Search Results

Use AHPA's Herbs of Commerce < Back Herbal Ingredients Should Be Listed Correctly Use AHPA's Herbs of Commerce Listing herbal ingredients on labels in the correct format is important. This year, there have been seven warning letters that reference missing or incorrect standardized common names (SCN) on labels. Sign up for the weekly Warning Letter Wednesday post. Here are some examples. 🔹Listing the name “manjishtha” is not a standardized common name (SCN), but “Indian madder” is acceptable because it’s listed in Herbs of Commerce. The Ayurvedic name for Indian madder (manjishtha) may follow the SCN in parentheses. 🔹If there is no SCN in Herbs of Commerce, the Latin binomial name must be present (e.g., Phalaris canariensis). 🔷FDA refers to the American Herbal Products Association (AHPA) Herbs of Commerce for standardized common names. This is one of the many things AHPA does to help make the supplement industry better. Thanks AHPA! 🔷As a friendly reminder, the plant part is also needed. Interestingly, “herb” is not sufficient according to this warning letter . From warning letter. “Your … product declares “herb,” which is not a plant part. If the entire or whole plant is used, then that information must be declared.” 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!

Replace “insomnia” with lower-risk alternatives < Back Insomnia claims continue to attract FDA attention Replace “insomnia” with lower-risk alternatives #WarningLetterWednesday highlights insomnia claims that continue to attract FDA's attention. There were 22 FDA warning letters in 2021 with insomnia claims, dramatically up from 14 in 2020, 2019 (13), and 2018 (7). This is a clear indication of an FDA enforcement trend and a good reminder for marketers to remove the high-risk buzzword "insomnia" from their marketing. As many of you know I have an "Asa Risk Scale" where certain claims are rated on a 1-5 risk scale, with anything 3+ likely to attract a warning letter. Insomnia is rated as a solid 3.5+, which means it should never be used. If truthful and not misleading here are some possible alternatives for insomnia. *feeling refreshed in the morning *a restful night's sleep *healthy slumber support *sleep support *supports a healthy night's sleep *support rest 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!

Distributors are responsible for the products they sell < Back Walmart & Amazon Issued Warning Letters for Adulterated Products & Disease Claims Distributors are responsible for the products they sell Amazon and Walmart were cited for selling a product with disease claims and adulterated with NSAIDs. The product is a nutraceutical and omega-3 product that contains undeclared diclofenac, a non-steroidal anti-inflammatory drug (NSAID). Both warning letters include comments where FDA highlights that the company (Amazon or Walmart) is the party that fulfills and distributes the product. According to supplement regulations, companies that distribute products have a level of GMP and regulatory responsibility. Essentially if a company markets, distributes, and sells a product, they are responsible, even on a marketplace site. This webinar with Nathalie Bougenies and Steven Yeager shows many items companies need to comply with these regulations. From Amazon warning letter. “These products were introduced or delivered for introduction into interstate commerce by Amazon via your Fulfillment by Amazon service.” There were also examples of claims on both the Amazon and Walmart sites, such as “arthritis.” This is the most common “itis” referenced in warning letters and is an important reminder to scan for higher-risk words like “arthritis.” I expect this action to possibly lead to these companies asking for more adulterant testing and a deeper look at disease claims. For example, if the word “arthritis” is on your Amazon page, I expect it to be flagged. This product was recalled in June 2022. It is unclear if the products in these warning letters are from the same recalled lot or a different batch. From warning letter. “Combate la artritis.”” (English translation: Fights arthritis.)” Interestingly, the disease claims were in Spanish, a good reminder that the FDA also pays attention to claims made in other languages. I welcome your thoughts on these notable warning letters. Read the Amazon warning letter . Read the Walmart 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!

