< Back Virtual Fireside Chat Friday Jan 19, 2024 Radicle Perspectives: Elevating the supplement industry Radicle Science There was no shortage of dietary supplement regulation and compliance talk in 2023. From FTC guidance and FDA’s response to NAC and NMN, to the Dietary Supplements Access Act, continued market disruption due to supply chains and inflation, not to mention authenticity issues continuing to plague major online retailers, what can we anticipate in 2024? Tune in to another insightful episode of Radicle Perspectives as we welcome our esteemed guest, Asa Waldstein, as we prognosticate about what 2024 has in store for dietary supplement regulations and compliance. Key Topics: Recap major industry news from 2023. Anticipate how these headlines from 2023 will impact regulations and compliance in 2024. Learn about other dietary supplement regulations and compliance issues beginning to percolate already. Register Previous Next

< Back Panel Discussion Wednesday Sep 21, 2022 Building Brands in Cannabis Naturally Boulder Boulder, CO CBD, THC, and Cannabis are all over the news. Consumers see the products in stores, are starting to see limited advertising, and are hearing anecdotes from their friends. Everyone is talking about it, but people have very little information about it. And, the information they do have varies by the state or community they live in. This creates an interesting business opportunity for entrepreneurs! For current brands looking to incorporate cannabinoid-based benefits of sleep, pain relief or calm there is obvious opportunity, but also, complexity and risk. For new brands launching into the space, there is a steep and unique learning curve in navigating formulation, branding, and distribution that is like no other industry. If you’ve wanted to learn more about this continually emerging, high-growth industry, Naturally Boulder has assembled a panel of experts to discuss the state of the industry, what’s hot and new, and how you can develop and build a powerhouse brand in the space. Learn More Previous Next

Regulatory compliance and marketing education on important issues in the dietary supplement industry. Helpful hints videos, blogs, and resources. Asa's public speaking schedule and webinar links. Consulting services for supplement marketing compliance. About Asa Waldstein Community, Compliance, Natural Health Principal of Supplement Advisory Group , specializing in practical regulatory support for dietary supplement marketers. We focus on finding marketing risks and providing practical marketing solutions on the web, social media, and product labels. I love educating about compliance best practices and lower-risk marketing strategies, which often change based on FDA/FTC enforcement trends. Building in-house expertise through education is part of my unique approach to regulatory consulting. I routinely speak at conferences on enforcement trends, industry compliance, and the nuances of effectively marketing products in the digital era. Check out my weekly Warning Letter Wednesday post . Learn More Email Me LinkedIn Home: About Home: Testimonials Testimonials Vardan Ter-Antonyan Chief Science Officer at 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. Free Introductory Regulatory Consult Available Online 15 Minute Consultation with Asa Waldstein 15 min Book Now Home: Video Player Regulatory Hints Videos Educational Tools: Free for the community Play Video Share Whole Channel This Video Facebook Twitter Pinterest Tumblr Copy Link Link Copied Now Playing MLM Company Cited For Claims Made By Their Affiliates 02:39 Play Video Now Playing FDA Crackdown on Anxiety Claims 03:19 Play Video Now Playing Art of Wordsmithing: Replace High-Risk Marketing "Buzzwords" 01:12 Play Video Now Playing Supplement Advisory Group: About Us 01:02 Play Video Watch with captions on What I Do For A Living Get in Touch Newsletter signup, ask regulatory questions, public speaking inquiries Submit Thanks for submitting! Home: Contact

In this interview, Professor Ted Dinan, Medical Director at Atlantia Clinical Trials, and Asa Waldstein, Principal at Supplement Advisory Group, discuss Atlantia’s expertise in clinical trials for CBD < Back The Future of CBD research, marketing, and regulation Mychealla Rice Interview In this interview, Professor Ted Dinan, Medical Director at Atlantia Clinical Trials, and Asa Waldstein, Principal at Supplement Advisory Group, discuss Atlantia’s expertise in clinical trials for CBD Read More Previous Next

When will FDA go after “Nature’s Ozempic” claims < Back Biomarker Claims Enforcement When will FDA go after “Nature’s Ozempic” claims Making biomarker claims about dietary supplements has some risks, and here I explore enforcement trends to be aware of. In recent years, the FDA has increased scrutiny of biomarker-related claims, especially those linked to serious health conditions like heart disease and diabetes. A significant shift occurred in 2022 when the FDA began issuing warning letters for claims that were previously considered risky but not ultra-high risk. These include statements such as "lowers LDLs," "lowers cholesterol," and even "lowers bad fats" without the use of higher-risk terminology like "hypertension." Other biomarker claims that have been cited include "lowering A1C levels and blood sugar," which implies an effect on diabetes management, and "reducing arterial plaque," which suggests an influence on preventing cardiovascular disease. Interestingly, while FDA has cited heart health-related biomarker claims, there have not been notable warning letters related to C-reactive protein (CRP) or other inflammatory biomarkers. FDA seems to generally take a "hands-off" approach regarding discussions of inflammatory biomarkers, as long as no explicit disease claims are made. This suggests that while some biomarker claims may fall into the grey area, companies should use caution and keep up to date on enforcement trends to avoid crossing into disease claim territory. One hot area to watch is GLP-1 claims, which, when combined with claims such as "Nature's Ozempic," may be enough for a warning letter. DATE ORIGINALLY POSTED: 9/25/24 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!

