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< Back Interview Tuesday Jun 15, 2021 Compliance Pitfalls to Avoid CBD Association Have a cannabinoid company and worried about falling victim to easily avoidable compliance pitfalls? If so, watch the CBD Association's vlog and learn from dietary supplement expert Asa Waldstein about the best business practices your company should be following. We also discuss the cannabinoid regulatory, marketing, and enforcement trend landscape. Learn More Previous Next

Following specifications prevents greater issues < Back Heavy Metal Contamination Leads to Recall Following specifications prevents greater issues High lead recall alert! A dietary supplement company in New York issued a recall for its finished product, Shatavari, due to high lead levels. Greetings from Expo West! Today's Warning Letter Wednesday reviews the importance of making and following specifications. Sign up for my weekly blog here , which allows you to search 150+ previous posts. The batch of high-lead products has been in circulation since 2022 and was recently tested by the Connecticut Department of Consumer Protection's Food & Standards Division, which resulted in the recall. Thank you for finding this CDCP! Botanicals contain "naturally occurring" amounts of heavy metals, especially in the roots, which is why ingredients and finished product specifications are required to test these items. The American Herbal Products Association (AHPA) is a good resource for understanding specifications, but keep in mind that retailers and states like California (Prop 65) may have their own requirements. The most common warning letter violations involve specifications being incorrectly written or followed. Here are a couple of Warning Letter Wednesday posts about this. 🔹 1/22/25: Incomplete Batch Records & Ingredient Specifications 🔹 7/31/24: GMP Manufacturing Lessons As Warning Letter Wednesday readers know, I am not a company or product basher, which is why I typically don't call out company names in my newsletter. I, however, always provide a link to the warning letter or case so inquisitive subscribers can explore publicly available documents. When I look at the recall notice in more detail, I also see labeling issues such as the Statement of Identity "Herbal Supplement" or Dietary Supplement" missing from the Principal Display Panel (PDP). This is considered a major labeling violation, and it signals deeper compliance issues to anyone who is a label reader. The adage "Where there's smoke, there's fire" is often true with labeling violations. I then ran Apex Compliance® on the company's website and found several over-the-top disease claims. Since recalls often lead to warning letters, now is the time for this company to remove these risky marketing phrases. Also, to anyone who sells Shatavari, expect the FDA to ask about your specifications and testing during your next inspection. 👉 I write about the joys of being a label reader while traveling here (280k impressions). 👉 Read about the recall here . DATE ORIGINALLY POSTED: 3/5/25 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!

Find and remove high-risk “buzzwords” < Back PTSD Claims Enforcement Increasing Find and remove high-risk “buzzwords” FDA enforcement of PTSD claims is increasing. This year there have been five PTSD-related warning letters, up from just three PTSD-related letters in all of 2021. This is an example of a high-risk “buzzword” to watch out for, and a great opportunity for companies to ensure this word is not lurking in any marketing. Look for high-risk words in: 🔷 Old social media posts. 🔷 Blogs: Here is a post about best practices for reducing risks when writing blogs. 🔷 Hashtags: Here is a video about this. Here's a post about removing high-risk "buzzwords". Most PTSD letters also mention CBD, meaning any company selling cannabinoids should especially ensure they are not using high-risk words. 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!

Do's and don'ts of puffery < Back Puffery Claims Explored Do's and don'ts of puffery Puffery is one of my favorite advertising compliance discussions. Last week, I attended the ACI Substantiation Conference in NYC, where puffery was widely discussed. A recent National Advertising Division (NAD) case determined that a beef jerky company’s “the best” and “Clearly the best” statements were puffery. OK, I know I write about supplements, but we can learn from the beef jerky NAD case. Also, I go into more detail about what constitutes puffery below. According to NAD, puffery is “an exaggerated, blustering, or boastful statement or general claim that could only be understood to be an expression of opinion, not a statement of fact.” From NAD case. “Old Trapper’s “Clearly the Best Beef Jerky” slogan, when used on its product packaging and website, conveys a message of corporate pride, and the use of “best” is not comparative as no specific competitor or ingredient is identified. In these contexts, the challenged claims are unquantifiable and, therefore, puffery.” “The claim “The Best Ingredients Create the Best Beef Jerky” which appears prominently on the Old Trapper website landing page, did not convey a specific comparative superiority message.” “Old Trapper’s 15-second YouTube video that depicted a single bag of Old Trapper jerky while “Old Trapper is Clearly the Best Beef Jerky. Clearly More. Clearly Nothing to Hide. Clearly Fresh. Clearly the Best”, did not convey a comparative superiority message because the video only featured Old Trapper, did not tout attributes other than a single reference to “clearly fresh,” and did not refer to or depict any competitors or competitors’ products.” NAD did however find that the company’s “We use only the highest quality ingredients” is an objective claim that requires support. If they had stayed with the “Only the best ingredients make the best products” claim, this would have likely been considered puffery. NAD looks at whether a claim is provable, measurable, or is an opinion. Here are three parameters of puffery (with examples). Thanks for this, NAD! 1) Puffery as exaggeration: We all remember the movie Elf, where Will Ferrell declares the crummy coffee was, in fact, the “World’s best of coffee.” This statement is so exaggerated that no reasonable consumer would believe this to be accurate. If a company advertised “Best cup of coffee in Boulder,” then perhaps it would no longer be puffery. Adding quantifiable comments such as “#1 coffee choice in Boulder” would require substantiation. 2) Puffery as an opinion: “The best almonds make the best almond milk.” was considered to be proof of corporate pride in its product and was not a comparative claim. This would require substantiation if it could be quantified, such as “We only use the best California almonds.” 3) Puffery from depictions and imagery: This example shows how context matters and that even if a claim is puffery, the corresponding imagery can make it a claim requiring substantiation. a. A statement that may have been puffery in isolation but was presented in the context of other claims that made it NOT puffery. Many of us may remember the “Hefty, hefty, hefty. Wimpy, wimpy, wimpy.” advertisements. NAD found that in a radio advertisement, this line was puffery, but when used in a television commercial featuring John Cena, who is very large, and Rob Schneider (much smaller), the visual commercial made Glad Bags seem wimpy. NAD has a podcast about puffery. Learn more here . Read the beef jerky NAD case here . DATE ORIGINALLY POSTED: 2/14/24 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!

