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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!

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

< 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

Companies marketing CBD products should avoid making disease claims < Back 300%+ Increase in CBD Warning Letters This Year Companies marketing CBD products should avoid making disease claims This year there have been 26 CBD-related warning letters. This is up from just seven in all of 2021. That is over a 300% increase, and we are only in August! This shows the FDA's growing intolerance for CBD products that make marketing disease claims. It is important to note all the CBD warning letters included high-risk disease claims such as Alzheimer's, depression, cancer, and PTSD. You may be saying, "of course, companies shouldn't make these claims," which I agree with. However, some of the 26 companies may not have known they were making disease claims, as forgotten several-year-old social media and blogs may have disease claims lurking in them. Here is a post about several-year-old social media posts being called out in a warning letter. CBD for animal products is mentioned in 30% of these 2022 warning letters. It is important to note that the FDA seems to have a lower "tolerance" for claims made about animal products. For example, mentions of "anxiety" and "inflammation" may be enough to attract an animal product warning letter. Still, some higher-risk words such as "depression" are usually present in the human letters. Some of the letters also include bizarre mentions, such as this example of a wrist band that was labeled as a supplement. The issue with this, of course, is that supplements must be ingested. Marketing products like this clearly show the FDA that the company does not understand the basics of dietary supplement regulations. From warning letter: "your website shows Supplement Facts panels for the "Tanka T-FLEX Band ….. your products' labeling states that the products are intended to be worn on the wrist. For example, your website describes how the "patented macromolecular technology works through direct contact with the skin to provide timed controlled-release of up to 30 days." 45% of the warning letters include the disease claim one-two punch "anxiety" and "depression." It should come as no surprise these two disease words continue to be called out in letters. Here is a video about this. Other Common high-risk words are "insomnia," “fibromyalgia,” and “Alzheimer's.” See this post and video for a deeper discussion. From warning letter “post on Instagram states, “What can #CBD do for #animals and our #furbabies ~ #anxiety #inflammation #arthritis #pain #seizures #cancer #cbdoil #health #dogs #cats #horses #cows #freestateoils ->> freestateoils.com/hemp-cbdpellets-for-farm-animals.” The post includes a graphic with photographs of several farm animals and pets, and includes statements such as, “Anti-ANXIETY || Anti - INFLAMMATORY || Anti – ARTHRITIC” The learning target here is the authorities look at the totality of the advertisement. This post is on a social media site that links back to a shopping cart; this is the material connection. The disease hashtags are claims and when a company adds its name in a hashtag, it further elevates the risk. The image with the animals and therapeutic claims such as "anti-anxiety" further demonstrate the intended use of animal disease prevention. Several of the warning letters include study citations. Even mentioning CBD studies on a commercial site is enough to attract a warning letter. Here is an example from one FDA warning letter. "Israeli researchers have launched three clinical trials that utilize CBD's anti-inflammatory properties as potential COVID-19." Here is a post about several CBD companies that received warning letters for similar infractions. More than half of these warning letters include claims made on social media. Here is a post about this. 47% of the warning letters include claims made in blogs. This is a continued enforcement trend, and several letters this year include claims made in old blogs that contained disease words. It is possible the companies didn't realize their several-year-old blogs contained high-risk words. A good reminder for a compliance "tune-up." Here is a post about this. 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!

Arthritis claims attract scrutiny < Back Tips For Understanding What A Claim Is Arthritis claims attract scrutiny Arthritis claims continue to be cited in warning letters. As many of you know, I love teaching about regulatory compliance to help you adjust your marketing and stay ahead of the regulatory curve. We hear about not “making claims,” but it can be challenging to know what a claim is. Here are a few general rules for avoiding high-risk claims that can lead to a warning letter. What other tips can you share? Anything ending in “itis,” such as “arthritis”. “Itis” means “inflammation of,” which helps me remember it should be avoided. Fun fact, “arthritis” is the most commonly referenced of all the words ending in “itis.” Other than “antioxidant” and perhaps “anti-aging,” words with “anti” should be avoided. Immune-related words like “antiviral” or “antitumor” are higher risk than “anti-inflammatory.” Words with an International Classification of Diseases (ICD) code. The name of any illness or syndrome, such as Alzheimer’s or IBS. Some are obvious, but some of the syndromes, like Leaky Gut Syndrome, may not be as obvious. Here is a post about this. Searching past FDA warning letters can help you learn what they’ve previously cited. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters “Better than drugs” statements attract FDA attention. Here’s a WLW post about this. FDA sent out 12 arthritis-related warning letters last year, so please avoid making these types of claims. This includes: Hashtags Showcased testimonials Citing clinical studies Product tags and meta tags Social share meta description FDA has been quiet with supplement warning letters, and I am in New Zealand, so this is a shorter post than normal. I am writing this WLW for the beautiful Coromandel. Yes, I love compliance and writing this post (smiles)! Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

