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 Wednesday Dec 3, 2025 Regulatory Reality Check: What Supplement Brands Need to Know About the Healthspan Category Naturally Informed Webinar Consumers aren’t just living longer... they want to live better. Consumers are demanding more than just longer lifespans—they’re seeking healthspan . This shift is transforming the supplement and functional foods markets. With global sales for older adult supplements projected to hit $265 billion by 2032, now is the time to understand where the market is headed—and how your brand or business can lead. At this three-day virtual event, you’ll hear from world-class experts covering: - The latest research in aging, longevity, and performance - Nutrition, lifestyle, and formulation insights driving product success - Opportunities in women’s health, mobility, cognition, and beauty-from-within - Marketing and regulatory perspectives shaping this high-growth sector Learn more and register Previous Next

Sponsored children’s content has increased disclosure requirements < Back Sponsored Video Disclosures: Found Incomplete Sponsored children’s content has increased disclosure requirements Videos must disclose material connections when making sponsored content. Here, we learn more about when material connection is needed and what constitutes disclosure, especially when children’s advertising is involved. In this NAD case, the very popular children’s YouTube channel Vlad and Nikki (405 million subscribers, 220 billion views) was cited for not properly disclosing material connections when marketing their own Vlad-and-Niki-branded products. One would think that the material connection is obvious, but here’s NAD’s thinking on the topic. From NAD. “CARU determined that not only does the relationship between Vlad and Niki’s videos and the advertiser, who is the party of the licensing and merchandising agreements, constitute a material connection, but because CMG is required to produce the videos under the terms of the agreement and shares in the revenue generated by sales of the Vlad-and-Niki branded products, CMG is also considered an endorser of the products.” Read more about influencer disclosure and best practices here . In some cases, these types of disclosures are appropriate, but as NAD states, they are not sufficient when children are involved. From NAD. “Other Sponsored Videos used language that CARU and the Federal Trade Commission (FTC) do not consider to be clear to children, such as “sponsored by” or “paid promotion” or the “#ad” disclosure in the description box of the video.” From NAD. “CARU recommends that … include language, in both text and audio in the video itself that is clear for children to understand, to clearly and conspicuously disclose the material connection to the video’s sponsor at standardized times (beginning and end and, for longer videos, after each ad break).” We can expect more of these “material connection disclosure” cases as the creator economy grows. The moral of the story is “When in doubt, disclose,” which can mean verbal and written disclosures. For support with influencer marketing compliance and guidance on how to market your products truthfully and effectively, contact me for a free consult. I love this stuff! Read the NAD case comments 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!

Replace “high risk” words with lower risk alternatives < Back Using words such as “inflammation” increase warning letter chances Replace “high risk” words with lower risk alternatives #WarningLetterWednesday High risk words should be avoided in all forms of marketing. The words "inflammation" or "anti-inflammatory" is being referenced in many warning letters. Read full warning letter here . If truthful and not misleading replacing "inflammation" with words such as discomfort, soothe, support-comfort, body-resilience can help convey a marketing message in a lower risk manner. 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!

Informational blogs on a commercial website are considered “labeling” < Back Learning targets: Blogs, risky words, testimonials, ingredient benefits Informational blogs on a commercial website are considered “labeling” Today's #WarningLetterWednesday is an important reminder that blogs, testimonials, and discussing ingredient benefits can easily cross the line into claims, especially when filled with high-risk buzzwords! 🔷The FDA and FTC look for a material connection. The material connection was evident in this warning letter, as there's a hyperlink (Call To Action) to a shopping cart, as noted here. ➡️From warning letter: On the "Prevent MRSA Infection" blog post ... which hyperlinks to the product webpage for B Complex. 🔷I discuss best practices for reducing risks on blogs here . 👓 🔷Ingredient descriptions on a commercial website may be implied product claims. I discuss this here . 🔷A good strategy is to ensure ingredient education is free of high-risk "buzzwords" or disease claims. Some examples are anti-inflammatory, insomnia, or anything ending in "itis" (arthritis). Here is a WLW post and video about this from a few months back. 🔷Product testimonials can be marketing claims, especially as they're highlighted in this company's "Customer Stories" section. ➡️From warning letter: "'I have been taking CellRenew since May of 2003. . . . This product has kept my arthritis at bay. . . .'" This company talks about viruses that are top of mind for the FDA, and I am unsurprised by this warning letter. Good job, Denver office! We've seen the Denver office focus on claims made in blogs before, a cautionary tale for companies in their district. Read the full warning letter here . Follow 👉My Warning Letter Wednesday LinkedIn Group for early WLW access. 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!

