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Use caution copy & pasting “ingredient benefits” onto commercial website < Back Learning targets: Children, risky words, intranasal, ingredient benefits Use caution copy & pasting “ingredient benefits” onto commercial website #WarningLetterWednesday is a cautionary tale for companies new to the space that are looking to market products. This company looks like a groovy crystal shop that started making topical products and products delivered to the eyes and nose. So what can we learn? 🔷Of course, there are high risks words referenced in the warning letter, Notably, the use of viruses, cancer, and so many more! 🔷Products delivered through the nose (intranasal) or as an eye drop are drugs and have a justifiable higher level of scrutiny. 🔷Products marketed for use by children are high-risk. 🔷This warning letter is a good teaching tool. Copying and pasting a product's "therapeutic uses" from a textbook or website is a great way to get into trouble. This appears to be the case here. ➡️From warning letter Colloidal silver is used to treat infections due to yeast; bacteria (tuberculosis, Lyme disease, bubonic plague, pneumonia, leprosy, gonorrhea, syphilis, scarlet fever, stomach ulcers, cholera); parasites (ringworm, malaria); and viruses (HIV/AIDS, pneumonia, herpes, shingles, warts). 🔷I understand these are obvious high-risk claims, but in some ways, this could have happened to any entrepreneur that doesn't understand the rules of marketing products. I have seen this happen several times with practitioners, herbalists, and even doctors that "cross the line" into marketing claims by using common therapeutic language such as anti-inflammatory and even "clears heat and resolves toxins." We talk about this here . ➡️From warning letter .... to heal skin irritations and scarring. 🔷Interestingly, there are a couple of references to helping skin irritations and scarring. I do not consider these to be high risk. They are likely a "pig pile" or a common secondary claim in warning letters. What are your thoughts on the risk level here? Read warning letter here . 👉In closing, I think the FDA would have left this company alone if there were not talking about viruses, selling products that go into the nose and eyes, are marketed as safe for children, and had just too many disease words to be avoided. I started a LinkedIn group just for warning letter discussion. Join 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!

Ensure weight loss products are tested for drugs < Back Weight Loss Claims Trigger FDA Product Testing Ensure weight loss products are tested for drugs This company was making weight loss claims, leading to FDA purchasing and testing their product. Sibutramine was found, but surprisingly, the company is still selling the product. I find this confusing and look to FDA to help remove these dangerous products from the market. Sign up and search all old Warning Letter Wednesday posts here. 🔷FDA reviewed the company’s website last December, and sometime after that, purchased and tested a product, which ended up containing the drug sibutramine. On February 8th of this year, FDA issued a public notification that this product contained a hidden drug ingredient. 🔹According to the warning letter, the company refused to recall the product. After finding the drug-spiked ingredient and issuing the public notification, I find it strange that the company didn’t comply with this request. At this point, do you think the FDA could/should have elevated this to a seizure or injunction? I don’t believe many drug-spiked products are in the market, but when the FDA finds them, I would like them removed in haste. 🔷Aside from the presence of the drug-spiked ingredient FDA also cited several “disease-type” claims. The claims in this letter, such as “burns fat,” “weight loss,” and “Lose 20 pounds in 20 days,” are not normally seen in warning letters unless ingredients like sibutramine are mentioned. This leads me to think FDA is scanning for these trigger words before testing the ingredients. Also, statements like these are more common in FTC and plaintiff attorney complaints. FTC’s “gut check” document on weight loss claims is worth a read. 🔷This company is lucky FDA didn’t dig any deeper into its website. I ran Apex Compliance on their site and found numerous “Alzheimer’s” and “virus and flu infection” statements. 🔷The moral of the story here is that if you are selling weight loss (or sexual health) products, ensure you are testing for undisclosed drug-spiked ingredients. Amazon already requires an annual test for this, but testing each product lot is not a bad idea. 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!

