< Back Presentation Saturday May 21, 2022 Medellin, Colombia: Pitfalls to Avoid When Entering the US Cannabinoid Product Market Bizcann Expo Columbia Medellin, Colombia There is so much that can go wrong when entering the US cannabinoid or supplement marketplace. In this session we discuss how to avoid common labeling, product manufacturing, registration, and marketing errors that can delay launches, or worse, attract the attention of the FDA and class action attorneys. See pictures and the post on Asa's speech here . Learn More Previous Next

< Back In-Person, Solo presentation Thursday Apr 11, 2024 Labeling & Making Claims NoCo Hemp Expo Estes Park, CO Join Asa as he delves into the latest enforcement trends, including warning letters and litigation, that shape the marketing landscape of the natural products industry. This session is designed to equip attendees with the knowledge to identify and avoid marketing strategies that could lead to legal complications, such as lawsuits or warning letters. By analyzing recent enforcement actions, Asa will provide practical insights on how to steer clear of "off limits" marketing areas while still effectively driving sales. Learn how to align your marketing practices with current regulations and protect your brand from potential legal challenges. See Asa's LinkedIn post about this event here . Learn more Previous Next

The FDA regulates based on intended use < Back Company Cited For Selling Selective Androgen Receptor Modulators (SARMs) The FDA regulates based on intended use The FDA sent a warning letter to a company distributing Selective Androgen Receptor Modulators (SARMs). SARMs are synthetic chemicals designed to mimic the effects of testosterone and other anabolic steroids. This is an excellent example that the FDA regulates based on the intended use. The company apparently was marketing this product for ingestible use but labeling as follows. From the warning letter. “Despite statements on your product labels marketing your SARMs products for “RESEARCH ONLY” and “Not for Human Consumption,” evidence obtained from your website establishes that your products are intended to be drugs for human use.” What is mind-blowing about this warning is that a company executive was sentenced to a year in prison last year for selling the same type of products! Here is the article by Steven Myers about this. Read the full 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!

Remove testimonials with claims < Back Digestive & Cholesterol Claims Cited in Warning Letter Remove testimonials with claims Digestive system claims like Crohn's and IBS occasionally show up in warning. Diseases like Crohn's Disease or syndromes like Irritable Bowel Syndrome should be removed, or if accurate, replaced with statements about stomach and digestive health support. 👉From warning letter. "I used to have terrible knife-like sharp pains in my stomach from the Crohn's and IBS, and a great deal of discomfort from the acid reflux. Dr. Miller's Holy Tea has cleared all of this up…." I'm writing this from a Soulshine retreat in Bali, so today's Warning Letter Wednesday will be brief. Testimonials are also cited in this warning letter. I expect many product reviews and testimonials to be called out in warning letters this year. I talk about engaging with testimonials here. Blood pressure and cholesterol claims enforcement are not slowing down, and I expect this trend to continue. Here is a post about this. 👉From warning letter "Regular use of Youthin Fat Burners may help control High Blood Pressure and Cholesterol" Read the full post 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!

Asa and other industry leaders interviewed < Back The blurred lines of the legality of Delta-8 Danielle Masterson Interview Asa and other industry leaders interviewed Read More Previous Next

In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters and other enforcement impacting manufacturers and marketers of dietary supplements. < Back FDA warning letter trends: Third-party reviews, eye products, 'Made in USA' claims Asa Waldstein Guest Article In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters and other enforcement impacting manufacturers and marketers of dietary supplements. Asa Waldstein rounds up the latest in agency actions against health and nutrition businesses. At a Glance FDA warns companies blurring lines between foods and supplements. FDA flags misuse of reviews — curated or highlighted customer reviews may count as product labeling. FTC cracks down on 'Made in USA' claims; what to do now. Read More Previous Next

Practitioners who sell supplements need to be aware that health and medical claims made in nutritional marketing can attract unwanted attention from the US Food and Drug Administration. < Back Common Practitioner Pitfalls to Avoid When Marketing Dietary Supplements Asa Waldstein Guest Article Practitioners who sell supplements need to be aware that health and medical claims made in nutritional marketing can attract unwanted attention from the US Food and Drug Administration. Read More Previous Next

< Back Adapting your Business Strategy to the Regulatory Outlook Sarah Burden Interview Read More Previous Next

Apex Compliance’s Asa Waldstein shares valuable insights for those seeking to avoid an FDA warning letter, a competitor case with the NAD or a referral to the FTC due to ad claims non-compliance. < Back SSG 2025: Asa Waldstein on FDA, FTC and NAD enforcement trends Cassandra Stern Interview Apex Compliance’s Asa Waldstein shares valuable insights for those seeking to avoid an FDA warning letter, a competitor case with the NAD or a referral to the FTC due to ad claims non-compliance. Regulatory scrutiny from the Federal Trade Commission (FTC), National Advertising Division (NAD) and the Food and Drug Administration (FDA) has gained momentum in 2025 across CPG categories, including dietary and nutritional supplements. At SupplySide Global in October, Asa Waldstein, principal at Apex Compliance and chair of the Supplement Advisory Group, discussed recent cases and shared insights on the latest trends shaping FDA warning letters, FTC oversight and NAD actions. Read More Previous Next

Asa Waldstein & other leaders interviewed < Back Carbon footprint labels could be coming to cannabis Laura Drotleff Interview Asa Waldstein & other leaders interviewed Read More Previous Next

Some of our favorite resources for helping to mitigate the risks associated with Made in the USA and All-natural claims. Home / Made in USA & All Natural / Made in the USA and All Natural These are common areas of enforcement and lawsuits.Here are some resources to help understand these regulations. Made in the USA Anchor 1 "Made in the USA" Claims Demystified video FTC guidance Great podcast on this topic Lawsuit updates (Truth in Advertising) All Natural Anchor 2 Video: What can you say and what are the risks Article on natural claims Back

Mouth pouches have emerged as one of the fastest growing CPG categories, signaling a major trend in nootropics as consumers seek functional ways to boost performance—sans nicotine. < Back A new generation of energy: Are pouches the next ‘big thing’ in active nutrition? Danielle Masterson Interview Mouth pouches have emerged as one of the fastest growing CPG categories, signaling a major trend in nootropics as consumers seek functional ways to boost performance—sans nicotine. Performance pouches are gaining popularity among consumers, including at the gym. "Some pouches are more likely to be considered supplements if they are consistent with ingestion (e.g. swallow) and they avoid sublingual/oromucosal drug-type positioning. Others appear to "borrow" nicotine pouch marketing (e.g., 'niccotine-free'), which can create classification and consumer-perception issues even though it may be labeled as a supplement." - Asa Waldstein Read More Previous Next