Uncompliant hashtags attract FDA attention < Back 6-Year-Old Social Media Posts & Hashtags in Warning Letter Uncompliant hashtags attract FDA attention Today's #WarningLetterWednesday reminds us that the FDA considers old social media posts and hashtags marketing claims. Six-year-old social media posts, uncompliant hashtags, and product tags are mentioned in this warning letter. We have spoken about the importance of cleaning old non-compliant social media posts many times. Today's WLW is another reminder. Here is a post and video about this from a few months back. From FDA warning letter On your June 2, (Facebook) 2016 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 on a social media page that link to a product shopping cart are considered marketing claims. It is important to remember the “linking to a shopping cart” portion is the material connection that turns a general statement into a marketing statement. Here is a “Hashtags Are Claims ” video you may enjoy. From FDA warning letter On your February 27, 2017(Instagram) post: “#anxietyrelief” Here is a post and video about identifying and replacing high-risk “buzzwords. ” This is the first step in making online marketing compliant. Interestingly, product tags are mentioned in this letter. Product tags, like metatags, are not likely to attract warning letters on their own. They do, however, signal intended use to the FDA/FTC, showing the authorities. From FDA warning letter “Tags: anxiety, . . natural depression remedy” “Medical studies indicate that L-theanine is neuroprotective and can improve symptoms of depression, anxiety, insomnia, and cognitive impairment. . . . Here is a WLW post from July 2021 where metatags are mentioned . 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 Interview Thursday Nov 23, 2023 Managing Dietary Supplement Marketing Risks, with Asa Waldstein of the Supplement Advisory Group NutraPreneur Episode Overview Episode Topic : Join us in this episode of NutraPreneur as we delve into the intricate world of compliance and best practices in the dietary supplement industry with Asa Waldstein, principal of the Supplement Advisory Group and founder of Apex Compliance . Discover the strategies and insights that have shaped Asa’s approach to regulatory adherence and how the Supplement Advisory Group navigates the dynamic landscape of dietary supplement regulations. Lessons You’ll Learn : In this episode, you’ll gain insights into key strategies for mitigating marketing risks, ensuring compliance, and fostering a community approach within the industry. Learn about practical lower-risk solutions and essential elements in marketing and product labeling that not only meet regulatory standards but also enhance consumer trust. Understand the challenges and success stories encountered in implementing compliance best practices and discover the critical regulatory challenges on the horizon. About Our Guest : Our esteemed guest, Asa Waldstein, is the principal of the Supplement Advisory Group and the founder of Apex Compliance. With a wealth of experience in the dietary supplement industry, Asa has been instrumental in guiding marketers toward lower-risk strategies, ensuring compliance with regulatory standards, and fostering a culture of regulatory adherence within the industry. Take a firsthand look at Warning Letter Wednesday and unlock the secrets of FDA scrutiny and industry pitfalls. Topics Covered : In this episode, Asa shares key strategies for crafting foolproof compliance in marketing and product labelling. Beyond the challenges, he champions a community-driven approach and spills industry collaboration secrets. A sneak peek into the Supplement Advisory Group’s regulatory game plan adds a practical touch, making compliance not just informative but an enjoyable ride for marketers. Watch Previous Next

< Back Webinar Wednesday Mar 12, 2025 Beyond the Aisle: Navigating Marketing Compliance in the Supplement Industry SENPA Staying compliant with marketing claims is one of the biggest challenges retailers face in the natural products industry. With regulatory scrutiny increasing, understanding the nuances of the Dietary Supplement Health and Education Act (DSHEA) is more important than ever. Join us for the next session of Beyond the Aisle: Navigating Natural Products Retail, where we welcome Asa Waldstein, a seasoned regulatory consultant and clinical herbalist and founder of Apex Compliance, to break down what retailers need to know about compliance. During this insightful session, Asa will provide: ✅ A clear understanding of DSHEA and its impact on the herbal and dietary supplement industry. ✅ The difference between structure/function claims and disease claims—and how they affect marketing. ✅ Practical strategies to ensure your store’s marketing remains compliant, from product signage to digital advertising. - Date: Wednesday, March 12, 2025 ⏰ Time: 2:00 PM EST Don't risk compliance missteps that could put your business at risk. Register now to gain expert insights from Asa and learn how to navigate marketing claims with confidence. Register Previous Next

< Back Presentation, Online Wednesday May 18, 2022 Microbiome: Mastering the Market Naturally Informed powdered by Wholefoods Magazine and Trust Transparency Center Asa Waldstein presents a regulatory and enforcement update on notable action happening in the microbiome space. Watch Previous Next

Citing ingredient research is a marketing claim < Back Uncompliant Product Name Leads To Warning Letter Citing ingredient research is a marketing claim #WarningLetterWednesday This company received a warning letter for claims made in a product name. The product “Covid-19 Immune Support” is a bold Covid prevention and treatment claim. This is a basic but important reminder that product names are marketing claims. The company was also cited for referencing Covid studies for an ingredient in their products. This “implied claim” enforcement is a continuing trend, and I caution companies to remove ingredient study references that contain disease words from their website. I talk more about this here . This is a joint FDA and FTC warning letter and includes a cease and desist demand. I talk more about what this means here . 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!

