< Back Solo presentation, Panel Discussion Wednesday Feb 14, 2024 Sports & Active Nutrition Summit USA Sports & Active Nutrition Summit USA San Diego The 2024 Sports & Active Nutrition Summit USA will return to San Diego for its sixth year on February 12, 13 & 14 at the Hyatt Regency Mission Bay. Produced by NutraIngredients-USA.com , this summit serves as a pivotal gathering for professionals in the sports and active nutrition sector, facilitating connections between cutting-edge science, business strategy, and key regulatory developments. This must attend three-day summit will showcase expert presentations, dynamic panel discussions, various networking opportunities, and a wellness program. It provides a comprehensive platform, serving as a one-stop shop for the latest indispensable insights in the realms of sports and active nutrition. See our most recent newsletter which highlighted this event. Learn More Previous Next

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!

Ingredient research can be considered a marketing claim < Back Product “Tags” With Disease Claims Elevate Risk Ingredient research can be considered a marketing claim Ingredient research on a commercial website can be considered a marketing claim, which continues to be cited in warning letters. The key point that turns “research” into a marketing claim is when the ingredient is in a product sold on the site. This is when “education” crosses the line into marketing. Here is a post about seven CBD companies that were cited for this earlier in the year. Today’s #WarningLetterWednesday is another example of this, but it also has some new learning opportunities. Products or category “tags” help Google and customers find specific posts, but they are also considered marketing. These tags demonstrate the content’s intended marketing use and should be used carefully. I suggest against using disease “tags” on any supplement marketing, and this warning letter cites a very high-risk category tag. From warning letter: Your website ….. also includes various “Category” tags, including “COVID-19,” that link to the blog post “How Does CBD Help to Fight Against COVID-19?.” The blog post has links to CannaAid products available for purchase. I write more about product tags and meta tags here . This letter also references a call to action where the blog post links to a shopping cart. Although blogs with implied disease claims are cited in warning letters, this “commercial bridge” likely elevates the risk of scrutiny. This company would have received the warning letter without the “Covid” tags and without linking to a shopping cart, but this shows how authorities may consider these factors when deciding to issue a warning letter. Here is a post about discussing ingredient benefits. This joint FDA/FTC letter includes a cease and desist. Learn more about these here . Read the full letter here . DATE ORIGINALLY POSTED: 11/16/22 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!

Marketing strategies should consider “reasonable consumer expectations” to avoid issues < Back GLP-1 Product Receives Warning Letter Marketing strategies should consider “reasonable consumer expectations” to avoid issues This is one of the cringiest Warning Letter Wednesday posts I've ever written. Wow! This company received a warning letter for making claims that it is better than Ozempic, has FDA approval, does not require a prescription, has no side effects, and is clinically proven in "clinical trials and was approved by the Food and Drug Administration last year." This is the first GLP-1-related "supplement" FDA warning letter. Interestingly, it came in a group of five letters; the other four were companies selling semaglutide (generic Ozempic) labeled as "RESEARCH USE ONLY," but FDA cites their secondary marketing claims as proof of the intended weight loss use. Good detective work FDA! This warning letter is a great study of how implied and express claims cross the compliance limits, such as with the before and after pictures, statements like "Only active GLP-1 is effective GLP-1," and "FDA approved" statements. Here is my opinion on some of the information I've gathered. It is unclear what the ingredients in the product are, but they are marketed as natural and side-effect-free. The product is not labeled as a supplement, but it lists "Clinically Proven" and "Metabolism boost drops for weight management" on the label. The before and after pictures are super cringy and likely violate FTC regulations against deceptive marketing. The product reviews feel doctored, and the entire vibe of the website seems like an AI-generated experiment. It gave me the heebie-jeebies, and I expect the FTC would have a field day with this site. There are other "supplements" for sale on the website, such as THC gummies and weight loss gummies, that are making claims related to anxiety reduction (thanks to Apex Compliance for helping me find these). And much more FDA also cites this company for making "FDA-approved" claims. As we know, supplements are FDA-regulated but not "approved." From warning letter. "webpage for ...includes the image of a blue circle with the claim, "FDA APPROVED" along with the statement,. . . was approved by the Food and Drug Administration last year." Implied GLP-1 statements are cited but they’re probably not the primary reason for this warning letter. From warning letter. “The Science of GLP-1 . . . The effectiveness of … lies in its dual-action approach, addressing intake and expenditure. On one hand, it suppresses appetite, aiding in reduced food consumption and subsequent weight loss. It also slows gastric emptying, prolonging the feeling of fullness over an extended period.” Bashing companies is not my style, as I believe in a "rising tide" and educational approach, as many companies who receive warning letters may not know any better, but this company's marketing feels calculated and intentional. Read the full warning letter here . DATE ORIGINALLY POSTED: 12/18/24 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!

