< Back Presentation Tuesday May 23, 2023 Regulatory compliance and reducing class action risk Naturally Informed - Microbiome: Mastering the Market 2023 A blurry concept only 5 years ago, the microbiome has become understood as perhaps the most critical environment impacting human health – and consumers know this. What they know less about is exactly how it works and what they can do to impact it. And the more things come into focus, the more we have yet to learn about these complex systems so fundamental to life – the science is evolving literally daily. This three-day intensive virtual conference will examine not only probiotics, prebiotics, synbiotics and postbiotics, but also numerous other microbiome- modulated interactions including the impact of stress and diet. Experts will examine leading-edge science, and deliver practical tools to leverage this science to competitive advantage and truly mastering the market. Register Previous Next

Small business learning lessons < Back Education vs Marketing Discussion Small business learning lessons Today's post highlights common mistakes made by a small herbal company. Looking at their mistakes can help show others what not to do. I am not picking on this company as they likely didn't know the rules of supplement marketing. One of the reasons I write Warning Letter Wednesday is to educate companies on the dos and don'ts of marketing. Please share to help get this knowledge to those who need it. Copying information for herbal texts can lead to trouble. Education is ok, but it crosses the line into marketing when used to sell products. This reference was likely copied from a book onto the company's website. I also see companies making this mistake when copying information from clinical studies to commercial websites or socials. The lesson here is that any statement used to sell products should be compliant. The "Asa rule" is that you shouldn't use it in secondary marketing pieces if you wouldn't put it on the label. 👉From warning letter. "Antispasmodic Tincture • To be used in cases of epilepsy, convulsions, lockjaw, delirium, tremors, fainting, cramps, hysteria, suspended animation, etc." Claims about "colds and flu" are high risk. This is obvious, but it is worth repeating. This phrase is in one of my "top 50" that comes preloaded in my Apex Compliance program. 👉From warning letter. "Echinacea's cold and flu fighting and healing ability alone has made it the #1 immune herb…" Product names are also cited as disease statements in this warning letter. Normally FDA does not normally reference product claims unless they are over the top. 👉From warning letter. "Insomnia Formula• Product name: The product name implies that the product is intended to cure, mitigate, treat, or prevent insomnia." 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!

Common labeling errors can be avoided < Back Supplement Labeling Errors lead to Warning Letter Common labeling errors can be avoided This warning letter has numerous labeling teaching opportunities, which is really exciting! I don’t think any of these violations would attract a warning letter on their own, but altogether they paint a picture of non-compliance. This letter cites a product that does not have the designation “dietary supplement” on the main label panel. This is called the statement of identity and is a core aspect of supplement labels. This is interesting! The company was cited for adding the “percent daily value” statement when it was not necessary. From warning letter. “product labels each bear the following statement: “Percent Daily Values based on a 2,000-calorie diet.” This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein” The lack of a heavy bar separating % DV from non-% DV ingredients in the supplement fact panel is cited. Formatting is important, and here are some FDA supplement fact panel examples . One of the most fascinating aspects of this warning letter is the comment that vitamin K2 does not qualify as vitamin K, which has a % DV. This is a relatively obscure regulation, and I don’t recall seeing this in a warning letter before. From warning letter. “Supplement Facts label incorrectly declares as a (b)(2)-dietary ingredient, “Vitamin K (as menaquinone-7)”. 21 CFR 101.9(c)(8)(iv) lists an RDI for vitamin K of 120 mcg based on the AI (adequate intake) that pertains only to phylloquinone. It’s “% DV,” not “DV %.” Yes, folks, we can learn a lot from warning letters. This is a minor but commonly overlooked item in supplement fact panels. From warning letter. “ the listing of “DV%” is incorrect but may be listed as “% DV”. Finally, the “%” symbol must follow each numerical value listed as a DV.” Oh my goodness, so many great learning lessons! Here is one about formatting. The FDA prefers the format list the supplement fact panel, then “Other Ingredients,” then the contact information. From warning letter. “product label fails to place the “Other Ingredients” list below the Supplement Facts label.” This label also does not include a domestic street address or phone number, which is required for adverse event reporting, and this is essential to a compliant supplement label. Here is a previous Warning Letter Wednesday post with more labeling lessons that include items called out in this letter, such as improper serving size Here is FDA’s labeling information . If you have additional labeling questions, I would be happy to try to be of help. As a resource, I get carried away with this “GMP Pitfalls and Best Practices” blog . I hope you find this useful. There are so many more lessons in this warning letter, including improper specifications. Read it 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!

