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Printed catalogs must be compliant < Back Product Names Are Marketing Claims Printed catalogs must be compliant This warning letter involves claims made in catalogs and product labels collected during a GMP inspection. Over 500 supplement executives and regulatory professionals receive Warning Letter Wednesday by email. 👉Sign up here . Everything the FDA investigator sees is “fair game.” Sometimes they gather non-compliant literature, and the company never hears from FDA, but in cases of extreme claims and GMP violations, this often turns into a 483 or a warning letter. In this brief video , learn about the difference between a 483 and a warning letter. There are a lot of non-compliant product names cited in this warning letter. Yes, product names are marketing and, therefore, must be compliant. Here are some particularly over-the-top examples. 👉From warning letter. “Children’s Antibiotic Formula … product name implies the product is intended to cure, mitigate, or treat bacterial infections.” 👉From warning letter. “Hepatitis C Formula Glycerite” and “Children’s Antiviral Formula.” A key learning point is anything can be collected and reviewed. This includes box stuffer promotional materials and printed catalogs. I remember during an inspection; we had haphazardly left old non-compliant product brochures lying around our shipping room. We were not using them anymore, but if the investigator had seen them, it could have led to a warning letter. I carry this lesson with me forever. Even claims which are not considered high-risk are cited in this letter. Here is an example from the company’s product catalog. 👉From warning letter “Product catalog: “A blend of herbs with antimicrobial, anti-inflammatory…actions….” There are also some glaring 483 citations that the company appeared not to address. This includes the "greatest hits" such as not setting specifications. I review GMP violations in previous Warning Letter Wednesday's . 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!

The FDA regulates based on intended use < Back Company Cited For Selling Selective Androgen Receptor Modulators (SARMs) The FDA regulates based on intended use The FDA sent a warning letter to a company distributing Selective Androgen Receptor Modulators (SARMs). SARMs are synthetic chemicals designed to mimic the effects of testosterone and other anabolic steroids. This is an excellent example that the FDA regulates based on the intended use. The company apparently was marketing this product for ingestible use but labeling as follows. From the warning letter. “Despite statements on your product labels marketing your SARMs products for “RESEARCH ONLY” and “Not for Human Consumption,” evidence obtained from your website establishes that your products are intended to be drugs for human use.” What is mind-blowing about this warning is that a company executive was sentenced to a year in prison last year for selling the same type of products! Here is the article by Steven Myers about this. 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!

Use AHPA's Herbs of Commerce < Back Herbal Ingredients Should Be Listed Correctly Use AHPA's Herbs of Commerce Listing herbal ingredients on labels in the correct format is important. This year, there have been seven warning letters that reference missing or incorrect standardized common names (SCN) on labels. Sign up for the weekly Warning Letter Wednesday post. Here are some examples. 🔹Listing the name “manjishtha” is not a standardized common name (SCN), but “Indian madder” is acceptable because it’s listed in Herbs of Commerce. The Ayurvedic name for Indian madder (manjishtha) may follow the SCN in parentheses. 🔹If there is no SCN in Herbs of Commerce, the Latin binomial name must be present (e.g., Phalaris canariensis). 🔷FDA refers to the American Herbal Products Association (AHPA) Herbs of Commerce for standardized common names. This is one of the many things AHPA does to help make the supplement industry better. Thanks AHPA! 🔷As a friendly reminder, the plant part is also needed. Interestingly, “herb” is not sufficient according to this warning letter . From warning letter. “Your … product declares “herb,” which is not a plant part. If the entire or whole plant is used, then that information must be declared.” 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 Stay in your lane: Novel delivery systems must comply with supplement regulations Judy Blatman Interview Asa and other industry leaders interviewed Read More Previous Next

< Back In-Person, Presentation Tuesday May 14, 2024 Vitafoods Europe Startup Innovation Challenge 2024 Vitafoods Europe Geneva, Switzerland Apex Compliance has been invited as a start up finalist. Asa Waldstein will be on stage as a "top 6" finalist in the most innovative digital solution for the nutraceutical industry. Apex Compliance and five other companies have been selected in this category. Most Innovative Service, Technology, or Digital Solution Supporting the Nutraceutical Industry This is a "shark tank" style pitch where Asa will present our technology to an expert panel behind closed doors and also present on stage to the Vitafoods Europe audience. See Asa's LinkedIn post about this event here . Learn 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!

