< 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

Product tags are marketing claims < Back FSMA Compliance Lessons Product tags are marketing claims For those still learning about FSMA, food labeling, nutrient content claims, and website marketing claims, reading this post and the entire warning letter is suggested. This letter is a lesson in what not to do when operating a conventional food company, but the supplement industry can also learn from the website disease claims and some of the FSMA requirements referenced here. Wow, this was a fun post to write, and I could have written a small novel with the learning opportunities. For now, here are the high points. 🔷First, let’s talk about the marketing claims (my favorite topic). 🔹 Product tags are mentioned in this warning letter. The company was using product tags to market the intended use of the product, such as “depression” and “anxiety.” I haven’t seen product tags cited in a warning letter for a while, but this is a good reminder that product tags are marketing. I write more about product tags and meta tags here . 🔹 The product descriptions also include numerous disease claims such as “Helps Fight Infections Like Cold & Flu.” Even though the company was inspected in April 2023, FDA did not start reviewing its website until three months later. This trend reminds companies that have been inspected to review their online marketing. Removing these serious claims would have helped the company avoid this scathing warning letter. I write more about this here . 🔷Several of the herbal products had a bizarre DSHEA-like disclaimer on the labels. The products were labeled with Nutrition Fact Panels but had the following warning. This is so weird I had to add it to this post. 👉From warning letter. “Statements regarding dietary supplement have not been evaluated by the FDA and are not intended to diagnose, treat, cure, or prevent and [sic] disease or health condition.” 👉FDA then adds these comments. “To the extent you intend these products to be conventional foods, you should not refer to them as dietary supplements. We note that, under section 201(ff)(2)(B) of the Act, a dietary supplement “means a product that . . . is not represented for use as a conventional food or as a sole item of a meal or the diet.” 🔷The term antioxidant has an FDA definition, but it’s not commonly cited in warning letters. In this letter, the company was labeling some of its herbal products with the term “powerful antioxidants,” but since the product doesn’t contain ingredients with a %DV like vitamin A, this is not a compliant claim. 🔷The warning letter also references that the cleaning products used for food contact surfaces are not for commercial food contact use. The lesson here is ensuring that the cleaning products used are suitable for food contact use and that they do not leave a residue. When I was overseeing supplement manufacturing facilities, we used food-grade hydrogen peroxide to clean food surfaces, which was also compliant with organic processor/handler regulations. 👉From warning letter. “You stated that you use Mrs. Meyer’s Clean Day Multi-Surface Concentrate as the main cleaning solution for cleaning all areas of the facility, including food-contact surfaces. This is labeled as a household cleaner, not for use on food-contact equipment in a food manufacturing facility.” 🔷The company provided a 483 response that seemed to be incomplete. As we’ve discussed many times, most 483s can be avoided with comprehensive responses. 483 responses must provide proof that the corrective action has been taken. Here, the company did not follow through on providing evidence of this. 👉The 483 responses stated in the warning letter that “all FDA-compliant Food Safety Program documentation to be completed within 3 weeks of receiving back a signed proposal, a deposit payment and a completed client intake questionnaire.” 👉FDA then responded: “We cannot fully evaluate your response because you did not submit the completed food safety program or how you will assure that your facility is compliant with all FDA requirements.” 🔷There are so many great CFR 117 learning opportunities in this letter, such as incomplete hazard analysis and labeling for major allergens and the identification and evaluation of pathogens like Salmonella in the supply chain. Determining if hazards exist and if they need preventative controls is a core principle of FSMA (CFR 117). 🔷This FDA document shows what CFR 117 regulations supplement companies must comply with. It’s also a good resource for FSMA in general. 🔷Advisory statement labeling: We’ve all seen statements like “May be packaged in a facility that also packs nuts.” Here’s FDA clarifies this is not a substitute for GMPs. 👉 From warning letter. Advisory labeling is not a substitute for adherence to current good manufacturing practices and, when used by a facility, food allergen preventive controls. 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!

