Presentation < Back Mental Wellbeing in Today's Digital Age Isabella Davis Press Mention, Data Mention Presentation Read More Previous Next

< Back Meet-Up Group Tuesday Feb 11, 2020 Founder's Night: Iconic CEO's share their stories Boulder Hemp-CBD Group Meet-Up Boulder Hemp-CBD Group Meet-Up hosted by Asa (In-person) A special Founders Night, a Fireside Chat format with two CEOs sharing their personal journeys, visions of where the market is going, and the host of decisions they need to make--business and regulatory both-as their companies grow. How do their companies deal with ever-changing regulations? How much budget and staff do they allocate for Regulatory compliance? Do venture capitalists take compliance into consideration when investing, both budget and company attitude? I am joined by special guests: Nancy Whiteman , well-known CEO of Wana Brands. Patrick Rea , CEO, and Co-Founder of Canopy Boulder See Pictures 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!

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

All claims should be substantiated < Back Key Takeaways From FTC “Warning” to ~670 Companies All claims should be substantiated Most of us have heard about the recent FTC notice of penalty offense sent to ~670 companies. To those not on the list, mazel tov. This FTC action puts these companies on notice that claims must be substantiated, and endorsement guidelines must be followed, or the companies can face fines of $50,120 per violation. Here is FTC’s press release , which includes links to the list of companies that received the warning and the letter to the recipients. This is worth reading, but I share some key points below. So why did “these” companies get cited? My Magic 8 ball did not tell me the answer, but I am guessing that search terms like “proven safety,” “scientifically proven,” and “clinically proven” were trigger words. Most of the companies on the list have exquisite compliance, and I verified this using my Apex Compliance program, but there are a few that certainly need a lot of regulatory help to be compliant. I wonder if these blanket “you haven’t done anything wrong, but you are warned” statements are fair. FTC could have found egregious violators with a quick Google search. The action warns companies about two sections of advertising basics: Substantiation & Endorsements Substantiation : We all know that claims should be substantiated, but here are the notable items from FTC’s Substantiation Notice. Product safety : FDA’s supplement regulations require products to be safe, and FTC reminds us that companies should have data to back to this. Discussing “proven safety” likely elevates the risk of FTC scrutiny. Supplements have parameters to ensure these are used safely. They have warnings about potential risks such as “not for use in pregnancy,” “may elevate blood pressure when used long term,” or “may interfere with medications,” and they also have serving suggestions to ensure they are used within safe constraints. I ask, “Is there any reason to claim safe supplements?” Health benefits : This is a broad statement. So, what is a “health benefit?” I think of structure-function statements such as “joint support” or “helps with sleep” as health benefit statements. FTC says all health benefits need to be substantiated, which is common knowledge, but I don’t think FTC will start asking companies for their structure-function dossiers anytime soon. I see this more as a gentle reminder about the basics of advertising and substantiation. However, implying there is clinical proof to support a structure-function claim will attract attention. Mitigates or treats disease : This is obvious, and I expect this to be where much of the FTC’s substantiation enforcement will be. This is even more reason to ensure marketing does not have disease claims. Apex Compliance, my patent pending SaaS compliance program, scan websites, YouTube, and uploaded content for compliance concerns like disease words. Learn more here . Clinically proven statements : This is also where FTC will likely focus its enforcement action. Stating that ingredients have “proven efficacy” or that products are “clinically proven” or “scientifically proven” is a high substantiation standard that will certainly attract FTC and plaintiff attorney scrutiny. Apex Compliance can scan for any phrase, such as “clinically proven.” Set up some time to learn about it here . The Substantiation Notice is not all about health claims. It also applies to claims about efficacy statements such as “phospholipids added for increased absorption” or “helps with weight loss” and performance claims like “fast-acting.” I don’t expect FTC action solely for these lower-risk statements, but the mantra is that everything should have substantiation. From FTC press release: “the notice is not limited to health claims and applies to any marketer making claims about the efficacy or performance of its products.” Endorsements : The other part of the FTC “warning” concerns endorsements. Here are some key points, but most are obvious. Our purchasing behavior is affected by influencers and product reviews, so steps to keep this part of marketing ethical are a good thing. Thanks, FTC! Falsely claiming a 3rd party endorsement of a product when they don’t, such as stating, “Tom Hanks loves my product.” Misrepresenting that an endorsement represents the experience or opinions of product users. Of course, someone shouldn’t say I take this product every day when they’ve never tried it. This FTC lawsuit against Google and iHeartMedia is a great example. Using an endorsement to make deceptive claims (like disease claims). If you can’t say it on a product label, an endorsement shouldn’t either. I write about how a customer social media post becomes an endorsed testimonial here . Failing to disclose material connection: This is so basic, but many influencers skip over this, especially on TikTok. Here are some tips for disclosing material connection. Fake reviews: Right on FTC! Yes, fake reviews are bad. How about withholding unfavorable reviews; this led to this 4.2 million dollar fine . 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 Wednesday Feb 19, 2025 Key Takeaways for Dietary Supplement Marketers NutraIngredients: Weight Management Summit San Diego The Weight Management Summit , hosted by NutraIngredients-USA and in association with Iovate Health Sciences . This dynamic half-day summit that dives deep into the rapidly transforming weight management landscape. Gain valuable insights into the latest market trends, evolving regulatory frameworks, and groundbreaking science behind dietary ingredients as natural alternatives to GLP-1 drugs, along with solutions to manage their side effects. Discover actionable strategies to effectively engage and inspire today’s informed consumer, equipping your brand to thrive in this competitive space. Learn More & Book Your Ticket Previous Next

