< Back In-Person, Solo presentation Thursday Apr 11, 2024 Labeling & Making Claims NoCo Hemp Expo Estes Park, CO Join Asa as he delves into the latest enforcement trends, including warning letters and litigation, that shape the marketing landscape of the natural products industry. This session is designed to equip attendees with the knowledge to identify and avoid marketing strategies that could lead to legal complications, such as lawsuits or warning letters. By analyzing recent enforcement actions, Asa will provide practical insights on how to steer clear of "off limits" marketing areas while still effectively driving sales. Learn how to align your marketing practices with current regulations and protect your brand from potential legal challenges. See Asa's LinkedIn post about this event here . Learn more Previous Next

The FDA regulates based on intended use < Back Company Cited For Selling Selective Androgen Receptor Modulators (SARMs) The FDA regulates based on intended use The FDA sent a warning letter to a company distributing Selective Androgen Receptor Modulators (SARMs). SARMs are synthetic chemicals designed to mimic the effects of testosterone and other anabolic steroids. This is an excellent example that the FDA regulates based on the intended use. The company apparently was marketing this product for ingestible use but labeling as follows. From the warning letter. “Despite statements on your product labels marketing your SARMs products for “RESEARCH ONLY” and “Not for Human Consumption,” evidence obtained from your website establishes that your products are intended to be drugs for human use.” What is mind-blowing about this warning is that a company executive was sentenced to a year in prison last year for selling the same type of products! Here is the article by Steven Myers about this. 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!

Qualifying claims makes them easier to substantiate < Back “Gum Detoxify” Claims Challenged Qualifying claims makes them easier to substantiate In an ongoing saga of the dental care and teeth whitening industry, a large company’s “gum detoxify” and other claims were challenged by a competitor in this National Advertising Division (NAD) case. Crest, the company making the “gum detoxify” claim, qualified the claims on their packaging by specifying what this actually means. This is a smart approach to ensuring that general claims like “detoxify” are not misinterpreted. NAD also reviewed the company’s supporting data for this narrow claim and found that it was supported. From NAD case : “In context, the “Gum Detoxify” claim is qualified by the claim “neutralizes plaque bacteria, even around the gumline, for 24 hours,” which narrows the claim meaning to communicate that the detoxification benefit relates specifically to plaque and gingivitis.” A key takeaway is that qualifying claims on product packaging can help ensure that “reasonable consumers” are not inadvertently misled. This is especially important in the tit-for-tat dental health product industry that is filled with NAD challenges. Also, NAD determined that the phrase “neutralizes plaque" does not mean it removes 100% of all plaque. Hey marketers, can you think of compliant ways to use “neutralize?” From NAD case : “NAD determined that the term “neutralizes” in the challenged claim “Neutralizes Plaque Bacteria, Even Around The Gumline, For Up To 24 Hours (With Twice A Day Brushing),” is not an absolute claim that 100% of plaque bacteria will be made entirely ineffective by brushing with Crest Gum Detoxify.” Read the NAD case here . DATE ORIGINALLY POSTED: 8/20/25 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 Panel Discussion, Presentation Friday May 14, 2021 What Can Marketers Learn From FDA/FTC Action Lucky Leaf Expo, Austin, TX 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

Copackers & distributors must comply with GMPs < Back Incomplete 483 Responses Copackers & distributors must comply with GMPs This copacker didn't have most of the basic GMP structure required for handling and distributing dietary supplements, and based on my reading of the letter FDA gave them plenty of opportunity to address their 483 responses. Unfortunately, this company likely didn't seek professional help and has earned a warning letter for poor GMP compliance and insufficient 483 responses. Here is what we can learn. Product retentions: We don't often see this cited in warning letters, but it is an integral part of GMPs and product investigations. In my days as a manufacturer, I frequently used product retentions to conduct customer complaints and investigations. I also used these products to help substantiate shelf life expiration dating. From warning letter. "You must retain reserve samples for one year past the shelf-life date (if shelf-life dating is used), or for two years from the date of distribution of the last batch of dietary supplements." The reason product retentions are rarely mentioned in warning letters is that they are a pretty simple 483 response. The company needs to update its policies and show its work, meaning it should provide proof that product retentions will be collected and saved for the proper amount of time. This company fell short of proving this to FDA, which is why it was added to the warning letter. From warning letter. "(from company) [w]e corrected and labeled retention samples before the end of our inspection" and "[w]e have a special location for retention samples and hold for are [sic] required to hold for 2 years for the lot." (from FDA) However, you did not provide any supporting documentation demonstrating you made these corrections. Further, the inspector did not observe any corrections prior to the closeout of the inspection. Consequently, we cannot evaluate the adequacy of your corrections at this time." Subpart G: This involves receiving dietary supplements for packaging. You will see the company did not prove the corrective action to FDA, which, In this case, should be so simple. 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. 483 response comments from warning letter. "Your "Inbound Policy" failed to provide written procedures regarding the examination of each immediate container or grouping of immediate containers in a shipment of product that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) for appropriate content label, container damage, or broken seals to determine whether the container condition may have resulted in contamination or deterioration of the received product." As a side comment, I love writing this weekly post. Please share with your community to help spread the word. You can sign up here for WLW and my monthly newsletter, and to learn more about my consulting company, Supplement Advisory Group , and my award-winning compliance software company, Apex Compliance . Your support means the world to me! Thank you! There are several other incomplete 483 responses cited in the letter. Read the full warning letter here . DATE ORIGINALLY POSTED: 8/14/24 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!