Ensure 483 responses are complete < Back GMP Violations & Unanswered 483s Lead to a Warning Letter Ensure 483 responses are complete #WarningLetterWednesday involves a company inspected by the FDA last year that received several 483s for common violations like not having proper component and product specifications. The company submitted 483 responses, but these responses were incomplete which led to a warning letter. From Warning Letter: “We acknowledge your response, received December 30, 2021, which acknowledged that specific elements needed to be updated and asserted that “[b]y March 31, 2022, MCACO will update and complete component specifications.” However, we are unable to evaluate the adequacy of your corrective action because you did not provide updated finished product specifications for review.” Here is a Warning Letter Wednesday post about this common GMP violation. The lesson here is to ensure that 483 violations are adequately addressed and that all grievances are met. Most 483s can be “walked back” and addressed before they become warning letters. Warning letters should be avoided. Learn more about the ramifications here . Here is a video about the differences between 483s and warning letters. Other violations cited in this warning letter include: * Not verifying a raw material supplier’s Certificate of Analysis (COA). Depending on the supplier’s Certificate of Analysis (COA), without validating the results with a third-party lab landed this company a 483. The FDA requires that manufacturers verify COAs, including microbial and heavy metals. From Warning Letter: “you have never conducted heavy metal and microbiological tests to confirm results provided by the supplier’s COA.” * Incomplete Master Manufacturing Records (MMR). From Warning Letter: “A description of the packaging and a representative label.” GMPs work backward from the label to ensure there is a 100% label claim at expiration. From Warning Letter: “Written instructions, including specific actions necessary to perform and verify points, steps or stages in the manufacturing process where control is necessary.” The MMR is essentially an easily replicated recipe that includes what goes into the blend, how to verify the numbers are correct, and the instructions for mixing and testing. Here is a very detailed WLW post about GMP violations and best practices. 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 old social posts < Back Social Media Disease Claims Earn Warning Letter Review old social posts Claims on social media can tip the scale to a warning letter. This warning letter is interesting. It includes topical products marketed as drugs, animal “drug” claims, and more, but today, I will be focusing on the social media claims. Please also forgive the brevity of this Warning Letter Wednesday as I am on a road trip visiting graduate schools with my daughter. FDA looks at the 10,000-foot view of a company’s online persona. One claim in isolation is probably not enough to trigger a warning letter unless it is very egregious (e.g., COVID). The agency chooses claims from all marketing, such as socials, websites, and YouTube, and pieces them together for one big picture of non-compliance. Most of the highest-risk claims in this warning letter are on social media. From warning letter. “On your Facebook account. June 27, 2022: • Under the heading “Benefits of Spirulina” [an ingredient in Fulvic Green]: − “[C]an reduce risk of cancer.” This shows how discussing ingredient benefits is a marketing claim. Since the post cited in the warning letter is almost two years old, it shows that even old social posts are active marketing in the eyes of FDA. The moral here is to review your old social post to ensure no “forgotten” high-risk disease claims are there. From warning letter. “On your Facebook account post, dated June 20, 2022:CAN PREVENT SEI-ZURES…used in traditional ayurvedic medi-cines as a cure for sei-zures and convulsions.” Discussing traditional use claims in this content is a disease claim and is therefore considered labeling. 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!

Review of NAD case < Back Finished Product: Clinical Study Required Review of NAD case Are clinical studies really needed on finished dietary supplements? Here, I review a recent National Advertising Division (NAD) case on the topic. Full disclosure: I like NAD, and their cases are a wealth of learning opportunities, but the interesting and somewhat mind-boggling portion of this case has to do with performance claims. Based on the information provided, it seems that NAD requires a finished product study to substantiate the “helps maintain healthy eyesight and visual performance” statement. 🔹 NAD states this is “because the studies and meta-analysis relied on by the advertiser were not conducted on the (product).” 🔹 NAD goes on to say, “NAD recommended the claim be discontinued but noted that nothing in its decision prevents (product) from tailoring its claims to the benefits specific ingredients in (product).” A takeaway here is attributing substantiated structure-function claims to ingredients like “vitamin C for skin health” rather than simply stating the product is used for skin health is a risk-lowering strategy. I still feel like I am missing something here because I can’t imagine agencies or courts requiring finished product studies for low-risk structure-function claims that do not state the product is clinically proven. I write more about these important points from the FTC’s Notice of Penalty Offence letters here . There’s more to this case , including bioavailability claims, and I suggest everyone read it. Please let me know 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!

All social media is “fair game” for enforcement < Back LinkedIn Posts Mentioned in Warning Letter All social media is “fair game” for enforcement It is no surprise that company social media posts are considered marketing claims, as they are commonly mentioned in warning letters. Interestingly, this letter references posts made on LinkedIn. This is a new aspect of enforcement, as previously, I have only seen claims made on a company's LinkedIn page mentioned in warning letters. I find it interesting the FDA is looking at actual posts on LinkedIn, which is an important reminder that all marketing must be compliant and is "fair game" for regulatory scrutiny. This warning letter is Covid-related, which, of course, is a very high risk; however, it is a reminder that hashtags and reposting content elevate risk. In this example, a "Covid study" is shared, and the material connection is solidified with a covid hashtag and a hashtag containing the product's name. From Warning Letter "More evidence that respiratory diseases should be treated in the nose and throat! .... # biovanta # science # covid" [from a post on your social media webpage at...." Read the full warning letter here. This joint FDA and FTC warning letter includes an FTC cease and desist prohibiting the company from making future Covid claims. This sets the FTC up to potentially impose financial penalties and has more "teeth" than a standard 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!

