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Schedule your free 15-minute introductory consultation today to get started. Please review our list of services to understand Supplement Advisory Group's offerings. https://www.supplementadvisorygroup.com/ You may also enjoy reviewing my regulatory hints video channel. https://www.youtube.com/c/DietarySupplementCBDRegulatoryCompliance I look forward to meeting with you! Kind regards, Asa **My services are not intended to replace legal advice. There are many wonderful attorneys out there. If you need a suggestion please let me know.

We can learn a lot from warning letters. Following FDA enforcement trends is a valuable tool for any savvy marketer, regulatory affairs professional, quality manager, or dietary supplement executive. We can adjust practices before they elevate to warning letters by learning how to read warning letters and act accordingly. This is why I write the weekly Warning Letter Wednesday post on LinkedIn, Twitter, and Facebook. This blog post is an extended version of my Warning Letter Wednesday posts. This warning letter is a great teaching case. Here are the learning targets. FDA Inspections Trigger Website Reviews Marketing Claims Distributors Responsibilities Common GMP errors *Writing and Following Specifications *Writing Procedures *Product Returns *Product Complaints Certain Herbs Are Not Allowed Common Allergen Labeling Domestic Street Address or Phone Number Languages Must Contain The Same Information Serving Size and Suggested Use Plant Parts Must Be Disclosed Correct Plant Listing Supplement Fact Panel: Line Thickness Percent Daily Values Label Requirement Expiration Dating FDA Inspections Trigger Website Reviews The company was inspected by FDA in March 2021 and was issued several 483s. The company's website was recently reviewed in February 2022, which led to a letter. Learn about the difference between a 483 and a warning letter here. Usually the FDA investigator reviews a company's website for disease claims before an inspection. That is likely still happening but this is the third recent warning letter where FDA inspections led to a website review at a later date. These website reviews were then elevated to a warning letter. I write these letters here and here. This is a fascinating enforcement trend to watch and a good reminder for companies to clean up their website claims if they have been inspected. This is one of my favorite services Supplement Advisory Group offers. Marketing Claims ➡️From warning letter: Although studies (of PS, an ingredient in your product) in humans with Alzheimer’s disease were less dramatic, they still produced significant improvements in cognitive function. In patients with mild dementia, significant cognitive and behavioral enhancing effects were observed. 👉Asa's commentary: These mistakes have been reviewed in previous Warning Letter Wednesday posts; High risk words and video, citing studies, and discussing ingredient benefits. Distributor Responsibilities The company uses a contract manufacturer to make their products. This does not mean the company does not have any GMP responsibilities. ➡️From warning letter: Quality control must approve for release, or reject, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution, and you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement 👉Asa's commentary: This means a company has to conduct some type of review and release before selling the product. This does not have to be complicated but it has to be written down and followed. If it's not written down it didn't happen is an FDA mantra. ➡️From warning letter: Although a firm may contract out certain dietary supplement manufacturing operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements. 👉Asa's commentary: This is boilerplate language but a good reminder that although working with a contract manufacturer does mitigate some risks, the basics of quality assurance should be in place. We discuss many of these topics here. Common GMP Errors Writing and Following Specifications ➡️From warning letter: You failed to have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement for distribution, as required by 21 CFR 111.140(b)(2) [see also 21 CFR 111.127(h)]. Specifically, your firm distributes the dietary supplements that are contract manufactured for you, but you had no records of a quality control review, approval, or rejection for your finished dietary supplement products. During the inspection, you informed our investigator that you do not review the documentation related to the finished dietary supplement products you receive from contract manufacturers to determine if those finished dietary supplement products have met specifications. 👉Asa's commentary: Not having and following specifications is one of the most common GMP violations. Specifications should be reviewed by a member of Quality and then approved, rejected, or quarantined. This allows problems to be found before products are shipped to the public. I write about this here. Writing Procedures ➡️From warning letter: You failed to establish and follow written procedures for holding and distributing operations, to comply with 21 CFR Part 111.453 that include the requirements for holding components, dietary supplements, packaging, and labels, 👉Asa's commentary: Writing and following procedures is an important part of GMPs. Procedures are the "directions" for doing things, commonly referred to as Standard Operating Procedures (SOPs). Product Returns ➡️From warning letter: You failed to establish and follow written procedures to fulfill the requirements that apply to returned dietary supplements, 👉Asa's commentary: We talk about the requirements for 21 CFR 111 Subpart M (Holding & Distributing) here, and we discuss how to handle a partially damaged shipment here. Product Complaints ➡️From warning letter: You failed to establish written procedures for the requirements to review and investigate a product complaint. 