Correct FDA 483s to avoid a warning letter < Back Most GMP violations involve setting & documenting specifications Correct FDA 483s to avoid a warning letter #WarningLetterWednesday reviews a cGMP manufacturing warning letter. This is a good teaching case about the basics of Good Manufacturing Practices (GMPs) for dietary supplements as this company made some of the most common mistakes. Regulatory expert Steven Yeager and I discuss “How to Prepare for FDA Inspections” in the following webinar . We’ve both helped oversee several FDA CFR 111 inspections with no warning letters and we have fun sharing our helpful tips and hints. Steven and I also presented a four-hour GMP and marketing compliance workshop here at the American Herbalists Guild. This letter includes the most common violation of not establishing and documenting specifications for the identity, purity, strength, and composition. Another common mistake is not having documentation showing a member of the quality team approved specifications and product labels. This role of quality is at the core of GMPs. Imagine the mix-ups and potential adulteration that could occur if the production team was allowed to apply labels without oversight. We recently saw this happen in a CBD company that inadvertently applied CBD labels to the THC product which resulted in serious adverse events. Another important reminder is the requirement to list the plant parts such as leaves or fruit. Also noted is the requirement to have proper Supplement Fact Panel line thickness and bolding. Although these will not attract a warning letter on their own it is better to have a correct label layout. There are so many more violations listed in this letter and I suggest reading the full warning letter here . It is interesting to look at the timelines in this warning letter. The inspection was in May of 2021 when a 483 was issued but the warning letter was not issued until six months later. This gave the company plenty of time to correct the 483 and avoid a letter. Learn more about the difference between 483’s and warning letters here . The very big surprise is the FDA didn’t appear to review the company’s website before the inspection. Normally, the best thing a company can do to prepare for a GMP inspection is to remove all high-risk online marketing claims as FDA investigators review websites and social media before the inspection. This company is very lucky as they still have LOTS of high-risk website claims. This is a strong risk for a repeat warning letter. Learn more about “Reasons to Avoid “Warning Letters” 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!

< Back GMP Pitfalls: Marketing, Manufacturing, & Labeling #WarningLetterWednesday 👉I got carried away writing this WLW post. Check out my blog for the detailed discussion. 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 the most detailed Warning Letter Wednesday I have written. ➡️ Read the full post here . 👉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. This is an enforcement trend and a reminder for those who have been inspected to clean up website claims. 👉I write about these letters here . 👉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 👉👉Join my Warning Letter Wednesday group . 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 hashtags, videos, and testimonials should be avoided < Back More Marketing Lessons From COVID Letter Claims in hashtags, videos, and testimonials should be avoided More overt COVID claims are cited in this warning letter. We all know that making COVID claims about supplements is wrong, but let's explore key learning lessons you can apply to your marketing. 🔹This warning letter cites claims made in YouTube videos, and I expect more to come. In this letter, FDA builds the "commercial bridge" from the YouTube page to where customers can order products. It probably wouldn't have been mentioned if this was truly an educational page with no shopping cart links. 👉From warning letter. "where you direct consumers to your websites …. respectively, to purchase your products. 🔹COVID hashtags are cited in this warning letter. Noncompliant hashtags are the quickest way to turn a compliant post into a disease claim. 🔹Testimonials are also mentioned in this letter. I'm always interested to learn what the authorities consider a third-party review and what they consider a marketing claim. In this letter, the reviews were on their own "Testimonials" page and were showcased, which is a clear marketing claim in the eyes of the agency. 🔹Asa rant: Most of the claims cited in the warning letter have been removed, but there are still A LOT of COVID claims on their product's website and socials. This is a small, publicly traded corporation, and I am surprised by its audacity. Is the next step an injunction? I do not know much about the agency's inner workings, but it seems this would have been a good joint FDA/FTC warning letter. FTC has more "teeth" and can require companies to stop making unsupported claims or face civil penalties of up to $46,517 per violation and requirements to refund customers. Also, this warning letter was issued last November but was just posted yesterday, and I find the timeline perplexing. 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!

< Back Interview, Online Tuesday Nov 23, 2021 Practitioner v Product Claims NuHerbs Asa Waldstein and Wilson Lau explore the differences between claims that practitioners can make within their scope of practice versus ones they can make as herbal product marketers. How to be mindful of where you are making claims and in what capacity you are making such claims. Asa shares tips on how to create compliant claims and how to turn high-risk claims into low-risk claims. Asa brings a unique viewpoint being both a clinical herbalist and a seasoned veteran of the dietary supplement industry. Asa writes a weekly #WarningLetterWednesday post where recent enforcement trends are reviewed. Here is a post where practitioner education crosses the line into marketing claims. Watch Previous Next

< Back Podcast, Interview Wednesday Jan 19, 2022 Thought Leadership and Compliance Move The Stairs Podcast Here's what we discuss: FDA's position of Hemp CBD. Why following enforcement trends is important for marketers. Reasons to clean up old social media posts. Step by step process in becoming a thought leader such as "What problem am I having and how can I be extremely helpful to others in helping to solve this?" Why being a thought leader can help companies react appropriately in a crisis or with important news. One great example is how to talk about the recent CBD study without making a product COVID claim. Press release benefits and best practices. Listen Previous Next