All social media is “fair game” for enforcement < Back LinkedIn Posts Mentioned in Warning Letter All social media is “fair game” for enforcement It is no surprise that company social media posts are considered marketing claims, as they are commonly mentioned in warning letters. Interestingly, this letter references posts made on LinkedIn. This is a new aspect of enforcement, as previously, I have only seen claims made on a company's LinkedIn page mentioned in warning letters. I find it interesting the FDA is looking at actual posts on LinkedIn, which is an important reminder that all marketing must be compliant and is "fair game" for regulatory scrutiny. This warning letter is Covid-related, which, of course, is a very high risk; however, it is a reminder that hashtags and reposting content elevate risk. In this example, a "Covid study" is shared, and the material connection is solidified with a covid hashtag and a hashtag containing the product's name. From Warning Letter "More evidence that respiratory diseases should be treated in the nose and throat! .... # biovanta # science # covid" [from a post on your social media webpage at...." Read the full warning letter here. This joint FDA and FTC warning letter includes an FTC cease and desist prohibiting the company from making future Covid claims. This sets the FTC up to potentially impose financial penalties and has more "teeth" than a standard 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!

< Back Presentation, Online Thursday Dec 7, 2023 Making Your (Compliant) Message Shine: Best Practices for Reaching & Engaging Consumers Naturally Informed The goal for 2023: to live stronger, longer. Consumers today are focused on extending health span, defined as the period of one’s life that one is healthy. Emphasis on the healthy, because we want to stay active and energized into our golden years. And more than ever before, younger generations are recognizing that to stay vibrant, one must be proactive. That realization has opened this market up to consumers of all ages who are seeking out nutritional supplements and functional foods and beverages to help them achieve their goals. During this three-day virtual conference, leading experts will discuss the active aging market and trending subcategories. Cognitive health, bone and joint support, libido, and more will be covered, with a look at the latest science on ingredients, consumer market trends, and business strategies. Join us for A+ education that can help you succeed in this space and master this market. Zoom Registration Register Previous Next

< Back Presentation, Panel Discussion Saturday Nov 6, 2021 Presenter: What Can Marketers Learn From FDA/FTC Action? Panelist: Business and Marketing Panel Lucky Leaf Expo, Houston, TX In this session, we review recent enforcement trends and discuss ways companies operating in the hemp-CBD marketplace can limit their risk, while still be truthful and not misleading. This includes identifying high-risk verbiage and providing examples of lower-risk ways to get the same message across. This discussion reviews the dos and don'ts of digital marketing such as best practices for blog posts. Learn more Previous Next

< Back Podcast Wednesday Feb 1, 2023 Asa Waldstein - Principal @ Supplement Advisory Group | FDA Enforcement Trends + Social Media Ingredients for Success Podcast On this episode, @AsaWaldstein Principal @ Supplement Advisory Group, joined the show to discuss FDA Enforcement Trends for 2023, Social Media Compliance, and his weekly newsletter, Warning Letter Wednesday. Asa is a Certified Clinical Herbalist and a 20-year dietary supplement executive. Asa's consulting company, Supplement Advisory Group, is a boutique group focusing on marketing risk analysis and practical marketing solutions for the web and social media. He chairs the American Herbal Products Association's (AHPA) Cannabis Committee. Watch Previous Next

According to a Federal Trade Commission official, settlements in a law enforcement sweep against CBD marketers send a "clear message" to the growing sector: "Don’t make spurious health claims that are unsupported by medical science." < Back FTC targets CBD marketers in law enforcement sweep Josh Long Interview According to a Federal Trade Commission official, settlements in a law enforcement sweep against CBD marketers send a "clear message" to the growing sector: "Don’t make spurious health claims that are unsupported by medical science." Read More Previous Next

