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Remove high-risk claims in all marketing materials < Back Product catalogs are considered extensions of the label Remove high-risk claims in all marketing materials #WarningLetterWednesday Claims made in product catalogs are considered marketing. This warning letter includes claims made on product labels, catalogs, newsletters, and brochures. This is a good reminder that anything used to sell a product is considered an extension of the label and, therefore, should be compliant. Here is a video about this . 🔷This timeline is interesting here. The company was inspected in June 2021, before, during, and after a recall for undeclared soy allergens. FDA then reviewed this company's website in February 2022, which is the basis for most of the items in this warning letter. This is a trend, as last week's WLW also talks about an FDA inspection that leads to a website review and a warning letter . 👉This is a good reminder for companies to clean up their websites before/during/after GMP inspections, as a complete website compliance clean-up may have prevented this letter. From the warning letter. ➡️From the product catalog on your website, On page 13: “Enzymes Plus: … This formula uses specialized enzymes that helps the body break down excess protein on scar tissue and fibrin in the blood vessels and internal organs. It also seems to help remove the protective protein coating on tumors, cancers, and parasites, helping the body render viruses and bacteria inert. This blend is combined with Magnesium (a natural blood thinner) and B-6 that the body uses to help lower Blood Pressure and dissolve blood clots.” 👉Read the full warning letter here . 👉👉Join my Warning Letter Wednesday group . Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Some of our favorite resources to help educate about marketing compliance. Marketing Compliance / Marketing Compliance These are common areas of enforcement and lawsuits.Here are some resources to help understand these regulations. Substantiation Tips and CARSE Health Products Compliance Guidance TikTok Music Copyright Litigation & Best Practices Common Plaintiff Lawsuits: Best Practices Asa's weekly Warning Letter Wednesday post FTC Document: How to Make Effective Disclosures in Digital Advertising FTC Document: Social Media Disclosures FTC's Dietary Supplement Advertising Guide For Industry Made in the USA lawsuit reference (TINA) Natural Claims article Made in the USA (Great Podcast!) Made in the USA FTC Guidance AHPA Hemp CBD Supplement Congress videos! FDA Label Claim Guidance FTC Guidance: Claim Substantiation FTC Guides Concerning the Use of Endorsements and Testimonials in Advertising AHPA Alerts: Stay up to date (AHPA members only) Other AHPA Guidance Documents Compliance essential for hemp CBD companies: Marketing FDA alerts (allergens, recalls, warning letters) Back

In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. < Back Q1 warning letter roundup with Asa Waldstein Asa Waldstein Guest Article In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. Read More Previous Next

< Back Interview Wednesday Nov 2, 2022 ‘Warning letter geek’ decodes marketing compliance SupplySide West Asa Waldstein is principal of the Supplement Advisory Group and the man behind 'Warning Letter Wednesdays.' His bread and butter is educating companies about the dos and don'ts of marketing. Watch Previous Next

< Back In-Person, Solo presentation Thursday Apr 11, 2024 Labeling & Making Claims NoCo Hemp Expo Estes Park, CO Join Asa as he delves into the latest enforcement trends, including warning letters and litigation, that shape the marketing landscape of the natural products industry. This session is designed to equip attendees with the knowledge to identify and avoid marketing strategies that could lead to legal complications, such as lawsuits or warning letters. By analyzing recent enforcement actions, Asa will provide practical insights on how to steer clear of "off limits" marketing areas while still effectively driving sales. Learn how to align your marketing practices with current regulations and protect your brand from potential legal challenges. See Asa's LinkedIn post about this event here . Learn more Previous Next

