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Small issues signify deeper noncompliance < Back GMP Labeling Lessons Small issues signify deeper noncompliance Dietary supplement labeling can be confusing, but ensuring that the "small things" like line thickness are compliant is important. When FDA looks at a label that is not quite right, it can signify greater compliance concerns and trigger them to look deeper, as the adage "Where there's smoke, there's fire" is often true. Let's look at this warning letter to see what we can learn. 🔹Address or phone number: This is an important part of GMPs and safety and is considered a major violation if missing. This is how consumers report adverse events to the company, which can help the company identify quality issues and, if necessary, serious adverse events that must be reported to the FDA. Learn more here . Also, if the company named is not the manufacturer, the label must clearly disclose this fact using a statement like "Manufactured for" or "Distributed by." 👉From warning letter: "The labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1] may receive a report of a serious adverse event with such dietary supplement." 🔹The correct order of ingredients is important. Learn more here . 🔹"Supplement Facts" should be set at full width of the nutrition label, in accordance with 21 CFR 101.36(b)(1)(i) 🔹The correct nomenclature should be used for items with a percent daily value. 👉From warning letter. "The source ingredient that supplies a dietary ingredient may be identified within the nutrition label in parentheses immediately following or indented beneath the name of a dietary ingredient and preceded by the words "as" or "from", e.g., "Calcium (as calcium pyruvate)". When a source ingredient is not identified within the nutrition label, it shall be listed in an ingredient statement." 🔹Formatting is important. 👉From warning letter. "The Supplement Facts label format requirements including the use of bolded text, hairlines, and/or light and heavy bars are not in accordance with 21 CFR 101.36(e)." 👉From warning letter. "The statement "**Daily Value not Established" must be within the Supplements Facts label." 🔹Common ingredient name must be listed. 👉From warning letter. ""Aquamin™" is not the common or usual name for Lithothamnion spp." There are lots of GMP violations in this letter, which is likely the primary reason for this letter. Read the full warning letter here . DATE ORIGINALLY POSTED: 2/5/25 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!

Find high-risk words lurking in old blogs, testimonials, and socials < Back FDA & FTC Crackdown on Products Marketed For Opioid Withdrawal Find high-risk words lurking in old blogs, testimonials, and socials FDA and FTC crackdown on products marketed for opioid withdrawal. The FDA and FTC recently sent five joint warning letters to companies marketing products for opioid withdrawal. Joint FDA/FTC warning letters are rare and a good signal for the industry to pay attention. These are not just warning letters but also 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. This is very serious! Here are some key takeaways. 🔷Products marketed for opioid and substance withdrawals remain high risk. 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. This is not a new trend, as opioid-related warning letters go back several years. Now is a great time to ensure these high-risk statements are not inadvertently lurking on a company website or social. The FDA is looking at several-year-old blogs and social media posts in the same manner as current ones. I developed a program to find any website keyword. Please get in touch with me for a free keyword compliance check. 🔷Other high-risk words such as depression and diabetes are mentioned in some of the letters. This should come as no surprise. Here is my blog from last year about depression claims . Here is my post about blood sugar claims enforcement . 🔷Claims made in blogs are prevalent in these letters. Here are my “best practices for reducing risks in blogs” post. 🔷Product reviews are also called out. From a warning letter: “From a review on your webpage …“Its [sic] been great to give up the opioids and feel good.” Four of the warning letters are directed toward kratom companies, and one is to an essential oil company. It is interesting to see what keywords and themes are common in these letters. Contact me for a deeper discussion on this. From a warning letter: “EUCALYPTUS OIL . . . The oil produces a stimulating effect on the body and mind. This aids in reducing the lethargy that may be experienced during opiate withdrawal.” Read the FDA roundup about this 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!