< Back Presentation Friday Sep 3, 2021 Marketing Compliance: Effective Strategies Open Discussion Southern Hemp Expo, Raleigh, NC The Southern Hemp Expo brings together unsurpassed education and networking with the Let’s Talk Hemp Speaker Series . Industry experts, speakers and exhibitors across the supply chain will show you how to RETHINK Hemp . A powerhouse line-up of industry leaders will be on stage to discuss hemp agriculture, business and investing, technology and innovation, wellness, textiles, fiber, food and beverage, composites and building materials — the whole supply chain of opportunity in hemp. Learn More Previous Next

Replace high-risk words on a commercial website < Back Discussing ingredient benefits is a marketing claim Replace high-risk words on a commercial website #WarningLetterWednesday Discussing ingredient benefits on a commercial website can easily cross into product disease claims. This is a common marketing mistake, and I suggest fighting the urge to explain ingredient benefits with high-risk language. 👉Here is a video about replacing high-risk words with lower-risk alternatives. ➡️From warning letter: Persimmon leaves have anti-hypertensive, anti-carcinogenic, and anti-mutagen properties." 👉These are common "claims" mistakes. Here is a video about tips for knowing if a claim is being made. 🔷Read my post about ingredient benefits from a few months ago here : ➡️From warning letter: "Chamomile's mildly sedating and muscle-relaxing effects can help those who suffer from insomnia . . . ." 👉Insomnia claims are high risk. I write about this here . 🔷This warning letter is interesting as there was first an in-person inspection in August 2021, then the FDA reviewed the company's website in November 2021 and recently in February 2022. This is a good reminder for companies to clean up their websites before/during/after GMP inspections, as it seems a few website edits could have prevented this letter. Citing studies can be looked as product marketing claims. ➡️From warning letter: Examples of some of the claims on your website's "TEA AND CANCER PREVENTION – NATIONAL CANCER INSTITUTE" page that provide evidence that your product is intended for use as a drug include: "More than 50 epidemiologic studies of the association between tea consumption and cancer risk have been published since 2006..... 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!

< Back Podcast Wednesday Dec 4, 2024 Unveiling Supplement Regulations: Asa’s Insights on Compliance and Ethical Marketing Natural Products Marketer Podcast Unlock the secrets of dietary supplement regulations with our esteemed guest, Asa, a seasoned regulatory consultant with a background in clinical herbalism. Discover the intricacies of FDA oversight in the supplement industry and learn why the notion that dietary supplements are unregulated is a myth. Asa’s journey from herbal studies in Boulder to advising companies on maintaining compliance provides unique perspectives and invaluable lessons for anyone navigating this complex field. Gain a deeper understanding of the transformative impact of the Dietary Supplement Health and Education Act (DSHEA) and its role in shaping the herbal and dietary supplement industry. We explore the distinction between structure/function claims and disease claims, and how these affect marketing strategies. Delve into the evolution of labeling and marketing regulations, and consider potential legislative updates that could further refine the guidelines set by DSHEA over the past three decades. Lastly, we tackle the challenges retailers face in complying with regulatory guidelines, particularly in the context of influencer marketing and digital platforms. Learn about the risks associated with unsubstantiated claims and how innovative tools like Apex Compliance software are helping companies stay in line with regulations. Through practical advice and expert insights, this episode equips businesses with the knowledge to market their health products ethically and legally. Listen to the Podcast Previous Next

Inflammation + arthritis claims = warning letter < Back Lessons From Inflammation Warning Letters Inflammation + arthritis claims = warning letter Inflammation claims were cited in 17 supplement-related warning letters last year. Here, we’ll look at the lessons we can learn from these letters. Statements like “reduces inflammation” or “anti-inflammatory” are disease claims, but they are not likely to attract a warning letter on their own. 47% of the inflammation claim warning letters (8 of 17) cited in 2023 warning letters include the word arthritis. 53% of these warning letters (9 of 17) include the word “cancer.” Here are some key takeaways. All 17 warning letters include high-risk claims like arthritis, cancer, or Monkeypox, with one exception. This warning letter exception is animal-related and “only” makes inflammation and anti-viral statements. Although risky, this is typically not enough to tip the scale into warning letter category unless it’s an animal product, as FDA has a lower “tolerance” for claims made about animals compared to human products. Although making inflammation claims carries some risk, they are unlikely to be the sole reason for a warning letter. This includes claims made on posts or platforms different from the inflammation claim. This demonstrates how FDA looks at disease claim enforcement. They look at the 10,000-foot view of a company’s online persona and piece together claims from areas like blogs and socials for one big picture of non-compliance. This shows that compliance is not done in a vacuum, and taking a holistic approach to compliance is important. This is one of the approaches we take at my regulatory consulting company, Supplement Advisory Group. Contact me to talk about your consulting needs. 41% of these warning letters involve claims on social media. This is a friendly reminder that even very old social media posts are considered active marketing. 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!

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!