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  • Workshops and Webinars | Asa Waldstein

    Workshops and Webinars / Workshops and Webinar Resources These are common areas of enforcement and lawsuits.Here are some resources to help understand these regulations. 06-10-22-webinar June 10th GMP & Marketing Claims Demystified Workshop: Resources Steven Yeager LinkedIn Asa Waldstein LinkedIn FDA Supplements Q&A 21 CFR 111 Subparts & descriptions 21 CFR 111 Reference guide Adverse Event Reporting guidance FDA Alerts (allergens, recalls, warning letters Common allergen labeling guidance AHPA Herbs of Commerce Labeling and Allergens Guidance Webinar: CGMP Basics for Hemp-CBD Companies: This is applicable to herbal supplement manufacturers. Regulatory hints YouTube channel AHPA Prop 65 Guidance Preparing for FDA GMP Facility Inspections Webinar Asa’s Regulatory Education Series Why avoid warning letter video Video about the risks of "THC Free" or "THC Free" labeling: Made in the USA Claims Demystified video All Natural: What can you say and what is the risk video Prop 65 webinar AHPA Prop 65 Resources 06-03-22-webinar June 3rd Webinar Resources Harris Bricken Canna Law Blog cGMP Basics for Hemp-CBD Companies Free Webinar AHPA Hemp CBD Supplement Congress videos! Regulatory: Blog, Events, Resources AHPA Labeling Guidance Document Getting Ready for FDA Inspections Webinar AHPA Prop 65 Guidance Regulatory Hints YouTube Channel and Prop 65 Webinar AHPA SOP Templates (members only) Asa’s Regulatory Education Series video channel AHPA’s Guidance Documents HerbalGram Cannabis Resources Asa’s Regulatory Consulting Company 05-04-22-webinar May 4th Webinar Resources Burdock: Food Safety & Regulatory Compliance Consultants for FDA AHPA Hemp CBD Supplement Congress videos! Why join AHPA's Cannabis Committee? Regulatory: Blog, Events, Resources AHPA Labeling Guidance Document AHPA NDI Workshop cGMP Basics for Hemp-CBD Companies Free Webinar AHPA Prop 65 Guidance Regulatory Hints YouTube Channel and Prop 65 Webinar AHPA’s Cannabis Committee AHPA’s Hemp Lexicon AHPA’s NDI Database AHPA’s Botanical Congress: May 24th Asa’s Regulatory Consulting Company Burdock Associates Webinar: GRAS & NDI Certification: Ask the expert Asa’s Next Event: Distributor Pitfalls to Avoid: Hemp and Supplement Products: Back

  • Labeling Compliance Resources

    Some of our favorite resources to help educate about labeling compliance. Labeling Compliance / Labeling Compliance These are common areas of enforcement and lawsuits.Here are some resources to help understand these regulations. FDA label claim guidance Compliance essentials for CBD companies: Labeling Back

