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Reading warning letters and finding trends and notable items is a hobby of mine. This Quten Research Institute's warning letter is interesting as the company implies benefits in the context of a disclaimer. From Warning Letter: Researchers theorize that some people that suffer from high blood pressure also exhibit CoQ10 deficiency. Multiple studies have reported that CoQ10 had a blood pressure lowering (hypotensive) effect and that this might be caused in part by correcting this deficiency. However, CoQ10 is not a substitute for your doctor prescribed treatment or acceptable treatment for high blood pressure on its own. The use of CoQ10 to help you manage your high blood pressure should only be done as part of a doctor-supervised and recommended regime (always consult your doctor!). Although warranted this letter is lighter in claims than most we see these days, but in the world of risk, companies receiving commercial value by insinuating a supplement is used for hypertension will attract attention. Always remove any disease words from marketing material. This includes "informational" blogs which are where many of the warning letter claims are being cited from. Also, no other platforms are mentioned here which is uncommon (socials, YouTube, hashtags). I did a quick social media search of this company and they appear to be compliant. Interestingly and justifiably we have seen more pain and inflammation statements pop up on recent letters, a sign of FDA enforcement trends getting stricter in this area. 💡 This is a warning to clever marketers looking for ways to sell products directly implied for disease claims. Inspired by a LinkedIn post by Rick Collins who perfectly said The overall point is that trying to be cute and dance around the wording of drug claims isn’t protective"

This is one of my favorite discussions! If compliance is not important in board room discussions then it will be hard to melt into company culture. If compliance is not part of company DNA it can accentuate the "Us Versus Them" mentality between Quality, Operations, and the C-Suite. This creates a vicious cycle which could eventually lead to terrible occurrences, such as companies falsifying records. We all know where this ends (jail). Here's a few thoughts on how to weave compliance into the company DNA #1 This starts from the top. Without a strong CEO & executive buy-in compliance culture will not be integrated in the company DNA. #2 Hire executives from your industry with a proven track record. This seems obvious but having members of the C-Suite who understand how to interpret regulations in a way that makes sense for YOUR company is valuable. They will help guide the compliance ship in the right way. Hiring from other industries such as apparel for a supplement company does not always fit. I discussed this here with Danielle Masterson on her NutraCast podcast. #3 Understand when to say goodbye to those who don't fit and won't change. Is an executive outspoken about choosing sketchy sales practices over compliance? Is so it's time to say goodbye. 👋 #4 Reinforce good behavior with a monthly compliance award. 👏 #5 Publicize your company compliance best practice culture deck. This is very Silicon Valley but there're some good lessons here. https://www.stitcher.com/show/masters-of-scale/episode/8-why-culture-matters-wnetflixs-reed-hastings-51210066 #6 Ongoing training on FDA/FTC enforcement trends I would also like to point out that Quality Management Systems (QMS) are best developed with operational efficiency in mind. A QMS can be robust but doesn't allow for company efficient and compliant growth which in turn will hurt the overall business. Since CFR 111 (supplements) has room for interpretation why not develop and implement a QMS that interprets regulations in a way that is #1 compliant, but also streamlines efficiency. It is common for QMS's to be developed in a vacuum that can hinder company efficiency. This post was inspired by a LinkedIn conversation. Thanks Nate Call!

I live near Boulder Colorado which is known to be the "Silicon Valley" of food. dietary supplement, and hemp innovation. I was surprised to see there was no hemp regulatory networking groups in the area so I started one. In any emerging market it's best for community to come together in best practice development and support. This started with signing up on Meetup and making the group announcement. I then found the space, recruited some great speakers, coerced my wonderful wife into skipping yoga to serve beverages, and picked the event title Ethical CBD Marketing: How to avoid FDA, FTC, and class action trouble. This was timely because three days after this event was announced in November the FDA sent the "Big 15" Warning Letters to CBD companies making outrageous claims. This was also during the very important IFR public comment period. The initial #BoulderHempCBDGroup meeting brought together brands looking for guidance, farmers unsure what the regulatory environment was going to look like, journalists passionate about the hemp/supplement world, laboratories unsure is they could continue testing, toxicologists doing safety studies, and many more. It was a huge success. My previously skeptical but loving wife said to me after the event "You have to host more of these events". This is where the Boulder Hemp-CBD Group & Regulatory Education Series was born. I am thankful for the several successful events we've had since then and am especially grateful to see the hemp community continue to come together to support each other in best practice development and support! This event included excellent presentations from industry leaders Frank Robison and Patrick C. McCarthy. These events have moved online but look forward to when we can all learn and network together!

Although this ingredient may be useful, discussing this in a format that implies sellable product usefulness crosses the compliance line. From Warning Letter: “‘What we are seeing here is, what we feel, a direct effect from what's happening with the coronavirus. Our customers are suggesting that using CBD is helping to ease the symptoms of COVID-19. We are seeing people literally flocking to purchase high quality CBD for the potential relief it gives,’ states Justin Elenburg, Patriot Supreme's CEO and Founder.” [Your post is followed by a picture of your CBD product, from a July 23, 2020, post on your Facebook page] Notice this Facebook post is near three months old? My suggestion is to check old social media posts for claims, then retroactively clean them up. This is one of the many reasons to learn how to read FDA/FTC trends. Warning Letter: For Our Vets LLC dba Patriot Supreme #boulderhempcbdgroup #regulatoryeducationseries #CBD #hempindustry

Warning letter references product tags and website search terms. Griffo Botanicals FDA/FTC warning letter references COVID related product tags and website search terms. This directs consumers to purchase products (material connection). Also noted is social media posts touting the products for COVID symptoms. This company shook a stick at the FDA with their numerous claims on Twitter, Amazon, Facebook, YouTube, citing studies and so much more. The FDA then tested their red yeast rice product for lovastatin and found levels "if taken at the maximum dose recommended on the label, your product would provide 85.8 mg lovastatin per day, which is above the maximum recommended daily dose of lovastatin in Mevacor and its generic counterparts." This dovetails into a broader discussion about naturally occurring CBD in hemp. Warning letter KetoKerri receives second warning letter which elevates risk of injunction. I expect stricter FTC action soon. This recent warning letter mentions claims made on Amazon, on social media, in Spanish, about children, and in videos. Our recent fireside chat was excellent. Listen to the full webinar here. This was an detailed discussion about the intersection of dietary supplements and hemp-CBD. #BoulderHempCBDGroup #RegulatoryEducationSeries