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Webinars are “fair game” for enforcement < Back MLM Distributors Cited in FTC Lawsuits Webinars are “fair game” for enforcement Warning Letter Wednesday primarily focuses on FDA-related enforcement, but occasionally I review interesting FTC actions. Today's #WarningLetterWednesday highlights three FTC cases against distributors of doTerra essential oils and supplements. doTerra is a network marketing company. This differs from last year's Young Living FDA warning letter, where the MLM parent company received the letter for claims largely made by its distributors (affiliates). Read more about this letter here . The claims in these three complaints were made in webinars in early 2022. FTC states they are "former healthcare practitioners who touted their expertise in recommending the products." Interestingly, FTC points out that the distributors named in these lawsuits use their medical background to market supplements. I'm sometimes asked if doctors can make statements about supplements they sell that non-doctors can't make. The answer is, of course, no, but in these cases, the distributor's medical background seems to be mentioned as another way they potentially misled consumers. Some of the cited claims imply products can support the immune system, and they dance around the idea they can protect or help with COVID. Since COVID claims are very high risk, even lightly implying protection is enough to attract agency action like a warning letter, administrative complaint, or lawsuit. Here is one example. From Lauren Busch FTC lawsuit. "LLV should be part of your daily routine, DDR Prime should be a nonnegotiable, especially with all the exposures we have in this world beyond just what's going on with COVID." A key takeaway is that all secondary marketing will be heavily scrutinized if any COVID claims are present. doTerra, the parent company from today's Warning Letter Wednesday, seems to do a good job at compliance. I ran my Apex Compliance program on their website and found just a few concerns. I'm happy to run a sample keyword check on your website; just let me know. The FTC complaint includes a permanent injunction against each defendant, stopping them from making unsubstantiated claims and also pay a $15,000 fine each. In my opinion, this monetary amount seems low, but it does send a cautionary tale that MLM distributors can be liable for the claims they make. COVID claims are likely why these distributors were targeted. "Brain fog" is also cited in one of the complaints. Do you consider this to be a disease claim? According to HHS, brain fog can be a symptom of long-haul COVID, a recognized disability under the Americans for Disabilities Act (ADA). My take is brain fog related to COVID symptoms is undoubtedly a disease claim, but brain fog not related to Covid isn't high risk. I feel "occasional brain fog" from time to time. I write about brain fog claims here . From FTC complaints: "The webinar was organized and promoted by doTERRA distributors …. and the registration link for the webinar was distributed on publicly accessible social media accounts." Interestingly, FTC references that access to the webinar is publicly available. If the webinar was closed to the public or invite-only, do you think it would have been cited in this complaint? Also, it seems the webinar recording may have been posted on YouTube, which, if true, maybe how the FTC found it. Companies and company representatives frequently record webinars and podcasts. Claims enforcement made in these formats are rare unless they are posted on YouTube, or the transcripts are hosted on a commercial website. My SaaS Apex Compliance program scans YouTube videos as well as websites and documents for risky keywords. Learn more here . Citing research is also mentioned in one of the complaints. From FTC lawsuit "slide displayed the abstract from an article titled "Computational evaluation of major components from plant essential oils as potent inhibitors of SARS-CoV-2 spike protein." We have previously discussed how citing COVID research to sell products can lead to warning letters. Read my comments on last year's FTC's 4.2 million dollar fine against Fashion Nova for allegedly hiding unfavorable product reviews here . Read about the FTC action 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 Saturday May 21, 2022 Medellin, Colombia: Pitfalls to Avoid When Entering the US Cannabinoid Product Market Bizcann Expo Columbia Medellin, Colombia There is so much that can go wrong when entering the US cannabinoid or supplement marketplace. In this session we discuss how to avoid common labeling, product manufacturing, registration, and marketing errors that can delay launches, or worse, attract the attention of the FDA and class action attorneys. See pictures and the post on Asa's speech here . Learn More Previous Next

Maximizing sales by reducing risk in web and social media marketing for supplement and hemp industries. About Asa Waldstein Principal of Supplement Advisory Group , dedicated to providing regulatory and marketing risk analysis for the supplement industry. I love educating and supporting a community approach to compliance best practice development and lower-risk marketing strategies, which often change based on FDA/FTC enforcement trends. 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 . I'm a Certified Clinical Herbalist (CCH) with 20+ years of experience developing and deploying organizational strategies across divisions in the dietary supplement industry. I've developed, manufactured, and marketed hundreds of dietary supplement products and have helped oversee three FDA GMP audits with no 483s. Former C-level executive integral in retooling operations, manufacturing, and QA to greatly improve order efficiency, fulfillment time, out of stocks, and excessive labor KPIs while supporting the company during the brisk revenue growth stage. Current Chair of American Herbal Products Association's (AHPA) dynamic Cannabis Committee and former board member. These affiliations allow me to continue to help drive hemp and dietary supplement regulations and compliance forward during this important time in the industry. Founder and host of Asa's Regulatory Hints YouTube channel . My herbalism research focuses on herbal therapeutics and identifying and ethically wildcrafting medicinal plants, skills now used when formulating, ordering, and approving ingredients. AboutVideo Free Introductory Regulatory Consult Available Online 15 Minute Consultation with Asa Waldstein 15 min Book Now