Carefully review all marketing materials < Back When Nutrient Claims Become Disease Statements Carefully review all marketing materials This warning letter involves a nut butter company that was making implied and express cancer claims on its website and product labels. This is an extreme example of what not to do and there are some good learning opportunities. Ingredient claims are product claims. Here, FDA references ingredient claims being used to help with cancer. These claims appear on the product page but even if they were separated from a shopping cart, such as in an ingredient blog, they would have likely attracted a warning letter. From warning letter. “[R]ecent studies have highlighted the potential of Brazil nuts, almonds, and cashews (ingredients in your Inspiration Butter) in fighting against cancer, thanks to their antioxidant properties and beneficial nutrients.” Claims about nutrients are product claims. This is interesting, as the statement references omegas and polyphenols, which the product contains, as fighting diseases. This is an possible example of what can go wrong when your marketing team is also your compliance team. Also, this was written on the product label! Oye vey! From warning letter. “(From the image of your product label) “THE POWER OF NUTRIENTS: Our uniquely tasty multi-nut butter blend contains Omega 3-6-9 fats with powerful antioxidant polyphenols, which studies have shown may . . . assist in the fight against certain diseases*.” Mission statements are marketing claims. This is pretty obvious as the company states they make products for people fighting cancer. In the past FDA has also cited mission statement related claims when they tie in product such as ‘I had cancer, and this inspired me to make these products.’ From warning letter. “OUR MISSION: We craft calorie-dense and nutrient-intense foods for people fighting cancer . . .. Organic BRAVEZIL BUTTER supports our mission of bringing naturally nutritious foods to market which ‘Fuel the Fight’.” If you market products online, you are on FDA’s radar. This company appears to be a small food manufacturer but since they advertise products on their website, it makes it easy for anyone with a computer, including FDA to find them. Here’s a post about this. Expect more “lower effort” warning letters. FDA’s budget unfortunately has suffered budgetary cutbacks. Web-surfing warning letters like this don’t require resource intensive in-person visits or product testing and we will see more of these in the future. To be fair this company seems to be well intentioned but they just have no idea about marketing compliance. This is one of the reasons why I enjoy writing Warning Letter Wednesday; to help get the world out about the basics, the nuances, the complexities and the best practices when marketing natural products. I really aim to help demystify the sometimes-confusing world of supplement and food marketing and I hope you enjoy it! Read the full warning letter here . DATE ORIGINALLY POSTED: 7/23/25 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 Presentation Tuesday Nov 15, 2022 Decoding the Regulations Around Cannabinoid Enforcement & Marketing Claims MJBizCon, Las Vegas, NV The FDA has not been shy about sending enforcement letters even with a lack of regulation and guidance. Operators in the hemp-CBD/cannabinoid marketplace can limit their risk, while still being truthful and not misleading. But what exactly is that magical line businesses cannot cross before getting a Dear John from the FDA? This session will identify high-risk marketing strategies and how to adapt accordingly. You will learn: - Recent enforcement trends across the industry - How to identify high-risk verbiage and example of lower-risk verbiage to communicate the same message - What is top of mind and what the FDA is looking for when reviewing claims in testimonials, hashtags influences and Tik Tok. - How to read enforcement actions (i.e. warning letters) and your next steps - Q&A at the end Session Date: Tuesday, November 15th, 2022 See the agenda here . Learn More Previous Next

