Dietary Supplement Regulatory Education Series

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For those attending SupplySide West, here are some information about a really action packed and informational session on the Monday of the show. Also, this article may be of interest.

Free webinar on Tuesday! We'll 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 Compliance? will demonstrate how their compliance tools help avoid costly FDA warning letters and litigation through efficient content review and risk management. Sign up here: https://lnkd.in/gHPZ54tA #Supplements #Compliance #TechnologySolutions

This #WarningLetterWednesday has some gems and is definitely worth reading. Please share your thoughts or let Asa Waldstein know if you would like to discuss more. https://lnkd.in/gqTPnh2W

Today's #WarningLetterWednesday shares what can go wrong when marketing cosmetics. Read the full post and search three years of previous posts below! I love this stuff! https://lnkd.in/giuvkv8x

This is a cautionary tale of how quality control, food safety oversight, and sanitation, even at one of the world's largest companies, can go wrong. Read the full post here. https://lnkd.in/gGYeape8 Salmonella was discovered at one of Pepsi's granola bar manufacturing facilities. Here's the timeline. ? 11/25/23: Sample confirmed to have Salmonella. ?12/12/23: Testing reconfirmed Salmonella after a suspected lab error investigation. The sample matched the same form of Salmonella that was previously found in the facility a few months before. ? Asa comments: Finding Salmonella in a facility is not uncommon, but not taking the proper steps to remove it from the facility with hazard analysis, cleaning, and testing is a concern. ?12/14/23: Company notified FDA of the recall of some lots of granola products. ?12/19/23: FDA sent the "swab patrol," which usually does not happen so quickly after a recall. One of the samples was positive for Salmonella in a crack in the floor. ? Asa comments: Floor cracks are common hiding places for these pathogens, which shows the importance of not only cleaning but also facility maintenance. ?1/3/24: From FDA: "We advised you of the whole genome sequencing (WGS) results via a conference call on January 3, 2024. You acknowledged that you had identified historical isolates of Salmonella Cubana in your facility since at least 2020. These findings may indicate that the same strain of Salmonella Cubana has survived since 2020." ?1/11/24: Company testing shows the Salmonella migrated to an area of a production line without a kill step, and they issued a recall for all products made at that facility. ? Asa Comments: Issuing a recall of this level is costly. Usually, the plant manager or the head of quality makes the call to "keep going" rather than stopping production and conducting a comprehensive cycle of repairing, cleaning, and swabbing until the pathogen has been eradicated. ?4/3/24: The company decided to close manufacturing operations at this facility. FDA goes on to share that the hazard analysis conducted at the facility after finding Salmonella in 2022 and 2023 was insufficient. From FDA. "Furthermore, your corporate PEM program states that "repeat positive results typically indicate further deep dive," but you did not have any records indicating corrective actions beyond normal cleaning/sanitizing and maintenance (e.g., "deep dive" corrective actions) were taken at your facility." I suggest all teams read the letter as a case study of what can go wrong. At my consulting company Supplement Advisory Group, we do not focus on these matters, but if you need food safety support or GMP auditing, I would be happy to share my preferred contacts. https://lnkd.in/g9zS-_sw #WarningLetterWednesday #Salmonella #FoodSafety

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. https://lnkd.in/gggaAJeY There’s more to this case, including bioavailability claims, and I suggest everyone read it. Please let me know your thoughts. https://lnkd.in/gWpHvzGD #WarningLetterWednesday #ClinicallyProven

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. #WarningLetterWednesday #Blog #Supplement

This company received a warning letter for selling tianeptine—a substance deemed dangerous and inappropriate for dietary supplements according to FDA. Read more about FDA’s position here. https://lnkd.in/gDNCh-tq In January FDA inspected this company and determined they sell tianeptine products, but I am unsure why it took until June to issue this letter. There may be a piece of the puzzle missing but this seems like a long time to take this action. I ask, what can we do to support FDA to remove drug-spiked products from the marketplace swiftly? It seems this same company (or its subsidiary) had about $1.3 million in kratom products seized by US Marshals on FDA’s request back in 2021. Read more about this here. https://lnkd.in/dHehPmB Here is a Warning Letter Wednesday post about kratom and opioid claims. https://lnkd.in/gGZKU-wF Here’s an interesting part of the warning letter. FDA cites claims made in an email newsletter. I’ve heard of companies being cited for claims made on labels, websites, socials, catalogs, or brochures but not for email-only newsletters. This shows that all marketing is labeling and is open to scrutiny. From warning letter. Examples of claims from your email blast promotional material, which links back to your website … that provide evidence of the intended use of these products as drugs FYI, at the time of writing, the company’s website was taken down. Read the full warning letter here. https://lnkd.in/gPR-gYUm #WarningLetterWednesday #Tianeptine #RegulatoryCompliance

Videos must disclose material connections when making sponsored content. Here, we learn more about when material connection is needed and what constitutes disclosure, especially when children’s advertising is involved. In this NAD case, the very popular children’s YouTube channel Vlad and Nikki (405 million subscribers, 220 billion views) was cited for not properly disclosing material connections when marketing their own Vlad-and-Niki-branded products. One would think that the material connection is obvious, but here’s NAD’s thinking on the topic. ??From NAD. “CARU determined that not only does the relationship between Vlad and Niki’s videos and the advertiser, who is the party of the licensing and merchandising agreements, constitute a material connection, but because CMG is required to produce the videos under the terms of the agreement and shares in the revenue generated by sales of the Vlad-and-Niki branded products, CMG is also considered an endorser of the products.” Read more about influencer disclosure and best practices here. https://lnkd.in/gPmYvS9e In some cases, these types of disclosures are appropriate, but as NAD states, they are not sufficient when children are involved. ??From NAD. “Other Sponsored Videos used language that CARU and the Federal Trade Commission (FTC) do not consider to be clear to children, such as “sponsored by” or “paid promotion” or the “#ad” disclosure in the description box of the video.” ??From NAD. “CARU recommends that … include language, in both text and audio in the video itself that is clear for children to understand, to clearly and conspicuously disclose the material connection to the video’s sponsor at standardized times (beginning and end and, for longer videos, after each ad break).” We can expect more of these “material connection disclosure” cases as the creator economy grows. The moral of the story is “When in doubt, disclose,” which can mean verbal and written disclosures. For support with influencer marketing compliance and guidance on how to market your products truthfully and effectively, contact me for a free consult. I love this stuff! https://lnkd.in/g8cgh4pj Read the NAD case comments here. https://lnkd.in/gcU4XUk6 #WarningLetterWednesday #InfluencerMarketing #VladAndNikki