Search Results

Use FDA’s helpful resource (Criterion 2) < Back Best Practices When Making Biomarker and Implied Claims Use FDA’s helpful resource (Criterion 2) I often talk about disease claims attracting warning letters, but it can be difficult to know where the line is between allowable structure-function claims and off-limits health claims. Thankfully, the FDA has published the "Small Entity Compliance Guide on Structure Function Claims," which provides a Q&A with 10 criteria to help determine if a statement is a disease claim or a structure-function claim. It's really helpful! In today's Warning Letter Wednesday, I am exploring Criterion #2, "Claims an effect on characteristic signs or symptoms of disease using scientific or lay terminology." This criterion shows the FDA's thinking on why biomarker claims like "lowers cholesterol" are disease claims. 👉From FDA Guide. "Some claims imply disease treatment or prevention because they are so intimately tied to a disease. For example, "inhibits platelet aggregation" or "reduces cholesterol" are such characteristic signs or symptoms associated with stroke and cardiovascular disease and interventions to treat those diseases that any claim about them would be an implied disease claim." 🔹 Asa Comments: This is where FDA shares insight on why biomarker claims like "lower LDLs" are disease claims. They also use heart disease examples, which highlight why most of the biomarker warning letters involve cardiovascular-related claims. I write more about this here in a post from 2022, and the enforcement trends have continued. 👉From FDA Guide: "Other signs or symptoms are associated with a wide range of disease and non-disease states and do not necessarily imply an effect on a specific disease. For example, although "improves absentmindedness" might imply treatment of Alzheimer's disease and "relieves stress and frustration" might imply treatment of anxiety disorders, both of these signs also are characteristic of non-disease states. So, if there is no context linking them to a disease, they would be appropriate structure/function claims." 🔹 Asa Comments: This shows how context matters and how structure-function claims can cross the line into disease claims. For example, in the FDA's "improved absentmindedness" example, if there was an image of a confused elderly person, this would elevate the likelihood of it being an Alzheimer's claim. 🔹 🔹 We've all seen the "maintain cholesterol levels already within a normal range statement, and this is where it comes from. The key takeaway here is being "absolutely clear" when making disease-adjacent is a safer strategy. Of course, I am just talking about FDA guidance here and this doesn't stop retailers like Amazon from unnecessarily flagging keywords like "cholesterol levels" which can lead to delisting. Retailers are increasingly tuning into "another regulatory group" to be aware of. 👉From FDA Guide. "There are many conditions that are "normal," but under certain circumstances are also disease claims. The rule states that such claims (for example, maintaining normal cholesterol levels) may be appropriate structure/function claims and would not imply disease if the claim made absolutely clear that the claim is referring to structure/function claims that are already normal. This context would remove the inference to an effect on a structure/function that was abnormal (for example, "maintain cholesterol levels that are already in the normal range")." 👉From FDA Guide. "The standard focuses on whether the labeling suggests that the product will produce a change in a set of one or more signs or symptoms that are characteristic of the disease. You can meet this standard using technical or layman's language and it isn't necessary that every possible sign or symptom is used." 🔹 Asa Comments: This section focuses on implied claims such as an EKG symbol, "lowers bad fats," or statements like "I never had to see my cardiologist again." Before-and-after pictures of an older person who no longer has mobility issues also apply here. In practicality, implied claims are somewhat less likely to attract regulatory issues because they may not contain "trigger words," but avoiding them is a good idea. Read FDA's Small Entity Compliance Guide on Structure Function Claims here . This is a great resource! DATE ORIGINALLY POSTED: 4/9/25 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!

Discussing ingredient benefits is marketing < Back Website “About Us” Claims Cited in Warning Letter Discussing ingredient benefits is marketing This warning letter cites claims made in the “About Us” section of the company’s website. Usually, when “About Us” claims are mentioned in warning letters, there is some hyperlinking to a shopping cart, but this letter mentions CBD and high-risk disease words such as Dravet Syndrome without any clear linking. The lesson here is simply talking about an ingredient can lead to a warning letter if that ingredient is sold on the website. From warning letter. “On your “About Us” webpage…CBD is FDA approved to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and Tuberous Sclerosis Complex.” This is the 34th CBD-related warning letter this year, up from just seven in 2021. This year certainly has been the year of the CBD warning letter, and I expect many more in 2023, including a crackdown on delta-8 and other isomer products. This company cited in this letter also sells fruits, such as mango and pineapple, that were apparently sprayed with CBD. FDA has been cracking down on CBD in food due to being favorable to children and the possibility of creating a safety concern. Read more about this here . This CBD fruit citation is another example that the days of “putting CBD in everything" are gone. Hashtags also play a prominent role in this warning letter. One post lists # anxiety and # depression. Over 30% of this year’s CBD warning letters mention the one-two punch of anxiety and depression. This post includes these two words together in hashtags is an excellent example of what not to do. From warning letter. “…promising results regarding #cannibidiols [sic] potential to assist with cognitive illnesses, including #anxiety and #depression.” Read the full warning letter . Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