Small issues signify deeper noncompliance < Back GMP Labeling Lessons Small issues signify deeper noncompliance Dietary supplement labeling can be confusing, but ensuring that the "small things" like line thickness are compliant is important. When FDA looks at a label that is not quite right, it can signify greater compliance concerns and trigger them to look deeper, as the adage "Where there's smoke, there's fire" is often true. Let's look at this warning letter to see what we can learn. 🔹Address or phone number: This is an important part of GMPs and safety and is considered a major violation if missing. This is how consumers report adverse events to the company, which can help the company identify quality issues and, if necessary, serious adverse events that must be reported to the FDA. Learn more here . Also, if the company named is not the manufacturer, the label must clearly disclose this fact using a statement like "Manufactured for" or "Distributed by." 👉From warning letter: "The labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1] may receive a report of a serious adverse event with such dietary supplement." 🔹The correct order of ingredients is important. Learn more here . 🔹"Supplement Facts" should be set at full width of the nutrition label, in accordance with 21 CFR 101.36(b)(1)(i) 🔹The correct nomenclature should be used for items with a percent daily value. 👉From warning letter. "The source ingredient that supplies a dietary ingredient may be identified within the nutrition label in parentheses immediately following or indented beneath the name of a dietary ingredient and preceded by the words "as" or "from", e.g., "Calcium (as calcium pyruvate)". When a source ingredient is not identified within the nutrition label, it shall be listed in an ingredient statement." 🔹Formatting is important. 👉From warning letter. "The Supplement Facts label format requirements including the use of bolded text, hairlines, and/or light and heavy bars are not in accordance with 21 CFR 101.36(e)." 👉From warning letter. "The statement "**Daily Value not Established" must be within the Supplements Facts label." 🔹Common ingredient name must be listed. 👉From warning letter. ""Aquamin™" is not the common or usual name for Lithothamnion spp." There are lots of GMP violations in this letter, which is likely the primary reason for this letter. Read the full warning letter here . DATE ORIGINALLY POSTED: 2/5/25 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 Podcast Thursday Jan 13, 2022 Compliance and Marketing Claims Canna Advocate Podcast A warning letter is a FTC notice to crack down on false claims. Why is this a problem? It can threaten your business! A warning letter requires legal resources to answer, which takes away your mental bandwidth. Warning letters are a public notice and can scare away investors. Also, warning letters are used for future class action lawsuits. Avoid the warning letter before it's an issue. Influencer marketing is an enforcement trend to pay attention to. People can make reviews and say whatever they want. But the seller must be careful to use reviews in a marketing campaign. Other terms to take seriously include, THC free or pesticide free. They maybe troublesome terms unless it's 100% true. Dietary supplement marketing examples that work include gaiaherbs.com . Future of Cannabis Marketing Future of the hemp and cannabis industry will be technologies that promote bio-availability products for efficiently absorbing cannabinoids and other nutraceuticals. Listen Previous Next

Product names are marketing < Back Small Herbal Company Cited For Marketing Claims Product names are marketing Even very small companies that market online can attract an FDA warning letter. I am still surprised when I hear companies saying they are not big enough to be on “FDA’s radar.” This warning letter shows that anyone, even a tiny company, is “fair game” for enforcement. Today’s Warning Letter Wednesday is a story of a small herb company cited for making serious disease claims, and I’m guessing they didn’t know the rules of dietary supplement marketing. This is one reason why I write Warning Letter Wednesday: to help raise awareness about enforcement trends and marketing rules in the digital era. 🔷Unfortunately, many schools do not teach the basics of DSHEA and marketing compliance. One of my missions is to educate these communities about the dos and don’ts of supplement marketing. Here is my speaking schedule , which includes three days of classes at next month’s International Herb Symposium at Wheaton College. Please let me know if I can extend free education to your school. I also offer customized marketing compliance company training called the “Regulatory Expert Package.” 🔷This warning letter contains numerous disease statements and is a cautionary tale of what not to do. This is one of the most glaring examples of a disease statement. Wow! 👉From warning letter. “[Echinacea Tonic] should be used for EVERY disease and illness.” 🔷The product names “Insomnia Formula” and “High Blood Pressure II” were cited in this warning letter. 👉From warning letter. “Insomnia Formula • Product name: The product name implies that the product is intended to cure, mitigate, treat, or prevent insomnia.” 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!

