< Back Panel Discussion Friday Oct 29, 2021 Marketing and legal panel on current regulatory topics and enforcement trends in Chicago, IL. USA CBD Expo, Chicago, IL I am joined by some excellent co-panelists! Nathalie Bougenies Adam Grossman Henry Baskerville Watch the presentation: https://youtu.be/CI1b7SQJnhk Learn More Previous Next

< Back Symposium Friday Jun 9, 2023 16th International Herb Symposium at Wheaton College in Norton, Massachusetts, on June 9-11, 2023 International Herb Symposium Asa teaches various GMP and marketing compliance classes at this three-day event. Learn More Previous Next

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!

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!

Distributors are responsible for the products they sell < Back Walmart & Amazon Issued Warning Letters for Adulterated Products & Disease Claims Distributors are responsible for the products they sell Amazon and Walmart were cited for selling a product with disease claims and adulterated with NSAIDs. The product is a nutraceutical and omega-3 product that contains undeclared diclofenac, a non-steroidal anti-inflammatory drug (NSAID). Both warning letters include comments where FDA highlights that the company (Amazon or Walmart) is the party that fulfills and distributes the product. According to supplement regulations, companies that distribute products have a level of GMP and regulatory responsibility. Essentially if a company markets, distributes, and sells a product, they are responsible, even on a marketplace site. This webinar with Nathalie Bougenies and Steven Yeager shows many items companies need to comply with these regulations. From Amazon warning letter. “These products were introduced or delivered for introduction into interstate commerce by Amazon via your Fulfillment by Amazon service.” There were also examples of claims on both the Amazon and Walmart sites, such as “arthritis.” This is the most common “itis” referenced in warning letters and is an important reminder to scan for higher-risk words like “arthritis.” I expect this action to possibly lead to these companies asking for more adulterant testing and a deeper look at disease claims. For example, if the word “arthritis” is on your Amazon page, I expect it to be flagged. This product was recalled in June 2022. It is unclear if the products in these warning letters are from the same recalled lot or a different batch. From warning letter. “Combate la artritis.”” (English translation: Fights arthritis.)” Interestingly, the disease claims were in Spanish, a good reminder that the FDA also pays attention to claims made in other languages. I welcome your thoughts on these notable warning letters. Read the Amazon warning letter . Read the Walmart 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!

Replace “insomnia” with lower-risk alternatives < Back Insomnia claims continue to attract FDA attention Replace “insomnia” with lower-risk alternatives #WarningLetterWednesday highlights insomnia claims that continue to attract FDA's attention. There were 22 FDA warning letters in 2021 with insomnia claims, dramatically up from 14 in 2020, 2019 (13), and 2018 (7). This is a clear indication of an FDA enforcement trend and a good reminder for marketers to remove the high-risk buzzword "insomnia" from their marketing. As many of you know I have an "Asa Risk Scale" where certain claims are rated on a 1-5 risk scale, with anything 3+ likely to attract a warning letter. Insomnia is rated as a solid 3.5+, which means it should never be used. If truthful and not misleading here are some possible alternatives for insomnia. *feeling refreshed in the morning *a restful night's sleep *healthy slumber support *sleep support *supports a healthy night's sleep *support rest 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!

Playful ads can attract scrutiny < Back Bashing Competitors Can Lead to Challenges Playful ads can attract scrutiny Bashing competitors, even unnamed ones, can lead to competitor challenges. In this post, I review this National Advertising Division case where General Mills challenges television commercials by Welch's Fruit Snacks. In the commercials, celebrity chef Gordon Ramsay throws away generically labeled "Fruit Flavored Snacks" by tossing them out of a window and even spitting them out. In my opinion, the commercial is actually pretty good. It can be watched here . 🔹From NAD. "NAD determined that one reasonable takeaway from the commercials is that the whole fruit content of Welch's Fruit Snacks makes it a superior product for consumers." NAD also determined that the dramatic throwing away of the generic products was considered "ash canning," which depicts "competing products like General Mills' fruit snacks as lacking any positive value." The term "ash canning" in advertising refers to a practice of depicting competing products as having little or no value and implies that the competing product is so inferior that it might as well be discarded like ashes. Here's another NAD case involving "ash canning," where a beer company was asked to discontinue a commercial with imagery and a "Light beer shouldn't talk like water. It should taste like beer. "statement. In the beer case, NAD offers this information regarding the needed substantiation. 🔹 "NAD determined that tasting "like water" is a measurable attribute. Reliable sensory testing could demonstrate whether consumers detect a watery taste or the complete absence of taste. Consumers may also reasonably expect that the statement is supported by such evidence. Good resource here; I came across the ABC Television: Advertising Standards & Guidelines document , which has some helpful high level information on things like puffery, ash canning, and substantiation of performance and efficacy claims. The moral of this story is to use caution when bashing even anonymous products, especially the litigious ones with deep pockets, to initiate challenges. Read the case summary here . DATE ORIGINALLY POSTED: 10/16/24 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!