Formats that are favorable to children should be avoided < Back Another Delta 8 Warning Letter Formats that are favorable to children should be avoided This is the tenth FDA delta 8 warning letter this year, which is an important reminder that delta 8 THC is still on FDA’s mind, especially when it’s sold in formats that are favorable to children, like candy ropes. Distributors are responsible: This website distributes products from several different companies, demonstrating that even companies that sell other’s products are responsible. I think of this as a mini-Amazon, and I expect more distributors selling high-risk items to be called out in the near future. Favorable to children: FDA takes dangerous products in forms that appeal to children very seriously. Products such as delta 8 infused snacks with names like “Not Ya Son’s Weed Bakedies Delta 8 THC 600MG Crispy Bites” were cited in this letter. The takeaway here is that companies selling delta 8 are a high risk for FDA enforcement, especially if they sell products in forms favorable to children, such as candy. Past delta 8 warning letters were jointly issued by FTC and FDA, which usually come with more “teeth,” such as a cease and desist. This company was “lucky” this is “only” an FDA warning letter. Since there are no marketing claims cited in this and many previous letters, you may be asking what the FTC has to do with this. Interestingly, marketing unsafe products, especially to children, is considered deceptive marketing. Go FTC! From the previous 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.” Also, I ran Apex Compliance on the company’s website and found a motherlode of high-risk claims such as cancer and opioid support statements. I wonder why FDA did not cite these. I’d love to show you what Apex Compliance finds on your site. Schedule a demo . I write more about FDA’s position on delta 8 and the previous warning letters here . Read the 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!

< Back Podcast Monday Oct 24, 2022 Avoiding Marketing Risk and Remaining Compliant To Be Blunt with Shayda Toradi Asa Waldstein's best practices for avoiding marketing risk while staying compliant, herbalism, hemp regulations, and much more! Listen Here Previous Next

Don’t engage with risky reviews < Back Product Reviews Become Marketing Don’t engage with risky reviews In this warning letter, the company engaged with "third-party" reviews on its website, which turned them into marketing. If product reviews are collected and displayed on a website, the agencies are generally "hands-off" as long as they are: Third-party Honest: The honest experience with the product. Here's an FTC case concerning Google and I Heart Radio from a couple of years ago. Not solicited: Such as "a free product for a favorable review." Non-curated: Don't favor positive reviews. Also, conglomerating reviews on a "Reviews" page can be considered curation. Non-compensated: No paid influencers or free products unless disclosed. Not showcased: Such as those highlighted in a banner or a social media image. Not engaged with: These reviews become marketing when a company showcases them in a banner or social media post or engages with them on their website or social media. When in doubt, don't engage is a good rule for product reviews and testimonials. Not hidden negative reviews: FTC pays attention to companies hiding negative reviews, and, in some cases, hands down big fines, such as this $4.2 million case against Fashion Nova . Some companies go the extra mile and delete any reviews or testimonials that contain disease words. This is fine as long as you have a documented policy that treats positive and negative reviews the same. Here's an example from the warning letter. From warning letter. "January 24, 2023 customer review states, "I have been using this CBD for my pup who has seizures for some time, since starting CBD she has not had one. I like that there are no unnecessary ingredients, and she takes it with no problems." (company) replied, "Thank you for the review, (b)(6) That is amazing news - we are so glad to hear that your pup's seizures stopped!!!" There is so much more to this warning letter. Read it here . DATE ORIGINALLY POSTED: 10/23/24 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!

< Back Interview Thursday Jun 4, 2020 Cannabis, CBD, Regulations, & AHPA CannabisRadio.com Concierge For a Better Living Cannabis, CBD, Regulations, and AHPA are what Asa Waldstein, a veteran of the dietary supplement industry, sit down and talk about in today’s episode of Concierge For Better Living with Doc Rob. During these tough times, it gets harder and harder to find the light at the end of the tunnel. Asa helps do this by diving deep into the dietary faction of cannabis. He also explains how old practices such as canning, can and are making a comeback in today’s cannabis industry. Listen Previous Next

< Back Webinar Wednesday Jan 20, 2021 Label & Marketing Claims: Fireside Chat Asa's Regulatory Education Series We discuss label and marketing claims which impact the dietary supplement and hemp industries. This is reviewed from a legal, regulatory, and marketing viewpoint. Made in the USA & All Natural: What can you say and what is the risk? Type of claims: structure-function, qualified, etc. What defines clinically proven? Review nutrient content claims: Free Of, Good Source, High-In A quick primer on Prop 65 including labeling Risks associated with making claims And more! I am joined by two expert guests. Douglas Kalman Ph.D., RD, FACN, FISSN , is the Vice President of Scientific Affairs for Nutrasource, a nutrition-centric Contract Research & Service Organization. Erica W. Stump is the owner and founder of the Erica W. Stump, P.A. law firm. Watch Previous Next