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Correct FDA 483s to avoid a warning letter < Back Most GMP violations involve setting & documenting specifications Correct FDA 483s to avoid a warning letter #WarningLetterWednesday reviews a cGMP manufacturing warning letter. This is a good teaching case about the basics of Good Manufacturing Practices (GMPs) for dietary supplements as this company made some of the most common mistakes. Regulatory expert Steven Yeager and I discuss “How to Prepare for FDA Inspections” in the following webinar . We’ve both helped oversee several FDA CFR 111 inspections with no warning letters and we have fun sharing our helpful tips and hints. Steven and I also presented a four-hour GMP and marketing compliance workshop here at the American Herbalists Guild. This letter includes the most common violation of not establishing and documenting specifications for the identity, purity, strength, and composition. Another common mistake is not having documentation showing a member of the quality team approved specifications and product labels. This role of quality is at the core of GMPs. Imagine the mix-ups and potential adulteration that could occur if the production team was allowed to apply labels without oversight. We recently saw this happen in a CBD company that inadvertently applied CBD labels to the THC product which resulted in serious adverse events. Another important reminder is the requirement to list the plant parts such as leaves or fruit. Also noted is the requirement to have proper Supplement Fact Panel line thickness and bolding. Although these will not attract a warning letter on their own it is better to have a correct label layout. There are so many more violations listed in this letter and I suggest reading the full warning letter here . It is interesting to look at the timelines in this warning letter. The inspection was in May of 2021 when a 483 was issued but the warning letter was not issued until six months later. This gave the company plenty of time to correct the 483 and avoid a letter. Learn more about the difference between 483’s and warning letters here . The very big surprise is the FDA didn’t appear to review the company’s website before the inspection. Normally, the best thing a company can do to prepare for a GMP inspection is to remove all high-risk online marketing claims as FDA investigators review websites and social media before the inspection. This company is very lucky as they still have LOTS of high-risk website claims. This is a strong risk for a repeat warning letter. Learn more about “Reasons to Avoid “Warning Letters” 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!

Formats that are favorable to children should be avoided < Back Another Delta 8 Warning Letter Formats that are favorable to children should be avoided This is the tenth FDA delta 8 warning letter this year, which is an important reminder that delta 8 THC is still on FDA’s mind, especially when it’s sold in formats that are favorable to children, like candy ropes. Distributors are responsible: This website distributes products from several different companies, demonstrating that even companies that sell other’s products are responsible. I think of this as a mini-Amazon, and I expect more distributors selling high-risk items to be called out in the near future. Favorable to children: FDA takes dangerous products in forms that appeal to children very seriously. Products such as delta 8 infused snacks with names like “Not Ya Son’s Weed Bakedies Delta 8 THC 600MG Crispy Bites” were cited in this letter. The takeaway here is that companies selling delta 8 are a high risk for FDA enforcement, especially if they sell products in forms favorable to children, such as candy. Past delta 8 warning letters were jointly issued by FTC and FDA, which usually come with more “teeth,” such as a cease and desist. This company was “lucky” this is “only” an FDA warning letter. Since there are no marketing claims cited in this and many previous letters, you may be asking what the FTC has to do with this. Interestingly, marketing unsafe products, especially to children, is considered deceptive marketing. Go FTC! From the previous 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.” Also, I ran Apex Compliance on the company’s website and found a motherlode of high-risk claims such as cancer and opioid support statements. I wonder why FDA did not cite these. I’d love to show you what Apex Compliance finds on your site. Schedule a demo . I write more about FDA’s position on delta 8 and the previous warning letters here . Read the full warning 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!

