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Small words can drastically increase claim risk < Back "Promotes Brain Health” Claim Challenged Small words can drastically increase claim risk A children’s brain health applesauce product received a National Advertising Division inquiry for cognitive and immune-related claims. This is an important reminder that claims, even if not high-risk, should always be substantiated. Learn more about my weekly post, and sign up here . Here’s what we can learn. Action words like “promote” can increase the type of substantiation needed. Here, it seems that NAD implies a difference between “promotes brain health” and making statements about supporting brain health. For statements related to the brain or immunity, I suggest replacing action words like “enhance” and “increase” with “support.” 👉From NAD. “NAD found that in context, the “promotes brain health” claim conveyed a message that the applesauce provided important cognitive benefits beyond simply supporting brain health. Given the gap between the strength of the DHA in the applesauce and that tested in the underlying studies, NAD concluded that the cognitive benefits message was not supported.” NAD also recommended that the company remove the “clean ingredients” claim, which was likely due to unnatural ingredients such as citric acid and ascorbic acid. This may have done the company a favor, as any type of “clean” or “pure” are easy lawsuit targets. Also, this product appears to have a Clean Label Project Certified seal, which shows that certifications should be used with caution. Read the NAD case decision . DATE ORIGINALLY POSTED: 1/29/25 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!

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!

Even lower risk statements can trigger NAD scrutiny < Back “Reduce Bloating” Claims Lead To NAD Case Even lower risk statements can trigger NAD scrutiny Even lower-risk statements can lead to scrutiny, as we see in this National Advertising Division (NAD) case. I do not consider any of the claims NAD cited to be high risk, but this shows that even low to mid-risk structure-function claims may attract NAD scrutiny. This, of course, reminds us that all marketing should be substantiated. Here are some of the claims mentioned in the NAD case. “Relieves symptoms of Menopause” “Relieves hot flashes” “Improve sleep quality” “Reduces bloating and gas” I am unable to determine if these were on-pack or off-pack claims. This matters (to me) because NAD’s position is that the company did not provide substantiation for these claims partially because there was “no testing on the product itself,” so I am hoping to understand how the company was positioning these claims. If they were on-label, then perhaps a reasonable consumer would think the entire product rather than the ingredients have been tested, but does this also apply to product pages or website statements? Interestingly, NAD reinforces its position that generally attributing benefits to ingredients may be okay, as we see in these wordy examples. From NAD case. “NAD noted that nothing in its decision would prevent (the company) from: Making claims regarding the ability of fennel and chaste berry to positively affect menopausal symptoms that are supported by the limited findings of the research in evidence. Making supported claims that describe the traditional or historic use of ashwagandha to support sleep or are carefully qualified to avoid any misleading implication about the product’s efficacy or health benefits. Describing the traditional or historic use of chamomile in reducing bloating and gas.” There are two main types of NAD cases. 1) Competitor challenges: This is where the competitor publicly challenges certain claims a company makes. This is a public process and does require a cost. 2) Monitoring cases: These are when NAD monitors different types of marketing and brings the cases themselves without a company challenger. This case was a monitoring case, which means they just happened to come across this company’s marketing. Read the full case here . DATE ORIGINALLY POSTED: 8/21/24 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!

Nutrient content claims must be compliant < Back Labeling Errors Lead to Warning Letter Nutrient content claims must be compliant This warning letter resulted from a GMP inspection and label review. Several labeling errors are cited in this letter, which are excellent learning lessons. FDA has clear requirements for nutrient content claims such as “good source,” “high in,” and “high potency.” From warning letter. Your …product label displays the following claim “Canary Seed … is high in protein content.” In the context of this label, FDA considers the claim “Canary Seed . . . is high in protein content.” Botanicals must be listed in the supplement fact panel according to AHPA’s Herbs of Commerce. Learn more about this book here . From warning letter. “the Supplement Facts label lists “guanabana” which is not a standardized common name listed in the reference Herbs of Commerce; soursop is the standardized common name for guanabana.” The words “Dietary Supplement” are not in bold and prominent font size. This is rarely cited in warning letters but is a friendly reminder of this regulation. From warning letter. “Your …. product label’s dietary supplement statement of identity is not presented in bold type on the principal display panel and in a size reasonably related to the most prominent printed matter on the principal display panel. (see 21 CFR 101.3(d))” There are so many lessons; 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!