< Back Symposium Friday Jun 9, 2023 16th International Herb Symposium at Wheaton College in Norton, Massachusetts, on June 9-11, 2023 International Herb Symposium Asa teaches various GMP and marketing compliance classes at this three-day event. Learn More Previous Next

Asa and other industry experts weigh in < Back Is your age verification process in place? Everything you need to know about selling in NY Danielle Masterson Interview Asa and other industry experts weigh in Read More Previous Next

< Back Webinar Thursday Mar 7, 2024 Pitfalls to Avoid When Marketing Products Velocity CPG Guest speaker Asa Waldstein reviews common pitfalls when marketing products that can lead to expensive litigation or agency action such as social media engagement, citing clinical studies, blogs, and influencer best practices. Register Previous Next

< Back Interview Thursday Mar 25, 2021 Herbalism, Compliance, & GMP's The Natural Nurse I speak with The Natural Nurse about herbalism, GMP's, and marketing compliance Listen Previous Next

< Back Webinar Thursday Jun 3, 2021 Distributor Pitfalls to Avoid Asa's Regulatory Education Series Nathalie Bougenies and Steven Yeager join me for our next Regulatory Education Series event. What companies need to consider when distributing products? Here are some of the topics we will cover. What contracts do distributors need to have in place? What CFR 111 requirements do distributors need to comply with? What Prop 65 liabilities do distributors carry? What is the liability of the distributor? What liabilities do platforms which sell lots of products and making claims have? How do distributors handle product returns? Do they need to be tested before going back into inventory? And more! Learn More Previous Next

< Back Webinar Tuesday Dec 10, 2019 Supplement cGMP Basics for Hemp-CBD Companies American Herbal Products Association This webinar provides an overview of dietary supplement current good manufacturing (cGMP) requirements for hemp-CBD products. Legal and industry experts provide strategies and resources to comply and document compliance with these federal manufacturing requirements designed to ensure product quality and safety. Topics Overview of cGMP requirements Strategies to comply and document compliance cGMP resources for hemp-CBD companies Preparing for and conducting an FDA cGMP inspection Presenters Tara Lin Couch , Ph.D., Sr. Dir. of Dietary Supplement and Tobacco Services, EAS Consulting Ricardo Carvajal , Esq., Director, Hyman, Phelps & McNamara PC Asa Waldstein Watch Previous Next

< Back Symposium Wednesday Nov 11, 2020 Symposium Keynote: Consumer Demand & the CBD Market: Intersections & Insights Michigan State University: Center for Research on Ingredient Safety Asa Waldstein Supplement Advisory Group: Consumer Demand & the CBD Marketplace, Intersections & Insights Patrick C. McCarthy ValidCare : Answering FDA’s Call for CBD Safety Data Jinpeng Li: Introduction to cannabinoids and the new wonder drug/consumer product: CBD Barbara Kaplan: Inhibition of Peripheral Immune Function and Neuroinflammation by CBD in EAE Brad Lampe: Derivation of an acceptable daily intake of orally-consumed cannabidiol (CBD) in adult consumers: challenges and limitations and more.. Watch Previous Next

< Back Webinar, Panel Discussion Thursday Jun 9, 2022 CBD Panel Discussion: Bridging the gap between science and regulation Atlantia Clinical Trials Asa Waldstein joins the Atlantia team to discuss how to use clinical data for marketing purposes to overcome regulatory hurdles that many CBD companies are encountering when commercializing their innovations. To many, CBD offers a variety of benefits when ingested, inhaled, or applied topically – with product marketing and advertising claims similarly ranging from calming effects to pain relief. Patient use fuels the research drive, which is rapidly increasing, and recent changes in the United States have paved the way for exciting new work. Both the safety and the potential therapeutic uses of these products need to be assessed for a range of indications. With the rapid expansion of new products, novel methods of use, and growing populations using these products for medical indications or for nonmedical use, regulatory restrictions are a major contributing factor to the limited data published addressing the most urgent questions on the potential effectiveness of products on the market for certain indications. Don't miss your opportunity to submit your CBD regulatory questions to our experts. Learn More & Register Previous Next