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Blogs are marketing statements < Back Blog Claims Result in Warning Letter Blogs are marketing statements This warning letter cites a kratom company for making disease claims related to opioid withdrawal, cancer, and depression in blogs. The learning targets in this Warning Letter Wednesday are: 1) Blogs are marketing claims 2) Comparing products to drugs is high risk 3) Scan websites for high-risk statements ✔ Blogs are marketing claims. Blogs continue to be cited in warning letters as they are "active" pieces of marketing, even if they are several years old. In this warning letter, the company talks about kava, an ingredient in its products being used for ADHD. If their products did not contain kava, this is low risk, but since this blog promotes its ingredients, this is essentially the same as putting "Our products help ADHD" right on the label. 👉 From warning letter (blog). "Here are ten amazing kava benefits you should be aware of . . . May Alleviate ADHD Symptoms[,] kava may be beneficial to people who suffer from attention deficit hyperactivity disorder (ADHD). ✔ Comparing product benefits to drugs is a great way to attract FDA attention. The example below is ultra-high risk because FDA is likely concerned that if people think the product works the same as cancer drugs, the consumer may forego lifesaving treatments for the natural (unproven) options. I am a fan of natural products, but it's important to market them in a compliant manner that does not inadvertently give people false hope about their uses. 👉 From warning letter. "Two of Kava's constituents …. have similar potency to the Alzheimer's disease treatment Memantine." 👉 I write more about the risks of comparing products to drugs . ✔ Most of the claims referenced in this letter have been removed, but there still are many claims on their website. I ran Apex Compliance and found dozens of very high-risk statements, especially when discussing their ingredient's benefits. There are also statements about helping COVID symptoms on their "forgotten" blog posts. I developed Apex Compliance to help companies identify and remove marketing risks on their websites and content before publishing. Learn more and schedule a demo . Also, DM me to schedule an Apex Compliance meeting at SupplySide West! 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!

Ensure ingredients are not on FDA’s “naughty list” < Back FDA cracks down on unsubmitted NDI ingredient hordenine Ensure ingredients are not on FDA’s “naughty list” The FDA is starting to crack down on unsubmitted NDI's. Today's #WarningLetterWednesday reviews a recent hordenine warning letter. Hordenine and higenamine warning letters also include high risk disease claim language. This is a good opportunity for companies selling these high risk ingredients to stop sales immediately and also to clean up their uncompliant marketing. From warning letter: On your product webpage for “OPTIMUM-CLA”: “Conjugated linoleum Acid (CLA): is a potent . . . anti-carcinogen, and anti-catabolic . . . Some of the common accolades of CLA are . . . is a cancer fighter. From warning letter: On your product webpage for “ADIPROPEN ULTRA”: “ADIPROPEN ULTRA is our new and improved version of Adipropen with added Vinpocetine, commonly referred to as ‘Viagra for the Brain.’ [I]t is more effective than Clenbuterol.” 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!

