Marketing strategies should consider “reasonable consumer expectations” to avoid issues < Back GLP-1 Product Receives Warning Letter Marketing strategies should consider “reasonable consumer expectations” to avoid issues This is one of the cringiest Warning Letter Wednesday posts I've ever written. Wow! This company received a warning letter for making claims that it is better than Ozempic, has FDA approval, does not require a prescription, has no side effects, and is clinically proven in "clinical trials and was approved by the Food and Drug Administration last year." This is the first GLP-1-related "supplement" FDA warning letter. Interestingly, it came in a group of five letters; the other four were companies selling semaglutide (generic Ozempic) labeled as "RESEARCH USE ONLY," but FDA cites their secondary marketing claims as proof of the intended weight loss use. Good detective work FDA! This warning letter is a great study of how implied and express claims cross the compliance limits, such as with the before and after pictures, statements like "Only active GLP-1 is effective GLP-1," and "FDA approved" statements. Here is my opinion on some of the information I've gathered. It is unclear what the ingredients in the product are, but they are marketed as natural and side-effect-free. The product is not labeled as a supplement, but it lists "Clinically Proven" and "Metabolism boost drops for weight management" on the label. The before and after pictures are super cringy and likely violate FTC regulations against deceptive marketing. The product reviews feel doctored, and the entire vibe of the website seems like an AI-generated experiment. It gave me the heebie-jeebies, and I expect the FTC would have a field day with this site. There are other "supplements" for sale on the website, such as THC gummies and weight loss gummies, that are making claims related to anxiety reduction (thanks to Apex Compliance for helping me find these). And much more FDA also cites this company for making "FDA-approved" claims. As we know, supplements are FDA-regulated but not "approved." From warning letter. "webpage for ...includes the image of a blue circle with the claim, "FDA APPROVED" along with the statement,. . . was approved by the Food and Drug Administration last year." Implied GLP-1 statements are cited but they’re probably not the primary reason for this warning letter. From warning letter. “The Science of GLP-1 . . . The effectiveness of … lies in its dual-action approach, addressing intake and expenditure. On one hand, it suppresses appetite, aiding in reduced food consumption and subsequent weight loss. It also slows gastric emptying, prolonging the feeling of fullness over an extended period.” Bashing companies is not my style, as I believe in a "rising tide" and educational approach, as many companies who receive warning letters may not know any better, but this company's marketing feels calculated and intentional. Read the full warning letter here . DATE ORIGINALLY POSTED: 12/18/24 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!

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!

Companies are responsible for co-manufactured products < Back Eye Care (Ophthalmic) Products Under Increased Scrutiny Companies are responsible for co-manufactured products This warning letter is interesting. This is an ophthalmic drug warning letter, but the supplement and cosmetic industries can glean helpful information here. Here, I review these learning opportunities. Claims on website and videos. Timeline: Could the company have avoided a warning letter? Ophthalmic (eye) drug products are under increased scrutiny. Manufacturer and distributor responsibilities Are you interested in a free discussion about high-risk claims on your website? I’ll run my compliance software and share the findings. Book your free session . ● Claims on website and videos. FDA has cited seven companies for claims in YouTube videos this year. What makes this interesting is the videos mentioned in this warning letter were embedded on the webpage rather than just on YouTube. This shows me that FDA is going the extra mile to review videos. Also, some of these videos are old, like this one from 2018. From warning letter. “From your March 16, 2018, YouTube video titled, “MSM Eye Massage (Eye Exercise)” on your… where you demonstrate an eye massage with one of your MSM eye drop products: “This MSM eye massage is great for inflammatory eye conditions, blepharitis, dry-eye, improving the lymph system, and stimulation of tears.” As a side note, Apex Compliance, my monthly compliance software, scans YouTube video transcripts for compliance issues in seconds. Learn more . ● Timeline . FDA tested one of the company’s products and found that it contained microbial contamination, which is very serious for products applied to the eyes. On August 21stof this year, FDA and the company had a virtual meeting, presumably to talk about the contaminated product. A few days later, the company issued a voluntary recall for this and some of their other products. At some point in August FDA reviewed the company’s website and found many drug claims. At some point in August FDA reviewed their website. If the company would have conducted a website compliance check when contacted by FDA, I wonder if they could have avoided a warning letter. ● Manufacturer and distributor responsibilities. This company was using contract manufacturers but apparently did not check their work. Here FDA reminds companies that they are responsible for the products they get made by co-manufacturers. If the company had conducted quality checks, they probably would have caught the microbial contamination before it led to a recall and subsequent warning letter. →From warning letter. “You are responsible for the quality of your drugs regardless of agreements in place with your contract facilities.” FDA also provides a link to this useful guidance document, Contract Manufacturing Arrangements for Drugs: Quality Agreements . ● Ophthalmic drug products are under increased scrutiny. There have been 21 ophthalmic FDA warning letters this year, compared with seven last year. This continued enforcement trend has involved some of the largest companies, such as Amazon. I write more about this . It sounds like the company did not follow the path of an OTC or other drugs. Anything added to the eyes has a high level of danger and should go through proper regulatory channels. →From warning letter. “new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect…. No FDA-approved application pursuant to section 505 of the FD&C Act, 21 USC 355, is in effect for these products.” 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!

