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Informational blogs on a commercial website are considered “labeling” < Back Learning targets: Blogs, risky words, testimonials, ingredient benefits Informational blogs on a commercial website are considered “labeling” Today's #WarningLetterWednesday is an important reminder that blogs, testimonials, and discussing ingredient benefits can easily cross the line into claims, especially when filled with high-risk buzzwords! 🔷The FDA and FTC look for a material connection. The material connection was evident in this warning letter, as there's a hyperlink (Call To Action) to a shopping cart, as noted here. ➡️From warning letter: On the "Prevent MRSA Infection" blog post ... which hyperlinks to the product webpage for B Complex. 🔷I discuss best practices for reducing risks on blogs here . 👓 🔷Ingredient descriptions on a commercial website may be implied product claims. I discuss this here . 🔷A good strategy is to ensure ingredient education is free of high-risk "buzzwords" or disease claims. Some examples are anti-inflammatory, insomnia, or anything ending in "itis" (arthritis). Here is a WLW post and video about this from a few months back. 🔷Product testimonials can be marketing claims, especially as they're highlighted in this company's "Customer Stories" section. ➡️From warning letter: "'I have been taking CellRenew since May of 2003. . . . This product has kept my arthritis at bay. . . .'" This company talks about viruses that are top of mind for the FDA, and I am unsurprised by this warning letter. Good job, Denver office! We've seen the Denver office focus on claims made in blogs before, a cautionary tale for companies in their district. Read the full warning letter here . Follow 👉My Warning Letter Wednesday LinkedIn Group for early WLW access. 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

< Back Podcast Monday Jan 3, 2022 The Supplement and CBD Advisor: Bridging the Regulatory and Marketing Gap Getting Transparent Podcast In this episode of Getting Transparent , Asa Waldstein, Founder and Principal of Supplement Advisory Group joins host Joe Witte to discuss the intersection of FDA regulations and marketing claims in the supplement and CBD industries. In addition to running his own advisory firm, Asa serves at the Cannabis Committee Chair, and on the Sustainability Committee for the American Herbal Products Association. Asa also founded the Supplement and Hemp Education Series and has extensive education in botany and is a certified clinical herbalist. And just as important, Asa is an avid hiker, skier and Grateful Dead fan! In this podcast episode, Asa shares wisdom on some of the following topics: How making certain marketing claims for your supplements and CBD can put your company at risk The unforeseen risks of FDA warning letters Managing claims on social media and blogs (and how to avoid FDA issues) Preparing for FDA audits “Regulatory compliance does not have to be scary…by reading enforcement trends, we’re then able to change our marketing approach in a way that can authentically connect with consumers, but can also keep us out of trouble.” - Asa Waldstein. Listen Previous Next

Free speech protections go away when there is marketing material connection < Back Affiliate Marketing Content Must Be Compliant Free speech protections go away when there is marketing material connection Affiliate marketers continue to be scrutinized for making claims. #WarningLetterWednesday A few years ago, affiliate warning letters were nearly nonexistent. Now regulators are savvy and are no longer tolerating claims where there is material connection. Affiliates develop content in hopes of bringing consumers to their site which then hyperlinks to a shopping cart for purchasing the mentioned product. Affiliates get a cut of sales which can be 30%, so you can see the incentive for sensationalized content. Affiliate relationships should also be disclosed clearly and conspicuously. Affiliates are responsible for the accuracy and compliance of their statements. The difference between "Average Jane" and affiliates is the material connection. If there is no material connection, including free product and employee/family relationships, consumers can say pretty much anything about products they like. Original Q&A published 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!

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!

Only use permitted dietary ingredients or face regulatory issues < Back Unauthorized NDI Leads To Warning Letter Only use permitted dietary ingredients or face regulatory issues Warm greetings from 35,000 feet, as I am flying back from a 3-day whirlwind trip to participate in the Vitafoods Startup Award finals in Geneva. This company received a warning letter for using N-Methyltyramine, an unauthorized New Dietary Ingredient (NDI), in its products. This shows that FDA is getting serious about enforcing the unauthorized NDI requirement. FDA has sent warning letters for Hordenine (a similar molecule to N-Methyltyramine) in the past, but using these types of ingredients typically isn’t enough to attract a letter unless disease claims or GMP violations are present. In this instance, there were no disease claims or GMP violations present which should give companies pause before using certain NDI ingredients. Read this WLW post about hordenine warning letters. I predict this may be paving the way for more CBD and kratom letters, even if there are no disease claims present. A similar ingredient to N-Methyltyramine is listed in FDA’s Information on Select Dietary Supplement Ingredients and Other Substances document . This includes some “off limits” products such as DMAA but also includes commonly used dietary ingredients like biotin. I would like to see this list clarified to show what FDA considers lawful dietary ingredients, unauthorized new dietary ingredients, and unallowed ingredients such as DMAA. Read the letter here . DATE ORIGINALLY POSTED: 5/15/24 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 Webinar Tuesday Aug 26, 2025 Keeping up with Claims: Navigating Marketing Compliance AHPA Webinar In this AHPA webinar, our expert speakers will review the types of permitted claims and FDA and FTC standards for substantiation to ensure your claims are truthful and not misleading. They will also cover trends in enforcement and litigation across a wide range of topics, including social media marketing and influencers, environmental claims, and recent FTC activity on country-of-origin claims. Event Details: Date: Tuesday, August 26, 2025 Time: 10-11:30am PT / 1-2:30pm ET Speakers: Asa Waldstein (Apex Compliance) William Frazier (National Advertising Division, BBB National Programs) Rend Al-Mondhiry (Amin Wasserman Gurnani) Graham Rigby (AHPA) – Moderator Registration: AHPA member: Included in membership Non-member: $199 Can't attend live? Registration includes on-demand access to the webinar recording and materials following the event. Don't miss out! Online Registration Previous Next

