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Distributors must comply with some GMP requirements < Back GMP Lessons For Distributors Distributors must comply with some GMP requirements Distributors are responsible for the products they hold and distribute. Here, I review a recent warning letter where the company was cited for GMP and labeling issues, and there are some excellent learning opportunities here. 🔹Listing mandatory nutrients: The cod liver oil product’s serving size is 5mL, but there are no calories, Total fat, or vitamin D listed in the supplement fact panel. These are some mandatory nutrients that must be listed if they are above the “zero level” per serving. For example, four calories is a “zero level,” but five or more calories must be declared. AHPA has some excellent guidance on this if you are a member, or here’s a link to the FDA regulations that are unfortunately a little clucky. Supplement Advisory Group, my consulting company, can help make your label and supplement fact panel compliant. Please contact me with your label compliance needs. 🔹DSHEA disclaimer: If there are structure-function claims on a label, the company must add the DSHEA disclaimer and correlate it with a symbol. Unfortunately, plaintiff attorneys have been using this regulation for lawsuits in the past two years. This is because the rules state the disclaimer must be on each label panel where the claim occurs. From warning letter. “The label makes structure-function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b)” 🔹Adverse Event Reporting address: This is an essential part of the safe regulation of supplements. 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) may receive a report of a serious adverse event with such dietary supplement.” 🔹Multiple languages: If a label lists information in two languages, the supplement fact panel must also be listed in both languages. This is a regulation I did not know about since I have only worked with English labels. From warning letter. “If a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. The product includes foreign language on the label but fails to declare all subsequent information in the Supplements Facts label in both languages as required.” 🔹Statement of identity: The product has a supplement fact panel but “Supplement” is not listed in the Principle Display Panel. Now the GMP issues. 🔹Storage must match label instructions. This one is interesting. The label lists a storage temperature, but the distributor apparently did not have procedures to control for this. From warning letter. “Your procedure does not include instructions on how to appropriately store these products based on the storage temperatures indicated on the product labels.” 🔹Designated quality personnel. Distributors must have qualified and trained quality personnel. Some SOPs, employee time allocation, and training could have avoided this part of the warning letter. From warning letter regarding their 483 response. “These documents assign the product receiving responsibility to the Purchasing Department, including the review of shipment documentation. However, neither document provides your firm’s quality control procedures for dietary supplement products, such as written procedures for conducting a material review and making a disposition decision in accordance with 21 CFR 111.113, including products contract manufactured for your firm’s own label.” There is a lot more to this warning letter. Read the full 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!

High risk “buzzwords” attract FDA/FTC “keyword web crawlers” < Back Step #1 in reducing risk is removing high-risk “buzzwords” High risk “buzzwords” attract FDA/FTC “keyword web crawlers” #WarningLetterWednesday Step #1 in reducing online marketing risk is removing high-risk "buzzwords". These include Alzheimer's, cancer, diabetes, PTSD, opioid support, depression, and of course COVID. Other "buzzwords" include pain, anxiety, inflammation, and arthritis. Today's warning letter is a smorgasbord of "buzzwords". Read it here . Authorities look at the 10,000-foot view of a company's online persona. One "buzzword" will likely not attract a warning letter, but claims on social media, videos, blogs, product reviews, hashtags, and ingredients descriptions elevate risk. The authorities piece them together for one big picture of noncompliance. The more "buzzwords" the higher chance of scrutiny. I suggest removing or replacing them with truthful, accurate, and not misleading options. Examples: Pain <> Discomfort Anxiety <> Mental resilience or balanced mood support Flu <> Seasonal immune support 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!

In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. < Back Q2 2025 warning letter roundup with Asa Waldstein Asa Waldstein Guest Article In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. Each quarter, I provide updates on notable FDA warning letters and enforcement trends. Understanding enforcement trends is essential for being a savvy marketer, regulatory affairs professional or dietary supplement executive. Have you wondered why FDA issues warning letters to certain companies and not others? FDA likes to make examples of companies not following the rules in areas they want to focus on, many of which I review here. Staying ahead of trouble is one of the critical and fun reasons to follow enforcement trends. This warning letter roundup focuses on social media warning letters, unallowable ingredients and a CBD update. I hope you enjoy it! Read More Previous Next

