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In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. < Back Q2 warning letter roundup with Asa Waldstein Asa Waldstein Guest Article In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. Read More Previous Next

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 Friday Feb 12, 2021 Preparing For FDA Inspections: Fireside Chat Asa's Regulatory Education Series Asa and Steven Yeager discuss tools on how to prepare for and execute a successful FDA inspection. This includes an "Ask Me Anything" session where you can ask anything from us. How To Prepare: (Examples include): No Claims on Web & Social Media Outside of Building Clean Back Doors locked (GMP prerequisite) SOP Ready: What to do during an FDA inspection And more! Company Conduct: Quickly Turn Around Requests Make Copies of Everything Correct Observations Immediately Work with the investigator And more! Steven Yeager is Director of Quality and Regulatory Affairs for Mountain Rose Herbs and has overseen several FDA GMP inspections. Learn more here . Watch Previous Next

Guest article in Yes Weekly < Back Tips for Lower Risk Marketing Supplements & CBD Products in the Coronavirus Era Asa Waldstein Guest Article Guest article in Yes Weekly Read More Previous Next

Asa and other industry leaders interviewed < Back Stay in your lane: Novel delivery systems must comply with supplement regulations Judy Blatman Interview Asa and other industry leaders interviewed Read More Previous Next

Asa and other industry leaders interviewed < Back Is FDA watching heart health supplements in 2023? 2023 Ingredient trends for food, drinks, dietary supplements, and natural products Jennifer Grebow Interview Asa and other industry leaders interviewed Read More Previous Next

< Back Virtual Fireside Chat Friday Jun 16, 2023 Substantiation Dossiers: Building Trust in Label Claims for Retailers, Influencers, and Consumers Radicle Science June 16, 2023 (10:00 am PT / 1:00 pm ET) The dietary supplement industry has no shortage of attention lately when it comes to the Federal Trade Commission and the recent notices of penalty offenses on label claims. Brands are reaching for substantiation dossiers as a means to provide their retailer partners, influencers, and customers assurance that their label claims are factually accurate. Join Radicle Perspectives with Asa Waldstein , Principal of Supplement Advisory Group , as we discuss how to mitigate label claim risk, the impact recent headlines have had on dietary supplement consumers, and what Asa sees is next when it comes to the FTC drama. Key Topics: Understanding label claim risks in the dietary supplement industry Strategies to mitigate label claim risk through substantiation dossiers Insights into the future of FTC regulations and its implications for the industry Watch On Demand Previous Next

Asa and other industry leaders weigh in. < Back 30 supplement industry voices suggest changes to DSHEA NBJ Interview Asa and other industry leaders weigh in. Asa Waldstein, Supplement Advisory Group: "Since DSHEA was enacted before the internet boom, I would like to see some clarification on what constitutes allowable marketing in the digital sphere. For instance, if the FDA would define the marketing compliance boundaries of reposting and social engagement and help explain why they consider a social media post from years past as active marketing, it could help companies better navigate compliance. There are also antiquated regulations that should be updated, such as 21 CFR 101.93(d), which states that the DSHEA disclaimer should be “on the same panel or page that bears the (structure/function) statement” on labels. This means that if there’s a structure/function claim on the principal display panel, then the DSHEA disclaimer should also be on the same panel. While the FDA does not seem to enforce this, plaintiff attorneys continue to cite this regulation in lawsuits, which creates unnecessary expense (and ugly labels) for supplement companies." Read More Previous Next

In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. < Back Q2 FDA warning letter roundup with Asa Waldstein Asa Waldstein Guest Article In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. Read More Previous Next

< Back Webinar Monday Jun 29, 2020 Hemp-CBD and Prop 65 Pitfalls to Avoid: Town Hall Asa's Regulatory Education Series We discuss California Prop 65 regulation changes and pitfalls to avoid. I will be joined by two very special guests which cover the expert legal, regulatory, and trade organization sides of the industry. Dave Rodman , Founder of the Rodman Law Group Jane Wilson is Director or Program Development for the American Herbal Products Association (AHPA) and is the resident Prop 65 expert for this important trade organization. Watch Previous Next

Asa and other industry leaders weigh in < Back 2025 State of the Industry Sean Moloughney Interview Asa and other industry leaders weigh in Asa Waldstein, Principal, Supplement Advisory Group : "Looking at the past can help predict future regulatory enforcement. There has been no FDA enforcement of claims made on TikTok, and FTC’s enforcement has been limited to a few cases in which notable influencers did not disclose material connections. I expect this minimal enforcement to ramp up over the next year. Also, I predict more FDA biomarker enforcement, which up until this point has only involved heart disease-related statements like “reduces LDL.” This big question is “Will FDA also target GLP-1 statements?” I suspect we will see this appear in some supplement warning letters, but only when higher-risk statements like “prevents obesity” and cringeworthy “nature’s Ozempic” phrases are present." Read the full article here . Read More Previous Next

< Back Webinar, Panel Discussion Thursday Jun 9, 2022 CBD Panel Discussion: Bridging the gap between science and regulation Atlantia Clinical Trials Asa Waldstein joins the Atlantia team to discuss how to use clinical data for marketing purposes to overcome regulatory hurdles that many CBD companies are encountering when commercializing their innovations. To many, CBD offers a variety of benefits when ingested, inhaled, or applied topically – with product marketing and advertising claims similarly ranging from calming effects to pain relief. Patient use fuels the research drive, which is rapidly increasing, and recent changes in the United States have paved the way for exciting new work. Both the safety and the potential therapeutic uses of these products need to be assessed for a range of indications. With the rapid expansion of new products, novel methods of use, and growing populations using these products for medical indications or for nonmedical use, regulatory restrictions are a major contributing factor to the limited data published addressing the most urgent questions on the potential effectiveness of products on the market for certain indications. Don't miss your opportunity to submit your CBD regulatory questions to our experts. Learn More & Register Previous Next