< Back Interview Thursday Apr 29, 2021 Compliance, Herbalism, and the FDA view on CBD LuvNCann I enjoy speaking about my opinion of the FDA's view on CBD, warning letters, herbalism, and so much more on this great podcast! This is a unique podcast started to support hosts Osiris and Nina in their quest for health and happiness while raising a son with epilepsy. They have curated some important discussions! Learn more Previous Next

No such thing as “too small to be on FDA’s radar” < Back Discussing Ingredient Benefits Leads to a Warning Letter No such thing as “too small to be on FDA’s radar” Small herb company cited for elderberry-oriented disease claims. This is a good reminder there is no such thing as “too small to be on the FDA’s radar.” Claims in the letter provide some good learning opportunities. Discussing ingredient benefits on a commercial website where those ingredients are sold is a marketing claim, even if there is no cross-linking to a product page. In this letter, the company made statements about elderberry in their “Elderberry 101” FAQs. Here is another post about this. From warning letter: “In 2004, a study on elderberry extract in flu patients revealed that symptoms were relieved 4 days sooner than patients who didn’t receive elderberry.” Claims made on social media are also cited. It seems like the majority of warning letters involve social media claims. The front and last line of defense is the company’s social media manager. Unfortunately, it’s common for these team members not to understand the nuances of supplement marketing. This is one of the reasons I make helpful hints regulatory videos such as this. From warning letter: “Benefits of Elderberry .. From Facebook “Another 2020 review of five elderberry studies concluded that, when taken within 48 hours of initial symptoms, elderberry supplements may reduce the length and severity of fever, headache, runny nose, and congestion associated with cold and flu.” Copying literature or “research” about an ingredient onto a commercial website or social media post is a common trap new supplement marketers fall into. I talk about this here . This is another example of a well-intentioned cottage herb company that didn’t understand the rules of marketing supplements, thus resulting in a warning letter. Once product marketing is posted online or on socials the risks of FDA/FTC scrutiny increase. Unfortunately, marketing compliance is not commonly taught at herb or natural medicine schools. Helping to educate this community is one of my missions, so please help me spread the good word of compliance. Read the full warning letter . Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Reporting of a SupplySide West presentation < Back Sales soar for probiotic-containing soft drinks Jeff Gelski Interview Reporting of a SupplySide West presentation Read More Previous Next

Well intentioned marketing claims can turn products into high-risk regulatory categories < Back Goat Milk Company Infant Formula Claims Well intentioned marketing claims can turn products into high-risk regulatory categories This goat milk supplement and food company was cited for claiming its goat milk product is an alternative to infant formula. This is a great example of how well-intentioned marketing statements can cross the line into a risky regulatory category. Let’s explore what went wrong. FDA looked at this company’s website and social media and determined their Goat Milk Formula Recipe Kit met the definition of infant formula because it was “purported to be or was represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.” Essentially, this means the company was promoting their product as infant formula. Here are some of FDA’s warning letter references. "We have created a formula recipe that mimics breast milk and follows the guidelines created by the 1980 Infant Formula Act.” Your February 12, 2024 (Facebook) post: “‘Infant formula is the number one regulated food in the U.S., and yet the allowable ingredients in off-the-shelf infant formula is often times very very poor. So there is a very good incentive to make your own formula.’ Get to know the creator, Joe Stout, and learn about the Goat Milk Formula Recipe on the GMF Livestream replay! . . . #DIYBabyFormula . . .” I ran Apex Compliance on their website and found A LOT of very high-risk marketing claims, and I suggest this company look at conducting a compliance audit. Apex Compliance was developed for this type of situation, sifting through large amounts of information and providing a line-by-line playbook showing where risky phrases occur, their risk rating, and some possible lower-risk alternatives. Learn more here . To give the company credit, they seemed to go above and beyond to correct the matter once FDA brought this to their attention. It seems that even though they worked diligently to correct their mistake, FDA issued the warning letter to “ensure the violation does not recur.” Infants are classified as a “vulnerable population,” and this warning letter language demonstrates how seriously FDA takes the infant formula category. From warning letter. “We acknowledge that after a teleconference with you on May 7, 2024, you voluntarily recalled all Goat Milk Formula Recipe Kit ... We are aware that you contacted all customers who received product during that timeframe to inform them that the product should not be used as an infant formula. Additionally, you issued a press release on May 10, 2024, clarifying to the general public that you do not recommend using this product for infants from 0-12 months of age. We also acknowledge that you removed the ability to purchase the Goat Milk Formula Recipe Kit from your website, and that you made some changes to your website and social media websites, including but not limited to removing the above-mentioned statements regarding use as an infant formula. However, due to the serious public health concerns related to your unlawful marketing of a new infant formula, it is essential that this violation does not recur.” Read the full warning letter here . DATE ORIGINALLY POSTED: 10/9/24 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!