Asa and other industry leaders interviewed. < Back FDA Objects to CBD Being Sold as a Dietary Supplement; Industry Leaders Speak Out Steven Hoffman Interview Asa and other industry leaders interviewed. Read More Previous Next

Hashtags elevate marketing risk < Back Discussing Ingredient Benefits Leads To Warning Letter Hashtags elevate marketing risk In the eyes of FDA, discussing product ingredients is a marketing claim, even if there is no direct cross-linking to a product page or shopping cart. This is a common mistake and a good reminder for companies to re-review their websites. Do you want Warning Letter Wednesday delivered to your inbox each week? Sign up here . 👉From warning letter. "On the … Health & Wellness page in the linked article titled: "WHAT IS CALCIUM? | CALCIUM BENEFITS” “[C]alcium supplements are tied to several health benefits including…lowering the risk of colon cancer…” 🔷This is obviously high risk, but it shows how an inexperienced and probably well-intentioned marketer can attract serious agency action. This is one of the reasons I write Warning Letter Wednesday, to help companies get into compliance before they get into trouble. 👉From warning letter. (Facebook) "What happens if a child doesn't get enough calcium?...Kids who don't get enough calcium will have increased risk of bone fractures, not able to reach potential height, and osteoporosis later in life….#dcal #dcalkids" 🔷Adding a product name in a hashtag significantly elevated the likelihood of scrutiny as it correlates the product to the claims in the post. 🔷Here is an example of when hair loss statements cross the line into disease claim category. By removing "alopecia," this would reduce the likelihood of FDA action. This is only the third FDA warning letter to mention "hair loss" claims in the past three years, and all letters included high-risk words. Even though "hair loss" statements are not top of mind for FDA, they are likely to be scrutinized by FDA, NAD, or plaintiff attorneys. Read more about NAD here . 👉From warning letter. "Do I need calcium for hair growth?... Low levels of vitamin D are associated with alopecia or hair loss. Adding vitamin D and calcium supplements may help create new hair follicles, which can play a role in hair growth." 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!

Blogs are “labeling” < Back Product Reviews Become Marketing Claims Blogs are “labeling” Do you have product reviews on your website? In general, FDA is "hands off" with true 3rd party, non-curated, non-compensated honest reviews unless they have been endorsed. Here are some examples of how companies endorse testimonials, which turns them into marketing claims. Showcasing reviews: This is when reviews are in a banner or highlighted in some way. This includes using them in social media posts. Engaging with reviews: In this warning letter, the company has dozens of customer reviews with disease words relating to things like neuralgia and arthritis. This company's product reviews appear to come through a third-party widget like TrustPilot, and these types of "third-party" reviews are typically not cited in warning letters unless the company has commented on them. This engagement endorses the review and converts it to a marketing claim in the eyes of the agencies. This includes companies "Liking" or "Saying Thanks" to customer reviews on their social media wall. Of all the disease-containing reviews on the website FDA only mentions the ones that the company responded to, which is why I suggest "fighting the urge" to engage with reviews that contain disease or outlandish claims. Here is an example from this warning letter. From warning letter. "January 25, 2023 customer review states, "Best place for CBD oil. Really helps my older dog's arthritis pain" (company) replied, "Thank you… We are grateful to provide great service and products that help to our community. Glad to hear that it's helping ease your dog's pain." Blogs are "labeling" At Supplement Advisory Group , I am often asked if blogs are marketing claims. If the blog discusses ingredients that are in products sold on the website, these are marketing claims that can lead to regulatory issues, even if there is no cross-linking or hyperlinking to product pages or a shopping cart. From a blog cited in the warning letter. "CBD may protect nerve cells from deteriorating, and a study from Frontiers in Pharmacology found that CBD can significantly decrease the negative effects of Alzheimer[']s and also improve cognitive ability." This warning letter includes claims made about animal "supplements." I have written about FDA's enforcement view of pet product claims here . This is also a CBD warning letter, which is uncommon these days. Hey, supplement and CBD companies, FDA is watching, and this warning letter could have been easily avoided. Let's set up some time to meet for free, and I would be happy to help point you in the right direction. I've dedicated my life to understanding the nuances of truthful marketing compliance. I would be glad to donate some time to help support your compliance. I also run a consulting company that can help with all levels of support, such as website reviews, listing support, and more. Read the full letter here . DATE ORIGINALLY POSTED: 9/11/24 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!