👉Asa's commentary: This is one of the most important parts of being a distributor of dietary supplements. If you are on contact name on the label, you are responsible for reviewing product complaints and informing the FDA of Serious Adverse Event Reports. Certain Herbs Are Not Allowed The FDA does not allow the use of certain plants they consider to be dangerous. Pinellia ternata, a TCM ingredient, was called out in this warning letter because it contains ephedrine alkaloids. Learn more about this here. In general, if a plant is not widely used in commerce, it is a red flag of potential danger, or a New Dietary Ingredient (NDI). Common Allergen Labeling ➡️From warning letter: ..the finished product label fails to declare the specific species of shellfish allergen sources as required. 👉Asa's commentary: The company disclosed the common allergen (crustaceans) but not the type of crustacean (e.g., Contains: shrimp). This is a common error that can be easily prevented. Here are the specific common allergens that need to be disclosed. The specific type of nut (e.g., almond, pecans, walnut, coconut). The specific type of fish (e.g., bass, flounder, Pollack). The specific type of crustacean shellfish (e.g., lobster, shrimp, crab). Domestic Street Address or Phone Number ➡️From warning letter: ..the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. 👉Asa's commentary: I review a lot of labels, and it is commonly overlooked. This is how supplement companies track customer complaints and inform the FDA of serious adverse events such as hospitalization Languages Must Contain The Same Information ➡️From warning letter: ..your product labels contain information in two languages but does not repeat all the required label information (including the nutrition information) in both languages. In accordance with 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 👉Asa's commentary: I do not review multi-language labels,, so this is a new one to me. There is so much to learn about GMPs. Serving Size and Suggested Use ➡️From warning letter: The “Directions” for your Hemorlyn product states to take “2-4 capsules per day with meals,” but the serving size lists “2 Capsules.” The serving size listed should be four capsules. 👉Asa's commentary: The maximum suggested amount consumed at one sitting is a serving size. For example, a serving size that reads take 1-5 capsules daily is a serving size of 5 capsules, which would need to be in the supplement facts panel. This is an amateur error that could have been prevented. Plant Parts Must Be Disclosed ➡️From warning letter: ..the labels fail to identify in English the part of the plant (e.g., root, leaves) for each of the botanical dietary ingredients in the products, as required by 21 CFR 101.4(h)(1). We note “herb” is not a recognized plant part. Furthermore, we note if an entire or whole plant is used, 👉Asa's commentary: Yes, it really is a rule to list the plant part. Replacing "herb" with "leaf" would be been accurate. This is a great example of what I call a "secondary claim" or a "minor violation" which is something not likely to attract a warning letter on its own/ Correct Plant Listing ➡️From warning letter: ..each product label fails to declare the common or usual name (standardized common name) or Latin binomial of each ingredient used. 👉Asa's commentary: The American Herbal Products Association's (AHPA) Herbs of Commerce is the reference for standardized common names. Thanks AHPA! Supplement Fact Panel: Line Thickness ➡️From warning letter: The Arthrolyn product’s Supplement Facts label fails to separate the (b)(2)- from the (b)(3)-dietary ingredients with a heavy bar. 👉Asa's commentary: Having the correct line thickness is part of a compliant label. Here is an example of correct line thickness and Supplement Fact Panel layout I made just for you. Label review is one on the many aspects of regulatory compliance my company covers. Percent Daily Values Label Requirement ➡️From warning letter: The Goldenlife product’s Supplement Facts label bears the following statement: “Percent Daily Values based on a 2,000 calorie diet.” This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein as required. 👉Asa's commentary: This is the first time I have seen this in a warning letter, wow. Expiration Dating ➡️From warning letter: Any expiration date you place on a product label should be supported by data that demonstrates the product’s shelf life 👉Asa's commentary: A company needs to have stability data in order to substantiate expiration, best, before, or freshness dates. Many of the items, such as label formatting and layout issues are not likely to lead to a warning letter. Incorrect label formating however is a red flag that the company is not following the basics of GMP-labeling compliance, and this may be a sign of deeper issues. The quickest way to attract a warning is by making disease claims. This, in combination with serious GMP violations, adds to the risk. The FDA's duty is to protect public safety and not verifying a product's quality may, in some rare circumstances, lead to serious health issues. For a free consultation regarding your compliant marketing contact me here. Disclaimer: The educational information provided on this website is for informational purposes only and does not constitute legal or regulatory advice. Contact an attorney for specific legal advice.

