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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

< 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

< Back Symposium Thursday Jun 10, 2021 cGMP's and Marketing Compliance for herbal product manufacturers International Herb Symposium cGMP's and Marketing Compliance for herbal product manufacturers, Learn More Previous Next

Ensure weight loss products are tested for drugs < Back Weight Loss Claims Trigger FDA Product Testing Ensure weight loss products are tested for drugs This company was making weight loss claims, leading to FDA purchasing and testing their product. Sibutramine was found, but surprisingly, the company is still selling the product. I find this confusing and look to FDA to help remove these dangerous products from the market. Sign up and search all old Warning Letter Wednesday posts here. 🔷FDA reviewed the company’s website last December, and sometime after that, purchased and tested a product, which ended up containing the drug sibutramine. On February 8th of this year, FDA issued a public notification that this product contained a hidden drug ingredient. 🔹According to the warning letter, the company refused to recall the product. After finding the drug-spiked ingredient and issuing the public notification, I find it strange that the company didn’t comply with this request. At this point, do you think the FDA could/should have elevated this to a seizure or injunction? I don’t believe many drug-spiked products are in the market, but when the FDA finds them, I would like them removed in haste. 🔷Aside from the presence of the drug-spiked ingredient FDA also cited several “disease-type” claims. The claims in this letter, such as “burns fat,” “weight loss,” and “Lose 20 pounds in 20 days,” are not normally seen in warning letters unless ingredients like sibutramine are mentioned. This leads me to think FDA is scanning for these trigger words before testing the ingredients. Also, statements like these are more common in FTC and plaintiff attorney complaints. FTC’s “gut check” document on weight loss claims is worth a read. 🔷This company is lucky FDA didn’t dig any deeper into its website. I ran Apex Compliance on their site and found numerous “Alzheimer’s” and “virus and flu infection” statements. 🔷The moral of the story here is that if you are selling weight loss (or sexual health) products, ensure you are testing for undisclosed drug-spiked ingredients. Amazon already requires an annual test for this, but testing each product lot is not a bad idea. 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!

Remove COVID claims including on YouTube < Back The First 2023 Warning Letter Belongs to a CBD Company Remove COVID claims including on YouTube The first "supplement" warning letter of 2023 belongs to a CBD company. 2022 was the year of the CBD warning letter, and FDA enforcement in this area appears to be continuing. This warning letter is another reminder that no company is "too small to be off FDA's radar." A video cited in this letter only had 19 views at the time I wrote this post! This is the most unpopular video I have ever seen cited in a warning letter demonstrating that any online marketing is fair game for enforcement. I write more about this here . This company was marketing a cannabinoid product for COVID protection on its website, socials, and YouTube. There were several similar warning letters last year involving companies citing research about cannabinoids and COVID. I usually take a "maybe they didn't know any better” attitude when looking at enforcement and compliance, but in this case, the company should have known better because of the well-publicized action against other CBD companies for this same type of statements. Here are some critical posts about CBD enforcement in 2022. CBD enforcement is top of mind for FDA. This includes animal warning letters . CBD and anxiety claims . Citing clinical studies . Natural Products Insider Q4 Update . This letter mentions several claims made in YouTube videos. Last year nine warning letters cited claims made on YouTube, and I expect this enforcement trend to continue. I write more about this here . This letter cites claims made on the company's social media from early in the pandemic. As we've discussed many times on Warning Letter Wednesday several times before, companies are responsible for all social media posts, even if they are several years old. From warning letter. "COVID prevention with CBD? Canada study shows it's possible. Might be time to start a daily dose of…… all-natural pharmaceutical grade CBD products…. USE CODE: COV19" [from a May 15, 2020, post on your Facebook social media webpage" This letter also cites the product code "COV19" which is a bold claim and further shows the intended marketing use of the product. This is a reminder that items like meta tags, product tags, search tags, and coupon codes are considered marketing. This is a joint FDA and FTC warning letter, which is common when COVID claims are cited. This is serious, and it also involves a cease and desist barring the company from making COVID-related claims or face injunction, a civil penalty of up to $46,517 per violation requirements to refund customers. 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!

Webinars are “fair game” for enforcement < Back MLM Distributors Cited in FTC Lawsuits Webinars are “fair game” for enforcement Warning Letter Wednesday primarily focuses on FDA-related enforcement, but occasionally I review interesting FTC actions. Today's #WarningLetterWednesday highlights three FTC cases against distributors of doTerra essential oils and supplements. doTerra is a network marketing company. This differs from last year's Young Living FDA warning letter, where the MLM parent company received the letter for claims largely made by its distributors (affiliates). Read more about this letter here . The claims in these three complaints were made in webinars in early 2022. FTC states they are "former healthcare practitioners who touted their expertise in recommending the products." Interestingly, FTC points out that the distributors named in these lawsuits use their medical background to market supplements. I'm sometimes asked if doctors can make statements about supplements they sell that non-doctors can't make. The answer is, of course, no, but in these cases, the distributor's medical background seems to be mentioned as another way they potentially misled consumers. Some of the cited claims imply products can support the immune system, and they dance around the idea they can protect or help with COVID. Since COVID claims are very high risk, even lightly implying protection is enough to attract agency action like a warning letter, administrative complaint, or lawsuit. Here is one example. From Lauren Busch FTC lawsuit. "LLV should be part of your daily routine, DDR Prime should be a nonnegotiable, especially with all the exposures we have in this world beyond just what's going on with COVID." A key takeaway is that all secondary marketing will be heavily scrutinized if any COVID claims are present. doTerra, the parent company from today's Warning Letter Wednesday, seems to do a good job at compliance. I ran my Apex Compliance program on their website and found just a few concerns. I'm happy to run a sample keyword check on your website; just let me know. The FTC complaint includes a permanent injunction against each defendant, stopping them from making unsubstantiated claims and also pay a $15,000 fine each. In my opinion, this monetary amount seems low, but it does send a cautionary tale that MLM distributors can be liable for the claims they make. COVID claims are likely why these distributors were targeted. "Brain fog" is also cited in one of the complaints. Do you consider this to be a disease claim? According to HHS, brain fog can be a symptom of long-haul COVID, a recognized disability under the Americans for Disabilities Act (ADA). My take is brain fog related to COVID symptoms is undoubtedly a disease claim, but brain fog not related to Covid isn't high risk. I feel "occasional brain fog" from time to time. I write about brain fog claims here . From FTC complaints: "The webinar was organized and promoted by doTERRA distributors …. and the registration link for the webinar was distributed on publicly accessible social media accounts." Interestingly, FTC references that access to the webinar is publicly available. If the webinar was closed to the public or invite-only, do you think it would have been cited in this complaint? Also, it seems the webinar recording may have been posted on YouTube, which, if true, maybe how the FTC found it. Companies and company representatives frequently record webinars and podcasts. Claims enforcement made in these formats are rare unless they are posted on YouTube, or the transcripts are hosted on a commercial website. My SaaS Apex Compliance program scans YouTube videos as well as websites and documents for risky keywords. Learn more here . Citing research is also mentioned in one of the complaints. From FTC lawsuit "slide displayed the abstract from an article titled "Computational evaluation of major components from plant essential oils as potent inhibitors of SARS-CoV-2 spike protein." We have previously discussed how citing COVID research to sell products can lead to warning letters. Read my comments on last year's FTC's 4.2 million dollar fine against Fashion Nova for allegedly hiding unfavorable product reviews here . Read about the FTC action 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!