Ensure GMPs are developed and followed. CBD is risky when added to OTC topicals. < Back Marketing CBD in OTC drugs is risky Ensure GMPs are developed and followed. CBD is risky when added to OTC topicals. #WarningLetterWednesday involves CBD in an OTC topical (hand sanitizer) and further defines FDA’s position regarding CBD as an active or inactive ingredient in OTC drugs. There are also numerous GMP violations that paint an overall picture of noncompliance. The references to CBD in this letter are worth reading. It is hard to defend adding CBD as an inactive ingredient if the amount of CBD is listed on the label or is marketed for CBD content. From warning letter: “Specifically, your product label for MEDICALLY MINDED 100% THC FREE Hand Sanitizer Gel prominently features on the Principal Display Panel (PDP) the statement, “200 MG CANNABINOIDS 100 MG CBD + 100MG CBG.” The product label also lists,.....a website that markets and sells CBD products for various therapeutic benefits. As noted above, CBD and CBG are not an active ingredient in any applicable final monograph”. Although is letter is only one of seven CBD-related warning letters in 2021 (down from 21 last year) it is essentially a teaching case about the importance of GMPs. The FDA sent two records requests which the company did not answer. Not answering these FDA requests is a prohibited act and is serious. The FDA then inspected the company and found serious violations including hand sanitizer that contained 0% ethanol and 58% methanol. This is dangerous! This then led to a national recall of the adulterated lot numbers of hand sanitizer. If the company had a proper Quality Management System (QMS) they would have responded to the FDA’s information request and may have prevented an inspection. They would have also identified the adulterated hand sanitizer before it shipped to the public and caused the subsequent recall. The company was issued a 483 which they didn’t respond to. Learn more about the differences between warning letters and 483’s here . Properly responding to a 483 is an important part of avoiding warning letters. Most 483’s can be addressed with the FDA before they are elevated into a warning letter. Learn more about reasons to avoid a warning letter here . The GMP violations include not setting specifications, quality not approving production procedures, and quality not controlling incoming components. Although these violations cite OTC drug manufacturing regulations, they are the basics all dietary supplement companies should be complying with. Not writing and following specifications is one of the most common supplement GMP citations. Read 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!

Ensure 483 responses are complete < Back Incomplete Batch Records & Ingredient Specifications Ensure 483 responses are complete This letter is a great reminder of the basics of Good Manufacturing Practices, starting with developing specifications to ensure the ingredients and products are correct and not contaminated with microbials or heavy metals. FDA inspected this company in January and February last year, and they provided 483 responses over the next couple of months. The findings during the inspection and the incomplete 483 responses led to this warning letter. Ingredient Heavy Metal Specifications: 🔹From warning letter. “You did not provide any heavy metal or microbial test specifications for your Acetyl-glutathione component.” Batch Production Record (BPR) Issues: 🔹From warning letter “A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing (21 CFR 111.260(f)).” 👉 Asa comments: This is important to identify whether ingredients were added correctly. For example, a lower-than-expected yield could signify missing ingredients or low capsule fill weight. 🔹From warning letter. “Documentation, at the date and time of performance, of labeling operations (21 CFR 111.260(k))” 👉 Asa comments: This is essential to verifying when processes were conducted, which can help identify issues before the product is released to the public. 🔹From warning letter. “An actual or representative label, or a cross-reference to the physical location of the actual or representative label used in production (21 CFR 111.260(k)(2))” 👉 Asa comments: Batch production records are recipes built in conjunction with the product label. Cross-referencing the label is a key part of ensuring the formula and label match. Master Manufacturing Record (MMR) Size: Each formula size should be its own MMR. 🔹From warning letter. “The MMR you provided in your April 8, 2024, response….not specific to a unique formulation of a dietary supplement and is not specific to batch size. Incomplete 483 Responses: The bizarre thing about the warning letter is that it could have been prevented. 🔹From warning letter. “Your response dated April 8, 2024, includes a document titled Returned Product Procedure. However, the procedure does not address the requirement for quality control to conduct a material review and make a disposition decision, as required by 21 CFR 111.510. The procedure states that the food safety officer will perform these activities.” 🔹Here is another reference to an incomplete 483 response. “Your current finished product specification sheet for your Acetyl-glutathione product lists the test method as N/A.” Quality Must Investigate To Prevent Bigger Potential Issues: The following section of the warning letter speaks to a core principle of GMPs: if there is a safety issue due to a product return, the company is required to ensure the return is not related to a problem that affects other batches. This does not need to be complicated, but it should be part of a product complaint or product return SOP. 🔹From warning letter related to the Returned Products Procedure. “Furthermore, the procedure also does not address the requirement that if the reason for a dietary supplement being returned implicates other batches, you must conduct an investigation of the manufacturing processes and each of those other batches to determine compliance with specifications.” There’s a lot more in this warning letter . DATE ORIGINALLY POSTED: 1/22/25 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!