Dietary supplements are great for hydration and liver support, but they cross the compliance line when marketed for hangovers. There have been 14 hangover-related FDA warning letters since the beginning of the pandemic including two this month. This is an enforcement trend that is top of mind for the FDA. Here Are The Learning Targets: FDA’s rationale for hangover being a claim Amazon storefront claims Discussing Ingredient Benefits Are Considered Marketing Claims Referencing Clinical Studies Can Be Looked at as Marketing Implied Claims Will Attract a Warning Letter Blogs Are Marketing Claims Follow Enforcement Trends: What was lower risk yesterday is high-risk tomorrow In the past making a hangover support statement would have been a relatively low risk, but in July 2020 the FDA issued seven warning letters to companies making hangover claims. In the accompanying policy statement press release Steven Tave, former director of FDA’s Office of Dietary Supplement Programs, stated Consumers may get the false impression that using these products can prevent or mitigate health problems caused by excessive drinking. Dietary supplements are not a substitute for responsibly limiting one’s alcohol consumption. Here is my guess as to why the FDA considers the word hangover a claim. Anything that prevents, treats, or cures symptoms of a disease is a medical claim. Amazon Storefront Claims In the past claims made on Amazon were considered "the unholy grail" of compliance, with little enforcement of the egregious claims used to market products. I am glad to see the FDA enforcing this and expect to see many more Amazon-related warning letters in the future. From Warning Letter: Crocin Rich plus is good for: … Help recovery of nerve and traumatic injury....Reduce Hangovers From another Warning Letter: Cure Your Hangover Fast; Milk Thistle … helps speed up the recovery process for your liver, getting rid of your hangover faster!” “Taking the product on a regular basis before drinking may also aid in reducing the possibility of a hangover in the morning. Using words such as cure and symptom demonstrate the intended use of a product to treat disease. It is important to remember the DHSEA disclaimer (Not intended to treat, diagnose, prevent, or cure) when developing marketing content. Here’s a video I made to help companies identify if a claim is being made. If accurate, replacing cure with support and replacing symptom with ailment can help to lower risk. I write about identifying and replacing high-risk buzzwords here. Other possible words for a hangover; imbibe or overindulge. From Warning Letter: Hangovers! Does anybody like them? Not a soul, but how can we stop ourselves from encountering one after a long night? Nutrovape now has the answer. With the new Nutrovape recover, you can make sure your hangovers don't ruin your days after a night of drinking. Discussing Ingredient Benefits Are Considered Marketing Claims From Warning Letter: The “Dihydromyricetin (DHM)” page in the “Health” section of your website: Dihydromyricetin . . . is used for anti-inflammatory, anti-hangover . . . benefits. Research in animal studies suggests several important mechanisms of action relating to DHM’s ability to protect against hangovers: . . . This is a common mistake made by well-intentioned writers and webpage designers that do not understand the nuances of dietary supplement marketing. Best practices here are separating the ingredient benefits discussion from the product page, removing high-risk words, and ensuring that a reasonable consumer will not think this is intended to sell a product. Here is a Warning Letter Wednesday post on this topic. Referencing Clinical studies Can Be Looked at as Marketing From Warning Letter: Research in animal studies suggests several important mechanisms of action relating to DHM’s ability to protect against hangovers. Here is a post and a video about clinically proven types of statements. Although not hangover-related, here is a NAD case decision and FTC administrative compliant that are interesting reads. Implied Claims Will Attract a Warning Letter From Warning Letter: More recently, Dihydromyricetin has received attention for its purported anti-hangover activity. Several studies suggest that it may lower markers of inflammatory liver disorders. Anecdotal reports indicate that this may carry over to alcohol-induced liver inflammation. Stating anecdotal reports indicate then adding a disease word is considered a suggested implied claim. Other examples of this include using “may” and “should” followed a high-risk buzzword. See my post on this here. Blogs Are Marketing Claims Informational blogs are considered extensions of the label. This warning letter references a light implication that CoQ10 is useful for hangover support. This statement was made about