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Copackers & distributors must comply with GMPs < Back Incomplete 483 Responses Copackers & distributors must comply with GMPs This copacker didn't have most of the basic GMP structure required for handling and distributing dietary supplements, and based on my reading of the letter FDA gave them plenty of opportunity to address their 483 responses. Unfortunately, this company likely didn't seek professional help and has earned a warning letter for poor GMP compliance and insufficient 483 responses. Here is what we can learn. Product retentions: We don't often see this cited in warning letters, but it is an integral part of GMPs and product investigations. In my days as a manufacturer, I frequently used product retentions to conduct customer complaints and investigations. I also used these products to help substantiate shelf life expiration dating. From warning letter. "You must retain reserve samples for one year past the shelf-life date (if shelf-life dating is used), or for two years from the date of distribution of the last batch of dietary supplements." The reason product retentions are rarely mentioned in warning letters is that they are a pretty simple 483 response. The company needs to update its policies and show its work, meaning it should provide proof that product retentions will be collected and saved for the proper amount of time. This company fell short of proving this to FDA, which is why it was added to the warning letter. From warning letter. "(from company) [w]e corrected and labeled retention samples before the end of our inspection" and "[w]e have a special location for retention samples and hold for are [sic] required to hold for 2 years for the lot." (from FDA) However, you did not provide any supporting documentation demonstrating you made these corrections. Further, the inspector did not observe any corrections prior to the closeout of the inspection. Consequently, we cannot evaluate the adequacy of your corrections at this time." Subpart G: This involves receiving dietary supplements for packaging. You will see the company did not prove the corrective action to FDA, which, In this case, should be so simple. 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. 483 response comments from warning letter. "Your "Inbound Policy" failed to provide written procedures regarding the examination of each immediate container or grouping of immediate containers in a shipment of product that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) for appropriate content label, container damage, or broken seals to determine whether the container condition may have resulted in contamination or deterioration of the received product." As a side comment, I love writing this weekly post. Please share with your community to help spread the word. You can sign up here for WLW and my monthly newsletter, and to learn more about my consulting company, Supplement Advisory Group , and my award-winning compliance software company, Apex Compliance . Your support means the world to me! Thank you! There are several other incomplete 483 responses cited in the letter. Read the full warning letter here . DATE ORIGINALLY POSTED: 8/14/24 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!

Review videos for compliance concerns < Back YouTube Claims Lead To Warning Letters Review videos for compliance concerns There have been three YouTube-related supplement warning letters this year, which shows FDA is not slowing down with this enforcement trend. Since this is a US holiday, I will keep today’s Warning Letter Wednesday brief. All of the 2023 YouTube-related warning letters also cite claims from other platforms like websites and other social media platforms. This means that “where there’s smoke, there’s fire,” and if there are claims on videos, there are most likely disease claims elsewhere in a company’s marketing. I just launched Apex Compliance , a compliance software designed to find risky phrases on websites, YouTube videos, and uploaded content before it gets you in trouble. I developed this SaaS tool to help companies fix their marketing before it leads to a warning letter or lawsuit. Learn more here . Two letters link to a shopping cart, and the other one references a video embedded on the website. This is the material connection that correlates the video to commerce. I doubt these videos would have been cited if there were no links to where customers can order products. Only one FDA warning letter in FDA’s warning letter archives mentions claims on Vimeo (that I can find). Here are the three letters: 👉ByPro Nutrition LLC 👉PharmaCanna 👉Spartan Enterprises Inc. 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!

Opioid support claims are high risk < Back Kratom Claims Enforcement Increasing Opioid support claims are high risk There have been four kratom warning letters this year compared to just one last year, a 400% increase. This shows there has never been a riskier time than now to market kratom with disease claims. All kratom warning letters this year involve claims related to opioid withdrawal. Products marketed for opioid and substance withdrawals remain a high risk as those suffering from addiction are considered a “vulnerable population” and are top of mind for the FDA/FTC. Other vulnerable populations are the elderly, children, and those with mental illness. Now is a great time to ensure these high-risk statements are not inadvertently hiding on a company website or socials. The FDA does not have a favorable position on kratom and considers it a New Dietary Ingredient (NDI) according to this import alert . The FDA also sent out this kratom alert where several US Marshall kratom seizures are highlighted. There also have numerous kratom-related recalls because of salmonella contamination. The key learning lessons are that if a company must sell kratom, they should be very careful not to make opioid withdrawal support or other disease claims, including statements in blogs or citing clinical studies. Also, investing in safety studies and testing every lot for microbials is advisable. I think safe and responsible kratom commerce may someday have a place in dietary supplements. The 2022 kratom warning letters are joint FDA and FTC warning letters. Also, they include cease and desist demands requiring the companies to stop making unsubstantiated claims or face injunction, civil penalties of up to $46,517 per violation, and requirements to refund customers. 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!

