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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

Some of my favorite regulatory resources. If there are other resources I should list here please let me know. Helpful Resources Here are some of my favorite regulatory resources. If there are other resources I should list here please let me know. Marketing Guidance This section covers helpful marketing resources, View Resources Prop 65 Guidance Prop 65 can be confusing. Here are some of my favorite resources. View Resources cGMP Guidance This section covers helpful GMP resources, View Resources Made in the USA and All Natural These are common plaintiff lawsuit targets. View Resources Labeling Guidance This section covers helpful labeling resources, View Resources NDI and GRAS Guidance This section covers helpful NDI and GRAS resources, View Resources Influencer Marketing & Product Reviews This section covers helpful influencer marketing resources. View Resources Home About Warning Letter Wednesday Work With Me Testimonials Appearances Press Regulatory Blog Resources More

Ensure material connection is disclosed properly < Back NAD Case: Influencer Material Disclosure Ensure material connection is disclosed properly This NAD case is a good reminder of the importance of influencers properly disclosing material connections in the same manner that endorsement is made. For example, suppose there is an image and no video/audio. In that case, then simply using hashtag#Ad or #(Company)Ambassador is sufficient, as long as these disclosures are not buried in a string of hashtags or below the “Read More” button. Now, according to the updated FTC guidelines, if an endorsement is made verbally, then the disclosure must also be made verbally. This kind of makes sense to me, but it becomes complicated when endorsements are made in Reels and Stories. Last year, FTC sent warning letters to several influencers and some sugar trade groups for not disclosing material connections in videos. I write about this here . Aside from that group of FTC letters, there hasn’t been much action with this new guidance, which is why this NAD case is so interesting. From NAD case stating what the company has agreed to do. "Requiring its influencers to include a verbal notice of their partnership with ... in any video influencer material." These rules ensure that consumers are not misled, which is important as we count on the honesty of reviews to make purchasing decisions. These disclosure requirements also apply to ambassadors, investors, and family members of companies. In this case, actor Demi Moore seemed to cross this line. From NAC case. "... challenged a social media post by Demi Moore in which she stated that her promotion of ... was "not an ad" and failed to disclose that she is an investor in the brand. The Demi Moore example is pretty over the top, but the likelihood that the other claims would have been cited in warning letter or agency action seems relatively low. This shows that “poking the bear,” which in this case is a very large company in the antacid space, can lead to increased challenger scrutiny. When in doubt, be very careful when disrupting category leader incumbents. Wondering what the National Advertising Division (NAD) is? Check out this post . There are some more interesting items in this case. Please 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!

“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!

Ensure statements are not disparaging < Back Best Practices When Making Competitor Comparison Claims Ensure statements are not disparaging Calling out the differences between your product and competitor products is permitted, but "poking the bear" often leads to competitor challenges. This NAD case involves a well-known mattress company challenging another competitor's claims as disparaging. The challenged claims in social media posts made statements such as the other mattress was "just a glorified air mattress." According to NAD, the advertisements created a "misleading impression, suggesting Sleep Number beds are comparable to temporary air mattresses that consumers would not use for their regular sleeping needs." Here is one example . So, where is the line between truthful comparison and being disparaging? Here are some tips. Truthful comparison : Keep the scope narrow and ensure you have supporting data while being careful with implied claims in imagery. 🔹 Truthful and supportable statements such as "Our foam conforms to your body shape while brand X's spring coils do not." 🔹 Comparisons based on objective tests or third-party data, such as "In lab testing, our mattress reduced pressure points by 30% versus air-chamber designs." 🔹 Puffery: I love this topic and have written more about it here . Disparaging claims : Implied claims like imagery matter! 🔹 Even if an actual statement is true, it can be disparaging if it infers negative connotations such as "basically an air mattress," which implies it is bad quality or uncomfortable unless there is undeniable and defensible supporting data. Read the NAD decision here . DATE ORIGINALLY POSTED: 4/30/25 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!