< Back Webinar Tuesday Sep 24, 2024 Technology solutions for marketing and manufacturing supplements in the US FoodChain ID Asa Waldstein of Apex Compliance and Jérôme Le Bloch and Amélie Denis of FoodChain ID partner in this educational webinar. They review technology solutions for ingredient suitability, marketing compliance, and more. Ingredient Suitability & Claims: FoodChain ID’s experts will guide you through determining ingredient suitability and navigating claims regulations in the U.S. Regulatory Compliance: Discover how FoodChain ID’s Supplements R&D Insight tool offers comprehensive regulatory data and scientific analysis to simplify compliance. Content & Enforcement Trends: Apex will demonstrate how their Compliance tools help avoid costly FDA warning letters and litigation through efficient content review and risk management. Learn More and Register Previous Next

< Back Panel Discussion, Webinar Tuesday Apr 9, 2024 New Technology: Opportunities and challenges in the dietary supplement industry AHPA Webinar Technology is evolving rapidly, with new tools emerging that impact our daily lives both personally and professionally. In the dietary supplement industry, innovations like A.I., blockchain, and zero knowledge proof are being applied in novel ways to improve the safety, quality, and efficacy of herbal and natural products. In this webinar, expert speakers will bring awareness to some of these new technologies and discuss: How new technologies can be used to support regulatory compliance, product integrity, and new ingredient discovery Potential advantages and disadvantages Associated risks and trends in litigation Speakers: Asa Waldstein (Supplement Advisory Group) Derek Lurth (HealthLoq) Dr. Swati Kalgaonkar (Brightseed) Carolyn Riggs (Ice Miller) Kristina Dahmann (Ice Miller) Moderator: Robert Marriott (AHPA) Registration: AHPA member: $199 Non-member: $399 Can't attend live? Registration includes on-demand access to the webinar recording and materials following the event. Don't miss out! Register Previous Next

A roundup of thought-provoking posts we saw on social media! < Back The Buzz in Natural: December 2024 WholeFoods Magazine Staff Press Mention A roundup of thought-provoking posts we saw on social media! Asa Waldstein , Principal of Supplement Advisory Group, got the industry digging out their dusty old photo albums when he posted: “I'm kicking off a new trend to celebrate the 30th anniversary of the Dietary Supplement Health and Education Act (DSHEA) of 1994, which paved the way for the supplements industry as we know it today. Withou t #DSHEA , there wouldn't be a lawful pathway for us to sell and enjoy supplements…Let the fun begin!” Waldstein’s challenge: Post a picture of yourself from 1994,, and share a short sentence about what you like about the supplement industry. Include the hashtag #DSHEA94Pic in the post. The industry accepted the challenge–check out #DSHEA94Pic on LinkedIn to see throwback pics from industry members throughout the supply chain. And join the fun! Post your 1994 photo (or as close as you can get) and let us know what you like about this industry! Read More Previous Next

Brands need to ensure regulatory responsibilities are accounted for at the start of a contract manufacturing partnership. < Back Compliance responsibilities when using a contract manufacturer Rachel Adams Press Mention Brands need to ensure regulatory responsibilities are accounted for at the start of a contract manufacturing partnership. Read More Previous Next

