Search Results

Ensure material connection is disclosed properly < Back NAD Case: Influencer Material Disclosure Ensure material connection is disclosed properly This NAD case is a good reminder of the importance of influencers properly disclosing material connections in the same manner that endorsement is made. For example, suppose there is an image and no video/audio. In that case, then simply using hashtag#Ad or #(Company)Ambassador is sufficient, as long as these disclosures are not buried in a string of hashtags or below the “Read More” button. Now, according to the updated FTC guidelines, if an endorsement is made verbally, then the disclosure must also be made verbally. This kind of makes sense to me, but it becomes complicated when endorsements are made in Reels and Stories. Last year, FTC sent warning letters to several influencers and some sugar trade groups for not disclosing material connections in videos. I write about this here . Aside from that group of FTC letters, there hasn’t been much action with this new guidance, which is why this NAD case is so interesting. From NAD case stating what the company has agreed to do. "Requiring its influencers to include a verbal notice of their partnership with ... in any video influencer material." These rules ensure that consumers are not misled, which is important as we count on the honesty of reviews to make purchasing decisions. These disclosure requirements also apply to ambassadors, investors, and family members of companies. In this case, actor Demi Moore seemed to cross this line. From NAC case. "... challenged a social media post by Demi Moore in which she stated that her promotion of ... was "not an ad" and failed to disclose that she is an investor in the brand. The Demi Moore example is pretty over the top, but the likelihood that the other claims would have been cited in warning letter or agency action seems relatively low. This shows that “poking the bear,” which in this case is a very large company in the antacid space, can lead to increased challenger scrutiny. When in doubt, be very careful when disrupting category leader incumbents. Wondering what the National Advertising Division (NAD) is? Check out this post . There are some more interesting items in this case. Please read it 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!

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!

“Brain Fog” claims related to Covid will attract scrutiny < Back Small Herbal Company in Big Trouble for Disease Claims “Brain Fog” claims related to Covid will attract scrutiny This is yet another example of a well-intentioned herbalist-owned, very small company being cited for disease claims. I write about how no company is “too small to be off FDA radar” here . This company is a farm that makes small-batch products, but unfortunately, they don’t seem to know the rules of dietary supplement marketing. All the claims cited in the FDA warning letter have been removed, but there is still a cancer treatment herbal kit for sale on their website. Unfortunately, the basics of DSHEA and marketing compliance are not taught in herb and acupuncture schools. One of my missions is to educate these communities about the basics of the dos and don’ts of supplement marketing. Here is my speaking schedule ; please let me know if I can extend free education to your school. Also interesting in this warning letter is the second mention of “brain fog” in FDA letters. Do you consider this to be a disease claim? According to HHS, brain fog can be a symptom of long-haul Covid, a recognized disability under the Americans for Disabilities Act (ADA). My take is brain fog related to Covid symptoms is undoubtedly a disease claim, but brain fog not related to Covid isn't high risk. I feel “occasional brain fog” from time to time. Due to the hashtags in this post, the correlation to Covid is undeniable. This is a good reminder that hashtags can be considered disease claims and tip the scale into the warning letter category. Here’s a video about this. From warning letter. “Plants geared towards cardiac and mental health, brain fog, respiratory issues, and fatigue . . . # postcovid, # postcovidsyndrome, # longcovidrecovery, # longcovidsymptoms This is a joint FDA and FTC warning letter, which is common when Covid claims are cited. This is very serious, and it also involves a cease and desist barring the company from making Covid-related claims or face injunction, a civil penalty of up to $46,517 per violation requirements to refund customers. 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!

Product claims must be compliant < Back Tea Product Cited for Blood Sugar, Cholesterol & Cancer Claims Product claims must be compliant This is a story of a small tea company that was cited for making risky disease claims on its website. The company probably didn’t realize they were breaking the rules, demonstrating a considerable opportunity for education in the herbal products market. This is one of the reasons I started Warning Letter Wednesday, to help educate companies on enforcement trends and marketing compliance. This is a reminder that even very small companies are “on FDA’s radar” if they market products online. I write about this here . There are many risky claims in this warning letter. These include blood pressure and cholesterol, which I wrote about last week . There are also claims about insomnia. There have been 20 insomnia-related warning letters this year, and this continues to be an FDA enforcement priority. There is even a cancer claim which is a justifiable automatic warning letter. From this FDA warning letter. “Keeps blood pressure under check.”- “Lowers cholesterol.”- “Controls blood sugar level.”- “Lowers the risk of cancer.” The company removed the items cited in the warning letter from its website. However, very risky posts mentioning claims such as “fights bacteria and viruses” are still on its social media. This again shows that company needs compliance support to understand what constitutes a claim. Here is a “What is a Claim” video . 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!

