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Packaging procedures prevent labeling issues < Back Major Allergen Labeling Issues Lead To Warning Letter Packaging procedures prevent labeling issues There are three lessons in this Warning Letter Wednesday post. Labeling major allergens, avoiding label mix-ups, and hazard analyses are required for conventional food. The specific type of allergen is needed for tree nuts, crustacean shellfish, and fish. This is still a common error that I see when reviewing dietary supplement labels. The specific species of fish (e.g., bass, flounder, tilapia, salmon or cod) The specific species of Crustacean shellfish (e.g., crab, lobster, or shrimp) The specific type of tree nut (e.g., almond, pecans, or walnuts) I review 10+ dietary supplement labels each month at my consulting company, Supplement Advisory Group . Contact me to learn more about this and my website/content compliance review services. I love this stuff. Proper labeling and packaging control can prevent dangerous and expensive mix-ups. This company put the wrong labels on which resulted in recalls and the warning letter. Proper packaging process control and documentation are critical in manufacturing, and up-front organization can prevent expensive issues. I use consultants like Nate Call & Blake Ebersole for Quality Management System development and implementation. If you want an introduction, please let me know. Conventional food companies must comply with all subparts of 21 CFR 117 , which include a risk-based hazard analysis. There are so many warning letters about this essential aspect of food safety. As a side point, dietary supplements need to only comply with some of the 21 CFR 117 subparts. Here is a good FDA resource that includes directions on listing major allergens and common seafood names. If you know of a better allergen resource, please do share. 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!

Review old videos for compliance < Back Seven YouTube Warning Letters This Year Review old videos for compliance There have been seven YouTube-related FDA warning letters this year, and I expect the trend to continue. This demonstrates that videos are marketing claims and are, therefore, fair game for enforcement. In YouTube warning letters, there is always a statement such as “This links to a website where you take orders for the products.” This is the link to commerce and establishes the “commercial bridge.” If there was no link to a shopping cart in the videos or elsewhere in the YouTube channel, I wonder if they would be cited in the warning letters. One of the features of Apex Compliance ™ is scanning YouTube videos for compliance concerns. What used to take several minutes or longer can now be done in seconds. I love this feature! Warning letters this year also include YouTube videos embedded on websites, not just videos hosted on a YouTube channel. This shows that claims made in any format, including those in embedded videos, are being scrutinized. Now is a good time to review your videos, especially the old and potentially forgotten ones, for compliance before they turn into warning letters or lawsuits. 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!

Screen all blogs and social media for disease claims < Back Disease Claims Turn Supplements Into Unapproved New Drugs Screen all blogs and social media for disease claims This #WarningLetterWednesday is an excellent lesson about turning a supplement into an “unapproved new drug” by making disease claims. Other lessons here are: ● LinkedIn claims cited again! ● Eight-year-old social media post! ● Claims made on social media are top of mind for the FDA. From Warning Letter: “Ayurveda has solutions for managing high blood pressure. . . . THREE PRODUCTS TO HELP HIGH BLOOD PRESSURE . . . Arjuna Arishtam supports healthy heart function and reduces high blood pressure.” Social media is mentioned in this warning letter. The citation below is boilerplate in warning letters, and it is a good reminder that directing consumers to a website to purchase the product is the “material connection.” If these social media sites did not link to a commercial website or shopping cart, they likely would not be cited in this letter. From Warning Letter: “these social media websites direct consumers to your website at https://lnkd.in/g-vvBiJH to purchase your products. An eight-year-old Facebook post is mentioned here, and this may be a record for the oldest post mentioned in a warning letter! As I’ve spoken about several times, the FDA looks at old social media posts in the same manner as current ones, and we talk about this here . From Warning Letter: “On an April 3, 2014, post from your Facebook social media website” Check out the citations at the bottom of the warning letter! They reference claims made on LinkedIn. I wrote about this just a couple of weeks ago, and it is a good reminder to clean up old social media pages, including LinkedIn. Join the discussion here : Pro tip: This post includes a high-risk hashtag, which makes it easy for the FDA to find claims in the cluttered world of LinkedIn. From Warning Letter “This webpage is also linked from a post on your LinkedIn social media website, which states “# Highbloodpressure does not have to be permanent: # Ayurveda has solutions for managing high blood pressure. When turning the light of Ayurveda onto HBP, there is a priority toward each person’s imbalance and recommendations are made based on the best diet and activities for each person.” Read the 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!