the ingredient CoQ10 in an educational blog. The FDA makes the correlation this is a marketing claim because a product sold on this website CoQ10 has the same name as the ingredient. From Warning Letter: Holiday Hangovers: After All That Partying, Which Nutrients Do You Need the Most (which references the ingredient Coenzyme Q10 contained in the product Nanoemulsified CoQ10) The compliance line between "informational" blogs and product blogs is very thin and is open to interpretation. If a company must use informational blogs on a commercial website it is important to make it clear the blog is for educational purposes only and remove all CTA's (Call To Actions) that link to a shopping cart or product page. Here is a detailed Warning Letter Wednesday post and a helpful video I made on the topic. Please share these with your content team as training tools or contact me for a free consultation. I love talking about this aspect of marketing and compliance. Follow Enforcement Trends: What was lower risk yesterday is high-risk tomorrow Earlier this year the FDA cracked down on companies making depression and anxiety claims which I write about here. Anyone who was paying attention to enforcement trends would have removed these words from their marketing, but the warning letters continue. As exemplified by the hangover enforcement timeline, what was a lower risk in the past may be high-risk tomorrow. I love enforcement trends; they give us an opportunity to learn from others' mistakes and course correct. Read my Reasons to Follow Enforcement Trends post for a detailed discussion. Also, reading my weekly Warning Letter Wednesday post or anything by Josh Long or Nathalie Bougenies are great ways to stay up to date with what the FDA is focusing on. For a free consultation regarding your compliant marketing contact me here. Disclaimer: The educational information provided on this website is for informational purposes only and does not constitute legal or regulatory advice. Contact an attorney for specific legal advice.

The popularity of medicinal mushrooms shows me the world is finally ready to embrace natural medicine. It is no surprise however to see mushroom product marketers being called out in warning letters for making high-risk claims. Here's a recent warning letter that covers many of the common mistakes to avoid. Most of this I've talked about here in my blog or my #WarningLetterWednesday LinkedIn post. Here Are The Learning Targets: * Follow Enforcement Trends: Depression & Anxiety Claims Are Super High-Risk *Hashtags Are Claims *High-Risk Words Should Be Avoided *Implying "Clinically Studied" Is High-Risk * Clean Up Claims On Old Social Media Posts * Social Media is Marketing Many warning letter recipients are not bad folks but perhaps just do not know any better. A purpose of my free Regulatory Education Series platform, my public speaking tour, and my free video channel is to educate those looking to raise the bar of ethics and compliance in the industry. Please share this blog or any of my content (with attribution) if it may be of value to your network. We are stronger together! Follow Enforcement Trends: Depression & Anxiety Claims Are Super High-Risk Earlier this year the FDA cracked down on companies making depression and anxiety claims which I write about here. Anyone who was paying attention to enforcement trends would have removed these words from their marketing. I love enforcement trends, they give us an opportunity to learn from other's mistakes and course correct. Read my Reasons To Follow Enforcement Trends post for a detailed discussion. Hashtags Are Claims It is pretty obvious but in this warning letter, the following hashtags were called out. #DepressionAndAnxiety #BeatDepression #BeatAnxiety The quickest way to wave a stick at the FDA/FTC is by using non-compliant hashtags, High-Risk Words Should Be Avoided I have developed a risk-rating system on a scale of 1-5. Here are some examples of words in the 5 of 5 risk categories: cancer, COVID, Alzheimer’s, depression, PTSD, Diabetes should never be used. Words such as pain and inflammation carry a risk level of 3 of 5. For context, anything 3+ is likely to attract a warning letter. Contact me for a list of other high-risk words to avoid with some possible lower-risk alternatives. Here are some tips to know if a claim is being made! I also made a video on this! Implying "Clinically Studied" Is High-Risk This is definitely a trend to watch out for. We are seeing references to clinically studied types of claims showing up not just in warning letters but also in class action lawsuits. A company cannot imply their commercial product has the same uses as a clinical study. We talk about what defines clinically proven here. There are many factors including serving amount, formulation, and delivery