Learn from others’ mistakes < Back Dietary Supplement Manufacturing & Marketing Lessons Learn from others’ mistakes Dietary supplement manufacturing and marketing issues are all cited in this warning letter. This feels like a trip way back in time when GMP regulations and compliance for “supplements” were likely not top of mind. Here’s what we can learn. GMP compliance: One of the many violations in this letter involves the Batch Production Record (BPR). Although these are fundamental aspects of GMP compliance, re-reviewing these glaring oversights is always a good reminder. Here are some of the issues FDA pointed out. 🔺Missing batch, lot, or control number. This is how the product is categorized and tracked. 🔺Missing the date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch or a cross-reference to records, such as individual equipment logs, where this information is retained. This proves that cleaning has occurred and is especially important when reviewing product quality investigations, such as verifying whether major allergen cleaning was conducted. 🔺Missing identity and weight or measure of each component used. 🔺Missing statement of the actual yield and a statement of the percentage of theoretical yield at appropriate processing phases. This is one way the formulations are verified to ensure ingredients were not missed or double-counted and that bottles have the correct weight. 🔺Missing initials of the person responsible for verifying the weight or measure of each component used in the batch. This is the doer and checker system to ensure weights are added correctly and then verified by another party. 🔺 Missing actual or representative label or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record. This is important to prevent labeling mix-ups, which can be very dangerous. 🔺Missing documentation at the time of performance that quality control personnel approved and released, or rejected, the batch for distribution. Quality must review and release/reject the batch without exception. Marketing claims: This warning letter contains some of the most sever disease claims I’ve read in a long time. The claims appear on website product pages and actual labels. 👉From warning letter. “Recommended Package: Cancer . . . This package contains the following products. . Calcium 2 OZ Bottle . . . Magnesium 2 OZ Bottle . . . Silver 2 OZ Bottle” 👉From warning letter, “On the product label for Silver, 8oz: - “Silver is a potent natural antibacterial, antiviral, and antifungal.” Sadly, the website remains filled with disease claims and non-compliant product labels. Read the full letter here . DATE ORIGINALLY POSTED: 7/2/25 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 Meet-Up Group Wednesday Jan 15, 2020 FDA and Class Action Enforcement Trends & Updates: Fireside Chat Asa's Regulatory Education Series Boulder Hemp-CBD Group Meet-Up hosted by Asa (In-person) In any rapidly emerging industry building a community to help support each other in education, compliance, and in developing best practices is always a good idea. This is a fireside chat format to discuss FDA and class action enforcement and trends. We expect an update from the FDA soon and we can likely guess there will be more lawsuits and perhaps more warning letters as well. I am joined by special guests: Garrett Graff , Managing Attorney of Hoban Law Group Dave Rodman , Founder of the Rodman Law Group Read more Previous Next