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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!

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