Review old social posts for regulatory “landmines” < Back Seven-Year-Old Facebook Post Leads To Warning Letter Review old social posts for regulatory “landmines” This company received a warning letter for claims made on its website and old social media posts. The oldest post cited in this letter is from 2016, which shows that even old and potentially “forgotten” social posts are active marketing in the eyes of the authorities. Many companies now have “clean” marketing, but they may have inadvertently overlooked the regulatory landmines in their old socials. Now is the time to review and update these old posts (and old blogs). Sign up for this weekly email ! 🔷 Some very high-risk language on Facebook is cited in the letter. 👉 From warning letter.” In a July 29, 2017 post: “Can Plaquex® help prevent cancer?...When I linked the facts of these three independent information sources, the thought came to me, that Plaquex® – Phosphatidylcholine – may be able to prevent cancer.” 🔷 Following the “breadcrumbs” in warning letters is always fun. For example, in this letter, FDA notes that the Facebook page links to a website (book-selling site) that links to another website where customers can order supplements. FDA rarely references anything over “two clicks,” which is what makes this so interesting. FYI, the two-click rule is an urban legend and, as demonstrated in this letter, does not protect from disease claim enforcement. This “commercial bridge” is important, as it’s often cited in warning letters. 🔷 Unfortunately, this warning letter has not stopped the company from continuing to make very high-risk claims, such as statements about ingredients being antidepressant and antiarthritic. Read the full letter . 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 Mar 24, 2022 2022 Regulatory and Compliance Update NoCo Hemp Expo, Denver, CO Speakers: Josh Hendrix , Jonathan Miller , Asa Waldstein , Samantha Walsh , Marielle Weintraub Today, there are a number of congressional bills and legislative and regulatory activity that can have an impact the hemp industry. Join this expert panel for an overview and analysis of key political, policy and regulatory activity that require the hemp industry’s attention, and how producers and marketers of CBD and other cannabinoids, in particular, can remain compliant in the face of USDA, FDA, EPA and other regulatory oversight. Learn More Previous Next

All marketing is “labeling” < Back Topical Product Claims Turn Magnesium Oil Into Drug All marketing is “labeling” FDA cited this company for selling a topical magnesium product that also contains ingredients like fulvic acid, vitamin B6, and MSM. Based on website claims FDA concluded the product was an analgesic drug. Here are some of the cited claims from the warning letter. “For muscle cramps or pains, spray directly on problem area.” “Designed to provide relief from body tension and soreness.” “Leg cramps and muscle soreness,” along with “migraines, insomnia, [and] fatigue.” FDA classified this as a “topical external analgesic (OTC) drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h,” which is allowed if the product is made using a specific OTC monograph (recipe) under applicable GMPs. Since the product did not follow the monograph, primarily because other “active” ingredients like MSM are not on the monograph, FDA deemed this product an unapproved new drug. To be fair, the other sections of the warning letter contain very serious disease claims like “cancer” and “depression,” which are likely the primary reason reasons for the letter. Some warning letters like this are very comprehensive and may cite “secondary” claims, which may not be enough to trigger a letter on its own. In the case of the magnesium oil, I doubt making claims about pain or soreness is enough for agency action, but listing diseases related to magnesium deficiency, such as insomnia, and then suggesting the product can address these deficiencies is high risk. I have seen some companies use the nutrient deficiency and disease claim strategy on dietary supplements, which is out of my risk tolerance, but when used on topical products that do not provide absorbable nutrients, it goes too far. As a friendly reminder, topical non-drug products are not allowed to “affect the structure or any function of the body,” which supplements are permitted to do. So would a topical product with a “relieve and soothe” claim attract a warning letter? This is unlikely unless there were adjacent claims like “helps with arthritis,” which turned the product into a drug. 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!

