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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!

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

Trustpilot reviews can be “marketing” < Back Product Review Engagement Trustpilot reviews can be “marketing” CBD in tampons? During a GMP inspection at this company’s facility in Bulgaria, FDA determined that CBD is a drug product that deems the tampons adulterated. This, along with some disease claims and other violations related to vaginal microbiome screening kit claims, led to a warning letter. This is the ninth CBD (or delta 8) related warning letter in 2024 which is 47% less than last year, showing that CBD enforcement continued to plummet. As we know FDA is not a fan of CBD, especially when they feel it can be harmful. From warning letter. “FDA evaluated the regulatory decision form that you provided the investigator to support not needing a 510(k) for the CBD Coated … Tampons and found the assessment was inadequate because the CBD coating raises significant concerns regarding safety and effectiveness of the devices due to the potential for local and systemic exposure of CBD, potential adverse events (e.g., reproductive/developmental toxicity) associated with CBD, and potential effects due to the uncertainty of the potency and quality of the CBD (e.g., psychoactive effects from possible contaminants like Delta-9-tetrahydrocannabinol).” Product reviews: Agencies like FDA are typically “hands off” with third party product reviews if they are non-curated, non-compensated, are truthful, and are not showcased. The exception is when a company engages with third party reviews that contain disease claims, as this is considered an endorsement and turns a product review into a marketing claim. Here’s an example from the warning letter where the company engaged with reviewed on its Trustpilot site. Claims in product reviews typically appear in warning letters when they appear on a company website, but I’ve not seen this cited when hosted on platforms like Trustpilot, which reinforces the “Don’t engage with product reviews when they are risky words” rule. From warning letter showing how the company engaged with a review. “Trustpilot Web Site: “We're really sorry to hear that the CBD tampons didn’t work for you. Research shows that different bodies have different responses to CBD, and just as other forms of pain relief, annoyingly it won’t work for everyone.” Complaints on Trustpilot not investigated. Product complaints and safety issues need to be adequately investigated. Typically, customer complaints are emailed or called into the company, and once the company is aware of potential issues, it is its obligation to investigate. Interestingly, in the example, FDA requires the company to investigate third-party reviews on the Trustpilot site since they engaged with these reviews. As I discussed above, engaging with third-party reviews is an endorsement and makes them marketing. In this example, it also shows FDA that the company is aware of the issues and triggers the investigation requirement. This is the first time I’ve seen FDA mention this for third party reviews and companies should take note. We can also extrapolate that the FDA will want companies engaging with customer complaints on social media to properly investigate the issues as well. From warning letter. “Complaints related to the addition of CBD to … Tampons that were listed in Trustpilot or third party systems were given responses by your firm, but not logged and evaluated appropriately in your complaint handling system. The complaints indicate CBD … Tampons may have an impact on the patients’ health (e.g. CBD drug interactions) that exceed the expected risks associated with regular (non-CBD) tampons.” The company was also cited for selling a vaginal microbiome screening kit which FDA does not consider a general wellness kit. They determined this by reviewing the product’s claims like “Detect bacteria that cause vaginal infections like yeast infections” from their Amazon store, Trustpilot page, and website. I had never read the “General Wellness: Policy for Low Risk Devices” document before and it worth knowing about. From warning letter. “Your firm markets the device with diagnostic claims that are outside the scope of a general wellness device as described in the FDA guidance document “General Wellness: Policy for Low Risk Devices” at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices; and therefore, your device would need to be submitted for premarket review by the FDA.” Read the full warning letter here . This Warning Letter Wednesday post marks 52 weekly posts this year and over 150 since I started writing WLW. Thank you for all of your support! You are appreciated! DATE ORIGINALLY POSTED: 1/1/25 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!

