The supplements labeled as weight loss products appear to be mislabeled as testing revealed the tejocote root was substituted with a potentially deadly plant. < Back New year, same problem: FDA issues tejocote root warning, finding the supplements adulterated with poisonous plant Danielle Masterson Interview The supplements labeled as weight loss products appear to be mislabeled as testing revealed the tejocote root was substituted with a potentially deadly plant. Read More Previous Next

Expect arterial health claims to be cited in the future < Back Biomarker Claims Lead to Warning Letter Expect arterial health claims to be cited in the future Blood sugar support claims continue to be cited in warning letters. This letter includes biomarker claims such as “improved blood sugar sensitivity and lower A1C.” Based on recent warning letters, listing these types of statements is now enough to attract a letter. I write more about this here . There are other biomarker claims cited in this letter, such as “increased levels of TT3 and TT4," "reduced mean fasting serum glucose," and "promotes arterial elasticity." Keep an eye on your marketing statements relating to arterial plaque and elasticity, as I predict we will see these cited in 2023. This is a warning to companies making similar biomarker claims, and now is the time to review marketing and find and replace these statements. In the past, biomarker claims were not typically enough for a warning letter, but the “Big 7” cardiovascular letters from November signal a change in FDA’s thinking. There are other commonly cited higher-risk claims, such as “diabetes” and “depression,” in this letter. The more of these words used in marketing, the higher the likelihood of receiving a warning letter. You may be saying, “these companies should know better,” and in many ways, I agree. However, they may not have understood that mentioning ingredients in blogs or citing ingredient research is considered marketing. These mistakes are all too common and are a sign of companies who don’t understand the nuanced rules of dietary supplement marketing. Educating on these topics is one of the reasons I write Warning Letter Wednesday. Blogs are mentioned in this warning letter. We are seeing blog titles like this mentioned in recent letters. They help bring traffic to the website but are also clear indications of intended marketing use. In this example, turmeric is in a product sold on the website, which is an implied claim. From warning letter. “Pain Support - Can Turmeric Relieve Arthritis, Joint Pain & Inflammation?” To round this letter out, there are statements such as “Reduce Chance of Catching A Cold.” Talking about reducing the duration of a cold, flu, or respiratory infection is off-limits and should be avoided. 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!

Remove “anxiety” on all marketing platforms < Back Anxiety claims enforcement up 95% in 2021 Remove “anxiety” on all marketing platforms #WarningLetterWednesday reviews the increase in anxiety claims enforcement. In 2021 there was 40 anxiety-related product FDA warning letters, a 95% increase over 2020 (21), which is a clear sign of the FDA’s enforcement priorities. Here is a breakdown of the 2021 anxiety warning letters. *75% (30) include both anxiety and depression. This shouldn’t come as a surprise to anyone following enforcement trends, as the FDA sent ten anxiety/depression letters last February. I write about this here . *45% (22) include claims made on social media. I would have guessed this number would be higher. *10% (4) include hashtag claims, and 25% (10) include claims made in testimonials. I expect warning letters with hashtag claims and testimonial claims to increase, which is an enforcement trend to watch. *All 2021 letters also include higher-risk disease words such as hypertension except for one that involved a drug spiked product (sibutramine). The FDA looks at a company’s complete online presence. One claim may not attract a warning letter, but, for example, claims made on social media, YouTube, Amazon, and blogs are pieced together for one big picture of noncompliance. *It is worth noting the 2021 warning letters did not include the term “occasional anxiousness,” which is, if substantiated, often considered not to be a disease claim. Anxiety is considered a 3.5 of 5 on the “Asa Risk Scale” and should not be used. If truthful and substantiated lower risk alternatives are: *happy mood support *balanced state of mind *mental resilience *support when things get overwhelming *helps support smiles 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 FDA warning letter roundup, dietary supplement consultant Asa Waldstein reviews trends over the last quarter and year, and he makes 2024 predictions. < Back Q4 warning letter roundup with Asa Waldstein Asa Waldstein Guest Article In his quarterly FDA warning letter roundup, dietary supplement consultant Asa Waldstein reviews trends over the last quarter and year, and he makes 2024 predictions. Read More Previous Next