Printed catalogs must be compliant < Back Product Names Are Marketing Claims Printed catalogs must be compliant This warning letter involves claims made in catalogs and product labels collected during a GMP inspection. Over 500 supplement executives and regulatory professionals receive Warning Letter Wednesday by email. 👉Sign up here . Everything the FDA investigator sees is “fair game.” Sometimes they gather non-compliant literature, and the company never hears from FDA, but in cases of extreme claims and GMP violations, this often turns into a 483 or a warning letter. In this brief video , learn about the difference between a 483 and a warning letter. There are a lot of non-compliant product names cited in this warning letter. Yes, product names are marketing and, therefore, must be compliant. Here are some particularly over-the-top examples. 👉From warning letter. “Children’s Antibiotic Formula … product name implies the product is intended to cure, mitigate, or treat bacterial infections.” 👉From warning letter. “Hepatitis C Formula Glycerite” and “Children’s Antiviral Formula.” A key learning point is anything can be collected and reviewed. This includes box stuffer promotional materials and printed catalogs. I remember during an inspection; we had haphazardly left old non-compliant product brochures lying around our shipping room. We were not using them anymore, but if the investigator had seen them, it could have led to a warning letter. I carry this lesson with me forever. Even claims which are not considered high-risk are cited in this letter. Here is an example from the company’s product catalog. 👉From warning letter “Product catalog: “A blend of herbs with antimicrobial, anti-inflammatory…actions….” There are also some glaring 483 citations that the company appeared not to address. This includes the "greatest hits" such as not setting specifications. I review GMP violations in previous Warning Letter Wednesday's . 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!

Amazon compliance still needs improving < Back FDA Crackdown on Animal Product Seizure Claims Amazon compliance still needs improving Six animal product companies received warning letters for making seizure, cancer, and other serious disease claims on Amazon, social media, and websites. You may be saying, “These companies should have known better,” and I agree, but what was bewildering is that three of these companies were cited for seizure-type claims on Amazon. This is surprising because these types of statements on a human supplement lead to delisting, but these letters have highlighted Amazon’s lack of enforcement in the nuanced animal “supplement” arena. I expect animal products making unallowable disease claims on Amazon to be delisted soon, as Amazon tends to be reactive when FDA warning letters are issued. For companies in the animal supplement space, working with the National Animal Supplement Council is a great path towards product compliance, and Apex Compliance , my marketing claims and compliance software product, is proud to be an NASC preferred supplier. From one of the warning letters. Yes, the name of the product is Epilepsy & Seizure Formula. “From your product webpage …” on Amazon… • “Epilepsy & Seizure Formula… Remedies for Dogs and Cats” Homeopathics : One of the warning letters included claims made about homepathics. This is an important reminder that FDA does not tolerate extreme disease claims made about homeopathic products. Here is my previous post about this. YouTube : One of the letters includes claims on YouTube. A new Apex Compliance feature allows you to scan entire YouTube channels for keywords and disease claims. This helps find issues before they lead to regulatory trouble. I love it! For those who are confused about what claims can be made about animal “supplements,” the answer is “not much.” This is because FDA takes a stricter approach against animal supplements compared to human supplements. Here are some differences in human and animal product claims enforcement with the caveat that all claims must be substantiated. Lower-risk structure-function claims like “joint support” are unlikely to attract warning letters in animal or human product marketing. Claims that push the compliance boundaries, like “reduces anxious feelings,” may attract an animal product warning letter but are unlikely to be the sole reason for a human product letter. This is because the FDA has a lower “tolerance” for these types of statements in animal products. I write about this here and here . Here are the six FDA warning letters. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/evolution-pets-llc-696281-11122024 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nutrition-strength-ltd-696350-11122024 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/energetic-essences-llc-dba-pet-essences-696395-11122024 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/veterinary-select-formula-dba-allergic-pet-696354-11122024 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intermarket-industries-inc-dba-doc-ackerman-pet-products-696352-11122024 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hdfrenchies-llc-dba-bully-baum-696351-11122024 DATE ORIGINALLY POSTED: 1/8/25 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!

Product reviews must be honest and truthful < Back Online company fined $4.2M for blocking negative product reviews Product reviews must be honest and truthful #WarningLetterWednesday Online company fined $4.2 million for blocking negative product reviews. The FTC alleges the company blocked product reviews with less than four stars. This is considered deceptive marketing and clearly warns companies that product reviews should be accurate. Here is what we can learn. 🔷Best practices for soliciting and posting reviews. From FTC letter ➡️Examples may include asking for reviews only from those likely to leave positive ones, preventing or discouraging submission of negative reviews, subjecting negative reviews to greater scrutiny, refusing to publish negative reviews, or otherwise not treating positive and negative reviews equally. 🔷Here are some FTC rules for possible exceptions to the "post all" rule. From FTC press release➡️(the company) must post on its website all customer reviews of products currently being sold—with the exception of reviews that contain obscene, sexually explicit, racist, or unlawful content and reviews that are unrelated to the product or customer services like shipping or returns. Here is a video about product reviews . Read the FTC press release . This is a different Warning Letter Wednesday because it is an FTC action (not FDA), and it involves a fine (not a warning letter) and doesn't include a supplement company. This is a good reminder that we can learn from other agency actions such as this one. 👉Join my Warning Letter Wednesday group 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!