Investigating customer complaints is a cornerstone of supplement safety and compliance < Back Failure to Report Serious Adverse Events Investigating customer complaints is a cornerstone of supplement safety and compliance Investigating customer complaints and reporting serious adverse events (SAERs) is a cornerstone of dietary supplement safety and compliance. In this warning letter, a supplement company that makes products for young children was cited for not properly investigating customer complaints, quality issues related to a product market withdrawal, and reporting SAERs to the FDA. This is a shocking and dangerous lesson in how a supplement company that was not following GMP regulations and properly investigating safety concerns has led to potentially serious health risks for its consumers, including babies. Here is an example of one of the complaints that were not reported within 15 days to FDA. 👉From warning letter. "You received a complaint (#(b)(4)) in which the complainant described their six-week-old infant choked on Gripe Water Original. Per your complaint record, the complainant explained their infant "(b)(4)." Your complaint record further explains the complainant attempted cardiopulmonary resuscitation (CPR) multiple times until the infant began breathing again. The complainant also reported that paramedics were called and looked over their infant." Side note: Babies are considered a "vulnerable population," which means the FDA pays special attention to the safety and compliance of products marketed to them, and for good reason. The violations in this warning letter are noncompliant for people of any age, but are dangerous for babies who don't have fully formed immune systems. Also, I ran Apex Compliance ® on their website and found some crazy disease claims! This warning letter includes some interesting labeling items that likely would not have been mentioned if there had not been other serious violations. 👉From warning letter. "The product's inner bottle labels do not bear nutrition information, as required by 21 CFR 101.36. The unit container is exempted from these requirements if the unit container bears the statement "This Unit Not Labeled for Retail Sale." 🔺Asa Comments: I understand that safe usage instructions, warnings, and allergen disclosure should be on an inner label, but I've never seen this cited in a warning letter. 👉From warning letter. The dosage guide and/or directions for use are placed above the Supplement Facts label, which is not in accordance with 21 CFR 101.2(a) and (e). Nutrition information should appear on the principal display panel (PDP) or directly to the right of the PDP with no intervening material in between. 🔺Asa Comments: Wow, I've also never seen this in a warning letter, and it's a widespread labeling practice. This warning letter reads like a scary book that has all the plots, including disease claims, improper 483 responses, and the FDA giving lots of opportunities for improvement. I suggest everyone read it. DATE ORIGINALLY POSTED: 6/25/25 Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

< Back Panel Discussion Wednesday Sep 21, 2022 Building Brands in Cannabis Naturally Boulder Boulder, CO CBD, THC, and Cannabis are all over the news. Consumers see the products in stores, are starting to see limited advertising, and are hearing anecdotes from their friends. Everyone is talking about it, but people have very little information about it. And, the information they do have varies by the state or community they live in. This creates an interesting business opportunity for entrepreneurs! For current brands looking to incorporate cannabinoid-based benefits of sleep, pain relief or calm there is obvious opportunity, but also, complexity and risk. For new brands launching into the space, there is a steep and unique learning curve in navigating formulation, branding, and distribution that is like no other industry. If you’ve wanted to learn more about this continually emerging, high-growth industry, Naturally Boulder has assembled a panel of experts to discuss the state of the industry, what’s hot and new, and how you can develop and build a powerhouse brand in the space. Learn More Previous Next

< Back Presentation, Online Friday Nov 18, 2022 Naturally Informed: Living Longer, Stronger & Healthier Virtual Conference Registration Naturally Informed powdered by Wholefoods Magazine and Trust Transparency Center Asa Waldstein presents a regulatory and enforcement update on notable action happening in emerging categories such as brain health; bone, muscle, and joint health; libido; immunity; heart health; eye health; and more! On Demand Access Previous Next

