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Brands need to ensure regulatory responsibilities are accounted for at the start of a contract manufacturing partnership. < Back Compliance responsibilities when using a contract manufacturer Rachel Adams Press Mention Brands need to ensure regulatory responsibilities are accounted for at the start of a contract manufacturing partnership. Read More Previous Next

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!

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!

< Back Interview Thursday Jul 15, 2021 Effective and practical marketing compliance Insider in the Afternoon We speak about structure-function claims, disease claims, marketing risk versus reward, and clever product names. Watch Previous Next

Regulatory consultant Asa Waldstein previews a SupplySide West education session on substantiating claims and clinical trials. Waldstein is moderating the Oct. 28 session that features two attorneys and two experts from contract research organizations. < Back Join me for SupplySide West workshop on nutritional ingredient claims, legal flames Asa Waldstein Guest Article Regulatory consultant Asa Waldstein previews a SupplySide West education session on substantiating claims and clinical trials. Waldstein is moderating the Oct. 28 session that features two attorneys and two experts from contract research organizations. Read More Previous Next

Companies marketing CBD products should avoid making disease claims < Back 300%+ Increase in CBD Warning Letters This Year Companies marketing CBD products should avoid making disease claims This year there have been 26 CBD-related warning letters. This is up from just seven in all of 2021. That is over a 300% increase, and we are only in August! This shows the FDA's growing intolerance for CBD products that make marketing disease claims. It is important to note all the CBD warning letters included high-risk disease claims such as Alzheimer's, depression, cancer, and PTSD. You may be saying, "of course, companies shouldn't make these claims," which I agree with. However, some of the 26 companies may not have known they were making disease claims, as forgotten several-year-old social media and blogs may have disease claims lurking in them. Here is a post about several-year-old social media posts being called out in a warning letter. CBD for animal products is mentioned in 30% of these 2022 warning letters. It is important to note that the FDA seems to have a lower "tolerance" for claims made about animal products. For example, mentions of "anxiety" and "inflammation" may be enough to attract an animal product warning letter. Still, some higher-risk words such as "depression" are usually present in the human letters. Some of the letters also include bizarre mentions, such as this example of a wrist band that was labeled as a supplement. The issue with this, of course, is that supplements must be ingested. Marketing products like this clearly show the FDA that the company does not understand the basics of dietary supplement regulations. From warning letter: "your website shows Supplement Facts panels for the "Tanka T-FLEX Band ….. your products' labeling states that the products are intended to be worn on the wrist. For example, your website describes how the "patented macromolecular technology works through direct contact with the skin to provide timed controlled-release of up to 30 days." 45% of the warning letters include the disease claim one-two punch "anxiety" and "depression." It should come as no surprise these two disease words continue to be called out in letters. Here is a video about this. Other Common high-risk words are "insomnia," “fibromyalgia,” and “Alzheimer's.” See this post and video for a deeper discussion. From warning letter “post on Instagram states, “What can #CBD do for #animals and our #furbabies ~ #anxiety #inflammation #arthritis #pain #seizures #cancer #cbdoil #health #dogs #cats #horses #cows #freestateoils ->> freestateoils.com/hemp-cbdpellets-for-farm-animals.” The post includes a graphic with photographs of several farm animals and pets, and includes statements such as, “Anti-ANXIETY || Anti - INFLAMMATORY || Anti – ARTHRITIC” The learning target here is the authorities look at the totality of the advertisement. This post is on a social media site that links back to a shopping cart; this is the material connection. The disease hashtags are claims and when a company adds its name in a hashtag, it further elevates the risk. The image with the animals and therapeutic claims such as "anti-anxiety" further demonstrate the intended use of animal disease prevention. Several of the warning letters include study citations. Even mentioning CBD studies on a commercial site is enough to attract a warning letter. Here is an example from one FDA warning letter. "Israeli researchers have launched three clinical trials that utilize CBD's anti-inflammatory properties as potential COVID-19." Here is a post about several CBD companies that received warning letters for similar infractions. More than half of these warning letters include claims made on social media. Here is a post about this. 47% of the warning letters include claims made in blogs. This is a continued enforcement trend, and several letters this year include claims made in old blogs that contained disease words. It is possible the companies didn't realize their several-year-old blogs contained high-risk words. A good reminder for a compliance "tune-up." Here is a post about this. 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!

Arthritis claims attract scrutiny < Back Tips For Understanding What A Claim Is Arthritis claims attract scrutiny Arthritis claims continue to be cited in warning letters. As many of you know, I love teaching about regulatory compliance to help you adjust your marketing and stay ahead of the regulatory curve. We hear about not “making claims,” but it can be challenging to know what a claim is. Here are a few general rules for avoiding high-risk claims that can lead to a warning letter. What other tips can you share? Anything ending in “itis,” such as “arthritis”. “Itis” means “inflammation of,” which helps me remember it should be avoided. Fun fact, “arthritis” is the most commonly referenced of all the words ending in “itis.” Other than “antioxidant” and perhaps “anti-aging,” words with “anti” should be avoided. Immune-related words like “antiviral” or “antitumor” are higher risk than “anti-inflammatory.” Words with an International Classification of Diseases (ICD) code. The name of any illness or syndrome, such as Alzheimer’s or IBS. Some are obvious, but some of the syndromes, like Leaky Gut Syndrome, may not be as obvious. Here is a post about this. Searching past FDA warning letters can help you learn what they’ve previously cited. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters “Better than drugs” statements attract FDA attention. Here’s a WLW post about this. FDA sent out 12 arthritis-related warning letters last year, so please avoid making these types of claims. This includes: Hashtags Showcased testimonials Citing clinical studies Product tags and meta tags Social share meta description FDA has been quiet with supplement warning letters, and I am in New Zealand, so this is a shorter post than normal. I am writing this WLW for the beautiful Coromandel. Yes, I love compliance and writing this post (smiles)! 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 Friday Sep 3, 2021 Marketing Compliance: Effective Strategies Open Discussion Southern Hemp Expo, Raleigh, NC The Southern Hemp Expo brings together unsurpassed education and networking with the Let’s Talk Hemp Speaker Series . Industry experts, speakers and exhibitors across the supply chain will show you how to RETHINK Hemp . A powerhouse line-up of industry leaders will be on stage to discuss hemp agriculture, business and investing, technology and innovation, wellness, textiles, fiber, food and beverage, composites and building materials — the whole supply chain of opportunity in hemp. Learn More Previous Next

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!