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

Hashtags elevate marketing risk < Back Discussing Ingredient Benefits Leads To Warning Letter Hashtags elevate marketing risk In the eyes of FDA, discussing product ingredients is a marketing claim, even if there is no direct cross-linking to a product page or shopping cart. This is a common mistake and a good reminder for companies to re-review their websites. Do you want Warning Letter Wednesday delivered to your inbox each week? Sign up here . 👉From warning letter. "On the … Health & Wellness page in the linked article titled: "WHAT IS CALCIUM? | CALCIUM BENEFITS” “[C]alcium supplements are tied to several health benefits including…lowering the risk of colon cancer…” 🔷This is obviously high risk, but it shows how an inexperienced and probably well-intentioned marketer can attract serious agency action. This is one of the reasons I write Warning Letter Wednesday, to help companies get into compliance before they get into trouble. 👉From warning letter. (Facebook) "What happens if a child doesn't get enough calcium?...Kids who don't get enough calcium will have increased risk of bone fractures, not able to reach potential height, and osteoporosis later in life….#dcal #dcalkids" 🔷Adding a product name in a hashtag significantly elevated the likelihood of scrutiny as it correlates the product to the claims in the post. 🔷Here is an example of when hair loss statements cross the line into disease claim category. By removing "alopecia," this would reduce the likelihood of FDA action. This is only the third FDA warning letter to mention "hair loss" claims in the past three years, and all letters included high-risk words. Even though "hair loss" statements are not top of mind for FDA, they are likely to be scrutinized by FDA, NAD, or plaintiff attorneys. Read more about NAD here . 👉From warning letter. "Do I need calcium for hair growth?... Low levels of vitamin D are associated with alopecia or hair loss. Adding vitamin D and calcium supplements may help create new hair follicles, which can play a role in hair growth." 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!

Blogs can be considered marketing < Back When “Educational” Blogs Become “Labeling” Blogs can be considered marketing I love educating about enforcement trends and regulatory marketing compliance, and I've been writing this weekly post for almost three years. I have two small companies in the dietary supplement marketing compliance space. Supplement Advisory Group is my consulting company that focuses on dietary supplement labeling and online marketing compliance support. Apex Compliance ™ is my subscription software product that helps find and replace risky marketing phrases on websites, videos, and content before publishing. I've dedicated my life to understanding enforcement trends as a way to inform compliant marketing. Today's post sums up common compliance oversights I commonly see in both of my companies. There have been no dietary supplement warning letters this week and I am attending a conference in NYC, so today's post will be brief. I'm writing this from beautiful Bryant Park, my NYC "office." I often see companies with compliant labels and product pages but have blogs on their websites filled with disease claims. In this post, we'll help demystify when "educational" blogs become marketing. If a supplement company writes about practices such as meditation or exercise being useful for diseases like anxiety, this is generally low risk. If the company mentions the benefits of ingredients they don't sell, again, this is low risk. Now, if there are blogs that talk about ingredients in products they sell, this crosses the line from education to product marketing, even if there are no hyperlinks or cross-linking. Just mentioning ingredients and then suggesting that they can help with diseases is enough to attract a warning letter. Here is an example of what I call the "common blog writer trap." Let's say a company writes a blog such as "5 Tips For Beating The Winter Blues." Typically, it would discuss winter blues and references disease names such as "depression." The blog would then talk about health-giving activities like meditation, snowboarding, working out, and journaling. The company may even talk about how there are studies suggesting that vitamin D supplementation can help. If the company doesn't sell vitamin D, then this blog is likely to be considered educational. However, if vitamin D is in any of their products, this crosses the line for product marketing. The more explicit the statement is, the more likely it is to be cited in a warning letter. For example, "Recent studies show that vitamin D supplementation can help alleviate many of the symptoms associated with depression." When in doubt, resist the urge to overexplain ingredient benefits, as this can result in a 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!

