“Brain Fog” claims related to Covid will attract scrutiny < Back Small Herbal Company in Big Trouble for Disease Claims “Brain Fog” claims related to Covid will attract scrutiny This is yet another example of a well-intentioned herbalist-owned, very small company being cited for disease claims. I write about how no company is “too small to be off FDA radar” here . This company is a farm that makes small-batch products, but unfortunately, they don’t seem to know the rules of dietary supplement marketing. All the claims cited in the FDA warning letter have been removed, but there is still a cancer treatment herbal kit for sale on their website. Unfortunately, the basics of DSHEA and marketing compliance are not taught in herb and acupuncture schools. One of my missions is to educate these communities about the basics of the dos and don’ts of supplement marketing. Here is my speaking schedule ; please let me know if I can extend free education to your school. Also interesting in this warning letter is the second mention of “brain fog” in FDA letters. 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. Due to the hashtags in this post, the correlation to Covid is undeniable. This is a good reminder that hashtags can be considered disease claims and tip the scale into the warning letter category. Here’s a video about this. From warning letter. “Plants geared towards cardiac and mental health, brain fog, respiratory issues, and fatigue . . . # postcovid, # postcovidsyndrome, # longcovidrecovery, # longcovidsymptoms This is a joint FDA and FTC warning letter, which is common when Covid claims are cited. This is very 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. 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!

Study design must be correct < Back Clinically Proven Claims Lead To Scrutiny Study design must be correct This NAD case shows that making “clinically proven” claims attracts the highest level of scrutiny. The National Advertising Division (NAD) has been paying close attention to skincare marketing claims, and this monitoring case shows that this trend is continuing. A celebrity-supported skincare brand was making the following statement. “Clinically-proven to quickly and visibly lift, firm, and diminish the appearance of fine lines for a revitalized eye area.” Reading NAD’s comments on the clinical study design is interesting. The clinical study “included instrumental measurements of skin hydration and elasticity, digital photographs, and participant questionnaires,” but NAD determined the subjective portion of the study questionnaire could not support all of the ‘clinically proven to quickly and visibly lift’ statements but “NAD found that other portions of the claim were supported, therefore recommended the claim be modified to reflect that the “quick” and “visible” results pertain only to hydration and “the appearance of fine lines.” This shows how even small marketing statements may be picked apart and should be adequately substantiated. There are also some other items in this case which are worth reading. Full disclosure: I am a big Reese fan, but the folks in charge of her brand ambassador compliance can learn from this. From NAD. “The National Advertising Division (NAD) also recommended that actress Reese Witherspoon’s status as a … brand ambassador be clearly and conspicuously disclosed. NAD’s inquiry further focused on whether the format of the challenged advertising gives the impression of editorial content from InStyle and Hello! Magazines and Sephora when, in fact, they are advertisements.” The company also discontinued the “#1 best selling product at Sephora” claim. NAD cases continue to reference claims like “#1 best selling” and “#1 doctor recommended,” which should be avoided unless the company has solid substantiation. These types of claims should not be confused with puffery statements such as “world’s best cup of coffee,” which are permitted. I write more about puffery here . Read the NAD case 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 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!

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

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!