Re-review marketing if FDA has inspected you < Back Online Marketing & GMP Lessons Re-review marketing if FDA has inspected you Learning about compliance is fun, and today’s Warning Letter Wednesday has critical teaching opportunities for marketing and GMP compliance. This is yet another example of a company being inspected by FDA; then, many months later, around the time of the inspection close out, FDA looked at the company’s online marketing and found a lot of no-nos. This is an enforcement trend that I write about in more detail here . First, the marketing issues : YouTube videos : Claims made in YouTube videos have been mentioned in three warning letters this year and I expect this trend to continue. Reviewing hours of YouTube videos for compliance concerns is painful, so I developed and patented a technology to help with this . In this warning letter FDA clearly shows the “material connection” or “commercial bridge” by referencing that the company placed its website on the screen. From warning letter. “the URL for your website … appears onscreen during the video and you state: “Very powerful anti-cancer properties…used in conjunction with chemotherapy and other cancer treatments, but not only does it have anti-cancer properties it also has a lot of other properties as well…the way that Taxane works in the body to fight cancer is it causes cell apoptosis in cancer cells.” Biomarker claims continue to be mentioned in warning letters. I go into more detail about this here . From warning letter. “Lowers LDL and Triglyceride Levels” Words with “anti” are disease claims , except for antioxidant and perhaps anti-aging. Words like anti-inflammatory have a risk rating of three out of five (Asa risk scale) which means they are not likely to attract a warning letter on their own, but words like anti-viral are very risky. From warning letter. Dr. Bob’s Parasite Killer is formulated with parasiticidal, anti-fungal, anti-viral, and antibacterial ingredients with the intention of killing everything in the digestive tract. Claims on product labels : We know that all marketing is an extension of the label, but I am still surprised by some of the “on-pack” claims companies put on the product label. No knowledgeable manufacturer would apply labels with these statements. From warning letter. “Dr. Bob’s Parasite Killer is formulated with parasiticidal, anti-fungal, anti-viral, and anti-bacterial ingredients with the intention of killing everything in the digestive tract.” Now the GMP learning opportunities : Component specifications are integral to GMPs, and each raw material must have written specifications. This is to ensure ingredients do not make it into inventory unless they’ve been checked. For example, suppose an ingredient’s visual specification was green and the product came in yellow, or the ingredient did not pass identity testing. In that case, the specification sheet should help catch and document this. From warning letter. “Yuan Zhi is an ingredient in your … but you did not establish such component specifications for Yuan Zhi.” Incomplete 483 responses are too common, and I write more about this here . From warning letter. “you did not provide any supporting documentation, such as copies of your specifications. We are unable to evaluate the adequacy of your corrective action, because you did not provide documentation to support that you have established component and finished product specifications.” Batch Production Records (BPRs) are the “recipe” and should have all adequate information, including copies of labels and cleaning records. Here are some of the items cited in this letter. The description and name of equipment used in producing the batch. This is important so cleaning can be documented. 🔷 The date and time of maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch or a cross-reference to records where this information is retained. 🔷 The unique identifier, such as a lot number and item number for each component, packaging, and label used. 🔷 The identity and weight or measure of each component used [21 CFR 111.260(e)]. A statement of the actual yield or theoretical yield at appropriate phases of processing. This is important to ensure the weight is correct. For example, a high yield could signify an ingredient may have been incorrectly weighed, and this may pose a safety concern. Documentation that the finished dietary supplement meets specifications. Documentation at the time of manufacturing, such as real-time quality checks. This includes bottle weight and label verification. Documentation that quality control personnel reviewed the batch production record and approved and released, or rejected, the batch for distribution. The job of quality is to review and release ingredients, in-process work, and finished products once it has been verified against its specification. Labeling issues were also cited. 🔷 Not listing the capsule in the label’s ingredients 🔷 Not listing the plant part such as ginkgo leaf. 🔷 Not using the standardized common name as described in AHPA’s Herbs of Commerce. Thanks, AHPA, for this resource! 🔷 Incorrect serving size. If the label states, “take 5-8 capsules,” the supplement fact panel must reflect the higher number. 🔷 Listing nutrients with zero amounts, like cholesterol, is not allowed on supplements but is standard for conventional food labels. 🔷 The company was cited for not listing black walnut as a major allergen. I ask, is black walnut a tree nut allergen? 🔷 DSHEA disclaimer: I don’t remember seeing this in a warning letter. The company was cited for apparently not having the DSHEA disclaimer on the label. From Warning Letter. Your … are each misbranded within the meaning of section 403(r)(6) [21 U.S.C. § 343(r)(6)] in that the products make structure-function claims but fail to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b). There are many more labeling items cited. 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!