size which play a role in this. Here are some egregious examples from the warning letter in grey. On the scientific studies webpage, under the heading “Lion’s Mane Scientific Studies”: • “Lion’s Mane May Be Effective in Combating Dementia/Alzheimer’s Disease” • “Lion’s Mane Has Shown In Studies That It Could Reduce Anxiety And Depression” • “Animal Testing Shows Lion’s Mane Helps Control Diabetes Symptoms By Keeping Blood Sugar Low” This is a good example of a company pushing out content without having a compliance review. I review this and more in this Hiring Supplement Experts for Rapid Company Growth blog post. I loved that post and poured by 20 years of experience into it! Clean Up Claims On Old Social Media Posts The authorities look at a very old social media in the same manner as a current one! In this warning letter, a 2019 tweet is referenced! Please please please, delete or clean up old non-compliant social media posts. I really don't want to tell you I told you so! Read about this in my Operation CBDeceit blog. From the warning letter in grey. Notice the 2019 date! On your social media website • “LVL:MAX . . . Protects Against Ulcers in the Stomach: Goodbye Pain… Relieves Depression and Anxiety… Lowers Cholesterol: Live Longer…Lower Inflammation…” [From a Nov 12, 2019 post] Social Media is Marketing Anything used to sell a product, including all commercial social media posts are marketing, and therefore must be compliant. Most warning letters reference social media I find it helpful to think of all marketing as an extension of the label. We wouldn't use the word anxiety on a label, so it's important to not use disease claims in any marketing, including social media infographics. Anything used to market must be truthful and not misleading. I hope you enjoy this warning letter report from the front line of compliance. I read every FDA warning letter and report back on enforcement trends. I love this aspect of compliance! For a free consultation regarding your compliant marketing contact me here. Disclaimer: The educational information provided on this website is for informational purposes only. Contact an attorney for specific legal advice.

Learning from others' mistakes helps you be compliant < Back Celebrating 200 Weekly WLW Posts! Learning from others' mistakes helps you be compliant 200 weeks of writing this weekly post. Wow, what a journey it's been! Finding my voice on LinkedIn and beyond was not easy. I didn't want to create drama and be too inflammatory, as this is not my style. I also didn't want to misrepresent my level of knowledge in areas I am not an expert in, as this felt contrived. Also, I know that LinkedIn is not Instagram, and memes and viral cat videos were not my style either. I first started by liking and then commenting on others' LinkedIn posts and following my guiding principles of being kind and helpful. Then I came to realize I REALLY LOVE writing about enforcement trends, as they can help us "read between the lines" of where future enforcement will happen. This allows companies to adjust their marketing and learn from others' mistakes before serious regulatory or litigation occurs. I started posting more about interesting enforcement trends, and since FDA's weekly newsletter used to be sent on Wednesdays, I decided to call this post Warning Letter Wednesday . Thank you to Steven Yeager for helping with this name! Over the past 200 weeks, enforcement trends have come and gone. Here are some of the key enforcement trends since I started writing WLW. 🔹 Targeting Opioid Withdrawal: Supplements marketed for opioid addiction or withdrawal continue to see increased enforcement. Even though some companies are well-intentioned and trying to be helpful, making these claims has a high likelihood of attracting a warning letter. 🔹 Hangover Cures: Claims about preventing hangovers went from lower to high-risk in July 2020 when FDA issued seven warning letters to hangover supplement companies. FDA stated that claims to treat hangover symptoms are essentially disease treatment claims since being inebriated is the disease-state of alcoholism. These letters also included FDA's temporary battle with NAC, which has now subsided. I use this group of letters as an example of why following enforcement trend changes is a critical part of marketing compliance. 🔹 CBD Enforcement Surge and Decline: The cannabinoid sector experienced a boom-and-bust enforcement trend. From 2018 to 2021, dozens of CBD companies received warning letters for disease claims (e.g., cancer, Alzheimer's). Enforcement then started to drop in 2022 when the FDA issued 34 warning letters to CBD and delta-8 products, and then in 2023 that number dropped to 15 – a 56% year-over-year decrease. Now, CBD enforcement, other than some very risky delta-8 type letters, seems to be nearly non-existent. FDA has been issuing about one CBD warning letter about every 3-6 months. Follow my SupplySide Supplement Journal quarterly Warning Letter Roundup for more information on this. 