Minor label issues signal deeper compliance issues < Back Labeling Lessons Minor label issues signal deeper compliance issues This warning letter has numerous examples of what not to do when labeling supplements. Here’s what we can learn. 🔹Incorrect statement of identity: The statement of identity is one of core required elements on supplement labels. “Dietary Supplement” is most common but if accurate terms like “Vitamin Supplement” or “Herbal Supplement” are allowed. In this warning letter, FDA cited “Nutritional Supplement” as not being a compliant statement of identity. You can see how “vitamin” is descriptive, whereas “nutritional” is not specific enough. 🔹Serving sizes: This product’s serving size is listed as 1 to 3 teaspoons twice a day, but the supplement fact panel lists the serving size as one teaspoon. A serving is the “maximum amount consumed per eating occasion,” which is three teaspoons in this example. The company could have kept the one-teaspoon serving size on the label by updating it to “one teaspoon up the 3x daily.” I review a lot of labels with my work at Supplement Advisory Group, and this issue is more common than you may think. 🔹Adverse event reporting: A full domestic address or domestic phone number is needed for adverse event reporting requirements. 🔹Supplement fact panel layout: 🔺From warning letter. “The statement “Daily Value Not Established” is not linked to a symbol linking it to the heading “%DV heading,” which is not in accordance with 21 CFR 101.36(b)(2)(iii)(F).” 🔺Servings per container: Did you know that the servings per container may be omitted when stated in the net quantity of contents declaration? 🔹Missing DSHEA disclaimer: From warning letter. “The labels make structure/function claims but fail to bear the required FDA disclaimer, in accordance with 21 CFR 101.93(b)-(e).” Are you interested in learning more about nutrient content claims? Here is my write-up . Here are more labeling citations from previous warning letters. Do you need support with labeling compliance? I love this stuff! Read the full warning letter . DATE ORIGINALLY POSTED: 6/11/25 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!

Asa and other leaders interviewed < Back Predictions for 2021: What's ahead for the hemp sector Hemp Industry Daily staff Interview Asa and other leaders interviewed Read More Previous Next