Learn from other’s mistakes < Back Arthritis Claims Enforcement Learn from other’s mistakes Since the beginning of 2023, 11 warning letters have been issued for arthritis-related supplements and topical product claims. Here, I explore these warning letters, look at common trends, and share key takeaways. Higher-risk disease claims : I have always wondered if making arthritis claims alone is enough to trigger a warning letter. The answer is surprisingly “not really.” All warning letters since the beginning of 2023 have included high-risk words like cancer, depression, and fibromyalgia, except one. This warning letter accompanied GMP citations and included arthritis claims that were part of an out-of-compliance OTC drug that did not follow the official monograph. Social media and YouTube : 45% (5 out of 11) mention claims on social media and YouTube. This is not a surprising number, and it shows FDA’s continued focus on social media marketing claims. Some of the cited social posts were a couple of years old, which is a reminder to ensure even those old posts are “clean” of disease claims. Are you interested in finding the high-risk statements on your website, videos, and content before publishing? My software product, Apex Compliance, can help you identify and replace these high-risk phrases before they lead to warning letters and lawsuits. Our AI has been custom-trained on compliance principles, including warning letters, and it helps you understand what compliant language looks like. Learn more and set up a free demo here . Blogs : 18% include claims made in blogs. I’ve written a lot of this before, such as in this post . GMP Inspections Lead to Marketing Review : 27% of letters started with a GMP inspection, which led to a marketing review. I write more about this here . Drug-spiked ingredients were mentioned in 18% of these letters . The moral of the story is to keep disease words like arthritis out of marketing, and they will signal to authorities to look deeper for other high-risk marketing phrases. 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 Online, Presentation Monday Nov 7, 2022 Labeling and Marketing Hemp-CBD Products: Best Practices & Pitfalls to Avoid Smither's Hemp & CBD Workshop Asa Waldstein reviews best practices, and common mistakes companies make when marketing and labeling hemp-CBD products. Anatomy of a CBD supplement label. A detailed review of how to comply with state and federal regulations. Marketing insights: A review of recent regulatory trends, common marketing oversights, and best practices for compliance. This includes looking at the nuances of social media engagement, reposting, and infographics. Asa will also discuss other enforcement areas, such as influencer marketing and blogs. Learn More Previous Next

Some of our favorite resources to help educate about influencer marketing and product review compliance. Influencer Marketing & Reviews / Influencer Marketing & Product Reviews These are common areas of enforcement and lawsuits.Here are some resources to help understand these regulations. Product reviews and testimonials podcast: Justin Prochnow How influencers can comply with FTC disclosure guidelines video FTC's Disclosures 101 for social media influencers FTC's featuring online customer reviews: A guide for platforms Influencers and CBD: Interview with Asa and a popular influencer Back

Consulting and advisory services for the dietary supplment and hemp industries. Formulation, GMP review, FDA/FTC enforcement trend analysis, company marketing risk training. COMPLIANT MARKETING STRATEGY REVIEW HELP AVOID WARNING LETTERS Review marketing and social media campaigns with a risk level-based analysis. Develop training and best practice documents. (social media interactions, biogs, hashtags, infographics, videos). SOCIAL MEDIA Effective marketing messaging with lower risk language. Best practices for social media managers. Do's and don'ts of reposting and hashtags. BUSINESS STRATEGY INCLUDING NEW SECTOR EXPANSION Industry expert review before expanding into supplement or hemp product categories. M&A compliance due diligence review before new acquisitions. EXPERT LABEL COMPLIANCE & COMPANY TRAININGS Product label reviews Company compliance trainings to help develop in-house expertise. Founded by Asa Waldstein , a dietary supplement and hemp expert with 20 years of experience developing and implementing compliant marketing and cGMP manufacturing processes. Asa has formulated, manufactured, and marketed hundreds of products in a compliant manner and has helped oversee three FDA CFR 111 audits without any 483s. Asa decided after years as an executive for other companies the best use of his skills was to open Supplement Advisory Group to serve the greater supplement and hemp marketplace. About Supplement Advisory Group Specializing in marketing risk analysis and practical marketing solutions on the web, social media, and product labels. We focus on finding marketing risks and providing practical lower-risk solutions on the web, social media, and product labels. This includes compliant marketing strategy review and claims risk analysis. We take a preventative approach to regulatory risk in the dietary supplement and hemp industries. Learn More Free Introductory Regulatory Consult Available Online 15 Minute Consultation with Asa Waldstein 15 min Book Now

Some of our favorite resources to help educate about cGMP manufacturing compliance. cGMP Guidance / cGMP Guidance These are common areas of enforcement and lawsuits.Here are some resources to help understand these regulations. New Cosmetic Regulations Webinar: cGMP Basics for Hemp-CBD Companies. This is an excellent training tool for your supplement or hemp company! Webinar: Preparing for FDA cGMP Facility Inspections Preparing for FDA Inspections: Fireside Chat Webinar Back

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