Search Results

Review old social posts < Back Social Media Disease Claims Earn Warning Letter Review old social posts Claims on social media can tip the scale to a warning letter. This warning letter is interesting. It includes topical products marketed as drugs, animal “drug” claims, and more, but today, I will be focusing on the social media claims. Please also forgive the brevity of this Warning Letter Wednesday as I am on a road trip visiting graduate schools with my daughter. FDA looks at the 10,000-foot view of a company’s online persona. One claim in isolation is probably not enough to trigger a warning letter unless it is very egregious (e.g., COVID). The agency chooses claims from all marketing, such as socials, websites, and YouTube, and pieces them together for one big picture of non-compliance. Most of the highest-risk claims in this warning letter are on social media. From warning letter. “On your Facebook account. June 27, 2022: • Under the heading “Benefits of Spirulina” [an ingredient in Fulvic Green]: − “[C]an reduce risk of cancer.” This shows how discussing ingredient benefits is a marketing claim. Since the post cited in the warning letter is almost two years old, it shows that even old social posts are active marketing in the eyes of FDA. The moral here is to review your old social post to ensure no “forgotten” high-risk disease claims are there. From warning letter. “On your Facebook account post, dated June 20, 2022:CAN PREVENT SEI-ZURES…used in traditional ayurvedic medi-cines as a cure for sei-zures and convulsions.” Discussing traditional use claims in this content is a disease claim and is therefore considered labeling. 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!

Learn from other’s mistakes < Back TCM Company GMP & Marketing Violations Learn from other’s mistakes FDA inspected this TCM manufacturing and product company earlier in the year, including looking at its product catalog and website. This led to GMP and disease claim citations. Let’s start with the disease claims. Some of these may be considered TCM verbiage, but this is an important reminder that using common Traditional Chinese Medicine (TCM) or herbal language doesn’t necessarily translate into compliant marketing. From warning letter. “Staunches bleeding, disperses swellings, and relieves pain” “Expels pathogens, resolves depression” Product catalog: This is a reminder that anything FDA sees during inspection can be reviewed, including shipping inserts. I remember years ago almost forgetting to discard old “potentially non-compliant” product brochures that were collecting dust on a shipping shelf. If FDA found these during an inspection, they would have been “fair game” for them to collect and review. Now for the GMP issues. There are a lot of learning opportunities here. Identity specifications. In most cases, organoleptic (e.g., color, taste, smell, feel) testing is not sufficient to determine botanical identity. However, if the plant came in whole leaf (rather than powder), for example, I think a case can be made that organoleptic testing may be sufficient. From warning letter. “Analysis of organoleptic factors does not provide unique information that is specific to each of these ingredients and thus cannot confirm the identity of each ingredient.” Metal detection. This is one we don’t see very often. From warning letter. “You failed to use effective measures to protect against the inclusion of metal or other foreign material in components and dietary supplements, as required by 21 CFR 111.365(i).” Incomplete MMR instructions. I like to think of the MMR and BPR as recipes. If a new team manufactures the product, does the MMR/BPR have all the needed instructions? This is to maintain consistency in product manufacturing. From warning letter. “Your master manufacturing records (MMR) failed to include written instructions and specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement products and that the dietary supplement is packaged and labeled.” Product specifications. Not having complete specifications is one of the most common GMP violations. Here FDA states that the provided microbial and heavy metal specifications are not enough to justify the product’s identity, purity, strength, and composition. I ask, if the product contained only botanicals, what else is needed to verify this? One answer is that a finished product composition test is needed, which is an expensive method to develop and test. From warning letter. “The physical and chemical factors do not constitute unique criteria that can confirm the identity of these products and do not evaluate the purity, strength, or composition of these finished products.” Here are some labeling citations. Structure function claims on labels not linked to FDA disclaimer . This is showing up in more warning letters. Plant parts should be listed on the label. I personally think that “herb” is descriptive, but according to FDA, it is not sufficient. From warning letter. For example, “herb” does not identify the plant part used in the product. If the whole or entire plant is used, that information must be listed. Listing the ingredient name common correctly. From warning letter. “Citrus” which is not the common or usual name of an ingredient. Solvents should be listed . This is not to be confused with processing aids, which, in most cases, do not need to be listed. From warning letter. “(the label) fail(s) to declare the solvent used in the extract within the ingredient list. Other comments in the warning letter are important reminders of labeling and GMP compliance. Expiration dates: The company did not have supporting data for its “best by” dates. Expiration or freshness dates are not required on supplements, but when they are used, the company must have supporting data. In my experience, this does not have to be super complicated and may include a time-zero and a 1 to 2-year-old product tested for organoleptic, microbial, and line item assay tests. Facility registration : It looks like the company did not update its facility registration within 60 days of important changes. Read the full warning letter here . DATE ORIGINALLY POSTED: 10/2/24 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!

Influencers must disclose material connection < Back FTC Letters To Sugar-Promoting Influencers Influencers must disclose material connection FTC sent warning letters to two trade associations and 12 influencers for not disclosing material connection in their posts promoting the safety of aspartame and sugar. This shows that FTC is serious about enforcing its endorsement guidelines. There were some interesting FDA warning letters to write about this week, but this FDA action was too sweet to pass up. Many of the actions included posts on TikTok. Amazingly, TikTok posts are rarely cited in agency action compared to other platforms such as Instagram. Why is this? Also, claims on TikTok have never been cited in an FDA warning letter, but I expect this to change in 2024. Read about the FTC action . FTC provides guidance on what conspicuous disclosure means. Learn more . #Ad may not be enough. In the past, adding #Ad may have been sufficient, but now, a disclosure must be made in the format it was delivered. This means that "if the representation is made through audible means, the disclosure should be made in at least the communication's audible portion." From FTC warning letter. "The video itself did not include any disclosures. Viewers can easily watch a video without reading disclosures in a post's text description. There should be clear and conspicuous disclosures in the videos themselves, for example, by superimposing much larger text over the videos. In your video, you made endorsements through both visual and audible means, so the disclosures should have been made in both the visual and audible portions." Reels must also have disclosures; adding a hashtag in the description is not enough. I understand most influencer rules, but this one is tough to comply with. From FTC warning letter. "Videos have many competing elements. We therefore do not think that a disclosure in a Reels post's text description is clear and conspicuous." Paid partnership is not adequate disclosure. Many platforms like Instagram require influencers to use their "Paid Partnership" heading. Unfortunately, this is not sufficient for disclosing the material connection. In the future, I'd like to see these platforms harmonize their requirements with FTC regulations. This FTC quote sums it up, and I applaud FTC for this action. "It's irresponsible for any trade group to hire influencers to tout its members' products and fail to ensure that the influencers come clean about that relationship," said Samuel Levine, Director of the FTC's Bureau of Consumer Protection. "That's certainly true for health and safety claims about sugar and aspartame, especially when made by registered dieticians and others upon whom people rely for advice about what to eat and drink." The moral of the story is to disclose material connection in all formats when necessary, audio, video, and clearly in text. Yikes, being an influencer is more difficult than it used to be. DATE ORIGINALLY POSTED: 11/22/23 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 Presentation Saturday Oct 8, 2022 What Can Marketers Learn From FDA/FTC Action? Lucky Leaf Expo, Jackson, MS 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

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!