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< Back Interview Saturday Aug 12, 2023 Regulatory Expert Asa Waldstein The Herbalist Hour Ep. 55 HerbRally The topic of regulatory compliance in the herbal industry is an incredibly important one, so it was an honor to have on Asa Waldstein, one of the leading experts in the field on the show. We delve into all sorts of topics in this interview: At what point should a smaller herbal company start being serious about making claims on their marketing efforts? Stories of smaller herbal companies who get warning letters from the FDA. Advice on getting started when it comes to marketing claims. We also chat about substantiation dossiers, using puns as claims in marketing your products, general business advice, his new software Apex Compliance, the time he spent with @MichaelFranti and a whole lot more! A huge THANK YOU to Asa for taking the time to share his expertise with all of us, and thanks to YOU for listening. I highly encourage you to sign up for Asa's " Warning Letter Wednesday " newsletter. Until the next episode, ~Mason Watch Previous Next

Screen all blogs and social media for disease claims < Back Disease Claims Turn Supplements Into Unapproved New Drugs Screen all blogs and social media for disease claims This #WarningLetterWednesday is an excellent lesson about turning a supplement into an “unapproved new drug” by making disease claims. Other lessons here are: ● LinkedIn claims cited again! ● Eight-year-old social media post! ● Claims made on social media are top of mind for the FDA. From Warning Letter: “Ayurveda has solutions for managing high blood pressure. . . . THREE PRODUCTS TO HELP HIGH BLOOD PRESSURE . . . Arjuna Arishtam supports healthy heart function and reduces high blood pressure.” Social media is mentioned in this warning letter. The citation below is boilerplate in warning letters, and it is a good reminder that directing consumers to a website to purchase the product is the “material connection.” If these social media sites did not link to a commercial website or shopping cart, they likely would not be cited in this letter. From Warning Letter: “these social media websites direct consumers to your website at https://lnkd.in/g-vvBiJH to purchase your products. An eight-year-old Facebook post is mentioned here, and this may be a record for the oldest post mentioned in a warning letter! As I’ve spoken about several times, the FDA looks at old social media posts in the same manner as current ones, and we talk about this here . From Warning Letter: “On an April 3, 2014, post from your Facebook social media website” Check out the citations at the bottom of the warning letter! They reference claims made on LinkedIn. I wrote about this just a couple of weeks ago, and it is a good reminder to clean up old social media pages, including LinkedIn. Join the discussion here : Pro tip: This post includes a high-risk hashtag, which makes it easy for the FDA to find claims in the cluttered world of LinkedIn. From Warning Letter “This webpage is also linked from a post on your LinkedIn social media website, which states “# Highbloodpressure does not have to be permanent: # Ayurveda has solutions for managing high blood pressure. When turning the light of Ayurveda onto HBP, there is a priority toward each person’s imbalance and recommendations are made based on the best diet and activities for each person.” Read the 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, In-Person Wednesday Nov 15, 2023 Avoid the Lawsuit - Top Labeling Mistakes Colorado Food Works Arvada, CO Are you thinking about updating your CPG product label in 2024? Thinking about making a “Healthy” Claim on your package? Is your functional food or beverage “Anti-Inflammatory”? In this month’s event we will be reviewing top labeling mistakes that can result in lawsuits and costly re-prints. Avoid the headache and join us for a panel of Labeling and Regulatory Experts along with an interactive scavenger hunt to find packaging errors. RSVP Previous Next

Review videos for compliance concerns < Back YouTube Claims Lead To Warning Letters Review videos for compliance concerns There have been three YouTube-related supplement warning letters this year, which shows FDA is not slowing down with this enforcement trend. Since this is a US holiday, I will keep today’s Warning Letter Wednesday brief. All of the 2023 YouTube-related warning letters also cite claims from other platforms like websites and other social media platforms. This means that “where there’s smoke, there’s fire,” and if there are claims on videos, there are most likely disease claims elsewhere in a company’s marketing. I just launched Apex Compliance , a compliance software designed to find risky phrases on websites, YouTube videos, and uploaded content before it gets you in trouble. I developed this SaaS tool to help companies fix their marketing before it leads to a warning letter or lawsuit. Learn more here . Two letters link to a shopping cart, and the other one references a video embedded on the website. This is the material connection that correlates the video to commerce. I doubt these videos would have been cited if there were no links to where customers can order products. Only one FDA warning letter in FDA’s warning letter archives mentions claims on Vimeo (that I can find). Here are the three letters: 👉ByPro Nutrition LLC 👉PharmaCanna 👉Spartan Enterprises Inc. 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 Workshop, Online Thursday Apr 21, 2022 Cannabis II: Marketing Compliance for the Hemp Industry Delaware Valley University Asa Waldstein trains future regulatory compliance professionals. Learn more Previous Next

