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Asa and other industry leaders interviewed < Back The blurred lines of the legality of Delta-8 Danielle Masterson Interview Asa and other industry leaders interviewed Read More Previous Next

< Back Panel Discussion Thursday Apr 13, 2023 Marketing Claims and Protecting Your Brand Naturally Los Angeles Leaders in the natural products space share their experience on how to market claims and protect your brand. Register Previous Next

< Back Webinar Friday Feb 12, 2021 Preparing For FDA Inspections: Fireside Chat Asa's Regulatory Education Series Asa and Steven Yeager discuss tools on how to prepare for and execute a successful FDA inspection. This includes an "Ask Me Anything" session where you can ask anything from us. How To Prepare: (Examples include): No Claims on Web & Social Media Outside of Building Clean Back Doors locked (GMP prerequisite) SOP Ready: What to do during an FDA inspection And more! Company Conduct: Quickly Turn Around Requests Make Copies of Everything Correct Observations Immediately Work with the investigator And more! Steven Yeager is Director of Quality and Regulatory Affairs for Mountain Rose Herbs and has overseen several FDA GMP inspections. Learn more here . Watch Previous Next

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!

Learn from other’s mistakes < Back Warning Letter Marketing Lessons Learn from other’s mistakes We can learn from others' mistakes, and this warning letter outlines what to avoid when marketing herbal supplements. This company was inspected by FDA and received some 483s, but today, I am going to focus on the website disease claims cited in the letter. From warning letter. "It's known to help reduce anxiety …." Asa comments: Suggestive words like "may" and "known to" do not allow us to make disease claims. If accurate, perhaps writing "occasional anxiety" would be lower risk, as this phrase likely represents normal life events and is not related to a disease I write about this here. https://www.asawaldstein.com/warning-letter-wednesday/anxiety-claims-enforcement-review From warning letter. "It's often used as a folk remedy for…the common cold and flu … helping allergies and sinus infections, treating diarrhea …." Asa Comments: Calling something a folk remedy or citing traditional use does not allow us to make strong disease claims like this. From warning letter. "From the list of hyperlinked "Tags" on the product page: "anxiety" "depression" Asa Comments: Product tags and meta tags are considered marketing. From warning letter. "Various studies have shown that it can be effective as a natural remedy for preventing and treating colds and flu …" Asa Comments: Citing studies and discussing clinical research is marketing, and it can also trigger plaintiff lawsuits, who love bringing action against companies making "clinically proven" claims. This is especially true for on-pack (on-the-label) statements. From warning letter. "The lions mane mushroom contains a variety of compounds… [that] have anti-inflammatory, anti-cancer…properties." Asa Comments: Discussing ingredient benefits on a website is a marketing claim, even if there is no hyperlinking to a shopping cart. This is a very common mistake that continues to be cited in warning letters. Okay, so I ran Apex Compliance™ on their website and was hoping that all disease claims were cleaned up. Unfortunately, I was WAY WRONG, as the site is still riddled with high-risk words like "cancer." Learn more about this award-winning compliance software, Apex Compliance ™. Can we envision a day when FDA requires companies who receive warning letters to go through some type of training? Is this a good idea or a terrible one? I suggest everyone read the full warning letter as a way to demonstrate what not to do. 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!

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

< Back Why CBD Companies Should Re-Examine Their Marketing Content -- NOW Palmate, LLC Interview Read More Previous Next

Hashtags can make compliant posts very non-compliant < Back Learning targets: Old social media posts, hashtags, sketchy ingredients, and high-risk claims Hashtags can make compliant posts very non-compliant #WarningLetterWednesday contains old social media posts, claims made in hashtags, sketchy ingredients, and high-risk claims. 🔷Old social media posts containing claims is a strong enforcement trend, but the ages of the posted cited in recent letters are more aged than the standard 2-3 years. I recently wrote about a 2014 re-tweet being mentioned in a letter here . 👉This letter includes Facebook posts from 2016. Wow, the FDA is digging deep into the company's social media, and this is an enforcement trend. Guess what, I made a "helpful hints" video about this. ➡️ From warning letter. June 2, 2016 (Facebook) post: “Phenibut is known as a GABA analogue. Outside the US many countries around the world use phenibut clinically for symptoms of PTSD, anxiety, depression and insomnia.” Hashtags are claims and this is a great example of how a company has taken a relatively lower risk post and made it high risk with a high risk hashtag. Here is a video on this topic. ➡️ From warning letter. On your February 27, 2017 (Instagram) post: #anxietyrelief” and “MOOD ELEVATION -ENHANCED SLEEP- HEIGHTENED FOCUS” 🔷I am unsurprised this letter contains the high-risk words anxiety and depression. Anxiety products claims enforcement was up 95% in 2021, and 75% of those warning letters had both anxiety and depression, a one-two compliance punch. It is important to remember this includes all online marketing, and these are pieced together for one picture of noncompliance. Here is a video and post about anxiety claims enforcement. 👉Insomnia claims are also mentioned in the letter which I have also written about here . These darn companies need to read Warning Letter Wednesday.😁 🔷There are some surprisingly low-risk structure-function claims cited in this warning letter. In my opinion, these are "secondary addition" claims that are not likely to attract a warning letter on their own. It is, however, interesting to see what the FDA considers a claim worthy of a warning letter "call out." ➡️ From warning letter. ..Product packaging: • “Stress Reducing • Mood Boosting” Also worth mentioning is the use of phenibut , which the FDA does not consider a dietary ingredient. 🔷Read the warning letter here . 👉Check out my WLW LinkedIn Group . 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!