🔹 COVID Enforcement: FDA and FTC crack down on COVID-19 claims. Several dietary supplement firms received joint FDA/FTC letters for COVID support claims. After this initial surge, COVID-related letters tapered off by late 2021 as the worst offenders were cited by regulatory action and updated their marketing. 🔹 Continued Reminders of GMP Compliance: FDA continues to focus on core compliance areas like labeling and GMPs. Since the beginning of WLW, a number of warning letters have cited the basics, such as products missing mandatory label elements, lack of allergen labeling, or specification-related GMP violations. These letters are a good reminder that FDA still enforces manufacturing and labeling accuracy. For example, one letter discussed in WLW described how a company's half-hearted recall and response on an undeclared allergen led to a warning letter, essentially for failing to follow through on promised corrective actions. 🔹 Rise of Biomarker Claims Scrutiny: In 2022 FDA sent out the "Big 7" warning letter, which was a group of letters citing biomarker claims related to heart disease. In the past, making biomarker claims like lowering cholesterol and lower LDLs was not "enough" to attract a warning letter unless higher risk words like hypertension were used. These letters signaled a more rigid shift in the FDA's enforcement of biomarker claims, which continues today. 🔹 Old Content Is "Active" Marketing: A theme over the past 200 weeks is that nothing on the internet or socials ever truly "expires" in FDA's eyes. Warning letters now routinely reference years-old Facebook posts, YouTube videos, or blog articles that companies may have forgotten to update. Here is a post where the FDA cited a 7+ year old re-tweet. 🔹 Major Retailers and Marketplace Enforcement : FDA is holding platforms like Amazon accountable for the products they distribute. Amazon has received several warning letters , including three in 2023. FDA stated that by fulfilling orders, Amazon "introduced" an unapproved new drug into interstate commerce by distributing. 👉 Here are SOME of my more notable and favorite posts. 🔹 MLM Company Cited For Claims Made By Their Affiliates : Marking the one-year anniversary of WLW, this post highlighted an FDA warning letter to a direct selling company for disease claims made by its independent consultants. It was the first time I could remember when a company was cited for its affiliates' claims, showing that brands can be held responsible for influencer/affiliate content. Key takeaway: Train and monitor all affiliates to avoid unapproved disease claims. 🔹 Product Tags and Meta Tags : This post revealed how even website tags can trigger enforcement. An FDA/FTC joint warning letter to a CBD company cited the use of a "COVID-19" category tag linking to a blog post about fighting COVID. 🔹 Unauthorized NDI Leads to Warning Letter: This post spotlighted the enforcement of the New Dietary Ingredient (NDI) rules. A company received a warning letter for using N-Methyltyramine even though the product made no disease claims. FDA rarely issued letters solely for unapproved ingredients unless other violations existed. Here, the absence of any disease or GMP violations "should give companies pause" about using ingredients lacking NDI notifications. 🔹 GLP-1 Product Receives Warning Letter: This is one of the "cringiest" cases I've seen. This recent post detailed a company marketing a purported supplement as a natural alternative to Ozempic. The firm claimed their product was "FDA approved," better than the prescription GLP-1 drug, had "no side effects," and was proven in clinical trials. It was the first warning letter involving a GLP-1 weight-loss "supplement" and came alongside letters to several vendors selling actual semaglutide (the active ingredient in Ozempic) as research chemicals. 🔹 Influencer Material Connection Disclosure: This recent post shifted focus to advertising compliance, using Kevin Hart as a case study. The comedian had promoted a sportswear brand and a bank on social media without obvious disclosure that he was a paid partner or owner, leading to an inquiry by NAD. The motto, " when in doubt, disclose," is a key takeaway here. Free Warning Letter Wednesday stickers for you all! Learn more here . I've written WLW while sick with COVID, while on family vacations in eight countries, including Tanzania, New Zealand, and my current travels in Laos and Thailand, and this has been a labor of regulatory love. Thank you to all my readers and supporters! You are very appreciated! DATE ORIGINALLY POSTED: 5/7/25 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!