Product names are marketing < Back Small Herbal Company Cited For Marketing Claims Product names are marketing Even very small companies that market online can attract an FDA warning letter. I am still surprised when I hear companies saying they are not big enough to be on “FDA’s radar.” This warning letter shows that anyone, even a tiny company, is “fair game” for enforcement. Today’s Warning Letter Wednesday is a story of a small herb company cited for making serious disease claims, and I’m guessing they didn’t know the rules of dietary supplement marketing. This is one reason why I write Warning Letter Wednesday: to help raise awareness about enforcement trends and marketing rules in the digital era. 🔷Unfortunately, many schools do not teach the basics of DSHEA and marketing compliance. One of my missions is to educate these communities about the dos and don’ts of supplement marketing. Here is my speaking schedule , which includes three days of classes at next month’s International Herb Symposium at Wheaton College. Please let me know if I can extend free education to your school. I also offer customized marketing compliance company training called the “Regulatory Expert Package.” 🔷This warning letter contains numerous disease statements and is a cautionary tale of what not to do. This is one of the most glaring examples of a disease statement. Wow! 👉From warning letter. “[Echinacea Tonic] should be used for EVERY disease and illness.” 🔷The product names “Insomnia Formula” and “High Blood Pressure II” were cited in this warning letter. 👉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!

Email newsletters are marketing < Back Company Cited For Selling Tianeptine Products Email newsletters are marketing This company received a warning letter for selling tianeptine—a substance deemed dangerous and inappropriate for dietary supplements according to FDA. Read more about FDA’s position here . In January FDA inspected this company and determined they sell tianeptine products, but I am unsure why it took until June to issue this letter. There may be a piece of the puzzle missing but this seems like a long time to take this action. I ask, what can we do to support FDA to remove drug-spiked products from the marketplace swiftly? It seems this same company (or its subsidiary) had about $1.3 million in kratom products seized by US Marshals on FDA’s request back in 2021. Read more about this here . Here is a Warning Letter Wednesday post about kratom and opioid claims . Here’s an interesting part of the warning letter. FDA cites claims made in an email newsletter. I’ve heard of companies being cited for claims made on labels, websites, socials, catalogs, or brochures but not for email-only newsletters. This shows that all marketing is labeling and is open to scrutiny. 🔹From warning letter. “Examples of claims from your email blast promotional material, which links back to your website … that provide evidence of the intended use of these products as drugs.” FYI, at the time of writing, the company’s website was taken down. 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!

Remove “anxiety” on all marketing platforms < Back Anxiety claims enforcement up 95% in 2021 Remove “anxiety” on all marketing platforms #WarningLetterWednesday reviews the increase in anxiety claims enforcement. In 2021 there was 40 anxiety-related product FDA warning letters, a 95% increase over 2020 (21), which is a clear sign of the FDA’s enforcement priorities. Here is a breakdown of the 2021 anxiety warning letters. *75% (30) include both anxiety and depression. This shouldn’t come as a surprise to anyone following enforcement trends, as the FDA sent ten anxiety/depression letters last February. I write about this here . *45% (22) include claims made on social media. I would have guessed this number would be higher. *10% (4) include hashtag claims, and 25% (10) include claims made in testimonials. I expect warning letters with hashtag claims and testimonial claims to increase, which is an enforcement trend to watch. *All 2021 letters also include higher-risk disease words such as hypertension except for one that involved a drug spiked product (sibutramine). The FDA looks at a company’s complete online presence. One claim may not attract a warning letter, but, for example, claims made on social media, YouTube, Amazon, and blogs are pieced together for one big picture of noncompliance. *It is worth noting the 2021 warning letters did not include the term “occasional anxiousness,” which is, if substantiated, often considered not to be a disease claim. Anxiety is considered a 3.5 of 5 on the “Asa Risk Scale” and should not be used. If truthful and substantiated lower risk alternatives are: *happy mood support *balanced state of mind *mental resilience *support when things get overwhelming *helps support 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!

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!

