< Back Presentation Tuesday May 23, 2023 Regulatory compliance and reducing class action risk Naturally Informed - Microbiome: Mastering the Market 2023 A blurry concept only 5 years ago, the microbiome has become understood as perhaps the most critical environment impacting human health – and consumers know this. What they know less about is exactly how it works and what they can do to impact it. And the more things come into focus, the more we have yet to learn about these complex systems so fundamental to life – the science is evolving literally daily. This three-day intensive virtual conference will examine not only probiotics, prebiotics, synbiotics and postbiotics, but also numerous other microbiome- modulated interactions including the impact of stress and diet. Experts will examine leading-edge science, and deliver practical tools to leverage this science to competitive advantage and truly mastering the market. Register Previous Next

Small business learning lessons < Back Education vs Marketing Discussion Small business learning lessons Today's post highlights common mistakes made by a small herbal company. Looking at their mistakes can help show others what not to do. I am not picking on this company as they likely didn't know the rules of supplement marketing. One of the reasons I write Warning Letter Wednesday is to educate companies on the dos and don'ts of marketing. Please share to help get this knowledge to those who need it. Copying information for herbal texts can lead to trouble. Education is ok, but it crosses the line into marketing when used to sell products. This reference was likely copied from a book onto the company's website. I also see companies making this mistake when copying information from clinical studies to commercial websites or socials. The lesson here is that any statement used to sell products should be compliant. The "Asa rule" is that you shouldn't use it in secondary marketing pieces if you wouldn't put it on the label. 👉From warning letter. "Antispasmodic Tincture • To be used in cases of epilepsy, convulsions, lockjaw, delirium, tremors, fainting, cramps, hysteria, suspended animation, etc." Claims about "colds and flu" are high risk. This is obvious, but it is worth repeating. This phrase is in one of my "top 50" that comes preloaded in my Apex Compliance program. 👉From warning letter. "Echinacea's cold and flu fighting and healing ability alone has made it the #1 immune herb…" Product names are also cited as disease statements in this warning letter. Normally FDA does not normally reference product claims unless they are over the top. 👉From warning letter. "Insomnia Formula• Product name: The product name implies that the product is intended to cure, mitigate, treat, or prevent insomnia." 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!

Common labeling errors can be avoided < Back Supplement Labeling Errors lead to Warning Letter Common labeling errors can be avoided This warning letter has numerous labeling teaching opportunities, which is really exciting! I don’t think any of these violations would attract a warning letter on their own, but altogether they paint a picture of non-compliance. This letter cites a product that does not have the designation “dietary supplement” on the main label panel. This is called the statement of identity and is a core aspect of supplement labels. This is interesting! The company was cited for adding the “percent daily value” statement when it was not necessary. From warning letter. “product labels each bear the following statement: “Percent Daily Values based on a 2,000-calorie diet.” This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein” The lack of a heavy bar separating % DV from non-% DV ingredients in the supplement fact panel is cited. Formatting is important, and here are some FDA supplement fact panel examples . One of the most fascinating aspects of this warning letter is the comment that vitamin K2 does not qualify as vitamin K, which has a % DV. This is a relatively obscure regulation, and I don’t recall seeing this in a warning letter before. From warning letter. “Supplement Facts label incorrectly declares as a (b)(2)-dietary ingredient, “Vitamin K (as menaquinone-7)”. 21 CFR 101.9(c)(8)(iv) lists an RDI for vitamin K of 120 mcg based on the AI (adequate intake) that pertains only to phylloquinone. It’s “% DV,” not “DV %.” Yes, folks, we can learn a lot from warning letters. This is a minor but commonly overlooked item in supplement fact panels. From warning letter. “ the listing of “DV%” is incorrect but may be listed as “% DV”. Finally, the “%” symbol must follow each numerical value listed as a DV.” Oh my goodness, so many great learning lessons! Here is one about formatting. The FDA prefers the format list the supplement fact panel, then “Other Ingredients,” then the contact information. From warning letter. “product label fails to place the “Other Ingredients” list below the Supplement Facts label.” This label also does not include a domestic street address or phone number, which is required for adverse event reporting, and this is essential to a compliant supplement label. Here is a previous Warning Letter Wednesday post with more labeling lessons that include items called out in this letter, such as improper serving size Here is FDA’s labeling information . If you have additional labeling questions, I would be happy to try to be of help. As a resource, I get carried away with this “GMP Pitfalls and Best Practices” blog . I hope you find this useful. There are so many more lessons in this warning letter, including improper specifications. Read it 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!

