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. < Back Cutting-Edge Solutions For Hemp Marketing Benzinga Cannabis Podcast Interview 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. Read More Previous Next

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< 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

The developing state and federal regulatory situation for ingestible CBD and hemp have made marketing these products a bit tricky. < Back The Complexities of Marketing Hemp Products Asa Waldstein Guest Article The developing state and federal regulatory situation for ingestible CBD and hemp have made marketing these products a bit tricky. Read More Previous Next

In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. < Back Q2 2025 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. Each quarter, I provide updates on notable FDA warning letters and enforcement trends. Understanding enforcement trends is essential for being a savvy marketer, regulatory affairs professional or dietary supplement executive. Have you wondered why FDA issues warning letters to certain companies and not others? FDA likes to make examples of companies not following the rules in areas they want to focus on, many of which I review here. Staying ahead of trouble is one of the critical and fun reasons to follow enforcement trends. This warning letter roundup focuses on social media warning letters, unallowable ingredients and a CBD update. I hope you enjoy it! 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!

Jennifer Adam and Asa Waldstein provide commentary in this article by Cassandra Stern. < Back Olly and BrainPack NAD decisions highlight challenges in supplement advertising Cassandra Stern Interview Jennifer Adam and Asa Waldstein provide commentary in this article by Cassandra Stern. "Small words can impact the amount of substantiation needed, which is why it is important to build a company culture of compliance and help the marketing, sales, regulatory, and social teams understand the guardrails or substantiation and what can go wrong if they are not followed." - Asa Waldstein Read More Previous Next

Review old videos for compliance < Back Seven YouTube Warning Letters This Year Review old videos for compliance There have been seven YouTube-related FDA warning letters this year, and I expect the trend to continue. This demonstrates that videos are marketing claims and are, therefore, fair game for enforcement. In YouTube warning letters, there is always a statement such as “This links to a website where you take orders for the products.” This is the link to commerce and establishes the “commercial bridge.” If there was no link to a shopping cart in the videos or elsewhere in the YouTube channel, I wonder if they would be cited in the warning letters. One of the features of Apex Compliance ™ is scanning YouTube videos for compliance concerns. What used to take several minutes or longer can now be done in seconds. I love this feature! Warning letters this year also include YouTube videos embedded on websites, not just videos hosted on a YouTube channel. This shows that claims made in any format, including those in embedded videos, are being scrutinized. Now is a good time to review your videos, especially the old and potentially forgotten ones, for compliance before they turn into warning letters or lawsuits. 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!

Guest article in Marijuana Business Daily < Back Staying on the Right Side of Regulators Asa Waldstein Guest Article Guest article in Marijuana Business Daily Read More Previous Next

Supplement should contain safe ingredients < Back 10 Companies Cited for NDIs and Impermissible Ingredients Supplement should contain safe ingredients The FDA issued ten warning letters to companies selling products with New Dietary Ingredients (NDIs) and other impermissible ingredients such as hordenine HCl. I see these ingredients in two categories. *NDIs: Higenamine, hordenine, octopamine *Impermissible dietary ingredients: 5-alpha-hydroxy-laxogenin, higenamine HCL, and hordenine HCL The FDA differentiates NDIs such as higenamine from impermissible dietary ingredients (higenamine HCl). You will notice that "HCL" (hydrochloride) here is the difference between an NDI and an impermissible ingredient. Here is how the FDA helps to define a dietary ingredient. From Warning Letter: Higenamine is a "dietary ingredient" under section 201(ff)(1)(F) of the FD&C Act [21 USC § 321(ff)(1)(F)] because it is a constituent of aconite, asarum, lotus, and other botanicals. Most of these warning letters include impermissible ingredients and NDIs with disease claims. There is one notable exception. This is the first time I've seen the FDA issue a warning letter solely for using a New Dietary Ingredient (NDI) without a disease claim. This is surprising! Read this letter . So what can we learn? 1) Companies should ensure they are not selling products containing any of these ingredients. I spoke about this "warning to industry" in a Warning Letter Wednesday post six months ago. 2) As I say each week, removing disease words helps to reduce risk. Here is a video about tips for understanding if a claim is made. 3) Most of these ingredients were removed from FDA's Dietary Supplement Ingredient Advisory List. Just because ingredients are removed from this list, this action shows FDA. is still serious about removing them from the food supply. Find the list here . Here is the FDA's constituent update . #WarningLetterWednesday 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 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