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Old social posts are “active” marketing < Back Animal Product Claims Under Increased Scrutiny Old social posts are “active” marketing Claims made about animal products seem to have a lower tolerated "acceptance level" than human products. This is a friendly reminder to take another look at your animal product marketing because there may be forgotten risky marketing statements that can come back and "bite you" (I couldn't help the animal pun). Here is one example. These are obvious disease claims that should be avoided, but usually, this would not "tip the scale" into warning letter territory in a human product. 👉From warning letter. "… for dogs was designed and tested to boost your do's natural defenses against the unique host of fungal, parasitic, viral, and bacterial pathogens that flourish in the desert southwest." 🔹No company is too small to be off FDA's radar. This company has a very small web and social media presence, but they were still discovered and cited. Anyone marketing products online is "fair game" for enforcement. I write more about this here . 🔹Seven-year-old social media posts are cited in this letter. Plenty of two- or three-year posts have been called out in warning letters, but a seven-year-old post is going way back. I ask, does anyone really look at these really old posts? In the eyes of the FDA, these are considered active marketing and, therefore, should be compliant. Here is a post about this. 🔹Scanning old social posts is critical to any compliance "clean up" project I conduct. These forgotten old posts provide only risk and no marketing benefit. Here is an old and relatively lower-risk example. 👉From warning letter. "From your social media website. On January 29, 2016 you posted: "Important information: frequently when pets first start showing symptoms of Valley Fever they do not register a titer and thus the reason for misdiagnosis and the wrong course of treatment. If your pet is showing any signs then start Desert Defense while you await the diagnostics!" DATE ORIGINALLY POSTED: 2/22/23 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!

Blogs are “labeling” < Back Product Reviews Become Marketing Claims Blogs are “labeling” Do you have product reviews on your website? In general, FDA is "hands off" with true 3rd party, non-curated, non-compensated honest reviews unless they have been endorsed. Here are some examples of how companies endorse testimonials, which turns them into marketing claims. Showcasing reviews: This is when reviews are in a banner or highlighted in some way. This includes using them in social media posts. Engaging with reviews: In this warning letter, the company has dozens of customer reviews with disease words relating to things like neuralgia and arthritis. This company's product reviews appear to come through a third-party widget like TrustPilot, and these types of "third-party" reviews are typically not cited in warning letters unless the company has commented on them. This engagement endorses the review and converts it to a marketing claim in the eyes of the agencies. This includes companies "Liking" or "Saying Thanks" to customer reviews on their social media wall. Of all the disease-containing reviews on the website FDA only mentions the ones that the company responded to, which is why I suggest "fighting the urge" to engage with reviews that contain disease or outlandish claims. Here is an example from this warning letter. From warning letter. "January 25, 2023 customer review states, "Best place for CBD oil. Really helps my older dog's arthritis pain" (company) replied, "Thank you… We are grateful to provide great service and products that help to our community. Glad to hear that it's helping ease your dog's pain." Blogs are "labeling" At Supplement Advisory Group , I am often asked if blogs are marketing claims. If the blog discusses ingredients that are in products sold on the website, these are marketing claims that can lead to regulatory issues, even if there is no cross-linking or hyperlinking to product pages or a shopping cart. From a blog cited in the warning letter. "CBD may protect nerve cells from deteriorating, and a study from Frontiers in Pharmacology found that CBD can significantly decrease the negative effects of Alzheimer[']s and also improve cognitive ability." This warning letter includes claims made about animal "supplements." I have written about FDA's enforcement view of pet product claims here . This is also a CBD warning letter, which is uncommon these days. Hey, supplement and CBD companies, FDA is watching, and this warning letter could have been easily avoided. Let's set up some time to meet for free, and I would be happy to help point you in the right direction. I've dedicated my life to understanding the nuances of truthful marketing compliance. I would be glad to donate some time to help support your compliance. I also run a consulting company that can help with all levels of support, such as website reviews, listing support, and more. Read the full letter here . DATE ORIGINALLY POSTED: 9/11/24 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!