Dietary supplement clinical triggers should be thoughtfully considered < Back Diseased Population Study Helps Trigger IND Requirement Dietary supplement clinical triggers should be thoughtfully considered A dietary supplement company conducting a clinical study was investigated by FDA’s Bioresearch Monitoring Program and found violations. According to FDA “this program includes inspections designed to evaluate the conduct of research and to help ensure that the rights, safety, and welfare of human subjects have been protected.” Based on my reading of the letter, it looks like one of the potential issues is the company studying people with insomnia (diseased population) and having disease endpoints. According to FDA, the company did not submit an Investigational New Drug (IND) application, which is required since the company, according to FDA, was studying the efficacy of their product to mitigate and treat insomnia.” From FDA: “Whether an investigational article is a drug or a dietary supplement depends on the intent of the investigation. Based on the study design of Protocol ABRI-002, the investigational product, …, as used in the clinical investigation, was a drug as defined in section 201(g)(1) of the FD&C Act, because … was studied for use in the treatment of insomnia.” The company responded with some interesting retorts. “Determining the effect of a dietary supplement on persons with a particular condition does not amount to an intended use of that supplement to treat that condition.” “(Company)also stated that because they are in the business of marketing and distributing dietary supplements and not performing clinical studies, there is no risk of future violations because there is no chance of future studies. If the study had a non-diseased population and endpoints, it probably would have been okay for a “supports normal sleep” statement. This is a classic chicken-and-egg situation. Because the protocol evaluated the product for the treatment of insomnia (according to FDA), a recognized disease, they viewed the product as an investigational drug and therefore required an IND. Can supplement clinical trials study diseased populations? In my opinion, it cannot be the sole basis for substantiation, but it can play a role in overall support. Here are some key takeaways. This is a complex warning letter, and I would love to hear your thoughts. Partnering with third parties who understand the legalities and nuances of clinical trials, rather than conducting them yourself, can help eliminate costly regulatory issues. Studying a diseased population is not a good standalone substantiation strategy for supplements. Possible actions that put this company on the FDA’s radar include alleged issues related to a California Attorney’s General settlement regarding automatic subscription renews, a Truth in Advertising (TINA.org) exposé, and press coverage over their “clinically proven” types of lawsuits. Read the full warning letter here . DATE ORIGINALLY POSTED: 7/16/25 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 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