Ingredient research can be considered a marketing claim < Back Product “Tags” With Disease Claims Elevate Risk Ingredient research can be considered a marketing claim Ingredient research on a commercial website can be considered a marketing claim, which continues to be cited in warning letters. The key point that turns “research” into a marketing claim is when the ingredient is in a product sold on the site. This is when “education” crosses the line into marketing. Here is a post about seven CBD companies that were cited for this earlier in the year. Today’s #WarningLetterWednesday is another example of this, but it also has some new learning opportunities. Products or category “tags” help Google and customers find specific posts, but they are also considered marketing. These tags demonstrate the content’s intended marketing use and should be used carefully. I suggest against using disease “tags” on any supplement marketing, and this warning letter cites a very high-risk category tag. From warning letter: Your website ….. also includes various “Category” tags, including “COVID-19,” that link to the blog post “How Does CBD Help to Fight Against COVID-19?.” The blog post has links to CannaAid products available for purchase. I write more about product tags and meta tags here . This letter also references a call to action where the blog post links to a shopping cart. Although blogs with implied disease claims are cited in warning letters, this “commercial bridge” likely elevates the risk of scrutiny. This company would have received the warning letter without the “Covid” tags and without linking to a shopping cart, but this shows how authorities may consider these factors when deciding to issue a warning letter. Here is a post about discussing ingredient benefits. This joint FDA/FTC letter includes a cease and desist. Learn more about these here . Read 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!

Study citations are marketing < Back GMP Inspection Leads to Online Scrutiny Study citations are marketing This is another example of a GMP inspection leading to a website and social media review. The initial FDA inspection was in April this year, but the website was not reviewed until September and October! This trend is common in warning letters, and FDA does not appear to critique online marketing until months after the initial inspection. This is a reminder for companies inspected in the past year to re-review online marketing to ensure there are no compliance concerns. This includes blog posts that cross the line from education to marketing. Study citations are marketing. There have been several letters where companies highlight research about ingredients like elderberry. This is considered marketing if those ingredients are in products sold on the site, and I talk more about this here . Now is a good time to review your elderberry and other ingredient marketing to ensure there are no “forgotten” ingredient claims. From warning letter. “The Study showed that Elderberry extract is effective in treatment of flu.” Testimonials are becoming more common in warning letters. This company copied a customer testimonial onto a social media image, which is considered “endorsing the testimonial.” From warning letter. “Facebook image post: Joint Support Capsules … Amazing. Really works. Muscle pain and nerve pain.” Several blog claims are cited in this warning letter. A common blog writer trap is to use sensational titles such as “Can Turmeric Help Reduce the Risk of Strokes”? As discussed above, this is a marketing claim if turmeric is sold on the site. Here are some best practices for reducing blog risk. There are several GMP violations cited in this warning letter. They probably wouldn’t have elevated to a warning letter if adequately addressed and if there were no online disease claims present. Companies continue to be cited for not demonstrating the identity of the finished herbal product blend, even if the individual ingredients have been tested and the blending has been validated. To show the finished product identity, a specific method needs to be developed. Does a small company need to spend valuable resources to develop a specific method just to confirm the identity of an herbal blend? I find this rigid interpretation of the regulations puzzling and a potential burden on industry. Setting herbal specifications too rigidly can lead to issues. This company was cited for not properly handling an ingredient that exceeded its lead limit of 1.45ppm, which is not a high level for an herbal ingredient. This would not have been an issue if the company had set a realistic lead level. This demonstrates the importance of setting up a practical Quality Management System (QMS). A QMS developed with GMPs but also operational efficiency in mind is essential to any growing business. Having a properly functioning QMS is critical, but an overburdensome approach to quality is restrictive. Some companies hire exquisite pharmaceutical managers to develop their QMS, and they get what they pay for, a rock-solid system that is pharma-level, but is this needed in a small to midsize company? Some citations went to quality concerns from 2016, showing that even several-year-old decisions regarding quality can come back to bite a company. The FDA did not feel the company’s 483 responses were sufficient. I write about how improper 483 responses can turn into a warning letter here . Read the full warning letter here . Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Arthritis claims attract scrutiny < Back Tips For Understanding What A Claim Is Arthritis claims attract scrutiny Arthritis claims continue to be cited in warning letters. As many of you know, I love teaching about regulatory compliance to help you adjust your marketing and stay ahead of the regulatory curve. We hear about not “making claims,” but it can be challenging to know what a claim is. Here are a few general rules for avoiding high-risk claims that can lead to a warning letter. What other tips can you share? Anything ending in “itis,” such as “arthritis”. “Itis” means “inflammation of,” which helps me remember it should be avoided. Fun fact, “arthritis” is the most commonly referenced of all the words ending in “itis.” Other than “antioxidant” and perhaps “anti-aging,” words with “anti” should be avoided. Immune-related words like “antiviral” or “antitumor” are higher risk than “anti-inflammatory.” Words with an International Classification of Diseases (ICD) code. The name of any illness or syndrome, such as Alzheimer’s or IBS. Some are obvious, but some of the syndromes, like Leaky Gut Syndrome, may not be as obvious. Here is a post about this. Searching past FDA warning letters can help you learn what they’ve previously cited. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters “Better than drugs” statements attract FDA attention. Here’s a WLW post about this. FDA sent out 12 arthritis-related warning letters last year, so please avoid making these types of claims. This includes: Hashtags Showcased testimonials Citing clinical studies Product tags and meta tags Social share meta description FDA has been quiet with supplement warning letters, and I am in New Zealand, so this is a shorter post than normal. I am writing this WLW for the beautiful Coromandel. Yes, I love compliance and writing this post (smiles)! Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Following SOPs is essential to compliance < Back GMP Issues Following SOPs is essential to compliance There are so many important GMP lessons in this warning letter. Let’s see what we can learn. Botanical identification methods: When developing botanical specifications, ensuring they are complete is essential. In the warning letter, the company apparently did not add crucial aspects of specifications. From warning letter. “None of these components have a listed specification target, range, reference, or test method.” Incomplete 483 responses: When responding to 483s, it is important to follow through. Here, FDA cites the company for seemingly not providing the promised information. From FDA: “We have reviewed your response dated November 10, 2023. In your response you state you will create specifications for raw materials and that you estimate it will take approximately 90 days. You did not provide any documentation of your specifications, so we cannot evaluate the implementation.” Internal audits are a good best practice but are generally not required unless an SOP states this. In this warning letter, the company is cited for not following its own SOP. The lesson here is ensuring SOPs are developed with the entire company’s capabilities in mind, as SOP requirements can paint a company into a compliance corner. From warning letter. “You did not conduct periodic Good Manufacturing (GMP) internal audits of the entire plant with documented corrective actions, as required by your SOP... An internal audit has not been conducted since 2022." Master Manufacturing Records (MMRs) are the “recipe and directions” for making products. When I was in manufacturing, I would describe the MMR as this: “If someone has never made this product before, they can pick up the MMR and figure out how to make it perfectly every time.” Here FDA cites the company for not having a theoretical yield. This “lily pad” approach to quality is important to help catch issues before product leaves the building. For example, calculating theoretical yields catches issues such as inadvertently omitted ingredients or low capsule fill weight. From warning letter. “Statement of the percentage of theoretical yield at appropriate phases of processing” Cross-referencing labels to the formula is an essential part of GMPs. From warning letter. “Your MMR did not include a description of packaging and a representative label.” From warning letter. “Your MMR for does not include instructions for capsule drying or packaging operations. In addition, the MMR does not contain detailed instructions for the encapsulation process.” Allergen advisory statements are mentioned in this letter. I have never added this warning ‘because major allergens are either in the product or they are not.’ From warning letter. The … product label declares “Allergy warning: Manufactured in facility that also handles milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybean.” Advisory labeling is not a substitute for adherence to current good manufacturing practices and, when used by a facility, food allergen preventive controls. See Guidance for Industry: Questions and Answers Regarding Food Allergens Labeling , The firm should make every effort to ensure that they and their suppliers have adequate GMPs in place to prevent the unintentional inclusion of allergens in their products and ingredients. Read the full letter here . DATE ORIGINALLY POSTED: 11/6/24 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!