Re-review online marketing after FDA inspection < Back Improper 483 responses Re-review online marketing after FDA inspection This company was inspected by FDA and received several common 483 violations, such as improper specifications and not having written procedures for cleaning and product returns. 🔷 From my reading of this warning letter, they could have probably avoided the GMP-related letter if they had responded correctly. People like Marian Boardley and Tara Couch can help with 483 responses. Here is FDA’s response to a poor 483 response. 👉 From warning letter. “we are unable to evaluate your corrective action because you have not provided revised “Raw Materials Spec Sheet” for the components used in the manufacture of the …. dietary supplements, nor have you provided finished product specifications for each of the products.” 🔷As with all warning letters, looking at the timing is important. The company was inspected in March and April this year and provided 483 responses in May. One month later, in June of this year, FDA reviewed the company’s website and found some violations, such as “anti-cancer” statements. They also cited the product name “Edema NatRelief” as a disease claim. Usually, product names must really push compliance boundaries to be cited, such as this warning letter from September, where the product “Full Body Antibiotic” was called out. As I’ve spoken about in previous posts, FDA has been reviewing websites 2-8 months after inspection, which is a friendly reminder to double-check online marketing if you’ve recently been visited by FDA. This is one of the reasons I developed Apex Compliance, which helps companies find the high-risk “forgotten landmines” before they become issues. In fact, I ran Apex Compliance on their website and found even riskier claims that were not mentioned here. Removing them now can help this company avoid repeat warning letters or lawsuits. Learn more about Apex Compliance . 🔷Some of the violations are scary. For example, identity testing for the Rauwolfia root ingredient was done by organoleptics rather than analytical testing. This ingredient is amazing at helping to lower blood pressure, but if the company received a Rauwolfia extract rather than the root powder, for example, this could have potentially led to a hypotensive (low blood pressure) crisis. 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!

Disease claims trigger deeper FDA review < Back Drug Spiked Warning Letters Disease claims trigger deeper FDA review FDA sent three warning letters this week to companies selling drug-spiked ingredients like diclofenac and methocarbamol. This is a short Warning Letter Wednesday as I am writing this from holiday on the Sea of Corinth in Greece. Follow previous WLWs here . This continues the trend of FDA testing products for drugs like these. I thought it would be interesting to explore what we can learn from these types of products. Disease claims, especially in the joint health category, can trigger FDA to examine the product and company more closely. From warning letter: “Artritis” (English translation: Arthritis)” Recalls signal manufacturing and quality issues and allow the FDA to look deeper at the company’s QA/QC processes. Here is FDA’s Health Fraud Database , which links to drug-spiked product notifications and recalls. This is a good resource to help you identify what potential contaminants to test for in your products. FDA follows the “breadcrumbs” of non-compliance. When FDA inspects a facility, issues a public notification, investigates a recall, or finds a brand with issues, it will “follow the trail” to see what other similar violations it can find. For example, when a recall is reported for a drug-spiked ingredient, the FDA will look to other places where this brand may be sold, such as marketplace sites. Many of the previous diclofenac spiked products included Spanish language supplement labels. This set of letters included both Chinese and Spanish language labels. This may be because, in some cases, there may be less quality control for products manufactured for the Spanish language community. DATE ORIGINALLY POSTED: 9/4/24 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!

Ensure ingredients are not on FDA’s “naughty list” < Back FDA cracks down on unsubmitted NDI ingredient hordenine Ensure ingredients are not on FDA’s “naughty list” The FDA is starting to crack down on unsubmitted NDI's. Today's #WarningLetterWednesday reviews a recent hordenine warning letter. Hordenine and higenamine warning letters also include high risk disease claim language. This is a good opportunity for companies selling these high risk ingredients to stop sales immediately and also to clean up their uncompliant marketing. From warning letter: On your product webpage for “OPTIMUM-CLA”: “Conjugated linoleum Acid (CLA): is a potent . . . anti-carcinogen, and anti-catabolic . . . Some of the common accolades of CLA are . . . is a cancer fighter. From warning letter: On your product webpage for “ADIPROPEN ULTRA”: “ADIPROPEN ULTRA is our new and improved version of Adipropen with added Vinpocetine, commonly referred to as ‘Viagra for the Brain.’ [I]t is more effective than Clenbuterol.” 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!