< 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

Learn from other’s mistakes < Back TCM Company GMP & Marketing Violations Learn from other’s mistakes FDA inspected this TCM manufacturing and product company earlier in the year, including looking at its product catalog and website. This led to GMP and disease claim citations. Let’s start with the disease claims. Some of these may be considered TCM verbiage, but this is an important reminder that using common Traditional Chinese Medicine (TCM) or herbal language doesn’t necessarily translate into compliant marketing. From warning letter. “Staunches bleeding, disperses swellings, and relieves pain” “Expels pathogens, resolves depression” Product catalog: This is a reminder that anything FDA sees during inspection can be reviewed, including shipping inserts. I remember years ago almost forgetting to discard old “potentially non-compliant” product brochures that were collecting dust on a shipping shelf. If FDA found these during an inspection, they would have been “fair game” for them to collect and review. Now for the GMP issues. There are a lot of learning opportunities here. Identity specifications. In most cases, organoleptic (e.g., color, taste, smell, feel) testing is not sufficient to determine botanical identity. However, if the plant came in whole leaf (rather than powder), for example, I think a case can be made that organoleptic testing may be sufficient. From warning letter. “Analysis of organoleptic factors does not provide unique information that is specific to each of these ingredients and thus cannot confirm the identity of each ingredient.” Metal detection. This is one we don’t see very often. From warning letter. “You failed to use effective measures to protect against the inclusion of metal or other foreign material in components and dietary supplements, as required by 21 CFR 111.365(i).” Incomplete MMR instructions. I like to think of the MMR and BPR as recipes. If a new team manufactures the product, does the MMR/BPR have all the needed instructions? This is to maintain consistency in product manufacturing. From warning letter. “Your master manufacturing records (MMR) failed to include written instructions and specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement products and that the dietary supplement is packaged and labeled.” Product specifications. Not having complete specifications is one of the most common GMP violations. Here FDA states that the provided microbial and heavy metal specifications are not enough to justify the product’s identity, purity, strength, and composition. I ask, if the product contained only botanicals, what else is needed to verify this? One answer is that a finished product composition test is needed, which is an expensive method to develop and test. From warning letter. “The physical and chemical factors do not constitute unique criteria that can confirm the identity of these products and do not evaluate the purity, strength, or composition of these finished products.” Here are some labeling citations. Structure function claims on labels not linked to FDA disclaimer . This is showing up in more warning letters. Plant parts should be listed on the label. I personally think that “herb” is descriptive, but according to FDA, it is not sufficient. From warning letter. For example, “herb” does not identify the plant part used in the product. If the whole or entire plant is used, that information must be listed. Listing the ingredient name common correctly. From warning letter. “Citrus” which is not the common or usual name of an ingredient. Solvents should be listed . This is not to be confused with processing aids, which, in most cases, do not need to be listed. From warning letter. “(the label) fail(s) to declare the solvent used in the extract within the ingredient list. Other comments in the warning letter are important reminders of labeling and GMP compliance. Expiration dates: The company did not have supporting data for its “best by” dates. Expiration or freshness dates are not required on supplements, but when they are used, the company must have supporting data. In my experience, this does not have to be super complicated and may include a time-zero and a 1 to 2-year-old product tested for organoleptic, microbial, and line item assay tests. Facility registration : It looks like the company did not update its facility registration within 60 days of important changes. Read the full warning letter here . DATE ORIGINALLY POSTED: 10/2/24 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 Online, Panel Discussion Thursday Jun 12, 2025 How a rapidly evolving world is transforming dietary supplement innovation – summit Inside the Bottle Summit The supplement industry plays a pivotal role in supporting consumer well-being. Today’s consumers want their supplements to do a lot –– provide benefits as marketed and do so in proven and personalized ways, all while remaining accessible and affordably within reach. The rapid adoption of AI can help deliver on the promise of personalization and impact the pace at which new discoveries and solutions can come to market. All of this must also happen in an environment of changing supply chain management and regulations within a global economy. The industry is ready to meet these challenges and will remain a key partner in improving consumer health. The supplement industry is transforming the way it approaches innovation, while maintaining integrity and its core vision for health. Our 2025 Inside the Bottle Summit places data and research at the center of the narrative. Join leading experts, share your voice in the community forum, learn about hot category trends and dive into the critical data-driven orientation that is shaping the dietary supplement industry today. Don’t miss this opportunity to build a roadmap for the future of your business. Age nda: Session 1 : NBJ and SPINS industry numbers and winning category predictions to get on shelf and stay on shelf Nutrition Business Journal Market Data Analyst Erika Rommel Craft unveils up-to-date supplement industry numbers and key factors influencing purchasing trends. SPINS Senior Director of Market Insights Scott Dicker joins Erika to overview product category winners driving growth and fueling new product opportunities. Build your supplement business strategy with concepts that meet consumers' desire for effective products that meet healthspan needs. This is do-not-miss content for anyone engaged in new product development and merchandising strategies. Session 2: What today’s consumers demand: How validated solutions are redefining brand trust and evidence-backed innovation Consumers want products that provide trusted solutions. How can the industry leverage AI to deliver personalized products that work –– validating that the promise of claims on pack and the intended benefits inside the bottle deliver? A “one size fits all” solution may obscure personalization. For brands to win in a competitive market they must focus on producing targeted solutions. Learn how precision insights powered by large and diverse population trial data provide personalization wisdom that can enable new market opportunities. Session 3 : Transforming health and product pipeline: Traditional wisdom supercharged by modern science and clinical methods Traditional wisdom and healing practices are the inspiration and foundation of the dietary supplement industry. Consumers rightly demand efficacious products. How can brands create products that appeal to the wisdom of the ages while confidently knowing the intended benefit will be delivered? This session dives into the value of evidence-based ingredients rooted in tradition and validated by research, overviewing ingredient lifecycle –– from traditional knowledge, to compound discovery, to clinical evidence –– for formulating and merchandising products with confidence. Session 4 : Nothing constant but change: Key perspectives on today’s regulatory landscape It has been stated that we live in interesting times. What’s happening today at FDA and what implications may there be for the U.S. dietary supplement industry regulatory landscape and enforcement? We’ll hear observations and insights from compliance expert Asa Waldstein on where the industry should maintain attention and consider potential action items to support a strong industry. Learn More and Access Webinar Previous Next