Asa Waldstein’s Post

Love this surprise shout-out to Warning Letter Wednesday! I've been writing the weekly #WarningLetterWednesday post for over 2.5 years. This has involved posting while sick with COVID, in the Serengeti watching the wildebeest migration, while at conferences, on family vacations, and when just plain exhausted. It is a labor of regulatory love, and receiving feedback like this warms the heart. Thank you so much Bruce Kneller!! Search 100+ old posts by keywords and sign up here. https://lnkd.in/g4kjgnZu #Supplements #RegulatoryCompliance

There are three lessons in this Warning Letter Wednesday post. Labeling major allergens, avoiding label mix-ups, and hazard analyses are required for conventional food. Sign up for the weekly Warning Letter Wednesday, and see 100+ previous posts here. https://lnkd.in/eB6Pxhzw The specific type of allergen is needed for tree nuts, crustacean shellfish, and fish. This is still a common error that I see when reviewing dietary supplement labels. • The specific species of fish (e.g., bass, flounder, tilapia, salmon or cod) • The specific species of Crustacean shellfish (e.g., crab, lobster, or shrimp) • The specific type of tree nut (e.g., almonds, pecans, or walnuts) I review 10+ dietary supplement labels each month at my consulting company, Supplement Advisory Group. Contact me to learn more about this and my website/content compliance review services. I love this stuff. Proper labeling and packaging control can prevent dangerous and expensive mix-ups. This company put the wrong labels on which resulted in recalls and the warning letter. Proper packaging process control and documentation are critical in manufacturing, and up-front organization can prevent expensive issues. I use consultants like Nate Call, CMQ/OE & Blake Ebersole for Quality Management System development and implementation. If you want an introduction, please let me know. Conventional food companies must comply with all subparts of 21 CFR 117, which include a risk-based hazard analysis. There are so many warning letters about this essential aspect of food safety. As a side point, dietary supplements need to only comply with some of the 21 CFR 117 subparts. https://lnkd.in/gb_WXfZF Here is a good FDA resource that includes directions on listing major allergens and common seafood names. If you know of a better allergen resource, please do share. https://lnkd.in/gBV92qMM Read the full warning letter here. https://lnkd.in/gxZ2Wu_j #WarningLetterWednesday #MajorAllergen #FSMA

Geneva! I am so excited to announce I've been invited to Vitafoods Europe as a Startup Innovation Finalist! Apex Compliance™ is a (top 6) finalist in the most innovative service, technology, or digital solution for the nutraceutical industry category! WOW! This is such a wonderful opportunity that involves a closed-door "shark tank" style pitch and then a public presentation the next day! Giving thanks! #Vitafoods #Supplements #RegulatoryCompliance

What a month it has been (so far)! Here are some of the highlights which include: *Invited to Vitafoods in Geneva to participate as a Start-Up Finalist (OMG)! *Speaking at three events *Attending Supplyside East & What's Up With Supps *Publishing two newsletters (and a weekly WLW post) *Record-breaking Apex Compliance™ subscribers and renewals *Invited to speak at the The Mushroom Summit where Paul Stamets will be the keynote *New Apex Compliance testimonials And more Sharing my excitement and gratitude with this short video. #WarningLetterWednesday #SupplysideEast #Supplements

Sharing this mind-blowingly exciting news! Apex Compliance™ has been invited to Vitafoods Europe next month as a Startup Innovation Finalist! Apex Compliance and five other companies have been selected in this category. 🔹 Most Innovative Service, Technology, or Digital Solution Supporting the Nutraceutical Industry This is a "shark tank" style pitch where I'll present our technology to an expert panel behind closed doors and also present on stage to the Vitafoods Europe audience. Come join me if you will be at Vitafoods. We have worked so hard on Apex Compliance, and there have been numerous late nights, working all weekends, and being stressed AF about finances, but since launch 9.5 months ago, things are going great! The best feeling is when we hear comments like "This will save us so much time" and "Apex software takes compliance to the next level." https://lnkd.in/eHbiBeex Startups test your patience and mind, but after winning the NutraIngredients Startup Innovation Award for the Sports & Active Nutrition Summit USA, reading the subscriber feedback, seeing the growing subscriber metrics and nearly nonexistent churn rate, and now being a finalist in Geneva, I am feeling less "crazy" about commercializing my compliance software vision. Thanks everyone for your kindness and support! #Supplements #RegulatoryCompliance #MarketingCompliance

