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< Back In-Person, Panel Discussion Wednesday Jun 25, 2025 Leveraging AI in Dietary Supplement R&D: Harnessing Innovation While Navigating Key Regulatory and IP Risks  American Conference Institute New York, NY As the dietary supplements industry continues to evolve, innovation is driving new product development and improved efficiencies.  From AI-powered R&D to advancements in manufacturing and supply chain optimization, companies are embracing cutting-edge technologies to stay competitive. However, these innovations also introduce complex regulatory, intellectual property, and compliance risks that must be carefully navigated.  Join industry leaders and experts as they explore:  AI’s role in dietary supplement R&D and product development: how artificial intelligence is transforming ingredient discovery, formulation, and clinical research  Understanding the applicable guidelines for using AI to support regulatory submissions/documents (GRAS, NDI, claims registrations, etc.) focused on safety, quality and efficacy of ingredients Navigating evolving FDA oversight and safety considerations when utilizing AI in product development Understanding the IP and competitive risks: navigating issues that can arise regarding the patentability of AI-discovered ingredients and formulations Learn More and Register Previous Next

Latest News I love writing guest articles and collaborating See appearances for Asa's events and podcasts Apr 15, 2025 Guest Article SupplySide Supplement Journal Asa Waldstein Q1 2025 warning letter roundup with Asa Waldstein In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. Read More Jan 31, 2025 Interview NutraIngredients USA Cassandra Stern Olly and BrainPack NAD decisions highlight challenges in supplement advertising Jennifer Adam and Asa Waldstein provide commentary in this article by Cassandra Stern. Read More As Olly appeals NAD’s decision and BrainPack modifies its claims, industry experts weigh in on the potential implications for dietary supplement advertising. Jan 15, 2025 Guest Article NutraIngredients USA Asa Waldstein Cognitive and memory warning letters and litigation trends: Best practices for reducing risk Cognition and memory products are big business, and the Food and Drug Administration (FDA), National Advertising Division (NAD), Federal Trade Commission (FTC) and plaintiff attorneys are paying attention. Read More Jan 7, 2025 Guest Article SupplySide Supplement Journal Asa Waldstein Q4 2024 warning letter roundup with Asa Waldstein In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. Read More Dec 3, 2024 Interview Nutraceuticals World Sean Moloughney 2025 State of the Industry Asa and other industry leaders weigh in Read More Experts discuss business drivers, regulatory challenges, and market opportunities. Nov 21, 2024 Press Mention WholeFoods Magazine WholeFoods Magazine Staff The Buzz in Natural: December 2024 A roundup of thought-provoking posts we saw on social media! Read More Oct 8, 2024 Guest Article Supplyside Supplement Journal Asa Waldstein Join me for SupplySide West workshop on nutritional ingredient claims, legal flames Regulatory consultant Asa Waldstein previews a SupplySide West education session on substantiating claims and clinical trials. Waldstein is moderating the Oct. 28 session that features two attorneys and two experts from contract research organizations. Read More Oct 3, 2024 Guest Article Natural Products Insider Asa Waldstein Q3 2024 warning letter roundup with Asa Waldstein In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. Read More Aug 19, 2024 Interview Vitafoods Insights Anthony Fletcher AI-powered tech makes customised regulatory compliance possible AI-powered proprietary technology could help the nutraceutical industry navigate the complexities of the regulatory world by finding – and replacing – risky marketing phrases on company websites. Read More Jun 24, 2024 Interview Natural Products Insider Josh Long FDA, industry experts reflect on DSHEA at 30 Summit The head of FDA's Office of Dietary Supplement Programs and a dozen others offered their perspective on the recent DSHEA at 30 Summit in Salt Lake City. Read More Jun 4, 2024 Interview New Hope Network NBJ 30 supplement industry voices suggest changes to DSHEA Asa and other industry leaders weigh in. Read More May 23, 2024 Interview NutraIngredients USA Danielle Masterson Is your age verification process in place? Everything you need to know about selling in NY Asa and other industry experts weigh in Read More Apr 18, 2024 Press Mention Vitafoods Insights Niamh Michail Revealed: The 18 finalists of the 2024 Vitafoods Europe Startup Innovation Challenge Find out which trailblazing startups were chosen for their innovative ingredients, finished products, and technologies for the 2024 Vitafoods Europe Startup Innovation Challenge. Read More Apr 5, 2024 Guest Article Natural Products Insider Asa Waldstein Q1 2024 warning letter roundup with Asa Waldstein Dietary supplement consultant Asa Waldstein reviews regulatory trends over the last quarter in his FDA warning letter roundup column. Read More Feb 27, 2024 Press Mention NutraIngredients USA Stephen Daniells Celebrating innovation The Sports & Active Nutrition Summit also celebrated its three new Start-Up Stars, innovative early-stage companies that are disrupting the sector. Read More Feb 23, 2024 Interview NutraIngredients USA Asia Sherman FTC settles with supplement startup over COVID claims A multi-year case involving dietary supplement startup PPO Lab, the Federal Trade Commission (FTC) and COVID-19-related health claims has come to a close, culminating in a truce that removes fines and lightens administrative burdens on the defendants. Read More Feb 15, 2024 Interview Radicle Science Sarah Burden Adapting your Business Strategy to the Regulatory Outlook Read More Jan 22, 2024 Interview NutraIngredients USA Danielle Masterson What can you say in weight loss claims? Experts weigh in With what feels like a weight loss medication takeover, many are betting that the GLP-1 receptor agonists will rescue America from its obesity epidemic. So what does this mean for the natural weight loss products? Read More Jan 4, 2024 Interview NutraIngredients USA Danielle Masterson New year, same problem: FDA issues tejocote root warning, finding the supplements adulterated with poisonous plant 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 Jan 3, 2024 Interview NutraIngredients USA Asia Sherman Q&A: Apex Compliance founder talks streamlining supplement regulatory marketing compliance Apex Compliance entered the dietary supplement space to simplify regulatory compliance by helping companies identify the words and phrases across marketing materials that trigger oversight agencies. Read More 1 2 3 4 5 1 ... 1 2 3 4 5 ... 5