Asa Waldstein & other leaders interviewed < Back USDA Final Hemp Rule draws mixed reactions from industry stakeholders Danielle Masterson Interview Asa Waldstein & other leaders interviewed Read More Previous Next

A look at the manufacturing and quality process < Back In-Process Quality Testing A look at the manufacturing and quality process GMP is basically a series of quality processes, such as holding, verifying, and then releasing. This is true for incoming raw materials and all in-process materials. This shows where some companies could make noncompliant decisions in the manufacturing process. Let's look into the manufacturing and quality-checking process and use a capsule product as an example. First, all of the ingredients, bulk capsules, and packaging need to be QC-checked and cleared. This is typically done by reviewing the raw material specification sheet, which shows what types of tests are needed. The samples are sent to a qualified lab and if everything passes, a member of Quality then releases the raw material. Next is blending: All ingredients are weighed by one employee and verified by another (called the doer-checker system). They are then blended, and then a member of Quality verifies that the weight matches the projected yield and verifies organoleptics such as color and smell. If the projected yield is too low, then an ingredient may have been forgotten, and if it's too high, then there is likely some other issue like a duplicate or mis-weighed ingredient. If all looks good, then the blend is released to the next step in the process. Next is encapsulation: A lot of variances can happen in the encapsulation process, so conducting R&D testing to ensure flowability and density is integral to a properly filled capsule. Quality typically checks the capsule weights consistently at the beginning of encapsulation, then about every 15-30 minutes to ensure they are weighing and looking good. After the encapsulation run is completed, Quality then verifies the projected yield of capsules to ensure they are within the predetermined range and releases them to the next step in the manufacturing process. If it is too high, then the capsules are underfilled, and the finished product will be below the label claim. If it is too low, then the capsules are overfilled, which may create a safety issue if there are ingredients that are unsafe at higher amounts. Packaging: The projected yield is calculated from the number of capsules, and bottles are typically weighed consistently when the runs starts, then every 15-30 minutes to ensure the correct number of capsules is in each bottle. Then, the final calculation is reviewed to verify the number of bottles is within the projected range. If it is too high, then the bottle may be underfilled, which is non-compliant. However, if it is too low, that is not necessarily a compliance issue, but it can indicate a money-losing project. Quality then takes a few finished products for sample retention (a GMP requirement) and sends a bottle or two for finished product testing. Once the test results come back, they are written on the finished product specification sheet, and if everything passes, it is released for sale. Celebration time! This lilypad approach to quality is designed to keep non-compliant materials out of the product facility and catch errors during the manufacturing process long before they reach the finished product. Of course, I am simplifying this, as a lot more goes into making a compliant product, but I thought you might enjoy this "behind-the-scenes" look at what goes into making a compliant dietary supplement product. DATE ORIGINALLY POSTED: 4/2/25 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 Symposium Friday Oct 16, 2020 4 Hour cGMP & Marketing Workshop with Steven Yeager & Asa Waldstein American Herbalist Guild (AHG) Annual Symposium Herbal supplement manufacturers and marketers need to have a solid understanding of current Good Manufacturing Practices (cGMP). In this interactive presentation, you'll learn about the intricacies of cGMP, including all CFR 111 subparts. We'll give you examples about how to comply with each section, practical steps for implementing them in your facility, and common mistakes to avoid. We also provide real-world examples of how to prepare for and conduct oneself should you have to undergo an FDA inspection. We review common marketing mistakes made by herbal manufacturers and marketers. Only $30 and supports this important organization Purchase Previous Next

