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< Back Podcast Wednesday Oct 22, 2025 Honest Health with Jeffrey Burke S02 E60 - Asa Waldstein Honest Health with Jeffrey Burke Podcast Honest and relevant answers for better health and well being with the best minds in the Natural Products Industry. Also, one on one chats with entertainers, athletes and public figures we all know and love. Host Jeffrey Burke welcomes Asa Waldstein, a regulatory expert in the natural products industry. They discuss the importance of marketing compliance, the risks associated with misleading claims, and the evolving landscape of regulations in the health sector. Asa shares insights on how to navigate marketing-language effectively, the role of social media in compliance, and the significance of consumer safety. The pair also discuss the challenges faced during the CBD boom and the importance of awareness in the industry. "I love educating about compliance best practices and lower-risk marketing strategies, which often change based on FDA/FTC enforcement trends. Building in-house expertise through education is part of my unique approach to regulatory consulting. I routinely speak at conferences on enforcement trends, industry compliance, and the nuances of effectively marketing products in the digital era. Check out my weekly Warning Letter Wednesday post." - Asa Waldstein Learn more and Listen Previous Next

< Back Presentation, In-Person Monday Oct 13, 2025 Microbiome & Probiotic Supplements: Best practices for compliant marketing Global Engage 13th Microbiome R&D & Business Collaboration Forum San Diego Asa Waldstein examines FDA, FTC, NAD, and litigation enforcement trends for dietary supplement and CPG products. He also shares risk-based insights for compliant marketing and provides an overview of the differences between food and pharmaceutical regulations. Join us for this interactive discussion. Learn More Previous Next

Old social posts are “active” marketing < Back Animal Product Claims Under Increased Scrutiny Old social posts are “active” marketing Claims made about animal products seem to have a lower tolerated "acceptance level" than human products. This is a friendly reminder to take another look at your animal product marketing because there may be forgotten risky marketing statements that can come back and "bite you" (I couldn't help the animal pun). Here is one example. These are obvious disease claims that should be avoided, but usually, this would not "tip the scale" into warning letter territory in a human product. 👉From warning letter. "… for dogs was designed and tested to boost your do's natural defenses against the unique host of fungal, parasitic, viral, and bacterial pathogens that flourish in the desert southwest." 🔹No company is too small to be off FDA's radar. This company has a very small web and social media presence, but they were still discovered and cited. Anyone marketing products online is "fair game" for enforcement. I write more about this here . 🔹Seven-year-old social media posts are cited in this letter. Plenty of two- or three-year posts have been called out in warning letters, but a seven-year-old post is going way back. I ask, does anyone really look at these really old posts? In the eyes of the FDA, these are considered active marketing and, therefore, should be compliant. Here is a post about this. 🔹Scanning old social posts is critical to any compliance "clean up" project I conduct. These forgotten old posts provide only risk and no marketing benefit. Here is an old and relatively lower-risk example. 👉From warning letter. "From your social media website. On January 29, 2016 you posted: "Important information: frequently when pets first start showing symptoms of Valley Fever they do not register a titer and thus the reason for misdiagnosis and the wrong course of treatment. If your pet is showing any signs then start Desert Defense while you await the diagnostics!" DATE ORIGINALLY POSTED: 2/22/23 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!

Test products like glycerin for adulterants < Back 11 Companies Cited For Not Testing For Contaminants Test products like glycerin for adulterants 11 companies were cited for failing to provide FDA information on contaminant testing for glycerin, propylene glycol, and other ingredients. These ingredients are most commonly adulterated with diethylene glycol (DEG) or ethylene glycol (EG). Warning Letter Wednesday is a weekly regulatory post where I review interesting warning letters as a way to inform our compliant manufacturing and marketing. Sign up to have this delivered to your inbox each week. 🔷These warning letters are directed at companies that make OTC and other drugs, but supplement companies can learn from these letters. Ensuring ingredients like glycerin and ethanol are tested for these possible impurities is essential. It seems FDA requires drug companies to test each batch for these contaminants. However, testing each batch of incoming supplement ingredients like glycerin is probably unnecessary if a company has verified the supplier and has SOPs and documentation to support reduced adulterant testing. In the past, I only tested my glycerin annually for DEG, but I had years of data to support this reduced testing. At the very least, testing annually or when changing vendors is a good idea. 👉 Other known contaminants are melamine in milk and methanol in ethanol. What other known contaminants does your company test for? 🔷Five of these companies never responded to FDA’s request for information. Not responding to FDA records requests is a prohibited act, which is serious. 🔷Nine of the companies who received warning letters are from other countries like India, South Korea, and Canada. Products from these companies have been placed on Import Alerts, meaning products may be detained, and entry into the US may be refused. Here is FDA’s “Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol” document . 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 Thursday Apr 13, 2023 Marketing Claims and Protecting Your Brand Naturally Los Angeles Leaders in the natural products space share their experience on how to market claims and protect your brand. Register 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

