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Brands should monitor influencer posts for compliance < Back Influencers Must Disclose Free Product Brands should monitor influencer posts for compliance Everyone loves free products, but influencers who receive free products and post about them must disclose this material connection. In a recent National Advertising Division monitoring case, a large publicly traded apparel and beauty brand was called out for its influencers not disclosing that they received free products. 👉From NAD case: “In exchange for receiving a clothing credit applicable towards … products, the influencers agree to publish a certain number of social media posts featuring (the brand). Here is what we can learn. 🔹Tagging a brand on a social media post is not disclosure. 🔹If an endorsement is made verbally, then the disclosure should also be made verbally. If the endorsement is not made verbally, then a # BrandAmbassador or “Thanks for the free product” is typically sufficient as long as it’s not buried below the “More” section. I made this video to show a possible way to disclose a free sample that can be fun and authentic. Providing influencers with examples like this can help maintain their compliance and authenticity. Read the NAD case here . DATE ORIGINALLY POSTED: 3/26/25 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!

Citing clinical studies on a commercial website is high risk < Back 7 CBD Companies Cited for Implied COVID claims Citing clinical studies on a commercial website is high risk Seven CBD companies cited for implied COVID claims in this #WarningLetterWednesday. These are the first CBD-related warning letters after the announcement of the COVID and acidic cannabinoid introductory studies and the biggest agency action against CBD in over a year. 🔷One learning target of the WLW post is discussing clinical studies on a commercial website can easily be considered marketing claims. There does not appear to be any overt call-to-action or link from the studies to a shopping cart. Discussing clinical studies about an ingredient (CBDA) is enough to attract a letter. COVID-related discussions are very high risk and do not, in my opinion, belong on a commercial website. From warning letter ➡️ Another separate study from the 2022 American Chemical Society and American Society of Pharmacognosy found that two cannabinoid acids (CBDa & CBGa) bind to spike proteins of SARSCOV-2. Thus, preventing the virus from entering cells and causing infection." [from your webpage} 👉 Read this warning letter here . 🔷 These warning letters are not surprising. We discuss this in Laura Drotleff''s Hemp Industry Daily article from January here . 👉From the article 👉with the number of "cringe-worthy product claims" aiming to cash in on scientists' research, companies promoting COVID research with links to products should consider FDA and FTC enforcement "a given," Waldstein said. "I predict we should see a batch of CBDA and COVID warning letters coming out in the next couple of months." 🔷There are several other learning targets, such as blogs on a commercial website, and social media hashtags are considered claims. 👉I discuss best practices for blogs and discussing ingredient benefits here . From another warning letter ➡️ “[H]eavensorganics #covid #covid19 #cbdhelps #cbdoil #naturesremedies #naturalremedy #natureheals” [From a January 25, 2022 post on your social media website 👉I discuss the risks with hashtags and social media posts here . These warning letters are uncommon joint FDA and FTC action, a "shot across the bow" and a clear warning to the industry of the agency'es. 👉 Read the FDA Roundup 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!

Sponsored children’s content has increased disclosure requirements < Back Sponsored Video Disclosures: Found Incomplete Sponsored children’s content has increased disclosure requirements Videos must disclose material connections when making sponsored content. Here, we learn more about when material connection is needed and what constitutes disclosure, especially when children’s advertising is involved. In this NAD case, the very popular children’s YouTube channel Vlad and Nikki (405 million subscribers, 220 billion views) was cited for not properly disclosing material connections when marketing their own Vlad-and-Niki-branded products. One would think that the material connection is obvious, but here’s NAD’s thinking on the topic. From NAD. “CARU determined that not only does the relationship between Vlad and Niki’s videos and the advertiser, who is the party of the licensing and merchandising agreements, constitute a material connection, but because CMG is required to produce the videos under the terms of the agreement and shares in the revenue generated by sales of the Vlad-and-Niki branded products, CMG is also considered an endorser of the products.” Read more about influencer disclosure and best practices here . In some cases, these types of disclosures are appropriate, but as NAD states, they are not sufficient when children are involved. From NAD. “Other Sponsored Videos used language that CARU and the Federal Trade Commission (FTC) do not consider to be clear to children, such as “sponsored by” or “paid promotion” or the “#ad” disclosure in the description box of the video.” From NAD. “CARU recommends that … include language, in both text and audio in the video itself that is clear for children to understand, to clearly and conspicuously disclose the material connection to the video’s sponsor at standardized times (beginning and end and, for longer videos, after each ad break).” We can expect more of these “material connection disclosure” cases as the creator economy grows. The moral of the story is “When in doubt, disclose,” which can mean verbal and written disclosures. For support with influencer marketing compliance and guidance on how to market your products truthfully and effectively, contact me for a free consult. I love this stuff! Read the NAD case comments 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!