< Back Podcast Monday Dec 20, 2021 Dietary Supplements, DSHEA, and Marketing Claims Health Quest Podcast This was a great conversation about the safety of dietary supplements, marketing claims, how to choose supplements, and the history of DSHEA. This conversation that is worth listening to if you are interested in supplement manufacturing, marketing, or are just a consumer looking to learn about the history of our wonderful supplement industry. Listen Previous Next

Asa and other industry leaders weigh in. < Back 30 supplement industry voices suggest changes to DSHEA NBJ Interview Asa and other industry leaders weigh in. Asa Waldstein, Supplement Advisory Group: "Since DSHEA was enacted before the internet boom, I would like to see some clarification on what constitutes allowable marketing in the digital sphere. For instance, if the FDA would define the marketing compliance boundaries of reposting and social engagement and help explain why they consider a social media post from years past as active marketing, it could help companies better navigate compliance. There are also antiquated regulations that should be updated, such as 21 CFR 101.93(d), which states that the DSHEA disclaimer should be “on the same panel or page that bears the (structure/function) statement” on labels. This means that if there’s a structure/function claim on the principal display panel, then the DSHEA disclaimer should also be on the same panel. While the FDA does not seem to enforce this, plaintiff attorneys continue to cite this regulation in lawsuits, which creates unnecessary expense (and ugly labels) for supplement companies." Read More Previous Next

Words like “may help with” is not a get-out-of-claims-jail-free card < Back Supplement & CBD company cited for disease claims Words like “may help with” is not a get-out-of-claims-jail-free card Supplement & CBD company cited for disease claims. #WarningLetterWednesday The FDA inspected the company facility in October 2021, then six months later reviewed the website for disease claims, finding many that resulted in a warning letter. This is a trend. In the past year, there have been several warning letters like this, where an FDA inspection led to a website review several months later, and many disease claims were uncovered. This is a friendly reminder to re-review the website for disease words after an FDA inspection, as they will look at this months later. Even well-intentioned companies may unknowingly have high-risk words lurking on old blogs and social media posts. Here is a post about this . From warning letter: “On your webpage for “Elderberry Plus Vitamin C”…“Aids with cold, flu and virus symptoms” Takeaway: This is an example of an unknowing copywriter using common language about elderberries, then copying this onto a product page. This is another reason to build a culture of compliance from within to help social and copywriter employees, the ‘front line of defense’ employees, understand how not to inadvertently turn a disease claim into a drug. I have lots of free content to support this, such as this post and video . This letter also includes CBD. There have been 26 CBD-related warning letters this year, up from just seven in 2021. This is a clear sign that the FDA will continue to focus on CBD companies making disease claims while essentially leaving CBD companies that follow GMP manufacturing practices and do not make risky claims alone. From warning letter: “CBD Gummies may help relieve pain, inflammation, anxiety, and depression.” Takeaway: Using words like “may” and “studies suggest” is not a get-out-of-claims-jail-free card. 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 Webinar Wednesday Mar 26, 2025 Women's Health Claims: Compliance, Risk, and Marketing Best Practices Naturally Informed Mastering the Market: Women's Wellness The women’s health market is having a major moment. After decades of being under-served and under-researched, the category is booming. That’s thanks to increased research, as well as to technology that is speeding advancements in product innovation and an increase in women in leadership who are shining a brighter light on the unique needs of women. During this three-day conference, leading researchers, healthcare practitioners, and industry innovators will gather to deliver the latest trends, emerging science, and practical, actionable know-how that can help you grow your business while serving this key market. Learn more and register Previous Next

