Disease claims trigger deeper FDA review < Back Drug Spiked Warning Letters Disease claims trigger deeper FDA review FDA sent three warning letters this week to companies selling drug-spiked ingredients like diclofenac and methocarbamol. This is a short Warning Letter Wednesday as I am writing this from holiday on the Sea of Corinth in Greece. Follow previous WLWs here . This continues the trend of FDA testing products for drugs like these. I thought it would be interesting to explore what we can learn from these types of products. Disease claims, especially in the joint health category, can trigger FDA to examine the product and company more closely. From warning letter: “Artritis” (English translation: Arthritis)” Recalls signal manufacturing and quality issues and allow the FDA to look deeper at the company’s QA/QC processes. Here is FDA’s Health Fraud Database , which links to drug-spiked product notifications and recalls. This is a good resource to help you identify what potential contaminants to test for in your products. FDA follows the “breadcrumbs” of non-compliance. When FDA inspects a facility, issues a public notification, investigates a recall, or finds a brand with issues, it will “follow the trail” to see what other similar violations it can find. For example, when a recall is reported for a drug-spiked ingredient, the FDA will look to other places where this brand may be sold, such as marketplace sites. Many of the previous diclofenac spiked products included Spanish language supplement labels. This set of letters included both Chinese and Spanish language labels. This may be because, in some cases, there may be less quality control for products manufactured for the Spanish language community. DATE ORIGINALLY POSTED: 9/4/24 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!

Distributors are responsible for the products they distribute < Back Amazon & Others Cited for Selling Injectables Distributors are responsible for the products they distribute Another Amazon warning letter, this time for distributing products apparently intended for injection, such as the “L-Carnitine Body Serum Ampoule.” This is part of a group of at least six warning letters issued to companies selling similar products. FDA did some good detective work here to determine whether the products were drugs masquerading as body care products. 👉From warning letter. “The QR code sticker on the product package directs to the URL website xxxx, which includes a link to the website xxxx, which redirects consumers to the website xxxx.” This final website then links to social media accounts where they cite claims like “Discover a non-surgical alternative to liposuction that effectively targets and eliminates unwanted fat, giving you the body confidence you’ve been striving for.” Although it does not seem the companies are explicitly marketing their products as injectables, the packaging and corresponding claims imply the intended use. As more GLP-1 injectable products receive warning letters, this appears to be part of a second wave targeting any type of injectable for fat loss. We should expect more warning letters like this, especially since other major retailers like Walmart seem to continue to offer some of these products. As we’ve discussed before, since Amazon handles (fulfills) the product, they have a responsibility to ensure the products they are distributing are compliant. I suggest everyone read the warning letter footnote that cited Amazon’s product handling. This is a good reminder that product distributors have responsibility and liability. I write more about this here . According to FDA, Amazon is “responsible for introducing or delivering for introduction into interstate commerce these products, which are unapproved new drugs.” FDA is rightfully concerned about injectable products being sold on the open market, as they refer to potential safety issues. 👉From warning letter. “These products are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.” Read the warning letter here . DATE ORIGINALLY POSTED: 3/12/25 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!

< Back Interview Thursday Nov 23, 2023 Managing Dietary Supplement Marketing Risks, with Asa Waldstein of the Supplement Advisory Group NutraPreneur Episode Overview Episode Topic : Join us in this episode of NutraPreneur as we delve into the intricate world of compliance and best practices in the dietary supplement industry with Asa Waldstein, principal of the Supplement Advisory Group and founder of Apex Compliance . Discover the strategies and insights that have shaped Asa’s approach to regulatory adherence and how the Supplement Advisory Group navigates the dynamic landscape of dietary supplement regulations. Lessons You’ll Learn : In this episode, you’ll gain insights into key strategies for mitigating marketing risks, ensuring compliance, and fostering a community approach within the industry. Learn about practical lower-risk solutions and essential elements in marketing and product labeling that not only meet regulatory standards but also enhance consumer trust. Understand the challenges and success stories encountered in implementing compliance best practices and discover the critical regulatory challenges on the horizon. About Our Guest : Our esteemed guest, Asa Waldstein, is the principal of the Supplement Advisory Group and the founder of Apex Compliance. With a wealth of experience in the dietary supplement industry, Asa has been instrumental in guiding marketers toward lower-risk strategies, ensuring compliance with regulatory standards, and fostering a culture of regulatory adherence within the industry. Take a firsthand look at Warning Letter Wednesday and unlock the secrets of FDA scrutiny and industry pitfalls. Topics Covered : In this episode, Asa shares key strategies for crafting foolproof compliance in marketing and product labelling. Beyond the challenges, he champions a community-driven approach and spills industry collaboration secrets. A sneak peek into the Supplement Advisory Group’s regulatory game plan adds a practical touch, making compliance not just informative but an enjoyable ride for marketers. Watch Previous Next