Helpful Resources See Appearances for Asa's Events and Podcasts See Asa's Regulatory Hints Videos which can be used as additional training tools Marketing Guidance Asa's weekly #WarningLetterWednesday post FTC Document: How to Make Effective Disclosures in Digital Advertising FTC Document: Social Media Disclosures FTC's Dietary Supplement Advertising Guide For Industry Made in the USA lawsuit reference (TINA) Natural Claims article Made in the USA (Great Podcast!) Made in the USA FTC Guidance AHPA Hemp CBD Supplement Congress videos! 9th Circuit Ruling S/F Josh Long article FDA Label Claim Guidance Regulatory: Blog, Events, Resources AHPA Labeling Guidance Document FTC Guidance: Claim Substantiation FTC Guides Concerning the Use of Endorsements and Testimonials in Advertising AHPA Alerts: Stay up to date (AHPA members only) Other AHPA Guidance Documents June 10th GMP & Marketing Claims Demystified Workshop: Resources Steven Yeager LinkedIn Asa Waldstein LinkedIn FDA Supplements Q&A 21 CFR 111 Subparts & descriptions 21 CFR 111 Reference guide Adverse Event Reporting guidance FDA Alerts (allergens, recalls, warning letters Common allergen labeling guidance AHPA Herbs of Commerce Labeling and Allergens Guidance Webinar: CGMP Basics for Hemp-CBD Companies: This is applicable to herbal supplement manufacturers. Regulatory hints YouTube channel AHPA Prop 65 Guidance Preparing for FDA GMP Facility Inspections Webinar Asa’s Regulatory Education Series Why avoid warning letter video Video about the risks of "THC Free" or "THC Free" labeling: Made in the USA Claims Demystified video All Natural: What can you say and what is the risk video Prop 65 webinar AHPA Prop 65 Resources May 4th Webinar Resources Burdock: Food Safety & Regulatory Compliance Consultants for FDA AHPA Hemp CBD Supplement Congress videos! Why join AHPA's Cannabis Committee? Regulatory: Blog, Events, Resources AHPA Labeling Guidance Document AHPA NDI Workshop cGMP Basics for Hemp-CBD Companies Free Webinar AHPA Prop 65 Guidance Regulatory Hints YouTube Channel and Prop 65 Webinar AHPA’s Cannabis Committee AHPA’s Hemp Lexicon AHPA’s NDI Database AHPA’s Botanical Congress: May 24th Asa’s Regulatory Consulting Company Burdock Associates Webinar: GRAS & NDI Certification: Ask the expert Asa’s Next Event: Distributor Pitfalls to Avoid: Hemp and Supplement Products: cGMP Guidance Other AHPA Guidance Documents Webinar: cGMP Basics for Hemp-CBD Companies. This is an excellent training tool for your supplement or hemp company! Webinar: Preparing for FDA cGMP Facility Inspections Preparing for FDA Inspections: Fireside Chat Webinar Regulatory: Blog, Events, Resources Labeling Guidance FDA Label Claim Guidance AHPA Labeling Guidance Document June 3rd Webinar Resources Harris Bricken Canna Law Blog cGMP Basics for Hemp-CBD Companies Free Webinar AHPA Hemp CBD Supplement Congress videos ! Regulatory: Blog, Events, Resources AHPA Labeling Guidance Document Getting Ready for FDA Inspections Webinar AHPA Prop 65 Guidance Regulatory Hints YouTube Channel and Prop 65 Webinar AHPA SOP Templates (members only) Asa’s Regulatory Education Series video channel AHPA’s Guidance Documents HerbalGram Cannabis Resources Asa’s Regulatory Consulting Company Prop 65 Guidance AHPA Expert Prop 65 Webinar Regulatory Videos AHPA Prop 65 Herbal Products Guidance AHPA Prop 65 Cannabis Guidance NDI and GRAS Guidance Burdock Associates Webinar : GRAS & NDI Certification: Ask the expert

