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Asa Waldstein, principal at Supplement Advisory Group, advises companies on how to navigate murky waters in today's marketplace. < Back Limiting Marketing Risk for Hemp and CBD Products Sheldon Baker Interview Asa Waldstein, principal at Supplement Advisory Group, advises companies on how to navigate murky waters in today's marketplace. Read More Previous Next

< Back Interview, Online Tuesday Nov 23, 2021 Practitioner v Product Claims NuHerbs Asa Waldstein and Wilson Lau explore the differences between claims that practitioners can make within their scope of practice versus ones they can make as herbal product marketers. How to be mindful of where you are making claims and in what capacity you are making such claims. Asa shares tips on how to create compliant claims and how to turn high-risk claims into low-risk claims. Asa brings a unique viewpoint being both a clinical herbalist and a seasoned veteran of the dietary supplement industry. Asa writes a weekly #WarningLetterWednesday post where recent enforcement trends are reviewed. Here is a post where practitioner education crosses the line into marketing claims. Watch Previous Next

< Back Webinar Wednesday Mar 12, 2025 Beyond the Aisle: Navigating Marketing Compliance in the Supplement Industry SENPA Staying compliant with marketing claims is one of the biggest challenges retailers face in the natural products industry. With regulatory scrutiny increasing, understanding the nuances of the Dietary Supplement Health and Education Act (DSHEA) is more important than ever. Join us for the next session of Beyond the Aisle: Navigating Natural Products Retail, where we welcome Asa Waldstein, a seasoned regulatory consultant and clinical herbalist and founder of Apex Compliance, to break down what retailers need to know about compliance. During this insightful session, Asa will provide: ✅ A clear understanding of DSHEA and its impact on the herbal and dietary supplement industry. ✅ The difference between structure/function claims and disease claims—and how they affect marketing. ✅ Practical strategies to ensure your store’s marketing remains compliant, from product signage to digital advertising. - Date: Wednesday, March 12, 2025 ⏰ Time: 2:00 PM EST Don't risk compliance missteps that could put your business at risk. Register now to gain expert insights from Asa and learn how to navigate marketing claims with confidence. Register Previous Next

< Back Podcast Wednesday Feb 1, 2023 Asa Waldstein - Principal @ Supplement Advisory Group | FDA Enforcement Trends + Social Media Ingredients for Success Podcast On this episode, @AsaWaldstein Principal @ Supplement Advisory Group, joined the show to discuss FDA Enforcement Trends for 2023, Social Media Compliance, and his weekly newsletter, Warning Letter Wednesday. Asa is a Certified Clinical Herbalist and a 20-year dietary supplement executive. Asa's consulting company, Supplement Advisory Group, is a boutique group focusing on marketing risk analysis and practical marketing solutions for the web and social media. He chairs the American Herbal Products Association's (AHPA) Cannabis Committee. Watch Previous Next

< Back Panel Discussion, In-Person Thursday Oct 30, 2025 The dietary supplement/food and beverage pipeline: Bridging the gap with science-backed ingredients SupplySide Global Mandalay Bay, Las Vegas As demand for convenient, wellness-driven products grows and pill fatigue sets in, today’s hottest supplement ingredients are breaking out of capsules and showing up in functional foods and beverages. Many of these science-backed ingredients currently claim self-affirmed GRAS (generally recognized as safe) status, opening the door for innovative formats that align with consumer expectations for efficacy, taste and accessibility. In this session, a panel of experts in regulatory affairs, product development and consumer insights will explore how manufacturers can navigate formulation, taste and compliance challenges while tapping into trends. Learn how supplement, food and beverage categories are converging, and what it means for ingredient positioning, innovation and future growth. Learn more and register Previous Next

< Back Interview Thursday Jun 4, 2020 Cannabis, CBD, Regulations, & AHPA CannabisRadio.com Concierge For a Better Living Cannabis, CBD, Regulations, and AHPA are what Asa Waldstein, a veteran of the dietary supplement industry, sit down and talk about in today’s episode of Concierge For Better Living with Doc Rob. During these tough times, it gets harder and harder to find the light at the end of the tunnel. Asa helps do this by diving deep into the dietary faction of cannabis. He also explains how old practices such as canning, can and are making a comeback in today’s cannabis industry. Listen Previous Next