All claims should be substantiated < Back Key Takeaways From FTC “Warning” to ~670 Companies All claims should be substantiated Most of us have heard about the recent FTC notice of penalty offense sent to ~670 companies. To those not on the list, mazel tov. This FTC action puts these companies on notice that claims must be substantiated, and endorsement guidelines must be followed, or the companies can face fines of $50,120 per violation. Here is FTC’s press release , which includes links to the list of companies that received the warning and the letter to the recipients. This is worth reading, but I share some key points below. So why did “these” companies get cited? My Magic 8 ball did not tell me the answer, but I am guessing that search terms like “proven safety,” “scientifically proven,” and “clinically proven” were trigger words. Most of the companies on the list have exquisite compliance, and I verified this using my Apex Compliance program, but there are a few that certainly need a lot of regulatory help to be compliant. I wonder if these blanket “you haven’t done anything wrong, but you are warned” statements are fair. FTC could have found egregious violators with a quick Google search. The action warns companies about two sections of advertising basics: Substantiation & Endorsements Substantiation : We all know that claims should be substantiated, but here are the notable items from FTC’s Substantiation Notice. Product safety : FDA’s supplement regulations require products to be safe, and FTC reminds us that companies should have data to back to this. Discussing “proven safety” likely elevates the risk of FTC scrutiny. Supplements have parameters to ensure these are used safely. They have warnings about potential risks such as “not for use in pregnancy,” “may elevate blood pressure when used long term,” or “may interfere with medications,” and they also have serving suggestions to ensure they are used within safe constraints. I ask, “Is there any reason to claim safe supplements?” Health benefits : This is a broad statement. So, what is a “health benefit?” I think of structure-function statements such as “joint support” or “helps with sleep” as health benefit statements. FTC says all health benefits need to be substantiated, which is common knowledge, but I don’t think FTC will start asking companies for their structure-function dossiers anytime soon. I see this more as a gentle reminder about the basics of advertising and substantiation. However, implying there is clinical proof to support a structure-function claim will attract attention. Mitigates or treats disease : This is obvious, and I expect this to be where much of the FTC’s substantiation enforcement will be. This is even more reason to ensure marketing does not have disease claims. Apex Compliance, my patent pending SaaS compliance program, scan websites, YouTube, and uploaded content for compliance concerns like disease words. Learn more here . Clinically proven statements : This is also where FTC will likely focus its enforcement action. Stating that ingredients have “proven efficacy” or that products are “clinically proven” or “scientifically proven” is a high substantiation standard that will certainly attract FTC and plaintiff attorney scrutiny. Apex Compliance can scan for any phrase, such as “clinically proven.” Set up some time to learn about it here . The Substantiation Notice is not all about health claims. It also applies to claims about efficacy statements such as “phospholipids added for increased absorption” or “helps with weight loss” and performance claims like “fast-acting.” I don’t expect FTC action solely for these lower-risk statements, but the mantra is that everything should have substantiation. From FTC press release: “the notice is not limited to health claims and applies to any marketer making claims about the efficacy or performance of its products.” Endorsements : The other part of the FTC “warning” concerns endorsements. Here are some key points, but most are obvious. Our purchasing behavior is affected by influencers and product reviews, so steps to keep this part of marketing ethical are a good thing. Thanks, FTC! Falsely claiming a 3rd party endorsement of a product when they don’t, such as stating, “Tom Hanks loves my product.” Misrepresenting that an endorsement represents the experience or opinions of product users. Of course, someone shouldn’t say I take this product every day when they’ve never tried it. This FTC lawsuit against Google and iHeartMedia is a great example. Using an endorsement to make deceptive claims (like disease claims). If you can’t say it on a product label, an endorsement shouldn’t either. I write about how a customer social media post becomes an endorsed testimonial here . Failing to disclose material connection: This is so basic, but many influencers skip over this, especially on TikTok. Here are some tips for disclosing material connection. Fake reviews: Right on FTC! Yes, fake reviews are bad. How about withholding unfavorable reviews; this led to this 4.2 million dollar fine . 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!