Learn from other’s marketing mistakes < Back Website Marketing Claims Lead To Warning Letter Learn from other’s marketing mistakes This company was cited for making high-risk claims related to colds, the flu, and viruses in product and ingredient descriptions. This warning letter is an excellent lesson on what not to do when marketing supplements. Learning from other’s mistakes can help inform compliant marketing, which is one of the reasons why I love writing Warning Letter Wednesday . Here are some high-risk “trigger words” from this letter that should always be avoided. These are some of the preloaded words Apex Compliance scans for when conducting website and content reviews. Antimicrobial, antiviral, and antifungal: Most words with “anti” should be avoided. Fight infection, viruses, influenza, cold and flu. Arthritis Diabetic support Even though the company removed the direct references in the warning letter, the rest of the website still contains product statements such as “Used for over 88 years as an alternative approach to treating cancer.” I’m always bewildered when I see companies only removing the statements called out in warning letters but leaving other high-risk claims elsewhere in their marketing. Perhaps we can support FDA to provide a more comprehensive warning letter list of violations or offer education to companies that do not understand the sometimes confusing world of supplement marketing. I volunteer to help, and my Apex Compliance product is also made for this. There are also lower-risk statements cited that are not likely to attract a warning letter on their own. These “secondary” claims are added when there are higher claims made, but they can help us understand what FDA considers a disease claim and what is an “allowable” structure-function claim. From warning letter. “a natural antihistamine that can help stop damaging particles in the body known as free radicals, which negatively impact how cells work. “ From warning letter. “Kudzu - an herb used in ancient medicine to ease an upset Stomach Ache.” I see companies making the mistake of overexplaining ingredients and products using widely available language such as “Garlic Bulb Extract - contains antimicrobial, antiviral and antifungal properties that assist in alleviating colds as well as other infections” all the time. This is an essential reminder that clinical studies, “educational” websites, and herbal texts do not always translate to compliant marketing. Marketing that focuses on quality-of-life statements such as “wellness support” and “help you feel like yourself” usually gets the message across without making disease claims. This is a shorter WLW than usual, as I’m writing this from the French Riviera on a family holiday. I invite you to read the 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!