Distributors must comply with some GMP requirements < Back GMP Lessons For Distributors Distributors must comply with some GMP requirements Distributors are responsible for the products they hold and distribute. Here, I review a recent warning letter where the company was cited for GMP and labeling issues, and there are some excellent learning opportunities here. 🔹Listing mandatory nutrients: The cod liver oil product’s serving size is 5mL, but there are no calories, Total fat, or vitamin D listed in the supplement fact panel. These are some mandatory nutrients that must be listed if they are above the “zero level” per serving. For example, four calories is a “zero level,” but five or more calories must be declared. AHPA has some excellent guidance on this if you are a member, or here’s a link to the FDA regulations that are unfortunately a little clucky. Supplement Advisory Group, my consulting company, can help make your label and supplement fact panel compliant. Please contact me with your label compliance needs. 🔹DSHEA disclaimer: If there are structure-function claims on a label, the company must add the DSHEA disclaimer and correlate it with a symbol. Unfortunately, plaintiff attorneys have been using this regulation for lawsuits in the past two years. This is because the rules state the disclaimer must be on each label panel where the claim occurs. From warning letter. “The label makes structure-function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b)” 🔹Adverse Event Reporting address: This is an essential part of the safe regulation of supplements. From warning letter. “The labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.” 🔹Multiple languages: If a label lists information in two languages, the supplement fact panel must also be listed in both languages. This is a regulation I did not know about since I have only worked with English labels. From warning letter. “If a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. The product includes foreign language on the label but fails to declare all subsequent information in the Supplements Facts label in both languages as required.” 🔹Statement of identity: The product has a supplement fact panel but “Supplement” is not listed in the Principle Display Panel. Now the GMP issues. 🔹Storage must match label instructions. This one is interesting. The label lists a storage temperature, but the distributor apparently did not have procedures to control for this. From warning letter. “Your procedure does not include instructions on how to appropriately store these products based on the storage temperatures indicated on the product labels.” 🔹Designated quality personnel. Distributors must have qualified and trained quality personnel. Some SOPs, employee time allocation, and training could have avoided this part of the warning letter. From warning letter regarding their 483 response. “These documents assign the product receiving responsibility to the Purchasing Department, including the review of shipment documentation. However, neither document provides your firm’s quality control procedures for dietary supplement products, such as written procedures for conducting a material review and making a disposition decision in accordance with 21 CFR 111.113, including products contract manufactured for your firm’s own label.” There is a lot more to this warning letter. Read the full 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!

Citing ingredient research is a marketing claim < Back Uncompliant Product Name Leads To Warning Letter Citing ingredient research is a marketing claim #WarningLetterWednesday This company received a warning letter for claims made in a product name. The product “Covid-19 Immune Support” is a bold Covid prevention and treatment claim. This is a basic but important reminder that product names are marketing claims. The company was also cited for referencing Covid studies for an ingredient in their products. This “implied claim” enforcement is a continuing trend, and I caution companies to remove ingredient study references that contain disease words from their website. I talk more about this here . This is a joint FDA and FTC warning letter and includes a cease and desist demand. I talk more about what this means 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!

Scan marketing for “mid-risk” heart health claims < Back IBS & Cholesterol Claims Cited in Warning Letter Scan marketing for “mid-risk” heart health claims This letter primarily cites digestive ailment claims such as Irritable Bowel Syndrome (IBS) and heart health claims such as “lowers cholesterol.” While these types of statements should be avoided, they are not usually enough to tip the scale into a warning letter. Do you want Warning Letter Wednesday delivered weekly to your inbox? Sign up here to join ~500 other regulatory professionals. Here are some key learning opportunities. 🔹Statements related to cholesterol and blood pressure should be avoided. In the past, statements like “lowering cholesterol and blood pressure” were not enough to attract a warning letter unless higher-risk disease words were present, but this seems to be changing. I write about last year’s crackdown on companies making biomarker claims here . I expect this trend to continue, so the learning target here is re-review all marketing and remove statements like these. • Lowers blood pressure • Lower A1C and LDLs • Lower arterial plaque • Lower blood sugar • Lower bad fats 🔹We have always known that Irritable Bowel Syndrome (IBS) is considered a claim, but it’s not commonly cited unless words like Crohn’s Disease are also used. I also suggest using caution when talking about bloating, constipation, and abdominal pain, as they may be symptoms of serious diseases. If accurate a potential risk mitigating factor is talking about occasional abdominal discomfort and attributing bloating to occasional overeating. These strategies help separate normal life events from those related to disease. 🔹The company receiving this warning letter appears to be very small, which again shows that us no one is too small to be off FDA’s radar. 🔹This company also makes statements in testimonials that have been highlighted on the website. When a company engages or calls outs a product review, this then becomes an endorsed testimonial, which is marketing. I write about the endorsement of social media claims 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!