Specifications continue to be cited < Back GMP Manufacturing Lessons Specifications continue to be cited Manufacturing supplements is not easy. I was a supplement manufacturing & marketing executive for 15 years before starting my regulatory marketing compliance company , and implementing continuous improvement into our Quality Management System required several full-time jobs. Step one in GMP compliance is setting and following specifications, and this Warning Letter Wednesday highlights several GMP lessons, especially the importance of specifications. Heavy metal specifications. Here, FDA cites the company for not establishing heavy metal specifications for botanical ingredients, which are especially at risk of heavy metal contamination. FDA notes that a lack of ingredient specifications may lead to issues in the finished product. I like this example because it demonstrates that stopping potential problems before they get to the production line is best. From warning letter. “The investigator noted that you failed to establish limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch of the dietary supplement.” Interestingly, the company did have finished product heavy metals specifications, but it seems FDA pushed back on their arsenic limits, asking for clarification on why they were set so high. This reminds us that specifications must have a scientific rationale. As a good reference point, the American Herbal Products Association (AHPA ) is an excellent resource for this. From warning letter. We note that the (b)(4) finished product specification for Lead is < (b)(4) ppm and for Arsenic is < (b)(4) ppm. Your batch record for (b)(4) batch (b)(4) reports lead results of (b)(4) ppm. Under 21 CFR 111.70(e), you must establish specifications for limits on those types of contamination that may adulterate, or may lead to adulteration of, the finished batch of dietary supplement to ensure the quality of the dietary supplement. We request that your response address the scientific basis for setting a specification for Lead at < (b)(4) ppm as a level that will not adulterate the dietary supplement. Testing by input. Over the past two years, FDA has increasingly been citing companies for testing finished products by input rather than using qualified analytical methods. The company’s 483 response seems to show that instead of providing a specification sheet example with valid testing methods, they apparently listed “input” as the test method. This part of the warning letter could have been avoided with a proper 483 response. FDA’s response, “measuring input may be a useful process control, but it is not an appropriate test method for determining the strength specification,” should be an essential mantra written on the wall of every QA/QC department. From warning letter. We received and reviewed your December 5, 2023, written response and determined it inadequate. Your finished product specification sheet for your (b)(4) product is lacking adequate strength specifications. The method listed on the finished product specification sheet for determining the strength of (b)(4) and (b)(4) in the finished product is by “input.” While measuring input may be a useful process control, it is not an appropriate test method for determining the strength specification of these ingredients in the finished batch of dietary supplement. Also, the company was cited for selling a product with a disease claim in the product’s title. This name was redacted in the warning letter, so I reached out to the company that received the letter to ask what the product’s name was, but I have not heard back from them. I’m always intrigued when I see product names cited in warning letters, and I’ve previously written about this here . From warning letter. “Product name, (b)(4) : The product name implies the product is intended to cure, mitigate, treat, or prevent migraines.” Labeling issues are also mentioned in this letter. Check out last week’s post for best practices for labeling dietary supplements. Read the full warning letter here . DATE ORIGINALLY POSTED: 7/31/24 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!

