Blogs are marketing statements < Back Blog Claims Result in Warning Letter Blogs are marketing statements This warning letter cites a kratom company for making disease claims related to opioid withdrawal, cancer, and depression in blogs. The learning targets in this Warning Letter Wednesday are: 1) Blogs are marketing claims 2) Comparing products to drugs is high risk 3) Scan websites for high-risk statements ✔ Blogs are marketing claims. Blogs continue to be cited in warning letters as they are "active" pieces of marketing, even if they are several years old. In this warning letter, the company talks about kava, an ingredient in its products being used for ADHD. If their products did not contain kava, this is low risk, but since this blog promotes its ingredients, this is essentially the same as putting "Our products help ADHD" right on the label. 👉 From warning letter (blog). "Here are ten amazing kava benefits you should be aware of . . . May Alleviate ADHD Symptoms[,] kava may be beneficial to people who suffer from attention deficit hyperactivity disorder (ADHD). ✔ Comparing product benefits to drugs is a great way to attract FDA attention. The example below is ultra-high risk because FDA is likely concerned that if people think the product works the same as cancer drugs, the consumer may forego lifesaving treatments for the natural (unproven) options. I am a fan of natural products, but it's important to market them in a compliant manner that does not inadvertently give people false hope about their uses. 👉 From warning letter. "Two of Kava's constituents …. have similar potency to the Alzheimer's disease treatment Memantine." 👉 I write more about the risks of comparing products to drugs . ✔ Most of the claims referenced in this letter have been removed, but there still are many claims on their website. I ran Apex Compliance and found dozens of very high-risk statements, especially when discussing their ingredient's benefits. There are also statements about helping COVID symptoms on their "forgotten" blog posts. I developed Apex Compliance to help companies identify and remove marketing risks on their websites and content before publishing. Learn more and schedule a demo . Also, DM me to schedule an Apex Compliance meeting at SupplySide West! 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!

Cosmetics are not "FDA-approved" < Back Marketing Claims Turn Cosmetics Into Drugs Cosmetics are not "FDA-approved" This warning letter shows us where the line is between allowable cosmetic claims, the "not really okay structure-function claims, and disease claims. In this letter, the disease claims tipped the scale to regulatory action. Cosmetics have a narrow definition of what types of marketing claims are allowed. First, let's start with FDA's cosmetic definition. "Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance." This is very narrow and leaves little room for bold marketing statements. Structure-function claims. Although not permitted for cosmetics FDA tends not to cite cosmetic companies for making lighter "supplement" structure-function claims such as "joint comfort" or "promotes skin elasticity." In this example, the company was making supplement-style claims about an ingredient in the formula. These types of statements, while not ultra-high risk, should still be avoided. From warning letter. "Magnesium Chloride helps with the normal functioning of cells, nerves, bones, and the heart." Disease claims. Here are some examples that cross the compliance line. From warning letter. "5 Benefits of Natural Progesterone Cream: Treats Fibroid Tumors . . . Helps Endometriosis" "Lower the risk of urinary tract infections (UTIs)" "May help relieve skin flares caused by Psoriasis & Eczema" GMP violations . This warning letter also includes GMP violations, such as the very common "you didn't test your glycerin for DEG" citation. I write more about this here . Cosmetics and supplements are not FDA-approved. I typically don't take pleasure in other company's misfortunes, but I rather enjoy seeing "FDA-approved" statements called out in warning letters. This serves as a reminder that cosmetics and supplements are not "FDA approved," which differs from "FDA registered." Interestingly, the website's "FDA approved" statement and the ambiguous website "FDA inspected and certified facility" claim were cited. I doubt the label claims would have been called out in this letter without the blatant "FDA-approved" website claims. I will add this to my Apex Compliance keyword lists, which helps companies find and replace risky statements before they lead to lawsuits or letters. ·From warning letter. "the website for Magnesium 50 mg Body Cream includes the image of a blue circle with the claim, "FDA * APPROVED * FACILITY." Further, the product labels and/or websites for the other seven before-listed products include statements that these products are made or manufactured in an "FDA inspected and Certified Facility," a "Certified FDA registered facility," I ran Apex Compliance on this company's website and found lots more very high-risk claims that can lead to additional warning letters or lawsuits. For example, "may help with depression" when promoting vitamin D ingredients. For just $500, I can provide a line-by-line report showing where risky phrases occur, a risk rating, notes, and more. Let me know if interested. There is a lot more to this letter. Read the full warning letter here . DATE ORIGINALLY POSTED: 8/28/24 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!