In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. < Back Q1 2025 warning letter roundup with Asa Waldstein Asa Waldstein Guest Article In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. At a Glance Six animal product companies received FDA warning letters for making serious disease claims. A warning letter reinforces the importance of following purity, strength and composition specifications. There was only one CBD-related warning letter this quarter, and it was a doozy. Read More Previous Next

“Extra” claims are often non-compliant < Back OTC Topical “Inactive” Ingredient Marketing Claims “Extra” claims are often non-compliant This warning letter involves claims made about a topical OTC menthol product. OTC products must follow monographs. These are essentially recipe books that guide the ingredients, dosages, labeling, and claims that products are allowed to be made. This is how OTC products are permitted to make claims like “Arthritis Pain Relief” that are out of bounds for cosmetic and personal care products. To check if a product is an OTC topical product or not, check the label. If it lists “Drug Facts” and lists “Inactive Ingredients” it is labeled as an OTC drug. This is another reason why cosmetic product labels should not list ingredients in “active” or “inactive” sections, as this implies the product is a drug. The product label has several violations cited in the warning letter. This shows that the product name is non-compliant and that therapeutic claims made about inactive ingredients are also not complaint. For all my regulatory nerds out there, here is a copy of the label I found online. 👉 From warning letter. “Temporarily relieves minor pain associated with cramps” [from the product label] 👉 From warning letter. “Menstrual Cramp RELIEF CREAM” 👉 From warning letter. “We believe in the power of plants and their therapeutic properties to offer solutions for menstrual discomforts.” The moral of the story is that OTC topicals provide a gateway to making otherwise risky and forbidden claims, but the rules are narrow and don’t allow for extra marketing statements, which can increase the likelihood of regulatory action. There are also drug-related GMP violations in this warning letter, which is worth reading. DATE ORIGINALLY POSTED: 4/16/25 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!