There are no FDA approved supplement facilities or supplement products < Back Supplement company’s brochures and online marketing lead to a warning letter There are no FDA approved supplement facilities or supplement products The FDA inspected a facility, then six months later they reviewed the company website. This is a continuing trend and a reminder to screen for disease words online, especially after a GMP inspection. Here the FDA refers to a product brochure as labeling. This is an important reminder that all marketing is an extension of the label. Here is a video about this. From warning letter: “On your product labeling (brochure) for “Kidz DHA,” which directs consumers to your website …. where the product is available for purchase: “DHA supplements are purported to treat certain health problems in children, such as allergies, asthma, and attention deficit-hyperactivity disorder (ADHD).” Several other disease words are mentioned in this letter, such as anti-bacterial and anti-inflammatory. As a rule, words containing “anti” should be avoided. The one exception here is antioxidant. Also interesting in this letter is the mention by FDA that they do not approve facilities or supplement products. If a company claims to have FDA approval of their supplements, this is a marker they do not understand the basics of dietary supplement regulations. From warning letter: "We note that your website includes the statement that …. are made . . . in an FDA approved facility.” Although certain facilities must register with FDA, FDA does not approve facilities. Read 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!

Replace high-risk words on a commercial website < Back Discussing ingredient benefits is a marketing claim Replace high-risk words on a commercial website #WarningLetterWednesday Discussing ingredient benefits on a commercial website can easily cross into product disease claims. This is a common marketing mistake, and I suggest fighting the urge to explain ingredient benefits with high-risk language. 👉Here is a video about replacing high-risk words with lower-risk alternatives. ➡️From warning letter: Persimmon leaves have anti-hypertensive, anti-carcinogenic, and anti-mutagen properties." 👉These are common "claims" mistakes. Here is a video about tips for knowing if a claim is being made. 🔷Read my post about ingredient benefits from a few months ago here : ➡️From warning letter: "Chamomile's mildly sedating and muscle-relaxing effects can help those who suffer from insomnia . . . ." 👉Insomnia claims are high risk. I write about this here . 🔷This warning letter is interesting as there was first an in-person inspection in August 2021, then the FDA reviewed the company's website in November 2021 and recently in February 2022. This is a good reminder for companies to clean up their websites before/during/after GMP inspections, as it seems a few website edits could have prevented this letter. Citing studies can be looked as product marketing claims. ➡️From warning letter: Examples of some of the claims on your website's "TEA AND CANCER PREVENTION – NATIONAL CANCER INSTITUTE" page that provide evidence that your product is intended for use as a drug include: "More than 50 epidemiologic studies of the association between tea consumption and cancer risk have been published since 2006..... 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!

Remove high-risk claims in all marketing materials < Back Product catalogs are considered extensions of the label Remove high-risk claims in all marketing materials #WarningLetterWednesday Claims made in product catalogs are considered marketing. This warning letter includes claims made on product labels, catalogs, newsletters, and brochures. This is a good reminder that anything used to sell a product is considered an extension of the label and, therefore, should be compliant. Here is a video about this . 🔷This timeline is interesting here. The company was inspected in June 2021, before, during, and after a recall for undeclared soy allergens. FDA then reviewed this company's website in February 2022, which is the basis for most of the items in this warning letter. This is a trend, as last week's WLW also talks about an FDA inspection that leads to a website review and a warning letter . 👉This is a good reminder for companies to clean up their websites before/during/after GMP inspections, as a complete website compliance clean-up may have prevented this letter. From the warning letter. ➡️From the product catalog on your website, On page 13: “Enzymes Plus: … This formula uses specialized enzymes that helps the body break down excess protein on scar tissue and fibrin in the blood vessels and internal organs. It also seems to help remove the protective protein coating on tumors, cancers, and parasites, helping the body render viruses and bacteria inert. This blend is combined with Magnesium (a natural blood thinner) and B-6 that the body uses to help lower Blood Pressure and dissolve blood clots.” 👉Read the full warning letter here . 👉👉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!