Citing clinical studies on a commercial website is high risk < Back 7 CBD Companies Cited for Implied COVID claims Citing clinical studies on a commercial website is high risk Seven CBD companies cited for implied COVID claims in this #WarningLetterWednesday. These are the first CBD-related warning letters after the announcement of the COVID and acidic cannabinoid introductory studies and the biggest agency action against CBD in over a year. 🔷One learning target of the WLW post is discussing clinical studies on a commercial website can easily be considered marketing claims. There does not appear to be any overt call-to-action or link from the studies to a shopping cart. Discussing clinical studies about an ingredient (CBDA) is enough to attract a letter. COVID-related discussions are very high risk and do not, in my opinion, belong on a commercial website. From warning letter ➡️ Another separate study from the 2022 American Chemical Society and American Society of Pharmacognosy found that two cannabinoid acids (CBDa & CBGa) bind to spike proteins of SARSCOV-2. Thus, preventing the virus from entering cells and causing infection." [from your webpage} 👉 Read this warning letter here . 🔷 These warning letters are not surprising. We discuss this in Laura Drotleff''s Hemp Industry Daily article from January here . 👉From the article 👉with the number of "cringe-worthy product claims" aiming to cash in on scientists' research, companies promoting COVID research with links to products should consider FDA and FTC enforcement "a given," Waldstein said. "I predict we should see a batch of CBDA and COVID warning letters coming out in the next couple of months." 🔷There are several other learning targets, such as blogs on a commercial website, and social media hashtags are considered claims. 👉I discuss best practices for blogs and discussing ingredient benefits here . From another warning letter ➡️ “[H]eavensorganics #covid #covid19 #cbdhelps #cbdoil #naturesremedies #naturalremedy #natureheals” [From a January 25, 2022 post on your social media website 👉I discuss the risks with hashtags and social media posts here . These warning letters are uncommon joint FDA and FTC action, a "shot across the bow" and a clear warning to the industry of the agency'es. 👉 Read the FDA Roundup 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!

Should ‘broad-spectrum’ CBD be defined? What about ‘isolate’? NY’s new extract rules could be model for nation < Back Leaders Weigh In On Proposed NY State Rule Ivan Moreno Interview Should ‘broad-spectrum’ CBD be defined? What about ‘isolate’? NY’s new extract rules could be model for nation Read More Previous Next

Hashtags can make compliant posts very non-compliant < Back Learning targets: Old social media posts, hashtags, sketchy ingredients, and high-risk claims Hashtags can make compliant posts very non-compliant #WarningLetterWednesday contains old social media posts, claims made in hashtags, sketchy ingredients, and high-risk claims. 🔷Old social media posts containing claims is a strong enforcement trend, but the ages of the posted cited in recent letters are more aged than the standard 2-3 years. I recently wrote about a 2014 re-tweet being mentioned in a letter here . 👉This letter includes Facebook posts from 2016. Wow, the FDA is digging deep into the company's social media, and this is an enforcement trend. Guess what, I made a "helpful hints" video about this. ➡️ From warning letter. June 2, 2016 (Facebook) post: “Phenibut is known as a GABA analogue. Outside the US many countries around the world use phenibut clinically for symptoms of PTSD, anxiety, depression and insomnia.” Hashtags are claims and this is a great example of how a company has taken a relatively lower risk post and made it high risk with a high risk hashtag. Here is a video on this topic. ➡️ From warning letter. On your February 27, 2017 (Instagram) post: #anxietyrelief” and “MOOD ELEVATION -ENHANCED SLEEP- HEIGHTENED FOCUS” 🔷I am unsurprised this letter contains the high-risk words anxiety and depression. Anxiety products claims enforcement was up 95% in 2021, and 75% of those warning letters had both anxiety and depression, a one-two compliance punch. It is important to remember this includes all online marketing, and these are pieced together for one picture of noncompliance. Here is a video and post about anxiety claims enforcement. 👉Insomnia claims are also mentioned in the letter which I have also written about here . These darn companies need to read Warning Letter Wednesday.😁 🔷There are some surprisingly low-risk structure-function claims cited in this warning letter. In my opinion, these are "secondary addition" claims that are not likely to attract a warning letter on their own. It is, however, interesting to see what the FDA considers a claim worthy of a warning letter "call out." ➡️ From warning letter. ..Product packaging: • “Stress Reducing • Mood Boosting” Also worth mentioning is the use of phenibut , which the FDA does not consider a dietary ingredient. 🔷Read the warning letter here . 👉Check out my WLW LinkedIn 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!