Blogs can easily cross the line from “education” to “disease claims” < Back Best Practices For Reducing Risk in Blogs Blogs can easily cross the line from “education” to “disease claims” This year, there have been five warning letters that include claims made in blogs, and the line between what is allowable and what is a claim continues to shrink. #WarningLetterWednesday It is easy for a well-intentioned content writer to cross the line from education into the disease claim category, which I wrote this post. I break blogs into two categories. Both are considered marketing and must be compliant, but dividing them into two categories helps clients understand how rigid they want their compliance to be. Ideally, there would be no "educational" or "science" blogs on a commercial website, but few companies follow this path. The life of a consultant is helping companies understand risk while also supporting their real-world, compliant and effective marketing. This is fun! Informational & Product Blogs Informational blogs: These are not intended to sell a product but are used to educate about ingredients and science. Crossing the line from informational into a product blog is very easy, so extreme care should be used. Removing all calls to action, such as linking to a shopping cart, can help lessen the implication that a blog is being used to sell a product. I discussed "educational" blogs and compliance with a top FTC official who said something similar to this. 'Why is a company using blogs on their commercial website if not to sell products.' This is the lens the FTC and FDA look at when reviewing marketing statements. I often use this example when educating about how "informational" blogs can easily cross the line into claims. Here's a post from last year about this. I also suggest removing any high-risk "buzzwords" from the blog, including pictures and clinical study URLs. Here is a post and video about finding and placing these high-risk disease words . Product blogs: These are considered "extensions of a product label" and, therefore, must be ultra compliant. If a company wouldn't write "pain" on the label, this word should not be used in a product blog. The same rules about "buzzwords" apply here. Here is a video about reducing risks when using blogs . Here is a detailed post where I discuss blogs and much more! "Warning Letter Review: What Went Wrong & How to Avoid " 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!

Words like “may help with” is not a get-out-of-claims-jail-free card < Back Supplement & CBD company cited for disease claims Words like “may help with” is not a get-out-of-claims-jail-free card Supplement & CBD company cited for disease claims. #WarningLetterWednesday The FDA inspected the company facility in October 2021, then six months later reviewed the website for disease claims, finding many that resulted in a warning letter. This is a trend. In the past year, there have been several warning letters like this, where an FDA inspection led to a website review several months later, and many disease claims were uncovered. This is a friendly reminder to re-review the website for disease words after an FDA inspection, as they will look at this months later. Even well-intentioned companies may unknowingly have high-risk words lurking on old blogs and social media posts. Here is a post about this . From warning letter: “On your webpage for “Elderberry Plus Vitamin C”…“Aids with cold, flu and virus symptoms” Takeaway: This is an example of an unknowing copywriter using common language about elderberries, then copying this onto a product page. This is another reason to build a culture of compliance from within to help social and copywriter employees, the ‘front line of defense’ employees, understand how not to inadvertently turn a disease claim into a drug. I have lots of free content to support this, such as this post and video . This letter also includes CBD. There have been 26 CBD-related warning letters this year, up from just seven in 2021. This is a clear sign that the FDA will continue to focus on CBD companies making disease claims while essentially leaving CBD companies that follow GMP manufacturing practices and do not make risky claims alone. From warning letter: “CBD Gummies may help relieve pain, inflammation, anxiety, and depression.” Takeaway: Using words like “may” and “studies suggest” is not a get-out-of-claims-jail-free card. 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!

Kratom companies should be aware < Back Kratom Company Issued Warning Letter for Opioid Support Claims Kratom companies should be aware FDA recently issued its first kratom warning letter of the year to a company making opioid withdrawal and support claims. 🔷So far this year FDA has been quiet on kratom enforcement compared with the four kratom-related warning letters they issued last. All these letters have the same theme, with the companies making opioid withdrawal and support claims. Products marketed for opioid and substance withdrawal remain a high risk as those suffering from addiction are considered a “vulnerable population” and are top of mind for the FDA/FTC. Other vulnerable populations are the elderly, children, and those with mental illness. 🔷This warning letter also makes a comparison to drugs. As we know, comparing an herb or supplement to a drug is a great way to attract FDA attention, as I wrote about here . 👉From warning letter. “Although kratom is not an opiate, it produces effects similar to opiate drugs. For this reason, kratom is often sought after for its analgesic effects. It is also used by those addicted to opioids to help with their withdrawal symptoms.” 🔷FDA has a very unfavorable position on kratom and considers it a New Dietary Ingredient (NDI) according to this import alert , but I am unaware of any successful kratom NDI submission at this time. FDA also sent out this kratom alert where several US Marshall kratom seizures are highlighted, including $3 million worth of kratom in February. There have also been numerous kratom-related recalls because of salmonella contamination. 🔷The family of a deceased person who apparently died from kratom use was just issued summary judgment in their case, which opens up not only the manufacturer but possibly the distributor to penalties. It seems like kratom is for sale everywhere, and I wonder if this case will give these smoke shops and gas stations pause before selling kratom. At the very least, I hope it will encourage distributors to do quality, labeling, and safety checks on the kratom products it sells. 👉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!