Discussing ingredient benefits is marketing < Back Website “About Us” Claims Cited in Warning Letter Discussing ingredient benefits is marketing This warning letter cites claims made in the “About Us” section of the company’s website. Usually, when “About Us” claims are mentioned in warning letters, there is some hyperlinking to a shopping cart, but this letter mentions CBD and high-risk disease words such as Dravet Syndrome without any clear linking. The lesson here is simply talking about an ingredient can lead to a warning letter if that ingredient is sold on the website. From warning letter. “On your “About Us” webpage…CBD is FDA approved to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and Tuberous Sclerosis Complex.” This is the 34th CBD-related warning letter this year, up from just seven in 2021. This year certainly has been the year of the CBD warning letter, and I expect many more in 2023, including a crackdown on delta-8 and other isomer products. This company cited in this letter also sells fruits, such as mango and pineapple, that were apparently sprayed with CBD. FDA has been cracking down on CBD in food due to being favorable to children and the possibility of creating a safety concern. Read more about this here . This CBD fruit citation is another example that the days of “putting CBD in everything" are gone. Hashtags also play a prominent role in this warning letter. One post lists # anxiety and # depression. Over 30% of this year’s CBD warning letters mention the one-two punch of anxiety and depression. This post includes these two words together in hashtags is an excellent example of what not to do. From warning letter. “…promising results regarding #cannibidiols [sic] potential to assist with cognitive illnesses, including #anxiety and #depression.” 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!

Ensure ingredients are GRAS for the marketed population < Back Printed Brochures Are Labeling Ensure ingredients are GRAS for the marketed population FDA has been paying close attention to probiotic products marketed to preterm infants recently, and this letter shows the continuing trend. There are ~100 searchable Warning Letter Wednesday posts here! You can search old posts for keywords. I've developed this as a resource for your regulatory, marketing, and executive teams. You can also sign up there to have Warning Letter Wednesday delivered to your inbox. 🔷An interesting part of this warning letter is that printed brochures are cited. Of course, all marketing is an extension of the label, but in this digital era, this is rare. FDA references claims made in a printed brochure that was given to hospital staff. Other than tradeshows and items gathered during GMP inspections, I can’t remember seeing printed brochures cited in the recent past. The lesson here is that even printed literature can elevate the risk of a warning letter. 👉From warning letter. Your “Probiotics and Preterm Infants: Clinical Evidence” handout provided by your sales representative to hospital staff has a section with the heading “Probiotics in the NICU: Clinical Evidence” that states, “Probiotics have shown to significantly improve outcomes” for “All-cause mortality,” “Necrotizing enterocolitis (NEC),” “Late-onset sepsis,” and “Feeding tolerance,” and that represents “Benefits of probiotics on NEC,” as “significantly reduc[ing] incidence of NEC in clinical studies.” The other marketing handout with the heading “The Promise of Similac Another Innovation Only From Similac” states that Similac® Probiotic Supplement undergoes safety testing to “ensure the probiotic is ready for hospital use” 🔷FDA took issue with a few of the probiotic ingredients in the product. For example, this probiotic is considered a new dietary ingredient (NDI), and the FDA states there is insufficient safety data to back up its use in preterm infants. According to a well-known supplier’s website, this ingredient is GRAS, but I wonder if the safety data applies to preterm infants. If the product was not marketed to preterm infants, it probably wouldn’t have been mentioned in this letter, in my humble opinion. 👉 From warning letter. “S. thermophilus (TH-4®), a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury, when used in preterm infants.” 🔷There is a lot more to this warning letter, such as FDA’s comments regarding the safety of B. infantis in preterm infants. Please share your thoughts on this. Here’s the FDA press announcement . Read the full 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!

