< 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

Ingredient studies may support product claims < Back NAD Case: Supporting Substantiation Ingredient studies may support product claims Where is the line between needing an ingredient study or a full product study for substantiation? This National Advertising Division (NAD) case explores the nuances of reasonable consumer interpretation of labeling claims. It’s really interesting! Here are my extrapolations. Study population matters: NAD examined the ashwagandha Randomized Controlled Trials (RCTs) and determined that one of the trials was insufficient for substantiation, as the study group consisted of perimenopausal women, and the product is not specifically marketed toward women in this group. From NAD case. “NAD determined that one study did not adequately support the claimed sexual health benefits due to its focus on perimenopausal women and thus could not qualify as competent and reliable support for the challenged claims.” Attributing benefits to ingredients is a “safer” strategy. It’s “common-ish knowledge” in certain regulatory circles that attributing benefits to ingredients rather than to the entire product may lessen the need for a product RCT. This can also help reduce litigation risk. What is odd is that Example #37 in FTC’s Health Products Compliance Guide seems to suggest that ingredient studies may not be enough. This got me thinking about context and the reasonable consumer takeaway. The theme is CONTEXT MATTERS, so reviewing the entire advertisement rather than just a specific claim is essential. From NAD case. “Of the eight express claims, five specifically named ashwagandha as providing the expected benefit. The three remaining challenged claims did not specifically reference ashwagandha, but appear in contexts that make clear that ashwagandha is the source of the claimed benefits. NAD determined that in this context, reasonable consumers would interpret the claims as attributing the product benefits to ashwagandha.” This a big victory for KSM-66 whose ashwagandha extract studies were likely used for substantiation. Read the NAD case here . DATE ORIGINALLY POSTED: 7/9/25 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!

Safety related product claims attract scrutiny < Back “Non-Toxic” Claims Require Extensive Substantiation Safety related product claims attract scrutiny Making a “Certified Non-Toxic” claim on a mouthwash triggered a competitor challenge. According to the National Advertising Division (NAD) comments, the substantiation provided by the company was not sufficient to support the claim. 👉From NAD. “In support of the “Certified Non-Toxic” claim, Oral Essentials submitted two cytotoxicity studies (one for its sensitivity mouthwash and one for its whitening mouthwash) and a certification statement from MADE SAFE, a third-party certification program that verifies ingredient safety and non-toxicity. Oral Essentials mouthwashes were certified by MADE SAFE at the time of manufacture.” 👉From NAD. “Strong evidence is needed for non-toxic claims due to potential health and environmental risks as well as the potential for consumers to misuse the product or take away a broader message about the product’s safety that is not supported by the claim.” 👉Apparently, the cytotoxicity studies did not exactly match the and did not address the “real-world” effects. From NAD. “NAD found Oral Essentials’ cytotoxicity studies did not support the challenged claims such studies do not reflect the real-world effects on humans and only address one form of toxicity. Additionally, the study formulations contained one less ingredient and differed from the current product ingredients.” It seems the position is that making a “Certified Non-Toxic” claim on a mouthwash label may give some consumers the idea that they can drink the whole bottle or put it in their eyes with no safety issues. I expect people to have more common sense than this, but I guess it is possible for a consumer to think that “Non-Toxic” means they can go nuts with it. I assume the same rationale would apply to toothpaste or any other product that is sparingly used internally. 🔹Don’t rely on certifications: The company also relied on a “MADE SAFE” certification, but this did not substantiate the claim because it was unclear to NAD which real-world factors were evaluated in the certification process, and the company's certification had expired in October 2024. At Supplement Advisory Group , my regulatory consulting company, I often share the “less-is-more” principle with clients. This means that every aspect of packaging will be scrutinized, and if it’s not necessary for marketing, removing it is a good idea. This is not always a popular opinion, but it is important to measure risk and reward while keeping substantiation in mind. Read more about the case here . DATE ORIGINALLY POSTED: 1/15/25 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!

Be nice to FDA investigators & follow inspection SOPs < Back Refusing FDA Inspection Access Be nice to FDA investigators & follow inspection SOPs GMP inspection preparedness is an essential part of business and compliance. This includes ensuring team members know how to conduct themselves during an inspection, what types of information FDA is allowed to request, and understanding what can go wrong if staff do not allow access to the specific areas of the facility. This warning letter is an extreme example of what not to do during an inspection. The company, a cosmetic and topical OTC manufacturer, was issued a letter for not allowing FDA to enter certain areas of their facility, but it doesn't stop there. Apparently, the quality manager shoved and shouted at FDA investigators? As my daughter would say, "WTF." From warning letter. "Quality Manager entered the laboratory and exhibited hostility by shoving and shouting at our investigators for conducting the inspection without their presence. Additionally, laboratory staff refused to open a drug stability chamber based on his hostile behavior. FDA inspectors are real people, and common courtesy goes a long way, such as offering them water (do not offer anything else as it is considered inappropriate), suggesting a good restaurant for lunch, and just being nice. It goes without saying that shouting and shoving anyone, especially FDA, is bad, and it would set up the rest of the inspection to go much worse than it could have. Employee training and mock FDA inspections are a critical part of a smooth "real" GMP inspection. It is standard practice for FDA to request a list of complaints to ensure they are being investigated properly. A customer complaint related to mold and its associated investigations was not disclosed in the list of complaints provided to the FDA. The section of the warning letter is sad and potentially speaks to an unfriendly and potentially fishy work environment. From warning letter. "While interviewing an employee regarding the undisclosed positive mold results for your …. your Quality Manager entered the room and began berating the employee, who then left the room, impeding FDA's review of your contamination investigation required under CGMP." There are several other GMP citations listed in the warning letter. Failure to Test Finished Products (21 CFR 211.165(a)). Failure to Test Components for Identity and Purity (21 CFR 211.84(d)). Testing glycerin for diethylene glycol (DEG) or ethylene glycol (EG) is mentioned here. FDA is very serious about this and has been mentioned in 40+ warning letters this year. Inadequate Facility and Storage Conditions (21 CFR 211.42(b)). Inadequate Quality Unit Oversight (21 CFR 211.22). Lack of Process Validation and Cleaning Validation (21 CFR 211.100(a) and 211.67(b)). This warning letter reads like a bad movie and makes the company look unprepared and non-compliant. Read the full letter here . DATE ORIGINALLY POSTED: 12/25/24 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!

