Workshops and Webinars / Workshops and Webinar Resources These are common areas of enforcement and lawsuits.Here are some resources to help understand these regulations. 06-10-22-webinar June 10th GMP & Marketing Claims Demystified Workshop: Resources Steven Yeager LinkedIn Asa Waldstein LinkedIn FDA Supplements Q&A 21 CFR 111 Subparts & descriptions 21 CFR 111 Reference guide Adverse Event Reporting guidance FDA Alerts (allergens, recalls, warning letters Common allergen labeling guidance AHPA Herbs of Commerce Labeling and Allergens Guidance Webinar: CGMP Basics for Hemp-CBD Companies: This is applicable to herbal supplement manufacturers. Regulatory hints YouTube channel AHPA Prop 65 Guidance Preparing for FDA GMP Facility Inspections Webinar Asa’s Regulatory Education Series Why avoid warning letter video Video about the risks of "THC Free" or "THC Free" labeling: Made in the USA Claims Demystified video All Natural: What can you say and what is the risk video Prop 65 webinar AHPA Prop 65 Resources 06-03-22-webinar June 3rd Webinar Resources Harris Bricken Canna Law Blog cGMP Basics for Hemp-CBD Companies Free Webinar AHPA Hemp CBD Supplement Congress videos! Regulatory: Blog, Events, Resources AHPA Labeling Guidance Document Getting Ready for FDA Inspections Webinar AHPA Prop 65 Guidance Regulatory Hints YouTube Channel and Prop 65 Webinar AHPA SOP Templates (members only) Asa’s Regulatory Education Series video channel AHPA’s Guidance Documents HerbalGram Cannabis Resources Asa’s Regulatory Consulting Company 05-04-22-webinar May 4th Webinar Resources Burdock: Food Safety & Regulatory Compliance Consultants for FDA AHPA Hemp CBD Supplement Congress videos! Why join AHPA's Cannabis Committee? Regulatory: Blog, Events, Resources AHPA Labeling Guidance Document AHPA NDI Workshop cGMP Basics for Hemp-CBD Companies Free Webinar AHPA Prop 65 Guidance Regulatory Hints YouTube Channel and Prop 65 Webinar AHPA’s Cannabis Committee AHPA’s Hemp Lexicon AHPA’s NDI Database AHPA’s Botanical Congress: May 24th Asa’s Regulatory Consulting Company Burdock Associates Webinar: GRAS & NDI Certification: Ask the expert Asa’s Next Event: Distributor Pitfalls to Avoid: Hemp and Supplement Products: Back

Asa and other industry leaders interviewed < Back Hemp and CBD Industry Responds to FDA’s Announcement on CBD Steven Hoffman Interview Asa and other industry leaders interviewed Read More Previous Next

Asa Waldstein & other leaders interviewed < Back AHPA Event Guides CBD Industry Danielle Masterson Asa Waldstein & other leaders interviewed Read More Previous Next

Former FDA officials and lawyers who advise clients on FDA regulations weigh in on a recent batch of warning letters targeting new dietary ingredients marketed in supplements. < Back NDI warning letters fuel criticism of FDA enforcement approach—again Josh Long Press Mention Former FDA officials and lawyers who advise clients on FDA regulations weigh in on a recent batch of warning letters targeting new dietary ingredients marketed in supplements. Read More Previous Next

< Back Why CBD Companies Should Re-Examine Their Marketing Content -- NOW Palmate, LLC Interview Read More Previous Next

Ensure GMPs are developed and followed. CBD is risky when added to OTC topicals. < Back Marketing CBD in OTC drugs is risky Ensure GMPs are developed and followed. CBD is risky when added to OTC topicals. #WarningLetterWednesday involves CBD in an OTC topical (hand sanitizer) and further defines FDA’s position regarding CBD as an active or inactive ingredient in OTC drugs. There are also numerous GMP violations that paint an overall picture of noncompliance. The references to CBD in this letter are worth reading. It is hard to defend adding CBD as an inactive ingredient if the amount of CBD is listed on the label or is marketed for CBD content. From warning letter: “Specifically, your product label for MEDICALLY MINDED 100% THC FREE Hand Sanitizer Gel prominently features on the Principal Display Panel (PDP) the statement, “200 MG CANNABINOIDS 100 MG CBD + 100MG CBG.” The product label also lists,.....a website that markets and sells CBD products for various therapeutic benefits. As noted above, CBD and CBG are not an active ingredient in any applicable final monograph”. Although is letter is only one of seven CBD-related warning letters in 2021 (down from 21 last year) it is essentially a teaching case about the importance of GMPs. The FDA sent two records requests which the company did not answer. Not answering these FDA requests is a prohibited act and is serious. The FDA then inspected the company and found serious violations including hand sanitizer that contained 0% ethanol and 58% methanol. This is dangerous! This then led to a national recall of the adulterated lot numbers of hand sanitizer. If the company had a proper Quality Management System (QMS) they would have responded to the FDA’s information request and may have prevented an inspection. They would have also identified the adulterated hand sanitizer before it shipped to the public and caused the subsequent recall. The company was issued a 483 which they didn’t respond to. Learn more about the differences between warning letters and 483’s here . Properly responding to a 483 is an important part of avoiding warning letters. Most 483’s can be addressed with the FDA before they are elevated into a warning letter. Learn more about reasons to avoid a warning letter here . The GMP violations include not setting specifications, quality not approving production procedures, and quality not controlling incoming components. Although these violations cite OTC drug manufacturing regulations, they are the basics all dietary supplement companies should be complying with. Not writing and following specifications is one of the most common supplement GMP citations. Read 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 In-Person, Panel Discussion Wednesday Jun 25, 2025 Leveraging AI in Dietary Supplement R&D: Harnessing Innovation While Navigating Key Regulatory and IP Risks  American Conference Institute New York, NY As the dietary supplements industry continues to evolve, innovation is driving new product development and improved efficiencies.  From AI-powered R&D to advancements in manufacturing and supply chain optimization, companies are embracing cutting-edge technologies to stay competitive. However, these innovations also introduce complex regulatory, intellectual property, and compliance risks that must be carefully navigated.  Join industry leaders and experts as they explore:  AI’s role in dietary supplement R&D and product development: how artificial intelligence is transforming ingredient discovery, formulation, and clinical research  Understanding the applicable guidelines for using AI to support regulatory submissions/documents (GRAS, NDI, claims registrations, etc.) focused on safety, quality and efficacy of ingredients Navigating evolving FDA oversight and safety considerations when utilizing AI in product development Understanding the IP and competitive risks: navigating issues that can arise regarding the patentability of AI-discovered ingredients and formulations Learn More and Register Previous Next