Ensure GMPs are developed and followed. CBD is risky when added to OTC topicals. < Back Marketing CBD in OTC drugs is risky Ensure GMPs are developed and followed. CBD is risky when added to OTC topicals. #WarningLetterWednesday involves CBD in an OTC topical (hand sanitizer) and further defines FDA’s position regarding CBD as an active or inactive ingredient in OTC drugs. There are also numerous GMP violations that paint an overall picture of noncompliance. The references to CBD in this letter are worth reading. It is hard to defend adding CBD as an inactive ingredient if the amount of CBD is listed on the label or is marketed for CBD content. From warning letter: “Specifically, your product label for MEDICALLY MINDED 100% THC FREE Hand Sanitizer Gel prominently features on the Principal Display Panel (PDP) the statement, “200 MG CANNABINOIDS 100 MG CBD + 100MG CBG.” The product label also lists,.....a website that markets and sells CBD products for various therapeutic benefits. As noted above, CBD and CBG are not an active ingredient in any applicable final monograph”. Although is letter is only one of seven CBD-related warning letters in 2021 (down from 21 last year) it is essentially a teaching case about the importance of GMPs. The FDA sent two records requests which the company did not answer. Not answering these FDA requests is a prohibited act and is serious. The FDA then inspected the company and found serious violations including hand sanitizer that contained 0% ethanol and 58% methanol. This is dangerous! This then led to a national recall of the adulterated lot numbers of hand sanitizer. If the company had a proper Quality Management System (QMS) they would have responded to the FDA’s information request and may have prevented an inspection. They would have also identified the adulterated hand sanitizer before it shipped to the public and caused the subsequent recall. The company was issued a 483 which they didn’t respond to. Learn more about the differences between warning letters and 483’s here . Properly responding to a 483 is an important part of avoiding warning letters. Most 483’s can be addressed with the FDA before they are elevated into a warning letter. Learn more about reasons to avoid a warning letter here . The GMP violations include not setting specifications, quality not approving production procedures, and quality not controlling incoming components. Although these violations cite OTC drug manufacturing regulations, they are the basics all dietary supplement companies should be complying with. Not writing and following specifications is one of the most common supplement GMP citations. Read 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!

Distributors are responsible for the products they sell < Back Walmart & Amazon Issued Warning Letters for Adulterated Products & Disease Claims Distributors are responsible for the products they sell Amazon and Walmart were cited for selling a product with disease claims and adulterated with NSAIDs. The product is a nutraceutical and omega-3 product that contains undeclared diclofenac, a non-steroidal anti-inflammatory drug (NSAID). Both warning letters include comments where FDA highlights that the company (Amazon or Walmart) is the party that fulfills and distributes the product. According to supplement regulations, companies that distribute products have a level of GMP and regulatory responsibility. Essentially if a company markets, distributes, and sells a product, they are responsible, even on a marketplace site. This webinar with Nathalie Bougenies and Steven Yeager shows many items companies need to comply with these regulations. From Amazon warning letter. “These products were introduced or delivered for introduction into interstate commerce by Amazon via your Fulfillment by Amazon service.” There were also examples of claims on both the Amazon and Walmart sites, such as “arthritis.” This is the most common “itis” referenced in warning letters and is an important reminder to scan for higher-risk words like “arthritis.” I expect this action to possibly lead to these companies asking for more adulterant testing and a deeper look at disease claims. For example, if the word “arthritis” is on your Amazon page, I expect it to be flagged. This product was recalled in June 2022. It is unclear if the products in these warning letters are from the same recalled lot or a different batch. From warning letter. “Combate la artritis.”” (English translation: Fights arthritis.)” Interestingly, the disease claims were in Spanish, a good reminder that the FDA also pays attention to claims made in other languages. I welcome your thoughts on these notable warning letters. Read the Amazon warning letter . Read the Walmart 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!