Here are tips on using FDA’s ingredient directory < Back Unallowable Ingredient Results in Warning Letter Here are tips on using FDA’s ingredient directory FDA cited a company for marketing sulbutiamine, an unallowable ingredient in their dietary supplement. This is different than the standard “drug-spiked” warning letter, where companies were hiding sildenafil and diclofenac in supplements. This company actually labeled their product as Sulbutiamine Plus Brain Support. I find this warning letter interesting for several reasons. First, I do not see Sulbutiamine listed in FDA’s “Information on Select Dietary Supplement Ingredients and Other Substances” link or in previous warning letters. This link can provide some helpful information to show FDA’s thinking on why certain ingredients may be allowable. Ingredients are listed by category. Here is the breakdown (from FDA). 🔹Category 2: Ingredient is the subject of a safety communication 🔹Category 3: Ingredient is not a “dietary ingredient” under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 🔹Category 4: Ingredient is excluded from the dietary supplement definition under section 201(ff)(3) of the FD&C Act 🔹Category 5: Dietary ingredient has not met the safety standard in section 402(f)(1)(A) of the FD&C Act 🔹Category 6: New dietary ingredient has not met the safety standard in section 402(f)(1)(B) of the FD&C Act 🔹Category 7: New dietary ingredient requiring a premarket safety notification under section 413(a)(2) of the FD&C Act, but for which no notification has been submitted This warning letter does not appear to mention that any commerce or testing occurred. It simply states that the company is selling a product with sulbutiamine, which is not a legal dietary ingredient or food additive. There is no statement such as “we reviewed your website over the past few months and see that you sell a product into interstate commerce.” FDA’s budget has been slashed, and we may see more of these low-lift letters in the future. I also ran the company’s website through Apex Compliance and found that the company is making disease claims on many other products but no disease claims are mentioned in this warning letter. I Googled sulbutiamine and found many well-known companies selling this ingredient. I expect more enforcement and private litigation around this ingredient in the near future. Read the warning letter . DATE ORIGINALLY POSTED: 5/21/25 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!

Opioid support claims are high risk < Back Kratom Claims Enforcement Increasing Opioid support claims are high risk There have been four kratom warning letters this year compared to just one last year, a 400% increase. This shows there has never been a riskier time than now to market kratom with disease claims. All kratom warning letters this year involve claims related to opioid withdrawal. Products marketed for opioid and substance withdrawals remain a high risk as 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. Now is a great time to ensure these high-risk statements are not inadvertently hiding on a company website or socials. The FDA does not have a favorable position on kratom and considers it a New Dietary Ingredient (NDI) according to this import alert . The FDA also sent out this kratom alert where several US Marshall kratom seizures are highlighted. There also have numerous kratom-related recalls because of salmonella contamination. The key learning lessons are that if a company must sell kratom, they should be very careful not to make opioid withdrawal support or other disease claims, including statements in blogs or citing clinical studies. Also, investing in safety studies and testing every lot for microbials is advisable. I think safe and responsible kratom commerce may someday have a place in dietary supplements. The 2022 kratom warning letters are joint FDA and FTC warning letters. Also, they 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. 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 “clinically proven” or “clinically studied” statements < Back “Clinically proven” statements are high risk Use caution with “clinically proven” or “clinically studied” statements #WarningLetterWednesday Implying "Clinically Proven" or even "Clinically Studied" is high risk. This is a trend to watch out for. We are seeing references to "clinically proven" types of claims showing up not just in warning letters but also in class action lawsuits and NAD complaints. The highest burden of proof is "clinically proven". This is rare in dietary supplements and should be used only if proper substantiation exists. The next highest burden of proof is "clinically studied". This requires the formula to be studied with scientifically significant methods. Bench or pilot tests may not qualify as "clinically studied". This can be difficult when using branded ingredients that may have been researched but perhaps do not meet a "clinically studied" standard. Most branded ingredients have sound research but some may not. It is important to conduct a proper review before using ingredient science on face value. A "clinically studied ingredient" is different than a "clinically studied product". There are many factors including serving size, formulation, and delivery form that play a role in this. We talk about what defines clinically proven here . If accurate, I prefer using descriptions such as "thoughtfully formulated with well-researched ingredients". What are your thoughts? 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!

