA has also cited companies for posting about clinical studies on social media. This includes sharing clinical studies that have ingredient and disease containing meta descriptions such as "X ingredient studied for depression. The moral here is when including citations in your marketing materials, ensure they are appropriately placed—ideally within a bibliography or as part of a balanced discussion of scientific literature. They should not be excessively prominent or showcased. The Small Entity Compliance Guide is also an excellent resource for helping us understand the nuances of dietary supplement marketing such as this. From FDA, "Examples of acceptable structure/function claims are "mild memory loss associated with aging," "noncystic acne," or "mild mood changes, cramps, and edema associated with the menstrual cycle." From FDA, "Examples of disease claims are "Alzheimer's disease or senile dementias in the elderly," "cystic acne," or "severe depression associated with the menstrual cycle." DATE ORIGINALLY POSTED: 9/18/24 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!