Expect arterial health claims to be cited in the future < Back Biomarker Claims Lead to Warning Letter Expect arterial health claims to be cited in the future Blood sugar support claims continue to be cited in warning letters. This letter includes biomarker claims such as “improved blood sugar sensitivity and lower A1C.” Based on recent warning letters, listing these types of statements is now enough to attract a letter. I write more about this here . There are other biomarker claims cited in this letter, such as “increased levels of TT3 and TT4," "reduced mean fasting serum glucose," and "promotes arterial elasticity." Keep an eye on your marketing statements relating to arterial plaque and elasticity, as I predict we will see these cited in 2023. This is a warning to companies making similar biomarker claims, and now is the time to review marketing and find and replace these statements. In the past, biomarker claims were not typically enough for a warning letter, but the “Big 7” cardiovascular letters from November signal a change in FDA’s thinking. There are other commonly cited higher-risk claims, such as “diabetes” and “depression,” in this letter. The more of these words used in marketing, the higher the likelihood of receiving a warning letter. You may be saying, “these companies should know better,” and in many ways, I agree. However, they may not have understood that mentioning ingredients in blogs or citing ingredient research is considered marketing. These mistakes are all too common and are a sign of companies who don’t understand the nuanced rules of dietary supplement marketing. Educating on these topics is one of the reasons I write Warning Letter Wednesday. Blogs are mentioned in this warning letter. We are seeing blog titles like this mentioned in recent letters. They help bring traffic to the website but are also clear indications of intended marketing use. In this example, turmeric is in a product sold on the website, which is an implied claim. From warning letter. “Pain Support - Can Turmeric Relieve Arthritis, Joint Pain & Inflammation?” To round this letter out, there are statements such as “Reduce Chance of Catching A Cold.” Talking about reducing the duration of a cold, flu, or respiratory infection is off-limits and should be avoided. 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!

< Back Interview Wednesday Nov 2, 2022 ‘Warning letter geek’ decodes marketing compliance SupplySide West Asa Waldstein is principal of the Supplement Advisory Group and the man behind 'Warning Letter Wednesdays.' His bread and butter is educating companies about the dos and don'ts of marketing. Watch Previous Next

Use qualified reference samples < Back Noncompliant Testing Methods Lead to Warning Letter Use qualified reference samples This company received 483s for GMP violations relating to testing methods and specifications. They were inspected in late 2021 and early 2022 and sent FDA five 483 responses last year. It seems these responses were not satisfactory, which led to this warning letter. There are numerous learning opportunities here. 🔷One of the violations was not having a strength test on a softgel product. It seems the company once had this, but it was removed 👉“at the request of the customer, as documented in your change control document.” A key learning lesson here is contract manufacturers should be flexible with their customers to a limit. Obviously, completely removing this test from the softgel specifications was a bad idea. Who knows, perhaps they could have found a more suitable strength test to satisfy GMP requirements and the customer. 🔷Unqualified reference standards are cited in this warning letter. The company was testing samples using FTIR, but the reference samples were not verified, which means they were likely from previous batches and not a purchased verified material. I will admit this is how I used to test identity circa 2010-ish. 👉From warning letter. “Identity testing using FTIR to compare the sample spectrum to an unverified reference sample is not an appropriate scientifically valid method” 🔷Identity testing in the finished product was brought up again, and this is a trend to watch. FDA requires the identity of each ingredient to be tested before blending and in the finished product. This is straightforward for some items but is costly and challenging if there are numerous botanical ingredients, as this requires developing expensive testing methods. I am unsure if this is the case in today’s #WarningLetterWednesday, but this is not the last time we will hear about this rigid pharmaceutical interpretation of supplement GMPs. I write about this here . 🔷Proving test method suitability is starting to appear in 483s and now in warning letters. This means that the FDA is asking why specific test methods are used. In the past, relying on a third-party lab for this was sufficient, but now, having suitability documentation on file for each method your lab uses is a good idea. Read the full 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!