Claims made on social are top of FDA’s mind < Back Twitter Claims Enforcement Increasing Claims made on social are top of FDA’s mind Claims cited on Twitter are increasingly appearing in warning letters. #WarningLetterWednesday This year there have been eight letters mentioning disease claims made on Twitter, up from just 12 Twitter-related letters in all of 2021. This is a strong enforcement trend to watch. Several recent warning letters mentioned tweets over 3+ years old, including this one that mentions a retweet from 2014! Wow, this is old! From the warning letter: You retweeted another user’s September 26, 2014 tweet, which said, “#lipoicacid [an ingredient in your R-Lipoic Acid Vegcaps 300 mg and R-Lipoic Acid Vegcaps 100 mg] model treats autonomic neuropathy…...is the best! I’ve tried it.” This is an important reminder to remove old social media posts that may contain disease claims. Here is a video about this . Many of these letters also include claims made in hashtags, which is a great way to attract FDA scrutiny. View my hashtags are claims video 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 Presentation Thursday Sep 30, 2021 The Growth of Green: A Hemp Industry Overview Denver University As a Coloradan, you hear plenty about hemp, but how much do you really know about the hemp industry? How and where is it grown and marketed? Who’s growing it? How, exactly, are Coloradans using hemp? What should you know about labels when buying hemp products? What are the key regulatory issues at play? Join Certified Clinical Herbalist Asa Waldstein as he answers these questions along with your specific queries in this timely and interactive discussion on all things hemp. Register Previous Next

Asa Waldstein & other leaders interviewed < Back AHPA Event Guides CBD Industry Danielle Masterson Asa Waldstein & other leaders interviewed Read More Previous Next

Amazon compliance still needs improving < Back FDA Crackdown on Animal Product Seizure Claims Amazon compliance still needs improving Six animal product companies received warning letters for making seizure, cancer, and other serious disease claims on Amazon, social media, and websites. You may be saying, “These companies should have known better,” and I agree, but what was bewildering is that three of these companies were cited for seizure-type claims on Amazon. This is surprising because these types of statements on a human supplement lead to delisting, but these letters have highlighted Amazon’s lack of enforcement in the nuanced animal “supplement” arena. I expect animal products making unallowable disease claims on Amazon to be delisted soon, as Amazon tends to be reactive when FDA warning letters are issued. For companies in the animal supplement space, working with the National Animal Supplement Council is a great path towards product compliance, and Apex Compliance , my marketing claims and compliance software product, is proud to be an NASC preferred supplier. From one of the warning letters. Yes, the name of the product is Epilepsy & Seizure Formula. “From your product webpage …” on Amazon… • “Epilepsy & Seizure Formula… Remedies for Dogs and Cats” Homeopathics : One of the warning letters included claims made about homepathics. This is an important reminder that FDA does not tolerate extreme disease claims made about homeopathic products. Here is my previous post about this. YouTube : One of the letters includes claims on YouTube. A new Apex Compliance feature allows you to scan entire YouTube channels for keywords and disease claims. This helps find issues before they lead to regulatory trouble. I love it! For those who are confused about what claims can be made about animal “supplements,” the answer is “not much.” This is because FDA takes a stricter approach against animal supplements compared to human supplements. Here are some differences in human and animal product claims enforcement with the caveat that all claims must be substantiated. Lower-risk structure-function claims like “joint support” are unlikely to attract warning letters in animal or human product marketing. Claims that push the compliance boundaries, like “reduces anxious feelings,” may attract an animal product warning letter but are unlikely to be the sole reason for a human product letter. This is because the FDA has a lower “tolerance” for these types of statements in animal products. I write about this here and here . Here are the six FDA warning letters. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/evolution-pets-llc-696281-11122024 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nutrition-strength-ltd-696350-11122024 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/energetic-essences-llc-dba-pet-essences-696395-11122024 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/veterinary-select-formula-dba-allergic-pet-696354-11122024 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intermarket-industries-inc-dba-doc-ackerman-pet-products-696352-11122024 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hdfrenchies-llc-dba-bully-baum-696351-11122024 DATE ORIGINALLY POSTED: 1/8/25 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!

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!

Discussing ingredient benefits is a marketing claim < Back Ayurvedic Product Company Receives Covid Warning Letter Discussing ingredient benefits is a marketing claim This company was cited for making immunity and Covid support claims, which remain top of mind for the authorities. There is never a suitable time to discuss Covid support claims when selling products, so a good practice is to remove all references to Covid or Coronavirus from any marketing platform, including old social posts. Removing these "buzzwords" dramatically helps to mitigate risk. Do you want Warning Letter Wednesday delivered to your inbox each week? Sign up here . Authorities look at the 10,000-foot view of a company's online persona. Unless egregious, one "buzzword" will likely not attract a warning letter, but claims on social media, videos, blogs, product reviews, hashtags, and ingredient descriptions elevate risk. The authorities piece them together for one big picture of non-compliance—the more "buzzwords," the higher chance of scrutiny. I suggest removing or replacing them with truthful, accurate, and not misleading options. This company is an all-in-one Sri Lankan travel agent, web designer, and Ayurvedic product seller who probably didn't realize they were breaking the law by making high-risk Covid claims. This is one of the missions of Warning Letter Wednesday; to educate unknowing companies about the dos and don'ts of marketing compliance. Sadly, this company still doesn't get it, as they removed the Covid statements cited in the warning letter but left claims relating to preventing heart attacks and fighting the flu. This is a good lesson about the nuances of supplement and food marketing for companies entering these industries. If you know any of these companies, please feel free to share some of my regulatory hints videos . This company was cited for discussing the benefits of its tea ingredient. I talk about how discussing ingredient benefits can lead to a warning letter here . This is also a joint FDA/FTC warning letter. I discuss more about what this means 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!