A weekly exploration of FDA warning letters and enforcement trends A weekly exploration of FDA warning letters and enforcement trends Get Warning Letter Wednesday in your Inbox Sign-Up Now! Select category Reset OTC Topical “Inactive” Ingredient Marketing Claims “Extra” claims are often non-compliant 4/16/25 Read More Influencers Must Disclose Free Product Brands should monitor influencer posts for compliance 3/26/25 Read More Heavy Metal Contamination Leads to Recall Following specifications prevents greater issues 3/5/25 Read More Environmental Claims Increase Scrutiny Ensure ESG claims are substantiated 2/12/25 Read More Incomplete Batch Records & Ingredient Specifications Ensure 483 responses are complete 1/22/25 Read More Product Review Engagement Trustpilot reviews can be “marketing” 1/1/25 Read More Basics of GMP’s Cited Functional mushroom products under increased scrutiny 12/11/24 Read More Influencers Must Disclose Material Connection Free products should also be disclosed 11/20/24 Read More Best Practices When Making Biomarker and Implied Claims Use FDA’s helpful resource (Criterion 2) 4/9/25 Read More Injectable CBD Warning Letter Curated testimonials are marketing claims 3/19/25 Read More Celebrity Endorsement Lessons Disclosing material connection is essential for compliance 2/26/25 Read More GMP Labeling Lessons Small issues signify deeper noncompliance 2/5/25 Read More “Non-Toxic” Claims Require Extensive Substantiation Safety related product claims attract scrutiny 1/15/25 Read More Refusing FDA Inspection Access Be nice to FDA investigators & follow inspection SOPs 12/26/24 Read More Fruit Snack Wars NAD challenge cases explored 12/4/24 Read More Warning Letter Issued for Eye Color Changing Drops Product reviews are marketing claims 11/13/24 Read More In-Process Quality Testing A look at the manufacturing and quality process 4/3/25 Read More Amazon & Others Cited for Selling Injectables Distributors are responsible for the products they distribute 3/12/25 Read More Records Refusal Leads To Warning Letter Take FDA inquiries seriously 2/19/25 Read More "Promotes Brain Health” Claim Challenged Small words can drastically increase claim risk 1/29/25 Read More FDA Crackdown on Animal Product Seizure Claims Amazon compliance still needs improving 1/9/25 Read More GLP-1 Product Receives Warning Letter Marketing strategies should consider “reasonable consumer expectations” to avoid issues 12/18/24 Read More Lack of Allergen Labeling Leads to Potential Death Nutrition fact panels must be in a compliant format 11/27/24 Read More GMP Issues Following SOPs is essential to compliance 11/7/24 Read More 1 2 3 ... 8 1 ... 1 2 3 4 5 6 7 8 ... 8

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!

Claims in videos are “fair game” for enforcement < Back YouTube Claims Lead To Warning Letter Claims in videos are “fair game” for enforcement YouTube video claims lead to a warning letter. The claims cited in this letter are not from people talking but from image text on the screen. This is the first time I have seen image text, not spoken words in a video, called out in a warning letter. This is the seventh warning letter this year that mentions claims made on YouTube. The FDA’s YouTube video search capabilities must have improved, and we can expect more enforcement of videos in the near future. Interestingly, I have found only one warning letter ever that mentions claims made on the Vimeo platform. Claims made on videos pique my interest, as YouTube video claims were nearly almost nonexistent a few years ago. I'm sometimes asked if purely educational video channels are fair game for FDA enforcement. My answer is “kind of” unless there is a commercial or material bridge; a URL on the channel, or In the comments that link back to where consumers can purchase similar products. No link to commerce = low risk of enforcement. The video cited in this letter provides a link to the commercial website in one of the video comments. From warning letter: “COCA LEAF REDUCES EATING ANXIETY ISSUES” at approximately 0:43sec in the video.” Read the full warning letter . DATE ORIGINALLY POSTED: 9/7/22 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 FDA sends 7 Cardiovascular Disease Related Warning Letters Social media engagement is back in warning letters! It has been some time since FDA cited “Liking” a post as an endorsement of the “testimonial.” One of the companies was cited for this and also for commenting on a post. I suggest companies fight the urge to engage with disease-related comments. 👉 From warning letter. “Yes, it really works! my bad cholesterol drooped by 60 pts . . .” You endorsed this testimonial by responding, “That is amazing Jon! Thank you for sharing.” A key takeaway from this group of seven letters is talking about lowering blood pressure, lowering cholesterol, or even mentioning lowering LDL or “bad fats” can lead to a warning letter. Heart disease-related claims have always been top of mind for FDA, but I found some of the “mid-risk” diagnostic claims, such as “LDL reduction,” surprising. I encourage everyone to review their heart products to ensure there is no mention of these types of statements. This signals FDA’s concern that these claims may encourage consumers not to use cholesterol-lowering and other heart disease medication. 👉 FDA news release. “Given that cardiovascular disease is the leading cause of death in the U.S., it’s important that the FDA protect the public from products and companies that make unlawful claims to treat it. Dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease and related conditions could potentially harm consumers who use these products instead of seeking safe and effective FDA-approved treatments from qualified health care providers,” said Cara Welch, Ph.D., director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition. Claims made in a company’s Amazon storefront were cited in two of these letters, and statements made on platforms like Amazon and Walmart continue to be cited in warning letters. Now is an excellent time to review all marketing material, including the “forgotten” content on Amazon, to ensure there are no implied cardiovascular disease claims. Nine warning letters mention claims made on YouTube this year, demonstrating that videos are marketing claims and are, therefore, fair game for enforcement. In warning letters that mention videos or social media, there is always a statement like “this links to a website where customers can order products.” This is the link to commerce and establishes the “commercial bridge.” Read more about YouTube claims enforcement . 👉 From warning letter. (2:57-3:08) “Now next is Hawthorn Berry [an ingredient in your BPS-5 product]. Used in traditional Chinese medicine for thousands of years, Hawthorn Berry is a popular ingredient used to fight back against blood pressure, blood disorders, and heart disease.” 🔹 Product names are considered claims, as seen in this recent warning letter. I agree “Cholesterol” is regarded as a claim, but it is not as blatant as other product names, such as “Anxiety support.” 👉 From warning letter. “The product’s name (iwi Cholesterol) is an implied claim that it reduces cholesterol.” 🔹 Discussing ingredient benefits is considered marketing in the eyes of FDA. Here is a video about this. 👉 From warning letter. “Garlic powder [an ingredient in CholestAid] has been found to help your body reduce high cholesterol.” DATE ORIGINALLY POSTED: 11/30/22 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!