The American Herbal Products Association hosted its first botanical congress outside the confines of the SupplySide Global trade show. < Back AHPA leans on past to embrace high-tech future at botanical congress Claudia Adrien Press Mention The American Herbal Products Association hosted its first botanical congress outside the confines of the SupplySide Global trade show. Read More Previous Next

Some of our favorite resources to help educate about marketing compliance. Marketing Compliance / Marketing Compliance These are common areas of enforcement and lawsuits.Here are some resources to help understand these regulations. Substantiation Tips and CARSE Health Products Compliance Guidance TikTok Music Copyright Litigation & Best Practices Common Plaintiff Lawsuits: Best Practices Asa's weekly Warning Letter Wednesday post FTC Document: How to Make Effective Disclosures in Digital Advertising FTC Document: Social Media Disclosures FTC's Dietary Supplement Advertising Guide For Industry Made in the USA lawsuit reference (TINA) Natural Claims article Made in the USA (Great Podcast!) Made in the USA FTC Guidance AHPA Hemp CBD Supplement Congress videos! FDA Label Claim Guidance FTC Guidance: Claim Substantiation FTC Guides Concerning the Use of Endorsements and Testimonials in Advertising AHPA Alerts: Stay up to date (AHPA members only) Other AHPA Guidance Documents Compliance essential for hemp CBD companies: Marketing FDA alerts (allergens, recalls, warning letters) Back

Asa Waldstein is our guest on KISC My Health Radio show with Peter Mingils and the King of Cranberries Stephen Lukawski. < Back KISC My Health Radio Show with Captain Cran Man Stephen Lukawski with Asa Waldstein and cohost Peter Mingils Stephen Lukawski Podcast Interview Asa Waldstein is our guest on KISC My Health Radio show with Peter Mingils and the King of Cranberries Stephen Lukawski. This week on KISC My Health Radio, Captain Cran Man Stephen Lukawski and Peter Mingils have the privilege of interviewing Asa Waldstein. Click "read more" below to learn more and listen to the interview. Read More Previous Next

Asa is interviewed by a well-known influencer on the topic. This is applicable to the dietary supplement industry as well. Read here: https://www.letstalkhemp.com/hemp-influencers/ < Back Influencers and CBD: Be Careful What You Say Cait Curley and Asa Waldstein Interview Asa is interviewed by a well-known influencer on the topic. This is applicable to the dietary supplement industry as well. Read here: https://www.letstalkhemp.com/hemp-influencers/ Read More Previous Next

Batch records should be complete < Back Improper Written Specifications Lead To Warning Letter Batch records should be complete This warning letter is interesting as it details some of FDA's thinking on test methods. Upon my initial reading of this letter, it seemed like FDA had an issue with HPTLC, but the problem was actually how the specification was written. HPTLC is mentioned in this letter. Here FDA states that HPTLC is not a parameter that can be tested to. More information is needed, such as the plant’s genus, species, and the plant part. From warning letter. “HPTLC” is not a qualitative or quantitative parameter to which a test result can be compared to verify the identity of the component.” Thanks to my friends at Alkemist Labs for talking this through with me. Your expertise is very appreciated! This is a shortened version of Warning Letter Wednesday as I’m currently attending Supplyside West. If you are here and want to discuss consulting or Apex Compliance™ Compliance, let me know. There are also other GMP violations in the letter, such as incomplete batch records. This example FDA cites the company for not having cleaning records. When I was a manufacturer, we would attach cleaning records to each batch record. As FDA notes below, this is not needed, but cross-referencing this information is required. 👉 From warning letter. “Your batch production record fails to include the date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch or a cross-reference to records, such as individual equipment logs, where this information is retained.” I recommend reading the full warning letter , as there are other labeling and testing citations that provide good learning opportunities. 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!