Learning from other’s mistakes is a good strategy < Back FDA Crackdown on Monkeypox Claims Learning from other’s mistakes is a good strategy FDA sent five warning letters this week to companies selling products for Monkeypox. This is a clear violation, but there are some critical learning lessons here. Sign up for this weekly Warning Letter Wednesday post here . 🔹One company is a wallpaper website with a few herbal tinctures containing uncompliant product descriptions. They probably just posted whatever content the tincture company provided, which shows that companies distributing supplements are on the hook for claims made on their platforms. Find my video and post about the distributors Amazon and Walmart here . 🔹Implied claims are marketing claims. In this blog post titled “What is Monkeypox,” the company says the product may help Monkeypox and then states, “we don’t know enough to be sure.” Suggestive words and phrases do not protect companies from implying their product will help diseases. 👉From warning letter: “What Can I Do To Protect My Family From Monkeypox?... products like Vitamin A, Vitamin D, Zinc, Mother’s Immunity, and Immunity Boost [each of these product names links to your page selling the product] . . . help to prevent viral infections in general and *MAY* help prevent Monkeypox (we simply do not know enough to say for sure if they will offer protection).” This company needs a lot of compliance help. I found 161 occurrences of “depression” and 2930 references to “infection” on their website. I offer website and social compliance cleanup services. Let’s talk about how I can help you avoid a warning letter. 🔹Another company has DSHEA disclaimers all over their disease-containing posts. This is not a “get out of warning letter jail free” card that allows companies to say whatever they want. The dietary supplement industry is nuanced and requires knowledge and care when marketing supplements. This is why I always suggest hiring dietary supplement experts to help grow your company. I write in detail about this 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!

Test “sketchy” products for adulterants < Back Company Selling Adulterated Product Leads To Additional Product Testing Test “sketchy” products for adulterants This warning letter includes drug-spiked products, disease claims, and CBD. It shines a light on how a small, potentially unscrupulous company can tarnish the supplement industry's reputation. Sign up here to have Warning Letter Wednesday delivered to your inbox. You can also search older posts here by keyword, which is a useful resource for your regulatory, marketing, and executive team. 🔷The order of events in this warning letter is interesting. FDA tested this company's product in April and found the presence of the undisclosed drugs Diclofenac, Dexamethasone, and Methocarbamol before posting the warning letter this week. I am unsure exactly how the process works, but I would prefer FDA act quicker to help remove these types of products from the market. This brings up the Mandatory Product Listing question; if FDA has all of that information, what will they do with it? 🔹In the past, I've seen FDA purchase and test products in the sketchy weight loss and male enhancement categories who were also making disease claims, but FDA testing joint health products is less common. One exception is a warning letter from last October which I write about here . What probably tipped off FDA is this company also sells a product that was part of an FDA consumer warning due to it containing Diclofenac, which is an NSAID. This likely led to FDA looking at the website, seeing the disease claims, and testing the other products. 🔹See the FDA consumer warning about this product. 🔷To top off several other issues, one of the products cited in this letter contains CBD. This is the first CBD-related warning letter this quarter which is surprising. As a data point during Q2 last year, there were 11 CBD-related warning letters. We are all aware that the CBD market has contracted, but some companies are still making over-the-top disease claims, especially in the Delta 8 market. 🔷There are several disease claims cited in this letter. In addition to these claims, I am sure the Bob Marley estate would take issue with potential trademark infringement. 👉From warning letter. "On the product labeling for "Bob Marley CannaKing" "REDUCES ANXIETY" "FIGHTS CANCER" "PARKINSON" "GLAUCOMA"" = Read the full warning letter , including the dangers of these undisclosed drugs. 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!