  • Privacy Policy | Asa Waldstein

    AsaWaldstein.com Online Privacy Policy Agreement November 24, 2020 Regulatory Education Events LLC dba Supplement Advisory Group LLC (AsaWaldstein.com) values its users' privacy. This Privacy Policy ("Policy") will help you understand how we collect and use personal information from those who visit our website or make use of our online facilities and services, and what we will and will not do with the information we collect. Our Policy has been designed and created to ensure those affiliated with Regulatory Education Events LLC of our commitment and realization of our obligation not only to meet, but to exceed, most existing privacy standards. We reserve the right to make changes to this Policy at any given time. If you want to make sure that you are up to date with the latest changes, we advise you to frequently visit this page. If at any point in time Regulatory Education Events LLC decides to make use of any personally identifiable information on file, in a manner vastly different from that which was stated when this information was initially collected, the user or users shall be promptly notified by email. Users at that time shall have the option as to whether to permit the use of their information in this separate manner. This Policy applies to Regulatory Education Events LLC and any subsidiary company listed below, and it governs any and all data collection and usage by us. Through the use of www.AsaWaldstein.com and any subsidiary website listed below, you are therefore consenting to the data collection procedures expressed in this Policy. Subsidiary Company: Supplement Advisory Group Subsidiary Website: AsaWaldstein.com Please note that this Policy does not govern the collection and use of information by companies that Regulatory Education Events LLC does not control, nor by individuals not employed or managed by us. If you visit a website that we mention or link to, be sure to review its privacy policy before providing the site with information. It is highly recommended and suggested that you review the privacy policies and statements of any website you choose to use or frequent to better understand the way in which websites garner, make use of and share the information collected. Specifically, this Policy will inform you of the following What personally identifiable information is collected from you through our website; Why we collect personally identifiable information and the legal basis for such collection; How we use the collected information and with whom it may be shared; What choices are available to you regarding the use of your data; and The security procedures in place to protect the misuse of your information. Information We Collect It is always up to you whether to disclose personally identifiable information to us, although if you elect not to do so, we reserve the right not to register you as a user or provide you with any products or services. This website collects various types of information, such as: Voluntarily provided information which may include your name, address, email address, billing and/or credit card information etc. which may be used when you purchase products and/or services and to deliver the services you have requested. Information automatically collected when visiting our website, which may include cookies, third party tracking technologies and server logs. In addition, Regulatory Education Events LLC may have the occasion to collect non-personal anonymous demographic information, such as age, gender, household income, political affiliation, race and religion, as well as the type of browser you are using, IP address, or type of operating system, which will assist us in providing and maintaining superior quality service. Regulatory Education Events LLC may also deem it necessary, from time to time, to follow websites that our users may frequent to gleam what types of services and products may be the most popular to customers or the general public. Please rest assured that this site will only collect personal information that you knowingly and willingly provide to us by way of surveys, completed membership forms, and emails. It is the intent of this site to use personal information only for the purpose for which it was requested, and any additional uses specifically provided for on this Policy. Why We Collect Information and For How Long We are collecting your data for several reasons: To better understand your needs and provide you with the services you have requested; To fulfill our legitimate interest in improving our services and products; To send you promotional emails containing information we think you may like when we have your consent to do so; To contact you to fill out surveys or participate in other types of market research, when we have your consent to do so; To customize our website according to your online behavior and personal preferences. The data we collect from you will be stored for no longer than necessary. The length of time we retain said information will be determined based upon the following criteria: the length of time your personal information remains relevant; the length of time it is reasonable to keep records to demonstrate that we have fulfilled our duties and obligations; any limitation periods within which claims might be made; any retention periods prescribed by law or recommended by regulators, professional bodies or associations; the type of contract we have with you, the existence of your consent, and our legitimate interest in keeping such information as stated in this Policy. Use of Information Collected Regulatory Education Events LLC does not now, nor will it in the future, sell, rent or lease any of its customer lists and/or names to any third parties. Regulatory Education Events LLC may collect and may make use of personal information to assist in the operation of our website and to ensure delivery of the services you need and request. At times, we may find it necessary to use personally identifiable information as a means to keep you informed of other possible products and/or services that may be available to you from www.AsaWaldstein.com and its subsidiaries. Regulatory Education Events LLC and its subsidiaries may also be in contact with you with regards to completing surveys and/or research questionnaires related to your opinion of current or potential future services that may be offered. Regulatory Education Events LLC uses various third-party social media features including but not limited to Facebook, Twitter, YouTube, LinkedIn and other interactive programs. These may collect your IP address and require cookies to work properly. These services are governed by the privacy policies of the providers and are not within Regulatory Education Events LLC's control. Disclosure of Information Regulatory Education Events LLC may not use or disclose the information provided by you except under the following circumstances: as necessary to provide services or products you have ordered; in other ways described in this Policy or to which you have otherwise consented; in the aggregate with other information in such a way so that your identity cannot reasonably be determined; as required by law, or in response to a subpoena or search warrant; to outside auditors who have agreed to keep the information confidential; as necessary to enforce the Terms of Service; as necessary to maintain, safeguard and preserve all the rights and property of Regulatory Education Events LLC. Non-Marketing Purposes Regulatory Education Events LLC greatly respects your privacy. We do maintain and reserve the right to contact you if needed for non-marketing purposes (such as bug alerts, security breaches, account issues, and/or changes in Regulatory Education Events LLC products and services). In