We can learn a lot from NAD cases < Back NAD Case: Sustainability & Clean Ingredient Substantiation We can learn a lot from NAD cases This company was making claims related to sustainability, “clean ingredients,” and efficacy. This is a really interesting case that we can learn a lot from! The National Advertising Division (NAD) is a great place to look for case law regarding substantiation requirements. Here, I review a recent NAD monitoring case against a cosmetic and flavor ingredient company. Clean Ingredients Here is the claim challenged by NAD. “Clean ingredients and clean formulas – we ban over 2000 ingredients that are known to be toxic to you and the environment.” NAD’s finding: “NAD found that it is not clear whether the over 2,000 ingredients … does not use in its products are associated with cosmetic products. Therefore, NAD recommended modifying the claim specifying banned ingredients typically used in cosmetic products.” Asa comments: This shows that if a product does not typically contain an ingredient, stating that the product is free of an unlikely ingredient may be misleading. Do you think this applies to labeling a product “no soy” if it’s very unlikely to contain soy? Sustainability Claims Here is the claim challenged by NAD. “Keeping 2 million sharks every year safe from liver harvesting.” To substantiate this claim, the company provided data regarding an estimated number of sharks killed and an estimate of the global demand for shark liver oil; however, this was insufficient to provide a reliable number. NAD’s finding: “NAD recommended that the claim be discontinued or modified to avoid referring to a numerical figure. NAD noted that nothing in its decision prevents …. from making a more general claim that sharks are not harvested for squalane found in (its) products.” Asa comments: Numerical claims require increased substantiation and should be avoided unless there is firm supporting data. Here is another numerical claim example. Challenged claim and NAD’s findings: “All of our ingredients are also ethically and sustainably sourced,” NAD determined that while … Supplier Code of Conduct might demonstrate its commitment to ensuring that ingredients are ethically and sustainably sourced, it does not demonstrate that all ingredients are, in fact, ethically and sustainably sourced. Asa comments: I wonder if the code of conduct would have substantiated a “some of our ingredients” statement. Efficacy Claim NAD challenged this efficacy claim: “(ingredient) locks in weightless moisture, calms and protects, and improves elasticity.” NAD’s findings: “(The company) relied on three studies that assessed the impact of squalane, in the form and range of the amount found in the … products, on these objectively measurable attributes.” Asa comments: This shows how important it is to have comparable studies. For example, if the studies were conducted using different forms and dosages, they may not have been sufficient for substantiation. This is a slightly shorter WLW than normal as I am celebrating my wife’s birthday Tuesday night, so no staying up late for me. 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 leaders interviewed < Back Predictions for 2021: What's ahead for the hemp sector Hemp Industry Daily staff Interview Asa and other leaders interviewed Read More Previous Next

< Back Interview Saturday Aug 12, 2023 Regulatory Expert Asa Waldstein The Herbalist Hour Ep. 55 HerbRally The topic of regulatory compliance in the herbal industry is an incredibly important one, so it was an honor to have on Asa Waldstein, one of the leading experts in the field on the show. We delve into all sorts of topics in this interview: At what point should a smaller herbal company start being serious about making claims on their marketing efforts? Stories of smaller herbal companies who get warning letters from the FDA. Advice on getting started when it comes to marketing claims. We also chat about substantiation dossiers, using puns as claims in marketing your products, general business advice, his new software Apex Compliance, the time he spent with @MichaelFranti and a whole lot more! A huge THANK YOU to Asa for taking the time to share his expertise with all of us, and thanks to YOU for listening. I highly encourage you to sign up for Asa's " Warning Letter Wednesday " newsletter. Until the next episode, ~Mason Watch Previous Next