Warning letters show claims made in socials, blogs, testimonials & hashtags < Back A Review of 56 Diabetes Related Warning Letters Warning letters show claims made in socials, blogs, testimonials & hashtags I reviewed all diabetes and blood sugar related FDA warning letters since the beginning of last year and found some interesting results. These findings provide a snapshot of where the FDA is finding and perhaps looking for risky words. We can learn a lot from this, and it's an excellent reminder for companies to re-review these areas to ensure no risky statements are lurking on their website or social platforms. There have been 56 blood sugar and diabetes-related FDA warning letters since the beginning of 2021. This is a lot, demonstrating the FDA's continuing attention to this high-risk diabetes and blood sugar category. 62% of these warning letters include claims made on social media. This should come as no surprise but is an important reminder to scan for high-risk words on socials, including old posts. Here is a post and video about this. 26% of these letters include claims made in blogs. This is a strong enforcement trend to watch as the FDA looks at old blogs in the same manner as current blogs. I have found this to be a common oversight, as companies have learned about compliance over the years and their new blogs are compliant, while their forgotten older blogs are riddled with disease claims. Scanning these forgotten blogs is a great way to reduce risk, and this is a service we at Supplement Advisory Group are often hired to conduct. Here is a post about best practices for reducing risk in blogs. 23% of these warning letters include claims made in testimonials. The FDA and FTC are generally "hands off" with non-curated, honest, 3rd party generated product reviews. These cross the line into marketing claims when a company engages with them or showcases them in any way, such as copying an Amazon review onto social media or showing them on a product page. Here is a post that shows how engaging with product reviews led to a company warning letter. 25% of these letters include hashtags. Hashtags are easily searchable and can turn compliant posts into disease claims with an uncompliant hashtag. Here is a video about this. 👉Here is a learning tool titled "Protect Your Company: Learn to read warning letters." I hope you enjoyed reading the synopsis, and I welcome your thoughts! 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 GMP Pitfalls: Marketing, Manufacturing, & Labeling #WarningLetterWednesday 👉I got carried away writing this WLW post. Check out my blog for the detailed discussion. We can learn a lot from warning letters. Following FDA enforcement trends is a valuable tool for any savvy marketer, regulatory affairs professional, quality manager, or dietary supplement executive. We can adjust practices before they elevate to warning letters by learning how to read warning letters and act accordingly. This is the most detailed Warning Letter Wednesday I have written. ➡️ Read the full post here . 👉FDA Inspections Trigger Website Reviews The company was inspected by FDA in March 2021 and was issued several 483s. The company's website was recently reviewed in February 2022, which led to a letter. Learn about the difference between a 483 and a warning letter here . Usually the FDA investigator reviews a company's website for disease claims before an inspection. That is likely still happening but this is the third recent warning letter where FDA inspections led to a website review at a later date. These website reviews were then elevated to a warning letter. This is an enforcement trend and a reminder for those who have been inspected to clean up website claims. 👉I write about these letters here . 👉This warning letter is a great teaching case. Here are the learning targets. 🔷FDA Inspections Trigger Website Reviews 🔷Marketing Claims 🔷Distributors Responsibilities 🔷Common GMP errors 🔷*Writing and Following Specifications 🔷*Writing Procedures 🔷*Product Returns 🔷*Product Complaints 🔷Certain Herbs Are Not Allowed 🔷Common Allergen Labeling 🔷Domestic Street Address or Phone Number 🔷Languages Must Contain The Same Information 🔷Serving Size and Suggested Use 🔷Plant Parts Must Be Disclosed 🔷Correct Plant Listing 🔷Supplement Fact Panel: Line Thickness 🔷Percent Daily Values Label Requirement 🔷Expiration Dating 👉👉Join my Warning Letter Wednesday group . 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!

