Small words can drastically increase claim risk < Back "Promotes Brain Health” Claim Challenged Small words can drastically increase claim risk A children’s brain health applesauce product received a National Advertising Division inquiry for cognitive and immune-related claims. This is an important reminder that claims, even if not high-risk, should always be substantiated. Learn more about my weekly post, and sign up here . Here’s what we can learn. Action words like “promote” can increase the type of substantiation needed. Here, it seems that NAD implies a difference between “promotes brain health” and making statements about supporting brain health. For statements related to the brain or immunity, I suggest replacing action words like “enhance” and “increase” with “support.” 👉From NAD. “NAD found that in context, the “promotes brain health” claim conveyed a message that the applesauce provided important cognitive benefits beyond simply supporting brain health. Given the gap between the strength of the DHA in the applesauce and that tested in the underlying studies, NAD concluded that the cognitive benefits message was not supported.” NAD also recommended that the company remove the “clean ingredients” claim, which was likely due to unnatural ingredients such as citric acid and ascorbic acid. This may have done the company a favor, as any type of “clean” or “pure” are easy lawsuit targets. Also, this product appears to have a Clean Label Project Certified seal, which shows that certifications should be used with caution. Read the NAD case decision . DATE ORIGINALLY POSTED: 1/29/25 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!

Use caution with Made in USA claims < Back FTC Letters to Amazon, Walmart & Other Sellers Use caution with Made in USA claims Four years of Warning Letter Wednesday posts! I am so grateful for your support! When I started writing this post, I had no idea it would turn into this! I’ve made so many friends, colleagues, and business connections because of this. I’ve also learned so much, as it allows me the time each week to dig into the nuances of enforcement trends, which I love! Made in the USA (MUSA) claims are top of mind for FTC. They recently sent four warning letters to companies alleging noncompliant MUSA product claims. Amazon and Walmart also received notification letters (not warning letters) that companies on their platform are making unqualified MUSA statements. In the letter, they reference products making claims like “Made in the USA” or “100% USA Made, “even though the third-party seller is based outside the United States or the product listing describes the item as “imported.” Key takeaways: If you sell on Amazon or Walmart, it is a good time to review your listings to ensure there are no unqualified MUSA claims in text, images, or videos, as they will likely be flagged and delisted. In the past, it seems these platforms didn’t worry too much about this, but now, with the FTC’s attention, I expect tighter scrutiny. An upcoming Apex Compliance feature will scan all of a company’s Amazon storefront product pages in one click for any specific words, such as “Made in the USA,” and then surface issues. I am so excited about this new feature! FTC also references claims made on company websites and social media, and Apex Compliance is already great at finding issues on many of these platforms! “Manufactured in USA” may be considered the same as “Made in the USA.” One warning letter references “high quality America [sic] manufactured products.” FTC also referenced “We use only the highest American-made construction,” “handcrafted in USA,” and “American Made.” Hashtags count. One warning letter referenced the hashtag # MadeinUSA. Noncompliance can be expensive. Here are some of the enforcement “teeth” FTC can use. “Issuance of civil investigative demands (administrative subpoenas), the filing of a federal lawsuit, a permanent injunction, and the imposition of civil penalties of up to $53,088 per violation.” Read the FTC’s press release , which links to the warning letters. This also includes information on how to meet the “all or virtually all” MUSA standard. DATE ORIGINALLY POSTED: 7/30/25 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!

Find high-risk words lurking in old blogs, testimonials, and socials < Back FDA & FTC Crackdown on Products Marketed For Opioid Withdrawal Find high-risk words lurking in old blogs, testimonials, and socials FDA and FTC crackdown on products marketed for opioid withdrawal. The FDA and FTC recently sent five joint warning letters to companies marketing products for opioid withdrawal. Joint FDA/FTC warning letters are rare and a good signal for the industry to pay attention. These are not just warning letters but also include cease and desist demands requiring the companies to stop making unsubstantiated claims or face injunction, civil penalties of up to $46,517 per violation, and requirements to refund customers. This is very serious! Here are some key takeaways. 🔷Products marketed for opioid and substance withdrawals remain high risk. Those suffering from addiction are considered a “vulnerable population” and are top of mind for the FDA/FTC. Other vulnerable populations are the elderly, children, and those with mental illness. This is not a new trend, as opioid-related warning letters go back several years. Now is a great time to ensure these high-risk statements are not inadvertently lurking on a company website or social. The FDA is looking at several-year-old blogs and social media posts in the same manner as current ones. I developed a program to find any website keyword. Please get in touch with me for a free keyword compliance check. 🔷Other high-risk words such as depression and diabetes are mentioned in some of the letters. This should come as no surprise. Here is my blog from last year about depression claims . Here is my post about blood sugar claims enforcement . 🔷Claims made in blogs are prevalent in these letters. Here are my “best practices for reducing risks in blogs” post. 🔷Product reviews are also called out. From a warning letter: “From a review on your webpage …“Its [sic] been great to give up the opioids and feel good.” Four of the warning letters are directed toward kratom companies, and one is to an essential oil company. It is interesting to see what keywords and themes are common in these letters. Contact me for a deeper discussion on this. From a warning letter: “EUCALYPTUS OIL . . . The oil produces a stimulating effect on the body and mind. This aids in reducing the lethargy that may be experienced during opiate withdrawal.” Read the FDA roundup about this 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!