certain circumstances, we may use our website, newspapers, or other public means to post a notice. Children under the age of 13 Regulatory Education Events LLC's website is not directed to, and does not knowingly collect personal identifiable information from, children under the age of thirteen (13). If it is determined that such information has been inadvertently collected on anyone under the age of thirteen (13), we shall immediately take the necessary steps to ensure that such information is deleted from our system's database, or in the alternative, that verifiable parental consent is obtained for the use and storage of such information. Anyone under the age of thirteen (13) must seek and obtain parent or guardian permission to use this website. Unsubscribe or Opt-Out All users and visitors to our website have the option to discontinue receiving communications from us by way of email or newsletters. To discontinue or unsubscribe from our website please send an email that you wish to unsubscribe to Asa@AsaWaldstein.com . If you wish to unsubscribe or opt-out from any third-party websites, you must go to that specific website to unsubscribe or opt-out. Regulatory Education Events LLC will continue to adhere to this Policy with respect to any personal information previously collected. Links to Other Websites Our website does contain links to affiliate and other websites. Regulatory Education Events LLC does not claim nor accept responsibility for any privacy policies, practices and/or procedures of other such websites. Therefore, we encourage all users and visitors to be aware when they leave our website and to read the privacy statements of every website that collects personally identifiable information. This Privacy Policy Agreement applies only and solely to the information collected by our website. Notice to European Union Users Regulatory Education Events LLC's operations are located primarily in the United States. If you provide information to us, the information will be transferred out of the European Union (EU) and sent to the United States. (The adequacy decision on the EU-US Privacy became operational on August 1, 2016. This framework protects the fundamental rights of anyone in the EU whose personal data is transferred to the United States for commercial purposes. It allows the free transfer of data to companies that are certified in the US under the Privacy Shield.) By providing personal information to us, you are consenting to its storage and use as described in this Policy. Security Regulatory Education Events LLC takes precautions to protect your information. When you submit sensitive information via the website, your information is protected both online and offline. Wherever we collect sensitive information (e.g. credit card information), that information is encrypted and transmitted to us in a secure way. You can verify this by looking for a lock icon in the address bar and looking for "https" at the beginning of the address of the webpage. While we use encryption to protect sensitive information transmitted online, we also protect your information offline. Only employees who need the information to perform a specific job (for example, billing or customer service) are granted access to personally identifiable information. The computers and servers in which we store personally identifiable information are kept in a secure environment. This is all done to prevent any loss, misuse, unauthorized access, disclosure or modification of the user's personal information under our control. The company also uses Secure Socket Layer (SSL) for authentication and private communications to build users' trust and confidence in the internet and website use by providing simple and secure access and communication of credit card and personal information. Acceptance of Terms By using this website, you are hereby accepting the terms and conditions stipulated within the Privacy Policy Agreement. If you are not in agreement with our terms and conditions, then you should refrain from further use of our sites. In addition, your continued use of our website. following the posting of any updates or changes to our terms and conditions shall mean that you agree and acceptance of such changes. How to Contact Us If you have any questions or concerns regarding the Privacy Policy Agreement related to our website, please feel free to contact us at the following email, telephone number or mailing address. Email: Asa@AsaWaldstein.com Mailing Address: Regulatory Education Events LLC, GDPR Disclosure: If you answered "yes" to the question Does your website comply with the General Data Protection Regulation ("GDPR")? then the Privacy Policy above includes language that is meant to account for such compliance. Nevertheless, in order to be fully compliant with GDPR regulations your company must fulfill other requirements such as: (i) doing an assessment of data processing activities to improve security; (ii) have a data processing agreement with any third party vendors; (iii) appoint a data protection officer for the company to monitor GDPR compliance; (iv) designate a representative based in the EU under certain circumstances; and (v) have a protocol in place to handle a potential data breach. For more details on how to make sure your company is fully compliant with GDPR, please visit the official website at https://gdpr.eu. FormSwift and its subsidiaries are in no way responsible for determining whether or not your company is in fact compliant with GDPR and takes no responsibility for the use you make of this Privacy Policy or for any potential liability your company may face in relation to any GDPR compliance issues. COPPA Compliance Disclosure: This Privacy Policy presumes that your website is not directed at children under the age of 13 and does not knowingly collect personal identifiable information from them or allow others to do the same through your site. If this is not true for your website or online service and you do collect such information (or allow others to do so), please be aware that you must be compliant with all COPPA regulations and guidelines in order to avoid violations which could lead to law enforcement actions, including civil penalties. In order to be fully compliant with COPPA your website or online service must fulfill other requirements such as: (i) posting a privacy policy which describes not only your practices, but also the practices of any others collecting personal information on your site or service — for example, plug-ins or ad networks; (ii) include a prominent link to your privacy policy anywhere you collect personal information from children; (iii) include a description of parental rights (e.g. that you won't require a child to disclose more information than is reasonably necessary, that they can review their child's personal information, direct you to delete it, and refuse to allow any further collection or use of the child's information, and the procedures to exercise their rights); (iv) give parents "direct notice" of your information practices before collecting information from their children; and (v) obtain the parents' "verifiable consent" before collecting, using or disclosing personal information from a child. For more information on the definition of these terms and how to make sure your website or online service is fully compliant with COPPA please visit https://www.ftc.gov/tips-advice/business-center/guidance/childrens-online- privacy-protection-rule-six-step-compliance. FormSwift and its subsidiaries are in no way responsible for determining whether or not your company is in fact compliant with COPPA and takes no responsibility for the use you make of this Privacy Policy or for any potential liability your company may face in relation to any COPPA compliance issues.