< Back Presentation Wednesday Jun 30, 2021 How to not turn your tea product into a drug World Tea Expo and Conference, Las Vegas Asa Waldstein's presentation at the 2021 World Tea Expo. He speaks about compliance, marketing pitfalls, and best practices. Watch Previous Next

Old posts are "active" marketing < Back "Forgotten" Old Social Media Posts Old posts are "active" marketing “Forgotten” social media posts from years ago are active marketing and are fair game for enforcement. Today, I’ll explore old social media warning letter citations that include retweeting, images, videos, LinkedIn, hashtags, and more. Retweeting: Retweeting (or is it called ReXing (smiles)) and reposting are considered endorsing the testimonial claim. For example, if a consumer wrote something nice about your product and you retweeted it, the information in the consumer tweet would now be your marketing. The risk increases if you add commentary such as “This is why we made the product.” → From warning letter. “You retweeted another user’s September 26, 2014 tweet, which said, “#lipoicacid [an ingredient in your …R-Lipoic Acid Vegcaps 100 mg] model treats autonomic neuropathy.” → Read this warning letter . LinkedIn: Warning letters that mention claims on LinkedIn are rare, and they usually cite issues on a company’s company page rather than individual posts or claims made in easily searchable disease hashtags like # Covid. In the past, it seemed like LinkedIn did not allow posts to be indexed for Google searches, but in the past couple of months this has seemed to change, meaning that old posts are more discoverable. Because of this, I expect more LinkedIn-related warning letters this year. Images and videos: FDA also cited claims made in images and videos. Here are some examples of 4.5-year-old Facebook and Twitter posts. ● IMAGES: This post shows that imagery, especially when added to the disease-word-containing text, can be considered marketing. Here’s a recent LinkedIn post about this. → From warning letter. February 9, 2019 Twitter post: An image of the “Vision Clarity Eye Drops” with the text, “Carnosine, a cataracts worst nightmare.” ● VIDEOS: This Facebook video also shows that even making implied claims can lead to a warning letter. → From warning letter. “July 11, 2019 Facebook video post. “We do not make any medical claims nor guarantees on any specific health issue, but we are very thankful that for over 10 years, people have been able to avoid having cataract surgery because they’ve used these drops.” → Read this letter . Hashtags: Here’s a 2019 post that includes hashtags. Hashtags are easily searchable and are easy targets for agencies looking for disease-containing posts. → From warning letter. “On your April 26, 2019 tweet: “Make Nutrovape Recover your best friend and say adios to a #hangover!” I am writing this from a beautiful beach overlook in Whangarei, New Zealand, where the birdsongs and water make an excellent place for concentration and relaxation. 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!

