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Warning letters show claims made in socials, blogs, testimonials & hashtags < Back A Review of 56 Diabetes Related Warning Letters Warning letters show claims made in socials, blogs, testimonials & hashtags I reviewed all diabetes and blood sugar related FDA warning letters since the beginning of last year and found some interesting results. These findings provide a snapshot of where the FDA is finding and perhaps looking for risky words. We can learn a lot from this, and it's an excellent reminder for companies to re-review these areas to ensure no risky statements are lurking on their website or social platforms. There have been 56 blood sugar and diabetes-related FDA warning letters since the beginning of 2021. This is a lot, demonstrating the FDA's continuing attention to this high-risk diabetes and blood sugar category. 62% of these warning letters include claims made on social media. This should come as no surprise but is an important reminder to scan for high-risk words on socials, including old posts. Here is a post and video about this. 26% of these letters include claims made in blogs. This is a strong enforcement trend to watch as the FDA looks at old blogs in the same manner as current blogs. I have found this to be a common oversight, as companies have learned about compliance over the years and their new blogs are compliant, while their forgotten older blogs are riddled with disease claims. Scanning these forgotten blogs is a great way to reduce risk, and this is a service we at Supplement Advisory Group are often hired to conduct. Here is a post about best practices for reducing risk in blogs. 23% of these warning letters include claims made in testimonials. The FDA and FTC are generally "hands off" with non-curated, honest, 3rd party generated product reviews. These cross the line into marketing claims when a company engages with them or showcases them in any way, such as copying an Amazon review onto social media or showing them on a product page. Here is a post that shows how engaging with product reviews led to a company warning letter. 25% of these letters include hashtags. Hashtags are easily searchable and can turn compliant posts into disease claims with an uncompliant hashtag. Here is a video about this. 👉Here is a learning tool titled "Protect Your Company: Learn to read warning letters." I hope you enjoyed reading the synopsis, and I welcome your thoughts! 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!

Following label format is important < Back Common Labeling Errors Lead to Warning Letter Following label format is important #WarningLetterWednesday focuses on label violations that helped lead to a warning letter. These are basic but important reminders. This company was inspected by the FDA when they collected product labels and issued 483s for common violations such as not correctly setting specifications. I talk more about these common violations and improper 483 responses here . Here are some label lessons from this warning letter. The serving size must match the suggested use. For example, a suggested use of “take 1-2 capsules” requires a two-capsule serving size, and FDA defines this as the “maximum amount consumed per eating occasion.” From FDA warning letter. “The (b)(4) label’s directions state to “Take 1-2 chewable tablets daily as needed, at bedtime.”, but the serving size listed in the Supplement Facts label is 1 tablet.” Items with a daily value percentage must be listed in the correct format. For example, listing “Vitamin B5” is incorrect, but “Pantothenic acid” is correct. The FDA also has a strict order that items with a DV% must be listed. I refer to AHPA’s labeling guidance for this, but I believe this document is now only available for members. Here is a decent FDA resource . From FDA warning letter. “Facts label fails to place pantothenic acid before biotin” I see companies posting labels online that have the incorrect layout and format. I’m not sure if these labeling violations would lead to a warning letter on their own, but they signal the FDA that more significant GMP violations may be occurring and likely triggers them to look deeper. “Where there’s smoke, there’s fire” is often true in GMP and label compliance. In my consulting practice, when I review labels that are way off in terms of compliance, I usually suggest that the brand owner look elsewhere for a manufacturing partner. Read the full warning 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!

< Back Interview Friday Feb 26, 2021 The Surprising Risks of Marketing CBD Products Hemp Startup Journey In this engaging conversation with FDA compliance expert Asa Waldstein, we discuss how to avoid an FDA warning letter which surprisingly goes way beyond what businesses state on a product label. We cover best practices for CBD company social media managers, effective marketing messages with lower risk language, dos and don'ts of reposting and hashtags, mitigating compliance risk, avoiding making CBD health claims, and how to market your products instead. You will find out what it means for Asa to Create Authentic Excitement in your differentiation strategy and the peace of mind you may get from it. We also discuss cGMP compliance and Asa's recommendations for Spectrum Labs' GMP accreditation journey. Watch or Listen Previous Next