Product review engagement leads to a warning letter < Back FDA Crackdown on CBD in Animal Products Product review engagement leads to a warning letter FDA crackdown on CBD in animal products. This month, we saw the fourth warning letter that mentions CBD in animal products. This is the 20th CBD-related FDA warning letter this year, up dramatically from only seven in all of 2021. This is an enforcement trend to watch! These warning letters involve companies marketing CBD products for farm animals and humans, but there are also some great learning opportunities for the broader dietary supplement market. The most interesting point is a company was cited for engaging with product reviews on their website. The product reviews look like third-party-generated content, such as from TrustPilot, of which the authorities have been “hands-off.” The company then comments on the product review, which contains disease claims, and this is similar to how a company may comment on social media. If the company had not engaged in commenting on the review, I doubt this would have been cited in this letter. This is an essential lesson for content writers and social media managers: fight the urge to engage when customers write product reviews with disease claims. The more attention is paid to them, the higher their chance of being scrutinized. From the warning letter “Customer review: “I wanted to ask if these pellets would help my goat, has a bad front leg, he holds it up a lot, the vet says it arthritis …Do you have anything that would ease the pain…” o Response from ….Hope Botanicals: “Yes, I think the pellets would be beneficial for your goat. We have lots of goat customers” Read the letter here . The critical point here is that true third-party product reviews seem to be safer from scrutiny, but they cross the line into a marketing claim when a company comments on them. This is considered substantiation of the customer statement, and the engagement changes into “an extension of the label.”. This lesson can be applied to social media engagement as well. “All Marketing is Labeling” video . These letters are also the “greatest hits” of what not to. · Old social media posts · Claims made in blogs, videos, hashtags · Testimonials are claims The FDA is concerned about CBD getting into the food supply. From Warning Letters: “The Agency is particularly concerned that you market one of your CBD products for food-producing animals”. Hashtags are also mentioned. From Haniel warning letter: “On a May 12, 2019 post on Instagram states, “What can # CBD do for #animals and # anxiety # inflammation # arthritis # pain # seizures # cancer # cbdoil Blogs are also mentioned in this letter. Remember, old blog posts are now commonly mentioned in warning letters. Here is my “Best Practices for Reducing Risk in Blogs” post . From warning letter: On your …. November 5, 2019 blog posting titled “Is CBD Safe for Dogs with Anxiety”: • “One of the most popular uses of CBD is to treat anxiety. In my opinion, the claims cited in this video are not considered high risk. This is a good reminder that even mid-level risk claims can attract a warning letter (see below). From Plantacea, LLC dba Kahm warning letter: “In a Product Display training video dated December 7, 2020 at https://www.youtube.com/watch?v=8BwdqTedTa0 , during the discussion of your “CBD Hemp Pellets” (from the 4:52 to 4:55 mark) the presenter states: “It’s also amazing for the anti-inflammatory effects that CBD has.” Here is an example of a high-risk claim that likely “tipped the scale” into the warning letter category. Note these social media post is four years old! From Plantacea, LLC dba Kahmwarning letter: On your Instagram social media website ….from posts on July 24, 2018: • “An article published in the February 2013 issue of The British Journal of Clinical Pharmacology states, ‘CBD. . . inhibits cancer cell migration, adhesion, and invasion.’” 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!

Common labeling errors can be avoided < Back Supplement Labeling Errors lead to Warning Letter Common labeling errors can be avoided This warning letter has numerous labeling teaching opportunities, which is really exciting! I don’t think any of these violations would attract a warning letter on their own, but altogether they paint a picture of non-compliance. This letter cites a product that does not have the designation “dietary supplement” on the main label panel. This is called the statement of identity and is a core aspect of supplement labels. This is interesting! The company was cited for adding the “percent daily value” statement when it was not necessary. From warning letter. “product labels each bear the following statement: “Percent Daily Values based on a 2,000-calorie diet.” This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein” The lack of a heavy bar separating % DV from non-% DV ingredients in the supplement fact panel is cited. Formatting is important, and here are some FDA supplement fact panel examples . One of the most fascinating aspects of this warning letter is the comment that vitamin K2 does not qualify as vitamin K, which has a % DV. This is a relatively obscure regulation, and I don’t recall seeing this in a warning letter before. From warning letter. “Supplement Facts label incorrectly declares as a (b)(2)-dietary ingredient, “Vitamin K (as menaquinone-7)”. 21 CFR 101.9(c)(8)(iv) lists an RDI for vitamin K of 120 mcg based on the AI (adequate intake) that pertains only to phylloquinone. It’s “% DV,” not “DV %.” Yes, folks, we can learn a lot from warning letters. This is a minor but commonly overlooked item in supplement fact panels. From warning letter. “ the listing of “DV%” is incorrect but may be listed as “% DV”. Finally, the “%” symbol must follow each numerical value listed as a DV.” Oh my goodness, so many great learning lessons! Here is one about formatting. The FDA prefers the format list the supplement fact panel, then “Other Ingredients,” then the contact information. From warning letter. “product label fails to place the “Other Ingredients” list below the Supplement Facts label.” This label also does not include a domestic street address or phone number, which is required for adverse event reporting, and this is essential to a compliant supplement label. Here is a previous Warning Letter Wednesday post with more labeling lessons that include items called out in this letter, such as improper serving size Here is FDA’s labeling information . If you have additional labeling questions, I would be happy to try to be of help. As a resource, I get carried away with this “GMP Pitfalls and Best Practices” blog . I hope you find this useful. There are so many more lessons in this warning letter, including improper specifications. Read it 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!