Small business learning lessons < Back Education vs Marketing Discussion Small business learning lessons Today's post highlights common mistakes made by a small herbal company. Looking at their mistakes can help show others what not to do. I am not picking on this company as they likely didn't know the rules of supplement marketing. One of the reasons I write Warning Letter Wednesday is to educate companies on the dos and don'ts of marketing. Please share to help get this knowledge to those who need it. Copying information for herbal texts can lead to trouble. Education is ok, but it crosses the line into marketing when used to sell products. This reference was likely copied from a book onto the company's website. I also see companies making this mistake when copying information from clinical studies to commercial websites or socials. The lesson here is that any statement used to sell products should be compliant. The "Asa rule" is that you shouldn't use it in secondary marketing pieces if you wouldn't put it on the label. 👉From warning letter. "Antispasmodic Tincture • To be used in cases of epilepsy, convulsions, lockjaw, delirium, tremors, fainting, cramps, hysteria, suspended animation, etc." Claims about "colds and flu" are high risk. This is obvious, but it is worth repeating. This phrase is in one of my "top 50" that comes preloaded in my Apex Compliance program. 👉From warning letter. "Echinacea's cold and flu fighting and healing ability alone has made it the #1 immune herb…" Product names are also cited as disease statements in this warning letter. Normally FDA does not normally reference product claims unless they are over the top. 👉From warning letter. "Insomnia Formula• Product name: The product name implies that the product is intended to cure, mitigate, treat, or prevent insomnia." Read the 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 weight loss products are tested for drugs < Back Weight Loss Claims Trigger FDA Product Testing Ensure weight loss products are tested for drugs This company was making weight loss claims, leading to FDA purchasing and testing their product. Sibutramine was found, but surprisingly, the company is still selling the product. I find this confusing and look to FDA to help remove these dangerous products from the market. Sign up and search all old Warning Letter Wednesday posts here. 🔷FDA reviewed the company’s website last December, and sometime after that, purchased and tested a product, which ended up containing the drug sibutramine. On February 8th of this year, FDA issued a public notification that this product contained a hidden drug ingredient. 🔹According to the warning letter, the company refused to recall the product. After finding the drug-spiked ingredient and issuing the public notification, I find it strange that the company didn’t comply with this request. At this point, do you think the FDA could/should have elevated this to a seizure or injunction? I don’t believe many drug-spiked products are in the market, but when the FDA finds them, I would like them removed in haste. 🔷Aside from the presence of the drug-spiked ingredient FDA also cited several “disease-type” claims. The claims in this letter, such as “burns fat,” “weight loss,” and “Lose 20 pounds in 20 days,” are not normally seen in warning letters unless ingredients like sibutramine are mentioned. This leads me to think FDA is scanning for these trigger words before testing the ingredients. Also, statements like these are more common in FTC and plaintiff attorney complaints. FTC’s “gut check” document on weight loss claims is worth a read. 🔷This company is lucky FDA didn’t dig any deeper into its website. I ran Apex Compliance on their site and found numerous “Alzheimer’s” and “virus and flu infection” statements. 🔷The moral of the story here is that if you are selling weight loss (or sexual health) products, ensure you are testing for undisclosed drug-spiked ingredients. Amazon already requires an annual test for this, but testing each product lot is not a bad idea. Read the full 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!

Following label format is important < Back Common Labeling Errors Lead to Warning Letter Following label format is important #WarningLetterWednesday focuses on label violations that helped lead to a warning letter. These are basic but important reminders. This company was inspected by the FDA when they collected product labels and issued 483s for common violations such as not correctly setting specifications. I talk more about these common violations and improper 483 responses here . Here are some label lessons from this warning letter. The serving size must match the suggested use. For example, a suggested use of “take 1-2 capsules” requires a two-capsule serving size, and FDA defines this as the “maximum amount consumed per eating occasion.” From FDA warning letter. “The (b)(4) label’s directions state to “Take 1-2 chewable tablets daily as needed, at bedtime.”, but the serving size listed in the Supplement Facts label is 1 tablet.” Items with a daily value percentage must be listed in the correct format. For example, listing “Vitamin B5” is incorrect, but “Pantothenic acid” is correct. The FDA also has a strict order that items with a DV% must be listed. I refer to AHPA’s labeling guidance for this, but I believe this document is now only available for members. Here is a decent FDA resource . From FDA warning letter. “Facts label fails to place pantothenic acid before biotin” I see companies posting labels online that have the incorrect layout and format. I’m not sure if these labeling violations would lead to a warning letter on their own, but they signal the FDA that more significant GMP violations may be occurring and likely triggers them to look deeper. “Where there’s smoke, there’s fire” is often true in GMP and label compliance. In my consulting practice, when I review labels that are way off in terms of compliance, I usually suggest that the brand owner look elsewhere for a manufacturing partner. 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 Workshop, Online Thursday Apr 21, 2022 Cannabis II: Marketing Compliance for the Hemp Industry Delaware Valley University Asa Waldstein trains future regulatory compliance professionals. Learn more Previous Next

< Back Online, Workshop Monday Sep 29, 2025 Herbal Product Marketing Claims & Strategies: Pitfalls to Avoid and Best Practices American Herbalists Guild This session examines current enforcement trends, including FDA warning letters and legal actions, and provides practical guidance for herbal supplement businesses and practitioners on how to minimize regulatory risk while maintaining truthful and non-misleading communications. Attendees will learn how to identify high-risk language and develop safer messaging alternatives. We’ll also cover digital marketing dos and don’ts, offering best practices for content such as blog posts, social media updates, product reviews, and influencer partnerships. Learn more and register Previous Next

< Back Interview Thursday May 6, 2021 The Rigorous Road to Compliance The Hoban Minute Asa sits down with The Hoban Minute to talk about his roots in herbalism, his career in the herbal products and supplement industry, the importance of regulatory compliance, and why creativity is the best tool for marketing cannabinoid products, and more! Learn more Previous Next