< Back Interview Thursday Nov 23, 2023 Managing Dietary Supplement Marketing Risks, with Asa Waldstein of the Supplement Advisory Group NutraPreneur Episode Overview Episode Topic : Join us in this episode of NutraPreneur as we delve into the intricate world of compliance and best practices in the dietary supplement industry with Asa Waldstein, principal of the Supplement Advisory Group and founder of Apex Compliance . Discover the strategies and insights that have shaped Asa’s approach to regulatory adherence and how the Supplement Advisory Group navigates the dynamic landscape of dietary supplement regulations. Lessons You’ll Learn : In this episode, you’ll gain insights into key strategies for mitigating marketing risks, ensuring compliance, and fostering a community approach within the industry. Learn about practical lower-risk solutions and essential elements in marketing and product labeling that not only meet regulatory standards but also enhance consumer trust. Understand the challenges and success stories encountered in implementing compliance best practices and discover the critical regulatory challenges on the horizon. About Our Guest : Our esteemed guest, Asa Waldstein, is the principal of the Supplement Advisory Group and the founder of Apex Compliance. With a wealth of experience in the dietary supplement industry, Asa has been instrumental in guiding marketers toward lower-risk strategies, ensuring compliance with regulatory standards, and fostering a culture of regulatory adherence within the industry. Take a firsthand look at Warning Letter Wednesday and unlock the secrets of FDA scrutiny and industry pitfalls. Topics Covered : In this episode, Asa shares key strategies for crafting foolproof compliance in marketing and product labelling. Beyond the challenges, he champions a community-driven approach and spills industry collaboration secrets. A sneak peek into the Supplement Advisory Group’s regulatory game plan adds a practical touch, making compliance not just informative but an enjoyable ride for marketers. Watch Previous Next

Don’t engage with risky reviews < Back Product Reviews Become Marketing Don’t engage with risky reviews In this warning letter, the company engaged with "third-party" reviews on its website, which turned them into marketing. If product reviews are collected and displayed on a website, the agencies are generally "hands-off" as long as they are: Third-party Honest: The honest experience with the product. Here's an FTC case concerning Google and I Heart Radio from a couple of years ago. Not solicited: Such as "a free product for a favorable review." Non-curated: Don't favor positive reviews. Also, conglomerating reviews on a "Reviews" page can be considered curation. Non-compensated: No paid influencers or free products unless disclosed. Not showcased: Such as those highlighted in a banner or a social media image. Not engaged with: These reviews become marketing when a company showcases them in a banner or social media post or engages with them on their website or social media. When in doubt, don't engage is a good rule for product reviews and testimonials. Not hidden negative reviews: FTC pays attention to companies hiding negative reviews, and, in some cases, hands down big fines, such as this $4.2 million case against Fashion Nova . Some companies go the extra mile and delete any reviews or testimonials that contain disease words. This is fine as long as you have a documented policy that treats positive and negative reviews the same. Here's an example from the warning letter. From warning letter. "January 24, 2023 customer review states, "I have been using this CBD for my pup who has seizures for some time, since starting CBD she has not had one. I like that there are no unnecessary ingredients, and she takes it with no problems." (company) replied, "Thank you for the review, (b)(6) That is amazing news - we are so glad to hear that your pup's seizures stopped!!!" There is so much more to this warning letter. Read it here . DATE ORIGINALLY POSTED: 10/23/24 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!

Before marketing products check with a supplement expert < Back Learning Targets: definition of supplements, safety claims, disease statements Before marketing products check with a supplement expert Today's #WarningLetterWednesday is cringeworthy but also contains learning lessons for product marketers and developers. The product is a vape that contains caffeine, is labeled as a supplement, makes overt safety claims, and uses high risk marketing disease claims. There are a lot of learning lessons here. Vapes by definition are very high risk. Adding caffeine into a smokable product with other herbal ingredients may seem like a good idea to an untrained development team, but it is actually exceptionally dangerous. Supplements are defined as products taken by mouth that contain a "dietary ingredient" intended to supplement the diet. Smokable products by definition cannot be supplements because they are not ingested. As a side comment this is also why "sublingual" delivery is not suitable for supplements, as it's a drug delivery term. I ask, what regulatory category does a vape with herbal ingredients belong to? Making safety claims on any product must be substantiated. When statements like this are made it seems more like optimistic and potentially deceptive marketing than hard science: (from warning letter) “Is it safe to inhale caffeine?.....Yes" There are also high risk marketing disease claims mentioned in this warning letter. These include references to "inflammation" which I discussed in last week's Warning Letter Wednesday here . Lots of claims here discuss ingredient benefits such as: (from warning letter) "Vitamin B12 has even more science-based health benefits including:....Supporting bone health and preventing osteoporosis...Uplifting mood and symptoms of depression" I review ingredient benefit claims in another Warning Letter Wednesday here . Read full warning letter here . DATE ORIGINALLY POSTED: 12/15/21 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!

