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Schedule your free 15-minute introductory consultation today to get started. Please review our list of services to understand Supplement Advisory Group's offerings. https://www.supplementadvisorygroup.com/ You may also enjoy reviewing my regulatory hints video channel. https://www.youtube.com/c/DietarySupplementCBDRegulatoryCompliance I look forward to meeting with you! Kind regards, Asa **My services are not intended to replace legal advice. There are many wonderful attorneys out there. If you need a suggestion please let me know.

We can learn a lot from warning letters. Following FDA enforcement trends is a valuable tool for any savvy marketer, regulatory affairs professional, quality manager, or dietary supplement executive. We can adjust practices before they elevate to warning letters by learning how to read warning letters and act accordingly. This is why I write the weekly Warning Letter Wednesday post on LinkedIn, Twitter, and Facebook. This blog post is an extended version of my Warning Letter Wednesday posts. This warning letter is a great teaching case. Here are the learning targets. FDA Inspections Trigger Website Reviews Marketing Claims Distributors Responsibilities Common GMP errors *Writing and Following Specifications *Writing Procedures *Product Returns *Product Complaints Certain Herbs Are Not Allowed Common Allergen Labeling Domestic Street Address or Phone Number Languages Must Contain The Same Information Serving Size and Suggested Use Plant Parts Must Be Disclosed Correct Plant Listing Supplement Fact Panel: Line Thickness Percent Daily Values Label Requirement Expiration Dating FDA Inspections Trigger Website Reviews The company was inspected by FDA in March 2021 and was issued several 483s. The company's website was recently reviewed in February 2022, which led to a letter. Learn about the difference between a 483 and a warning letter here. Usually the FDA investigator reviews a company's website for disease claims before an inspection. That is likely still happening but this is the third recent warning letter where FDA inspections led to a website review at a later date. These website reviews were then elevated to a warning letter. I write these letters here and here. This is a fascinating enforcement trend to watch and a good reminder for companies to clean up their website claims if they have been inspected. This is one of my favorite services Supplement Advisory Group offers. Marketing Claims ➡️From warning letter: Although studies (of PS, an ingredient in your product) in humans with Alzheimer’s disease were less dramatic, they still produced significant improvements in cognitive function. In patients with mild dementia, significant cognitive and behavioral enhancing effects were observed. 👉Asa's commentary: These mistakes have been reviewed in previous Warning Letter Wednesday posts; High risk words and video, citing studies, and discussing ingredient benefits. Distributor Responsibilities The company uses a contract manufacturer to make their products. This does not mean the company does not have any GMP responsibilities. ➡️From warning letter: Quality control must approve for release, or reject, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution, and you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement 👉Asa's commentary: This means a company has to conduct some type of review and release before selling the product. This does not have to be complicated but it has to be written down and followed. If it's not written down it didn't happen is an FDA mantra. ➡️From warning letter: Although a firm may contract out certain dietary supplement manufacturing operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements. 👉Asa's commentary: This is boilerplate language but a good reminder that although working with a contract manufacturer does mitigate some risks, the basics of quality assurance should be in place. We discuss many of these topics here. Common GMP Errors Writing and Following Specifications ➡️From warning letter: You failed to have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement for distribution, as required by 21 CFR 111.140(b)(2) [see also 21 CFR 111.127(h)]. Specifically, your firm distributes the dietary supplements that are contract manufactured for you, but you had no records of a quality control review, approval, or rejection for your finished dietary supplement products. During the inspection, you informed our investigator that you do not review the documentation related to the finished dietary supplement products you receive from contract manufacturers to determine if those finished dietary supplement products have met specifications. 👉Asa's commentary: Not having and following specifications is one of the most common GMP violations. Specifications should be reviewed by a member of Quality and then approved, rejected, or quarantined. This allows problems to be found before products are shipped to the public. I write about this here. Writing Procedures ➡️From warning letter: You failed to establish and follow written procedures for holding and distributing operations, to comply with 21 CFR Part 111.453 that include the requirements for holding components, dietary supplements, packaging, and labels, 👉Asa's commentary: Writing and following procedures is an important part of GMPs. Procedures are the "directions" for doing things, commonly referred to as Standard Operating Procedures (SOPs). Product Returns ➡️From warning letter: You failed to establish and follow written procedures to fulfill the requirements that apply to returned dietary supplements, 👉Asa's commentary: We talk about the requirements for 21 CFR 111 Subpart M (Holding & Distributing) here, and we discuss how to handle a partially damaged shipment here. Product Complaints ➡️From warning letter: You failed to establish written procedures for the requirements to review and investigate a product complaint. 