Asa and other industry leaders interviewed < Back Product Reviews & Marketing Claims Kate Robertson Interview Asa and other industry leaders interviewed Read More Previous Next

Presentation < Back Mental Wellbeing in Today's Digital Age Isabella Davis Press Mention, Data Mention Presentation Read More Previous Next

Claims in videos are “fair game” for enforcement < Back YouTube Claims Lead To Warning Letter Claims in videos are “fair game” for enforcement YouTube video claims lead to a warning letter. The claims cited in this letter are not from people talking but from image text on the screen. This is the first time I have seen image text, not spoken words in a video, called out in a warning letter. This is the seventh warning letter this year that mentions claims made on YouTube. The FDA’s YouTube video search capabilities must have improved, and we can expect more enforcement of videos in the near future. Interestingly, I have found only one warning letter ever that mentions claims made on the Vimeo platform. Claims made on videos pique my interest, as YouTube video claims were nearly almost nonexistent a few years ago. I'm sometimes asked if purely educational video channels are fair game for FDA enforcement. My answer is “kind of” unless there is a commercial or material bridge; a URL on the channel, or In the comments that link back to where consumers can purchase similar products. No link to commerce = low risk of enforcement. The video cited in this letter provides a link to the commercial website in one of the video comments. From warning letter: “COCA LEAF REDUCES EATING ANXIETY ISSUES” at approximately 0:43sec in the video.” Read the full warning letter . DATE ORIGINALLY POSTED: 9/7/22 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!

Review old social posts < Back Social Media Disease Claims Earn Warning Letter Review old social posts Claims on social media can tip the scale to a warning letter. This warning letter is interesting. It includes topical products marketed as drugs, animal “drug” claims, and more, but today, I will be focusing on the social media claims. Please also forgive the brevity of this Warning Letter Wednesday as I am on a road trip visiting graduate schools with my daughter. FDA looks at the 10,000-foot view of a company’s online persona. One claim in isolation is probably not enough to trigger a warning letter unless it is very egregious (e.g., COVID). The agency chooses claims from all marketing, such as socials, websites, and YouTube, and pieces them together for one big picture of non-compliance. Most of the highest-risk claims in this warning letter are on social media. From warning letter. “On your Facebook account. June 27, 2022: • Under the heading “Benefits of Spirulina” [an ingredient in Fulvic Green]: − “[C]an reduce risk of cancer.” This shows how discussing ingredient benefits is a marketing claim. Since the post cited in the warning letter is almost two years old, it shows that even old social posts are active marketing in the eyes of FDA. The moral here is to review your old social post to ensure no “forgotten” high-risk disease claims are there. From warning letter. “On your Facebook account post, dated June 20, 2022:CAN PREVENT SEI-ZURES…used in traditional ayurvedic medi-cines as a cure for sei-zures and convulsions.” Discussing traditional use claims in this content is a disease claim and is therefore considered labeling. 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!