Do not engage with customer “disease” testimonials < Back Saying “Thanks” on a Social Post Leads to Warning Letter Do not engage with customer “disease” testimonials If a company engages with a post on its social media wall, this is considered “endorsing the testimonial” and is marketing. It has been quite a while since we have seen a company cited for this, and honestly, I thought FDA had stopped enforcing this until the recent warning letter . Sign up for weekly Warning Letter Wednesday posts here . There are a few interesting aspects to this warning letter. Even saying “thanks for commenting” or “liking” a post is an “endorsement.” Based on this, I guess that smiley face emojis should also be avoided when posts have a disease or disease-treatment claims. The lesson here is that any engagement turns a customer comment into a marketing claim. Companies should review old social posts to ensure there is no engagement on customer comments with disease-type claims. FDA may look back several years on a company’s social media page. Claims made on Amazon and Walmart are cited in this letter. Companies commonly focus on website compliance but often overlook “old” marketing statements on these platforms. FDA is paying close attention to these platforms. This was part of the “Big 7” cardiovascular-related warning letters from a few weeks ago, which show that even talking about diagnostics related to heart disease, such as “lowers LDLs” can lead to a warning letter. I write about this in detail here . From warning letter. “You also endorsed the following responses to your post by liking them: “I just got my blood test back my total cholesterol went down 56 points and my bad cholesterol went down 82 points.” FDA cited claims made on a company testimonials page. The authorities have been “hands off” with non-curated, non-compensated, third-party product reviews. These cross the line into marketing if they are showcased on banners or, in this case, on a specific testimonials page. DATE ORIGINALLY POSTED: 12/14/22 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!

Distributors are responsible for products they sell < Back Amazon Receives 3rd Warning Letter This Year Distributors are responsible for products they sell Amazon just received its third warning letter this year and the fifth in the last 15 months! All of these letters are for selling adulterated or unallowable products. What makes this warning letter interesting is that it’s for a sexual enhancement product that was adulterated with sildenafil (Viagra). Amazon requires some mandatory third-party tests for products in this high-risk category, but I wonder why the drug-spiked ingredients were not found here. Perhaps after the initial batch tests, a subsequent non-tested batch contained the drug-spiked ingredients? ❗️Warning Letter Wednesday is available as a free weekly email. Sign up here . 🔷When we look at other Amazon warning letters, FDA seems to “follow the breadcrumbs” from other warning letters, recalls, or issues to Amazon. For example, this warning letter references products that were part of a drug-spiked recall in August. I would think that Amazon has the technological capability to find and remove recalled products from its platform. These types of warning letters come in groups so if companies were selling any of the adulterated brands cited in this warning letter, removing them from commerce now can help to avoid a letter. 🔷Amazon warning letters state that Amazon handles the products as opposed to them being dropped-shipped by the vendors. In my opinion, this “handling” is important to designate Amazon’s responsibility. I wonder if this means that marketplace sites that don’t actually touch the products have a lower risk of distributor scrutiny. 👉From warning letter. “Amazon distributed each of the products directly to individual U.S. consumers on behalf of third parties. Each of the products was “fulfilled” by Amazon; your website states, “Fulfillment by Amazon (FBA) is a service that allows you to outsource order fulfillment to Amazon. Sign up for Amazon FBA to send products to Amazon’s global network of fulfillment centers and offer customers free, two-day shipping through Prime. When a customer makes a purchase, Amazon fulfillment specialists can pick, pack, and ship the order. We can also provide customer service and process returns for those orders.” 🔷Other recent Amazon warning letters were for ophthalmic (eye), homeopathic products for molluscum contagiosum, Diclofenac spiked products and disease claims, and skin tag removal products. Read the full warning letter . DATE ORIGINALLY POSTED: 12/27/23 Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. < Back Q3 2024 warning letter roundup with Asa Waldstein Asa Waldstein Guest Article In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. At a Glance Minor label violations, such as fact panel line thickness, continue to be cited in warning letters. A NAD case involving a popular children's YouTube channel highlighted the complexities and need for material disclosure. FDA warning letters underscore that elaborating on studies or posting about them on social media can be problematic. Read More Previous Next