👉Asa's commentary: This is one of the most important parts of being a distributor of dietary supplements. If you are on contact name on the label, you are responsible for reviewing product complaints and informing the FDA of Serious Adverse Event Reports. Certain Herbs Are Not Allowed The FDA does not allow the use of certain plants they consider to be dangerous. Pinellia ternata, a TCM ingredient, was called out in this warning letter because it contains ephedrine alkaloids. Learn more about this here. In general, if a plant is not widely used in commerce, it is a red flag of potential danger, or a New Dietary Ingredient (NDI). Common Allergen Labeling ➡️From warning letter: ..the finished product label fails to declare the specific species of shellfish allergen sources as required. 👉Asa's commentary: The company disclosed the common allergen (crustaceans) but not the type of crustacean (e.g., Contains: shrimp). This is a common error that can be easily prevented. Here are the specific common allergens that need to be disclosed. The specific type of nut (e.g., almond, pecans, walnut, coconut). The specific type of fish (e.g., bass, flounder, Pollack). The specific type of crustacean shellfish (e.g., lobster, shrimp, crab). Domestic Street Address or Phone Number ➡️From warning letter: ..the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. 👉Asa's commentary: I review a lot of labels, and it is commonly overlooked. This is how supplement companies track customer complaints and inform the FDA of serious adverse events such as hospitalization Languages Must Contain The Same Information ➡️From warning letter: ..your product labels contain information in two languages but does not repeat all the required label information (including the nutrition information) in both languages. In accordance with 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 👉Asa's commentary: I do not review multi-language labels,, so this is a new one to me. There is so much to learn about GMPs. Serving Size and Suggested Use ➡️From warning letter: The “Directions” for your Hemorlyn product states to take “2-4 capsules per day with meals,” but the serving size lists “2 Capsules.” The serving size listed should be four capsules. 👉Asa's commentary: The maximum suggested amount consumed at one sitting is a serving size. For example, a serving size that reads take 1-5 capsules daily is a serving size of 5 capsules, which would need to be in the supplement facts panel. This is an amateur error that could have been prevented. Plant Parts Must Be Disclosed ➡️From warning letter: ..the labels fail to identify in English the part of the plant (e.g., root, leaves) for each of the botanical dietary ingredients in the products, as required by 21 CFR 101.4(h)(1). We note “herb” is not a recognized plant part. Furthermore, we note if an entire or whole plant is used, 👉Asa's commentary: Yes, it really is a rule to list the plant part. Replacing "herb" with "leaf" would be been accurate. This is a great example of what I call a "secondary claim" or a "minor violation" which is something not likely to attract a warning letter on its own/ Correct Plant Listing ➡️From warning letter: ..each product label fails to declare the common or usual name (standardized common name) or Latin binomial of each ingredient used. 👉Asa's commentary: The American Herbal Products Association's (AHPA) Herbs of Commerce is the reference for standardized common names. Thanks AHPA! Supplement Fact Panel: Line Thickness ➡️From warning letter: The Arthrolyn product’s Supplement Facts label fails to separate the (b)(2)- from the (b)(3)-dietary ingredients with a heavy bar. 👉Asa's commentary: Having the correct line thickness is part of a compliant label. Here is an example of correct line thickness and Supplement Fact Panel layout I made just for you. Label review is one on the many aspects of regulatory compliance my company covers. Percent Daily Values Label Requirement ➡️From warning letter: The Goldenlife product’s Supplement Facts label bears the following statement: “Percent Daily Values based on a 2,000 calorie diet.” This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein as required. 👉Asa's commentary: This is the first time I have seen this in a warning letter, wow. Expiration Dating ➡️From warning letter: Any expiration date you place on a product label should be supported by data that demonstrates the product’s shelf life 👉Asa's commentary: A company needs to have stability data in order to substantiate expiration, best, before, or freshness dates. Many of the items, such as label formatting and layout issues are not likely to lead to a warning letter. Incorrect label formating however is a red flag that the company is not following the basics of GMP-labeling compliance, and this may be a sign of deeper issues. The quickest way to attract a warning is by making disease claims. This, in combination with serious GMP violations, adds to the risk. The FDA's duty is to protect public safety and not verifying a product's quality may, in some rare circumstances, lead to serious health issues. For a free consultation regarding your compliant marketing contact me here. Disclaimer: The educational information provided on this website is for informational purposes only and does not constitute legal or regulatory advice. Contact an attorney for specific legal advice.