Reduce litigation by following labeling rules < Back Nutrient Content Claims Guidance Reduce litigation by following labeling rules Nutrient content claims can lead to litigation and are often cited in warning letters, although they are not typically the primary reason for a letter. Following all the rules can be confusing, so here's some guidance on how to be compliant. Thank you to the thousands of wonderful weekly Warning Letter Wednesday readers. I hope this helps (smiles). "Good Source" Claims 10-19% DV: Terms like "good source," "contains," or "provides." Example: "Good source of magnesium" must have at least 10% DV magnesium per serving. "High" & "Rich In" Claims 20%: Terms like "high," "rich in," or "excellent source of." Example: "Rich in magnesium" must have at least 20% DV magnesium per serving. "High Potency" Claims: 100% DV: Example: "High potency magnesium" must have at least 100% DV magnesium per serving. For multi-ingredient foods, at least two-thirds of the vitamins and minerals must meet these criteria. I actually did not know this until I researched for this post. Fiber Claims: When claiming high fiber content, the total fat content must also be disclosed if the food is not low in fat. Antioxidant Claims: The nutrients have recognized antioxidant activity like vitamins A, C, and E meet % DV requirements. This means that items without a %DV, like botanicals, cannot be listed as antioxidants. Mentioning the effect on the antioxidant system, however, is not high risk. These rules are nuanced. Learn more here . Include the names of the antioxidant nutrients in the claim, such as "high in antioxidants vitamins A and C." "More" & "Enriched" Claims 10% DV: Terms like "more," "fortified," "enriched," "added," "extra," "plus," and" compared to a reference food.Must comply with fortification policies, and comparisons with the reference food must be clearly stated. Sugar Content Claims: Terms such as "sugar-free" and "no added sugar" can be used in some instances, but they can lead to lawsuits. Here is an excellent article by Todd Harrison, Kristen Klesh, and others. It has a VERY helpful table that can help avoid the common litigation surrounding "not a low-calorie food" requirements. Cholesterol and Fat Claims: This continues to be mentioned in warning letters as a secondary (not the primary reason for a letter) citation. "Cholesterol Free" and "No Trans Fat" claims must be made in accordance with specific FDA guidelines. Declarations for mono- and polyunsaturated fats must be made under 21 CFR 101.9(c)(2)(ii) and (iv) if such claims are made unless the food qualifies as "fat-free" under 21 CFR 101.62(b)(1). Calorie Content Claims "Calorie Free" Claims: If the food contains less than 5 calories per serving, terms like "calorie-free" or "zero calories" can be used. "Low Calorie" Claims: For foods that provide 40 calories or less per serving for larger servings and smaller servings, if not more than 40 calories per 50 grams. "Reduced Calorie" Claims: "Reduced calorie" claims are permissible if the food contains at least 25% fewer calories per serving than a reference food. Here are some helpful resources. Specific Requirements for Nutrient Content Claims Nutrient content claims for "good source," "high," "more," and "high potency" Warning: This is for informational purposes only. Please check labels and marketing content with your competent legal or regulatory counsel. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Unsafe products marketed to children are deceptive < Back FDA/FTC Delta 8 Warning Letters Unsafe products marketed to children are deceptive Products like Doweedos Delta-8 Edible Chips were cited in yesterday's joint FDA/FTC warning letters. There were actually six warning letters sent in this enforcement action group, but for some reason, only five were joint FDA/FTC letters, and one was just an FDA letter. The FTC has more "teeth" than FDA, and these joint letters should send warning shots to sellers of THC and delta 8 products that are packaged favorably to children. Unfortunately, since this is not the first of these actions , I am unsure if the delta 8 market has gotten (or cares) about the message. One of the most interesting parts of this action is the use of Section 5 of the FTC Act, which prohibits unfair or deceptive acts. This prohibition includes practices that present unwarranted health or safety risks. Delta 8 poses dangers, especially to children, in favorable formats like cookies and bright-colored candy that looks like store-bought food. This is considered deceptive marketing. From warning letter. "Preventing practices that present unwarranted health and safety risks, particularly to children, is one of the Commission's highest priorities." Distributors are responsible: The companies in this enforcement action appear to be distributors of other products, showing that marketplace websites can be on the hook for what they sell. In the past FDA has primarily focused on large distributors like Amazon or websites selling dangerous products like delta 8. FDA does not like delta 8 for good reason, as shown in this consumer update . Delta 8 can be dangerous, and according to data from National poison control centers, 2,362 delta 8 exposure cases had been reported, including "One pediatric case was coded with a medical outcome of death." This report warns consumers that delta 8 products are widely available in forms favorable to children, such as chocolates and candies. This should have given the delta 8 industry pause, but these products have unfortunately continued to increase. The warning letters go into great detail about how the products mimic candy and other typical children's junk food. Here are some of the more appalling (and humorous) examples. Trips Ahoy Chocolate Chip Cookies: Flaming Hot Weedos Double Stuff Stoneo cookies This FTC quote sums it up nicely. "Companies that market and sell edible THC products that are easily mistaken for snacks and candy are not only acting illegally, but they are also putting the health of young children at risk," said Samuel Levine, Director of the FTC's Bureau of Consumer Protection. "Those that prioritize profits in front of children's safety are at serious risk of legal action." FDA reviewed many of these websites starting earlier this year and, according to the warning letters, re-reviewed the websites over the past few months. I ask, "What can we do to support the agency in removing these products from the market quickly, rather than having to go through the several months-long process they did here?" I think we can all agree taking these products out of the potential hands of kids is a good thing. In some instances, the online sellers removed only the products mentioned in the warning letters but continued to sell dangerous products. I ask, "Will they continue to sell these products, or will they face additional enforcement action?" After writing Warning Letter Wednesday for three years, I am still amazed by some of the bold claims and adulterated products sold, but this company won my "most OTT" prize. In addition to the delta 8 products cited in this warning letter , they are also selling pounds of psilocybin mushrooms from their website. The last I checked, these were Schedule 1 drugs, which means the potential for big legal issues. Oy vey! Here's the FTC press release on this action. DATE ORIGINALLY POSTED: 7/17/24 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!

< Back Webinar Thursday Jun 3, 2021 Distributor Pitfalls to Avoid Asa's Regulatory Education Series Nathalie Bougenies and Steven Yeager join me for our next Regulatory Education Series event. What companies need to consider when distributing products? Here are some of the topics we will cover. What contracts do distributors need to have in place? What CFR 111 requirements do distributors need to comply with? What Prop 65 liabilities do distributors carry? What is the liability of the distributor? What liabilities do platforms which sell lots of products and making claims have? How do distributors handle product returns? Do they need to be tested before going back into inventory? And more! Learn More Previous Next