Functional mushroom products under increased scrutiny < Back Basics of GMP’s Cited Functional mushroom products under increased scrutiny Functional mushroom products are undergoing a renaissance, and FDA is paying close attention to how these products are tested and manufactured. This is likely because of the mass recall and potential fatalities associated with the Diamond Shruumz products. Learn more about this cringy and dangerous recall here . Today’s Warning Letter Wednesday highlights GMP violations related to functional mushroom incoming product testing, QC release, product returns, incomplete 483 responses, and sample retention. These are important reminders of the basic GMP requirements, and we can learn from this company’s oversights. 🔹The company appears to be a copacker that received bulk mushroom gummies for packaging and labeling. They did not have even the most basic procedures in place for receiving and packaging dietary supplements. This seems like an operation that just buys bulk products then packages and labels them without quality checks. Yikes! If I had to guess, they were probably the cheapest option, which goes to show that if a price is too good to be true, it probably is. This is accurate not only for products but also for regulatory consulting as well. 👉From warning letter. “During the inspection, you did not have any procedures in place for the dietary supplement products you receive for packaging and labeling.” 🔹Product returns are common and having a procedure of how to handle these products is essential. This warning letter indicates that returned products were possibly re-sold without proper review, which is terrifying. This is how counterfeit, or dangerous products work their way into the supply chain. 👉From warning letter. “You do not have any procedures in place for the handling of returned dietary supplements, to include the identification and quarantine of the products until quality control personnel conduct a material review and make a disposition decision.” 🔹Product retentions are important, as they allow us to retest products when there are customer complaints. FDA requires they be kept one year past expiration date or two years past the last date of distribution. In my contract manufacturing days saving three bottles per lot number was sufficient. Also, retained samples can potentially be used to substantiate expiration dating. 👉From warning letter. “ You did not retain reserve samples for the required time for use in appropriate investigations.” The FDA gave this company ample opportunity to comply with the 483 violations but, as noted in the warning letters, the responses were incomplete which led to this warning letter. When in doubt, hire an expert for 483 responses. Read the full letter here . DATE ORIGINALLY POSTED: 12/11/24 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!

< Back Webinar Thursday Jul 23, 2020 Enforcement Trend Analysis CBDIA Webinar: FDA/FTC Asa Waldstein reviews warning letters and gives examples of how to lower marketing risk for the cannabinoid and dietary supplement industries Here are some other lower-risk ways to communicate how your product can help: Balanced state of mind Happy mood support A good night’s sleep supports the body’s health Support resilience Slumber support for optimal health Mental equilibrium Be kind to your body with hemp oil, your body systems will thank you! Watch Previous Next

< Back Meet-Up Group Tuesday Dec 17, 2019 Ethical CBD Marketing: How to avoid FDA, FTC, and class action trouble Asa's Regulatory Education Series The first Boulder Hemp-CBD Group Meet-Up hosted by Asa (In-person) What can we learn from recent "Big 15" Warning Letters, revised Consumer Update, and recent class action news? Have you ever wondered why some companies receive FDA Warning Letters and are unsure about how to ethically market your product without getting into trouble? Are you looking for clarification about what the FDA is enforcing and how to read Warning Letter trends? What is a claim and what are the risks when making them on your website or social media? Can I get in trouble for "Liking" a post? If I link to a clinical study is this allowable? Do I need to be careful with blogs? What is the Farm Bill IFR and how do I submit comments? What is an attorney's opinion on recent class-action lawsuits? This event will focus on a discussion about the dos and don'ts of labeling, marketing, and selling Hemp-CBD and much more! I am honored to be joined by very special guests: Patrick McCarthy, Validcare CEO Frank Robison, Founder of the Robison Law Group LLC. View Pictures Previous Next

< Back Webinar Thursday Mar 7, 2024 Pitfalls to Avoid When Marketing Products Velocity CPG Guest speaker Asa Waldstein reviews common pitfalls when marketing products that can lead to expensive litigation or agency action such as social media engagement, citing clinical studies, blogs, and influencer best practices. Register Previous Next

< Back Webinar Thursday Apr 23, 2020 Ethical Product Marketing in the Coronavirus Era: Town Hall Asa's Regulatory Education Series Discussing the do's and don'ts of marketing products during the Coronavirus era. I will be joined by two special guests which cover the expert legal, regulatory, and marketing sides of the industry. Linda Nielander is VP of Sales and Marketing for Quicksilver Scientific. Erica W. Stump is the owner and founder the Erica W. Stump, P.A. law firm. Watch Previous Next

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!