The FDA investigation, which closed April 1, tied recalled moringa supplements to more than 100 illnesses, drawing renewed industry attention to testing, traceability and supplier verification practices. < Back Moringa recalls spotlight pathogen risks across botanical supply chains Cassandra Stern Interview The FDA investigation, which closed April 1, tied recalled moringa supplements to more than 100 illnesses, drawing renewed industry attention to testing, traceability and supplier verification practices. Moringa outbreaks triggered recalls across multiple brands. "We have already seen over 20 total FDA recalls so far this year, with nearly a dozen of those specifically involving pathogens like Salmonella and Listeria ." -Asa Waldstein Read More Previous Next

< Back In-Person, Presentation Tuesday May 19, 2026 Using Technology to Review and Develop More Compliant Claims 2026 NASC Annual Conference Arizona Grand Resort & Spa Phoenix, AZ Explore how technology can help teams proactively identify and correct compliance issues across websites, social media, existing materials, and pre-published content. This session will highlight practical approaches for using digital review tools to improve consistency, reduce manual burden, and support more confident, compliant communications in an increasingly fast-moving marketplace. Read about it here . Asa presenting at the 2026 NASC Conference Agenda & Registration Previous Next

The U.S. Food and Drug Administration (FDA) rarely goes after eBay sellers, which is exactly why it caught Asa Waldstein’s eye. < Back FDA flags eBay listing over GLP-1 claims in rare warning letter Danielle Masterson Interview The U.S. Food and Drug Administration (FDA) rarely goes after eBay sellers, which is exactly why it caught Asa Waldstein’s eye. According to Waldstein, founder and principal of Apex Compliance, there have been only four eBay-related warning letters in recent years – two of which occurred recently. "What is notable about this warning letter is that the FDA does not appear to have purchased or tested the product, which is often the case with more shady-looking weight-loss product," he said. Instead, the apparent basis for the warning letter is the drug-related claims made for the product. "Usually it has to do with more disease claims, so it might be GLP-1, blood sugar support and then maybe a claim in a hashtag or a claim in social media," he said. "But usually these types of claims are not enough for a warning letter. They usually are enough for FDA to test the product. And in this instance, FDA actually didn't test the product. They said GLP-1, blood sugar support claims – that's enough for a warning letter. So that was significant." Read More Previous Next

Companies that build proactive regulatory frameworks are scaling faster, earning retailer trust and outpacing competitors that treat compliance as an afterthought. < Back Compliance as a competitive edge for pet supplement, treat companies Lisa Cleaver Interview Companies that build proactive regulatory frameworks are scaling faster, earning retailer trust and outpacing competitors that treat compliance as an afterthought. For pet supplement and treat companies eyeing sustainable growth, regulatory compliance is no longer just a box to check — it is increasingly a business strategy. According to Asa Waldstein, principal, Apex Compliance, the companies best positioned for long-term success are those that build compliance into their operations long before they are required to. Read More Previous Next

< Back Podcast Wednesday Mar 25, 2026 Compliance For Natural Products Marketing with Asa Waldstein Natural Products Marketer Podcast I f you sell supplements or natural products and you market online, you can’t assume you’re “too small” for regulators to notice. We sit down with compliance expert Asa Waldstein to map the real enforcement trends we’re seeing, from FDA warning letters to behind-the-scenes demand letters that can escalate into expensive litigation. We also dig into what happens after a warning letter, why the response matters, and how public enforcement can ripple into reputation damage and investor hesitation. We get practical about the everyday situations that trip up independent retailers and brands: ingredient blogs that reference diseases, “educational” clinical study links that quietly turn into illegal disease claims, and the persistent myth that a couple clicks away from the shopping cart keeps you safe. Asa shares a simple way to sanity-check content through a reasonable-consumer lens, plus how old posts, inherited websites, and multi-year social content still count as active marketing in FDA’s eyes. Then we tackle a major modern landmine: reviews and testimonials. Google Business Profile reviews, website review widgets, social comments, and even automated carousels can create compliance risk, especially when your team replies, likes, or reacts to disease-claim testimonials and accidentally “adopts” them as marketing. We also talk regulatory technology and how tools like Apex Compliance can flag trigger words, assign risk levels, and suggest safer wording so you can move faster with more confidence. If you want to grow with better supplement marketing, smarter SEO, and fewer compliance headaches, listen through and share this with someone who touches your website or social media. Listen to the podcast Previous Next

< Back Presentation, Online Wednesday Mar 25, 2026 From “Gut Health” to Litigation: Marketing Microbiome Supplements Without Stepping Over the Line Naturally Informed 2026 Microbiome Event Asa Waldstein breaks down how current enforcement is shaping microbiome supplement marketing, how to communicate gut, immune, metabolic, mood, and “whole-body” benefits without drifting into disease claims. We’ll cover structure/function boundaries, common missteps that attract scrutiny, and litigation trends driving demand letters and class actions. Using microbiome-specific examples (including biomarker-adjacent language and clinical-study “spin”) Learn more and register Previous Next