Scan marketing for “mid-risk” heart health claims < Back IBS & Cholesterol Claims Cited in Warning Letter Scan marketing for “mid-risk” heart health claims This letter primarily cites digestive ailment claims such as Irritable Bowel Syndrome (IBS) and heart health claims such as “lowers cholesterol.” While these types of statements should be avoided, they are not usually enough to tip the scale into a warning letter. Do you want Warning Letter Wednesday delivered weekly to your inbox? Sign up here to join ~500 other regulatory professionals. Here are some key learning opportunities. 🔹Statements related to cholesterol and blood pressure should be avoided. In the past, statements like “lowering cholesterol and blood pressure” were not enough to attract a warning letter unless higher-risk disease words were present, but this seems to be changing. I write about last year’s crackdown on companies making biomarker claims here . I expect this trend to continue, so the learning target here is re-review all marketing and remove statements like these. • Lowers blood pressure • Lower A1C and LDLs • Lower arterial plaque • Lower blood sugar • Lower bad fats 🔹We have always known that Irritable Bowel Syndrome (IBS) is considered a claim, but it’s not commonly cited unless words like Crohn’s Disease are also used. I also suggest using caution when talking about bloating, constipation, and abdominal pain, as they may be symptoms of serious diseases. If accurate a potential risk mitigating factor is talking about occasional abdominal discomfort and attributing bloating to occasional overeating. These strategies help separate normal life events from those related to disease. 🔹The company receiving this warning letter appears to be very small, which again shows that us no one is too small to be off FDA’s radar. 🔹This company also makes statements in testimonials that have been highlighted on the website. When a company engages or calls outs a product review, this then becomes an endorsed testimonial, which is marketing. I write about the endorsement of social media claims 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!

< Back Webinar Tuesday Sep 24, 2024 Technology solutions for marketing and manufacturing supplements in the US FoodChain ID Asa Waldstein of Apex Compliance and Jérôme Le Bloch and Amélie Denis of FoodChain ID partner in this educational webinar. They review technology solutions for ingredient suitability, marketing compliance, and more. Ingredient Suitability & Claims: FoodChain ID’s experts will guide you through determining ingredient suitability and navigating claims regulations in the U.S. Regulatory Compliance: Discover how FoodChain ID’s Supplements R&D Insight tool offers comprehensive regulatory data and scientific analysis to simplify compliance. Content & Enforcement Trends: Apex will demonstrate how their Compliance tools help avoid costly FDA warning letters and litigation through efficient content review and risk management. Learn More and Register Previous Next

Use caution copy & pasting “ingredient benefits” onto commercial website < Back Learning targets: Children, risky words, intranasal, ingredient benefits Use caution copy & pasting “ingredient benefits” onto commercial website #WarningLetterWednesday is a cautionary tale for companies new to the space that are looking to market products. This company looks like a groovy crystal shop that started making topical products and products delivered to the eyes and nose. So what can we learn? 🔷Of course, there are high risks words referenced in the warning letter, Notably, the use of viruses, cancer, and so many more! 🔷Products delivered through the nose (intranasal) or as an eye drop are drugs and have a justifiable higher level of scrutiny. 🔷Products marketed for use by children are high-risk. 🔷This warning letter is a good teaching tool. Copying and pasting a product's "therapeutic uses" from a textbook or website is a great way to get into trouble. This appears to be the case here. ➡️From warning letter Colloidal silver is used to treat infections due to yeast; bacteria (tuberculosis, Lyme disease, bubonic plague, pneumonia, leprosy, gonorrhea, syphilis, scarlet fever, stomach ulcers, cholera); parasites (ringworm, malaria); and viruses (HIV/AIDS, pneumonia, herpes, shingles, warts). 🔷I understand these are obvious high-risk claims, but in some ways, this could have happened to any entrepreneur that doesn't understand the rules of marketing products. I have seen this happen several times with practitioners, herbalists, and even doctors that "cross the line" into marketing claims by using common therapeutic language such as anti-inflammatory and even "clears heat and resolves toxins." We talk about this here . ➡️From warning letter .... to heal skin irritations and scarring. 🔷Interestingly, there are a couple of references to helping skin irritations and scarring. I do not consider these to be high risk. They are likely a "pig pile" or a common secondary claim in warning letters. What are your thoughts on the risk level here? Read warning letter here . 👉In closing, I think the FDA would have left this company alone if there were not talking about viruses, selling products that go into the nose and eyes, are marketed as safe for children, and had just too many disease words to be avoided. I started a LinkedIn group just for warning letter discussion. Join 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!