Dietary supplements are great for hydration and liver support, but they cross the compliance line when marketed for hangovers. There have been 14 hangover-related FDA warning letters since the beginning of the pandemic including two this month. This is an enforcement trend that is top of mind for the FDA. Here Are The Learning Targets: FDA’s rationale for hangover being a claim Amazon storefront claims Discussing Ingredient Benefits Are Considered Marketing Claims Referencing Clinical Studies Can Be Looked at as Marketing Implied Claims Will Attract a Warning Letter Blogs Are Marketing Claims Follow Enforcement Trends: What was lower risk yesterday is high-risk tomorrow In the past making a hangover support statement would have been a relatively low risk, but in July 2020 the FDA issued seven warning letters to companies making hangover claims. In the accompanying policy statement press release Steven Tave, former director of FDA’s Office of Dietary Supplement Programs, stated Consumers may get the false impression that using these products can prevent or mitigate health problems caused by excessive drinking. Dietary supplements are not a substitute for responsibly limiting one’s alcohol consumption. Here is my guess as to why the FDA considers the word hangover a claim. Anything that prevents, treats, or cures symptoms of a disease is a medical claim. Amazon Storefront Claims In the past claims made on Amazon were considered "the unholy grail" of compliance, with little enforcement of the egregious claims used to market products. I am glad to see the FDA enforcing this and expect to see many more Amazon-related warning letters in the future. From Warning Letter: Crocin Rich plus is good for: … Help recovery of nerve and traumatic injury....Reduce Hangovers From another Warning Letter: Cure Your Hangover Fast; Milk Thistle … helps speed up the recovery process for your liver, getting rid of your hangover faster!” “Taking the product on a regular basis before drinking may also aid in reducing the possibility of a hangover in the morning. Using words such as cure and symptom demonstrate the intended use of a product to treat disease. It is important to remember the DHSEA disclaimer (Not intended to treat, diagnose, prevent, or cure) when developing marketing content. Here’s a video I made to help companies identify if a claim is being made. If accurate, replacing cure with support and replacing symptom with ailment can help to lower risk. I write about identifying and replacing high-risk buzzwords here. Other possible words for a hangover; imbibe or overindulge. From Warning Letter: Hangovers! Does anybody like them? Not a soul, but how can we stop ourselves from encountering one after a long night? Nutrovape now has the answer. With the new Nutrovape recover, you can make sure your hangovers don't ruin your days after a night of drinking. Discussing Ingredient Benefits Are Considered Marketing Claims From Warning Letter: The “Dihydromyricetin (DHM)” page in the “Health” section of your website: Dihydromyricetin . . . is used for anti-inflammatory, anti-hangover . . . benefits. Research in animal studies suggests several important mechanisms of action relating to DHM’s ability to protect against hangovers: . . . This is a common mistake made by well-intentioned writers and webpage designers that do not understand the nuances of dietary supplement marketing. Best practices here are separating the ingredient benefits discussion from the product page, removing high-risk words, and ensuring that a reasonable consumer will not think this is intended to sell a product. Here is a Warning Letter Wednesday post on this topic. Referencing Clinical studies Can Be Looked at as Marketing From Warning Letter: Research in animal studies suggests several important mechanisms of action relating to DHM’s ability to protect against hangovers. Here is a post and a video about clinically proven types of statements. Although not hangover-related, here is a NAD case decision and FTC administrative compliant that are interesting reads. Implied Claims Will Attract a Warning Letter From Warning Letter: More recently, Dihydromyricetin has received attention for its purported anti-hangover activity. Several studies suggest that it may lower markers of inflammatory liver disorders. Anecdotal reports indicate that this may carry over to alcohol-induced liver inflammation. Stating anecdotal reports indicate then adding a disease word is considered a suggested implied claim. Other examples of this include using “may” and “should” followed a high-risk buzzword. See my post on this here. Blogs Are Marketing Claims Informational blogs are considered extensions of the label. This warning letter references a light implication that CoQ10 is useful for hangover support. This statement was made about the ingredient CoQ10 in an educational blog. The FDA makes the correlation this is a marketing claim because a product sold on this website CoQ10 has the same name as the ingredient. From Warning Letter: Holiday Hangovers: After All That Partying, Which Nutrients Do You Need the Most (which references the ingredient Coenzyme Q10 contained in the product Nanoemulsified CoQ10) The compliance line between "informational" blogs and product blogs is very thin and is open to interpretation. If a company must use informational blogs on a commercial website it is important to make it clear the blog is for educational purposes only and remove all CTA's (Call To Actions) that link to a shopping cart or product page. Here is a detailed Warning Letter Wednesday post and a helpful video I made on the topic. Please share these with your content team as training tools or contact me for a free consultation. I love talking about this aspect of marketing and compliance. Follow Enforcement Trends: What was lower risk yesterday is high-risk tomorrow Earlier this year the FDA cracked down on companies making depression and anxiety claims which I write about here. Anyone who was paying attention to enforcement trends would have removed these words from their marketing, but the warning letters continue. As exemplified by the hangover enforcement timeline, what was a lower risk in the past may be high-risk tomorrow. I love enforcement trends; they give us an opportunity to learn from others' mistakes and course correct. Read my Reasons to Follow Enforcement Trends post for a detailed discussion. Also, reading my weekly Warning Letter Wednesday post or anything by Josh Long or Nathalie Bougenies are great ways to stay up to date with what the FDA is focusing on. For a free consultation regarding your compliant marketing contact me here. Disclaimer: The educational information provided on this website is for informational purposes only and does not constitute legal or regulatory advice. Contact an attorney for specific legal advice.