A weekly exploration of FDA warning letters and enforcement trends A weekly exploration of FDA warning letters and enforcement trends Get Warning Letter Wednesday in your Inbox Sign-Up Now! Select category Reset Celebrating 200 Weekly WLW Posts! Learning from others' mistakes helps you be compliant 5/7/25 Read More OTC Topical “Inactive” Ingredient Marketing Claims “Extra” claims are often non-compliant 4/16/25 Read More Influencers Must Disclose Free Product Brands should monitor influencer posts for compliance 3/26/25 Read More Heavy Metal Contamination Leads to Recall Following specifications prevents greater issues 3/5/25 Read More Environmental Claims Increase Scrutiny Ensure ESG claims are substantiated 2/12/25 Read More Incomplete Batch Records & Ingredient Specifications Ensure 483 responses are complete 1/22/25 Read More Product Review Engagement Trustpilot reviews can be “marketing” 1/1/25 Read More Basics of GMP’s Cited Functional mushroom products under increased scrutiny 12/11/24 Read More Best Practices When Making Competitor Comparison Claims Ensure statements are not disparaging 4/30/25 Read More Best Practices When Making Biomarker and Implied Claims Use FDA’s helpful resource (Criterion 2) 4/9/25 Read More Injectable CBD Warning Letter Curated testimonials are marketing claims 3/19/25 Read More Celebrity Endorsement Lessons Disclosing material connection is essential for compliance 2/26/25 Read More GMP Labeling Lessons Small issues signify deeper noncompliance 2/5/25 Read More “Non-Toxic” Claims Require Extensive Substantiation Safety related product claims attract scrutiny 1/15/25 Read More Refusing FDA Inspection Access Be nice to FDA investigators & follow inspection SOPs 12/26/24 Read More Fruit Snack Wars NAD challenge cases explored 12/4/24 Read More Navigating the Risks of Therapy-Adjacent Health Claims Use FDA's helpful resource (Criterion 7) 4/23/25 Read More In-Process Quality Testing A look at the manufacturing and quality process 4/3/25 Read More Amazon & Others Cited for Selling Injectables Distributors are responsible for the products they distribute 3/12/25 Read More Records Refusal Leads To Warning Letter Take FDA inquiries seriously 2/19/25 Read More "Promotes Brain Health” Claim Challenged Small words can drastically increase claim risk 1/29/25 Read More FDA Crackdown on Animal Product Seizure Claims Amazon compliance still needs improving 1/9/25 Read More GLP-1 Product Receives Warning Letter Marketing strategies should consider “reasonable consumer expectations” to avoid issues 12/18/24 Read More Lack of Allergen Labeling Leads to Potential Death Nutrition fact panels must be in a compliant format 11/27/24 Read More 1 2 3 ... 8 1 ... 1 2 3 4 5 6 7 8 ... 8

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!