Companies are responsible for co-manufactured products < Back Eye Care (Ophthalmic) Products Under Increased Scrutiny Companies are responsible for co-manufactured products This warning letter is interesting. This is an ophthalmic drug warning letter, but the supplement and cosmetic industries can glean helpful information here. Here, I review these learning opportunities. Claims on website and videos. Timeline: Could the company have avoided a warning letter? Ophthalmic (eye) drug products are under increased scrutiny. Manufacturer and distributor responsibilities Are you interested in a free discussion about high-risk claims on your website? I’ll run my compliance software and share the findings. Book your free session . ● Claims on website and videos. FDA has cited seven companies for claims in YouTube videos this year. What makes this interesting is the videos mentioned in this warning letter were embedded on the webpage rather than just on YouTube. This shows me that FDA is going the extra mile to review videos. Also, some of these videos are old, like this one from 2018. From warning letter. “From your March 16, 2018, YouTube video titled, “MSM Eye Massage (Eye Exercise)” on your… where you demonstrate an eye massage with one of your MSM eye drop products: “This MSM eye massage is great for inflammatory eye conditions, blepharitis, dry-eye, improving the lymph system, and stimulation of tears.” As a side note, Apex Compliance, my monthly compliance software, scans YouTube video transcripts for compliance issues in seconds. Learn more . ● Timeline . FDA tested one of the company’s products and found that it contained microbial contamination, which is very serious for products applied to the eyes. On August 21stof this year, FDA and the company had a virtual meeting, presumably to talk about the contaminated product. A few days later, the company issued a voluntary recall for this and some of their other products. At some point in August FDA reviewed the company’s website and found many drug claims. At some point in August FDA reviewed their website. If the company would have conducted a website compliance check when contacted by FDA, I wonder if they could have avoided a warning letter. ● Manufacturer and distributor responsibilities. This company was using contract manufacturers but apparently did not check their work. Here FDA reminds companies that they are responsible for the products they get made by co-manufacturers. If the company had conducted quality checks, they probably would have caught the microbial contamination before it led to a recall and subsequent warning letter. →From warning letter. “You are responsible for the quality of your drugs regardless of agreements in place with your contract facilities.” FDA also provides a link to this useful guidance document, Contract Manufacturing Arrangements for Drugs: Quality Agreements . ● Ophthalmic drug products are under increased scrutiny. There have been 21 ophthalmic FDA warning letters this year, compared with seven last year. This continued enforcement trend has involved some of the largest companies, such as Amazon. I write more about this . It sounds like the company did not follow the path of an OTC or other drugs. Anything added to the eyes has a high level of danger and should go through proper regulatory channels. →From warning letter. “new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect…. No FDA-approved application pursuant to section 505 of the FD&C Act, 21 USC 355, is in effect for these products.” 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!

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!