Learn from other’s mistakes < Back Warning Letter Marketing Lessons Learn from other’s mistakes We can learn from others' mistakes, and this warning letter outlines what to avoid when marketing herbal supplements. This company was inspected by FDA and received some 483s, but today, I am going to focus on the website disease claims cited in the letter. From warning letter. "It's known to help reduce anxiety …." Asa comments: Suggestive words like "may" and "known to" do not allow us to make disease claims. If accurate, perhaps writing "occasional anxiety" would be lower risk, as this phrase likely represents normal life events and is not related to a disease I write about this here. https://www.asawaldstein.com/warning-letter-wednesday/anxiety-claims-enforcement-review From warning letter. "It's often used as a folk remedy for…the common cold and flu … helping allergies and sinus infections, treating diarrhea …." Asa Comments: Calling something a folk remedy or citing traditional use does not allow us to make strong disease claims like this. From warning letter. "From the list of hyperlinked "Tags" on the product page: "anxiety" "depression" Asa Comments: Product tags and meta tags are considered marketing. From warning letter. "Various studies have shown that it can be effective as a natural remedy for preventing and treating colds and flu …" Asa Comments: Citing studies and discussing clinical research is marketing, and it can also trigger plaintiff lawsuits, who love bringing action against companies making "clinically proven" claims. This is especially true for on-pack (on-the-label) statements. From warning letter. "The lions mane mushroom contains a variety of compounds… [that] have anti-inflammatory, anti-cancer…properties." Asa Comments: Discussing ingredient benefits on a website is a marketing claim, even if there is no hyperlinking to a shopping cart. This is a very common mistake that continues to be cited in warning letters. Okay, so I ran Apex Compliance™ on their website and was hoping that all disease claims were cleaned up. Unfortunately, I was WAY WRONG, as the site is still riddled with high-risk words like "cancer." Learn more about this award-winning compliance software, Apex Compliance ™. Can we envision a day when FDA requires companies who receive warning letters to go through some type of training? Is this a good idea or a terrible one? I suggest everyone read the full warning letter as a way to demonstrate what not to do. 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!

Informational blogs on a commercial website are considered “labeling” < Back Learning targets: Blogs, risky words, testimonials, ingredient benefits Informational blogs on a commercial website are considered “labeling” Today's #WarningLetterWednesday is an important reminder that blogs, testimonials, and discussing ingredient benefits can easily cross the line into claims, especially when filled with high-risk buzzwords! 🔷The FDA and FTC look for a material connection. The material connection was evident in this warning letter, as there's a hyperlink (Call To Action) to a shopping cart, as noted here. ➡️From warning letter: On the "Prevent MRSA Infection" blog post ... which hyperlinks to the product webpage for B Complex. 🔷I discuss best practices for reducing risks on blogs here . 👓 🔷Ingredient descriptions on a commercial website may be implied product claims. I discuss this here . 🔷A good strategy is to ensure ingredient education is free of high-risk "buzzwords" or disease claims. Some examples are anti-inflammatory, insomnia, or anything ending in "itis" (arthritis). Here is a WLW post and video about this from a few months back. 🔷Product testimonials can be marketing claims, especially as they're highlighted in this company's "Customer Stories" section. ➡️From warning letter: "'I have been taking CellRenew since May of 2003. . . . This product has kept my arthritis at bay. . . .'" This company talks about viruses that are top of mind for the FDA, and I am unsurprised by this warning letter. Good job, Denver office! We've seen the Denver office focus on claims made in blogs before, a cautionary tale for companies in their district. Read the full warning letter here . Follow 👉My Warning Letter Wednesday LinkedIn Group for early WLW access. 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!

Plan for FDA inspections by addressing common violations < Back GMP inspection leads to a warning letter for disease claims and GMP violations Plan for FDA inspections by addressing common violations GMP inspection leads to a warning letter for disease claims and GMP violations. #WarningLetterWednesday In this letter, common GMP violations such as setting specifications and the company’s inadequate 483 responses led to the warning letter. Most 483s can be addressed before they become a warning letter. Here’s a recent “GMP Violations & Unanswered 483s Lead to a Warning Letter” post and video about this. I wrote this very detailed post about GMP pitfalls as a training tool, and I hope you enjoy it. Learn about the differences between 483s and warning letters here . Disease claims from the product label and website are mentioned in this letter. From FDA warning letter. “On your product label: “Take if suffering from glaucoma or ocular hypertension.” This falls under the “treatment” part of diseases. Remember the DSHEA disclaimer “not intended to diagnose, treat, cure, or prevent disease.” From FDA warning letter. “Alereve was developed to better treat patients’ ocular allergies without exacerbating their dry eye component in fact, our initial study demonstrated that some patient’s Dry Eye Syndrome was significantly improved with Alereve treatment” In my opinion, this is added as a “pigpile” or” secondary claim” and would not attract a warning letter unless higher risk claims are present. The best way to avoid a warning letter is to remove claims made web and on social media, including blogs and old social media posts ! 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!

