Opioid support claims are high risk < Back Kratom Claims Enforcement Increasing Opioid support claims are high risk There have been four kratom warning letters this year compared to just one last year, a 400% increase. This shows there has never been a riskier time than now to market kratom with disease claims. All kratom warning letters this year involve claims related to opioid withdrawal. Products marketed for opioid and substance withdrawals remain a high risk as those suffering from addiction are considered a “vulnerable population” and are top of mind for the FDA/FTC. Other vulnerable populations are the elderly, children, and those with mental illness. Now is a great time to ensure these high-risk statements are not inadvertently hiding on a company website or socials. The FDA does not have a favorable position on kratom and considers it a New Dietary Ingredient (NDI) according to this import alert . The FDA also sent out this kratom alert where several US Marshall kratom seizures are highlighted. There also have numerous kratom-related recalls because of salmonella contamination. The key learning lessons are that if a company must sell kratom, they should be very careful not to make opioid withdrawal support or other disease claims, including statements in blogs or citing clinical studies. Also, investing in safety studies and testing every lot for microbials is advisable. I think safe and responsible kratom commerce may someday have a place in dietary supplements. The 2022 kratom warning letters are joint FDA and FTC warning letters. Also, they include cease and desist demands requiring the companies to stop making unsubstantiated claims or face injunction, civil penalties of up to $46,517 per violation, and requirements to refund customers. 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!

Use caution with “clinically proven” or “clinically studied” statements < Back “Clinically proven” statements are high risk Use caution with “clinically proven” or “clinically studied” statements #WarningLetterWednesday Implying "Clinically Proven" or even "Clinically Studied" is high risk. This is a trend to watch out for. We are seeing references to "clinically proven" types of claims showing up not just in warning letters but also in class action lawsuits and NAD complaints. The highest burden of proof is "clinically proven". This is rare in dietary supplements and should be used only if proper substantiation exists. The next highest burden of proof is "clinically studied". This requires the formula to be studied with scientifically significant methods. Bench or pilot tests may not qualify as "clinically studied". This can be difficult when using branded ingredients that may have been researched but perhaps do not meet a "clinically studied" standard. Most branded ingredients have sound research but some may not. It is important to conduct a proper review before using ingredient science on face value. A "clinically studied ingredient" is different than a "clinically studied product". There are many factors including serving size, formulation, and delivery form that play a role in this. We talk about what defines clinically proven here . If accurate, I prefer using descriptions such as "thoughtfully formulated with well-researched ingredients". What are your thoughts? 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!

We can learn a lot from NAD cases < Back NAD Case: Sustainability & Clean Ingredient Substantiation We can learn a lot from NAD cases This company was making claims related to sustainability, “clean ingredients,” and efficacy. This is a really interesting case that we can learn a lot from! The National Advertising Division (NAD) is a great place to look for case law regarding substantiation requirements. Here, I review a recent NAD monitoring case against a cosmetic and flavor ingredient company. Clean Ingredients Here is the claim challenged by NAD. “Clean ingredients and clean formulas – we ban over 2000 ingredients that are known to be toxic to you and the environment.” NAD’s finding: “NAD found that it is not clear whether the over 2,000 ingredients … does not use in its products are associated with cosmetic products. Therefore, NAD recommended modifying the claim specifying banned ingredients typically used in cosmetic products.” Asa comments: This shows that if a product does not typically contain an ingredient, stating that the product is free of an unlikely ingredient may be misleading. Do you think this applies to labeling a product “no soy” if it’s very unlikely to contain soy? Sustainability Claims Here is the claim challenged by NAD. “Keeping 2 million sharks every year safe from liver harvesting.” To substantiate this claim, the company provided data regarding an estimated number of sharks killed and an estimate of the global demand for shark liver oil; however, this was insufficient to provide a reliable number. NAD’s finding: “NAD recommended that the claim be discontinued or modified to avoid referring to a numerical figure. NAD noted that nothing in its decision prevents …. from making a more general claim that sharks are not harvested for squalane found in (its) products.” Asa comments: Numerical claims require increased substantiation and should be avoided unless there is firm supporting data. Here is another numerical claim example. Challenged claim and NAD’s findings: “All of our ingredients are also ethically and sustainably sourced,” NAD determined that while … Supplier Code of Conduct might demonstrate its commitment to ensuring that ingredients are ethically and sustainably sourced, it does not demonstrate that all ingredients are, in fact, ethically and sustainably sourced. Asa comments: I wonder if the code of conduct would have substantiated a “some of our ingredients” statement. Efficacy Claim NAD challenged this efficacy claim: “(ingredient) locks in weightless moisture, calms and protects, and improves elasticity.” NAD’s findings: “(The company) relied on three studies that assessed the impact of squalane, in the form and range of the amount found in the … products, on these objectively measurable attributes.” Asa comments: This shows how important it is to have comparable studies. For example, if the studies were conducted using different forms and dosages, they may not have been sufficient for substantiation. This is a slightly shorter WLW than normal as I am celebrating my wife’s birthday Tuesday night, so no staying up late for me. Read the NAD case 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 Thursday Jun 3, 2021 Distributor Pitfalls to Avoid Asa's Regulatory Education Series Nathalie Bougenies and Steven Yeager join me for our next Regulatory Education Series event. What companies need to consider when distributing products? Here are some of the topics we will cover. What contracts do distributors need to have in place? What CFR 111 requirements do distributors need to comply with? What Prop 65 liabilities do distributors carry? What is the liability of the distributor? What liabilities do platforms which sell lots of products and making claims have? How do distributors handle product returns? Do they need to be tested before going back into inventory? And more! Learn More Previous Next

