Search Results

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!

< 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

Ensure 483 responses are complete < Back GMP Violations & Unanswered 483s Lead to a Warning Letter Ensure 483 responses are complete #WarningLetterWednesday involves a company inspected by the FDA last year that received several 483s for common violations like not having proper component and product specifications. The company submitted 483 responses, but these responses were incomplete which led to a warning letter. From Warning Letter: “We acknowledge your response, received December 30, 2021, which acknowledged that specific elements needed to be updated and asserted that “[b]y March 31, 2022, MCACO will update and complete component specifications.” However, we are unable to evaluate the adequacy of your corrective action because you did not provide updated finished product specifications for review.” Here is a Warning Letter Wednesday post about this common GMP violation. The lesson here is to ensure that 483 violations are adequately addressed and that all grievances are met. Most 483s can be “walked back” and addressed before they become warning letters. Warning letters should be avoided. Learn more about the ramifications here . Here is a video about the differences between 483s and warning letters. Other violations cited in this warning letter include: * Not verifying a raw material supplier’s Certificate of Analysis (COA). Depending on the supplier’s Certificate of Analysis (COA), without validating the results with a third-party lab landed this company a 483. The FDA requires that manufacturers verify COAs, including microbial and heavy metals. From Warning Letter: “you have never conducted heavy metal and microbiological tests to confirm results provided by the supplier’s COA.” * Incomplete Master Manufacturing Records (MMR). From Warning Letter: “A description of the packaging and a representative label.” GMPs work backward from the label to ensure there is a 100% label claim at expiration. From Warning Letter: “Written instructions, including specific actions necessary to perform and verify points, steps or stages in the manufacturing process where control is necessary.” The MMR is essentially an easily replicated recipe that includes what goes into the blend, how to verify the numbers are correct, and the instructions for mixing and testing. Here is a very detailed WLW post about GMP violations and best practices. 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 industry leaders interviewed < Back Is FDA watching heart health supplements in 2023? 2023 Ingredient trends for food, drinks, dietary supplements, and natural products Jennifer Grebow Interview Asa and other industry leaders interviewed Read More Previous Next

Re-review websites if inspected by FDA < Back Batch Production Record & Labeling Lessons Re-review websites if inspected by FDA This company is a small manufacturing facility and storefront that is reminiscent of the companies I would order herbs from in the 1990s. Since then, herbal regulations have matured, but unfortunately, this company has not evolved into the highly regulated world of herbal supplements. Sign up for this weekly newsletter . 🔷This letter contains serious GMP violations such as not having specifications and providing incomplete 483 responses like “(we) are still in the process of establishing and implementing the systems.” It also contains many serious online disease claims, and this letter exemplifies how a well-intentioned herbal store can become non-compliant. This is a cautionary tale about the complexities and penalties for companies looking to manufacture and market herbal products. 🔷The disease claims cited in this letter are numerous, but I’ll focus on what we can learn from Batch Production Record GMP violations. I suggest everyone read the full warning letter . You can also comment or message me with specific questions or commentary. 🔷Batch Product Record (BPR) lessons from this warning letter. 🔹Date/time of equipment maintenance, cleaning, and sanitizing record 🔹Statement of actual and theoretical yield. This is how manufacturers can find issues before products ship. For example, if the theoretical yield is off, this signals that too much or too little of an ingredient was added. 🔹Date and initials of each person weighing and verifying component weights. 🔹Labels: The unique identifier assigned to packaging and labels used, the quantity of the packaging and labels used, and, when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels. 🔷More labeling issues are cited in this warning letter, such as not listing the Latin or the standardized common name of plants as noted in American Herbal Products Association (AHPA) ’s Herbs of Commerce, or listing the plant part (e.g., root). These did not lead to the warning letter, but we can learn about labeling best practices. For example, indenting the ingredients under a proprietary blend is apparently a rule. From warning letter. “Dietary ingredients are not indented under the title “Proprietary Herbal Blend” 🔷FDA reviewed this company’s website a few months after the initial inspection. This is a reminder for all companies to re-review their online marketing if they have been recently inspected. This may save you from getting a warning letter. This is one of the reasons I invented and patented Apex Compliance . 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!