Implied marketing statements should be compliant < Back Suggestive Words Like “May Help” Do Not Allow Risky Marketing Claims Implied marketing statements should be compliant I like to think of suggestive words like “may” and “could” as the compliance version of “with all due respect.” If I say “with all due respect” to someone, it doesn’t allow me to say whatever I want. The same is true with marketing statements. In this warning letter, the company was cited for making many suggestive disease claims. Marketers can learn what not to do from these examples. From warning letter. “Maca may also help…lower blood pressure ….” “It is known for aiding in…constipation, diarrhea, and diabetes!” It’s thought to be particularly effective against allergies and sinus infections.” “It’s often used as a folk remedy for…the common cold and flu.” This is a shorter Warning Letter Wednesday than normal as I’m attending the Organic and Natural Health Association conference in Florida, where I’m presenting Apex Compliance and participating in an "Amazon: Opportunities and Threats" panel. 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 Webinar Wednesday Jun 15, 2022 cGMP Facility Inspections Conducted by FDA: How Inspection Ready are You? AHPA Webinar This webinar is designed to help businesses in the dietary supplement industry understand the elements of current Good Manufacturing Practice (cGMP) regulations (21 CFR 111) that are the primary focus during U.S. Food and Drug Administration (FDA) facility inspections. FDA inspects facilities to ensure their compliance with regulations and laws surrounding the manufacturing, labeling, and handling of food, drugs, medical devices, and cosmetics that are commercially distributed in the U.S. Attend this webinar to gain insight on how FDA approaches GMP facility inspections, with the goal of understanding how to always be inspection ready as an organization, and how best to prepare for inspection by FDA. This knowledge will assist businesses in better allocating and directing their compliance resources. Prior to the COVID-19 pandemic, an inspector could drop by your facility at any time without advance warning. In light of the pandemic, FDA will now pre-announce domestic onsite inspections of regulated businesses, excluding tobacco inspections. Having a plan in place that includes inspection best practices will go a long way in eliminating the stress that undoubtedly comes when you’re put on notice that an inspection is imminent. Join us on June 15, 2022 (10am-12pm PT / 1-3pm ET), when our expert presenters will: Provide an overview of the current cGMP enforcement landscape – who, what, where and why FDA can inspect Provide examples of how to prepare for an FDA inspection Review the dos and don’ts of working with an FDA inspector in your facility Share first account FDA inspection experiences Presenters Asa Waldstein , CEO, Supplement Advisory Group Will Woodlee, Esq., , Partner, Kleinfeld, Kaplan & Becker, LLP / AHPA General Counsel Steven Yeager , Director of Quality and Regulatory Affairs, Mountain Rose Herbs Cost AHPA Members: $199 Non-Members: $399 Register Previous Next

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 Podcast, Interview Monday Feb 14, 2022 Asa Waldstein demystifies the CBD marketplace Health Quest Podcast In this interview Asa Waldstein will explain how CBD is regulated and how consumers can identify trustworthy companies and products. Asa describes some of the challenges faced by companies as well. The challenges are significant. CBD is regulated one way by FDA and states regulate CBD in variety of ways. The quality and potency of CBD products is all over the place with many products being unreliable for numerous reasons. Asa also gives us numerous resources that will help give clarity. Listen Previous Next

< Back Panel Discussion Wednesday Mar 29, 2023 Claims, Compliance, COA panel NoCo Hemp Expo Colorado Springs, CO For nearly a decade, NoCo Hemp Expo — the world’s most comprehensive industrial hemp exposition and conference — has brought together international business and government leaders, academia, nonprofits, media and the public to collaborate on important initiatives, opportunities and solutions for the future of a crop and an industry that can have significant positive impact on human, animal and planetary health. Claims, Compliance, COA panelists include: Asa Waldstein Marielle Weintraub, Ph.D. Christopher Hudalla Holly Bell Jackie Bowen Learn More Previous Next