Delta-8 is a high-risk ingredient < Back Unallowable Ingredient “Enough” to Trigger Regulatory Action Delta-8 is a high-risk ingredient There has been a recent enforcement trend where having an unallowable ingredient in a product can result in a warning letter, even if no disease claims or GMP violations are mentioned. This warning letter is the sixth CBD or delta-8 related warning letter this year, which shows that FDA is still taking this enforcement seriously, especially when delta-8 is added. Here’s a recent write-up on an unallowable (or possibly an un-submitted NDI) ingredient triggering a warning letter. I usually don’t call out company or product names, but this one is too strange to pass up. From warning letter: “Trippy Smak’d Fuk’d Blend Watermelon 1500 mg Gummies” I would call this letter a “low effort” warning letter, but FDA actually purchased the product and tested it for delta-8. The moral of the story is that any company selling delta-8, even if they are not making disease claims, should be put on notice that the FDA is paying attention, especially if the delta-8 products are in packaging and formats favorable to children. Learn more about FDA’s position and its safety concerns here . Read the letter here . DATE ORIGINALLY POSTED: 8/13/25 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

< Back Interview Sunday Feb 21, 2021 Know Your Legal GMP's Herbally Yours I talk about my herbalism journey, the American Herbalist Guild, dietary supplement safety, AHPA, GMP's, and more! Listen Here Previous Next

Disease claims trigger deeper FDA review < Back Drug Spiked Warning Letters Disease claims trigger deeper FDA review FDA sent three warning letters this week to companies selling drug-spiked ingredients like diclofenac and methocarbamol. This is a short Warning Letter Wednesday as I am writing this from holiday on the Sea of Corinth in Greece. Follow previous WLWs here . This continues the trend of FDA testing products for drugs like these. I thought it would be interesting to explore what we can learn from these types of products. Disease claims, especially in the joint health category, can trigger FDA to examine the product and company more closely. From warning letter: “Artritis” (English translation: Arthritis)” Recalls signal manufacturing and quality issues and allow the FDA to look deeper at the company’s QA/QC processes. Here is FDA’s Health Fraud Database , which links to drug-spiked product notifications and recalls. This is a good resource to help you identify what potential contaminants to test for in your products. FDA follows the “breadcrumbs” of non-compliance. When FDA inspects a facility, issues a public notification, investigates a recall, or finds a brand with issues, it will “follow the trail” to see what other similar violations it can find. For example, when a recall is reported for a drug-spiked ingredient, the FDA will look to other places where this brand may be sold, such as marketplace sites. Many of the previous diclofenac spiked products included Spanish language supplement labels. This set of letters included both Chinese and Spanish language labels. This may be because, in some cases, there may be less quality control for products manufactured for the Spanish language community. DATE ORIGINALLY POSTED: 9/4/24 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!

Distributors are responsible for the products they distribute < Back Amazon & Others Cited for Selling Injectables Distributors are responsible for the products they distribute Another Amazon warning letter, this time for distributing products apparently intended for injection, such as the “L-Carnitine Body Serum Ampoule.” This is part of a group of at least six warning letters issued to companies selling similar products. FDA did some good detective work here to determine whether the products were drugs masquerading as body care products. 👉From warning letter. “The QR code sticker on the product package directs to the URL website xxxx, which includes a link to the website xxxx, which redirects consumers to the website xxxx.” This final website then links to social media accounts where they cite claims like “Discover a non-surgical alternative to liposuction that effectively targets and eliminates unwanted fat, giving you the body confidence you’ve been striving for.” Although it does not seem the companies are explicitly marketing their products as injectables, the packaging and corresponding claims imply the intended use. As more GLP-1 injectable products receive warning letters, this appears to be part of a second wave targeting any type of injectable for fat loss. We should expect more warning letters like this, especially since other major retailers like Walmart seem to continue to offer some of these products. As we’ve discussed before, since Amazon handles (fulfills) the product, they have a responsibility to ensure the products they are distributing are compliant. I suggest everyone read the warning letter footnote that cited Amazon’s product handling. This is a good reminder that product distributors have responsibility and liability. I write more about this here . According to FDA, Amazon is “responsible for introducing or delivering for introduction into interstate commerce these products, which are unapproved new drugs.” FDA is rightfully concerned about injectable products being sold on the open market, as they refer to potential safety issues. 👉From warning letter. “These products are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.” Read the warning letter here . DATE ORIGINALLY POSTED: 3/12/25 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!