Well intentioned marketing claims can turn products into high-risk regulatory categories < Back Goat Milk Company Infant Formula Claims Well intentioned marketing claims can turn products into high-risk regulatory categories This goat milk supplement and food company was cited for claiming its goat milk product is an alternative to infant formula. This is a great example of how well-intentioned marketing statements can cross the line into a risky regulatory category. Let’s explore what went wrong. FDA looked at this company’s website and social media and determined their Goat Milk Formula Recipe Kit met the definition of infant formula because it was “purported to be or was represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.” Essentially, this means the company was promoting their product as infant formula. Here are some of FDA’s warning letter references. "We have created a formula recipe that mimics breast milk and follows the guidelines created by the 1980 Infant Formula Act.” Your February 12, 2024 (Facebook) post: “‘Infant formula is the number one regulated food in the U.S., and yet the allowable ingredients in off-the-shelf infant formula is often times very very poor. So there is a very good incentive to make your own formula.’ Get to know the creator, Joe Stout, and learn about the Goat Milk Formula Recipe on the GMF Livestream replay! . . . #DIYBabyFormula . . .” I ran Apex Compliance on their website and found A LOT of very high-risk marketing claims, and I suggest this company look at conducting a compliance audit. Apex Compliance was developed for this type of situation, sifting through large amounts of information and providing a line-by-line playbook showing where risky phrases occur, their risk rating, and some possible lower-risk alternatives. Learn more here . To give the company credit, they seemed to go above and beyond to correct the matter once FDA brought this to their attention. It seems that even though they worked diligently to correct their mistake, FDA issued the warning letter to “ensure the violation does not recur.” Infants are classified as a “vulnerable population,” and this warning letter language demonstrates how seriously FDA takes the infant formula category. From warning letter. “We acknowledge that after a teleconference with you on May 7, 2024, you voluntarily recalled all Goat Milk Formula Recipe Kit ... We are aware that you contacted all customers who received product during that timeframe to inform them that the product should not be used as an infant formula. Additionally, you issued a press release on May 10, 2024, clarifying to the general public that you do not recommend using this product for infants from 0-12 months of age. We also acknowledge that you removed the ability to purchase the Goat Milk Formula Recipe Kit from your website, and that you made some changes to your website and social media websites, including but not limited to removing the above-mentioned statements regarding use as an infant formula. However, due to the serious public health concerns related to your unlawful marketing of a new infant formula, it is essential that this violation does not recur.” Read the full warning letter here . DATE ORIGINALLY POSTED: 10/9/24 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!

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!

Formats that are favorable to children should be avoided < Back Another Delta 8 Warning Letter Formats that are favorable to children should be avoided This is the tenth FDA delta 8 warning letter this year, which is an important reminder that delta 8 THC is still on FDA’s mind, especially when it’s sold in formats that are favorable to children, like candy ropes. Distributors are responsible: This website distributes products from several different companies, demonstrating that even companies that sell other’s products are responsible. I think of this as a mini-Amazon, and I expect more distributors selling high-risk items to be called out in the near future. Favorable to children: FDA takes dangerous products in forms that appeal to children very seriously. Products such as delta 8 infused snacks with names like “Not Ya Son’s Weed Bakedies Delta 8 THC 600MG Crispy Bites” were cited in this letter. The takeaway here is that companies selling delta 8 are a high risk for FDA enforcement, especially if they sell products in forms favorable to children, such as candy. Past delta 8 warning letters were jointly issued by FTC and FDA, which usually come with more “teeth,” such as a cease and desist. This company was “lucky” this is “only” an FDA warning letter. Since there are no marketing claims cited in this and many previous letters, you may be asking what the FTC has to do with this. Interestingly, marketing unsafe products, especially to children, is considered deceptive marketing. Go FTC! From the previous warning letter. “Section 5 of the FTC Act prohibits unfair or deceptive acts or practices in or affecting commerce. This prohibition includes practices that present unwarranted health or safety risks….. preventing practices that present unwarranted health and safety risks, particularly to children, is one of the Commission’s highest priorities.” Also, I ran Apex Compliance on the company’s website and found a motherlode of high-risk claims such as cancer and opioid support statements. I wonder why FDA did not cite these. I’d love to show you what Apex Compliance finds on your site. Schedule a demo . I write more about FDA’s position on delta 8 and the previous warning letters here . 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!

Printed catalogs must be compliant < Back Product Names Are Marketing Claims Printed catalogs must be compliant This warning letter involves claims made in catalogs and product labels collected during a GMP inspection. Over 500 supplement executives and regulatory professionals receive Warning Letter Wednesday by email. 👉Sign up here . Everything the FDA investigator sees is “fair game.” Sometimes they gather non-compliant literature, and the company never hears from FDA, but in cases of extreme claims and GMP violations, this often turns into a 483 or a warning letter. In this brief video , learn about the difference between a 483 and a warning letter. There are a lot of non-compliant product names cited in this warning letter. Yes, product names are marketing and, therefore, must be compliant. Here are some particularly over-the-top examples. 👉From warning letter. “Children’s Antibiotic Formula … product name implies the product is intended to cure, mitigate, or treat bacterial infections.” 👉From warning letter. “Hepatitis C Formula Glycerite” and “Children’s Antiviral Formula.” A key learning point is anything can be collected and reviewed. This includes box stuffer promotional materials and printed catalogs. I remember during an inspection; we had haphazardly left old non-compliant product brochures lying around our shipping room. We were not using them anymore, but if the investigator had seen them, it could have led to a warning letter. I carry this lesson with me forever. Even claims which are not considered high-risk are cited in this letter. Here is an example from the company’s product catalog. 👉From warning letter “Product catalog: “A blend of herbs with antimicrobial, anti-inflammatory…actions….” There are also some glaring 483 citations that the company appeared not to address. This includes the "greatest hits" such as not setting specifications. I review GMP violations in previous Warning Letter Wednesday's . Read the 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!