The popularity of medicinal mushrooms shows me the world is finally ready to embrace natural medicine. It is no surprise however to see mushroom product marketers being called out in warning letters for making high-risk claims. Here's a recent warning letter that covers many of the common mistakes to avoid. Most of this I've talked about here in my blog or my #WarningLetterWednesday LinkedIn post. Here Are The Learning Targets: * Follow Enforcement Trends: Depression & Anxiety Claims Are Super High-Risk *Hashtags Are Claims *High-Risk Words Should Be Avoided *Implying "Clinically Studied" Is High-Risk * Clean Up Claims On Old Social Media Posts * Social Media is Marketing Many warning letter recipients are not bad folks but perhaps just do not know any better. A purpose of my free Regulatory Education Series platform, my public speaking tour, and my free video channel is to educate those looking to raise the bar of ethics and compliance in the industry. Please share this blog or any of my content (with attribution) if it may be of value to your network. We are stronger together! Follow Enforcement Trends: Depression & Anxiety Claims Are Super High-Risk Earlier this year the FDA cracked down on companies making depression and anxiety claims which I write about here. Anyone who was paying attention to enforcement trends would have removed these words from their marketing. I love enforcement trends, they give us an opportunity to learn from other's mistakes and course correct. Read my Reasons To Follow Enforcement Trends post for a detailed discussion. Hashtags Are Claims It is pretty obvious but in this warning letter, the following hashtags were called out. #DepressionAndAnxiety #BeatDepression #BeatAnxiety The quickest way to wave a stick at the FDA/FTC is by using non-compliant hashtags, High-Risk Words Should Be Avoided I have developed a risk-rating system on a scale of 1-5. Here are some examples of words in the 5 of 5 risk categories: cancer, COVID, Alzheimer’s, depression, PTSD, Diabetes should never be used. Words such as pain and inflammation carry a risk level of 3 of 5. For context, anything 3+ is likely to attract a warning letter. Contact me for a list of other high-risk words to avoid with some possible lower-risk alternatives. Here are some tips to know if a claim is being made! I also made a video on this! Implying "Clinically Studied" Is High-Risk This is definitely a trend to watch out for. We are seeing references to clinically studied types of claims showing up not just in warning letters but also in class action lawsuits. A company cannot imply their commercial product has the same uses as a clinical study. We talk about what defines clinically proven here. There are many factors including serving amount, formulation, and delivery size which play a role in this. Here are some egregious examples from the warning letter in grey. On the scientific studies webpage, under the heading “Lion’s Mane Scientific Studies”: • “Lion’s Mane May Be Effective in Combating Dementia/Alzheimer’s Disease” • “Lion’s Mane Has Shown In Studies That It Could Reduce Anxiety And Depression” • “Animal Testing Shows Lion’s Mane Helps Control Diabetes Symptoms By Keeping Blood Sugar Low” This is a good example of a company pushing out content without having a compliance review. I review this and more in this Hiring Supplement Experts for Rapid Company Growth blog post. I loved that post and poured by 20 years of experience into it! Clean Up Claims On Old Social Media Posts The authorities look at a very old social media in the same manner as a current one! In this warning letter, a 2019 tweet is referenced! Please please please, delete or clean up old non-compliant social media posts. I really don't want to tell you I told you so! Read about this in my Operation CBDeceit blog. From the warning letter in grey. Notice the 2019 date! On your social media website • “LVL:MAX . . . Protects Against Ulcers in the Stomach: Goodbye Pain… Relieves Depression and Anxiety… Lowers Cholesterol: Live Longer…Lower Inflammation…” [From a Nov 12, 2019 post] Social Media is Marketing Anything used to sell a product, including all commercial social media posts are marketing, and therefore must be compliant. Most warning letters reference social media I find it helpful to think of all marketing as an extension of the label. We wouldn't use the word anxiety on a label, so it's important to not use disease claims in any marketing, including social media infographics. Anything used to market must be truthful and not misleading. I hope you enjoy this warning letter report from the front line of compliance. I read every FDA warning letter and report back on enforcement trends. I love this aspect of compliance! For a free consultation regarding your compliant marketing contact me here. Disclaimer: The educational information provided on this website is for informational purposes only. Contact an attorney for specific legal advice.

< 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