“Arthritis” claims elevate risk < Back Testimonials & Video Claims Lead To Warning Letter “Arthritis” claims elevate risk The timeline of the FDA interaction is notable. The company was inspected last August, then FDA reviewed their website in October and November, then reviewed it again in March 2023. If the company had cleaned up its website before the last FDA website review, it probably could have avoided this warning letter. Do your teammates ever ask you what happens if you receive a warning letter? I made a one-minute video about this. Testimonials are cited in the letter. Third-party non-curated, non-compensated, honest reviews are unlikely to be scrutinized, but they become marketing when used to sell products. This includes: ●“Liking” or “saying thanks” on a social post ●Interacting with a product review ●Showcasing a product review This company has a page specifically for testimonials which makes them curated, which is marketing. →From warning letter. On your Testimonials page: “I prefer … over chronic use of Rx or OTC NSAIDS for arthritis due to the potential renal and gastric side effects of chronic NSAID use.” As we have discussed before, claiming a supplement is better than drugs is a quick way to irritate FDA and attract a warning letter. No GMP manufacturing claims are cited in this letter, which means they are probably doing a good job making the product, but they have crossed the compliance line with their marketing claims. If interested in talking about the nuances of marketing compliance, I would be happy to meet for 30 minutes at no charge. I am here to (try to) help! YouTube claims are cited again in this warning letter. This is the third FDA warning letter that mentions YouTube videos this year. Are you interested in seeing the others? You can search old Warning Letter Wednesday posts by keyword here . This is intended to be an ongoing resource for your regulatory and marketing teams. Claims about “pain” are cited in this warning letter. While it is unlikely a company would receive a warning letter without higher-risk words like “arthritis,” occurrences of “pain” do elevate the overall likelihood of agency action. Did you know that “arthritis” is the most common “itis” in warning letters? If accurate, replacing “arthritis” with “joint discomfort” can help to lower risk. →From warning letter. “… is made of 12 key ingredients - each chosen for its specific ability to address the complex causes of pain.” I’m writing this #WarningLetterWednesday post as I fly to Vitafoods in Geneva, where I am speaking about US supplement regulations and marketing best practices . Let’s meet if you are in Geneva! 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 Thursday Mar 7, 2024 Pitfalls to Avoid When Marketing Products Velocity CPG Guest speaker Asa Waldstein reviews common pitfalls when marketing products that can lead to expensive litigation or agency action such as social media engagement, citing clinical studies, blogs, and influencer best practices. Register Previous Next

Some of our favorite resources to help educate about Prop 65. Prop 65 Guidance / Proposition 65 Guidance These are common areas of enforcement and lawsuits.Here are some resources to help understand these regulations. AHPA expert Prop 65 webinar AHPA Prop 65 herbal products guidance AHPA Prop 65 cannabis guidance Back

< 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

In his quarterly FDA warning letter roundup, dietary supplement consultant Asa Waldstein reviews trends over the last quarter and year, and he makes 2024 predictions. < Back Q4 warning letter roundup with Asa Waldstein Asa Waldstein Guest Article In his quarterly FDA warning letter roundup, dietary supplement consultant Asa Waldstein reviews trends over the last quarter and year, and he makes 2024 predictions. Read More Previous Next