Blogs on a commercial website are marketing claims < Back CBD Company Cited For Claims Made in Blogs and Socials Blogs on a commercial website are marketing claims This CBD #WarningLetterWednesday is a great teaching case as it cites many of the common mistakes we talk about each week. Here is what we can learn: Blogs on a commercial website are marketing claims. CBD is not allowed in OTC topicals. Hashtags, ingredient benefits, and product tags appear in more warning letters. Most of the cited claims in this warning letter are from blogs and social media. Here's one of several examples. From Warning Letter: "On the Blog post, "How to Use CBD to Combat Holiday Stress":.. "Reduced Anxiety and Depression" Blogs on a commercial website are "fair game" for enforcement and a key lesson from this WL. I write about best practices for blogs here. http://ow.ly/KMo250IYL43 High-risk words never belong on a commercial website, especially the "anxiety and depression" one-two punch. Here's my video about this. http://ow.ly/tuI350IYL48 From Warning Letter: "Although CBD is listed as an inactive ingredient in the labels of your .... "1000 mg Pain Relief Cream" products, the product labeling clearly represents CBD as an active ingredient" This product is labeled with drug facts and lists CBD as an inactive ingredient, but the label boldly lists "1000mg CBD". From Warning Letter: … "Even if CBD could be considered an inactive ingredient in your .... "1000 mg Pain Relief Cream" products, these products would still need an approved drug application to be legally marketed" The FDA's position is that CBD is not a suitable active or inactive ingredient in OTC topical drugs. Please read my article about this. http://ow.ly/N8rq50IYL3X From Warning Letter: "On your January 6, 2021 Instagram…"# CBDforArthritis # Anxiety” Hashtags are an enforcement trend to watch . Here's a video about this. From Warning Letter: “product_tag-dog-cancer-cbd” Product tags are mentioned in this warning letter . I wrote about this last week. From Warning Letter: "Orange Essential Oil [an ingredient in CBD Super Cider] may naturally relieve anxiety, . . . depression and inflammation of the body." Discussing ingredient benefits on a commercial website is a high risk . There's much more to talk about in this letter that I do not have room for. Read 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!

Batch records should be complete < Back Improper Written Specifications Lead To Warning Letter Batch records should be complete This warning letter is interesting as it details some of FDA's thinking on test methods. Upon my initial reading of this letter, it seemed like FDA had an issue with HPTLC, but the problem was actually how the specification was written. HPTLC is mentioned in this letter. Here FDA states that HPTLC is not a parameter that can be tested to. More information is needed, such as the plant’s genus, species, and the plant part. From warning letter. “HPTLC” is not a qualitative or quantitative parameter to which a test result can be compared to verify the identity of the component.” Thanks to my friends at Alkemist Labs for talking this through with me. Your expertise is very appreciated! This is a shortened version of Warning Letter Wednesday as I’m currently attending Supplyside West. If you are here and want to discuss consulting or Apex Compliance™ Compliance, let me know. There are also other GMP violations in the letter, such as incomplete batch records. This example FDA cites the company for not having cleaning records. When I was a manufacturer, we would attach cleaning records to each batch record. As FDA notes below, this is not needed, but cross-referencing this information is required. 👉 From warning letter. “Your batch production record fails to include the date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch or a cross-reference to records, such as individual equipment logs, where this information is retained.” I recommend reading the full warning letter , as there are other labeling and testing citations that provide good learning opportunities. 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!