Asa and other industry leaders interviewed < Back Hemp Leaders Look Ahead to 2022 Jean Lotus Interview Asa and other industry leaders interviewed Read More Previous Next

The software, named Apex Compliance, finds risky terms and phrases and suggests alternatives on websites, YouTube videos and in uploaded content < Back New software emerges to help nutrition and dietary supplement companies vet marketing claims Nutraceutical Interview The software, named Apex Compliance, finds risky terms and phrases and suggests alternatives on websites, YouTube videos and in uploaded content Read More Previous Next

Product formats & packaging should not appeal to children < Back FDA/FTC Cites Six Companies For Selling Delta 8 Products Product formats & packaging should not appeal to children FDA and FTC recently sent six joint warning letters to companies selling delta 8 products that were favorable to children. Thank you, FDA and FTC! These warning letters highlight some of the most over-the-top examples of products going too far, and I applaud the authorities for taking action. Here are some of the highlights: 🔷 More than disease claims: All of these warning letters do not include disease claims. This shows the agency is starting to think differently about enforcing cannabinoid products, and if they feel there is a safety issue, they will take action. Last year FDA shocked everyone by sending this letter to a company that was not making disease claims but was adding CBD to a caffeine-containing beverage. 🔷 Unfair or deceptive marketing is cited in these letters, which is where FTC comes in. Delta 8 poses dangers, especially to children, in favorable formats like gummies which are considered deceptive marketing. I find this approach fascinating and clever. 👉 From warning letter “Section 5 of the FTC Act prohibits unfair or deceptive acts or practices in or affecting commerce. This prohibition includes practices that present unwarranted health or safety risks….. preventing practices that present unwarranted health and safety risks, particularly to children, is one of the Commission’s highest priorities.” 🔷 Some of the most egregious products are Cheetos Crunchy Flamin’ Hot THC Infused Chips and Doritos Nacho Cheese THC Infused Chips. Wow, in addition to trademark issues, this company took it way too far. 🔷 Safety is cited as a primary reason for some of these letters, such as this example where similar products resulted in adverse event reports. 👉 From warning letter : “Ten of the reports specifically mention the edible product to be a copycat of popular foods. Your Sour Worms” 🔷 Some of these letters were issued to marketplace sites where numerous third-party products were sold. This shows that companies are responsible for the products they sell, as exemplified by last year’s Amazon and Walmart warning letters . 🔷 We are all aware of FDA’s unfavorable position on CBD, but they really do not care for delta 8 with good reason, as exemplified in last year’s consumer update . Delta 8 can be dangerous, and according to data from National poison control centers, 2,362 delta 8 exposure cases had been reported, including “One pediatric case was coded with a medical outcome of death.” This report warns consumers that delta 8 products are widely available in forms favorable to children, such as chocolates and candies. This should have given the delta 8 industry pause, but these products have unfortunately continued to proliferate. 🔷 Although most of the products cited in this letter have been removed, there are still some brazen products being sold, such as a carton of cookies that contains 30mg delta 9 THC per cookie. OMG! There is much more to read in the FDA news release . DATE ORIGINALLY POSTED: 7/12/23 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!

Warning letters show claims made in socials, blogs, testimonials & hashtags < Back A Review of 56 Diabetes Related Warning Letters Warning letters show claims made in socials, blogs, testimonials & hashtags I reviewed all diabetes and blood sugar related FDA warning letters since the beginning of last year and found some interesting results. These findings provide a snapshot of where the FDA is finding and perhaps looking for risky words. We can learn a lot from this, and it's an excellent reminder for companies to re-review these areas to ensure no risky statements are lurking on their website or social platforms. There have been 56 blood sugar and diabetes-related FDA warning letters since the beginning of 2021. This is a lot, demonstrating the FDA's continuing attention to this high-risk diabetes and blood sugar category. 62% of these warning letters include claims made on social media. This should come as no surprise but is an important reminder to scan for high-risk words on socials, including old posts. Here is a post and video about this. 26% of these letters include claims made in blogs. This is a strong enforcement trend to watch as the FDA looks at old blogs in the same manner as current blogs. I have found this to be a common oversight, as companies have learned about compliance over the years and their new blogs are compliant, while their forgotten older blogs are riddled with disease claims. Scanning these forgotten blogs is a great way to reduce risk, and this is a service we at Supplement Advisory Group are often hired to conduct. Here is a post about best practices for reducing risk in blogs. 23% of these warning letters include claims made in testimonials. The FDA and FTC are generally "hands off" with non-curated, honest, 3rd party generated product reviews. These cross the line into marketing claims when a company engages with them or showcases them in any way, such as copying an Amazon review onto social media or showing them on a product page. Here is a post that shows how engaging with product reviews led to a company warning letter. 25% of these letters include hashtags. Hashtags are easily searchable and can turn compliant posts into disease claims with an uncompliant hashtag. Here is a video about this. 👉Here is a learning tool titled "Protect Your Company: Learn to read warning letters." I hope you enjoyed reading the synopsis, and I welcome your thoughts! 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!