Following specifications prevents greater issues < Back Heavy Metal Contamination Leads to Recall Following specifications prevents greater issues High lead recall alert! A dietary supplement company in New York issued a recall for its finished product, Shatavari, due to high lead levels. Greetings from Expo West! Today's Warning Letter Wednesday reviews the importance of making and following specifications. Sign up for my weekly blog here , which allows you to search 150+ previous posts. The batch of high-lead products has been in circulation since 2022 and was recently tested by the Connecticut Department of Consumer Protection's Food & Standards Division, which resulted in the recall. Thank you for finding this CDCP! Botanicals contain "naturally occurring" amounts of heavy metals, especially in the roots, which is why ingredients and finished product specifications are required to test these items. The American Herbal Products Association (AHPA) is a good resource for understanding specifications, but keep in mind that retailers and states like California (Prop 65) may have their own requirements. The most common warning letter violations involve specifications being incorrectly written or followed. Here are a couple of Warning Letter Wednesday posts about this. 🔹 1/22/25: Incomplete Batch Records & Ingredient Specifications 🔹 7/31/24: GMP Manufacturing Lessons As Warning Letter Wednesday readers know, I am not a company or product basher, which is why I typically don't call out company names in my newsletter. I, however, always provide a link to the warning letter or case so inquisitive subscribers can explore publicly available documents. When I look at the recall notice in more detail, I also see labeling issues such as the Statement of Identity "Herbal Supplement" or Dietary Supplement" missing from the Principal Display Panel (PDP). This is considered a major labeling violation, and it signals deeper compliance issues to anyone who is a label reader. The adage "Where there's smoke, there's fire" is often true with labeling violations. I then ran Apex Compliance® on the company's website and found several over-the-top disease claims. Since recalls often lead to warning letters, now is the time for this company to remove these risky marketing phrases. Also, to anyone who sells Shatavari, expect the FDA to ask about your specifications and testing during your next inspection. 👉 I write about the joys of being a label reader while traveling here (280k impressions). 👉 Read about the recall here . DATE ORIGINALLY POSTED: 3/5/25 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!

Be nice to FDA investigators & follow inspection SOPs < Back Refusing FDA Inspection Access Be nice to FDA investigators & follow inspection SOPs GMP inspection preparedness is an essential part of business and compliance. This includes ensuring team members know how to conduct themselves during an inspection, what types of information FDA is allowed to request, and understanding what can go wrong if staff do not allow access to the specific areas of the facility. This warning letter is an extreme example of what not to do during an inspection. The company, a cosmetic and topical OTC manufacturer, was issued a letter for not allowing FDA to enter certain areas of their facility, but it doesn't stop there. Apparently, the quality manager shoved and shouted at FDA investigators? As my daughter would say, "WTF." From warning letter. "Quality Manager entered the laboratory and exhibited hostility by shoving and shouting at our investigators for conducting the inspection without their presence. Additionally, laboratory staff refused to open a drug stability chamber based on his hostile behavior. FDA inspectors are real people, and common courtesy goes a long way, such as offering them water (do not offer anything else as it is considered inappropriate), suggesting a good restaurant for lunch, and just being nice. It goes without saying that shouting and shoving anyone, especially FDA, is bad, and it would set up the rest of the inspection to go much worse than it could have. Employee training and mock FDA inspections are a critical part of a smooth "real" GMP inspection. It is standard practice for FDA to request a list of complaints to ensure they are being investigated properly. A customer complaint related to mold and its associated investigations was not disclosed in the list of complaints provided to the FDA. The section of the warning letter is sad and potentially speaks to an unfriendly and potentially fishy work environment. From warning letter. "While interviewing an employee regarding the undisclosed positive mold results for your …. your Quality Manager entered the room and began berating the employee, who then left the room, impeding FDA's review of your contamination investigation required under CGMP." There are several other GMP citations listed in the warning letter. Failure to Test Finished Products (21 CFR 211.165(a)). Failure to Test Components for Identity and Purity (21 CFR 211.84(d)). Testing glycerin for diethylene glycol (DEG) or ethylene glycol (EG) is mentioned here. FDA is very serious about this and has been mentioned in 40+ warning letters this year. Inadequate Facility and Storage Conditions (21 CFR 211.42(b)). Inadequate Quality Unit Oversight (21 CFR 211.22). Lack of Process Validation and Cleaning Validation (21 CFR 211.100(a) and 211.67(b)). This warning letter reads like a bad movie and makes the company look unprepared and non-compliant. Read the full letter here . DATE ORIGINALLY POSTED: 12/25/24 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!