Ensure ingredients are lawful for supplements < Back Hordenine HCL Ingredient Leads To Warning Letter Ensure ingredients are lawful for supplements The product in this warning letter contains hordenine HCL, which FDA does not consider a dietary ingredient. Adding this into a supplement makes it an adulterated product which is a violation that, although unlikely, could potentially lead to other penalties such as criminal action. 👉From warning letter. "Because hordenine HCl does not qualify as a dietary ingredient and is not GRAS or otherwise exempt from the food additive definition, your …. products are adulterated " I see ingredients like this in two categories. 🔷NDIs: Hordenine, higenamine, octopamine 🔷Impermissible dietary ingredients: Hordenine HCL, higenamine HCL The FDA differentiates NDIs such as hordenine from impermissible dietary ingredients such as hordenine HCl. You will notice that "HCL" (hydrochloride) is the difference between an NDI and an impermissible ingredient. Here is a warning letter where FDA states hordenine in an NDI. This is really interesting. The reason this company received a warning letter is simply because they added this impermissible ingredient into a supplement. This letter does not contain disease claims or reference the use of pharmaceutical drugs like sildenafil, which is rare. I ran Apex Compliance , my compliance program, on their website and found several disease claims that surprisingly went undiscovered by FDA. This is a great reminder that now is the time for an online compliance tune-up. This is a service I offer, or this program will be available in just a couple of weeks. In a bizarre warning letter notation FDA writes that the company's terms and conditions state they are the property of another company. FDA contacted this other company, who said they have no relationship with the company in this letter. I can only guess this company may have copied another's terms and conditions without changing names. Who knows, but it is worth reading here. 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!

Dangerous products will be cited even if they do not contain disease claims < Back Delta-8 Inhalable Product Dangerous products will be cited even if they do not contain disease claims Shocking warning letter! After writing this post for over 200 weeks, I am rarely surprised. However, this warning letter highlights some truly audacious and potentially extremely unsafe THC and mushroom vape products. FDA cited this company for selling an inhalable delta-8 THC product called “D9 Smashers Peach Mango Delta-8.” However, I found some even more over-the-top products on their website, such as these products. Some of these ingredients I’ve never heard of, and I doubt their inhalant safety has been verified. 👉From website (product contains):“ Mushroom Extract, THC-A Diamonds, THC-P D8 & D10 THC, CBD Live Resin” and “ Loaded with Delta 11, Delta 8 Live Resin, HHC., THC-P., & THC-JD.” There are also candy bars containing high amounts of THC and mushroom extracts in packaging that are considered “favorable to children.” Some of the product labels also contain cartoon characters with titles like “Darth Vapor.” Read about FDA/FTC’s thoughts on this and delta-8 safety. In previous FDA/FTC warning letters, the FTC used Section 5 as a rationale for deceptive marketing allegations when delta-8 was sold in formats favorable to children, like gummies. I find this approach fascinating and clever. 👉“Section 5 of the FTC Act prohibits unfair or deceptive acts or practices in or affecting commerce. This prohibition includes practices that present unwarranted health or safety risks….. preventing practices that present unwarranted health and safety risks, particularly to children, is one of the Commission’s highest priorities.” So, what can we learn other than the obvious takeaways? FDA reviewed this company’s website over a long period in May and December of 2024 and then again in January 2025. I assume if the company had “gotten its act together,” it could have avoided this letter. I am not an expert on FDA processes and resource allocations, but it seems this letter should have been issued long ago. I am curious what resources we can lobby for that will help FDA get these bad products off the market sooner. I ran Apex Compliance ® on their website and found disease claims that, surprisingly, were not mentioned in this warning letter. If you are interested in a copy of the scan, send me a note. Read the full FDA warning letter . DATE ORIGINALLY POSTED: 6/4/25 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!