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Websites are considered “labeling” < Back OTC Drug Website Claims Websites are considered “labeling” I am far from an expert in OTC products, but this warning letter also includes herbal extracts, which I find interesting. OTC drugs follow strict monographs that describe the type of claims that can be made and the active ingredient recipe that must be followed. 🔷Here is the active ingredient definition from FDA, which essentially means that inactive ingredients cannot have a therapeutic effect: “Active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans.” 🔷 Website claims: This company added herbs as inactive ingredients but makes disease claims about them on their website. Aside from the directions, much of the actual label seems to be compliant, but statements made on websites are still considered labeling in the eyes of the FDA. This is a great example of how marketing statements can elevate the risk of scrutiny. Using software like my compliance program, Apex Compliance™ , can help prevent companies from receiving these preventable actions. 👉 From warning letter. “Hops adds a bitter flavor and is a stability agent. In herbal medicine, this plant is known to benefit conditions such as anxiety and insomnia…Passion Flower Is a climbing vine with beautiful flowers, and is recommended as a sedative and antispasmodic agent.” 🔷FDA also references that if the product is used as directed, it exceeds the maximum suggested daily amount in the OTC monograph. I am far from a safety expert, but this probably pushed FDA to issue the warning letter. 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!

Only use permitted dietary ingredients or face regulatory issues < Back Unauthorized NDI Leads To Warning Letter Only use permitted dietary ingredients or face regulatory issues Warm greetings from 35,000 feet, as I am flying back from a 3-day whirlwind trip to participate in the Vitafoods Startup Award finals in Geneva. This company received a warning letter for using N-Methyltyramine, an unauthorized New Dietary Ingredient (NDI), in its products. This shows that FDA is getting serious about enforcing the unauthorized NDI requirement. FDA has sent warning letters for Hordenine (a similar molecule to N-Methyltyramine) in the past, but using these types of ingredients typically isn’t enough to attract a letter unless disease claims or GMP violations are present. In this instance, there were no disease claims or GMP violations present which should give companies pause before using certain NDI ingredients. Read this WLW post about hordenine warning letters. I predict this may be paving the way for more CBD and kratom letters, even if there are no disease claims present. A similar ingredient to N-Methyltyramine is listed in FDA’s Information on Select Dietary Supplement Ingredients and Other Substances document . This includes some “off limits” products such as DMAA but also includes commonly used dietary ingredients like biotin. I would like to see this list clarified to show what FDA considers lawful dietary ingredients, unauthorized new dietary ingredients, and unallowed ingredients such as DMAA. Read the 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 COVID claims including on YouTube < Back The First 2023 Warning Letter Belongs to a CBD Company Remove COVID claims including on YouTube The first "supplement" warning letter of 2023 belongs to a CBD company. 2022 was the year of the CBD warning letter, and FDA enforcement in this area appears to be continuing. This warning letter is another reminder that no company is "too small to be off FDA's radar." A video cited in this letter only had 19 views at the time I wrote this post! This is the most unpopular video I have ever seen cited in a warning letter demonstrating that any online marketing is fair game for enforcement. I write more about this here . This company was marketing a cannabinoid product for COVID protection on its website, socials, and YouTube. There were several similar warning letters last year involving companies citing research about cannabinoids and COVID. I usually take a "maybe they didn't know any better” attitude when looking at enforcement and compliance, but in this case, the company should have known better because of the well-publicized action against other CBD companies for this same type of statements. Here are some critical posts about CBD enforcement in 2022. CBD enforcement is top of mind for FDA. This includes animal warning letters . CBD and anxiety claims . Citing clinical studies . Natural Products Insider Q4 Update . This letter mentions several claims made in YouTube videos. Last year nine warning letters cited claims made on YouTube, and I expect this enforcement trend to continue. I write more about this here . This letter cites claims made on the company's social media from early in the pandemic. As we've discussed many times on Warning Letter Wednesday several times before, companies are responsible for all social media posts, even if they are several years old. From warning letter. "COVID prevention with CBD? Canada study shows it's possible. Might be time to start a daily dose of…… all-natural pharmaceutical grade CBD products…. USE CODE: COV19" [from a May 15, 2020, post on your Facebook social media webpage" This letter also cites the product code "COV19" which is a bold claim and further shows the intended marketing use of the product. This is a reminder that items like meta tags, product tags, search tags, and coupon codes are considered marketing. This is a joint FDA and FTC warning letter, which is common when COVID claims are cited. This is serious, and it also involves a cease and desist barring the company from making COVID-related claims or face injunction, a civil penalty of up to $46,517 per violation requirements to refund customers. 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!

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!

Advisory labeling is not a replacement for allergen control program < Back Undeclared Allergens Lead To Recalls Advisory labeling is not a replacement for allergen control program Is major allergen labeling complicated? The answer is maybe sometimes, but it doesn’t have to be. Here, I review recent allergen labeling-related recalls and provide some helpful resource links. It seems like recall alerts for undeclared allergens happen every week, but even though recalls for undeclared allergens are common, allergen-related warning letters are uncommon, which makes this week’s Warning Letter Wednesday interesting (to me at least). One company has had four recalls related to undeclared major allergens since 2019, and here’s how the recent mix-up happened. This is, unfortunately, a common mistake and is the reason why GMPs and process control exist. · From warning letter. “You indicated that you were scheduled to run “Hamburger Cheeseburger Macaroni Skillet Meal”; however, the line supplier mistakenly brought the incorrect cartons to the production line, and the lab tech failed to verify that the correct cartons were used.” Read this warning letter here . Another company received a warning letter because of an inadequate FDA communications request response. They are also a conventional food company that had an undeclared allergen recall, which was apparently due to a formulation change without changing the label. The purpose of Warning Letter Wednesday is to educate, and this is a perfect example of a half-hearted response and no follow-through that led to an avoidable warning letter. Yikes! · From warning letter. “Your proposed action to prevent reoccurrence indicated that there would be no formulation changes without the signatures of the buyers and the owners.” ….” FDA sent you an email giving you an opportunity to provide FDA additional corrective actions to address the root cause of the undeclared major food allergen involved in your recall; however, you did not respond.” Read this warning letter here . Here are FDA’s comments on major allergen disclosure (from warning letters). The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act [21 USC § 343(w)(1)(A)]; or The common or usual name of the major food allergen in the list of ingredients is followed in parenthesis by the name of the food source from which the major food allergen is derived (e.g., “Whey (Milk)”), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 USC § 343(w)(1)(B)].” So how about allergen advisory statements like “This product was manufactured in a facility that handles peanuts, soy, and milk?” According to this FDA guidance document, “Advisory labeling, such as “may contain [allergen],” is not a substitute for adherence to current good manufacturing practices and, when used by a facility, food allergen preventive controls.” Read this FDA’s “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry” document here . Here’s how you sign up for FDA recall alerts . 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!