Do not over-explain clinical research < Back Best Practices For Using Clinical Study Citations Do not over-explain clinical research Using clinical study citations can be a crucial part of product marketing. If the study citations are from well-powered studies using competent and reliable scientific evidence, they can bolster the brand's scientifically supported position, which is important to many customers. I have heard this also helps boost Google's SEO rankings. There is, however, a fine line between compliantly using clinical study stations and making high-risk disease claims. When can clinical study citations be used? FDA addresses this question in the Small Entity Compliance Guide On Structure-Function Claims . From FDA. "Can I use citations of publications that relate to my product's intended use in labeling if the publication title or the journal name mentions a disease name? Yes, but some limitations apply. If the citation implies treatment or prevention of a disease, it is a disease claim. Thus, if in the context of the labeling as a whole, its presence suggests treatment or prevention of disease (for example, by placement on the immediate product label or packaging, inappropriate prominence, or lack of relationship to the product's express claims), the citation is a disease claim. If the citation is used in labeling, its context determines if it is a disease claim. A citation that is used in the bibliography section of labeling, is included in a balanced discussion of the scientific literature, is not excessively prominent relative to other citations, and provides legitimate support for a structure/function claim made for the product would not be a disease claim." Asa comments. Adding citations at the bottom of a scientific blog is not likely to attract a warning letter, but the keywords do attract attention. For example, words like Alzheimer's will be picked up by web crawlers and invite attention. This means if you are using clinical citations in product marketing, ensure these are not construed as marketing by showcasing them. Also, double-checking the rest of your web and social marketing is crucial, as extra attention will be paid to ALL marketing. Elaborating on the studies does cross the line into marketing, as we see with this recent warning letter . From warning letter. "In another recent study, correlations between CBD and blood pressure were examined. Two groups were evaluated, one being test subjects who were given CBD and the other being a control group with a placebo. All subjects were exposed to stressors that would induce a higher blood pressure. The study concluded that a dose of CBD was helpful to reducing blood pressure." FDA has also cited companies for posting about clinical studies on social media. This includes sharing clinical studies that have ingredient and disease containing meta descriptions such as "X ingredient studied for depression. The moral here is when including citations in your marketing materials, ensure they are appropriately placed—ideally within a bibliography or as part of a balanced discussion of scientific literature. They should not be excessively prominent or showcased. The Small Entity Compliance Guide is also an excellent resource for helping us understand the nuances of dietary supplement marketing such as this. From FDA, "Examples of acceptable structure/function claims are "mild memory loss associated with aging," "noncystic acne," or "mild mood changes, cramps, and edema associated with the menstrual cycle." From FDA, "Examples of disease claims are "Alzheimer's disease or senile dementias in the elderly," "cystic acne," or "severe depression associated with the menstrual cycle." DATE ORIGINALLY POSTED: 9/18/24 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!

