Search Results

Replace high-risk words on a commercial website < Back Discussing ingredient benefits is a marketing claim Replace high-risk words on a commercial website #WarningLetterWednesday Discussing ingredient benefits on a commercial website can easily cross into product disease claims. This is a common marketing mistake, and I suggest fighting the urge to explain ingredient benefits with high-risk language. 👉Here is a video about replacing high-risk words with lower-risk alternatives. ➡️From warning letter: Persimmon leaves have anti-hypertensive, anti-carcinogenic, and anti-mutagen properties." 👉These are common "claims" mistakes. Here is a video about tips for knowing if a claim is being made. 🔷Read my post about ingredient benefits from a few months ago here : ➡️From warning letter: "Chamomile's mildly sedating and muscle-relaxing effects can help those who suffer from insomnia . . . ." 👉Insomnia claims are high risk. I write about this here . 🔷This warning letter is interesting as there was first an in-person inspection in August 2021, then the FDA reviewed the company's website in November 2021 and recently in February 2022. This is a good reminder for companies to clean up their websites before/during/after GMP inspections, as it seems a few website edits could have prevented this letter. Citing studies can be looked as product marketing claims. ➡️From warning letter: Examples of some of the claims on your website's "TEA AND CANCER PREVENTION – NATIONAL CANCER INSTITUTE" page that provide evidence that your product is intended for use as a drug include: "More than 50 epidemiologic studies of the association between tea consumption and cancer risk have been published since 2006..... 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!

< Back Podcast Wednesday Dec 4, 2024 Unveiling Supplement Regulations: Asa’s Insights on Compliance and Ethical Marketing Natural Products Marketer Podcast Unlock the secrets of dietary supplement regulations with our esteemed guest, Asa, a seasoned regulatory consultant with a background in clinical herbalism. Discover the intricacies of FDA oversight in the supplement industry and learn why the notion that dietary supplements are unregulated is a myth. Asa’s journey from herbal studies in Boulder to advising companies on maintaining compliance provides unique perspectives and invaluable lessons for anyone navigating this complex field. Gain a deeper understanding of the transformative impact of the Dietary Supplement Health and Education Act (DSHEA) and its role in shaping the herbal and dietary supplement industry. We explore the distinction between structure/function claims and disease claims, and how these affect marketing strategies. Delve into the evolution of labeling and marketing regulations, and consider potential legislative updates that could further refine the guidelines set by DSHEA over the past three decades. Lastly, we tackle the challenges retailers face in complying with regulatory guidelines, particularly in the context of influencer marketing and digital platforms. Learn about the risks associated with unsubstantiated claims and how innovative tools like Apex Compliance software are helping companies stay in line with regulations. Through practical advice and expert insights, this episode equips businesses with the knowledge to market their health products ethically and legally. Listen to the Podcast Previous Next

Inflammation + arthritis claims = warning letter < Back Lessons From Inflammation Warning Letters Inflammation + arthritis claims = warning letter Inflammation claims were cited in 17 supplement-related warning letters last year. Here, we’ll look at the lessons we can learn from these letters. Statements like “reduces inflammation” or “anti-inflammatory” are disease claims, but they are not likely to attract a warning letter on their own. 47% of the inflammation claim warning letters (8 of 17) cited in 2023 warning letters include the word arthritis. 53% of these warning letters (9 of 17) include the word “cancer.” Here are some key takeaways. All 17 warning letters include high-risk claims like arthritis, cancer, or Monkeypox, with one exception. This warning letter exception is animal-related and “only” makes inflammation and anti-viral statements. Although risky, this is typically not enough to tip the scale into warning letter category unless it’s an animal product, as FDA has a lower “tolerance” for claims made about animals compared to human products. Although making inflammation claims carries some risk, they are unlikely to be the sole reason for a warning letter. This includes claims made on posts or platforms different from the inflammation claim. This demonstrates how FDA looks at disease claim enforcement. They look at the 10,000-foot view of a company’s online persona and piece together claims from areas like blogs and socials for one big picture of non-compliance. This shows that compliance is not done in a vacuum, and taking a holistic approach to compliance is important. This is one of the approaches we take at my regulatory consulting company, Supplement Advisory Group. Contact me to talk about your consulting needs. 41% of these warning letters involve claims on social media. This is a friendly reminder that even very old social media posts are considered active marketing. 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 citations are marketing < Back GMP Inspection Leads to Online Scrutiny Study citations are marketing This is another example of a GMP inspection leading to a website and social media review. The initial FDA inspection was in April this year, but the website was not reviewed until September and October! This trend is common in warning letters, and FDA does not appear to critique online marketing until months after the initial inspection. This is a reminder for companies inspected in the past year to re-review online marketing to ensure there are no compliance concerns. This includes blog posts that cross the line from education to marketing. Study citations are marketing. There have been several letters where companies highlight research about ingredients like elderberry. This is considered marketing if those ingredients are in products sold on the site, and I talk more about this here . Now is a good time to review your elderberry and other ingredient marketing to ensure there are no “forgotten” ingredient claims. From warning letter. “The Study showed that Elderberry extract is effective in treatment of flu.” Testimonials are becoming more common in warning letters. This company copied a customer testimonial onto a social media image, which is considered “endorsing the testimonial.” From warning letter. “Facebook image post: Joint Support Capsules … Amazing. Really works. Muscle pain and nerve pain.” Several blog claims are cited in this warning letter. A common blog writer trap is to use sensational titles such as “Can Turmeric Help Reduce the Risk of Strokes”? As discussed above, this is a marketing claim if turmeric is sold on the site. Here are some best practices for reducing blog risk. There are several GMP violations cited in this warning letter. They probably wouldn’t have elevated to a warning letter if adequately addressed and if there were no online disease claims present. Companies continue to be cited for not demonstrating the identity of the finished herbal product blend, even if the individual ingredients have been tested and the blending has been validated. To show the finished product identity, a specific method needs to be developed. Does a small company need to spend valuable resources to develop a specific method just to confirm the identity of an herbal blend? I find this rigid interpretation of the regulations puzzling and a potential burden on industry. Setting herbal specifications too rigidly can lead to issues. This company was cited for not properly handling an ingredient that exceeded its lead limit of 1.45ppm, which is not a high level for an herbal ingredient. This would not have been an issue if the company had set a realistic lead level. This demonstrates the importance of setting up a practical Quality Management System (QMS). A QMS developed with GMPs but also operational efficiency in mind is essential to any growing business. Having a properly functioning QMS is critical, but an overburdensome approach to quality is restrictive. Some companies hire exquisite pharmaceutical managers to develop their QMS, and they get what they pay for, a rock-solid system that is pharma-level, but is this needed in a small to midsize company? Some citations went to quality concerns from 2016, showing that even several-year-old decisions regarding quality can come back to bite a company. The FDA did not feel the company’s 483 responses were sufficient. I write about how improper 483 responses can turn into a warning letter here . 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!