When will FDA go after “Nature’s Ozempic” claims < Back Biomarker Claims Enforcement When will FDA go after “Nature’s Ozempic” claims Making biomarker claims about dietary supplements has some risks, and here I explore enforcement trends to be aware of. In recent years, the FDA has increased scrutiny of biomarker-related claims, especially those linked to serious health conditions like heart disease and diabetes. A significant shift occurred in 2022 when the FDA began issuing warning letters for claims that were previously considered risky but not ultra-high risk. These include statements such as "lowers LDLs," "lowers cholesterol," and even "lowers bad fats" without the use of higher-risk terminology like "hypertension." Other biomarker claims that have been cited include "lowering A1C levels and blood sugar," which implies an effect on diabetes management, and "reducing arterial plaque," which suggests an influence on preventing cardiovascular disease. Interestingly, while FDA has cited heart health-related biomarker claims, there have not been notable warning letters related to C-reactive protein (CRP) or other inflammatory biomarkers. FDA seems to generally take a "hands-off" approach regarding discussions of inflammatory biomarkers, as long as no explicit disease claims are made. This suggests that while some biomarker claims may fall into the grey area, companies should use caution and keep up to date on enforcement trends to avoid crossing into disease claim territory. One hot area to watch is GLP-1 claims, which, when combined with claims such as "Nature's Ozempic," may be enough for a warning letter. DATE ORIGINALLY POSTED: 9/25/24 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!

Unsafe products marketed to children are deceptive < Back FDA/FTC Delta 8 Warning Letters Unsafe products marketed to children are deceptive Products like Doweedos Delta-8 Edible Chips were cited in yesterday's joint FDA/FTC warning letters. There were actually six warning letters sent in this enforcement action group, but for some reason, only five were joint FDA/FTC letters, and one was just an FDA letter. The FTC has more "teeth" than FDA, and these joint letters should send warning shots to sellers of THC and delta 8 products that are packaged favorably to children. Unfortunately, since this is not the first of these actions , I am unsure if the delta 8 market has gotten (or cares) about the message. One of the most interesting parts of this action is the use of Section 5 of the FTC Act, which prohibits unfair or deceptive acts. This prohibition includes practices that present unwarranted health or safety risks. Delta 8 poses dangers, especially to children, in favorable formats like cookies and bright-colored candy that looks like store-bought food. This is considered deceptive marketing. From warning letter. "Preventing practices that present unwarranted health and safety risks, particularly to children, is one of the Commission's highest priorities." Distributors are responsible: The companies in this enforcement action appear to be distributors of other products, showing that marketplace websites can be on the hook for what they sell. In the past FDA has primarily focused on large distributors like Amazon or websites selling dangerous products like delta 8. FDA does not like delta 8 for good reason, as shown in this consumer update . Delta 8 can be dangerous, and according to data from National poison control centers, 2,362 delta 8 exposure cases had been reported, including "One pediatric case was coded with a medical outcome of death." This report warns consumers that delta 8 products are widely available in forms favorable to children, such as chocolates and candies. This should have given the delta 8 industry pause, but these products have unfortunately continued to increase. The warning letters go into great detail about how the products mimic candy and other typical children's junk food. Here are some of the more appalling (and humorous) examples. Trips Ahoy Chocolate Chip Cookies: Flaming Hot Weedos Double Stuff Stoneo cookies This FTC quote sums it up nicely. "Companies that market and sell edible THC products that are easily mistaken for snacks and candy are not only acting illegally, but they are also putting the health of young children at risk," said Samuel Levine, Director of the FTC's Bureau of Consumer Protection. "Those that prioritize profits in front of children's safety are at serious risk of legal action." FDA reviewed many of these websites starting earlier this year and, according to the warning letters, re-reviewed the websites over the past few months. I ask, "What can we do to support the agency in removing these products from the market quickly, rather than having to go through the several months-long process they did here?" I think we can all agree taking these products out of the potential hands of kids is a good thing. In some instances, the online sellers removed only the products mentioned in the warning letters but continued to sell dangerous products. I ask, "Will they continue to sell these products, or will they face additional enforcement action?" After writing Warning Letter Wednesday for three years, I am still amazed by some of the bold claims and adulterated products sold, but this company won my "most OTT" prize. In addition to the delta 8 products cited in this warning letter , they are also selling pounds of psilocybin mushrooms from their website. The last I checked, these were Schedule 1 drugs, which means the potential for big legal issues. Oy vey! Here's the FTC press release on this action. DATE ORIGINALLY POSTED: 7/17/24 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!