Advisory labeling is not a replacement for allergen control program < Back Undeclared Allergens Lead To Recalls Advisory labeling is not a replacement for allergen control program Is major allergen labeling complicated? The answer is maybe sometimes, but it doesn’t have to be. Here, I review recent allergen labeling-related recalls and provide some helpful resource links. It seems like recall alerts for undeclared allergens happen every week, but even though recalls for undeclared allergens are common, allergen-related warning letters are uncommon, which makes this week’s Warning Letter Wednesday interesting (to me at least). One company has had four recalls related to undeclared major allergens since 2019, and here’s how the recent mix-up happened. This is, unfortunately, a common mistake and is the reason why GMPs and process control exist. · From warning letter. “You indicated that you were scheduled to run “Hamburger Cheeseburger Macaroni Skillet Meal”; however, the line supplier mistakenly brought the incorrect cartons to the production line, and the lab tech failed to verify that the correct cartons were used.” Read this warning letter here . Another company received a warning letter because of an inadequate FDA communications request response. They are also a conventional food company that had an undeclared allergen recall, which was apparently due to a formulation change without changing the label. The purpose of Warning Letter Wednesday is to educate, and this is a perfect example of a half-hearted response and no follow-through that led to an avoidable warning letter. Yikes! · From warning letter. “Your proposed action to prevent reoccurrence indicated that there would be no formulation changes without the signatures of the buyers and the owners.” ….” FDA sent you an email giving you an opportunity to provide FDA additional corrective actions to address the root cause of the undeclared major food allergen involved in your recall; however, you did not respond.” Read this warning letter here . Here are FDA’s comments on major allergen disclosure (from warning letters). The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act [21 USC § 343(w)(1)(A)]; or The common or usual name of the major food allergen in the list of ingredients is followed in parenthesis by the name of the food source from which the major food allergen is derived (e.g., “Whey (Milk)”), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 USC § 343(w)(1)(B)].” So how about allergen advisory statements like “This product was manufactured in a facility that handles peanuts, soy, and milk?” According to this FDA guidance document, “Advisory labeling, such as “may contain [allergen],” is not a substitute for adherence to current good manufacturing practices and, when used by a facility, food allergen preventive controls.” Read this FDA’s “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry” document here . Here’s how you sign up for FDA recall alerts . DATE ORIGINALLY POSTED: 3/13/24 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!

< Back Panel Discussion, In-Person Thursday Oct 30, 2025 The dietary supplement/food and beverage pipeline: Bridging the gap with science-backed ingredients SupplySide Global Mandalay Bay, Las Vegas As demand for convenient, wellness-driven products grows and pill fatigue sets in, today’s hottest supplement ingredients are breaking out of capsules and showing up in functional foods and beverages. Many of these science-backed ingredients currently claim self-affirmed GRAS (generally recognized as safe) status, opening the door for innovative formats that align with consumer expectations for efficacy, taste and accessibility. In this session, a panel of experts in regulatory affairs, product development and consumer insights will explore how manufacturers can navigate formulation, taste and compliance challenges while tapping into trends. Learn how supplement, food and beverage categories are converging, and what it means for ingredient positioning, innovation and future growth. Learn more and register Previous Next

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!

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 . DATE ORIGINALLY POSTED: 11/16/22 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 can easily cross the line from “education” to “disease claims” < Back Best Practices For Reducing Risk in Blogs Blogs can easily cross the line from “education” to “disease claims” This year, there have been five warning letters that include claims made in blogs, and the line between what is allowable and what is a claim continues to shrink. #WarningLetterWednesday It is easy for a well-intentioned content writer to cross the line from education into the disease claim category, which I wrote this post. I break blogs into two categories. Both are considered marketing and must be compliant, but dividing them into two categories helps clients understand how rigid they want their compliance to be. Ideally, there would be no "educational" or "science" blogs on a commercial website, but few companies follow this path. The life of a consultant is helping companies understand risk while also supporting their real-world, compliant and effective marketing. This is fun! Informational & Product Blogs Informational blogs: These are not intended to sell a product but are used to educate about ingredients and science. Crossing the line from informational into a product blog is very easy, so extreme care should be used. Removing all calls to action, such as linking to a shopping cart, can help lessen the implication that a blog is being used to sell a product. I discussed "educational" blogs and compliance with a top FTC official who said something similar to this. 'Why is a company using blogs on their commercial website if not to sell products.' This is the lens the FTC and FDA look at when reviewing marketing statements. I often use this example when educating about how "informational" blogs can easily cross the line into claims. Here's a post from last year about this. I also suggest removing any high-risk "buzzwords" from the blog, including pictures and clinical study URLs. Here is a post and video about finding and placing these high-risk disease words . Product blogs: These are considered "extensions of a product label" and, therefore, must be ultra compliant. If a company wouldn't write "pain" on the label, this word should not be used in a product blog. The same rules about "buzzwords" apply here. Here is a video about reducing risks when using blogs . Here is a detailed post where I discuss blogs and much more! "Warning Letter Review: What Went Wrong & How to Avoid " 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!

Cognition and memory products are big business, and the Food and Drug Administration (FDA), National Advertising Division (NAD), Federal Trade Commission (FTC) and plaintiff attorneys are paying attention. < Back Cognitive and memory warning letters and litigation trends: Best practices for reducing risk Asa Waldstein Guest Article Cognition and memory products are big business, and the Food and Drug Administration (FDA), National Advertising Division (NAD), Federal Trade Commission (FTC) and plaintiff attorneys are paying attention. Cognition and memory products are big business, and the Food and Drug Administration (FDA), National Advertising Division (NAD), Federal Trade Commission (FTC) and plaintiff attorneys are paying attention. This leads to warning letters, competitor challenges and lawsuits, but it can be confusing to know how to discuss ingredients and products without crossing the compliance line or becoming an easy lawsuit target. In this article, I’ll review enforcement trends and best practices to help keep you out of trouble while continuing to educate your consumers and grow your business. Read More Previous Next