Key GMP learning opportunities explored < Back Incomplete 483 Responses Lead to Warning Letter Key GMP learning opportunities explored We can learn a lot from warning letters. This manufacturer was inspected in April 2022, where they received some 483s. The company subsequently responded to some 483s, but according to the warning letter, “Not all of the items on the issued Form 483 were addressed in your response.” In my experience, most 483s can be addressed before they become warning letters. I talk about improper 483 responses here. Here is an example from the warning letter. From warning letter. “We have reviewed your June 23, 2022 response to the form FDA 483. We are unable to evaluate the adequacy of your response because you did not provide documentation demonstrating you have established specifications… You provide documents you describe as revised finished product specifications for the … product. We note that these documents do not demonstrate that you have established specifications that provide standards to confirm the identity, purity, strength, and composition of the finished batch of your dietary supplements. For example, the finished product specification for … product lists an “identification” specification of “Conforms to Standard” with a test method of “Eurofins or eq.” and a frequency of “Rotational.” “Conforms to standard” does not specify the extent to which the component must conform. “Eurofins or eq.” is not a test method, and “Rotational” does not describe the frequency of when testing is to occur. Let’s break this down. 🔹Identification: The company lists the type of identification as “conforms to standard” but does not provide information on what that standard is. The company is close but, unfortunately, falls short of GMP requirements. Here is howI think about GMP documents, such as this specification sheet. Will someone unfamiliar with your process be able to step in and understand how to test the product if there is no “institutional knowledge?” It is the "recipe" for staff to follow. 🔹Test method: The company lists “Eurofins or eq” which is the name of the laboratory, not the name of the method, such as “AOAC 121804.” 🔹Frequency of testing is listed as “Rotational,” which is not sufficient. It should state “Test all” or refer to an SOP on skip lot testing. Incorrect reference samples are also cited. 👉From warning letter. "You failed to establish and follow laboratory control processes that are reviewed and approved by quality control personnel to use criteria for selecting standard reference materials used in performing tests and examinations… Specifically, the FTIR analysis performed by your third-party laboratory uses previous shipments of components as the reference for testing and they do not own a reference library for the FTIR tests. Testing components against previous shipments of the component may confirm receipt of the same component but this does not ensure the identity, purity, quality, and strength of the component is thoroughly characterized.” I admit this is how I tested identity around 2010 until I realized that having a qualified reference sample was essential. In this example, the third-party lab should have handled this rather than just depending on previously provided reference samples, and the quality personnel should not have allowed this. One more learning opportunity. 🔹Theoretical yield calculation helps “error-proof” manufacturing. Let’s use the example of a capsule product. First, the powder needs to be blended. If the theoretical yield is off, this will signify too much or too little of an ingredient was added and, therefore, should not “pass” to the encapsulation process. 🔹The same Is true for encapsulation. If a company has substantially more capsules than the theoretical yield, this signifies the capsules are underweight and not at label claim. The production should be stopped for evaluation here. 🔹If the yield is too high in bottling, this shows there are likely not enough capsules in each bottle. This lily-pad approach to quality is designed to stop problems before they happen. From warning letter: "A statement of the theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process and the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary." Interested in learning more about GMPs? Here are a few webinars you may enjoy. 🔹Distributor requirements for supplements . 🔹Getting ready for FDA inspections . There are so many learning lessons. Read the full 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!

Product reviews are marketing claims < Back Warning Letter Issued for Eye Color Changing Drops Product reviews are marketing claims Do you ever see products and think to yourself, "This can't be safe" or "What regulatory category does that fall into?" After reading this recent warning letter that was issued to a company making ophthalmic (eyedrop) products designed to change people's eye color, I thought to myself, "Is this actually a product that people are putting in their eyes?" Sign up for this weekly newsletter and search three years of previous weekly posts here . According to FDA, making claims such as "Lighten & Brighten Dark Your Eye Color, Speed Up the Eye Color Changing Process" are unapproved drug claims. This is the 13th ophthalmic-related warning letter this year, which shows that if you make a product that goes into the eyes, use extreme caution in product marketing and cleanliness. Also, there's been a group of ophthalmic letters that involve MSM and other ingredients that generally should not be placed in the eyes. I write about this here . Also explore other homeopathic-related ophthalmic warning letters here . Product reviews are cited in this warning letter. This is a reminder that when reviews are curated on a "Reviews" page, FDA looks at them as being showcased, which means they are marketing and fair game for enforcement. There seems to be a fine line between third-party, non-curated reviews on a website and "marketing" reviews curated on a reviews page. I rarely call out companies by name on Warning Letter Wednesday, but looking at how the company formatted their reviews page is an example of what not to do, and avoiding this can help keep you out of trouble. From FDA letter. "On the webpage https://lnkd.in/gemFTh54 . Customer review from 05/17/2024: "I've had brown eyes for years, and they were blue when I was born! Now, after 5 months, I bought it hoping for green eyes, and it works well. It has changed my eyes, and now having green eyes is what I'm most excited about." This company appears to continue to sell the product, which means we can likely expect more decisive FDA action soon. What do you think? Read the full letter here . DATE ORIGINALLY POSTED: 11/13/24 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!

< 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