Screen all blogs and social media for disease claims < Back Disease Claims Turn Supplements Into Unapproved New Drugs Screen all blogs and social media for disease claims This #WarningLetterWednesday is an excellent lesson about turning a supplement into an “unapproved new drug” by making disease claims. Other lessons here are: ● LinkedIn claims cited again! ● Eight-year-old social media post! ● Claims made on social media are top of mind for the FDA. From Warning Letter: “Ayurveda has solutions for managing high blood pressure. . . . THREE PRODUCTS TO HELP HIGH BLOOD PRESSURE . . . Arjuna Arishtam supports healthy heart function and reduces high blood pressure.” Social media is mentioned in this warning letter. The citation below is boilerplate in warning letters, and it is a good reminder that directing consumers to a website to purchase the product is the “material connection.” If these social media sites did not link to a commercial website or shopping cart, they likely would not be cited in this letter. From Warning Letter: “these social media websites direct consumers to your website at https://lnkd.in/g-vvBiJH to purchase your products. An eight-year-old Facebook post is mentioned here, and this may be a record for the oldest post mentioned in a warning letter! As I’ve spoken about several times, the FDA looks at old social media posts in the same manner as current ones, and we talk about this here . From Warning Letter: “On an April 3, 2014, post from your Facebook social media website” Check out the citations at the bottom of the warning letter! They reference claims made on LinkedIn. I wrote about this just a couple of weeks ago, and it is a good reminder to clean up old social media pages, including LinkedIn. Join the discussion here : Pro tip: This post includes a high-risk hashtag, which makes it easy for the FDA to find claims in the cluttered world of LinkedIn. From Warning Letter “This webpage is also linked from a post on your LinkedIn social media website, which states “# Highbloodpressure does not have to be permanent: # Ayurveda has solutions for managing high blood pressure. When turning the light of Ayurveda onto HBP, there is a priority toward each person’s imbalance and recommendations are made based on the best diet and activities for each person.” Read the 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 Panel Discussion, In-Person Wednesday Nov 15, 2023 Avoid the Lawsuit - Top Labeling Mistakes Colorado Food Works Arvada, CO Are you thinking about updating your CPG product label in 2024? Thinking about making a “Healthy” Claim on your package? Is your functional food or beverage “Anti-Inflammatory”? In this month’s event we will be reviewing top labeling mistakes that can result in lawsuits and costly re-prints. Avoid the headache and join us for a panel of Labeling and Regulatory Experts along with an interactive scavenger hunt to find packaging errors. RSVP Previous Next

Review videos for compliance concerns < Back YouTube Claims Lead To Warning Letters Review videos for compliance concerns There have been three YouTube-related supplement warning letters this year, which shows FDA is not slowing down with this enforcement trend. Since this is a US holiday, I will keep today’s Warning Letter Wednesday brief. All of the 2023 YouTube-related warning letters also cite claims from other platforms like websites and other social media platforms. This means that “where there’s smoke, there’s fire,” and if there are claims on videos, there are most likely disease claims elsewhere in a company’s marketing. I just launched Apex Compliance , a compliance software designed to find risky phrases on websites, YouTube videos, and uploaded content before it gets you in trouble. I developed this SaaS tool to help companies fix their marketing before it leads to a warning letter or lawsuit. Learn more here . Two letters link to a shopping cart, and the other one references a video embedded on the website. This is the material connection that correlates the video to commerce. I doubt these videos would have been cited if there were no links to where customers can order products. Only one FDA warning letter in FDA’s warning letter archives mentions claims on Vimeo (that I can find). Here are the three letters: 👉ByPro Nutrition LLC 👉PharmaCanna 👉Spartan Enterprises Inc. 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 Workshop, Online Thursday Apr 21, 2022 Cannabis II: Marketing Compliance for the Hemp Industry Delaware Valley University Asa Waldstein trains future regulatory compliance professionals. Learn more Previous Next