< 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!

Kratom 7-OH products are highly scrutinized < Back Product Reviews Are Marketing Claims Kratom 7-OH products are highly scrutinized This is one of the only occurrences I’ve seen where “third-party” website product reviews were cited in a warning letter. There are, however, a few caveats and key takeaways. Let’s review in more detail. This was part of a group of five warning letters recently sent to companies selling 7-hydroxymitragynine (7-OH) kratom products. FDA is not a fan of these kratom products, especially those containing the highly purified 7-OH. This elevated the level of scrutiny, in my opinion. This warning letter primarily cited customer website reviews containing disease claims. When I looked at the website (and the Wayback Machine site), I expected to see showcased testimonials in a banner or image, and I was wrong. The reviews appeared in a format similar to many website product review widgets, lacking engagement and showcasing. Check it out . Sure, product reviews have been cited in many letters, but these were curated, showcased, or engaged with. If product reviews are displayed on a website, agencies typically take a "hands-off" approach if they meet the following criteria: Third-party: They come from independent sources. Honest: Reflect genuine user experiences. (Example: The FTC’s case involving Google and iHeartRadio.) Not solicited: Avoid exchanges like “free product for a positive review.” Do not selectively highlight only positive feedback. Even gathering reviews on a dedicated "Reviews" page may be viewed as curation. Uncompensated: No payments or free products unless clearly disclosed. Not showcased: Avoid featuring reviews in banners, ads, or social media images. No engagement: Don’t respond to or amplify reviews on your site or social platforms. Engaging turns reviews into marketing, which changes the compliance landscape. No suppression of negatives: Don’t hide unfavorable reviews. The FTC has issued major fines for this practice, like the $4.2 million case against Fashion Nova. There were other claims cited in the letter from the website and social, but they were not high-risk. From warning letter : “On your Instagram social media account. “Hydroxie strips are ultra-concentrated – powerful by design . . . they’re a simple way to empower your calm, focus, and clarity.”” I don’t think that if this weren’t a 7-OH product, these items and the “third-party” product reviews would have been mentioned. What are your thoughts? Also, AHPA has some new kratom labeling guidance that is helpful. DATE ORIGINALLY POSTED: 8/6/25 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!

Biomarkers claims elevate enforcement risk < Back Animal Product Testimonials Lead to Warning Letter Biomarkers claims elevate enforcement risk Claims about animal products were cited in today’s warning letter. Most statements involve customer testimonials with biomarkers such as “kidney values,” and “liver count,” and some other disease statements. Animal product claims seem to have a lower “acceptance level” than human supplements. For example, mentions of “pain” or “anxious feelings” are probably not enough to attract a warning letter for a human product, but these seem to tip the scale into warning letter category for animal products. This, of course, is not the case with this letter, where several very high-risk statements like “kill most urinary infections” are present. 🔷Here are my thoughts on testimonials. The authorities have been “hands off” in going after companies for third-party user-generated non-compensated reviews, such as those that appear to come through widgets like Trust Pilot. These “protections” go away when the review is engaged with , or showcased such as in a website banner, social post, or on their own review page. This warning letter congregated product reviews on their own page, which means they are curated and are, therefore, marketing. 🔷Here are my thoughts on biomarkers. In the past, claims about biomarkers such as “lowers LDLs” were not cited in warning letters unless higher-risk words were present. This changed last year when FDA sent warning letters to companies solely based on heart disease-related biomarkers, even when no disease words like “heart disease” were present. I write about this here . Heart disease-related biomarkers are high-risk, but others, such as creatine or bilirubin, do not seem to attract the same scrutiny. This is what makes this warning letter interesting, and I wonder if there were no high-risk disease words used if FDA would have cited the company simply for statements like “liver levels.” Read the full warning letter . DATE ORIGINALLY POSTED: 7/26/23 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!

< Back Virtual Course Friday May 19, 2023 Ethics in Marketing Dietary Supplements: Common Practitioner Pitfalls to Avoid AcuHealth Academy • Understand what the FDA considers a disease claim. • Understand the repercussions of not complying. • Review common practitioner marketing mistakes. • Understand enforcement trends to protect your business. • Strategies for ethical and effective marketing. Register Previous Next

< Back Presentation, Panel Discussion Saturday Nov 6, 2021 Presenter: What Can Marketers Learn From FDA/FTC Action? Panelist: Business and Marketing Panel Lucky Leaf Expo, Houston, TX In this session, we review recent enforcement trends and discuss ways companies operating in the hemp-CBD marketplace can limit their risk, while still be truthful and not misleading. This includes identifying high-risk verbiage and providing examples of lower-risk ways to get the same message across. This discussion reviews the dos and don'ts of digital marketing such as best practices for blog posts. Learn more Previous Next

< Back Podcast Wednesday Feb 1, 2023 Asa Waldstein - Principal @ Supplement Advisory Group | FDA Enforcement Trends + Social Media Ingredients for Success Podcast On this episode, @AsaWaldstein Principal @ Supplement Advisory Group, joined the show to discuss FDA Enforcement Trends for 2023, Social Media Compliance, and his weekly newsletter, Warning Letter Wednesday. Asa is a Certified Clinical Herbalist and a 20-year dietary supplement executive. Asa's consulting company, Supplement Advisory Group, is a boutique group focusing on marketing risk analysis and practical marketing solutions for the web and social media. He chairs the American Herbal Products Association's (AHPA) Cannabis Committee. Watch Previous Next