Use qualified reference samples < Back Noncompliant Testing Methods Lead to Warning Letter Use qualified reference samples This company received 483s for GMP violations relating to testing methods and specifications. They were inspected in late 2021 and early 2022 and sent FDA five 483 responses last year. It seems these responses were not satisfactory, which led to this warning letter. There are numerous learning opportunities here. 🔷One of the violations was not having a strength test on a softgel product. It seems the company once had this, but it was removed 👉“at the request of the customer, as documented in your change control document.” A key learning lesson here is contract manufacturers should be flexible with their customers to a limit. Obviously, completely removing this test from the softgel specifications was a bad idea. Who knows, perhaps they could have found a more suitable strength test to satisfy GMP requirements and the customer. 🔷Unqualified reference standards are cited in this warning letter. The company was testing samples using FTIR, but the reference samples were not verified, which means they were likely from previous batches and not a purchased verified material. I will admit this is how I used to test identity circa 2010-ish. 👉From warning letter. “Identity testing using FTIR to compare the sample spectrum to an unverified reference sample is not an appropriate scientifically valid method” 🔷Identity testing in the finished product was brought up again, and this is a trend to watch. FDA requires the identity of each ingredient to be tested before blending and in the finished product. This is straightforward for some items but is costly and challenging if there are numerous botanical ingredients, as this requires developing expensive testing methods. I am unsure if this is the case in today’s #WarningLetterWednesday, but this is not the last time we will hear about this rigid pharmaceutical interpretation of supplement GMPs. I write about this here . 🔷Proving test method suitability is starting to appear in 483s and now in warning letters. This means that the FDA is asking why specific test methods are used. In the past, relying on a third-party lab for this was sufficient, but now, having suitability documentation on file for each method your lab uses is a good idea. 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!

“Arthritis” claims elevate risk < Back Testimonials & Video Claims Lead To Warning Letter “Arthritis” claims elevate risk The timeline of the FDA interaction is notable. The company was inspected last August, then FDA reviewed their website in October and November, then reviewed it again in March 2023. If the company had cleaned up its website before the last FDA website review, it probably could have avoided this warning letter. Do your teammates ever ask you what happens if you receive a warning letter? I made a one-minute video about this. Testimonials are cited in the letter. Third-party non-curated, non-compensated, honest reviews are unlikely to be scrutinized, but they become marketing when used to sell products. This includes: ●“Liking” or “saying thanks” on a social post ●Interacting with a product review ●Showcasing a product review This company has a page specifically for testimonials which makes them curated, which is marketing. →From warning letter. On your Testimonials page: “I prefer … over chronic use of Rx or OTC NSAIDS for arthritis due to the potential renal and gastric side effects of chronic NSAID use.” As we have discussed before, claiming a supplement is better than drugs is a quick way to irritate FDA and attract a warning letter. No GMP manufacturing claims are cited in this letter, which means they are probably doing a good job making the product, but they have crossed the compliance line with their marketing claims. If interested in talking about the nuances of marketing compliance, I would be happy to meet for 30 minutes at no charge. I am here to (try to) help! YouTube claims are cited again in this warning letter. This is the third FDA warning letter that mentions YouTube videos this year. Are you interested in seeing the others? You can search old Warning Letter Wednesday posts by keyword here . This is intended to be an ongoing resource for your regulatory and marketing teams. Claims about “pain” are cited in this warning letter. While it is unlikely a company would receive a warning letter without higher-risk words like “arthritis,” occurrences of “pain” do elevate the overall likelihood of agency action. Did you know that “arthritis” is the most common “itis” in warning letters? If accurate, replacing “arthritis” with “joint discomfort” can help to lower risk. →From warning letter. “… is made of 12 key ingredients - each chosen for its specific ability to address the complex causes of pain.” I’m writing this #WarningLetterWednesday post as I fly to Vitafoods in Geneva, where I am speaking about US supplement regulations and marketing best practices . Let’s meet if you are in Geneva! 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!

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

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!

< 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!

< 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