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All social media is “fair game” for enforcement < Back LinkedIn Posts Mentioned in Warning Letter All social media is “fair game” for enforcement It is no surprise that company social media posts are considered marketing claims, as they are commonly mentioned in warning letters. Interestingly, this letter references posts made on LinkedIn. This is a new aspect of enforcement, as previously, I have only seen claims made on a company's LinkedIn page mentioned in warning letters. I find it interesting the FDA is looking at actual posts on LinkedIn, which is an important reminder that all marketing must be compliant and is "fair game" for regulatory scrutiny. This warning letter is Covid-related, which, of course, is a very high risk; however, it is a reminder that hashtags and reposting content elevate risk. In this example, a "Covid study" is shared, and the material connection is solidified with a covid hashtag and a hashtag containing the product's name. From Warning Letter "More evidence that respiratory diseases should be treated in the nose and throat! .... # biovanta # science # covid" [from a post on your social media webpage at...." Read the full warning letter here. This joint FDA and FTC warning letter includes an FTC cease and desist prohibiting the company from making future Covid claims. This sets the FTC up to potentially impose financial penalties and has more "teeth" than a standard 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!

Claims in hashtags, videos, and testimonials should be avoided < Back More Marketing Lessons From COVID Letter Claims in hashtags, videos, and testimonials should be avoided More overt COVID claims are cited in this warning letter. We all know that making COVID claims about supplements is wrong, but let's explore key learning lessons you can apply to your marketing. 🔹This warning letter cites claims made in YouTube videos, and I expect more to come. In this letter, FDA builds the "commercial bridge" from the YouTube page to where customers can order products. It probably wouldn't have been mentioned if this was truly an educational page with no shopping cart links. 👉From warning letter. "where you direct consumers to your websites …. respectively, to purchase your products. 🔹COVID hashtags are cited in this warning letter. Noncompliant hashtags are the quickest way to turn a compliant post into a disease claim. 🔹Testimonials are also mentioned in this letter. I'm always interested to learn what the authorities consider a third-party review and what they consider a marketing claim. In this letter, the reviews were on their own "Testimonials" page and were showcased, which is a clear marketing claim in the eyes of the agency. 🔹Asa rant: Most of the claims cited in the warning letter have been removed, but there are still A LOT of COVID claims on their product's website and socials. This is a small, publicly traded corporation, and I am surprised by its audacity. Is the next step an injunction? I do not know much about the agency's inner workings, but it seems this would have been a good joint FDA/FTC warning letter. FTC has more "teeth" and can require companies to stop making unsupported claims or face civil penalties of up to $46,517 per violation and requirements to refund customers. Also, this warning letter was issued last November but was just posted yesterday, and I find the timeline perplexing. 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!

Well intentioned marketing claims can turn products into high-risk regulatory categories < Back Goat Milk Company Infant Formula Claims Well intentioned marketing claims can turn products into high-risk regulatory categories This goat milk supplement and food company was cited for claiming its goat milk product is an alternative to infant formula. This is a great example of how well-intentioned marketing statements can cross the line into a risky regulatory category. Let’s explore what went wrong. FDA looked at this company’s website and social media and determined their Goat Milk Formula Recipe Kit met the definition of infant formula because it was “purported to be or was represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.” Essentially, this means the company was promoting their product as infant formula. Here are some of FDA’s warning letter references. "We have created a formula recipe that mimics breast milk and follows the guidelines created by the 1980 Infant Formula Act.” Your February 12, 2024 (Facebook) post: “‘Infant formula is the number one regulated food in the U.S., and yet the allowable ingredients in off-the-shelf infant formula is often times very very poor. So there is a very good incentive to make your own formula.’ Get to know the creator, Joe Stout, and learn about the Goat Milk Formula Recipe on the GMF Livestream replay! . . . #DIYBabyFormula . . .” I ran Apex Compliance on their website and found A LOT of very high-risk marketing claims, and I suggest this company look at conducting a compliance audit. Apex Compliance was developed for this type of situation, sifting through large amounts of information and providing a line-by-line playbook showing where risky phrases occur, their risk rating, and some possible lower-risk alternatives. Learn more here . To give the company credit, they seemed to go above and beyond to correct the matter once FDA brought this to their attention. It seems that even though they worked diligently to correct their mistake, FDA issued the warning letter to “ensure the violation does not recur.” Infants are classified as a “vulnerable population,” and this warning letter language demonstrates how seriously FDA takes the infant formula category. From warning letter. “We acknowledge that after a teleconference with you on May 7, 2024, you voluntarily recalled all Goat Milk Formula Recipe Kit ... We are aware that you contacted all customers who received product during that timeframe to inform them that the product should not be used as an infant formula. Additionally, you issued a press release on May 10, 2024, clarifying to the general public that you do not recommend using this product for infants from 0-12 months of age. We also acknowledge that you removed the ability to purchase the Goat Milk Formula Recipe Kit from your website, and that you made some changes to your website and social media websites, including but not limited to removing the above-mentioned statements regarding use as an infant formula. However, due to the serious public health concerns related to your unlawful marketing of a new infant formula, it is essential that this violation does not recur.” Read the full warning letter here . DATE ORIGINALLY POSTED: 10/9/24 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!

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!