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< Back Webinar Tuesday Dec 10, 2019 Supplement cGMP Basics for Hemp-CBD Companies American Herbal Products Association This webinar provides an overview of dietary supplement current good manufacturing (cGMP) requirements for hemp-CBD products. Legal and industry experts provide strategies and resources to comply and document compliance with these federal manufacturing requirements designed to ensure product quality and safety. Topics Overview of cGMP requirements Strategies to comply and document compliance cGMP resources for hemp-CBD companies Preparing for and conducting an FDA cGMP inspection Presenters Tara Lin Couch , Ph.D., Sr. Dir. of Dietary Supplement and Tobacco Services, EAS Consulting Ricardo Carvajal , Esq., Director, Hyman, Phelps & McNamara PC Asa Waldstein Watch Previous Next

< Back Symposium Wednesday Nov 11, 2020 Symposium Keynote: Consumer Demand & the CBD Market: Intersections & Insights Michigan State University: Center for Research on Ingredient Safety Asa Waldstein Supplement Advisory Group: Consumer Demand & the CBD Marketplace, Intersections & Insights Patrick C. McCarthy ValidCare : Answering FDA’s Call for CBD Safety Data Jinpeng Li: Introduction to cannabinoids and the new wonder drug/consumer product: CBD Barbara Kaplan: Inhibition of Peripheral Immune Function and Neuroinflammation by CBD in EAE Brad Lampe: Derivation of an acceptable daily intake of orally-consumed cannabidiol (CBD) in adult consumers: challenges and limitations and more.. Watch Previous Next

< Back Webinar, Panel Discussion Thursday Jun 9, 2022 CBD Panel Discussion: Bridging the gap between science and regulation Atlantia Clinical Trials Asa Waldstein joins the Atlantia team to discuss how to use clinical data for marketing purposes to overcome regulatory hurdles that many CBD companies are encountering when commercializing their innovations. To many, CBD offers a variety of benefits when ingested, inhaled, or applied topically – with product marketing and advertising claims similarly ranging from calming effects to pain relief. Patient use fuels the research drive, which is rapidly increasing, and recent changes in the United States have paved the way for exciting new work. Both the safety and the potential therapeutic uses of these products need to be assessed for a range of indications. With the rapid expansion of new products, novel methods of use, and growing populations using these products for medical indications or for nonmedical use, regulatory restrictions are a major contributing factor to the limited data published addressing the most urgent questions on the potential effectiveness of products on the market for certain indications. Don't miss your opportunity to submit your CBD regulatory questions to our experts. Learn More & Register Previous Next

< Back Presentation, In-Person Thursday Oct 26, 2023 Microbiome Products: Enforcement & Marketing Compliance Supplyside West Las Vegas A universe unfolding: Uncovering the mysteries of the microbiome and its connection to health Despite a deluge of new information—and a steady stream of microbiome-related studies expanding the available data on human microbiome composition and function—ingredient researchers are only beginning to understand the individual microbial species and their biological roles. Luckily, artificial intelligence (AI) and machine learning are proving to be game changers in our understanding of these expanding datasets. Technology could bring transformational change through the development of predictive models for personalized therapeutic interventions or disease interception. But before that lofty goal is reached, biotics providers are discovering the impact that bacteria-based ingredients can have on a wide range of health systems beyond gut health, including the gut-brain axis, a connection to healthy skin, and the influence of dysbiosis on host immunity and disease. The session covered: Innovation in product development across a range of consumer-facing solutions that include prebiotics, probiotics, synbiotics and postbiotics. The segment expansion of probiotics into sports nutrition, weight management, inflammation targeting and cosmetics, as well as bone health, women’s health, kidney and respiratory function, cognitive performance, and stress and sleep. The accumulation of in vivo and clinical data indicating that probiotics could represent important allies in the fight against obesity and associated metabolic health concerns. Learn More Previous Next

< Back Presentation Tuesday Aug 30, 2022 Common Mistakes and Best Practices for Online Supplement Sales Positively Natural Marketplace Las Vegas, NV In this interactive discussion, Asa Waldstein reviews common and preventable mistakes companies make when selling supplements online. This includes the nuances of discussing ingredient benefits, social media, and blogs. Asa will also review enforcement trends and share best practices to sell products without inadvertently crossing the line into high-risk marketing. Please bring your questions to this session. Learn More Previous Next