According to a Federal Trade Commission official, settlements in a law enforcement sweep against CBD marketers send a "clear message" to the growing sector: "Don’t make spurious health claims that are unsupported by medical science." < Back FTC targets CBD marketers in law enforcement sweep Josh Long Interview According to a Federal Trade Commission official, settlements in a law enforcement sweep against CBD marketers send a "clear message" to the growing sector: "Don’t make spurious health claims that are unsupported by medical science." Read More Previous Next

Formats that are favorable to children should be avoided < Back Another Delta 8 Warning Letter Formats that are favorable to children should be avoided This is the tenth FDA delta 8 warning letter this year, which is an important reminder that delta 8 THC is still on FDA’s mind, especially when it’s sold in formats that are favorable to children, like candy ropes. Distributors are responsible: This website distributes products from several different companies, demonstrating that even companies that sell other’s products are responsible. I think of this as a mini-Amazon, and I expect more distributors selling high-risk items to be called out in the near future. Favorable to children: FDA takes dangerous products in forms that appeal to children very seriously. Products such as delta 8 infused snacks with names like “Not Ya Son’s Weed Bakedies Delta 8 THC 600MG Crispy Bites” were cited in this letter. The takeaway here is that companies selling delta 8 are a high risk for FDA enforcement, especially if they sell products in forms favorable to children, such as candy. Past delta 8 warning letters were jointly issued by FTC and FDA, which usually come with more “teeth,” such as a cease and desist. This company was “lucky” this is “only” an FDA warning letter. Since there are no marketing claims cited in this and many previous letters, you may be asking what the FTC has to do with this. Interestingly, marketing unsafe products, especially to children, is considered deceptive marketing. Go FTC! From the previous warning letter. “Section 5 of the FTC Act prohibits unfair or deceptive acts or practices in or affecting commerce. This prohibition includes practices that present unwarranted health or safety risks….. preventing practices that present unwarranted health and safety risks, particularly to children, is one of the Commission’s highest priorities.” Also, I ran Apex Compliance on the company’s website and found a motherlode of high-risk claims such as cancer and opioid support statements. I wonder why FDA did not cite these. I’d love to show you what Apex Compliance finds on your site. Schedule a demo . I write more about FDA’s position on delta 8 and the previous warning letters here . Read the full warning letter . Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

< Back Podcast Monday Oct 24, 2022 Avoiding Marketing Risk and Remaining Compliant To Be Blunt with Shayda Toradi Asa Waldstein's best practices for avoiding marketing risk while staying compliant, herbalism, hemp regulations, and much more! Listen Here Previous Next