The Sports & Active Nutrition Summit also celebrated its three new Start-Up Stars, innovative early-stage companies that are disrupting the sector. < Back Celebrating innovation Stephen Daniells Press Mention The Sports & Active Nutrition Summit also celebrated its three new Start-Up Stars, innovative early-stage companies that are disrupting the sector. Read More Previous Next

< Back Workshop Tuesday Apr 19, 2022 Marketing and Regulatory Compliance for 5th Year PharmD Students (2022) Massachusetts College of Pharmacy and Health Sciences This course reviews common product online and social media marketing pitfalls to avoid. We also discuss strategies to give graduates a leg up in nuanced and competitive world or product marketing Learn More Previous Next

Delta-8 is a high-risk ingredient < Back Unallowable Ingredient “Enough” to Trigger Regulatory Action Delta-8 is a high-risk ingredient There has been a recent enforcement trend where having an unallowable ingredient in a product can result in a warning letter, even if no disease claims or GMP violations are mentioned. This warning letter is the sixth CBD or delta-8 related warning letter this year, which shows that FDA is still taking this enforcement seriously, especially when delta-8 is added. Here’s a recent write-up on an unallowable (or possibly an un-submitted NDI) ingredient triggering a warning letter. I usually don’t call out company or product names, but this one is too strange to pass up. From warning letter: “Trippy Smak’d Fuk’d Blend Watermelon 1500 mg Gummies” I would call this letter a “low effort” warning letter, but FDA actually purchased the product and tested it for delta-8. The moral of the story is that any company selling delta-8, even if they are not making disease claims, should be put on notice that the FDA is paying attention, especially if the delta-8 products are in packaging and formats favorable to children. Learn more about FDA’s position and its safety concerns here . Read the letter here . DATE ORIGINALLY POSTED: 8/13/25 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!

Product claims must be compliant < Back Tea Product Cited for Blood Sugar, Cholesterol & Cancer Claims Product claims must be compliant This is a story of a small tea company that was cited for making risky disease claims on its website. The company probably didn’t realize they were breaking the rules, demonstrating a considerable opportunity for education in the herbal products market. This is one of the reasons I started Warning Letter Wednesday, to help educate companies on enforcement trends and marketing compliance. This is a reminder that even very small companies are “on FDA’s radar” if they market products online. I write about this here . There are many risky claims in this warning letter. These include blood pressure and cholesterol, which I wrote about last week . There are also claims about insomnia. There have been 20 insomnia-related warning letters this year, and this continues to be an FDA enforcement priority. There is even a cancer claim which is a justifiable automatic warning letter. From this FDA warning letter. “Keeps blood pressure under check.”- “Lowers cholesterol.”- “Controls blood sugar level.”- “Lowers the risk of cancer.” The company removed the items cited in the warning letter from its website. However, very risky posts mentioning claims such as “fights bacteria and viruses” are still on its social media. This again shows that company needs compliance support to understand what constitutes a claim. Here is a “What is a Claim” video . Read the full warning 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!

Uncompliant hashtags attract FDA attention < Back 6-Year-Old Social Media Posts & Hashtags in Warning Letter Uncompliant hashtags attract FDA attention Today's #WarningLetterWednesday reminds us that the FDA considers old social media posts and hashtags marketing claims. Six-year-old social media posts, uncompliant hashtags, and product tags are mentioned in this warning letter. We have spoken about the importance of cleaning old non-compliant social media posts many times. Today's WLW is another reminder. Here is a post and video about this from a few months back. From FDA warning letter On your June 2, (Facebook) 2016 post: “Phenibut is known as a GABA analogue. Outside the US many countries around the world use phenibut clinically for symptoms of PTSD, anxiety, depression and insomnia.” Hashtags on a social media page that link to a product shopping cart are considered marketing claims. It is important to remember the “linking to a shopping cart” portion is the material connection that turns a general statement into a marketing statement. Here is a “Hashtags Are Claims ” video you may enjoy. From FDA warning letter On your February 27, 2017(Instagram) post: “#anxietyrelief” Here is a post and video about identifying and replacing high-risk “buzzwords. ” This is the first step in making online marketing compliant. Interestingly, product tags are mentioned in this letter. Product tags, like metatags, are not likely to attract warning letters on their own. They do, however, signal intended use to the FDA/FTC, showing the authorities. From FDA warning letter “Tags: anxiety, . . natural depression remedy” “Medical studies indicate that L-theanine is neuroprotective and can improve symptoms of depression, anxiety, insomnia, and cognitive impairment. . . . Here is a WLW post from July 2021 where metatags are mentioned . 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!

< Back Presentation, Online Thursday Dec 7, 2023 Making Your (Compliant) Message Shine: Best Practices for Reaching & Engaging Consumers Naturally Informed The goal for 2023: to live stronger, longer. Consumers today are focused on extending health span, defined as the period of one’s life that one is healthy. Emphasis on the healthy, because we want to stay active and energized into our golden years. And more than ever before, younger generations are recognizing that to stay vibrant, one must be proactive. That realization has opened this market up to consumers of all ages who are seeking out nutritional supplements and functional foods and beverages to help them achieve their goals. During this three-day virtual conference, leading experts will discuss the active aging market and trending subcategories. Cognitive health, bone and joint support, libido, and more will be covered, with a look at the latest science on ingredients, consumer market trends, and business strategies. Join us for A+ education that can help you succeed in this space and master this market. Zoom Registration Register Previous Next

< Back Podcast, Interview Monday Feb 14, 2022 Asa Waldstein demystifies the CBD marketplace Health Quest Podcast In this interview Asa Waldstein will explain how CBD is regulated and how consumers can identify trustworthy companies and products. Asa describes some of the challenges faced by companies as well. The challenges are significant. CBD is regulated one way by FDA and states regulate CBD in variety of ways. The quality and potency of CBD products is all over the place with many products being unreliable for numerous reasons. Asa also gives us numerous resources that will help give clarity. Listen Previous Next