Distributors are responsible for products they sell < Back Amazon Receives 3rd Warning Letter This Year Distributors are responsible for products they sell Amazon just received its third warning letter this year and the fifth in the last 15 months! All of these letters are for selling adulterated or unallowable products. What makes this warning letter interesting is that it’s for a sexual enhancement product that was adulterated with sildenafil (Viagra). Amazon requires some mandatory third-party tests for products in this high-risk category, but I wonder why the drug-spiked ingredients were not found here. Perhaps after the initial batch tests, a subsequent non-tested batch contained the drug-spiked ingredients? ❗️Warning Letter Wednesday is available as a free weekly email. Sign up here . 🔷When we look at other Amazon warning letters, FDA seems to “follow the breadcrumbs” from other warning letters, recalls, or issues to Amazon. For example, this warning letter references products that were part of a drug-spiked recall in August. I would think that Amazon has the technological capability to find and remove recalled products from its platform. These types of warning letters come in groups so if companies were selling any of the adulterated brands cited in this warning letter, removing them from commerce now can help to avoid a letter. 🔷Amazon warning letters state that Amazon handles the products as opposed to them being dropped-shipped by the vendors. In my opinion, this “handling” is important to designate Amazon’s responsibility. I wonder if this means that marketplace sites that don’t actually touch the products have a lower risk of distributor scrutiny. 👉From warning letter. “Amazon distributed each of the products directly to individual U.S. consumers on behalf of third parties. Each of the products was “fulfilled” by Amazon; your website states, “Fulfillment by Amazon (FBA) is a service that allows you to outsource order fulfillment to Amazon. Sign up for Amazon FBA to send products to Amazon’s global network of fulfillment centers and offer customers free, two-day shipping through Prime. When a customer makes a purchase, Amazon fulfillment specialists can pick, pack, and ship the order. We can also provide customer service and process returns for those orders.” 🔷Other recent Amazon warning letters were for ophthalmic (eye), homeopathic products for molluscum contagiosum, Diclofenac spiked products and disease claims, and skin tag removal products. Read the full warning letter . DATE ORIGINALLY POSTED: 12/27/23 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 FDA's helpful resource (Criterion 7) < Back Navigating the Risks of Therapy-Adjacent Health Claims Use FDA's helpful resource (Criterion 7) Navigating allowable and off-limits claims can be confusing. Fortunately, the FDA offers a helpful resource, The “Small Entity Compliance Guide on Structure/Function Claims” which includes a Q&A format outlining 10 key criteria to help distinguish between disease claims and structure-function claims. In today's Warning Letter Wednesday, I am exploring Criterion #7, "Claims to augment a therapy or drug intended to diagnose, mitigate, treat, cure, or prevent a disease." This criterion shows the FDA's thinking on why statements like “useful on your chemotherapy journey” or “take with antibiotics” are disease claims. 👉From FDA Guide. “A claim that a dietary supplement will augment a particular therapy or drug action that is intended to diagnose, mitigate, treat, cure, or prevent disease is a disease claim.” 🔹 Asa Comments: The best example of what not to do is from this 2021 warning letter where the company stated “ Vitamin C May Combat Cancer & Ease Cancer Treatment.” This is an issue because it claims to support or ease an oncology treatment and the vitamin C is positioned as an adjunct to drug therapy. 👉From FDA Guide. “A dietary supplement may state that it is useful in providing nutritional support, as long as that claim doesn't imply disease.” 🔹 Asa Comments: This is an interesting one as there is a fine line between making statements like “Omega 3’s are helpful at supporting mood” and making a “People with depression are often low in Omega 3’s, which is why we made this fish oil product” which would be crossing the compliance line. 👉From FDA Guide. In general, mentioning the name of a specific therapy, drug, or drug action will associate the claim with the intended use of the therapy, drug, or drug action and be a disease claim. 🔹 Asa Comments: Another 2021 warning letter shows us that FDA will flag supplements claiming to reduce the side effects of drugs. This is an area of the regulation that can be improved in my opinion as it’s well known that prescription drugs have side effects such as hurting the microbiome that can be lessened by taking probiotics. Addressing drug induced nutrient deficiencies is vital to health such as with statins which are known to deplete CoQ10 which is crucial to heart health. While a statement like “Replenishes CoQ10 lost when you’re on a statin ” may attract regulatory scrutiny, sticking with “Take CoQ10 as part of your heart wellness protocol” are lower risk, if substantiated. 👉 From warning letter. “Helps to reduce the risk of antibiotic-associated diarrhea…” When supplements are marketed to be taken with drugs this can also lead to litigation as we saw with the Culterelle case . This involves a probiotic product being labeled to be taken with antibiotics. Read FDA's Small Entity Compliance Guide on Structure Function Claims here . This is a great resource! DATE ORIGINALLY POSTED: 4/23/25 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!

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!

All dietary ingredients must be tested for identity < Back Company Cited For Not Testing Known Contaminants All dietary ingredients must be tested for identity Testing for known contaminants is an essential part of GMPs. This company was cited for not conducting proper identification and known contaminant testing on glycerin, an ingredient used in its manufacturing. The known contaminant in glycerin is diethylene glycol (DEG). During one GMP inspection I helped oversee, FDA was happy to see we had tested for DEG in glycerin. This showed we were aware of the potential safety issue with glycerin and were taking steps to ensure the finished product was safe. Learn more with the FDA’s guidance document , Testing of Glycerin for Diethylene Glycol. Other known contaminants are melamine in milk and methanol in ethanol. What other known contaminants does your company test for? The company that received this letter is an OTC and homeopathic drug manufacturer, but supplement folks can learn from this. Also, FDA cited the company for not proving their method was sufficient to test for DEG. As I discussed last week , proving test method suitability is top of mind for FDA investigators. Read the full 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!