  • Resources | Asa Waldstein

    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

  • Testimonials | Asa Waldstein

    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.

  • Meet With Me | Asa Waldstein

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  • Regulatory Blog | Asa Waldstein

    Join Regulatory Happiness Awaits! All Posts Search Asa Waldstein Mar 15, 2022 7 min GMP Pitfalls: Marketing, Manufacturing, & Labeling 398 2 likes. Post not marked as liked 2 Asa Waldstein Dec 29, 2021 4 min Hangover Claims Continue to Attract FDA Attention 391 2 likes. Post not marked as liked 2 Asa Waldstein Sep 21, 2021 3 min Lessons From The Front Line: Warning Letter Review 310 1 like. Post not marked as liked 1 Asa Waldstein May 31, 2021 4 min FTC Crackdown on Kushly Industries Marketing Claims 463 2 likes. Post not marked as liked 2 Asa Waldstein Apr 11, 2021 6 min Compliance Lessons: In-Depth Warning Letter Discussion 881 2 likes. Post not marked as liked 2 Asa Waldstein Mar 28, 2021 3 min The Return of In-Person Trade Shows? 222 Post not marked as liked Asa Waldstein Feb 28, 2021 3 min How To Advertise Without Making Claims 790 2 likes. Post not marked as liked 2 Asa Waldstein Feb 21, 2021 3 min FDA Crackdown on Anxiety & Depression Claims 517 Post not marked as liked Asa Waldstein Feb 20, 2021 5 min Warning Letter Review: What went wrong & how to avoid 842 1 like. Post not marked as liked 1 Asa Waldstein Feb 15, 2021 6 min Hiring Dietary Supplement Experts For Rapid Company Growth 426 Post not marked as liked Asa Waldstein Jan 5, 2021 2 min Reasons To Follow FDA/FTC Enforcement Trends 256 Post not marked as liked Asa Waldstein Dec 17, 2020 4 min FTC’s Operation CBDeceit Brings Action Against CBD Companies 933 Post not marked as liked Asa Waldstein Dec 12, 2020 2 min No Escape for Disease Claims 105 Post not marked as liked Asa Waldstein Dec 10, 2020 2 min Creating a Company Culture of Compliance 116 Post not marked as liked Asa Waldstein Nov 19, 2020 2 min Celebrating One Year! Boulder Hemp-CBD Group 59 Post not marked as liked Asa Waldstein Oct 15, 2020 1 min Implying symptomatic use of CBD for COVID as relates to "material connection" will get a letter 41 Post not marked as liked Asa Waldstein Oct 12, 2020 1 min Interesting Warning Letters: Search terms, product tags, Amazon, and more 71 Post not marked as liked

