< 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

Asa and other industry leaders weigh in. < Back 30 supplement industry voices suggest changes to DSHEA NBJ Interview Asa and other industry leaders weigh in. Asa Waldstein, Supplement Advisory Group: "Since DSHEA was enacted before the internet boom, I would like to see some clarification on what constitutes allowable marketing in the digital sphere. For instance, if the FDA would define the marketing compliance boundaries of reposting and social engagement and help explain why they consider a social media post from years past as active marketing, it could help companies better navigate compliance. There are also antiquated regulations that should be updated, such as 21 CFR 101.93(d), which states that the DSHEA disclaimer should be “on the same panel or page that bears the (structure/function) statement” on labels. This means that if there’s a structure/function claim on the principal display panel, then the DSHEA disclaimer should also be on the same panel. While the FDA does not seem to enforce this, plaintiff attorneys continue to cite this regulation in lawsuits, which creates unnecessary expense (and ugly labels) for supplement companies." Read More Previous Next

Words like “may help with” is not a get-out-of-claims-jail-free card < Back Supplement & CBD company cited for disease claims Words like “may help with” is not a get-out-of-claims-jail-free card Supplement & CBD company cited for disease claims. #WarningLetterWednesday The FDA inspected the company facility in October 2021, then six months later reviewed the website for disease claims, finding many that resulted in a warning letter. This is a trend. In the past year, there have been several warning letters like this, where an FDA inspection led to a website review several months later, and many disease claims were uncovered. This is a friendly reminder to re-review the website for disease words after an FDA inspection, as they will look at this months later. Even well-intentioned companies may unknowingly have high-risk words lurking on old blogs and social media posts. Here is a post about this . From warning letter: “On your webpage for “Elderberry Plus Vitamin C”…“Aids with cold, flu and virus symptoms” Takeaway: This is an example of an unknowing copywriter using common language about elderberries, then copying this onto a product page. This is another reason to build a culture of compliance from within to help social and copywriter employees, the ‘front line of defense’ employees, understand how not to inadvertently turn a disease claim into a drug. I have lots of free content to support this, such as this post and video . This letter also includes CBD. There have been 26 CBD-related warning letters this year, up from just seven in 2021. This is a clear sign that the FDA will continue to focus on CBD companies making disease claims while essentially leaving CBD companies that follow GMP manufacturing practices and do not make risky claims alone. From warning letter: “CBD Gummies may help relieve pain, inflammation, anxiety, and depression.” Takeaway: Using words like “may” and “studies suggest” is not a get-out-of-claims-jail-free card. 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 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

Ensure statements are not disparaging < Back Best Practices When Making Competitor Comparison Claims Ensure statements are not disparaging Calling out the differences between your product and competitor products is permitted, but "poking the bear" often leads to competitor challenges. This NAD case involves a well-known mattress company challenging another competitor's claims as disparaging. The challenged claims in social media posts made statements such as the other mattress was "just a glorified air mattress." According to NAD, the advertisements created a "misleading impression, suggesting Sleep Number beds are comparable to temporary air mattresses that consumers would not use for their regular sleeping needs." Here is one example . So, where is the line between truthful comparison and being disparaging? Here are some tips. Truthful comparison : Keep the scope narrow and ensure you have supporting data while being careful with implied claims in imagery. 🔹 Truthful and supportable statements such as "Our foam conforms to your body shape while brand X's spring coils do not." 🔹 Comparisons based on objective tests or third-party data, such as "In lab testing, our mattress reduced pressure points by 30% versus air-chamber designs." 🔹 Puffery: I love this topic and have written more about it here . Disparaging claims : Implied claims like imagery matter! 🔹 Even if an actual statement is true, it can be disparaging if it infers negative connotations such as "basically an air mattress," which implies it is bad quality or uncomfortable unless there is undeniable and defensible supporting data. Read the NAD decision here . DATE ORIGINALLY POSTED: 4/30/25 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 Saturday Oct 8, 2022 What Can Marketers Learn From FDA/FTC Action? Lucky Leaf Expo, Jackson, MS 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