Blogs on a commercial website are marketing claims < Back CBD Company Cited For Claims Made in Blogs and Socials Blogs on a commercial website are marketing claims This CBD #WarningLetterWednesday is a great teaching case as it cites many of the common mistakes we talk about each week. Here is what we can learn: Blogs on a commercial website are marketing claims. CBD is not allowed in OTC topicals. Hashtags, ingredient benefits, and product tags appear in more warning letters. Most of the cited claims in this warning letter are from blogs and social media. Here's one of several examples. From Warning Letter: "On the Blog post, "How to Use CBD to Combat Holiday Stress":.. "Reduced Anxiety and Depression" Blogs on a commercial website are "fair game" for enforcement and a key lesson from this WL. I write about best practices for blogs here. http://ow.ly/KMo250IYL43 High-risk words never belong on a commercial website, especially the "anxiety and depression" one-two punch. Here's my video about this. http://ow.ly/tuI350IYL48 From Warning Letter: "Although CBD is listed as an inactive ingredient in the labels of your .... "1000 mg Pain Relief Cream" products, the product labeling clearly represents CBD as an active ingredient" This product is labeled with drug facts and lists CBD as an inactive ingredient, but the label boldly lists "1000mg CBD". From Warning Letter: … "Even if CBD could be considered an inactive ingredient in your .... "1000 mg Pain Relief Cream" products, these products would still need an approved drug application to be legally marketed" The FDA's position is that CBD is not a suitable active or inactive ingredient in OTC topical drugs. Please read my article about this. http://ow.ly/N8rq50IYL3X From Warning Letter: "On your January 6, 2021 Instagram…"# CBDforArthritis # Anxiety” Hashtags are an enforcement trend to watch . Here's a video about this. From Warning Letter: “product_tag-dog-cancer-cbd” Product tags are mentioned in this warning letter . I wrote about this last week. From Warning Letter: "Orange Essential Oil [an ingredient in CBD Super Cider] may naturally relieve anxiety, . . . depression and inflammation of the body." Discussing ingredient benefits on a commercial website is a high risk . There's much more to talk about in this letter that I do not have room for. Read full warning letter 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!

Plan for FDA inspections by addressing common violations < Back GMP inspection leads to a warning letter for disease claims and GMP violations Plan for FDA inspections by addressing common violations GMP inspection leads to a warning letter for disease claims and GMP violations. #WarningLetterWednesday In this letter, common GMP violations such as setting specifications and the company’s inadequate 483 responses led to the warning letter. Most 483s can be addressed before they become a warning letter. Here’s a recent “GMP Violations & Unanswered 483s Lead to a Warning Letter” post and video about this. I wrote this very detailed post about GMP pitfalls as a training tool, and I hope you enjoy it. Learn about the differences between 483s and warning letters here . Disease claims from the product label and website are mentioned in this letter. From FDA warning letter. “On your product label: “Take if suffering from glaucoma or ocular hypertension.” This falls under the “treatment” part of diseases. Remember the DSHEA disclaimer “not intended to diagnose, treat, cure, or prevent disease.” From FDA warning letter. “Alereve was developed to better treat patients’ ocular allergies without exacerbating their dry eye component in fact, our initial study demonstrated that some patient’s Dry Eye Syndrome was significantly improved with Alereve treatment” In my opinion, this is added as a “pigpile” or” secondary claim” and would not attract a warning letter unless higher risk claims are present. The best way to avoid a warning letter is to remove claims made web and on social media, including blogs and old social media posts ! Read the 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 Presentation Tuesday Aug 30, 2022 Common Mistakes and Best Practices for Online Supplement Sales Positively Natural Marketplace Las Vegas, NV In this interactive discussion, Asa Waldstein reviews common and preventable mistakes companies make when selling supplements online. This includes the nuances of discussing ingredient benefits, social media, and blogs. Asa will also review enforcement trends and share best practices to sell products without inadvertently crossing the line into high-risk marketing. Please bring your questions to this session. Learn More Previous Next