Clinical study parameters must match claims < Back Lessons From NAD Decision Clinical study parameters must match claims Most of the claims here are not high-risk, but this demonstrates that even lower-risk statements, especially when combined with "clinically proven" types of claims, can lead to increased scrutiny and potentially increased substantiation requirements. I usually write about FDA supplement warning letters, but they've been relatively quiet this year, so today's Warning Letter Wednesday discusses an interesting National Advertising Division (NAD) decision. NAD is a self-regulatory body under Better Business Bureau (BBB) programs, and I enjoy reading NAD cases to look for clues about claims substantiation and enforcement. After reviewing the substantiation, NAD recommended that the company discontinue the following claims. All "clinically tested," "scientifically tested," "mood support," "calmPM S symptoms," "ease cramps, bloat and moodiness" and help consumers "experience a better period" claims and Express and implied ingredient claims for ashwagandha, magnesium, vitamin B6, turmeric, and chasteberry. Natural claims It seems the company had conducted a clinical study on its OTC product and its dietary supplement botanicals product together, but NAD found tissues with the study. Unfortunately, there is no specific information on the study, such as if it was blinded or placebo-controlled. From NAD. "NAD found that the study did not meet the standard for competent and reliable scientific evidence." "several significant flaws, which rendered it insufficiently reliable to provide a reasonable basis for Pamprin Botanical's establishment and health-related claims." I've noticed that some companies use additional "creativity" in their Amazon descriptions, and this NAD case shows that even claims on Amazon are fair game for scrutiny. This is obvious, but it is uncommon for claims on Amazon pages to be cited unless they are high-risk disease statements. From NAD statement. "The National Advertising Division (NAD) determined that, in context, the "tried and trusted" claim that appeared on the Amazon product tile refers to Pamprin's history and that no modification was necessary." I find the company's approach to marketing the OTC and supplement products together to be an interesting strategy, and I wonder what FDA's position is on marketing drugs and supplements together in an instance like this. A little more about NAD. NAD reviews advertising disputes between competitors and other claims it becomes aware of. It is where companies can challenge each other's claims they feel are affecting their sales. NAD evaluates the truthfulness and accuracy of advertising and offers a streamlined resolution process to address advertising disputes. However, unlike a regulatory court, NAD cannot enforce its decisions, but if a company doesn't comply with NAD's recommendations, NAD can refer the case to the appropriate governmental regulatory authority, such as the Federal Trade Commission (FTC). This can also alert plaintiff attorneys. Read the NAD case here . It's really interesting and definitely worth checking out. 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!

The FDA/FTC look at old posts the same as current ones < Back Clean up old social media posts The FDA/FTC look at old posts the same as current ones #WarningLetterWednesday highlights very old social media posts called out in this warning letter. It is common for the FDA to look back a couple of years on social media posts, but this warning letter mentions a 2014 re-tweet and several three-year-old Facebook posts. This is an excellent reminder to clean up old social media posts, as the FDA/FTC looks at old posts similarly to current ones. I even made a video about this. Re-tweeting and re-posting can be seen as marketing claims, especially if a company adds commentary to the original post. This is the first time I have seen a re-tweet without company commentary called out in a warning letter. This is surprising and shows the viewpoint of the FDA's West Division 5 office, which has rarely issued marketing-only warning letters. It is interesting to see what online marketing claims each FDA division focuses on, and I will dig deeper into this fascinating aspect of enforcement at a later date. There are several high-risk disease words mentioned in this warning letter, such as Parkinson's, antidepressant, anti-tumor, and hashtag diabetes, which likely was why this company received a letter. Here's a video I made about removing and replacing high-risk "buzzwords" being the most crucial first step to becoming compliant. Claims made on Amazon are also referenced in the warning letter. It is no longer considered the "unholy grail" of disease claims, and I expect to see more Amazon warning letters in the future. Read the warning letter here . I've been writing about these enforcement trends for a while now. You may enjoy reading my regulatory blogs here . It can be challenging to find content on LinkedIn, so I started this Warning Letter Wednesday Group . Please check it out. 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!

Nutrition fact panels must be in a compliant format < Back Lack of Allergen Labeling Leads to Potential Death Nutrition fact panels must be in a compliant format Allergen labeling regulations are important. They help people with severe allergies avoid products that can make them sick or worse. In this example, the company allegedly did not disclose peanuts and eggs, which led to an anaphylactic death. 👉From warning letter. “On January 23, 2024, after being notified of a consumer complaint received by the FDA regarding an anaphylactic death associated with …. your firm recalled the cookies. The products contained peanuts and eggs but your printed label on the package did not contain an allergen statement or ingredient declaration for peanuts or eggs.” The warning letter goes on to state that there are missing and extra ingredients on the label, which shows that the company’s quality control procedures need a serious review. Disclosing major allergens is easy. Here are the two options. I always prefer the “Contains” option as it’s more apparent to the consumer. 👉The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]; or 👉The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., “Whey (Milk)”), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)]. The Nutrition Facts Panel (NFP) is also not in the correct format. There are differences between a Supplement Fact Panel and an NFP. This FDA reference is pretty good. 👉From warning letter. “The calorie declaration is not shown bolded and in larger print size, as required by 21 CFR 101.9(d)(1)(iii). b. It lacks the declaration for added sugars, as required by 21 CFR 101.9(c)(6)(iii) c. It lacks the declaration for the required vitamins and minerals, vitamin D and potassium, as required by 21 CFR 101.9(c)(8)(ii)” Here are some examples of compliant NFPs . Read the warning letter here . DATE ORIGINALLY POSTED: 11/27/24 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!