Ensure statements are not disparaging < Back Best Practices When Making Competitor Comparison Claims Ensure statements are not disparaging Calling out the differences between your product and competitor products is permitted, but "poking the bear" often leads to competitor challenges. This NAD case involves a well-known mattress company challenging another competitor's claims as disparaging. The challenged claims in social media posts made statements such as the other mattress was "just a glorified air mattress." According to NAD, the advertisements created a "misleading impression, suggesting Sleep Number beds are comparable to temporary air mattresses that consumers would not use for their regular sleeping needs." Here is one example . So, where is the line between truthful comparison and being disparaging? Here are some tips. Truthful comparison : Keep the scope narrow and ensure you have supporting data while being careful with implied claims in imagery. 🔹 Truthful and supportable statements such as "Our foam conforms to your body shape while brand X's spring coils do not." 🔹 Comparisons based on objective tests or third-party data, such as "In lab testing, our mattress reduced pressure points by 30% versus air-chamber designs." 🔹 Puffery: I love this topic and have written more about it here . Disparaging claims : Implied claims like imagery matter! 🔹 Even if an actual statement is true, it can be disparaging if it infers negative connotations such as "basically an air mattress," which implies it is bad quality or uncomfortable unless there is undeniable and defensible supporting data. Read the NAD decision here . DATE ORIGINALLY POSTED: 4/30/25 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!

Learn from other’s mistakes < Back Warning Letter Marketing Lessons Learn from other’s mistakes We can learn from others' mistakes, and this warning letter outlines what to avoid when marketing herbal supplements. This company was inspected by FDA and received some 483s, but today, I am going to focus on the website disease claims cited in the letter. From warning letter. "It's known to help reduce anxiety …." Asa comments: Suggestive words like "may" and "known to" do not allow us to make disease claims. If accurate, perhaps writing "occasional anxiety" would be lower risk, as this phrase likely represents normal life events and is not related to a disease I write about this here. https://www.asawaldstein.com/warning-letter-wednesday/anxiety-claims-enforcement-review From warning letter. "It's often used as a folk remedy for…the common cold and flu … helping allergies and sinus infections, treating diarrhea …." Asa Comments: Calling something a folk remedy or citing traditional use does not allow us to make strong disease claims like this. From warning letter. "From the list of hyperlinked "Tags" on the product page: "anxiety" "depression" Asa Comments: Product tags and meta tags are considered marketing. From warning letter. "Various studies have shown that it can be effective as a natural remedy for preventing and treating colds and flu …" Asa Comments: Citing studies and discussing clinical research is marketing, and it can also trigger plaintiff lawsuits, who love bringing action against companies making "clinically proven" claims. This is especially true for on-pack (on-the-label) statements. From warning letter. "The lions mane mushroom contains a variety of compounds… [that] have anti-inflammatory, anti-cancer…properties." Asa Comments: Discussing ingredient benefits on a website is a marketing claim, even if there is no hyperlinking to a shopping cart. This is a very common mistake that continues to be cited in warning letters. Okay, so I ran Apex Compliance™ on their website and was hoping that all disease claims were cleaned up. Unfortunately, I was WAY WRONG, as the site is still riddled with high-risk words like "cancer." Learn more about this award-winning compliance software, Apex Compliance ™. Can we envision a day when FDA requires companies who receive warning letters to go through some type of training? Is this a good idea or a terrible one? I suggest everyone read the full warning letter as a way to demonstrate what not to do. 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!

Discussing ingredient benefits is "marketing" < Back Discussing Ingredient Science Discussing ingredient benefits is "marketing" Helping you understand the fine line between education and product marketing is one of the reasons I love writing Warning Letter Wednesday. We continue to see well intentioned companies perhaps unknowingly cross the line from “education” to “disease claims.” Here I explore how discussing science easily become disease claim marketing. From warning letter. These lessons teach us what not to do. “In another recent study, correlations between CBD and blood pressure were examined. Two groups were evaluated, one being test subjects who were given CBD and the other being a control group with a placebo. All subjects were exposed to stressors that would induce a higher blood pressure. The study concluded that a dose of CBD was helpful to reducing blood pressure.” "CBD has been studied for its possible uses for children, and while the science is still preliminary, there are some promising opportunities. One of the best is the use of CBD for children with autism. One study of 188 children with autism, ages 5 to 18, found that some symptoms, such as seizures, restlessness and rage attacks, were lessened.” How can you use science in marketing? Here’s what the FDA’s Small Entity Compliance Guide on Structure-Function Claims says. This basically means that some citations are permitted but ensuring the context does not imply your product treats or help diseases is essential to compliance. As with many things we “know it when we see it.” Examples of cross the compliance boundaries include social media posts which mention the ingredient and the disease name, social posts with where the meta description mentions the ingredient and disease, company or ingredient hashtags on carefully worded scientific literature posts. Also, science that is showcased on product or ingredient pages often may be considered non-compliant. From FDA (Question and Answer). “Can I use citations of publications that relate to my product's intended use in labeling if the publication title or the journal name mentions a disease name? Yes, but some limitations apply. If the citation implies treatment or prevention of a disease, it is a disease claim. Thus, if in the context of the labeling as a whole its presence implies treatment or prevention of disease (for example, by placement on the immediate product label or packaging, inappropriate prominence, or lack of relationship to the product's express claims), the citation is a disease claim. If the citation is used in labeling, its context determines if it is a disease claim. A citation that is used in the bibliography section of labeling, is included in a balanced discussion of the scientific literature, is not excessively prominent relative to other citations, and provides legitimate support for a structure/function claim made for the product would not be a disease claim.” DATE ORIGINALLY POSTED: 10/30/24 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!