Functional mushroom products under increased scrutiny < Back Basics of GMP’s Cited Functional mushroom products under increased scrutiny Functional mushroom products are undergoing a renaissance, and FDA is paying close attention to how these products are tested and manufactured. This is likely because of the mass recall and potential fatalities associated with the Diamond Shruumz products. Learn more about this cringy and dangerous recall here . Today’s Warning Letter Wednesday highlights GMP violations related to functional mushroom incoming product testing, QC release, product returns, incomplete 483 responses, and sample retention. These are important reminders of the basic GMP requirements, and we can learn from this company’s oversights. 🔹The company appears to be a copacker that received bulk mushroom gummies for packaging and labeling. They did not have even the most basic procedures in place for receiving and packaging dietary supplements. This seems like an operation that just buys bulk products then packages and labels them without quality checks. Yikes! If I had to guess, they were probably the cheapest option, which goes to show that if a price is too good to be true, it probably is. This is accurate not only for products but also for regulatory consulting as well. 👉From warning letter. “During the inspection, you did not have any procedures in place for the dietary supplement products you receive for packaging and labeling.” 🔹Product returns are common and having a procedure of how to handle these products is essential. This warning letter indicates that returned products were possibly re-sold without proper review, which is terrifying. This is how counterfeit, or dangerous products work their way into the supply chain. 👉From warning letter. “You do not have any procedures in place for the handling of returned dietary supplements, to include the identification and quarantine of the products until quality control personnel conduct a material review and make a disposition decision.” 🔹Product retentions are important, as they allow us to retest products when there are customer complaints. FDA requires they be kept one year past expiration date or two years past the last date of distribution. In my contract manufacturing days saving three bottles per lot number was sufficient. Also, retained samples can potentially be used to substantiate expiration dating. 👉From warning letter. “ You did not retain reserve samples for the required time for use in appropriate investigations.” The FDA gave this company ample opportunity to comply with the 483 violations but, as noted in the warning letters, the responses were incomplete which led to this warning letter. When in doubt, hire an expert for 483 responses. Read the full letter here . DATE ORIGINALLY POSTED: 12/11/24 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 Thursday Jul 23, 2020 Enforcement Trend Analysis CBDIA Webinar: FDA/FTC Asa Waldstein reviews warning letters and gives examples of how to lower marketing risk for the cannabinoid and dietary supplement industries Here are some other lower-risk ways to communicate how your product can help: Balanced state of mind Happy mood support A good night’s sleep supports the body’s health Support resilience Slumber support for optimal health Mental equilibrium Be kind to your body with hemp oil, your body systems will thank you! Watch Previous Next

< Back Meet-Up Group Tuesday Dec 17, 2019 Ethical CBD Marketing: How to avoid FDA, FTC, and class action trouble Asa's Regulatory Education Series The first Boulder Hemp-CBD Group Meet-Up hosted by Asa (In-person) What can we learn from recent "Big 15" Warning Letters, revised Consumer Update, and recent class action news? Have you ever wondered why some companies receive FDA Warning Letters and are unsure about how to ethically market your product without getting into trouble? Are you looking for clarification about what the FDA is enforcing and how to read Warning Letter trends? What is a claim and what are the risks when making them on your website or social media? Can I get in trouble for "Liking" a post? If I link to a clinical study is this allowable? Do I need to be careful with blogs? What is the Farm Bill IFR and how do I submit comments? What is an attorney's opinion on recent class-action lawsuits? This event will focus on a discussion about the dos and don'ts of labeling, marketing, and selling Hemp-CBD and much more! I am honored to be joined by very special guests: Patrick McCarthy, Validcare CEO Frank Robison, Founder of the Robison Law Group LLC. View Pictures Previous Next

Remove “anxiety” on all marketing platforms < Back Anxiety claims enforcement up 95% in 2021 Remove “anxiety” on all marketing platforms #WarningLetterWednesday reviews the increase in anxiety claims enforcement. In 2021 there was 40 anxiety-related product FDA warning letters, a 95% increase over 2020 (21), which is a clear sign of the FDA’s enforcement priorities. Here is a breakdown of the 2021 anxiety warning letters. *75% (30) include both anxiety and depression. This shouldn’t come as a surprise to anyone following enforcement trends, as the FDA sent ten anxiety/depression letters last February. I write about this here . *45% (22) include claims made on social media. I would have guessed this number would be higher. *10% (4) include hashtag claims, and 25% (10) include claims made in testimonials. I expect warning letters with hashtag claims and testimonial claims to increase, which is an enforcement trend to watch. *All 2021 letters also include higher-risk disease words such as hypertension except for one that involved a drug spiked product (sibutramine). The FDA looks at a company’s complete online presence. One claim may not attract a warning letter, but, for example, claims made on social media, YouTube, Amazon, and blogs are pieced together for one big picture of noncompliance. *It is worth noting the 2021 warning letters did not include the term “occasional anxiousness,” which is, if substantiated, often considered not to be a disease claim. Anxiety is considered a 3.5 of 5 on the “Asa Risk Scale” and should not be used. If truthful and substantiated lower risk alternatives are: *happy mood support *balanced state of mind *mental resilience *support when things get overwhelming *helps support smiles 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!