Claims made on social are top of FDA’s mind < Back Twitter Claims Enforcement Increasing Claims made on social are top of FDA’s mind Claims cited on Twitter are increasingly appearing in warning letters. #WarningLetterWednesday This year there have been eight letters mentioning disease claims made on Twitter, up from just 12 Twitter-related letters in all of 2021. This is a strong enforcement trend to watch. Several recent warning letters mentioned tweets over 3+ years old, including this one that mentions a retweet from 2014! Wow, this is old! From the warning letter: You retweeted another user’s September 26, 2014 tweet, which said, “#lipoicacid [an ingredient in your R-Lipoic Acid Vegcaps 300 mg and R-Lipoic Acid Vegcaps 100 mg] model treats autonomic neuropathy…...is the best! I’ve tried it.” This is an important reminder to remove old social media posts that may contain disease claims. Here is a video about this . Many of these letters also include claims made in hashtags, which is a great way to attract FDA scrutiny. View my hashtags are claims video 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!

Test “sketchy” products for adulterants < Back Company Selling Adulterated Product Leads To Additional Product Testing Test “sketchy” products for adulterants This warning letter includes drug-spiked products, disease claims, and CBD. It shines a light on how a small, potentially unscrupulous company can tarnish the supplement industry's reputation. Sign up here to have Warning Letter Wednesday delivered to your inbox. You can also search older posts here by keyword, which is a useful resource for your regulatory, marketing, and executive team. 🔷The order of events in this warning letter is interesting. FDA tested this company's product in April and found the presence of the undisclosed drugs Diclofenac, Dexamethasone, and Methocarbamol before posting the warning letter this week. I am unsure exactly how the process works, but I would prefer FDA act quicker to help remove these types of products from the market. This brings up the Mandatory Product Listing question; if FDA has all of that information, what will they do with it? 🔹In the past, I've seen FDA purchase and test products in the sketchy weight loss and male enhancement categories who were also making disease claims, but FDA testing joint health products is less common. One exception is a warning letter from last October which I write about here . What probably tipped off FDA is this company also sells a product that was part of an FDA consumer warning due to it containing Diclofenac, which is an NSAID. This likely led to FDA looking at the website, seeing the disease claims, and testing the other products. 🔹See the FDA consumer warning about this product. 🔷To top off several other issues, one of the products cited in this letter contains CBD. This is the first CBD-related warning letter this quarter which is surprising. As a data point during Q2 last year, there were 11 CBD-related warning letters. We are all aware that the CBD market has contracted, but some companies are still making over-the-top disease claims, especially in the Delta 8 market. 🔷There are several disease claims cited in this letter. In addition to these claims, I am sure the Bob Marley estate would take issue with potential trademark infringement. 👉From warning letter. "On the product labeling for "Bob Marley CannaKing" "REDUCES ANXIETY" "FIGHTS CANCER" "PARKINSON" "GLAUCOMA"" = Read the full warning letter , including the dangers of these undisclosed drugs. 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!