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!

Regulatory compliance and marketing education on important issues in the dietary supplement industry. Helpful hints videos, blogs, and resources. Asa's public speaking schedule and webinar links. Consulting services for supplement marketing compliance. About Asa Waldstein Community, Compliance, Natural Health Principal of Supplement Advisory Group , specializing in practical regulatory support for dietary supplement marketers. We focus on finding marketing risks and providing practical marketing solutions on the web, social media, and product labels. I love educating about compliance best practices and lower-risk marketing strategies, which often change based on FDA/FTC enforcement trends. Building in-house expertise through education is part of my unique approach to regulatory consulting. I routinely speak at conferences on enforcement trends, industry compliance, and the nuances of effectively marketing products in the digital era. Check out my weekly Warning Letter Wednesday post . Learn More Email Me LinkedIn Home: About Home: Testimonials Testimonials Vardan Ter-Antonyan Chief Science Officer at Green Compass Global, Ltd Asa is one of the best experts and specialists of Regulatory Affairs in the dietary supplement and hemp space. If you are in need of any regulatory services when it comes to your labels, your operation, or anything else, contact Asa and he’ll make sure you are well equipped to face any regulatory inspection including the notorious FDA. Free Introductory Regulatory Consult Available Online 15 Minute Consultation with Asa Waldstein 15 min Book Now Home: Video Player Regulatory Hints Videos Educational Tools: Free for the community Play Video Share Whole Channel This Video Facebook Twitter Pinterest Tumblr Copy Link Link Copied Now Playing MLM Company Cited For Claims Made By Their Affiliates 02:39 Play Video Now Playing FDA Crackdown on Anxiety Claims 03:19 Play Video Now Playing Art of Wordsmithing: Replace High-Risk Marketing "Buzzwords" 01:12 Play Video Now Playing Supplement Advisory Group: About Us 01:02 Play Video Watch with captions on What I Do For A Living Get in Touch Newsletter signup, ask regulatory questions, public speaking inquiries Submit Thanks for submitting! Home: Contact

All dietary ingredients must be tested for identity < Back Company Cited For Not Testing Known Contaminants All dietary ingredients must be tested for identity Testing for known contaminants is an essential part of GMPs. This company was cited for not conducting proper identification and known contaminant testing on glycerin, an ingredient used in its manufacturing. The known contaminant in glycerin is diethylene glycol (DEG). During one GMP inspection I helped oversee, FDA was happy to see we had tested for DEG in glycerin. This showed we were aware of the potential safety issue with glycerin and were taking steps to ensure the finished product was safe. Learn more with the FDA’s guidance document , Testing of Glycerin for Diethylene Glycol. Other known contaminants are melamine in milk and methanol in ethanol. What other known contaminants does your company test for? The company that received this letter is an OTC and homeopathic drug manufacturer, but supplement folks can learn from this. Also, FDA cited the company for not proving their method was sufficient to test for DEG. As I discussed last week , proving test method suitability is top of mind for FDA investigators. 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!

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!