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NAD challenge cases explored < Back Fruit Snack Wars NAD challenge cases explored The fruit snack wars are on! A few months ago, I wrote about General Mills challenging television commercials by Welch's Fruit Snacks (PIM's). In the commercials, chef Gordon Ramsay throws away "Fruit Flavored Snacks" by tossing them out of a window. That post includes information on "ash canning," an advertising term that describes the practice of portraying competing products as so inferior that they might as well be discarded like ashes. Read that post here . In this case, Welch's Fruit Snacks (PIM's), who was previously on the defense, challenged several claims made by the Mott's brand of General Mills. This shows that bringing NAD cases can have the added ramification of reciprocal action. 👉From NAD. Although these seem minor, they will likely lead to plaintiff lawsuits and demand letters, which are the biggest"impacts" of NAD decisions. "NAD found that General Mills failed to support these implied claims through challenged social media posts and by reviews reposted by General Mills, including: 🔹"These are great. Way [sic] to get my kids to eat fruits and vegetables. They have [had] a package each night after dinner for years and years." 🔹"My kids love eating these and I love the fact that it's made with real fruits and vegetables and no artificial colors. It helps with trying to show them how to eat mindfully and healthy." You may be asking yourself what the big deal is with fruit snacks. I looked this up. Apparently, this is a $4 billion industry in the US. Also, as a complete aside, every time I hear the name Mott's, I think about this 1987 commercial . Read the NAD case here . DATE ORIGINALLY POSTED: 12/4/24 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 Panel Discussion Friday Mar 26, 2021 Regulatory Reality on the Horizon NoCo Hemp Expo, Denver, CO I am honored to share the stage with industry icons Robert Hoban and Tim Gordon . They are some of my industry favorites, and I am so excited about our regulatory panel! The industrial hemp business community is encouraged to stay vigilant, involved and up to date as a number of federal and state bills, USDA, FDA and DEA proposed regulations, and other policy activities impact the hemp market – and your business – on state, national and international levels. Learn more Previous Next

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!

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

< Back Webinar Wednesday Oct 12, 2022 10 Herbal Product Marketing Tips & Pitfalls to Avoid with Asa Waldstein Herb Rally LIVE WEBINAR HOSTED ON ZOOM Asa Waldstein reviews common marketing pitfalls to avoid, such as social media engagement, hashtags, reposting, product reviews, citing studies, and blogs. He will provide practical information on implementing lower-risk marketing strategies without impacting sales. This is a town hall and presentation format so please bring your questions. This online event is LIVE and FREE. Register Previous Next

< Back Podcast, Interview Wednesday Jan 19, 2022 Thought Leadership and Compliance Move The Stairs Podcast Here's what we discuss: FDA's position of Hemp CBD. Why following enforcement trends is important for marketers. Reasons to clean up old social media posts. Step by step process in becoming a thought leader such as "What problem am I having and how can I be extremely helpful to others in helping to solve this?" Why being a thought leader can help companies react appropriately in a crisis or with important news. One great example is how to talk about the recent CBD study without making a product COVID claim. Press release benefits and best practices. Listen Previous Next

The American Herbal Products Association (AHPA) has published a Hemp Lexicon intended to support the standardization of the terminology used in the cultivation, processing, manufacturing, and labeling of hemp and products derived from hemp as defined in U.S. federal law. < Back AHPA publishes Hemp Lexicon Asa Waldstein Interviewed Interview The American Herbal Products Association (AHPA) has published a Hemp Lexicon intended to support the standardization of the terminology used in the cultivation, processing, manufacturing, and labeling of hemp and products derived from hemp as defined in U.S. federal law. Read More Previous Next

Scan socials and websites for risky words like “hordenine” < Back Blood Sugar, Arthritis & Immunity Claims Lead to Warning Letter Scan socials and websites for risky words like “hordenine” The warning letter has a unique “we offer the following comment” section. FDA references bitter orange extract (Citrus aurantium) as an ingredient in the Supplement Fact Panel. It then refers to the product ingredient page where the company states that ingredients like hordenine are components of bitter orange extract. From warning letter. “Bitter orange extract contains neuroactive agents, synephrine, hordenine, and octopamine.” This is detailed diligence by FDA, showing that small copywriter comments can lead to increased scrutiny. FDA goes on to mention the previous hordenine and octopamine warning letters. I write about this here . I suggest scanning websites to see if keywords such as hordenine and octopamine show up. I offer this service and can do this at no charge if you mention “Warning Letter Wednesday.” Many of the claims cited in this warning letter involve the company discussing ingredient benefits. I wrote about this on a #WarningLetterWednesday just a few weeks ago. Blood sugar claims enforcement continues to be top of mind for FDA, and there are several citations in the warning letter. I review 56 diabetes-related warning letters here. Old social media posts are also mentioned in this letter. This includes a post from early in the pandemic with the high-risk word “coronavirus.” I would guess the company had long forgotten about this post. Here is a WLW write-up and video about this. Words ending in “itis” (meaning “inflammation of”) are disease claims, and the most commonly cited “itis” in warning letters is arthritis. This letter references five occurrences of this word, demonstrating that words like arthritis do not belong in supplement marketing. 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!

< Back Podcast Monday Apr 24, 2023 GMPs and Dietary Supplements: A Conversation With the Experts CHPA Chat If you are in the consumer healthcare industry, you probably know about GMPs, or Good Manufacturing Practices. But what do they specifically mean when it comes to dietary supplements, and how do VMS companies prepare for an FDA inspection? Listen Previous Next

According to a Federal Trade Commission official, settlements in a law enforcement sweep against CBD marketers send a "clear message" to the growing sector: "Don’t make spurious health claims that are unsupported by medical science." < Back FTC targets CBD marketers in law enforcement sweep Josh Long Interview According to a Federal Trade Commission official, settlements in a law enforcement sweep against CBD marketers send a "clear message" to the growing sector: "Don’t make spurious health claims that are unsupported by medical science." Read More Previous Next

< Back Solo presentation, Panel Discussion Wednesday Feb 14, 2024 Sports & Active Nutrition Summit USA Sports & Active Nutrition Summit USA San Diego The 2024 Sports & Active Nutrition Summit USA will return to San Diego for its sixth year on February 12, 13 & 14 at the Hyatt Regency Mission Bay. Produced by NutraIngredients-USA.com , this summit serves as a pivotal gathering for professionals in the sports and active nutrition sector, facilitating connections between cutting-edge science, business strategy, and key regulatory developments. This must attend three-day summit will showcase expert presentations, dynamic panel discussions, various networking opportunities, and a wellness program. It provides a comprehensive platform, serving as a one-stop shop for the latest indispensable insights in the realms of sports and active nutrition. See our most recent newsletter which highlighted this event. Learn More Previous Next