Functional mushroom products under increased scrutiny < Back Basics of GMP’s Cited Functional mushroom products under increased scrutiny Functional mushroom products are undergoing a renaissance, and FDA is paying close attention to how these products are tested and manufactured. This is likely because of the mass recall and potential fatalities associated with the Diamond Shruumz products. Learn more about this cringy and dangerous recall here . Today’s Warning Letter Wednesday highlights GMP violations related to functional mushroom incoming product testing, QC release, product returns, incomplete 483 responses, and sample retention. These are important reminders of the basic GMP requirements, and we can learn from this company’s oversights. 🔹The company appears to be a copacker that received bulk mushroom gummies for packaging and labeling. They did not have even the most basic procedures in place for receiving and packaging dietary supplements. This seems like an operation that just buys bulk products then packages and labels them without quality checks. Yikes! If I had to guess, they were probably the cheapest option, which goes to show that if a price is too good to be true, it probably is. This is accurate not only for products but also for regulatory consulting as well. 👉From warning letter. “During the inspection, you did not have any procedures in place for the dietary supplement products you receive for packaging and labeling.” 🔹Product returns are common and having a procedure of how to handle these products is essential. This warning letter indicates that returned products were possibly re-sold without proper review, which is terrifying. This is how counterfeit, or dangerous products work their way into the supply chain. 👉From warning letter. “You do not have any procedures in place for the handling of returned dietary supplements, to include the identification and quarantine of the products until quality control personnel conduct a material review and make a disposition decision.” 🔹Product retentions are important, as they allow us to retest products when there are customer complaints. FDA requires they be kept one year past expiration date or two years past the last date of distribution. In my contract manufacturing days saving three bottles per lot number was sufficient. Also, retained samples can potentially be used to substantiate expiration dating. 👉From warning letter. “ You did not retain reserve samples for the required time for use in appropriate investigations.” The FDA gave this company ample opportunity to comply with the 483 violations but, as noted in the warning letters, the responses were incomplete which led to this warning letter. When in doubt, hire an expert for 483 responses. Read the full letter here . DATE ORIGINALLY POSTED: 12/11/24 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!

Small issues signify deeper noncompliance < Back GMP Labeling Lessons Small issues signify deeper noncompliance Dietary supplement labeling can be confusing, but ensuring that the "small things" like line thickness are compliant is important. When FDA looks at a label that is not quite right, it can signify greater compliance concerns and trigger them to look deeper, as the adage "Where there's smoke, there's fire" is often true. Let's look at this warning letter to see what we can learn. 🔹Address or phone number: This is an important part of GMPs and safety and is considered a major violation if missing. This is how consumers report adverse events to the company, which can help the company identify quality issues and, if necessary, serious adverse events that must be reported to the FDA. Learn more here . Also, if the company named is not the manufacturer, the label must clearly disclose this fact using a statement like "Manufactured for" or "Distributed by." 👉From warning letter: "The labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1] may receive a report of a serious adverse event with such dietary supplement." 🔹The correct order of ingredients is important. Learn more here . 🔹"Supplement Facts" should be set at full width of the nutrition label, in accordance with 21 CFR 101.36(b)(1)(i) 🔹The correct nomenclature should be used for items with a percent daily value. 👉From warning letter. "The source ingredient that supplies a dietary ingredient may be identified within the nutrition label in parentheses immediately following or indented beneath the name of a dietary ingredient and preceded by the words "as" or "from", e.g., "Calcium (as calcium pyruvate)". When a source ingredient is not identified within the nutrition label, it shall be listed in an ingredient statement." 🔹Formatting is important. 👉From warning letter. "The Supplement Facts label format requirements including the use of bolded text, hairlines, and/or light and heavy bars are not in accordance with 21 CFR 101.36(e)." 👉From warning letter. "The statement "**Daily Value not Established" must be within the Supplements Facts label." 🔹Common ingredient name must be listed. 👉From warning letter. ""Aquamin™" is not the common or usual name for Lithothamnion spp." There are lots of GMP violations in this letter, which is likely the primary reason for this letter. Read the full warning letter here . DATE ORIGINALLY POSTED: 2/5/25 Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

< Back Interview Saturday Aug 12, 2023 Regulatory Expert Asa Waldstein The Herbalist Hour Ep. 55 HerbRally The topic of regulatory compliance in the herbal industry is an incredibly important one, so it was an honor to have on Asa Waldstein, one of the leading experts in the field on the show. We delve into all sorts of topics in this interview: At what point should a smaller herbal company start being serious about making claims on their marketing efforts? Stories of smaller herbal companies who get warning letters from the FDA. Advice on getting started when it comes to marketing claims. We also chat about substantiation dossiers, using puns as claims in marketing your products, general business advice, his new software Apex Compliance, the time he spent with @MichaelFranti and a whole lot more! A huge THANK YOU to Asa for taking the time to share his expertise with all of us, and thanks to YOU for listening. I highly encourage you to sign up for Asa's " Warning Letter Wednesday " newsletter. Until the next episode, ~Mason Watch Previous Next