  • Press

    Latest News I love writing guest articles and collaborating See appearances for Asa's events and podcasts Jun 4, 2024 Interview New Hope Network Read More NBJ 30 supplement industry voices suggest changes to DSHEA Asa and other industry leaders weigh in. Asa Waldstein, Supplement Advisory Group: "Since DSHEA was enacted before the internet boom, I would like to see some clarification on what constitutes allowable marketing in the digital sphere. For instance, if the FDA would define the marketing compliance boundaries of reposting and social engagement and help explain why they consider a social media post from years past as active marketing, it could help companies better navigate compliance. There are also antiquated regulations that should be updated, such as 21 CFR 101.93(d), which states that the DSHEA disclaimer should be “on the same panel or page that bears the (structure/function) statement” on labels. This means that if there’s a structure/function claim on the principal display panel, then the DSHEA disclaimer should also be on the same panel. While the FDA does not seem to enforce this, plaintiff attorneys continue to cite this regulation in lawsuits, which creates unnecessary expense (and ugly labels) for supplement companies." May 23, 2024 Interview NutraIngredients USA Read More Danielle Masterson Is your age verification process in place? Everything you need to know about selling in NY Asa and other industry experts weigh in Apr 18, 2024 Press Mention Vitafoods Insights Read More Niamh Michail Revealed: The 18 finalists of the 2024 Vitafoods Europe Startup Innovation Challenge Find out which trailblazing startups were chosen for their innovative ingredients, finished products, and technologies for the 2024 Vitafoods Europe Startup Innovation Challenge. Apr 5, 2024 Guest Article Natural Products Insider Read More Asa Waldstein Q1 2024 warning letter roundup with Asa Waldstein Dietary supplement consultant Asa Waldstein reviews regulatory trends over the last quarter in his FDA warning letter roundup column. Feb 27, 2024 Press Mention NutraIngredients USA Read More Stephen Daniells Celebrating innovation The Sports & Active Nutrition Summit also celebrated its three new Start-Up Stars, innovative early-stage companies that are disrupting the sector. Feb 23, 2024 Interview NutraIngredients USA Read More Asia Sherman FTC settles with supplement startup over COVID claims A multi-year case involving dietary supplement startup PPO Lab, the Federal Trade Commission (FTC) and COVID-19-related health claims has come to a close, culminating in a truce that removes fines and lightens administrative burdens on the defendants. Feb 15, 2024 Interview Radicle Science Read More Sarah Burden Adapting your Business Strategy to the Regulatory Outlook ​ Jan 22, 2024 Interview NutraIngredients USA Read More Danielle Masterson What can you say in weight loss claims? Experts weigh in With what feels like a weight loss medication takeover, many are betting that the GLP-1 receptor agonists will rescue America from its obesity epidemic. So what does this mean for the natural weight loss products? Jan 4, 2024 Interview NutraIngredients USA Read More Danielle Masterson New year, same problem: FDA issues tejocote root warning, finding the supplements adulterated with poisonous plant The supplements labeled as weight loss products appear to be mislabeled as testing revealed the tejocote root was substituted with a potentially deadly plant. Jan 3, 2024 Interview NutraIngredients USA Read More Asia Sherman Q&A: Apex Compliance founder talks streamlining supplement regulatory marketing compliance Apex Compliance entered the dietary supplement space to simplify regulatory compliance by helping companies identify the words and phrases across marketing materials that trigger oversight agencies. Jan 2, 2024 Guest Article Natural Products Insider Read More Asa Waldstein Q4 warning letter roundup with Asa Waldstein In his quarterly FDA warning letter roundup, dietary supplement consultant Asa Waldstein reviews trends over the last quarter and year, and he makes 2024 predictions. Oct 31, 2023 Interview Food Business News Read More Jeff Gelski Sales soar for probiotic-containing soft drinks Reporting of a SupplySide West presentation Oct 10, 2023 Guest Article Natural Products Insider Read More Asa Waldstein Q3 warning letter roundup with Asa Waldstein In his quarterly FDA warning letter roundup, dietary supplement consultant Asa Waldstein reviews trends around homeopathic products, claims made in YouTube videos, delta-8 THC, and more. Aug 9, 2023 Interview Nutraceutical Business Review Read More Nutraceutical New software emerges to help nutrition and dietary supplement companies vet marketing claims The software, named Apex Compliance, finds risky terms and phrases and suggests alternatives on websites, YouTube videos and in uploaded content Aug 8, 2023 Interview Nutritional Outlook Read More Jennifer Grebow Regulatory compliance software helps supplement, nutrition, functional food, and cannabis brands vet their marketing claims Called Apex Compliance, the software detects risky marketing terms and phrases and suggests lower-risk alternatives. Jul 13, 2023 Interview Natural Products Insider Read More Kelly Teal FDA targets AK Forte distributor for selling drugs, not supplements Suprimo Imports still lists for sale products targeted by FDA in a warning letter, raising the question whether the company will face any legal or criminal action. Jul 11, 2023 Guest Article Natural Products Insider Read More Asa Waldstein Q2 warning letter roundup with Asa Waldstein In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. Jul 6, 2023 Interview NutraIngredients Read More Danielle Masterson New software makes in-house regulatory expertise accessible From his humble beginnings using keyboard shortcuts to unleashing the power of AI, regulatory risk master Asa Waldstein details how he developed a tool to identify trigger words. Apr 26, 2023 Interview Natural Products Insider Read More ​ Ten experts reflect on state of U.S. hemp industry Asa and other industry experts interviewed Apr 21, 2023 Podcast Interview Bezinga Read More Benzinga Cannabis Cutting-Edge Solutions For Hemp Marketing In the latest episode of The Hoban Minute, straight from the NOCO 9 trade show in Colorado Springs, Xavier interviews Asa Waldstein, founder of Apex Compliance and principal at Supplement Advisory Group. Xavier gets a first look at Asa’s new compliance tool, Apex, and the two discuss the dire need for marketing claim reviews in the hemp cannabinoid product space and how Apex Compliance is a tool designed specifically to help brands, marketers, consultants, and more navigate the ever-changing regulations around marketing their products. 1 2 3 4 1 ... 1 2 3 4 ... 4

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