Disclosing material connection is essential for compliance < Back Celebrity Endorsement Lessons Disclosing material connection is essential for compliance Lessons in endorsement guidelines. Celebrity Kevin Hart came under the scrutiny of the National Advertising Division’s (NAD) monitoring of endorsement disclosure compliance. These are interesting cases with some good learning opportunities. Here’s what went wrong. Kevin Hart is an equity owner of a clothing brand and commonly posts about it. Here, the company incorrectly believed that since Kevin Hart is a partial owner, then perhaps no additional disclosures were needed. While this may be true if the brand was called “Kevin Hart Clothing” or something like that, NAD’s comments show that it is not common knowledge he is an owner. 🔹From NAD case. “Fabletics asserted that a material connection disclosure might not be necessary given Hart’s prominent role and public association with the brand. However, as a significant segment of the audience might not be aware of Hart’s affiliation with Fabletics due to varying levels of engagement with athletic brands, comedians, or celebrity endorsements.” Disclosures need to be clear and conspicuous. For example, the updated posts include the hashtag “FableticsPartner” above the “more” button. As a general rule, disclosures made below the “more” button or buried in hashtags are not sufficient. They may appear different on some phones or devices, so ensuring compliance across different viewing platforms may be somewhat onerous to review, but it is an essential part of compliance. The previous disclosures that include tagging such @fableticsmen and/or “@fabletics” after the “more” button were not enough to disclose material connection clearly. Another NAD and Kevin Hart case, this time with JPMorgan Chase Bank, also includes disclosures. The hashtag “chasepartner” was positioned below the “more” section which as discussed above is unclear disclosure. What is fascinating is that Kevin Hart not only corrected the placement of the hashtag (this is good) but also changed hashtag “chasepartner” to “chase_partner,” which I am unsure was needed. What do you think? The moral of the story is when in doubt, disclose. I made this disclosure video from my daughter’s snowboard rail jam over the weekend as a fun way to educate about disclosures. This includes tips on when verbal disclosures are needed. Fabletics NAD case Chase NAD case DATE ORIGINALLY POSTED: 2/26/25 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!

Test ingredients for common adulterants < Back OTC Companies Cited For Refusing Records Request Test ingredients for common adulterants When FDA asks for records, companies should generally comply or they can face warning letters. This year FDA has sent eight warning letters to OTC companies refusing to respond to FDA’s request for records requests. This is a steep jump from only two similar letters in all of 2022. 🔷Yes, I know these are OTC-related and not supplement warning letters , but we can still learn a few things and also be amused by some of the responses, such as a company saying they were “not prepared to allow the FDA to audit and inspect.” Here is the timeline: 🔹March 17, 2023, the FDA sent an electronic request for records and other to the contact email address provided in your registration file. This request went unanswered. 🔹Second and third requests were sent via email on April 6 and April 18, 2023. 🔹On April 19, 2023, you responded stating that you were “not prepared to allow the FDA to audit and inspect” your firm. 🔹The Agency sent a follow-up written request for such records and other information on April 28, 2023, to your registered address on file; however, we received a delivery failure notification. 🔷Testing for contaminants: These “refusal to comply” letters were issued to OTC companies, four of whom were selling products with ingredients like glycerin. FDA pays extra attention to these types of ingredients as they may be susceptible to Diethylene Glycol (DEG) and Ethylene Glycol (EG) contamination. Dietary supplement companies can learn from this and test glycerin and ethanol for these common adulterants. This is good business, and FDA will want to see these tests when inspecting your or your comanufacturer’s facility. I write more about this here . 🔷This is not to be confused with the FDA’s Remote Regulatory Assessment (RRA) program, which is voluntary. Complying with this can help deprioritize FDA from visiting your facility and seems like a good idea if documents are in order. What are your thoughts on RRAs? 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!

The FDA regulates based on intended use < Back Company Cited For Selling Selective Androgen Receptor Modulators (SARMs) The FDA regulates based on intended use The FDA sent a warning letter to a company distributing Selective Androgen Receptor Modulators (SARMs). SARMs are synthetic chemicals designed to mimic the effects of testosterone and other anabolic steroids. This is an excellent example that the FDA regulates based on the intended use. The company apparently was marketing this product for ingestible use but labeling as follows. From the warning letter. “Despite statements on your product labels marketing your SARMs products for “RESEARCH ONLY” and “Not for Human Consumption,” evidence obtained from your website establishes that your products are intended to be drugs for human use.” What is mind-blowing about this warning is that a company executive was sentenced to a year in prison last year for selling the same type of products! Here is the article by Steven Myers about this. 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!

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!