Test ingredients for common adulterants < Back OTC Companies Cited For Refusing Records Request Test ingredients for common adulterants When FDA asks for records, companies should generally comply or they can face warning letters. This year FDA has sent eight warning letters to OTC companies refusing to respond to FDA’s request for records requests. This is a steep jump from only two similar letters in all of 2022. 🔷Yes, I know these are OTC-related and not supplement warning letters , but we can still learn a few things and also be amused by some of the responses, such as a company saying they were “not prepared to allow the FDA to audit and inspect.” Here is the timeline: 🔹March 17, 2023, the FDA sent an electronic request for records and other to the contact email address provided in your registration file. This request went unanswered. 🔹Second and third requests were sent via email on April 6 and April 18, 2023. 🔹On April 19, 2023, you responded stating that you were “not prepared to allow the FDA to audit and inspect” your firm. 🔹The Agency sent a follow-up written request for such records and other information on April 28, 2023, to your registered address on file; however, we received a delivery failure notification. 🔷Testing for contaminants: These “refusal to comply” letters were issued to OTC companies, four of whom were selling products with ingredients like glycerin. FDA pays extra attention to these types of ingredients as they may be susceptible to Diethylene Glycol (DEG) and Ethylene Glycol (EG) contamination. Dietary supplement companies can learn from this and test glycerin and ethanol for these common adulterants. This is good business, and FDA will want to see these tests when inspecting your or your comanufacturer’s facility. I write more about this here . 🔷This is not to be confused with the FDA’s Remote Regulatory Assessment (RRA) program, which is voluntary. Complying with this can help deprioritize FDA from visiting your facility and seems like a good idea if documents are in order. What are your thoughts on RRAs? 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 Panel Discussion Friday Jun 25, 2021 Update on Cannabinoid Product Regulation Hemp Leaders Summit, Fort Lauderdale, Fl Asa Waldstein moderates this FDA and legal compliance panel. Richard Cleland , Assistant Director, Bureau of Consumer Protection, Division of Advertising Practices, Federal Trade Commission Dr. Matthew Curran , Food Safety Director, Florida Department of Agriculture and Consumer Services Learn More Previous Next

A weekly exploration of FDA warning letters and enforcement trends A weekly exploration of FDA warning letters and enforcement trends Get Warning Letter Wednesday in your Inbox Sign-Up Now! Select category Reset “Gum Detoxify” Claims Challenged Qualifying claims makes them easier to substantiate 8/20/25 Read More FTC Letters to Amazon, Walmart & Other Sellers Use caution with Made in USA claims 7/30/25 Read More NAD Case: Supporting Substantiation Ingredient studies may support product claims 7/9/25 Read More When Topical OTC Manufacturing Goes Wrong Test glycerin for contaminants 6/18/25 Read More Avoid Comparing Products to Drugs (most of the time) Use FDA’s helpful resource (criterion 6) 5/28/25 Read More Celebrating 200 Weekly WLW Posts! Learning from others' mistakes helps you be compliant 5/7/25 Read More OTC Topical “Inactive” Ingredient Marketing Claims “Extra” claims are often non-compliant 4/16/25 Read More Influencers Must Disclose Free Product Brands should monitor influencer posts for compliance 3/26/25 Read More Unallowable Ingredient “Enough” to Trigger Regulatory Action Delta-8 is a high-risk ingredient 8/13/25 Read More When Nutrient Claims Become Disease Statements Carefully review all marketing materials 7/23/25 Read More Dietary Supplement Manufacturing & Marketing Lessons Learn from others’ mistakes 7/2/25 Read More Labeling Lessons Minor label issues signal deeper compliance issues 6/11/25 Read More Unallowable Ingredient Results in Warning Letter Here are tips on using FDA’s ingredient directory 5/21/25 Read More Best Practices When Making Competitor Comparison Claims Ensure statements are not disparaging 4/30/25 Read More Best Practices When Making Biomarker and Implied Claims Use FDA’s helpful resource (Criterion 2) 4/9/25 Read More Injectable CBD Warning Letter Curated testimonials are marketing claims 3/19/25 Read More Product Reviews Are Marketing Claims Kratom 7-OH products are highly scrutinized 8/6/25 Read More Diseased Population Study Helps Trigger IND Requirement Dietary supplement clinical triggers should be thoughtfully considered 7/16/25 Read More Failure to Report Serious Adverse Events Investigating customer complaints is a cornerstone of supplement safety and compliance 6/25/25 Read More Delta-8 Inhalable Product Dangerous products will be cited even if they do not contain disease claims 6/4/25 Read More 3 Animal Product Companies Receive Warning Letters Extra attention is paid to animal CBD products 5/15/25 Read More Navigating the Risks of Therapy-Adjacent Health Claims Use FDA's helpful resource (Criterion 7) 4/23/25 Read More In-Process Quality Testing A look at the manufacturing and quality process 4/3/25 Read More Amazon & Others Cited for Selling Injectables Distributors are responsible for the products they distribute 3/12/25 Read More 1 2 3 ... 9 1 ... 1 2 3 4 5 6 7 8 9 ... 9