Use FDA’s helpful resource (criterion 6) < Back Avoid Comparing Products to Drugs (most of the time) Use FDA’s helpful resource (criterion 6) Comparing supplements to drugs is a great way to irritate FDA and attract a warning letter. In today's Warning Letter Wednesday, I am exploring Criterion #6, "Claims to be a substitute for a product that is a therapy for a disease." This criterion shows the FDA's thinking on why products marketed as alternatives to prescription drugs may be disease claims. I often discuss disease claims attracting warning letters, but it can be difficult to know where the line is between allowable structure-function claims and off-limits health claims. Thankfully, the FDA has published the "Small Entity Compliance Guide on Structure-Function Claims," which provides a Q&A with 10 criteria to help determine if a statement is a disease claim or a structure-function claim. It's really helpful! 👉From FDA Guide. "A claim that a product is a substitute for a drug or other therapy for disease, or has fewer side effects than a therapy for disease, is an implied disease claim. Such claims carry with them the clear implication that the dietary supplement is intended for the same disease treatment or prevention purpose as the therapeutic product." 🔹Asa Comments. FDA pays extra attention to drug comparison claims when the ramifications of not taking that drug can have serious consequences, such as heart disease and depression medications. Here is an example from a warning letter. " Numerous double-blind studies have shown that 5-HTP has equal effectiveness compared to drugs like Prozac, Paxil, and Zoloft (SSRI's)." 👉From FDA Guide. "However, if a dietary supplement claims to be a substitute for a drug that is not intended to treat or prevent disease (i.e., a drug intended to affect the structure or function of the body), the claim comparing the drug and the dietary supplement would not be a disease claim." 🔹Asa Comments. I have to be honest. I don't think I've ever read this portion of this criterion, which clarifies that not all drug action comparisons may be a deal breaker. The key point here is not to use disease terminology. Here are some possible examples. 🔺Possible allowable structure-function claim. "Ginger-Plus calms the stomach as effectively as Dramamine so you can enjoy the ride. without drowsiness." If substantiated, this may be allowed since motion sickness is not a disease, according to the FDA preamble . 🔺Example of how it would cross the line into a disease claim. "Stops nausea like prescription anti-vomiting drugs." DATE ORIGINALLY POSTED: 5/28/25 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!

FDA will test suspicious products for drugs < Back Male Enhancement Products Found with Drug-Spiked Ingredients FDA will test suspicious products for drugs FDA has issued two drug-spiked product warning letters this year! This is the type of action I appreciate seeing the FDA do, as this small number of bad actors in the market gives the dietary supplement industry a bad name. Sign up for my weekly Warning Letter Wednesday post. FDA tested these products and found them to contain active ingredients in Viagra and Cialis. The company's product claims about erectile dysfunction likely triggered FDA to test these products, and several ED claims are cited in the warning letters. Erectile dysfunction may be considered a disease claim and should be avoided. But how about libido, sexual performance, and aphrodisiac claims? Do you think these types of statements are structure-function statements? In my opinion, libido-type claims attract FDA attention and require additional testing on Amazon, but they, if substantiated, are likely in the lower-risk category as long as companies are testing to ensure there are no unintentional drug-spiked ingredients. I rarely tell jokes on Warning Letter Wednesday, but I can’t help this one. “Why did the lizard go to the doctor?... He had reptile dysfunction.” In this warning letter , the timeline is perplexing. FDA inspected the manufacturer and conducted a website review in June 2022. FDA tested a product and found the presence of sildenafil which is the active ingredient in Viagra. Then in August 2022, the company issued a recall for one lot of the seven-count product. Two months later FDA issued a public notification warning consumers about these products, and now in January 2023, the company was issued a warning letter. What can we do to help get these drug-spiked products off the markets sooner? This warning letter from yesterday also has an even more bizarre timeline. FDA reviewed the website and potentially tested products in May 2022. In July 2022 FDA issued a public notification warning consumers about the presence of tadalafil in these products. Then, just last month FDA re-reviewed their website and found the company apparently still selling these products, which led to this warning letter. Again I ask, ‘What can we do to help get these drug-spiked products off the markets sooner?’ 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 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