Comparison to drugs is high risk < Back Ingredient Benefits, Clinical Studies, & Blogs Lead to Warning Letter Comparison to drugs is high risk Comparing a supplement product to a drug is a quick way to attract FDA attention. In this warning letter, the company compared turmeric, an ingredient in their product, to the effectiveness of NSAIDs (such as aspirin). Although, in many cases, it may be true that supplements can work better than drugs without side effects, these statements do not belong in compliant marketing. Below is the statement cited in the warning letter. The use of disease words like “inflammation” and “pain” and the reference to clinical studies added to the risk of scrutiny. Instead, sticking with statements about an ingredient’s soothing properties and quality of life statements such as “feel ready to go hiking” can be a lower-risk marketing strategy. 👉From warning letter. “….are a great option for those looking for a natural alternative to over-the-counter pain relievers. In fact, studies show that turmeric is just as – if not more – effective in reducing inflammation and joint pain than NSAIDs.” 🔷This company already received a warning letter last December, which I write about here . It seems FDA deleted the December warning letter and reissued it recently, as the person named in the original warning letter was not part of the company at that time. 🔷There are several references to clinical studies in this warning letter. Implying that an ingredient or product has supporting clinical data, such as “studies show” statements, can lead to increased scrutiny, especially from FTC and plaintiff attorneys. Here’s a post about “clinically proven” claims . 👉From warning letter. “2016 study showed that taking a high dose of 1000 mg of curcumin each day for an average of 8-12 weeks helped reduce inflammation and joint pain.” 🔷Blogs are commonly referenced in warning letters, and this company crossed the line from education to marketing by talking about ingredients they sell. Even if there is no cross-linking, simply mentioning an ingredient in a disease context, such as a “Thyme is a strong antimicrobial that can help promote relief,” can elevate warning letter and litigation risk. I see companies making this mistake all the time. There is a lot more to this warning letter, including numerous GMP violations. See my previous post about this, or read the full warning letter 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!

< Back Panel Discussion Friday Mar 26, 2021 Regulatory Reality on the Horizon NoCo Hemp Expo, Denver, CO I am honored to share the stage with industry icons Robert Hoban and Tim Gordon . They are some of my industry favorites, and I am so excited about our regulatory panel! The industrial hemp business community is encouraged to stay vigilant, involved and up to date as a number of federal and state bills, USDA, FDA and DEA proposed regulations, and other policy activities impact the hemp market – and your business – on state, national and international levels. Learn more Previous Next

Correct FDA 483s to avoid a warning letter < Back Most GMP violations involve setting & documenting specifications Correct FDA 483s to avoid a warning letter #WarningLetterWednesday reviews a cGMP manufacturing warning letter. This is a good teaching case about the basics of Good Manufacturing Practices (GMPs) for dietary supplements as this company made some of the most common mistakes. Regulatory expert Steven Yeager and I discuss “How to Prepare for FDA Inspections” in the following webinar . We’ve both helped oversee several FDA CFR 111 inspections with no warning letters and we have fun sharing our helpful tips and hints. Steven and I also presented a four-hour GMP and marketing compliance workshop here at the American Herbalists Guild. This letter includes the most common violation of not establishing and documenting specifications for the identity, purity, strength, and composition. Another common mistake is not having documentation showing a member of the quality team approved specifications and product labels. This role of quality is at the core of GMPs. Imagine the mix-ups and potential adulteration that could occur if the production team was allowed to apply labels without oversight. We recently saw this happen in a CBD company that inadvertently applied CBD labels to the THC product which resulted in serious adverse events. Another important reminder is the requirement to list the plant parts such as leaves or fruit. Also noted is the requirement to have proper Supplement Fact Panel line thickness and bolding. Although these will not attract a warning letter on their own it is better to have a correct label layout. There are so many more violations listed in this letter and I suggest reading the full warning letter here . It is interesting to look at the timelines in this warning letter. The inspection was in May of 2021 when a 483 was issued but the warning letter was not issued until six months later. This gave the company plenty of time to correct the 483 and avoid a letter. Learn more about the difference between 483’s and warning letters here . The very big surprise is the FDA didn’t appear to review the company’s website before the inspection. Normally, the best thing a company can do to prepare for a GMP inspection is to remove all high-risk online marketing claims as FDA investigators review websites and social media before the inspection. This company is very lucky as they still have LOTS of high-risk website claims. This is a strong risk for a repeat warning letter. Learn more about “Reasons to Avoid “Warning Letters” 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!