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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!

Review of NAD case < Back Finished Product: Clinical Study Required Review of NAD case Are clinical studies really needed on finished dietary supplements? Here, I review a recent National Advertising Division (NAD) case on the topic. Full disclosure: I like NAD, and their cases are a wealth of learning opportunities, but the interesting and somewhat mind-boggling portion of this case has to do with performance claims. Based on the information provided, it seems that NAD requires a finished product study to substantiate the “helps maintain healthy eyesight and visual performance” statement. 🔹 NAD states this is “because the studies and meta-analysis relied on by the advertiser were not conducted on the (product).” 🔹 NAD goes on to say, “NAD recommended the claim be discontinued but noted that nothing in its decision prevents (product) from tailoring its claims to the benefits specific ingredients in (product).” A takeaway here is attributing substantiated structure-function claims to ingredients like “vitamin C for skin health” rather than simply stating the product is used for skin health is a risk-lowering strategy. I still feel like I am missing something here because I can’t imagine agencies or courts requiring finished product studies for low-risk structure-function claims that do not state the product is clinically proven. I write more about these important points from the FTC’s Notice of Penalty Offence letters here . There’s more to this case , including bioavailability claims, and I suggest everyone read it. Please let me know 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!

All social media is “fair game” for enforcement < Back LinkedIn Posts Mentioned in Warning Letter All social media is “fair game” for enforcement It is no surprise that company social media posts are considered marketing claims, as they are commonly mentioned in warning letters. Interestingly, this letter references posts made on LinkedIn. This is a new aspect of enforcement, as previously, I have only seen claims made on a company's LinkedIn page mentioned in warning letters. I find it interesting the FDA is looking at actual posts on LinkedIn, which is an important reminder that all marketing must be compliant and is "fair game" for regulatory scrutiny. This warning letter is Covid-related, which, of course, is a very high risk; however, it is a reminder that hashtags and reposting content elevate risk. In this example, a "Covid study" is shared, and the material connection is solidified with a covid hashtag and a hashtag containing the product's name. From Warning Letter "More evidence that respiratory diseases should be treated in the nose and throat! .... # biovanta # science # covid" [from a post on your social media webpage at...." Read the full warning letter here. This joint FDA and FTC warning letter includes an FTC cease and desist prohibiting the company from making future Covid claims. This sets the FTC up to potentially impose financial penalties and has more "teeth" than a standard 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!

Claims in hashtags, videos, and testimonials should be avoided < Back More Marketing Lessons From COVID Letter Claims in hashtags, videos, and testimonials should be avoided More overt COVID claims are cited in this warning letter. We all know that making COVID claims about supplements is wrong, but let's explore key learning lessons you can apply to your marketing. 🔹This warning letter cites claims made in YouTube videos, and I expect more to come. In this letter, FDA builds the "commercial bridge" from the YouTube page to where customers can order products. It probably wouldn't have been mentioned if this was truly an educational page with no shopping cart links. 👉From warning letter. "where you direct consumers to your websites …. respectively, to purchase your products. 🔹COVID hashtags are cited in this warning letter. Noncompliant hashtags are the quickest way to turn a compliant post into a disease claim. 🔹Testimonials are also mentioned in this letter. I'm always interested to learn what the authorities consider a third-party review and what they consider a marketing claim. In this letter, the reviews were on their own "Testimonials" page and were showcased, which is a clear marketing claim in the eyes of the agency. 🔹Asa rant: Most of the claims cited in the warning letter have been removed, but there are still A LOT of COVID claims on their product's website and socials. This is a small, publicly traded corporation, and I am surprised by its audacity. Is the next step an injunction? I do not know much about the agency's inner workings, but it seems this would have been a good joint FDA/FTC warning letter. FTC has more "teeth" and can require companies to stop making unsupported claims or face civil penalties of up to $46,517 per violation and requirements to refund customers. Also, this warning letter was issued last November but was just posted yesterday, and I find the timeline perplexing. 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!

Well intentioned marketing claims can turn products into high-risk regulatory categories < Back Goat Milk Company Infant Formula Claims Well intentioned marketing claims can turn products into high-risk regulatory categories This goat milk supplement and food company was cited for claiming its goat milk product is an alternative to infant formula. This is a great example of how well-intentioned marketing statements can cross the line into a risky regulatory category. Let’s explore what went wrong. FDA looked at this company’s website and social media and determined their Goat Milk Formula Recipe Kit met the definition of infant formula because it was “purported to be or was represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.” Essentially, this means the company was promoting their product as infant formula. Here are some of FDA’s warning letter references. "We have created a formula recipe that mimics breast milk and follows the guidelines created by the 1980 Infant Formula Act.” Your February 12, 2024 (Facebook) post: “‘Infant formula is the number one regulated food in the U.S., and yet the allowable ingredients in off-the-shelf infant formula is often times very very poor. So there is a very good incentive to make your own formula.’ Get to know the creator, Joe Stout, and learn about the Goat Milk Formula Recipe on the GMF Livestream replay! . . . #DIYBabyFormula . . .” I ran Apex Compliance on their website and found A LOT of very high-risk marketing claims, and I suggest this company look at conducting a compliance audit. Apex Compliance was developed for this type of situation, sifting through large amounts of information and providing a line-by-line playbook showing where risky phrases occur, their risk rating, and some possible lower-risk alternatives. Learn more here . To give the company credit, they seemed to go above and beyond to correct the matter once FDA brought this to their attention. It seems that even though they worked diligently to correct their mistake, FDA issued the warning letter to “ensure the violation does not recur.” Infants are classified as a “vulnerable population,” and this warning letter language demonstrates how seriously FDA takes the infant formula category. From warning letter. “We acknowledge that after a teleconference with you on May 7, 2024, you voluntarily recalled all Goat Milk Formula Recipe Kit ... We are aware that you contacted all customers who received product during that timeframe to inform them that the product should not be used as an infant formula. Additionally, you issued a press release on May 10, 2024, clarifying to the general public that you do not recommend using this product for infants from 0-12 months of age. We also acknowledge that you removed the ability to purchase the Goat Milk Formula Recipe Kit from your website, and that you made some changes to your website and social media websites, including but not limited to removing the above-mentioned statements regarding use as an infant formula. However, due to the serious public health concerns related to your unlawful marketing of a new infant formula, it is essential that this violation does not recur.” Read the full warning letter here . DATE ORIGINALLY POSTED: 10/9/24 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!