Re-review marketing if FDA has inspected you < Back Online Marketing & GMP Lessons Re-review marketing if FDA has inspected you Learning about compliance is fun, and today’s Warning Letter Wednesday has critical teaching opportunities for marketing and GMP compliance. This is yet another example of a company being inspected by FDA; then, many months later, around the time of the inspection close out, FDA looked at the company’s online marketing and found a lot of no-nos. This is an enforcement trend that I write about in more detail here . First, the marketing issues : YouTube videos : Claims made in YouTube videos have been mentioned in three warning letters this year and I expect this trend to continue. Reviewing hours of YouTube videos for compliance concerns is painful, so I developed and patented a technology to help with this . In this warning letter FDA clearly shows the “material connection” or “commercial bridge” by referencing that the company placed its website on the screen. From warning letter. “the URL for your website … appears onscreen during the video and you state: “Very powerful anti-cancer properties…used in conjunction with chemotherapy and other cancer treatments, but not only does it have anti-cancer properties it also has a lot of other properties as well…the way that Taxane works in the body to fight cancer is it causes cell apoptosis in cancer cells.” Biomarker claims continue to be mentioned in warning letters. I go into more detail about this here . From warning letter. “Lowers LDL and Triglyceride Levels” Words with “anti” are disease claims , except for antioxidant and perhaps anti-aging. Words like anti-inflammatory have a risk rating of three out of five (Asa risk scale) which means they are not likely to attract a warning letter on their own, but words like anti-viral are very risky. From warning letter. Dr. Bob’s Parasite Killer is formulated with parasiticidal, anti-fungal, anti-viral, and antibacterial ingredients with the intention of killing everything in the digestive tract. Claims on product labels : We know that all marketing is an extension of the label, but I am still surprised by some of the “on-pack” claims companies put on the product label. No knowledgeable manufacturer would apply labels with these statements. From warning letter. “Dr. Bob’s Parasite Killer is formulated with parasiticidal, anti-fungal, anti-viral, and anti-bacterial ingredients with the intention of killing everything in the digestive tract.” Now the GMP learning opportunities : Component specifications are integral to GMPs, and each raw material must have written specifications. This is to ensure ingredients do not make it into inventory unless they’ve been checked. For example, suppose an ingredient’s visual specification was green and the product came in yellow, or the ingredient did not pass identity testing. In that case, the specification sheet should help catch and document this. From warning letter. “Yuan Zhi is an ingredient in your … but you did not establish such component specifications for Yuan Zhi.” Incomplete 483 responses are too common, and I write more about this here . From warning letter. “you did not provide any supporting documentation, such as copies of your specifications. We are unable to evaluate the adequacy of your corrective action, because you did not provide documentation to support that you have established component and finished product specifications.” Batch Production Records (BPRs) are the “recipe” and should have all adequate information, including copies of labels and cleaning records. Here are some of the items cited in this letter. The description and name of equipment used in producing the batch. This is important so cleaning can be documented. 🔷 The date and time of maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch or a cross-reference to records where this information is retained. 🔷 The unique identifier, such as a lot number and item number for each component, packaging, and label used. 🔷 The identity and weight or measure of each component used [21 CFR 111.260(e)]. A statement of the actual yield or theoretical yield at appropriate phases of processing. This is important to ensure the weight is correct. For example, a high yield could signify an ingredient may have been incorrectly weighed, and this may pose a safety concern. Documentation that the finished dietary supplement meets specifications. Documentation at the time of manufacturing, such as real-time quality checks. This includes bottle weight and label verification. Documentation that quality control personnel reviewed the batch production record and approved and released, or rejected, the batch for distribution. The job of quality is to review and release ingredients, in-process work, and finished products once it has been verified against its specification. Labeling issues were also cited. 🔷 Not listing the capsule in the label’s ingredients 🔷 Not listing the plant part such as ginkgo leaf. 