Asa Waldstein’s Post

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

Flash back to 2019! This was one of my favorite days in the supplement industry! Dietary Supplement Day on the Hill! It captures a wonderful moment in time, and I can't help but smile when I look at it. Who else was there? I stood on my tippy toes to get in this picture. 😁 Learn more: https://lnkd.in/guHiHJWM

I had a fun time speaking at NoCo Hemp Expo® yesterday in beautiful Estes Park, CO. My interactive presentation covered best practices for labeling and marketing products. For those who do not know, Estes Park is at the foot of Rocky Mountain National Park, which is so beautiful! Before my talk today, I saw a bald eagle and an osprey. I've had the great honor of speaking at NoCo for some years now, including this fun memory from 2021 with Robert Hoban and Tim Gordon! https://lnkd.in/gDYc5rU #RegulatoryEducationSeries #RegulatoryCompliance

Yesterday was fun! I was invited to speak with some really smart MBA students at CU Boulder. We reviewed advertising claims and enforcement trends, which was fabulous! Thanks, Heather Kennedy, for the invite, and thanks, Myranda Owca and crew, for the GREAT discussion! Then, I walked across campus to the monthly Rocky Mountain Artificial Intelligence Interest Meetup. I am lucky to live in such as beautiful place! #RegulatoryEducationSeries #Boulder #Supplments

FDA cited this company for selling a topical magnesium product that also contains ingredients like fulvic acid, vitamin B6, and MSM. Based on website claims FDA concluded the product was an analgesic drug. Here are some of the cited claims from the warning letter. • “For muscle cramps or pains, spray directly on problem area.” • “Designed to provide relief from body tension and soreness.” • “Leg cramps and muscle soreness,” along with “migraines, insomnia, [and] fatigue.” FDA classified this as a “topical external analgesic (OTC) drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h,” which is allowed if the product is made using a specific OTC monograph (recipe) under applicable GMPs. Since the product did not follow the monograph, primarily because other “active” ingredients like MSM are not on the monograph, FDA deemed this product an unapproved new drug. To be fair, the other sections of the warning letter contain very serious disease claims like “cancer” and “depression,” which are likely the primary reason reasons for the letter. Some warning letters like this are very comprehensive and may cite “secondary” claims, which may not be enough to trigger a letter on its own. In the case of the magnesium oil, I doubt making claims about pain or soreness is enough for agency action, but listing diseases related to magnesium deficiency, such as insomnia, and then suggesting the product can address these deficiencies is high risk. I have seen some companies use the nutrient deficiency and disease claim strategy on dietary supplements, which is out of my risk tolerance, but when used on topical products that do not provide absorbable nutrients, it goes too far. As a friendly reminder, topical non-drug products are not allowed to “affect the structure or any function of the body,” which supplements are permitted to do. So would a topical product with a “relieve and soothe” claim attract a warning letter? This is unlikely unless there were adjacent claims like “helps with arthritis,” which turned the product into a drug. Read the full warning letter here. https://lnkd.in/gKr9BU_W #WarningLetterWednesday #Magnesium #DrugClaim

I just can't get enough! I also publish a monthly regulatory newsletter where I share Warning Letter Wednesday highlights and other interesting industry updates. This month I highlight the American Herbal Products Association (AHPA) 30 Years of DSHEA video, Steven Mister eloquently talking about the NYS supplement restriction bill, NDIN master files by Stephen Daniells, Ryan Sensenbrenner AI article, and more. Read the newsletter and sign up for free here. https://lnkd.in/g9JT2nxB #Supplements #RegulatoryCompliance #WarningLetterWednesday #Amazon

In this Natural Products Insider column, I review FTC's enforcement of their new disclosure guidelines for influencers, inflammation claims, OTC drugs, the lack of CBD enforcement, and more. ➡ Read the article here: https://lnkd.in/gcfYUG6 I writing this quarterly column for a couple of years now and love it! Thanks Josh Long for the opportunity! #Supplements #RegulatoryEducationSeries #InfluencerMarketing

Apex Compliance™ visits Haleon! This is a fun memory from two months ago when I visited Haleon in NJ for an interactive Apex Compliance demo. This is a GREAT group, and we had a fabulous time! Learn more about Apex Compliance and schedule a demo here. https://lnkd.in/gK56dyyp https://lnkd.in/gPaeuGiR