Don’t engage with risky reviews < Back Product Reviews Become Marketing Don’t engage with risky reviews In this warning letter, the company engaged with "third-party" reviews on its website, which turned them into marketing. If product reviews are collected and displayed on a website, the agencies are generally "hands-off" as long as they are: Third-party Honest: The honest experience with the product. Here's an FTC case concerning Google and I Heart Radio from a couple of years ago. Not solicited: Such as "a free product for a favorable review." Non-curated: Don't favor positive reviews. Also, conglomerating reviews on a "Reviews" page can be considered curation. Non-compensated: No paid influencers or free products unless disclosed. Not showcased: Such as those highlighted in a banner or a social media image. Not engaged with: These reviews become marketing when a company showcases them in a banner or social media post or engages with them on their website or social media. When in doubt, don't engage is a good rule for product reviews and testimonials. Not hidden negative reviews: FTC pays attention to companies hiding negative reviews, and, in some cases, hands down big fines, such as this $4.2 million case against Fashion Nova . Some companies go the extra mile and delete any reviews or testimonials that contain disease words. This is fine as long as you have a documented policy that treats positive and negative reviews the same. Here's an example from the warning letter. From warning letter. "January 24, 2023 customer review states, "I have been using this CBD for my pup who has seizures for some time, since starting CBD she has not had one. I like that there are no unnecessary ingredients, and she takes it with no problems." (company) replied, "Thank you for the review, (b)(6) That is amazing news - we are so glad to hear that your pup's seizures stopped!!!" There is so much more to this warning letter. Read it here . DATE ORIGINALLY POSTED: 10/23/24 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 Interview Thursday Jun 4, 2020 Cannabis, CBD, Regulations, & AHPA CannabisRadio.com Concierge For a Better Living Cannabis, CBD, Regulations, and AHPA are what Asa Waldstein, a veteran of the dietary supplement industry, sit down and talk about in today’s episode of Concierge For Better Living with Doc Rob. During these tough times, it gets harder and harder to find the light at the end of the tunnel. Asa helps do this by diving deep into the dietary faction of cannabis. He also explains how old practices such as canning, can and are making a comeback in today’s cannabis industry. Listen Previous Next

< Back Webinar Wednesday Jan 20, 2021 Label & Marketing Claims: Fireside Chat Asa's Regulatory Education Series We discuss label and marketing claims which impact the dietary supplement and hemp industries. This is reviewed from a legal, regulatory, and marketing viewpoint. Made in the USA & All Natural: What can you say and what is the risk? Type of claims: structure-function, qualified, etc. What defines clinically proven? Review nutrient content claims: Free Of, Good Source, High-In A quick primer on Prop 65 including labeling Risks associated with making claims And more! I am joined by two expert guests. Douglas Kalman Ph.D., RD, FACN, FISSN , is the Vice President of Scientific Affairs for Nutrasource, a nutrition-centric Contract Research & Service Organization. Erica W. Stump is the owner and founder of the Erica W. Stump, P.A. law firm. Watch Previous Next

Specifications continue to be cited < Back GMP Manufacturing Lessons Specifications continue to be cited Manufacturing supplements is not easy. I was a supplement manufacturing & marketing executive for 15 years before starting my regulatory marketing compliance company , and implementing continuous improvement into our Quality Management System required several full-time jobs. Step one in GMP compliance is setting and following specifications, and this Warning Letter Wednesday highlights several GMP lessons, especially the importance of specifications. Heavy metal specifications. Here, FDA cites the company for not establishing heavy metal specifications for botanical ingredients, which are especially at risk of heavy metal contamination. FDA notes that a lack of ingredient specifications may lead to issues in the finished product. I like this example because it demonstrates that stopping potential problems before they get to the production line is best. From warning letter. “The investigator noted that you failed to establish limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch of the dietary supplement.” Interestingly, the company did have finished product heavy metals specifications, but it seems FDA pushed back on their arsenic limits, asking for clarification on why they were set so high. This reminds us that specifications must have a scientific rationale. As a good reference point, the American Herbal Products Association (AHPA ) is an excellent resource for this. From warning letter. We note that the (b)(4) finished product specification for Lead is < (b)(4) ppm and for Arsenic is < (b)(4) ppm. Your batch record for (b)(4) batch (b)(4) reports lead results of (b)(4) ppm. Under 21 CFR 111.70(e), you must establish specifications for limits on those types of contamination that may adulterate, or may lead to adulteration of, the finished batch of dietary supplement to ensure the quality of the dietary supplement. We request that your response address the scientific basis for setting a specification for Lead at < (b)(4) ppm as a level that will not adulterate the dietary supplement. Testing by input. Over the past two years, FDA has increasingly been citing companies for testing finished products by input rather than using qualified analytical methods. The company’s 483 response seems to show that instead of providing a specification sheet example with valid testing methods, they apparently listed “input” as the test method. This part of the warning letter could have been avoided with a proper 483 response. FDA’s response, “measuring input may be a useful process control, but it is not an appropriate test method for determining the strength specification,” should be an essential mantra written on the wall of every QA/QC department. From warning letter. We received and reviewed your December 5, 2023, written response and determined it inadequate. Your finished product specification sheet for your (b)(4) product is lacking adequate strength specifications. The method listed on the finished product specification sheet for determining the strength of (b)(4) and (b)(4) in the finished product is by “input.” While measuring input may be a useful process control, it is not an appropriate test method for determining the strength specification of these ingredients in the finished batch of dietary supplement. Also, the company was cited for selling a product with a disease claim in the product’s title. This name was redacted in the warning letter, so I reached out to the company that received the letter to ask what the product’s name was, but I have not heard back from them. I’m always intrigued when I see product names cited in warning letters, and I’ve previously written about this here . From warning letter. “Product name, (b)(4) : The product name implies the product is intended to cure, mitigate, treat, or prevent migraines.” Labeling issues are also mentioned in this letter. Check out last week’s post for best practices for labeling dietary supplements. Read the full warning letter here . DATE ORIGINALLY POSTED: 7/31/24 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!

