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!

< Back In-Person, Presentation Friday Sep 5, 2025 Marketing Compliance & Best Practices For Natural Product Marketers: An exploration into enforcement trends and technology solutions SENPA Natural Industry Alliance SOHO Expo Orlando, FL SOHO EXPO is a Natural Products Industry Trade Show and Convention produced since 1971 by SENPA a non-profit Trade Association with proceeds from the show staying within the industry. SOHO EXPO offers the right mix of the natural products industry, and is located at the beautiful Gaylord Palms Resort and Convention Center in Orlando, FL. Join Asa Waldstein for an interactive deep dive into the evolving world of marketing compliance for natural product marketers. This session explores enforcement trends, such as FDA warning letters and litigation, to help inform compliant and effective marketing. This presentation provides actionable insights and pitfalls to avoid for independent retailers or brands of all sizes. Attendees are encouraged to bring their questions to this discussion. Learn more and register Previous Next

< Back Online Tuesday Dec 10, 2024 Navigating GLP-1 Regulatory Compliance: Marketing Best Practices in the Supplement Industry Naturally Informed Active Aging Event This presentation will delve into the current marketing landscape surrounding GLP-1 in the U.S. supplement industry. Asa will look at biomarker enforcement, such as LDLs, to gain insights into marketing best practices, focusing on compliant strategies and pitfalls to avoid when promoting GLP-1-related products. Learn More and Register Previous Next

Before marketing products check with a supplement expert < Back Learning Targets: definition of supplements, safety claims, disease statements Before marketing products check with a supplement expert Today's #WarningLetterWednesday is cringeworthy but also contains learning lessons for product marketers and developers. The product is a vape that contains caffeine, is labeled as a supplement, makes overt safety claims, and uses high risk marketing disease claims. There are a lot of learning lessons here. Vapes by definition are very high risk. Adding caffeine into a smokable product with other herbal ingredients may seem like a good idea to an untrained development team, but it is actually exceptionally dangerous. Supplements are defined as products taken by mouth that contain a "dietary ingredient" intended to supplement the diet. Smokable products by definition cannot be supplements because they are not ingested. As a side comment this is also why "sublingual" delivery is not suitable for supplements, as it's a drug delivery term. I ask, what regulatory category does a vape with herbal ingredients belong to? Making safety claims on any product must be substantiated. When statements like this are made it seems more like optimistic and potentially deceptive marketing than hard science: (from warning letter) “Is it safe to inhale caffeine?.....Yes" There are also high risk marketing disease claims mentioned in this warning letter. These include references to "inflammation" which I discussed in last week's Warning Letter Wednesday here . Lots of claims here discuss ingredient benefits such as: (from warning letter) "Vitamin B12 has even more science-based health benefits including:....Supporting bone health and preventing osteoporosis...Uplifting mood and symptoms of depression" I review ingredient benefit claims in another Warning Letter Wednesday here . Read full warning letter here . DATE ORIGINALLY POSTED: 12/15/21 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!

Hire experts to help with 483 responses < Back GMP Violations Continue to be Cited in Warning Letters Hire experts to help with 483 responses FDA continues to issue more warning letters to companies that do not adequately respond to 483 violations. The violations and 483 responses provide excellent learning opportunities. Here are some key takeaways. ● Documentation. This is a rather embarrassing reminder that FDA can look at any controlled document. “If it’s not written down, it didn’t happen” is a vital part of GMPs. → From warning letter. “The tablet run sheet for … includes out of specification fill weights… The tablet run sheet has weights throughout in the range and notes “tablet won’t hit the weight so running.” A corrective action approved by the firm’s quality unit was not documented.” ● Common (major) allergen disclosure . When disclosing the major allergens fish, crustaceans, or tree nuts (most cases), the specific type should be disclosed, such as “Contains fish (tuna).” I remember when the FALCPA was enacted in 2004, my third year as a supplement manufacturer. → From warning letter. “the finished product labels fail to declare the major food allergen, shrimp and crab, as required by section 403(w)(1) of the Act. Specifically, as you have chosen to use a “Contains” statement, you must declare the specific type of Crustacean shellfish.” ● Herb common names . The American Herbal Products Association (AHPA) Herbs of Commerce book is the FDA-recognized way to list the common names of herbs. This book is essential for supplement companies and consultants. → From warning letter. “Your … Facts label declares the … but fails to state the standardized common name “(b)(4) ” as listed in the reference Herbs of Commerce, as incorporated by 21 CFR 101.4(h).” ● Finished product composition. This has been showing up in more warning letters and 483s and is a rigid interpretation of the finished product composition requirements. Let’s say there is a blend of herbal ingredients that have been tested for identity and purity. If they are blended with a validated procedure and encapsulated, FDA requires a company to prove composition in the finished product even if there are no specific constituents, such as curcuminoid content, to test. It is my understanding FDA has been encouraging companies to develop expensive finished product composition tests to verify this. This is a new and burdensome enforcement trend to watch. → From warning letter. “The input of the various dietary ingredients during production and subsequent analysis of a single dietary ingredient alone in the finished product is not sufficient to verify specifications for identity, purity, strength, and composition in a finished product because inputting specific amounts of various ingredients during manufacturing does not ensure that specifications are met in the finished product, nor does later testing for a single dietary ingredient assess any other components within the finished product.” Adverse event reporting address on labels. A domestic street address or phone number is required on labels which is an essential aspect of dietary supplement safety. An email, website, or QR code is not sufficient. → From warning letter. “Your product label is misbranded within the meaning of section 403(y) of the Act [21 USC § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.” Read the full warning letter here . The 483 responses are humorous. 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!