Tune in to hear Asa Waldstein of the Supplement Advisory Group, a boutique group focusing on marketing risk analysis and practical marketing solutions for the web and social media, discuss the latest need-to-know regulatory information impacting the cognition, adaptogen, and nootropic space. < Back Regulatory and Enforcement Update on Notable Action in the Cognition, Adaptogen & Nootropic Space Maggie Jaqua Press Mention Tune in to hear Asa Waldstein of the Supplement Advisory Group, a boutique group focusing on marketing risk analysis and practical marketing solutions for the web and social media, discuss the latest need-to-know regulatory information impacting the cognition, adaptogen, and nootropic space. Read More Previous Next

Old social posts are “active” marketing < Back Animal Product Claims Under Increased Scrutiny Old social posts are “active” marketing Claims made about animal products seem to have a lower tolerated "acceptance level" than human products. This is a friendly reminder to take another look at your animal product marketing because there may be forgotten risky marketing statements that can come back and "bite you" (I couldn't help the animal pun). Here is one example. These are obvious disease claims that should be avoided, but usually, this would not "tip the scale" into warning letter territory in a human product. 👉From warning letter. "… for dogs was designed and tested to boost your do's natural defenses against the unique host of fungal, parasitic, viral, and bacterial pathogens that flourish in the desert southwest." 🔹No company is too small to be off FDA's radar. This company has a very small web and social media presence, but they were still discovered and cited. Anyone marketing products online is "fair game" for enforcement. I write more about this here . 🔹Seven-year-old social media posts are cited in this letter. Plenty of two- or three-year posts have been called out in warning letters, but a seven-year-old post is going way back. I ask, does anyone really look at these really old posts? In the eyes of the FDA, these are considered active marketing and, therefore, should be compliant. Here is a post about this. 🔹Scanning old social posts is critical to any compliance "clean up" project I conduct. These forgotten old posts provide only risk and no marketing benefit. Here is an old and relatively lower-risk example. 👉From warning letter. "From your social media website. On January 29, 2016 you posted: "Important information: frequently when pets first start showing symptoms of Valley Fever they do not register a titer and thus the reason for misdiagnosis and the wrong course of treatment. If your pet is showing any signs then start Desert Defense while you await the diagnostics!" DATE ORIGINALLY POSTED: 2/22/23 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!

Do not engage with customer “disease” testimonials < Back Saying “Thanks” on a Social Post Leads to Warning Letter Do not engage with customer “disease” testimonials If a company engages with a post on its social media wall, this is considered “endorsing the testimonial” and is marketing. It has been quite a while since we have seen a company cited for this, and honestly, I thought FDA had stopped enforcing this until the recent warning letter . Sign up for weekly Warning Letter Wednesday posts here . There are a few interesting aspects to this warning letter. Even saying “thanks for commenting” or “liking” a post is an “endorsement.” Based on this, I guess that smiley face emojis should also be avoided when posts have a disease or disease-treatment claims. The lesson here is that any engagement turns a customer comment into a marketing claim. Companies should review old social posts to ensure there is no engagement on customer comments with disease-type claims. FDA may look back several years on a company’s social media page. Claims made on Amazon and Walmart are cited in this letter. Companies commonly focus on website compliance but often overlook “old” marketing statements on these platforms. FDA is paying close attention to these platforms. This was part of the “Big 7” cardiovascular-related warning letters from a few weeks ago, which show that even talking about diagnostics related to heart disease, such as “lowers LDLs” can lead to a warning letter. I write about this in detail here . From warning letter. “You also endorsed the following responses to your post by liking them: “I just got my blood test back my total cholesterol went down 56 points and my bad cholesterol went down 82 points.” FDA cited claims made on a company testimonials page. The authorities have been “hands off” with non-curated, non-compensated, third-party product reviews. These cross the line into marketing if they are showcased on banners or, in this case, on a specific testimonials page. DATE ORIGINALLY POSTED: 12/14/22 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 Presentation Saturday May 21, 2022 Medellin, Colombia: Pitfalls to Avoid When Entering the US Cannabinoid Product Market Bizcann Expo Columbia Medellin, Colombia There is so much that can go wrong when entering the US cannabinoid or supplement marketplace. In this session we discuss how to avoid common labeling, product manufacturing, registration, and marketing errors that can delay launches, or worse, attract the attention of the FDA and class action attorneys. See pictures and the post on Asa's speech here . Learn More Previous Next

< 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