Free products should also be disclosed < Back Influencers Must Disclose Material Connection Free products should also be disclosed Disclosing material connections is an important part of influencer and ambassador marketing, including when customers receive free products and post about them. Drunk Elephant, a well-known skincare brand, was recently targeted by the National Advertising Division (NAD) for alleged violations of their influencers and ambassadors not disclosing material connection. Here’s what we can learn. 👉 From NAD case: "A company influencer states “@Drunk Elephant you did it again – you guys know I’m obsessed with the bronzing drops… hashtag#drunkelephantpartner .” NAD goes on to state “The hashtag is on the fifth line and only visible if the viewer clicks on the hyperlink “more.” 🔹Takeaway: Hiding material connection below the “more” section is not considered conspicuous and is therefore not compliant. Adding disclosures at the beginning of the post is always best. Also since this is a video post where the endorsement is made verbally the disclosure should be made verbally as well. 🔹Unpaid product is compensation: In this example the unpaid consumer who receives free product does not disclose material connection. If they would have said “Thanks for the free product” or “I love this free sample” that would be sufficient disclosure. 👉 From NAD case: “The other TikTok video post was created by … an unpaid influencer who received free product from the company. (The) video post did not feature a material connection disclosure. The text accompanying her post states “b-goldi illuminating drops are 10/10.” NAD noted that receiving free product constitutes a material connection that requires disclosure.” Generally speaking, there are two main types of NAD cases. 1) Challenge cases: This is when a competitor challenges the validity of another company’s claims. There is a cost associated with this and typically only larger companies participate in this. This is important to keep in mind if you are “poking the bear” of a large company. For example, saying a product works better than an incumbent product is a quick way to attract a challenge case. 2) Monitoring cases: NAD looks at different categories of claims and then finds claims to challenge. This Drunk Elephant example is a challenge case and since there is little enforcement of TikTok, I expect more NAD scrutiny of this platform. Read the full case here . DATE ORIGINALLY POSTED: 11/20/24 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!

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!

< Back Panel Discussion, Workshop Monday Oct 28, 2024 Education session – Ingredient claims and legal flames: An interactive workshop to dodge regulatory heat SupplySide West Las Vegas, NV Noncompliant dietary supplement ingredient claims can be one of the reasons the Food and Drug Administration comes knocking. In this education session and interactive workshop, experts will dissect the U.S. regulations, laws and guidance that govern ingredient claims, as well as applicable court cases. The audience will apply these learnings in live polling, and then discuss and debate the results. If you’re a professional in marketing, science or regulatory affairs, don’t miss this practical, hands-on workshop. Katie Bond of Keller and Heckman LLP Stephanie-Anne Girard of SGS Nutrasource Corey Hilmas of KGK Science Josh Long of SupplySide Supplement Journal Theodora ("Teddy") McCormick of Epstein Becker & Green, P.C. Asa Waldstein of Supplement Advisory Group and Apex Compliance View Event Schedule Previous Next

Asa Waldstein quoted < Back FDA, FTC slap CBD industry with seven warning letters related to COVID claims Hemp Industry Daily Relevant Article Asa Waldstein quoted Read More Previous Next

Use caution copy & pasting “ingredient benefits” onto commercial website < Back Learning targets: Children, risky words, intranasal, ingredient benefits Use caution copy & pasting “ingredient benefits” onto commercial website #WarningLetterWednesday is a cautionary tale for companies new to the space that are looking to market products. This company looks like a groovy crystal shop that started making topical products and products delivered to the eyes and nose. So what can we learn? 🔷Of course, there are high risks words referenced in the warning letter, Notably, the use of viruses, cancer, and so many more! 🔷Products delivered through the nose (intranasal) or as an eye drop are drugs and have a justifiable higher level of scrutiny. 🔷Products marketed for use by children are high-risk. 🔷This warning letter is a good teaching tool. Copying and pasting a product's "therapeutic uses" from a textbook or website is a great way to get into trouble. This appears to be the case here. ➡️From warning letter Colloidal silver is used to treat infections due to yeast; bacteria (tuberculosis, Lyme disease, bubonic plague, pneumonia, leprosy, gonorrhea, syphilis, scarlet fever, stomach ulcers, cholera); parasites (ringworm, malaria); and viruses (HIV/AIDS, pneumonia, herpes, shingles, warts). 🔷I understand these are obvious high-risk claims, but in some ways, this could have happened to any entrepreneur that doesn't understand the rules of marketing products. I have seen this happen several times with practitioners, herbalists, and even doctors that "cross the line" into marketing claims by using common therapeutic language such as anti-inflammatory and even "clears heat and resolves toxins." We talk about this here . ➡️From warning letter .... to heal skin irritations and scarring. 🔷Interestingly, there are a couple of references to helping skin irritations and scarring. I do not consider these to be high risk. They are likely a "pig pile" or a common secondary claim in warning letters. What are your thoughts on the risk level here? Read warning letter here . 👉In closing, I think the FDA would have left this company alone if there were not talking about viruses, selling products that go into the nose and eyes, are marketed as safe for children, and had just too many disease words to be avoided. I started a LinkedIn group just for warning letter discussion. Join 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!