There are no FDA approved supplement facilities or supplement products < Back Supplement company’s brochures and online marketing lead to a warning letter There are no FDA approved supplement facilities or supplement products The FDA inspected a facility, then six months later they reviewed the company website. This is a continuing trend and a reminder to screen for disease words online, especially after a GMP inspection. Here the FDA refers to a product brochure as labeling. This is an important reminder that all marketing is an extension of the label. Here is a video about this. From warning letter: “On your product labeling (brochure) for “Kidz DHA,” which directs consumers to your website …. where the product is available for purchase: “DHA supplements are purported to treat certain health problems in children, such as allergies, asthma, and attention deficit-hyperactivity disorder (ADHD).” Several other disease words are mentioned in this letter, such as anti-bacterial and anti-inflammatory. As a rule, words containing “anti” should be avoided. The one exception here is antioxidant. Also interesting in this letter is the mention by FDA that they do not approve facilities or supplement products. If a company claims to have FDA approval of their supplements, this is a marker they do not understand the basics of dietary supplement regulations. From warning letter: "We note that your website includes the statement that …. are made . . . in an FDA approved facility.” Although certain facilities must register with FDA, FDA does not approve facilities. Read 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!

< Back In-Person, Panel Discussion Thursday Jan 23, 2025 Our Commitment to Product Integrity Organic & Natural Health Association Fort Lauderdale, FL 12:15 – 1:30 pm Our Commitment to Product Integrity Amy Summers Founder & President Pitch Publicity & INICIVOX- Moderator Deleo de Leonardis, CEO Co- Founder, Purity IQ Erin Taraborrelli, Program Manager, Labeling & Training Services, SGS nutrasource Ray Martinez, President, Florida Supplement Sandra Baek Lee , CEO, NJ Labs Asa Waldstein, Founder and Principal, Apex Compliance Learn More Previous Next

Well intentioned marketing claims can turn products into high-risk regulatory categories < Back Goat Milk Company Infant Formula Claims Well intentioned marketing claims can turn products into high-risk regulatory categories This goat milk supplement and food company was cited for claiming its goat milk product is an alternative to infant formula. This is a great example of how well-intentioned marketing statements can cross the line into a risky regulatory category. Let’s explore what went wrong. FDA looked at this company’s website and social media and determined their Goat Milk Formula Recipe Kit met the definition of infant formula because it was “purported to be or was represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.” Essentially, this means the company was promoting their product as infant formula. Here are some of FDA’s warning letter references. "We have created a formula recipe that mimics breast milk and follows the guidelines created by the 1980 Infant Formula Act.” Your February 12, 2024 (Facebook) post: “‘Infant formula is the number one regulated food in the U.S., and yet the allowable ingredients in off-the-shelf infant formula is often times very very poor. So there is a very good incentive to make your own formula.’ Get to know the creator, Joe Stout, and learn about the Goat Milk Formula Recipe on the GMF Livestream replay! . . . #DIYBabyFormula . . .” I ran Apex Compliance on their website and found A LOT of very high-risk marketing claims, and I suggest this company look at conducting a compliance audit. Apex Compliance was developed for this type of situation, sifting through large amounts of information and providing a line-by-line playbook showing where risky phrases occur, their risk rating, and some possible lower-risk alternatives. Learn more here . To give the company credit, they seemed to go above and beyond to correct the matter once FDA brought this to their attention. It seems that even though they worked diligently to correct their mistake, FDA issued the warning letter to “ensure the violation does not recur.” Infants are classified as a “vulnerable population,” and this warning letter language demonstrates how seriously FDA takes the infant formula category. From warning letter. “We acknowledge that after a teleconference with you on May 7, 2024, you voluntarily recalled all Goat Milk Formula Recipe Kit ... We are aware that you contacted all customers who received product during that timeframe to inform them that the product should not be used as an infant formula. Additionally, you issued a press release on May 10, 2024, clarifying to the general public that you do not recommend using this product for infants from 0-12 months of age. We also acknowledge that you removed the ability to purchase the Goat Milk Formula Recipe Kit from your website, and that you made some changes to your website and social media websites, including but not limited to removing the above-mentioned statements regarding use as an infant formula. However, due to the serious public health concerns related to your unlawful marketing of a new infant formula, it is essential that this violation does not recur.” Read the full warning letter here . DATE ORIGINALLY POSTED: 10/9/24 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!