🔷 Not using the standardized common name as described in AHPA’s Herbs of Commerce. Thanks, AHPA, for this resource! 🔷 Incorrect serving size. If the label states, “take 5-8 capsules,” the supplement fact panel must reflect the higher number. 🔷 Listing nutrients with zero amounts, like cholesterol, is not allowed on supplements but is standard for conventional food labels. 🔷 The company was cited for not listing black walnut as a major allergen. I ask, is black walnut a tree nut allergen? 🔷 DSHEA disclaimer: I don’t remember seeing this in a warning letter. The company was cited for apparently not having the DSHEA disclaimer on the label. From Warning Letter. Your … are each misbranded within the meaning of section 403(r)(6) [21 U.S.C. § 343(r)(6)] in that the products make structure-function claims but fail to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b). There are many more labeling items cited. Read 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 caution with “clinically proven” or “clinically studied” statements < Back “Clinically proven” statements are high risk Use caution with “clinically proven” or “clinically studied” statements #WarningLetterWednesday Implying "Clinically Proven" or even "Clinically Studied" is high risk. This is a trend to watch out for. We are seeing references to "clinically proven" types of claims showing up not just in warning letters but also in class action lawsuits and NAD complaints. The highest burden of proof is "clinically proven". This is rare in dietary supplements and should be used only if proper substantiation exists. The next highest burden of proof is "clinically studied". This requires the formula to be studied with scientifically significant methods. Bench or pilot tests may not qualify as "clinically studied". This can be difficult when using branded ingredients that may have been researched but perhaps do not meet a "clinically studied" standard. Most branded ingredients have sound research but some may not. It is important to conduct a proper review before using ingredient science on face value. A "clinically studied ingredient" is different than a "clinically studied product". There are many factors including serving size, formulation, and delivery form that play a role in this. We talk about what defines clinically proven here . If accurate, I prefer using descriptions such as "thoughtfully formulated with well-researched ingredients". What are your thoughts? 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!

Increase in claims cited in blogs and social media < Back Anxiety Claims Enforcement Review Increase in claims cited in blogs and social media Anxiety claims enforcement continues to be top of mind for the FDA. In this #WarningLetterWednesday I compare 2022 anxiety claims enforcement with the same time last year. I found some interesting data points that help us understand where the FDA is finding risky items. These learning tools can alert companies where to look for risky keywords that may be lurking on company websites and social media. Here are some key takeaways: 27% of this year’s warning letters mention claims made in hashtags compared with 20% in the same period last year. This shows that hashtags are indeed marketing claims and can tip the scale into the warning letter category if they are non-compliant. Here is my “Hashtags Are Marketing Claims” video . Warning letters citing blogs and anxiety claims more than doubled (63%) over the same period last year (30%). It is now common to see a several-year-old blog mentioned in a warning letter; a good reminder to ensure all blogs, including the old ones, are compliant. Here is my “Best Practices for Reducing Risk in Blogs” post . Social media enforcement continues to be a trend to watch. This is exemplified by the 63% anxiety claims number this year compared to 40% in the same period last year. The two most drastic changes this year were with CBD and animal anxiety claims. 72% of this year’s letters mention CBD, up from just 16% in the same period last year. This shows the FDA’s increasing intolerance of companies marketing CBD with disease claims. There has never been a riskier time to market CBD products; I go into detail about this here . This year, animal and anxiety warning letters increased from 10% to 45%. I write about this enforcement trend here . The one-two punch of both “anxiety” and “depression” is mentioned in about ¾ all of the 2021/22 anxiety warning letters. There have been 22 anxiety-related FDA warning letters this year compared to 30 in the same period last year. I was a little surprised by the low number this year. It is worth noting that “occasional anxiety” was mentioned zero times in these warning letters. The key takeaway is that focusing on life occurrences such as “occasional anxiety” or “occasional inflammation” may be a lower-risk marketing strategy. 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!