Correct FDA 483s to avoid a warning letter < Back Most GMP violations involve setting & documenting specifications Correct FDA 483s to avoid a warning letter #WarningLetterWednesday reviews a cGMP manufacturing warning letter. This is a good teaching case about the basics of Good Manufacturing Practices (GMPs) for dietary supplements as this company made some of the most common mistakes. Regulatory expert Steven Yeager and I discuss “How to Prepare for FDA Inspections” in the following webinar . We’ve both helped oversee several FDA CFR 111 inspections with no warning letters and we have fun sharing our helpful tips and hints. Steven and I also presented a four-hour GMP and marketing compliance workshop here at the American Herbalists Guild. This letter includes the most common violation of not establishing and documenting specifications for the identity, purity, strength, and composition. Another common mistake is not having documentation showing a member of the quality team approved specifications and product labels. This role of quality is at the core of GMPs. Imagine the mix-ups and potential adulteration that could occur if the production team was allowed to apply labels without oversight. We recently saw this happen in a CBD company that inadvertently applied CBD labels to the THC product which resulted in serious adverse events. Another important reminder is the requirement to list the plant parts such as leaves or fruit. Also noted is the requirement to have proper Supplement Fact Panel line thickness and bolding. Although these will not attract a warning letter on their own it is better to have a correct label layout. There are so many more violations listed in this letter and I suggest reading the full warning letter here . It is interesting to look at the timelines in this warning letter. The inspection was in May of 2021 when a 483 was issued but the warning letter was not issued until six months later. This gave the company plenty of time to correct the 483 and avoid a letter. Learn more about the difference between 483’s and warning letters here . The very big surprise is the FDA didn’t appear to review the company’s website before the inspection. Normally, the best thing a company can do to prepare for a GMP inspection is to remove all high-risk online marketing claims as FDA investigators review websites and social media before the inspection. This company is very lucky as they still have LOTS of high-risk website claims. This is a strong risk for a repeat warning letter. Learn more about “Reasons to Avoid “Warning Letters” 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!

Flu & virus claims are enough for regulatory action < Back Website & Social Claims Lead To Warning Letter Flu & virus claims are enough for regulatory action This company was making claims about virus and flu prevention on its website and social media accounts, which led to a warning letter. Here are some of the high-risk claims from the warning letter. 🔹“Support the immune system against virus and germs” 🔹“Vitamin C stimulates antibody production to aid the immune system in reducing the severity and duration of colds” Many may not know that I have a certified clinical herbalist background, and I love plant medicine. Some botanicals do have antiviral properties, such as the wonderful osha plant here in the Rocky Mountains, and herbal texts and people talk about the benefits of plants. This is OK, but it crosses the compliance line when companies use these descriptors to market their products. It seems this is what happened here: a potentially unaware company copying and pasting product benefits from herbal texts, scientific journals, or ChatGPT. Here are a few basic rules for avoiding this issue. 🔹Avoid words ending in “itis,” which means “inflammation of.” 🔹Avoid most words with “anti” such as “antiviral.” 🔹Avoid comparing products to drugs, especially those in the mental health, blood sugar, or heart health categories. 🔹Use caution in the immune category. For example, “immune support” may be allowed with substantiation, but “use when sick” is going too far. 🔹Search Warning Letter Wednesday for what others have been cited for. I’ve written this for ~3 years, and old posts are searchable by keyword. There are also several mid-risk claims in this warning letter. Even though they should be avoided in dietary supplement marketing, they are not typically enough for a warning letter. Here are some examples of mid-risk claims. From warning letter. 🔹“Helps…and pain of the throat” 🔹“DIMINISHES PHLEGM: …. contains a generous dose of ginger, which has been used for centuries as a natural decongestant and antihistamine." 🔹“ALLEVIATES SORE THROATS: …. has a generous amount of honey which will quickly reduce inflammation and soothe your respiratory system.” Read the full warning letter . DATE ORIGINALLY POSTED: 8/7/24 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!

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!