Citing studies leads to increased scrutiny < Back Citing Clinical Studies & Labeling Errors Lead To Warning Letter Citing studies leads to increased scrutiny Citing clinical studies, labeling, and formulation errors lead to a beverage warning letter. #WarningLetterWednesday I'm sometimes asked if supplements can make disease claims with competent and reliable scientific evidence. Unfortunately not; even if a Randomized Controlled Clinical Study (RCT) was conducted on a supplement, the FDA does not allow disease claims in supplements or foods. Citing studies with disease claims on a commercial website is a common error that increases the chance of scrutiny, in my opinion. From warning letter: “Green tea has been shown in studies to naturally lower blood pressure” Nutrient content claims are cited in this warning letter. The company labeled their product “nitrogen enriched,” but because there is no DV% for nitrogen, it can’t comply with this regulation. Read more amount other nutrient content claims like “good source of” and “high potency” here . This warning letter mentions the word “stevia,” which is an incomplete ingredient description, and this is a friendly reminder to add the plant part or other information to ingredient listings. From warning letter: “stevia” does not meet the ingredient declaration requirements of 21 CFR 101.4 because it is not specific or descriptive enough to be a common or usual name. Simply declaring “stevia” does not identify whether the ingredient is stevia leaf, crude stevia extract, or purified steviol glycosides.” Here is another interesting example of an inaccurate ingredient listing. From warning letter: “hydrogen enriched RO water” are not common or usual names as required by 21 CFR 101.4 because “RO” is not a widely used abbreviation established by common usage. In addition, as explained above, hydrogen must be declared as a separate ingredient of these beverages, rather than as part of the name of the water ingredient.” The FDA cites a different Nutritional Facts Panel listing on the website “label” and the product label. This is the first time I have seen this mentioned in a letter, and it is a great reminder to have continuity in marketing and labeling. From warning letter: On your website, the product page … includes an image of its Nutrition Facts panel showing that the product contains 9 grams of sugar per serving. However, the physical label collected for this product during our inspection declares 0 grams of sugar per serving” There are even more interesting aspects, and I suggest reading the full 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!

Use qualified reference samples < Back Noncompliant Testing Methods Lead to Warning Letter Use qualified reference samples This company received 483s for GMP violations relating to testing methods and specifications. They were inspected in late 2021 and early 2022 and sent FDA five 483 responses last year. It seems these responses were not satisfactory, which led to this warning letter. There are numerous learning opportunities here. 🔷One of the violations was not having a strength test on a softgel product. It seems the company once had this, but it was removed 👉“at the request of the customer, as documented in your change control document.” A key learning lesson here is contract manufacturers should be flexible with their customers to a limit. Obviously, completely removing this test from the softgel specifications was a bad idea. Who knows, perhaps they could have found a more suitable strength test to satisfy GMP requirements and the customer. 🔷Unqualified reference standards are cited in this warning letter. The company was testing samples using FTIR, but the reference samples were not verified, which means they were likely from previous batches and not a purchased verified material. I will admit this is how I used to test identity circa 2010-ish. 👉From warning letter. “Identity testing using FTIR to compare the sample spectrum to an unverified reference sample is not an appropriate scientifically valid method” 🔷Identity testing in the finished product was brought up again, and this is a trend to watch. FDA requires the identity of each ingredient to be tested before blending and in the finished product. This is straightforward for some items but is costly and challenging if there are numerous botanical ingredients, as this requires developing expensive testing methods. I am unsure if this is the case in today’s #WarningLetterWednesday, but this is not the last time we will hear about this rigid pharmaceutical interpretation of supplement GMPs. I write about this here . 🔷Proving test method suitability is starting to appear in 483s and now in warning letters. This means that the FDA is asking why specific test methods are used. In the past, relying on a third-party lab for this was sufficient, but now, having suitability documentation on file for each method your lab uses is a good idea. 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!