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

Following SOPs is essential to compliance < Back GMP Issues Following SOPs is essential to compliance There are so many important GMP lessons in this warning letter. Let’s see what we can learn. Botanical identification methods: When developing botanical specifications, ensuring they are complete is essential. In the warning letter, the company apparently did not add crucial aspects of specifications. From warning letter. “None of these components have a listed specification target, range, reference, or test method.” Incomplete 483 responses: When responding to 483s, it is important to follow through. Here, FDA cites the company for seemingly not providing the promised information. From FDA: “We have reviewed your response dated November 10, 2023. In your response you state you will create specifications for raw materials and that you estimate it will take approximately 90 days. You did not provide any documentation of your specifications, so we cannot evaluate the implementation.” Internal audits are a good best practice but are generally not required unless an SOP states this. In this warning letter, the company is cited for not following its own SOP. The lesson here is ensuring SOPs are developed with the entire company’s capabilities in mind, as SOP requirements can paint a company into a compliance corner. From warning letter. “You did not conduct periodic Good Manufacturing (GMP) internal audits of the entire plant with documented corrective actions, as required by your SOP... An internal audit has not been conducted since 2022." Master Manufacturing Records (MMRs) are the “recipe and directions” for making products. When I was in manufacturing, I would describe the MMR as this: “If someone has never made this product before, they can pick up the MMR and figure out how to make it perfectly every time.” Here FDA cites the company for not having a theoretical yield. This “lily pad” approach to quality is important to help catch issues before product leaves the building. For example, calculating theoretical yields catches issues such as inadvertently omitted ingredients or low capsule fill weight. From warning letter. “Statement of the percentage of theoretical yield at appropriate phases of processing” Cross-referencing labels to the formula is an essential part of GMPs. From warning letter. “Your MMR did not include a description of packaging and a representative label.” From warning letter. “Your MMR for does not include instructions for capsule drying or packaging operations. In addition, the MMR does not contain detailed instructions for the encapsulation process.” Allergen advisory statements are mentioned in this letter. I have never added this warning ‘because major allergens are either in the product or they are not.’ From warning letter. The … product label declares “Allergy warning: Manufactured in facility that also handles milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybean.” Advisory labeling is not a substitute for adherence to current good manufacturing practices and, when used by a facility, food allergen preventive controls. See Guidance for Industry: Questions and Answers Regarding Food Allergens Labeling , The firm should make every effort to ensure that they and their suppliers have adequate GMPs in place to prevent the unintentional inclusion of allergens in their products and ingredients. Read the full letter here . DATE ORIGINALLY POSTED: 11/6/24 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!