A wonderful Supplyside East and fabulous What's Up With Supps! It was so good to see everyone! Also, I’m thankful so many of you got to meet my daughter Nova at the WUWS event!! She’s heard about Warning Letter Wednesday for years including me having to take a few hours for it during family vacations and it was great for her to hear how loved it is🙏🙏. Thanks for all the kind words! Also, I received the best gift! It’s a lavender Apex Compliance™ lavender eye pillow that reads “Dreaming about regulatory compliance.” The best! Thanks SO much Sarah Burden from Radicle Science!! #Supplements #SupplysideEast #WarningLetterWednesday

Since the beginning of 2023, 11 warning letters have been issued for arthritis-related supplements and topical product claims. Here, I explore these warning letters, look at common trends, and share key takeaways. Higher-risk disease claims: I have always wondered if making arthritis claims alone is enough to trigger a warning letter. The answer is surprisingly “not really.” All warning letters since the beginning of 2023 have included high-risk words like cancer, depression, and fibromyalgia, except one. This warning letter accompanied GMP citations and included arthritis claims that were part of an out-of-compliance OTC drug that did not follow the official monograph. Social media and YouTube: 45% (5 out of 11) mention claims on social media and YouTube. This is not a surprising number, and it shows FDA’s continued focus on social media marketing claims. Some of the cited social posts were a couple of years old, which is a reminder to ensure even those old posts are “clean” of disease claims.   Are you interested in finding the high-risk statements on your website, videos, and content before publishing? My software product, Apex Compliance™, can help you identify and replace these high-risk phrases before they lead to warning letters and lawsuits. Our AI has been custom-trained on compliance principles, including warning letters, and it helps you understand what compliant language looks like. Learn more and set up a free demo here. https://lnkd.in/gK56dyyp   Blogs: 18% include claims made in blogs. I’ve written a lot of this before, such as in this post. https://lnkd.in/g6PETxEq   GMP Inspections Lead to Marketing Review: 27% of letters started with a GMP inspection, which led to a marketing review. I write more about this here. https://lnkd.in/gHhhV3E7   Drug-spiked ingredients were mentioned in 18% of these letters. https://lnkd.in/gWpRXw6F   The moral of the story is to keep disease words like arthritis out of marketing, and they will signal to authorities to look deeper for other high-risk marketing phrases. #WarningLetterWednesday #Arthritis #Supplements #RegulatoryCompliance

The April monthly newsletter has been posted! Read the newsletter and sign up for free here. https://lnkd.in/g9JT2nxB In my monthly newsletter, I review interesting enforcement trends and news in the supplement industry. This month: 🔹 American Herbal Products Association (AHPA) 30 Years of DSHEA video 🔹 Ryan Sensenbrenner's AI article 🔹 Steven Mister eloquently talks about the NYS supplement restriction bill 🔹 NDIN master files discussion by Stephen Daniells 🔹 Amazon seller policy update discussion 🔹 GREAT podcast from Venable LLP about how to mitigate class action risk 🔹 DSHEA Summit by NutraIngredients & United Natural Products Alliance And more! #RegulatoryEducationSeries #WarningLetterWednesday #Supplements

New Amazing Apex Compliance™ Testimonial! Thank you Taylor Maharaj from Care/of for sharing these kind words! "As a Regulatory Manager in the dietary supplement industry, I've found that Apex Compliance™ has significantly enhanced our regulatory compliance approach. Asa's innovative platform not only ensures our content aligns with regulatory standards but also allows for customization to suit our company's specific needs. This user-friendly tool has streamlined our review process, proving invaluable for marketing evaluations like emails, SEO articles, and influencer videos on YouTube. Apex Compliance™ is an essential tool for anyone in the industry looking to bolster their regulatory compliance efforts. It's a transformative solution that offers peace of mind and ensures efficient adherence to regulatory standards."

I am looking forward to attending this important event in Salt Lake City on June 10th! Thank you NutraIngredients & United Natural Products Alliance!! #Supplements #RegulatoryCompliance https://lnkd.in/gC9hUpfy