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!

Workshops and Webinars / Workshops and Webinar Resources These are common areas of enforcement and lawsuits.Here are some resources to help understand these regulations. 06-10-22-webinar June 10th GMP & Marketing Claims Demystified Workshop: Resources Steven Yeager LinkedIn Asa Waldstein LinkedIn FDA Supplements Q&A 21 CFR 111 Subparts & descriptions 21 CFR 111 Reference guide Adverse Event Reporting guidance FDA Alerts (allergens, recalls, warning letters Common allergen labeling guidance AHPA Herbs of Commerce Labeling and Allergens Guidance Webinar: CGMP Basics for Hemp-CBD Companies: This is applicable to herbal supplement manufacturers. Regulatory hints YouTube channel AHPA Prop 65 Guidance Preparing for FDA GMP Facility Inspections Webinar Asa’s Regulatory Education Series Why avoid warning letter video Video about the risks of "THC Free" or "THC Free" labeling: Made in the USA Claims Demystified video All Natural: What can you say and what is the risk video Prop 65 webinar AHPA Prop 65 Resources 06-03-22-webinar June 3rd Webinar Resources Harris Bricken Canna Law Blog cGMP Basics for Hemp-CBD Companies Free Webinar AHPA Hemp CBD Supplement Congress videos! Regulatory: Blog, Events, Resources AHPA Labeling Guidance Document Getting Ready for FDA Inspections Webinar AHPA Prop 65 Guidance Regulatory Hints YouTube Channel and Prop 65 Webinar AHPA SOP Templates (members only) Asa’s Regulatory Education Series video channel AHPA’s Guidance Documents HerbalGram Cannabis Resources Asa’s Regulatory Consulting Company 05-04-22-webinar May 4th Webinar Resources Burdock: Food Safety & Regulatory Compliance Consultants for FDA AHPA Hemp CBD Supplement Congress videos! Why join AHPA's Cannabis Committee? Regulatory: Blog, Events, Resources AHPA Labeling Guidance Document AHPA NDI Workshop cGMP Basics for Hemp-CBD Companies Free Webinar AHPA Prop 65 Guidance Regulatory Hints YouTube Channel and Prop 65 Webinar AHPA’s Cannabis Committee AHPA’s Hemp Lexicon AHPA’s NDI Database AHPA’s Botanical Congress: May 24th Asa’s Regulatory Consulting Company Burdock Associates Webinar: GRAS & NDI Certification: Ask the expert Asa’s Next Event: Distributor Pitfalls to Avoid: Hemp and Supplement Products: Back

Asa and other industry leaders interviewed < Back Hemp and CBD Industry Responds to FDA’s Announcement on CBD Steven Hoffman Interview Asa and other industry leaders interviewed Read More Previous Next

Asa Waldstein & other leaders interviewed < Back AHPA Event Guides CBD Industry Danielle Masterson Asa Waldstein & other leaders interviewed Read More Previous Next

Former FDA officials and lawyers who advise clients on FDA regulations weigh in on a recent batch of warning letters targeting new dietary ingredients marketed in supplements. < Back NDI warning letters fuel criticism of FDA enforcement approach—again Josh Long Press Mention Former FDA officials and lawyers who advise clients on FDA regulations weigh in on a recent batch of warning letters targeting new dietary ingredients marketed in supplements. Read More Previous Next

< Back Why CBD Companies Should Re-Examine Their Marketing Content -- NOW Palmate, LLC Interview Read More Previous Next

Ensure GMPs are developed and followed. CBD is risky when added to OTC topicals. < Back Marketing CBD in OTC drugs is risky Ensure GMPs are developed and followed. CBD is risky when added to OTC topicals. #WarningLetterWednesday involves CBD in an OTC topical (hand sanitizer) and further defines FDA’s position regarding CBD as an active or inactive ingredient in OTC drugs. There are also numerous GMP violations that paint an overall picture of noncompliance. The references to CBD in this letter are worth reading. It is hard to defend adding CBD as an inactive ingredient if the amount of CBD is listed on the label or is marketed for CBD content. From warning letter: “Specifically, your product label for MEDICALLY MINDED 100% THC FREE Hand Sanitizer Gel prominently features on the Principal Display Panel (PDP) the statement, “200 MG CANNABINOIDS 100 MG CBD + 100MG CBG.” The product label also lists,.....a website that markets and sells CBD products for various therapeutic benefits. As noted above, CBD and CBG are not an active ingredient in any applicable final monograph”. Although is letter is only one of seven CBD-related warning letters in 2021 (down from 21 last year) it is essentially a teaching case about the importance of GMPs. The FDA sent two records requests which the company did not answer. Not answering these FDA requests is a prohibited act and is serious. The FDA then inspected the company and found serious violations including hand sanitizer that contained 0% ethanol and 58% methanol. This is dangerous! This then led to a national recall of the adulterated lot numbers of hand sanitizer. If the company had a proper Quality Management System (QMS) they would have responded to the FDA’s information request and may have prevented an inspection. They would have also identified the adulterated hand sanitizer before it shipped to the public and caused the subsequent recall. The company was issued a 483 which they didn’t respond to. Learn more about the differences between warning letters and 483’s here . Properly responding to a 483 is an important part of avoiding warning letters. Most 483’s can be addressed with the FDA before they are elevated into a warning letter. Learn more about reasons to avoid a warning letter here . The GMP violations include not setting specifications, quality not approving production procedures, and quality not controlling incoming components. Although these violations cite OTC drug manufacturing regulations, they are the basics all dietary supplement companies should be complying with. Not writing and following specifications is one of the most common supplement GMP citations. Read 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!