< Back Meet-Up Group Tuesday Feb 11, 2020 Founder's Night: Iconic CEO's share their stories Boulder Hemp-CBD Group Meet-Up Boulder Hemp-CBD Group Meet-Up hosted by Asa (In-person) A special Founders Night, a Fireside Chat format with two CEOs sharing their personal journeys, visions of where the market is going, and the host of decisions they need to make--business and regulatory both-as their companies grow. How do their companies deal with ever-changing regulations? How much budget and staff do they allocate for Regulatory compliance? Do venture capitalists take compliance into consideration when investing, both budget and company attitude? I am joined by special guests: Nancy Whiteman , well-known CEO of Wana Brands. Patrick Rea , CEO, and Co-Founder of Canopy Boulder See Pictures Previous Next

Old blogs & posts are “active” marketing < Back 15 CBD & Delta-9 Warning Letters in 2023 Old blogs & posts are “active” marketing Two weeks ago, FDA sent its 15th CBD and delta-8 warning letter of 2023. Although this seems like a high number, it was down from 34 last year. So why the dramatic reduction in enforcement action? One reason is many CBD companies were started by people not familiar with the nuanced rules of marketing ingestible products. These businesses and the inexperienced operators that were making risky marketing claims have moved to other industries, and there are simply no longer thousands of noncompliant CBD companies. 💡 I've been writing this weekly post for ~2.5 years (yes, EVERY week). Sign up for the email newsletter and see old posts here . There still are however, some companies selling CBD, and today’s Warning Letter Wednesday has good learning opportunities for the supplement and cannabinoid industries. 🔷Old blog posts are marketing. The days of 2020 are thankfully behind us, but all of the content produced back then is still active marketing in the eyes of the FDA. This warning letter cited several posts, including this one from November 2020. The lesson here is going back and reviewing old social media and blog posts is an essential part of compliance as these “forgotten” posts continue to be cited in marketing. 👉From warning letter. “A November 12, 2020 blog post titled “CBD, COVID-19, And The Novel Coronavirus” which contains claims such as “On the more promising side of research, a research team based out of Augusta University (GA) found a potential protective role for CBD as part of the treatment of COVID-19” 🔷Social media Here is a post where the company makes high-risk statements on their Facebook and Instagram. 👉From warning letter. “Experimental evidence is limited, and more research is needed, but studies on pain and inflammation, breast cancer, epilepsy, and other conditions have found a greater therapeutic effectiveness of whole-plant or full-spectrum cannabis products than isolated cannabinoids.” Read the full letter . DATE ORIGINALLY POSTED: 1/10/24 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 online marketing if inspected by FDA < Back TCM Company Cited for Claims & GMP Violations Re-review online marketing if inspected by FDA This Traditional Chinese Medicine (TCM) product company was cited for GMP violations and disease claims. This warning letter contains critical GMP and marketing lessons such as labeling, testing, and marketing essentials. Here, we unpack some critical takeaways as a learning opportunity to help keep you out of trouble. This company was inspected by FDA and received some 483s, which led to their website being reviewed for disease claims months after the inspection. As we've spoken about many times here on Warning Letter Wednesday, it is imperative for companies that are inspected by FDA to ensure their websites are "clear" of risky claims. This is one of the reasons I developed Apex Compliance . To learn more about Apex Compliance, contact me. Here are some key labeling takeaways. The botanical ingredients are not in the standardized common name as noted in AHPA's Herbs of Commerce. They appear to be the TCM names, which is fine, but the common or Latin names are also required. If a label lists information in another language than English, all required information must also be listed in that secondary language. Admittedly, I've never thought about this, but it makes sense from a consumer protection standpoint. The plant parts were missing from a label. Many of the GMP violations cited here have to do with specifications. Specifications are integral to GMPs, and each raw material and finished product must have specifications for identity, purity, strength, and composition. I suggest reading through the warning letter to review FDA's comments. Master Manufacturing Records (MMRs) are the recipe telling the staff how to make a product. Here are several missing items that were cited in this letter. Description of packaging and a representative label. A complete list of components. The weight or measure of each