Trustpilot reviews can be “marketing” < Back Product Review Engagement Trustpilot reviews can be “marketing” CBD in tampons? During a GMP inspection at this company’s facility in Bulgaria, FDA determined that CBD is a drug product that deems the tampons adulterated. This, along with some disease claims and other violations related to vaginal microbiome screening kit claims, led to a warning letter. This is the ninth CBD (or delta 8) related warning letter in 2024 which is 47% less than last year, showing that CBD enforcement continued to plummet. As we know FDA is not a fan of CBD, especially when they feel it can be harmful. From warning letter. “FDA evaluated the regulatory decision form that you provided the investigator to support not needing a 510(k) for the CBD Coated … Tampons and found the assessment was inadequate because the CBD coating raises significant concerns regarding safety and effectiveness of the devices due to the potential for local and systemic exposure of CBD, potential adverse events (e.g., reproductive/developmental toxicity) associated with CBD, and potential effects due to the uncertainty of the potency and quality of the CBD (e.g., psychoactive effects from possible contaminants like Delta-9-tetrahydrocannabinol).” Product reviews: Agencies like FDA are typically “hands off” with third party product reviews if they are non-curated, non-compensated, are truthful, and are not showcased. The exception is when a company engages with third party reviews that contain disease claims, as this is considered an endorsement and turns a product review into a marketing claim. Here’s an example from the warning letter where the company engaged with reviewed on its Trustpilot site. Claims in product reviews typically appear in warning letters when they appear on a company website, but I’ve not seen this cited when hosted on platforms like Trustpilot, which reinforces the “Don’t engage with product reviews when they are risky words” rule. From warning letter showing how the company engaged with a review. “Trustpilot Web Site: “We're really sorry to hear that the CBD tampons didn’t work for you. Research shows that different bodies have different responses to CBD, and just as other forms of pain relief, annoyingly it won’t work for everyone.” Complaints on Trustpilot not investigated. Product complaints and safety issues need to be adequately investigated. Typically, customer complaints are emailed or called into the company, and once the company is aware of potential issues, it is its obligation to investigate. Interestingly, in the example, FDA requires the company to investigate third-party reviews on the Trustpilot site since they engaged with these reviews. As I discussed above, engaging with third-party reviews is an endorsement and makes them marketing. In this example, it also shows FDA that the company is aware of the issues and triggers the investigation requirement. This is the first time I’ve seen FDA mention this for third party reviews and companies should take note. We can also extrapolate that the FDA will want companies engaging with customer complaints on social media to properly investigate the issues as well. From warning letter. “Complaints related to the addition of CBD to … Tampons that were listed in Trustpilot or third party systems were given responses by your firm, but not logged and evaluated appropriately in your complaint handling system. The complaints indicate CBD … Tampons may have an impact on the patients’ health (e.g. CBD drug interactions) that exceed the expected risks associated with regular (non-CBD) tampons.” The company was also cited for selling a vaginal microbiome screening kit which FDA does not consider a general wellness kit. They determined this by reviewing the product’s claims like “Detect bacteria that cause vaginal infections like yeast infections” from their Amazon store, Trustpilot page, and website. I had never read the “General Wellness: Policy for Low Risk Devices” document before and it worth knowing about. From warning letter. “Your firm markets the device with diagnostic claims that are outside the scope of a general wellness device as described in the FDA guidance document “General Wellness: Policy for Low Risk Devices” at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices; and therefore, your device would need to be submitted for premarket review by the FDA.” Read the full warning letter here . This Warning Letter Wednesday post marks 52 weekly posts this year and over 150 since I started writing WLW. Thank you for all of your support! You are appreciated! DATE ORIGINALLY POSTED: 1/1/25 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!

Claims in videos are “fair game” for enforcement < Back YouTube Claims Lead To Warning Letter Claims in videos are “fair game” for enforcement YouTube video claims lead to a warning letter. The claims cited in this letter are not from people talking but from image text on the screen. This is the first time I have seen image text, not spoken words in a video, called out in a warning letter. This is the seventh warning letter this year that mentions claims made on YouTube. The FDA’s YouTube video search capabilities must have improved, and we can expect more enforcement of videos in the near future. Interestingly, I have found only one warning letter ever that mentions claims made on the Vimeo platform. Claims made on videos pique my interest, as YouTube video claims were nearly almost nonexistent a few years ago. I'm sometimes asked if purely educational video channels are fair game for FDA enforcement. My answer is “kind of” unless there is a commercial or material bridge; a URL on the channel, or In the comments that link back to where consumers can purchase similar products. No link to commerce = low risk of enforcement. The video cited in this letter provides a link to the commercial website in one of the video comments. From warning letter: “COCA LEAF REDUCES EATING ANXIETY ISSUES” at approximately 0:43sec in the video.” Read the full warning letter . DATE ORIGINALLY POSTED: 9/7/22 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 Feb 29, 2024 The Regulatory Universe & AI Naturally Informed Asa is excited to participate in "The Regulatory Universe & AI" discussion with technology genus Akash Shah at this Naturally Informed event. Asa will be talking about how technology and AI can make regulatory marketing compliance better, and will also share his "recipe" for how to best use AI and algorithms together. Your questions will be answered in a Q&A format. Learn More & Register Previous Next