A look at the manufacturing and quality process < Back In-Process Quality Testing A look at the manufacturing and quality process GMP is basically a series of quality processes, such as holding, verifying, and then releasing. This is true for incoming raw materials and all in-process materials. This shows where some companies could make noncompliant decisions in the manufacturing process. Let's look into the manufacturing and quality-checking process and use a capsule product as an example. First, all of the ingredients, bulk capsules, and packaging need to be QC-checked and cleared. This is typically done by reviewing the raw material specification sheet, which shows what types of tests are needed. The samples are sent to a qualified lab and if everything passes, a member of Quality then releases the raw material. Next is blending: All ingredients are weighed by one employee and verified by another (called the doer-checker system). They are then blended, and then a member of Quality verifies that the weight matches the projected yield and verifies organoleptics such as color and smell. If the projected yield is too low, then an ingredient may have been forgotten, and if it's too high, then there is likely some other issue like a duplicate or mis-weighed ingredient. If all looks good, then the blend is released to the next step in the process. Next is encapsulation: A lot of variances can happen in the encapsulation process, so conducting R&D testing to ensure flowability and density is integral to a properly filled capsule. Quality typically checks the capsule weights consistently at the beginning of encapsulation, then about every 15-30 minutes to ensure they are weighing and looking good. After the encapsulation run is completed, Quality then verifies the projected yield of capsules to ensure they are within the predetermined range and releases them to the next step in the manufacturing process. If it is too high, then the capsules are underfilled, and the finished product will be below the label claim. If it is too low, then the capsules are overfilled, which may create a safety issue if there are ingredients that are unsafe at higher amounts. Packaging: The projected yield is calculated from the number of capsules, and bottles are typically weighed consistently when the runs starts, then every 15-30 minutes to ensure the correct number of capsules is in each bottle. Then, the final calculation is reviewed to verify the number of bottles is within the projected range. If it is too high, then the bottle may be underfilled, which is non-compliant. However, if it is too low, that is not necessarily a compliance issue, but it can indicate a money-losing project. Quality then takes a few finished products for sample retention (a GMP requirement) and sends a bottle or two for finished product testing. Once the test results come back, they are written on the finished product specification sheet, and if everything passes, it is released for sale. Celebration time! This lilypad approach to quality is designed to keep non-compliant materials out of the product facility and catch errors during the manufacturing process long before they reach the finished product. Of course, I am simplifying this, as a lot more goes into making a compliant product, but I thought you might enjoy this "behind-the-scenes" look at what goes into making a compliant dietary supplement product. DATE ORIGINALLY POSTED: 4/2/25 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 Symposium Friday Oct 16, 2020 4 Hour cGMP & Marketing Workshop with Steven Yeager & Asa Waldstein American Herbalist Guild (AHG) Annual Symposium Herbal supplement manufacturers and marketers need to have a solid understanding of current Good Manufacturing Practices (cGMP). In this interactive presentation, you'll learn about the intricacies of cGMP, including all CFR 111 subparts. We'll give you examples about how to comply with each section, practical steps for implementing them in your facility, and common mistakes to avoid. We also provide real-world examples of how to prepare for and conduct oneself should you have to undergo an FDA inspection. We review common marketing mistakes made by herbal manufacturers and marketers. Only $30 and supports this important organization Purchase 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

< Back Online, Workshop Monday Sep 29, 2025 Herbal Product Marketing Claims & Strategies: Pitfalls to Avoid and Best Practices American Herbalists Guild This session examines current enforcement trends, including FDA warning letters and legal actions, and provides practical guidance for herbal supplement businesses and practitioners on how to minimize regulatory risk while maintaining truthful and non-misleading communications. Attendees will learn how to identify high-risk language and develop safer messaging alternatives. We’ll also cover digital marketing dos and don’ts, offering best practices for content such as blog posts, social media updates, product reviews, and influencer partnerships. Learn more and register Previous Next

< Back Symposium Wednesday Nov 11, 2020 Symposium Keynote: Consumer Demand & the CBD Market: Intersections & Insights Michigan State University: Center for Research on Ingredient Safety Asa Waldstein Supplement Advisory Group: Consumer Demand & the CBD Marketplace, Intersections & Insights Patrick C. McCarthy ValidCare : Answering FDA’s Call for CBD Safety Data Jinpeng Li: Introduction to cannabinoids and the new wonder drug/consumer product: CBD Barbara Kaplan: Inhibition of Peripheral Immune Function and Neuroinflammation by CBD in EAE Brad Lampe: Derivation of an acceptable daily intake of orally-consumed cannabidiol (CBD) in adult consumers: challenges and limitations and more.. Watch Previous Next

< Back Presentation Thursday Sep 30, 2021 The Growth of Green: A Hemp Industry Overview Denver University As a Coloradan, you hear plenty about hemp, but how much do you really know about the hemp industry? How and where is it grown and marketed? Who’s growing it? How, exactly, are Coloradans using hemp? What should you know about labels when buying hemp products? What are the key regulatory issues at play? Join Certified Clinical Herbalist Asa Waldstein as he answers these questions along with your specific queries in this timely and interactive discussion on all things hemp. Register Previous Next