Study citations are marketing < Back GMP Inspection Leads to Online Scrutiny Study citations are marketing This is another example of a GMP inspection leading to a website and social media review. The initial FDA inspection was in April this year, but the website was not reviewed until September and October! This trend is common in warning letters, and FDA does not appear to critique online marketing until months after the initial inspection. This is a reminder for companies inspected in the past year to re-review online marketing to ensure there are no compliance concerns. This includes blog posts that cross the line from education to marketing. Study citations are marketing. There have been several letters where companies highlight research about ingredients like elderberry. This is considered marketing if those ingredients are in products sold on the site, and I talk more about this here . Now is a good time to review your elderberry and other ingredient marketing to ensure there are no “forgotten” ingredient claims. From warning letter. “The Study showed that Elderberry extract is effective in treatment of flu.” Testimonials are becoming more common in warning letters. This company copied a customer testimonial onto a social media image, which is considered “endorsing the testimonial.” From warning letter. “Facebook image post: Joint Support Capsules … Amazing. Really works. Muscle pain and nerve pain.” Several blog claims are cited in this warning letter. A common blog writer trap is to use sensational titles such as “Can Turmeric Help Reduce the Risk of Strokes”? As discussed above, this is a marketing claim if turmeric is sold on the site. Here are some best practices for reducing blog risk. There are several GMP violations cited in this warning letter. They probably wouldn’t have elevated to a warning letter if adequately addressed and if there were no online disease claims present. Companies continue to be cited for not demonstrating the identity of the finished herbal product blend, even if the individual ingredients have been tested and the blending has been validated. To show the finished product identity, a specific method needs to be developed. Does a small company need to spend valuable resources to develop a specific method just to confirm the identity of an herbal blend? I find this rigid interpretation of the regulations puzzling and a potential burden on industry. Setting herbal specifications too rigidly can lead to issues. This company was cited for not properly handling an ingredient that exceeded its lead limit of 1.45ppm, which is not a high level for an herbal ingredient. This would not have been an issue if the company had set a realistic lead level. This demonstrates the importance of setting up a practical Quality Management System (QMS). A QMS developed with GMPs but also operational efficiency in mind is essential to any growing business. Having a properly functioning QMS is critical, but an overburdensome approach to quality is restrictive. Some companies hire exquisite pharmaceutical managers to develop their QMS, and they get what they pay for, a rock-solid system that is pharma-level, but is this needed in a small to midsize company? Some citations went to quality concerns from 2016, showing that even several-year-old decisions regarding quality can come back to bite a company. The FDA did not feel the company’s 483 responses were sufficient. I write about how improper 483 responses can turn into a warning letter here . 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!

Claims made on social are top of FDA’s mind < Back Twitter Claims Enforcement Increasing Claims made on social are top of FDA’s mind Claims cited on Twitter are increasingly appearing in warning letters. #WarningLetterWednesday This year there have been eight letters mentioning disease claims made on Twitter, up from just 12 Twitter-related letters in all of 2021. This is a strong enforcement trend to watch. Several recent warning letters mentioned tweets over 3+ years old, including this one that mentions a retweet from 2014! Wow, this is old! From the warning letter: You retweeted another user’s September 26, 2014 tweet, which said, “#lipoicacid [an ingredient in your R-Lipoic Acid Vegcaps 300 mg and R-Lipoic Acid Vegcaps 100 mg] model treats autonomic neuropathy…...is the best! I’ve tried it.” This is an important reminder to remove old social media posts that may contain disease claims. Here is a video about this . Many of these letters also include claims made in hashtags, which is a great way to attract FDA scrutiny. View my hashtags are claims video 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!

Free products should also be disclosed < Back Influencers Must Disclose Material Connection Free products should also be disclosed Disclosing material connections is an important part of influencer and ambassador marketing, including when customers receive free products and post about them. Drunk Elephant, a well-known skincare brand, was recently targeted by the National Advertising Division (NAD) for alleged violations of their influencers and ambassadors not disclosing material connection. Here’s what we can learn. 👉 From NAD case: "A company influencer states “@Drunk Elephant you did it again – you guys know I’m obsessed with the bronzing drops… hashtag#drunkelephantpartner .” NAD goes on to state “The hashtag is on the fifth line and only visible if the viewer clicks on the hyperlink “more.” 🔹Takeaway: Hiding material connection below the “more” section is not considered conspicuous and is therefore not compliant. Adding disclosures at the beginning of the post is always best. Also since this is a video post where the endorsement is made verbally the disclosure should be made verbally as well. 🔹Unpaid product is compensation: In this example the unpaid consumer who receives free product does not disclose material connection. If they would have said “Thanks for the free product” or “I love this free sample” that would be sufficient disclosure. 👉 From NAD case: “The other TikTok video post was created by … an unpaid influencer who received free product from the company. (The) video post did not feature a material connection disclosure. The text accompanying her post states “b-goldi illuminating drops are 10/10.” NAD noted that receiving free product constitutes a material connection that requires disclosure.” Generally speaking, there are two main types of NAD cases. 1) Challenge cases: This is when a competitor challenges the validity of another company’s claims. There is a cost associated with this and typically only larger companies participate in this. This is important to keep in mind if you are “poking the bear” of a large company. For example, saying a product works better than an incumbent product is a quick way to attract a challenge case. 2) Monitoring cases: NAD looks at different categories of claims and then finds claims to challenge. This Drunk Elephant example is a challenge case and since there is little enforcement of TikTok, I expect more NAD scrutiny of this platform. Read the full case here . DATE ORIGINALLY POSTED: 11/20/24 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!