CBD enforcement is top of mind for FDA < Back FDA Issues Five CBD-Related Warning Letters CBD enforcement is top of mind for FDA CBD-related FDA warning letters are up over 420% this year, and this recent batch of five warning letters has some excellent learning opportunities. The biggest news is one of these letters does not include disease claims. There may have been one or two CBD letters ever that did not include risky claims. The products cited are beverages that contain some caffeine and hemp extract. FDA's concern is related to CBD posing delayed caffeine metabolism. If you sell CBD and caffeine products, I would remove them from the market asap. This warning letter confirms that the labeled "hemp extract" is CBD by testing, citing a COA on the website, and citing blogs on the website. It's interesting to see how FDA "ties it all together." I ask, "If there was no caffeine in the product, would the company have been issued a warning letter?" Here is the letter . Many of these letters include CBD in food products such as lollipops, cookies, and infused sugar. This is a problem for FDA because these food formats are favorable to children who may consume too much CBD resulting in a possible health concern. These are not form factors used in the supplement industry; they seem unnecessary and poor formats for delivering CBD. FDA purchased and tested products from all five companies that received warning letters. I have not seen a reference to the FDA purchasing and testing products in any 2022 warning letters. What are your thoughts on this? Two of these warning letters reference five-year-old social media posts. Here's a post about this. One warning letter mentions Delta-8. Here's a video about Delta-8 enforcement. More YouTube claims are cited, including a 3-year-old video in this letter . When social media and YouTube claims are mentioned in letters, FDA demonstrates the commercial bridge with statements like this "which direct consumers to your website to purchase your products." Here is a post about this. From one of the warning letters. "From your YouTube social media" "July 16, 2019 video – "CBD has been shown to help with a lot of different things like anxiety, stress, pain, and inflammation, and even help with seizures." 40% of this year's CBD warning letters involve CBD and animal products, which continue to attract increased scrutiny. The FDA seems to have a lower "allowance" for claims about CBD and animal products. For example, "anxious feelings" for pets may be enough to attract a warning letter, whereas it's unlikely this statement would trigger a human product warning letter on its own. Here's a post and video about animal and CBD claims enforcement. Two of the letters include references to OTC drugs, including one involving sunscreen and CBD. This letter cites CBD as an active ingredient in the sunscreen product, a huge error. Anyone who has been paying attention knows FDA takes an unfavorable stance on CBD as an active or an inactive ingredient in OTCs. I write more about this here . Here's the warning letter that mentions sunscreen. Here's FDA's constituent update on these warning letters. 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!