Following SOPs is essential to compliance < Back GMP Issues Following SOPs is essential to compliance There are so many important GMP lessons in this warning letter. Let’s see what we can learn. Botanical identification methods: When developing botanical specifications, ensuring they are complete is essential. In the warning letter, the company apparently did not add crucial aspects of specifications. From warning letter. “None of these components have a listed specification target, range, reference, or test method.” Incomplete 483 responses: When responding to 483s, it is important to follow through. Here, FDA cites the company for seemingly not providing the promised information. From FDA: “We have reviewed your response dated November 10, 2023. In your response you state you will create specifications for raw materials and that you estimate it will take approximately 90 days. You did not provide any documentation of your specifications, so we cannot evaluate the implementation.” Internal audits are a good best practice but are generally not required unless an SOP states this. In this warning letter, the company is cited for not following its own SOP. The lesson here is ensuring SOPs are developed with the entire company’s capabilities in mind, as SOP requirements can paint a company into a compliance corner. From warning letter. “You did not conduct periodic Good Manufacturing (GMP) internal audits of the entire plant with documented corrective actions, as required by your SOP... An internal audit has not been conducted since 2022." Master Manufacturing Records (MMRs) are the “recipe and directions” for making products. When I was in manufacturing, I would describe the MMR as this: “If someone has never made this product before, they can pick up the MMR and figure out how to make it perfectly every time.” Here FDA cites the company for not having a theoretical yield. This “lily pad” approach to quality is important to help catch issues before product leaves the building. For example, calculating theoretical yields catches issues such as inadvertently omitted ingredients or low capsule fill weight. From warning letter. “Statement of the percentage of theoretical yield at appropriate phases of processing” Cross-referencing labels to the formula is an essential part of GMPs. From warning letter. “Your MMR did not include a description of packaging and a representative label.” From warning letter. “Your MMR for does not include instructions for capsule drying or packaging operations. In addition, the MMR does not contain detailed instructions for the encapsulation process.” Allergen advisory statements are mentioned in this letter. I have never added this warning ‘because major allergens are either in the product or they are not.’ From warning letter. The … product label declares “Allergy warning: Manufactured in facility that also handles milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybean.” Advisory labeling is not a substitute for adherence to current good manufacturing practices and, when used by a facility, food allergen preventive controls. See Guidance for Industry: Questions and Answers Regarding Food Allergens Labeling , The firm should make every effort to ensure that they and their suppliers have adequate GMPs in place to prevent the unintentional inclusion of allergens in their products and ingredients. Read the full letter here . DATE ORIGINALLY POSTED: 11/6/24 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!

Study design must be correct < Back Clinically Proven Claims Lead To Scrutiny Study design must be correct This NAD case shows that making “clinically proven” claims attracts the highest level of scrutiny. The National Advertising Division (NAD) has been paying close attention to skincare marketing claims, and this monitoring case shows that this trend is continuing. A celebrity-supported skincare brand was making the following statement. “Clinically-proven to quickly and visibly lift, firm, and diminish the appearance of fine lines for a revitalized eye area.” Reading NAD’s comments on the clinical study design is interesting. The clinical study “included instrumental measurements of skin hydration and elasticity, digital photographs, and participant questionnaires,” but NAD determined the subjective portion of the study questionnaire could not support all of the ‘clinically proven to quickly and visibly lift’ statements but “NAD found that other portions of the claim were supported, therefore recommended the claim be modified to reflect that the “quick” and “visible” results pertain only to hydration and “the appearance of fine lines.” This shows how even small marketing statements may be picked apart and should be adequately substantiated. There are also some other items in this case which are worth reading. Full disclosure: I am a big Reese fan, but the folks in charge of her brand ambassador compliance can learn from this. From NAD. “The National Advertising Division (NAD) also recommended that actress Reese Witherspoon’s status as a … brand ambassador be clearly and conspicuously disclosed. NAD’s inquiry further focused on whether the format of the challenged advertising gives the impression of editorial content from InStyle and Hello! Magazines and Sephora when, in fact, they are advertisements.” The company also discontinued the “#1 best selling product at Sephora” claim. NAD cases continue to reference claims like “#1 best selling” and “#1 doctor recommended,” which should be avoided unless the company has solid substantiation. These types of claims should not be confused with puffery statements such as “world’s best cup of coffee,” which are permitted. I write more about puffery here . Read the NAD case 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 Product Reviews & Marketing Claims Kate Robertson Interview Asa and other industry leaders interviewed Read More Previous Next