Old posts are "active" marketing < Back "Forgotten" Old Social Media Posts Old posts are "active" marketing “Forgotten” social media posts from years ago are active marketing and are fair game for enforcement. Today, I’ll explore old social media warning letter citations that include retweeting, images, videos, LinkedIn, hashtags, and more. Retweeting: Retweeting (or is it called ReXing (smiles)) and reposting are considered endorsing the testimonial claim. For example, if a consumer wrote something nice about your product and you retweeted it, the information in the consumer tweet would now be your marketing. The risk increases if you add commentary such as “This is why we made the product.” → From warning letter. “You retweeted another user’s September 26, 2014 tweet, which said, “#lipoicacid [an ingredient in your …R-Lipoic Acid Vegcaps 100 mg] model treats autonomic neuropathy.” → Read this warning letter . LinkedIn: Warning letters that mention claims on LinkedIn are rare, and they usually cite issues on a company’s company page rather than individual posts or claims made in easily searchable disease hashtags like # Covid. In the past, it seemed like LinkedIn did not allow posts to be indexed for Google searches, but in the past couple of months this has seemed to change, meaning that old posts are more discoverable. Because of this, I expect more LinkedIn-related warning letters this year. Images and videos: FDA also cited claims made in images and videos. Here are some examples of 4.5-year-old Facebook and Twitter posts. ● IMAGES: This post shows that imagery, especially when added to the disease-word-containing text, can be considered marketing. Here’s a recent LinkedIn post about this. → From warning letter. February 9, 2019 Twitter post: An image of the “Vision Clarity Eye Drops” with the text, “Carnosine, a cataracts worst nightmare.” ● VIDEOS: This Facebook video also shows that even making implied claims can lead to a warning letter. → From warning letter. “July 11, 2019 Facebook video post. “We do not make any medical claims nor guarantees on any specific health issue, but we are very thankful that for over 10 years, people have been able to avoid having cataract surgery because they’ve used these drops.” → Read this letter . Hashtags: Here’s a 2019 post that includes hashtags. Hashtags are easily searchable and are easy targets for agencies looking for disease-containing posts. → From warning letter. “On your April 26, 2019 tweet: “Make Nutrovape Recover your best friend and say adios to a #hangover!” I am writing this from a beautiful beach overlook in Whangarei, New Zealand, where the birdsongs and water make an excellent place for concentration and relaxation. 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!

What hemp leaders have learned about compensation and recruitment strategies in a young industry < Back Hiring and Recruiting Practices Hemp Industry Daily staff Interview What hemp leaders have learned about compensation and recruitment strategies in a young industry Read More Previous Next

How we work together Free Introduction $ 0 0$ 15 Minute Meeting (one time) Valid for one month Select Review socials, web, marketing materials, business strategy or just chat. Silver $ 250 250$ Services provided on a per hour basis Select All services available (3 hour minimum) $250 per hour Gold $ 0 0$ Hire me on retainer Free Plan Select On call regulatory consultant: GMP's & more Plans starting at just 5 hours per month Discounted rate applies for 3/6/9 month contracts Platinum $ 0 0$ Hire me on a project basis Free Plan Select This can include soup to nuts go to market services Full website and marketing review Content writing services

“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!

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. < Back AI-powered tech makes customised regulatory compliance possible Anthony Fletcher Interview 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 Previous Next

Hemp Industry 2023 Opportunities Report < Back FDA Warning Letters, activity and actions in 2022 and what that means for 2023 Let's Talk Hemp Contributing Author Hemp Industry 2023 Opportunities Report Read More Previous Next

< Back Webinar Friday Feb 12, 2021 Preparing For FDA Inspections: Fireside Chat Asa's Regulatory Education Series Asa and Steven Yeager discuss tools on how to prepare for and execute a successful FDA inspection. This includes an "Ask Me Anything" session where you can ask anything from us. How To Prepare: (Examples include): No Claims on Web & Social Media Outside of Building Clean Back Doors locked (GMP prerequisite) SOP Ready: What to do during an FDA inspection And more! Company Conduct: Quickly Turn Around Requests Make Copies of Everything Correct Observations Immediately Work with the investigator And more! Steven Yeager is Director of Quality and Regulatory Affairs for Mountain Rose Herbs and has overseen several FDA GMP inspections. Learn more here . Watch Previous Next

In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. < Back Q3 2024 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 Minor label violations, such as fact panel line thickness, continue to be cited in warning letters. A NAD case involving a popular children's YouTube channel highlighted the complexities and need for material disclosure. FDA warning letters underscore that elaborating on studies or posting about them on social media can be problematic. Read More Previous Next

Labeling disputes over protein content and daily values continue to attract legal attention, particularly in California < Back Three recently filed lawsuits highlight legal risk in protein labeling compliance Cassandra Stern Interview Labeling disputes over protein content and daily values continue to attract legal attention, particularly in California Three newly filed class action lawsuits against supplement brands Pescience, Huel and OWYN reflect an ongoing trent of litigation over protein content claims and labeling compliance. At issue in each case are alleged violations of FDA rules regarding how protein content and daily values must be calculated and displayed on product labels. Read More Previous Next