Product formats & packaging should not appeal to children < Back FDA/FTC Cites Six Companies For Selling Delta 8 Products Product formats & packaging should not appeal to children FDA and FTC recently sent six joint warning letters to companies selling delta 8 products that were favorable to children. Thank you, FDA and FTC! These warning letters highlight some of the most over-the-top examples of products going too far, and I applaud the authorities for taking action. Here are some of the highlights: 🔷 More than disease claims: All of these warning letters do not include disease claims. This shows the agency is starting to think differently about enforcing cannabinoid products, and if they feel there is a safety issue, they will take action. Last year FDA shocked everyone by sending this letter to a company that was not making disease claims but was adding CBD to a caffeine-containing beverage. 🔷 Unfair or deceptive marketing is cited in these letters, which is where FTC comes in. Delta 8 poses dangers, especially to children, in favorable formats like gummies which are considered deceptive marketing. I find this approach fascinating and clever. 👉 From warning letter “Section 5 of the FTC Act prohibits unfair or deceptive acts or practices in or affecting commerce. This prohibition includes practices that present unwarranted health or safety risks….. preventing practices that present unwarranted health and safety risks, particularly to children, is one of the Commission’s highest priorities.” 🔷 Some of the most egregious products are Cheetos Crunchy Flamin’ Hot THC Infused Chips and Doritos Nacho Cheese THC Infused Chips. Wow, in addition to trademark issues, this company took it way too far. 🔷 Safety is cited as a primary reason for some of these letters, such as this example where similar products resulted in adverse event reports. 👉 From warning letter : “Ten of the reports specifically mention the edible product to be a copycat of popular foods. Your Sour Worms” 🔷 Some of these letters were issued to marketplace sites where numerous third-party products were sold. This shows that companies are responsible for the products they sell, as exemplified by last year’s Amazon and Walmart warning letters . 🔷 We are all aware of FDA’s unfavorable position on CBD, but they really do not care for delta 8 with good reason, as exemplified in last year’s consumer update . Delta 8 can be dangerous, and according to data from National poison control centers, 2,362 delta 8 exposure cases had been reported, including “One pediatric case was coded with a medical outcome of death.” This report warns consumers that delta 8 products are widely available in forms favorable to children, such as chocolates and candies. This should have given the delta 8 industry pause, but these products have unfortunately continued to proliferate. 🔷 Although most of the products cited in this letter have been removed, there are still some brazen products being sold, such as a carton of cookies that contains 30mg delta 9 THC per cookie. OMG! There is much more to read in the FDA news release . 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!

Safety related product claims attract scrutiny < Back “Non-Toxic” Claims Require Extensive Substantiation Safety related product claims attract scrutiny Making a “Certified Non-Toxic” claim on a mouthwash triggered a competitor challenge. According to the National Advertising Division (NAD) comments, the substantiation provided by the company was not sufficient to support the claim. 👉From NAD. “In support of the “Certified Non-Toxic” claim, Oral Essentials submitted two cytotoxicity studies (one for its sensitivity mouthwash and one for its whitening mouthwash) and a certification statement from MADE SAFE, a third-party certification program that verifies ingredient safety and non-toxicity. Oral Essentials mouthwashes were certified by MADE SAFE at the time of manufacture.” 👉From NAD. “Strong evidence is needed for non-toxic claims due to potential health and environmental risks as well as the potential for consumers to misuse the product or take away a broader message about the product’s safety that is not supported by the claim.” 👉Apparently, the cytotoxicity studies did not exactly match the and did not address the “real-world” effects. From NAD. “NAD found Oral Essentials’ cytotoxicity studies did not support the challenged claims such studies do not reflect the real-world effects on humans and only address one form of toxicity. Additionally, the study formulations contained one less ingredient and differed from the current product ingredients.” It seems the position is that making a “Certified Non-Toxic” claim on a mouthwash label may give some consumers the idea that they can drink the whole bottle or put it in their eyes with no safety issues. I expect people to have more common sense than this, but I guess it is possible for a consumer to think that “Non-Toxic” means they can go nuts with it. I assume the same rationale would apply to toothpaste or any other product that is sparingly used internally. 🔹Don’t rely on certifications: The company also relied on a “MADE SAFE” certification, but this did not substantiate the claim because it was unclear to NAD which real-world factors were evaluated in the certification process, and the company's certification had expired in October 2024. At Supplement Advisory Group , my regulatory consulting company, I often share the “less-is-more” principle with clients. This means that every aspect of packaging will be scrutinized, and if it’s not necessary for marketing, removing it is a good idea. This is not always a popular opinion, but it is important to measure risk and reward while keeping substantiation in mind. Read more about the case here . DATE ORIGINALLY POSTED: 1/15/25 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!