Trustpilot reviews can be “marketing” < Back Product Review Engagement Trustpilot reviews can be “marketing” CBD in tampons? During a GMP inspection at this company’s facility in Bulgaria, FDA determined that CBD is a drug product that deems the tampons adulterated. This, along with some disease claims and other violations related to vaginal microbiome screening kit claims, led to a warning letter. This is the ninth CBD (or delta 8) related warning letter in 2024 which is 47% less than last year, showing that CBD enforcement continued to plummet. As we know FDA is not a fan of CBD, especially when they feel it can be harmful. From warning letter. “FDA evaluated the regulatory decision form that you provided the investigator to support not needing a 510(k) for the CBD Coated … Tampons and found the assessment was inadequate because the CBD coating raises significant concerns regarding safety and effectiveness of the devices due to the potential for local and systemic exposure of CBD, potential adverse events (e.g., reproductive/developmental toxicity) associated with CBD, and potential effects due to the uncertainty of the potency and quality of the CBD (e.g., psychoactive effects from possible contaminants like Delta-9-tetrahydrocannabinol).” Product reviews: Agencies like FDA are typically “hands off” with third party product reviews if they are non-curated, non-compensated, are truthful, and are not showcased. The exception is when a company engages with third party reviews that contain disease claims, as this is considered an endorsement and turns a product review into a marketing claim. Here’s an example from the warning letter where the company engaged with reviewed on its Trustpilot site. Claims in product reviews typically appear in warning letters when they appear on a company website, but I’ve not seen this cited when hosted on platforms like Trustpilot, which reinforces the “Don’t engage with product reviews when they are risky words” rule. From warning letter showing how the company engaged with a review. “Trustpilot Web Site: “We're really sorry to hear that the CBD tampons didn’t work for you. Research shows that different bodies have different responses to CBD, and just as other forms of pain relief, annoyingly it won’t work for everyone.” Complaints on Trustpilot not investigated. Product complaints and safety issues need to be adequately investigated. Typically, customer complaints are emailed or called into the company, and once the company is aware of potential issues, it is its obligation to investigate. Interestingly, in the example, FDA requires the company to investigate third-party reviews on the Trustpilot site since they engaged with these reviews. As I discussed above, engaging with third-party reviews is an endorsement and makes them marketing. In this example, it also shows FDA that the company is aware of the issues and triggers the investigation requirement. This is the first time I’ve seen FDA mention this for third party reviews and companies should take note. We can also extrapolate that the FDA will want companies engaging with customer complaints on social media to properly investigate the issues as well. From warning letter. “Complaints related to the addition of CBD to … Tampons that were listed in Trustpilot or third party systems were given responses by your firm, but not logged and evaluated appropriately in your complaint handling system. The complaints indicate CBD … Tampons may have an impact on the patients’ health (e.g. CBD drug interactions) that exceed the expected risks associated with regular (non-CBD) tampons.” The company was also cited for selling a vaginal microbiome screening kit which FDA does not consider a general wellness kit. They determined this by reviewing the product’s claims like “Detect bacteria that cause vaginal infections like yeast infections” from their Amazon store, Trustpilot page, and website. I had never read the “General Wellness: Policy for Low Risk Devices” document before and it worth knowing about. From warning letter. “Your firm markets the device with diagnostic claims that are outside the scope of a general wellness device as described in the FDA guidance document “General Wellness: Policy for Low Risk Devices” at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices; and therefore, your device would need to be submitted for premarket review by the FDA.” Read the full warning letter here . This Warning Letter Wednesday post marks 52 weekly posts this year and over 150 since I started writing WLW. Thank you for all of your support! You are appreciated! DATE ORIGINALLY POSTED: 1/1/25 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!

Regulatory compliance and marketing education on important issues in the dietary supplement industry. Helpful hints videos, blogs, and resources. Asa's public speaking schedule and webinar links. Consulting services for supplement marketing compliance. About Asa Waldstein Community, Compliance, Natural Health Principal of Supplement Advisory Group , specializing in practical regulatory support for dietary supplement marketers. We focus on finding marketing risks and providing practical marketing solutions on the web, social media, and product labels. I love educating about compliance best practices and lower-risk marketing strategies, which often change based on FDA/FTC enforcement trends. Building in-house expertise through education is part of my unique approach to regulatory consulting. I routinely speak at conferences on enforcement trends, industry compliance, and the nuances of effectively marketing products in the digital era. Check out my weekly Warning Letter Wednesday post . Learn More Email Me LinkedIn Home: About Home: Testimonials Testimonials Vardan Ter-Antonyan Chief Science Officer at Green Compass Global, Ltd Asa is one of the best experts and specialists of Regulatory Affairs in the dietary supplement and hemp space. If you are in need of any regulatory services when it comes to your labels, your operation, or anything else, contact Asa and he’ll make sure you are well equipped to face any regulatory inspection including the notorious FDA. Free Introductory Regulatory Consult Available Online 15 Minute Consultation with Asa Waldstein 15 min Book Now Home: Video Player Regulatory Hints Videos Educational Tools: Free for the community Play Video Share Whole Channel This Video Facebook Twitter Pinterest Tumblr Copy Link Link Copied Now Playing MLM Company Cited For Claims Made By Their Affiliates 02:39 Play Video Now Playing FDA Crackdown on Anxiety Claims 03:19 Play Video Now Playing Art of Wordsmithing: Replace High-Risk Marketing "Buzzwords" 01:12 Play Video Now Playing Supplement Advisory Group: About Us 01:02 Play Video Watch with captions on What I Do For A Living Get in Touch Newsletter signup, ask regulatory questions, public speaking inquiries Submit Thanks for submitting! Home: Contact