Ensure ESG claims are substantiated < Back Environmental Claims Increase Scrutiny Ensure ESG claims are substantiated We love the environment, but companies making broad sustainability claims are asking for increased scrutiny. This is because statements like “environmentally friendly” and “sustainably sourced” can be interpreted in many ways, and providing the required substantiation is very difficult. A leading meat stick brand faced a challenge at the National Advertising Division (NAD) over its environmental and sourcing claims. In NAD cases, companies typically provide substantiating data to support their claims for review. However, rather than defending its claims, the company chose to remove the challenged environmental statements, including references to the product being “carbon neutral” and “sustainable.” 👉 From NAD. “(NAD) will treat the claims, for compliance purposes, as though NAD recommended they be discontinued.” Here are a few comments and best practices when making “eco” type claims. Provide measurable outcomes: For example, “Our packaging uses 30% post-consumer recycled content” is less likely to be challenged than “Our packaging is recyclable and sustainable.” Stay Away from Broad Claims: Statements like “No carbon footprint” are well-intentioned but are difficult to support without an offset program or verified calculation on all products. Specific vs. Broad Claims Example 🔹Broad Claim (Risky): “Our protein powder is eco-friendly and helps save the planet.” 🔹Specific Claim (Less Risky): “Our protein powder uses 25% less plastic per container compared to our 2021 packaging, reducing material waste.” Read the NAD decision here . DATE ORIGINALLY POSTED: 2/12/25 Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Study citations are marketing < Back GMP Inspection Leads to Online Scrutiny Study citations are marketing This is another example of a GMP inspection leading to a website and social media review. The initial FDA inspection was in April this year, but the website was not reviewed until September and October! This trend is common in warning letters, and FDA does not appear to critique online marketing until months after the initial inspection. This is a reminder for companies inspected in the past year to re-review online marketing to ensure there are no compliance concerns. This includes blog posts that cross the line from education to marketing. Study citations are marketing. There have been several letters where companies highlight research about ingredients like elderberry. This is considered marketing if those ingredients are in products sold on the site, and I talk more about this here . Now is a good time to review your elderberry and other ingredient marketing to ensure there are no “forgotten” ingredient claims. From warning letter. “The Study showed that Elderberry extract is effective in treatment of flu.” Testimonials are becoming more common in warning letters. This company copied a customer testimonial onto a social media image, which is considered “endorsing the testimonial.” From warning letter. “Facebook image post: Joint Support Capsules … Amazing. Really works. Muscle pain and nerve pain.” Several blog claims are cited in this warning letter. A common blog writer trap is to use sensational titles such as “Can Turmeric Help Reduce the Risk of Strokes”? As discussed above, this is a marketing claim if turmeric is sold on the site. Here are some best practices for reducing blog risk. There are several GMP violations cited in this warning letter. They probably wouldn’t have elevated to a warning letter if adequately addressed and if there were no online disease claims present. Companies continue to be cited for not demonstrating the identity of the finished herbal product blend, even if the individual ingredients have been tested and the blending has been validated. To show the finished product identity, a specific method needs to be developed. Does a small company need to spend valuable resources to develop a specific method just to confirm the identity of an herbal blend? I find this rigid interpretation of the regulations puzzling and a potential burden on industry. Setting herbal specifications too rigidly can lead to issues. This company was cited for not properly handling an ingredient that exceeded its lead limit of 1.45ppm, which is not a high level for an herbal ingredient. This would not have been an issue if the company had set a realistic lead level. This demonstrates the importance of setting up a practical Quality Management System (QMS). A QMS developed with GMPs but also operational efficiency in mind is essential to any growing business. Having a properly functioning QMS is critical, but an overburdensome approach to quality is restrictive. Some companies hire exquisite pharmaceutical managers to develop their QMS, and they get what they pay for, a rock-solid system that is pharma-level, but is this needed in a small to midsize company? Some citations went to quality concerns from 2016, showing that even several-year-old decisions regarding quality can come back to bite a company. The FDA did not feel the company’s 483 responses were sufficient. I write about how improper 483 responses can turn into a warning letter here . Read the full warning letter here . Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

< Back In-Person, Workshop Monday Sep 15, 2025 Small Business Bootcamp AHPA Cincinnati, OH Entering the herbal and dietary supplement industry can be daunting, especially for smaller businesses. From manufacturing and marketing compliance to branding and quality agreements, there are endless things to learn to responsibly grow your business. Join AHPA for their first-ever Small Business Bootcamp , a 1-day workshop in Cincinnati, OH, held in conjunction with AHPA's Botanical Congress and United Plant Savers' International Herb Symposium . You'll learn from expert faculty, engage in focused breakout sessions, and network with other business owners and industry members. Workshop materials, including presentation slides, will be shared with attendees. Event Details: Date: Monday, Sept. 15, 2025 Time: 8:00 AM - 5:00 PM (check-in and breakfast at 7:30 AM) Faculty: Holly Bayne , Law Office of Bayne & Associates Thomas Dick , Mountain Rose Herbs Asa Waldstein , Apex Compliance Steven Yeager , Mountain Rose Herbs The agenda includes sessions on: The intricacies of current Good Manufacturing Practices (cGMP), including CFR 111 subparts and real-world examples of how to prepare for and act during an FDA inspection Best practices for marketing compliance, with detail about the nuances of how to label and market in a way that lowers FDA, FTC, and lawsuit risk Branding and marketing for herbal businesses, with expert guidance on storytelling, visual identity, customer connection, and a personalized critique of your current brand strategy Navigating supply and manufacturing contracts, quality agreements, and managing compliance obligations effectively Registration: AHPA member: $299 Non-members: $399 Registration includes breakfast and lunch, and attendees are invited to a post-workshop reception with their classmates and other AHPA members. Space is limited! Register by May 30 to secure your spot and SAVE $50 with early bird registration. Additional savings for groups and UpS members available. Contact Alexis Durham at adurham@ahpa.org for more information. Register here and learn more Previous Next

How we work together Free Introduction $ 0 0$ 15 Minute Meeting (one time) Valid for one month Select Review socials, web, marketing materials, business strategy or just chat. Silver $ 250 250$ Services provided on a per hour basis Select All services available (3 hour minimum) $250 per hour Gold $ 0 0$ Hire me on retainer Free Plan Select On call regulatory consultant: GMP's & more Plans starting at just 5 hours per month Discounted rate applies for 3/6/9 month contracts Platinum $ 0 0$ Hire me on a project basis Free Plan Select This can include soup to nuts go to market services Full website and marketing review Content writing services