Biomarkers claims elevate enforcement risk < Back Animal Product Testimonials Lead to Warning Letter Biomarkers claims elevate enforcement risk Claims about animal products were cited in today’s warning letter. Most statements involve customer testimonials with biomarkers such as “kidney values,” and “liver count,” and some other disease statements. Animal product claims seem to have a lower “acceptance level” than human supplements. For example, mentions of “pain” or “anxious feelings” are probably not enough to attract a warning letter for a human product, but these seem to tip the scale into warning letter category for animal products. This, of course, is not the case with this letter, where several very high-risk statements like “kill most urinary infections” are present. 🔷Here are my thoughts on testimonials. The authorities have been “hands off” in going after companies for third-party user-generated non-compensated reviews, such as those that appear to come through widgets like Trust Pilot. These “protections” go away when the review is engaged with , or showcased such as in a website banner, social post, or on their own review page. This warning letter congregated product reviews on their own page, which means they are curated and are, therefore, marketing. 🔷Here are my thoughts on biomarkers. In the past, claims about biomarkers such as “lowers LDLs” were not cited in warning letters unless higher-risk words were present. This changed last year when FDA sent warning letters to companies solely based on heart disease-related biomarkers, even when no disease words like “heart disease” were present. I write about this here . Heart disease-related biomarkers are high-risk, but others, such as creatine or bilirubin, do not seem to attract the same scrutiny. This is what makes this warning letter interesting, and I wonder if there were no high-risk disease words used if FDA would have cited the company simply for statements like “liver levels.” Read the full warning letter . DATE ORIGINALLY POSTED: 7/26/23 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!

Re-review online marketing if inspected by FDA < Back TCM Company Cited for Claims & GMP Violations Re-review online marketing if inspected by FDA This Traditional Chinese Medicine (TCM) product company was cited for GMP violations and disease claims. This warning letter contains critical GMP and marketing lessons such as labeling, testing, and marketing essentials. Here, we unpack some critical takeaways as a learning opportunity to help keep you out of trouble. This company was inspected by FDA and received some 483s, which led to their website being reviewed for disease claims months after the inspection. As we've spoken about many times here on Warning Letter Wednesday, it is imperative for companies that are inspected by FDA to ensure their websites are "clear" of risky claims. This is one of the reasons I developed Apex Compliance . To learn more about Apex Compliance, contact me. Here are some key labeling takeaways. The botanical ingredients are not in the standardized common name as noted in AHPA's Herbs of Commerce. They appear to be the TCM names, which is fine, but the common or Latin names are also required. If a label lists information in another language than English, all required information must also be listed in that secondary language. Admittedly, I've never thought about this, but it makes sense from a consumer protection standpoint. The plant parts were missing from a label. Many of the GMP violations cited here have to do with specifications. Specifications are integral to GMPs, and each raw material and finished product must have specifications for identity, purity, strength, and composition. I suggest reading through the warning letter to review FDA's comments. Master Manufacturing Records (MMRs) are the recipe telling the staff how to make a product. Here are several missing items that were cited in this letter. Description of packaging and a representative label. A complete list of components. The weight or measure of each component. Any intentional overage amount. This is to accommodate for shelf life testing and manufacturing variance. A statement of theoretical yield. This is so the company can find problems before the product gets to the next stage of production. For example, if too much of an ingredient was added, the weight should potentially be over the theoretical yield. In the past, my team accidentally added one kilo rather than 0.1 kilo, and calculating the yield caught the error. Specifications are needed for each point, step, or stage in the manufacturing process where control is necessary One person weighs or measures a component, and another person verifies the weight or measure. This is known as the doer/checker system to ensure weighing issues are prevented. This can be difficult to achieve in small companies. And many more items. Unqualified reference standards continue to be called out in warning letters. This company was cited for not using a validated reference standard for FT-IR identity tests. This essentially means if you are testing for something like chamomile powder, you must purchase a qualified sample and test against this standard. Yes, I know GMPs can be burdensome. There has never been a more challenging time than now to be a supplement manufacturer. I feel your pain. From warning letter. "You do not have an adequate identity specification because you are not conducting identity testing against a qualified reference standard." An Out Of Specification (OOS) was cited in this letter. An ingredient or product was OOS for zinc, but the company retested using a different method. FDA took issue with this, which is a learning lesson to ensure retests use the same method. This seems obvious, but in the heat of the pressure to release products, these items can sometimes be inadvertently overlooked. From warning letter. "The investigation testing was performed using a different methodology and by a different laboratory than the laboratory which conducted the original analysis, thus making it difficult to compare the results and to verify accuracy." The website states that products can only be purchased by a practitioner and that no retail sale is available. This is very interesting from a "material connection" point of view. If there is a material connection (e.g., commerce on the website), this is what FDA uses to connect marketing disease claims to commerce. If there is no commerce on the website or linked websites, FDA seems to rarely call out disease claims, which makes this example a rarity. Full disclosure: I have no way to verify if this was a recent change since the warning letter. If anyone knows, please let me know. There are so many GMP learning opportunities 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!