Ensure 483 responses are complete < Back GMP Violations & Unanswered 483s Lead to a Warning Letter Ensure 483 responses are complete #WarningLetterWednesday involves a company inspected by the FDA last year that received several 483s for common violations like not having proper component and product specifications. The company submitted 483 responses, but these responses were incomplete which led to a warning letter. From Warning Letter: “We acknowledge your response, received December 30, 2021, which acknowledged that specific elements needed to be updated and asserted that “[b]y March 31, 2022, MCACO will update and complete component specifications.” However, we are unable to evaluate the adequacy of your corrective action because you did not provide updated finished product specifications for review.” Here is a Warning Letter Wednesday post about this common GMP violation. The lesson here is to ensure that 483 violations are adequately addressed and that all grievances are met. Most 483s can be “walked back” and addressed before they become warning letters. Warning letters should be avoided. Learn more about the ramifications here . Here is a video about the differences between 483s and warning letters. Other violations cited in this warning letter include: * Not verifying a raw material supplier’s Certificate of Analysis (COA). Depending on the supplier’s Certificate of Analysis (COA), without validating the results with a third-party lab landed this company a 483. The FDA requires that manufacturers verify COAs, including microbial and heavy metals. From Warning Letter: “you have never conducted heavy metal and microbiological tests to confirm results provided by the supplier’s COA.” * Incomplete Master Manufacturing Records (MMR). From Warning Letter: “A description of the packaging and a representative label.” GMPs work backward from the label to ensure there is a 100% label claim at expiration. From Warning Letter: “Written instructions, including specific actions necessary to perform and verify points, steps or stages in the manufacturing process where control is necessary.” The MMR is essentially an easily replicated recipe that includes what goes into the blend, how to verify the numbers are correct, and the instructions for mixing and testing. Here is a very detailed WLW post about GMP violations and best practices. 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!

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

Blogs on a commercial website are marketing claims < Back CBD Company Cited For Claims Made in Blogs and Socials Blogs on a commercial website are marketing claims This CBD #WarningLetterWednesday is a great teaching case as it cites many of the common mistakes we talk about each week. Here is what we can learn: Blogs on a commercial website are marketing claims. CBD is not allowed in OTC topicals. Hashtags, ingredient benefits, and product tags appear in more warning letters. Most of the cited claims in this warning letter are from blogs and social media. Here's one of several examples. From Warning Letter: "On the Blog post, "How to Use CBD to Combat Holiday Stress":.. "Reduced Anxiety and Depression" Blogs on a commercial website are "fair game" for enforcement and a key lesson from this WL. I write about best practices for blogs here. http://ow.ly/KMo250IYL43 High-risk words never belong on a commercial website, especially the "anxiety and depression" one-two punch. Here's my video about this. http://ow.ly/tuI350IYL48 From Warning Letter: "Although CBD is listed as an inactive ingredient in the labels of your .... "1000 mg Pain Relief Cream" products, the product labeling clearly represents CBD as an active ingredient" This product is labeled with drug facts and lists CBD as an inactive ingredient, but the label boldly lists "1000mg CBD". From Warning Letter: … "Even if CBD could be considered an inactive ingredient in your .... "1000 mg Pain Relief Cream" products, these products would still need an approved drug application to be legally marketed" The FDA's position is that CBD is not a suitable active or inactive ingredient in OTC topical drugs. Please read my article about this. http://ow.ly/N8rq50IYL3X From Warning Letter: "On your January 6, 2021 Instagram…"# CBDforArthritis # Anxiety” Hashtags are an enforcement trend to watch . Here's a video about this. From Warning Letter: “product_tag-dog-cancer-cbd” Product tags are mentioned in this warning letter . I wrote about this last week. From Warning Letter: "Orange Essential Oil [an ingredient in CBD Super Cider] may naturally relieve anxiety, . . . depression and inflammation of the body." Discussing ingredient benefits on a commercial website is a high risk . There's much more to talk about in this letter that I do not have room for. Read full warning letter Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

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!