< Back Webinar Thursday May 21, 2020 Regulatory Hurdles Associated with Cannabis & Its Concentrates Burdock Group Consultants Interesting topics for the CBD and hemp industries. FDA/FTC enforcement trends Truth in labeling cGMP Compliance Animal products Epidiolex desceduling And more... Tatiane Berdum: Host, Burdock Group Elan Sudberg: CEO, Alkemist Labs Dr. Marielle Weintraub: President, US Hemp Authority Brett Goldman: Industry Regulatory Expert Asa Waldstein: AHPA Cannabis Commitee Chair Watch Previous Next

< Back Online, Panel Discussion Thursday Jun 12, 2025 How a rapidly evolving world is transforming dietary supplement innovation – summit Inside the Bottle Summit The supplement industry plays a pivotal role in supporting consumer well-being. Today’s consumers want their supplements to do a lot –– provide benefits as marketed and do so in proven and personalized ways, all while remaining accessible and affordably within reach. The rapid adoption of AI can help deliver on the promise of personalization and impact the pace at which new discoveries and solutions can come to market. All of this must also happen in an environment of changing supply chain management and regulations within a global economy. The industry is ready to meet these challenges and will remain a key partner in improving consumer health. The supplement industry is transforming the way it approaches innovation, while maintaining integrity and its core vision for health. Our 2025 Inside the Bottle Summit places data and research at the center of the narrative. Join leading experts, share your voice in the community forum, learn about hot category trends and dive into the critical data-driven orientation that is shaping the dietary supplement industry today. Don’t miss this opportunity to build a roadmap for the future of your business. Age nda: Session 1 : NBJ and SPINS industry numbers and winning category predictions to get on shelf and stay on shelf Nutrition Business Journal Market Data Analyst Erika Rommel Craft unveils up-to-date supplement industry numbers and key factors influencing purchasing trends. SPINS Senior Director of Market Insights Scott Dicker joins Erika to overview product category winners driving growth and fueling new product opportunities. Build your supplement business strategy with concepts that meet consumers' desire for effective products that meet healthspan needs. This is do-not-miss content for anyone engaged in new product development and merchandising strategies. Session 2: What today’s consumers demand: How validated solutions are redefining brand trust and evidence-backed innovation Consumers want products that provide trusted solutions. How can the industry leverage AI to deliver personalized products that work –– validating that the promise of claims on pack and the intended benefits inside the bottle deliver? A “one size fits all” solution may obscure personalization. For brands to win in a competitive market they must focus on producing targeted solutions. Learn how precision insights powered by large and diverse population trial data provide personalization wisdom that can enable new market opportunities. Session 3 : Transforming health and product pipeline: Traditional wisdom supercharged by modern science and clinical methods Traditional wisdom and healing practices are the inspiration and foundation of the dietary supplement industry. Consumers rightly demand efficacious products. How can brands create products that appeal to the wisdom of the ages while confidently knowing the intended benefit will be delivered? This session dives into the value of evidence-based ingredients rooted in tradition and validated by research, overviewing ingredient lifecycle –– from traditional knowledge, to compound discovery, to clinical evidence –– for formulating and merchandising products with confidence. Session 4 : Nothing constant but change: Key perspectives on today’s regulatory landscape It has been stated that we live in interesting times. What’s happening today at FDA and what implications may there be for the U.S. dietary supplement industry regulatory landscape and enforcement? We’ll hear observations and insights from compliance expert Asa Waldstein on where the industry should maintain attention and consider potential action items to support a strong industry. Learn More and Access Webinar Previous Next

Remove “anxiety” on all marketing platforms < Back Anxiety claims enforcement up 95% in 2021 Remove “anxiety” on all marketing platforms #WarningLetterWednesday reviews the increase in anxiety claims enforcement. In 2021 there was 40 anxiety-related product FDA warning letters, a 95% increase over 2020 (21), which is a clear sign of the FDA’s enforcement priorities. Here is a breakdown of the 2021 anxiety warning letters. *75% (30) include both anxiety and depression. This shouldn’t come as a surprise to anyone following enforcement trends, as the FDA sent ten anxiety/depression letters last February. I write about this here . *45% (22) include claims made on social media. I would have guessed this number would be higher. *10% (4) include hashtag claims, and 25% (10) include claims made in testimonials. I expect warning letters with hashtag claims and testimonial claims to increase, which is an enforcement trend to watch. *All 2021 letters also include higher-risk disease words such as hypertension except for one that involved a drug spiked product (sibutramine). The FDA looks at a company’s complete online presence. One claim may not attract a warning letter, but, for example, claims made on social media, YouTube, Amazon, and blogs are pieced together for one big picture of noncompliance. *It is worth noting the 2021 warning letters did not include the term “occasional anxiousness,” which is, if substantiated, often considered not to be a disease claim. Anxiety is considered a 3.5 of 5 on the “Asa Risk Scale” and should not be used. If truthful and substantiated lower risk alternatives are: *happy mood support *balanced state of mind *mental resilience *support when things get overwhelming *helps support smiles 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