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< 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

Ensure substantiation is suitable for each claim < Back Learning Lessons From NAD Ensure substantiation is suitable for each claim I usually write about FDA warning letters, but today I will highlight a recent National Advertising Division (NAD) decision. NAD is a self-regulatory body under Better Business Bureau (BBB) programs, and I enjoy reading NAD cases to look for clues about claims substantiation and enforcement. Here are some marketing pieces NAD took issue with in this case. 👉From NAD complaint. "posts referenced the … Health Start Study, communicating that children taking …. visited the doctor less, missed fewer days of school, took fewer over-the-counter or prescription drugs and consumed less fast food/prescription drugs. DSSRC determined that the … Health Start Study was not the type of competent, reliable scientific evidence required for such claims and recommended that the claims be discontinued in the context in which they were communicated." Asa commentary: This shows that statements like "missing fewer days of school" are considered marketing claims and that these types of studies are insufficient substantiation. 👉From NAD complaint. "For the long-form videos shared on …., which include doctors making broad health claims related to use of the product, DSSRC determined that they may conflate certain health-related messages and that claims communicated in the videos are not supported by evidence in the record. DSSRC recommended that …. remove these videos or redact the portions of the video that make reference to the unsupported claims." Asa commentary: This shows that long-form videos will be scrutinized for marketing claims. These can be difficult to control because conversational discussions about product claims can easily cross the line. 🔷A little more about NAD. 🔹NAD reviews advertising disputes between competitors and other claims it becomes aware of. It is where companies can challenge each other's claims they feel are affecting their sales. NAD evaluates the truthfulness and accuracy of advertising and offers a streamlined resolution process to address advertising disputes. However, unlike a regulatory court, NAD cannot enforce its decisions, but if a company doesn't comply with NAD's recommendations, NAD can refer the case to the appropriate governmental regulatory authority, such as the Federal Trade Commission (FTC). This can also alert plaintiff attorneys. 🔹Interestingly, this complaint was not brought by a competitor but by a non-governmental advocacy group (NGO). The company in this complaint is an MLM which seems to attract more NAD scrutiny than other traditional supplement marketing channels. Read more about the case here . Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Some of our favorite resources to help educate about NDIs and GRAS. NDI and GRAS Guidance / NDI and GRAS Guidance These are common areas of enforcement and lawsuits.Here are some resources to help understand these regulations. Product reviews and testimonials podcast: Justin Prochnow How influencers can comply with FTC disclosure guidelines video FTC's Disclosures 101 for social media influencers FTC's featuring online customer reviews: A guide for platforms Influencers and CBD: Interview with Asa and a popular influencer Back

< Back Presentation Friday Sep 3, 2021 Marketing Compliance: Effective Strategies Open Discussion Southern Hemp Expo, Raleigh, NC The Southern Hemp Expo brings together unsurpassed education and networking with the Let’s Talk Hemp Speaker Series . Industry experts, speakers and exhibitors across the supply chain will show you how to RETHINK Hemp . A powerhouse line-up of industry leaders will be on stage to discuss hemp agriculture, business and investing, technology and innovation, wellness, textiles, fiber, food and beverage, composites and building materials — the whole supply chain of opportunity in hemp. Learn 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!

Some of our favorite resources to help educate about marketing compliance. Marketing Compliance / Marketing Compliance These are common areas of enforcement and lawsuits.Here are some resources to help understand these regulations. Substantiation Tips and CARSE Health Products Compliance Guidance TikTok Music Copyright Litigation & Best Practices Common Plaintiff Lawsuits: Best Practices Asa's weekly Warning Letter Wednesday post FTC Document: How to Make Effective Disclosures in Digital Advertising FTC Document: Social Media Disclosures FTC's Dietary Supplement Advertising Guide For Industry Made in the USA lawsuit reference (TINA) Natural Claims article Made in the USA (Great Podcast!) Made in the USA FTC Guidance AHPA Hemp CBD Supplement Congress videos! FDA Label Claim Guidance FTC Guidance: Claim Substantiation FTC Guides Concerning the Use of Endorsements and Testimonials in Advertising AHPA Alerts: Stay up to date (AHPA members only) Other AHPA Guidance Documents Compliance essential for hemp CBD companies: Marketing FDA alerts (allergens, recalls, warning letters) Back

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

< Back Interview Wednesday Nov 2, 2022 ‘Warning letter geek’ decodes marketing compliance SupplySide West Asa Waldstein is principal of the Supplement Advisory Group and the man behind 'Warning Letter Wednesdays.' His bread and butter is educating companies about the dos and don'ts of marketing. Watch Previous Next