Re-review websites if inspected by FDA < Back Batch Production Record & Labeling Lessons Re-review websites if inspected by FDA This company is a small manufacturing facility and storefront that is reminiscent of the companies I would order herbs from in the 1990s. Since then, herbal regulations have matured, but unfortunately, this company has not evolved into the highly regulated world of herbal supplements. Sign up for this weekly newsletter . 🔷This letter contains serious GMP violations such as not having specifications and providing incomplete 483 responses like “(we) are still in the process of establishing and implementing the systems.” It also contains many serious online disease claims, and this letter exemplifies how a well-intentioned herbal store can become non-compliant. This is a cautionary tale about the complexities and penalties for companies looking to manufacture and market herbal products. 🔷The disease claims cited in this letter are numerous, but I’ll focus on what we can learn from Batch Production Record GMP violations. I suggest everyone read the full warning letter . You can also comment or message me with specific questions or commentary. 🔷Batch Product Record (BPR) lessons from this warning letter. 🔹Date/time of equipment maintenance, cleaning, and sanitizing record 🔹Statement of actual and theoretical yield. This is how manufacturers can find issues before products ship. For example, if the theoretical yield is off, this signals that too much or too little of an ingredient was added. 🔹Date and initials of each person weighing and verifying component weights. 🔹Labels: The unique identifier assigned to packaging and labels used, the quantity of the packaging and labels used, and, when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels. 🔷More labeling issues are cited in this warning letter, such as not listing the Latin or the standardized common name of plants as noted in American Herbal Products Association (AHPA) ’s Herbs of Commerce, or listing the plant part (e.g., root). These did not lead to the warning letter, but we can learn about labeling best practices. For example, indenting the ingredients under a proprietary blend is apparently a rule. From warning letter. “Dietary ingredients are not indented under the title “Proprietary Herbal Blend” 🔷FDA reviewed this company’s website a few months after the initial inspection. This is a reminder for all companies to re-review their online marketing if they have been recently inspected. This may save you from getting a warning letter. This is one of the reasons I invented and patented Apex Compliance . 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 Meet-Up Group Tuesday Dec 17, 2019 Ethical CBD Marketing: How to avoid FDA, FTC, and class action trouble Asa's Regulatory Education Series The first Boulder Hemp-CBD Group Meet-Up hosted by Asa (In-person) What can we learn from recent "Big 15" Warning Letters, revised Consumer Update, and recent class action news? Have you ever wondered why some companies receive FDA Warning Letters and are unsure about how to ethically market your product without getting into trouble? Are you looking for clarification about what the FDA is enforcing and how to read Warning Letter trends? What is a claim and what are the risks when making them on your website or social media? Can I get in trouble for "Liking" a post? If I link to a clinical study is this allowable? Do I need to be careful with blogs? What is the Farm Bill IFR and how do I submit comments? What is an attorney's opinion on recent class-action lawsuits? This event will focus on a discussion about the dos and don'ts of labeling, marketing, and selling Hemp-CBD and much more! I am honored to be joined by very special guests: Patrick McCarthy, Validcare CEO Frank Robison, Founder of the Robison Law Group LLC. View Pictures Previous Next