component. Any intentional overage amount. This is to accommodate for shelf life testing and manufacturing variance. A statement of theoretical yield. This is so the company can find problems before the product gets to the next stage of production. For example, if too much of an ingredient was added, the weight should potentially be over the theoretical yield. In the past, my team accidentally added one kilo rather than 0.1 kilo, and calculating the yield caught the error. Specifications are needed for each point, step, or stage in the manufacturing process where control is necessary One person weighs or measures a component, and another person verifies the weight or measure. This is known as the doer/checker system to ensure weighing issues are prevented. This can be difficult to achieve in small companies. And many more items. Unqualified reference standards continue to be called out in warning letters. This company was cited for not using a validated reference standard for FT-IR identity tests. This essentially means if you are testing for something like chamomile powder, you must purchase a qualified sample and test against this standard. Yes, I know GMPs can be burdensome. There has never been a more challenging time than now to be a supplement manufacturer. I feel your pain. From warning letter. "You do not have an adequate identity specification because you are not conducting identity testing against a qualified reference standard." An Out Of Specification (OOS) was cited in this letter. An ingredient or product was OOS for zinc, but the company retested using a different method. FDA took issue with this, which is a learning lesson to ensure retests use the same method. This seems obvious, but in the heat of the pressure to release products, these items can sometimes be inadvertently overlooked. From warning letter. "The investigation testing was performed using a different methodology and by a different laboratory than the laboratory which conducted the original analysis, thus making it difficult to compare the results and to verify accuracy." The website states that products can only be purchased by a practitioner and that no retail sale is available. This is very interesting from a "material connection" point of view. If there is a material connection (e.g., commerce on the website), this is what FDA uses to connect marketing disease claims to commerce. If there is no commerce on the website or linked websites, FDA seems to rarely call out disease claims, which makes this example a rarity. Full disclosure: I have no way to verify if this was a recent change since the warning letter. If anyone knows, please let me know. There are so many GMP learning opportunities here. Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Minor label issues signal deeper compliance issues < Back Labeling Lessons Minor label issues signal deeper compliance issues This warning letter has numerous examples of what not to do when labeling supplements. Here’s what we can learn. 🔹Incorrect statement of identity: The statement of identity is one of core required elements on supplement labels. “Dietary Supplement” is most common but if accurate terms like “Vitamin Supplement” or “Herbal Supplement” are allowed. In this warning letter, FDA cited “Nutritional Supplement” as not being a compliant statement of identity. You can see how “vitamin” is descriptive, whereas “nutritional” is not specific enough. 🔹Serving sizes: This product’s serving size is listed as 1 to 3 teaspoons twice a day, but the supplement fact panel lists the serving size as one teaspoon. A serving is the “maximum amount consumed per eating occasion,” which is three teaspoons in this example. The company could have kept the one-teaspoon serving size on the label by updating it to “one teaspoon up the 3x daily.” I review a lot of labels with my work at Supplement Advisory Group, and this issue is more common than you may think. 🔹Adverse event reporting: A full domestic address or domestic phone number is needed for adverse event reporting requirements. 🔹Supplement fact panel layout: 🔺From warning letter. “The statement “Daily Value Not Established” is not linked to a symbol linking it to the heading “%DV heading,” which is not in accordance with 21 CFR 101.36(b)(2)(iii)(F).” 🔺Servings per container: Did you know that the servings per container may be omitted when stated in the net quantity of contents declaration? 🔹Missing DSHEA disclaimer: From warning letter. “The labels make structure/function claims but fail to bear the required FDA disclaimer, in accordance with 21 CFR 101.93(b)-(e).” Are you interested in learning more about nutrient content claims? Here is my write-up . Here are more labeling citations from previous warning letters. Do you need support with labeling compliance? I love this stuff! Read the full warning letter . DATE ORIGINALLY POSTED: 6/11/25 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!