Learn from other’s mistakes < Back TCM Company GMP & Marketing Violations Learn from other’s mistakes FDA inspected this TCM manufacturing and product company earlier in the year, including looking at its product catalog and website. This led to GMP and disease claim citations. Let’s start with the disease claims. Some of these may be considered TCM verbiage, but this is an important reminder that using common Traditional Chinese Medicine (TCM) or herbal language doesn’t necessarily translate into compliant marketing. From warning letter. “Staunches bleeding, disperses swellings, and relieves pain” “Expels pathogens, resolves depression” Product catalog: This is a reminder that anything FDA sees during inspection can be reviewed, including shipping inserts. I remember years ago almost forgetting to discard old “potentially non-compliant” product brochures that were collecting dust on a shipping shelf. If FDA found these during an inspection, they would have been “fair game” for them to collect and review. Now for the GMP issues. There are a lot of learning opportunities here. Identity specifications. In most cases, organoleptic (e.g., color, taste, smell, feel) testing is not sufficient to determine botanical identity. However, if the plant came in whole leaf (rather than powder), for example, I think a case can be made that organoleptic testing may be sufficient. From warning letter. “Analysis of organoleptic factors does not provide unique information that is specific to each of these ingredients and thus cannot confirm the identity of each ingredient.” Metal detection. This is one we don’t see very often. From warning letter. “You failed to use effective measures to protect against the inclusion of metal or other foreign material in components and dietary supplements, as required by 21 CFR 111.365(i).” Incomplete MMR instructions. I like to think of the MMR and BPR as recipes. If a new team manufactures the product, does the MMR/BPR have all the needed instructions? This is to maintain consistency in product manufacturing. From warning letter. “Your master manufacturing records (MMR) failed to include written instructions and specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement products and that the dietary supplement is packaged and labeled.” Product specifications. Not having complete specifications is one of the most common GMP violations. Here FDA states that the provided microbial and heavy metal specifications are not enough to justify the product’s identity, purity, strength, and composition. I ask, if the product contained only botanicals, what else is needed to verify this? One answer is that a finished product composition test is needed, which is an expensive method to develop and test. From warning letter. “The physical and chemical factors do not constitute unique criteria that can confirm the identity of these products and do not evaluate the purity, strength, or composition of these finished products.” Here are some labeling citations. Structure function claims on labels not linked to FDA disclaimer . This is showing up in more warning letters. Plant parts should be listed on the label. I personally think that “herb” is descriptive, but according to FDA, it is not sufficient. From warning letter. For example, “herb” does not identify the plant part used in the product. If the whole or entire plant is used, that information must be listed. Listing the ingredient name common correctly. From warning letter. “Citrus” which is not the common or usual name of an ingredient. Solvents should be listed . This is not to be confused with processing aids, which, in most cases, do not need to be listed. From warning letter. “(the label) fail(s) to declare the solvent used in the extract within the ingredient list. Other comments in the warning letter are important reminders of labeling and GMP compliance. Expiration dates: The company did not have supporting data for its “best by” dates. Expiration or freshness dates are not required on supplements, but when they are used, the company must have supporting data. In my experience, this does not have to be super complicated and may include a time-zero and a 1 to 2-year-old product tested for organoleptic, microbial, and line item assay tests. Facility registration : It looks like the company did not update its facility registration within 60 days of important changes. Read the full warning letter here . DATE ORIGINALLY POSTED: 10/2/24 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!

Influencers must disclose material connection < Back FTC Letters To Sugar-Promoting Influencers Influencers must disclose material connection FTC sent warning letters to two trade associations and 12 influencers for not disclosing material connection in their posts promoting the safety of aspartame and sugar. This shows that FTC is serious about enforcing its endorsement guidelines. There were some interesting FDA warning letters to write about this week, but this FDA action was too sweet to pass up. Many of the actions included posts on TikTok. Amazingly, TikTok posts are rarely cited in agency action compared to other platforms such as Instagram. Why is this? Also, claims on TikTok have never been cited in an FDA warning letter, but I expect this to change in 2024. Read about the FTC action . FTC provides guidance on what conspicuous disclosure means. Learn more . #Ad may not be enough. In the past, adding #Ad may have been sufficient, but now, a disclosure must be made in the format it was delivered. This means that "if the representation is made through audible means, the disclosure should be made in at least the communication's audible portion." From FTC warning letter. "The video itself did not include any disclosures. Viewers can easily watch a video without reading disclosures in a post's text description. There should be clear and conspicuous disclosures in the videos themselves, for example, by superimposing much larger text over the videos. In your video, you made endorsements through both visual and audible means, so the disclosures should have been made in both the visual and audible portions." Reels must also have disclosures; adding a hashtag in the description is not enough. I understand most influencer rules, but this one is tough to comply with. From FTC warning letter. "Videos have many competing elements. We therefore do not think that a disclosure in a Reels post's text description is clear and conspicuous." Paid partnership is not adequate disclosure. Many platforms like Instagram require influencers to use their "Paid Partnership" heading. Unfortunately, this is not sufficient for disclosing the material connection. In the future, I'd like to see these platforms harmonize their requirements with FTC regulations. This FTC quote sums it up, and I applaud FTC for this action. "It's irresponsible for any trade group to hire influencers to tout its members' products and fail to ensure that the influencers come clean about that relationship," said Samuel Levine, Director of the FTC's Bureau of Consumer Protection. "That's certainly true for health and safety claims about sugar and aspartame, especially when made by registered dieticians and others upon whom people rely for advice about what to eat and drink." The moral of the story is to disclose material connection in all formats when necessary, audio, video, and clearly in text. Yikes, being an influencer is more difficult than it used to be. DATE ORIGINALLY POSTED: 11/22/23 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!