< Back Panel Discussion Thursday Oct 7, 2021 Smither's Hemp & CBD Workshop Online Event Moderator: Asa Waldstein Expert panelists: Vanessa Snyder from Eurofins David Dawson, Ph.D. from Via Innovations Alex Capano, from Ecofibre Limited Dr Parveen Bhatarah from Association for the Cannabinoid Industry Alex: What textile and food innovations that you are excited about? Please talk about what market segments you are interested in (Scientific & Category Perspective) (Alex feel free to reframe this question) Please share some of the eco-benefits of the wonderful hemp plant. David: What do you look for in a cannabis or hemp testing lab? What cannabis and nutraceutical delivery forms are you excited about and what are some of the hindrances in bringing them to commercialization? Vanessa: With so many labs in the space, how do you explain to customers what to look for in a reputable lab? Are there certain form factors that are difficult to test (gummies or liposomes) and how do Eurofins handle this? How do you see the future of hemp looking as an ingredient in animal feed? Parveen: What considerations should US supplement companies that are looking to expand into the UK be aware of? What are some of the key drivers for the hemp sector investment, and what can companies be working on to attract funding? Watch the panel recording Previous Next

Safety related product claims attract scrutiny < Back “Non-Toxic” Claims Require Extensive Substantiation Safety related product claims attract scrutiny Making a “Certified Non-Toxic” claim on a mouthwash triggered a competitor challenge. According to the National Advertising Division (NAD) comments, the substantiation provided by the company was not sufficient to support the claim. 👉From NAD. “In support of the “Certified Non-Toxic” claim, Oral Essentials submitted two cytotoxicity studies (one for its sensitivity mouthwash and one for its whitening mouthwash) and a certification statement from MADE SAFE, a third-party certification program that verifies ingredient safety and non-toxicity. Oral Essentials mouthwashes were certified by MADE SAFE at the time of manufacture.” 👉From NAD. “Strong evidence is needed for non-toxic claims due to potential health and environmental risks as well as the potential for consumers to misuse the product or take away a broader message about the product’s safety that is not supported by the claim.” 👉Apparently, the cytotoxicity studies did not exactly match the and did not address the “real-world” effects. From NAD. “NAD found Oral Essentials’ cytotoxicity studies did not support the challenged claims such studies do not reflect the real-world effects on humans and only address one form of toxicity. Additionally, the study formulations contained one less ingredient and differed from the current product ingredients.” It seems the position is that making a “Certified Non-Toxic” claim on a mouthwash label may give some consumers the idea that they can drink the whole bottle or put it in their eyes with no safety issues. I expect people to have more common sense than this, but I guess it is possible for a consumer to think that “Non-Toxic” means they can go nuts with it. I assume the same rationale would apply to toothpaste or any other product that is sparingly used internally. 🔹Don’t rely on certifications: The company also relied on a “MADE SAFE” certification, but this did not substantiate the claim because it was unclear to NAD which real-world factors were evaluated in the certification process, and the company's certification had expired in October 2024. At Supplement Advisory Group , my regulatory consulting company, I often share the “less-is-more” principle with clients. This means that every aspect of packaging will be scrutinized, and if it’s not necessary for marketing, removing it is a good idea. This is not always a popular opinion, but it is important to measure risk and reward while keeping substantiation in mind. Read more about the case here . DATE ORIGINALLY POSTED: 1/15/25 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!

Practitioners who sell supplements need to be aware that health and medical claims made in nutritional marketing can attract unwanted attention from the US Food and Drug Administration. < Back Common Practitioner Pitfalls to Avoid When Marketing Dietary Supplements Asa Waldstein Guest Article Practitioners who sell supplements need to be aware that health and medical claims made in nutritional marketing can attract unwanted attention from the US Food and Drug Administration. Read More Previous Next

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!