Marketing in all languages should be compliant < Back Disease Claims Lead To Warning Letter Marketing in all languages should be compliant FDA issued a warning letter yesterday for Spanish language disease claims made on product labels and the company’s website. Examples of these claims include “cancer,” “antiviral,” and “arthritis.” Surprisingly, there have only been a small number of warning letters for dietary supplements issued by the FDA this year, which is why I was so excited to read this letter today. In April of this year, FDA purchased supplements from this company by calling the phone number listed on the website. Typically, FDA issues warning letters by simply flagging the online claims without purchasing products. I wonder if this is part of the continued adulterant testing of Spanish-language joint health products that are also making over-the-top disease claims such as thes e . This warning letter is a great example of claims to avoid, such as “diabetes,” “hypertension,” “antiviral,” and “prevent infections.” Read the full letter here . This letter shows that all products, even those in other languages, are fair game for scrutiny. This company’s website appears to be shut down, which seems to happen frequently when small companies get warning letters. Do you think this is enough to dissuade companies from making serious disease claims about their products? 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 May 21, 2020 Regulatory Hurdles Associated with Cannabis & Its Concentrates Burdock Group Consultants Interesting topics for the CBD and hemp industries. FDA/FTC enforcement trends Truth in labeling cGMP Compliance Animal products Epidiolex desceduling And more... Tatiane Berdum: Host, Burdock Group Elan Sudberg: CEO, Alkemist Labs Dr. Marielle Weintraub: President, US Hemp Authority Brett Goldman: Industry Regulatory Expert Asa Waldstein: AHPA Cannabis Commitee Chair Watch Previous Next

Use FDA’s helpful resource (Criterion 2) < Back Best Practices When Making Biomarker and Implied Claims Use FDA’s helpful resource (Criterion 2) I often talk about 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! In today's Warning Letter Wednesday, I am exploring Criterion #2, "Claims an effect on characteristic signs or symptoms of disease using scientific or lay terminology." This criterion shows the FDA's thinking on why biomarker claims like "lowers cholesterol" are disease claims. 👉From FDA Guide. "Some claims imply disease treatment or prevention because they are so intimately tied to a disease. For example, "inhibits platelet aggregation" or "reduces cholesterol" are such characteristic signs or symptoms associated with stroke and cardiovascular disease and interventions to treat those diseases that any claim about them would be an implied disease claim." 🔹 Asa Comments: This is where FDA shares insight on why biomarker claims like "lower LDLs" are disease claims. They also use heart disease examples, which highlight why most of the biomarker warning letters involve cardiovascular-related claims. I write more about this here in a post from 2022, and the enforcement trends have continued. 👉From FDA Guide: "Other signs or symptoms are associated with a wide range of disease and non-disease states and do not necessarily imply an effect on a specific disease. For example, although "improves absentmindedness" might imply treatment of Alzheimer's disease and "relieves stress and frustration" might imply treatment of anxiety disorders, both of these signs also are characteristic of non-disease states. So, if there is no context linking them to a disease, they would be appropriate structure/function claims." 🔹 Asa Comments: This shows how context matters and how structure-function claims can cross the line into disease claims. For example, in the FDA's "improved absentmindedness" example, if there was an image of a confused elderly person, this would elevate the likelihood of it being an Alzheimer's claim. 🔹 🔹 We've all seen the "maintain cholesterol levels already within a normal range statement, and this is where it comes from. The key takeaway here is being "absolutely clear" when making disease-adjacent is a safer strategy. Of course, I am just talking about FDA guidance here and this doesn't stop retailers like Amazon from unnecessarily flagging keywords like "cholesterol levels" which can lead to delisting. Retailers are increasingly tuning into "another regulatory group" to be aware of. 👉From FDA Guide. "There are many conditions that are "normal," but under certain circumstances are also disease claims. The rule states that such claims (for example, maintaining normal cholesterol levels) may be appropriate structure/function claims and would not imply disease if the claim made absolutely clear that the claim is referring to structure/function claims that are already normal. This context would remove the inference to an effect on a structure/function that was abnormal (for example, "maintain cholesterol levels that are already in the normal range")." 👉From FDA Guide. "The standard focuses on whether the labeling suggests that the product will produce a change in a set of one or more signs or symptoms that are characteristic of the disease. You can meet this standard using technical or layman's language and it isn't necessary that every possible sign or symptom is used." 🔹 Asa Comments: This section focuses on implied claims such as an EKG symbol, "lowers bad fats," or statements like "I never had to see my cardiologist again." Before-and-after pictures of an older person who no longer has mobility issues also apply here. In practicality, implied claims are somewhat less likely to attract regulatory issues because they may not contain "trigger words," but avoiding them is a good idea. Read FDA's Small Entity Compliance Guide on Structure Function Claims here . This is a great resource! DATE ORIGINALLY POSTED: 4/9/25 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!

< Back Interview Thursday May 6, 2021 The Rigorous Road to Compliance The Hoban Minute Asa sits down with The Hoban Minute to talk about his roots in herbalism, his career in the herbal products and supplement industry, the importance of regulatory compliance, and why creativity is the best tool for marketing cannabinoid products, and more! Learn 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!

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!