High risk “buzzwords” attract FDA/FTC “keyword web crawlers” < Back Step #1 in reducing risk is removing high-risk “buzzwords” High risk “buzzwords” attract FDA/FTC “keyword web crawlers” #WarningLetterWednesday Step #1 in reducing online marketing risk is removing high-risk "buzzwords". These include Alzheimer's, cancer, diabetes, PTSD, opioid support, depression, and of course COVID. Other "buzzwords" include pain, anxiety, inflammation, and arthritis. Today's warning letter is a smorgasbord of "buzzwords". Read it here . Authorities look at the 10,000-foot view of a company's online persona. One "buzzword" will likely not attract a warning letter, but claims on social media, videos, blogs, product reviews, hashtags, and ingredients descriptions elevate risk. The authorities piece them together for one big picture of noncompliance. The more "buzzwords" the higher chance of scrutiny. I suggest removing or replacing them with truthful, accurate, and not misleading options. Examples: Pain <> Discomfort Anxiety <> Mental resilience or balanced mood support Flu <> Seasonal immune support 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!

Implied marketing statements should be compliant < Back Suggestive Words Like “May Help” Do Not Allow Risky Marketing Claims Implied marketing statements should be compliant I like to think of suggestive words like “may” and “could” as the compliance version of “with all due respect.” If I say “with all due respect” to someone, it doesn’t allow me to say whatever I want. The same is true with marketing statements. In this warning letter, the company was cited for making many suggestive disease claims. Marketers can learn what not to do from these examples. From warning letter. “Maca may also help…lower blood pressure ….” “It is known for aiding in…constipation, diarrhea, and diabetes!” It’s thought to be particularly effective against allergies and sinus infections.” “It’s often used as a folk remedy for…the common cold and flu.” This is a shorter Warning Letter Wednesday than normal as I’m attending the Organic and Natural Health Association conference in Florida, where I’m presenting Apex Compliance and participating in an "Amazon: Opportunities and Threats" panel. 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!

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!

Scan socials and websites for risky words like “hordenine” < Back Blood Sugar, Arthritis & Immunity Claims Lead to Warning Letter Scan socials and websites for risky words like “hordenine” The warning letter has a unique “we offer the following comment” section. FDA references bitter orange extract (Citrus aurantium) as an ingredient in the Supplement Fact Panel. It then refers to the product ingredient page where the company states that ingredients like hordenine are components of bitter orange extract. From warning letter. “Bitter orange extract contains neuroactive agents, synephrine, hordenine, and octopamine.” This is detailed diligence by FDA, showing that small copywriter comments can lead to increased scrutiny. FDA goes on to mention the previous hordenine and octopamine warning letters. I write about this here . I suggest scanning websites to see if keywords such as hordenine and octopamine show up. I offer this service and can do this at no charge if you mention “Warning Letter Wednesday.” Many of the claims cited in this warning letter involve the company discussing ingredient benefits. I wrote about this on a #WarningLetterWednesday just a few weeks ago. Blood sugar claims enforcement continues to be top of mind for FDA, and there are several citations in the warning letter. I review 56 diabetes-related warning letters here. Old social media posts are also mentioned in this letter. This includes a post from early in the pandemic with the high-risk word “coronavirus.” I would guess the company had long forgotten about this post. Here is a WLW write-up and video about this. Words ending in “itis” (meaning “inflammation of”) are disease claims, and the most commonly cited “itis” in warning letters is arthritis. This letter references five occurrences of this word, demonstrating that words like arthritis do not belong in supplement marketing. 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!

Product reviews are marketing claims < Back Warning Letter Issued for Eye Color Changing Drops Product reviews are marketing claims Do you ever see products and think to yourself, "This can't be safe" or "What regulatory category does that fall into?" After reading this recent warning letter that was issued to a company making ophthalmic (eyedrop) products designed to change people's eye color, I thought to myself, "Is this actually a product that people are putting in their eyes?" Sign up for this weekly newsletter and search three years of previous weekly posts here . According to FDA, making claims such as "Lighten & Brighten Dark Your Eye Color, Speed Up the Eye Color Changing Process" are unapproved drug claims. This is the 13th ophthalmic-related warning letter this year, which shows that if you make a product that goes into the eyes, use extreme caution in product marketing and cleanliness. Also, there's been a group of ophthalmic letters that involve MSM and other ingredients that generally should not be placed in the eyes. I write about this here . Also explore other homeopathic-related ophthalmic warning letters here . Product reviews are cited in this warning letter. This is a reminder that when reviews are curated on a "Reviews" page, FDA looks at them as being showcased, which means they are marketing and fair game for enforcement. There seems to be a fine line between third-party, non-curated reviews on a website and "marketing" reviews curated on a reviews page. I rarely call out companies by name on Warning Letter Wednesday, but looking at how the company formatted their reviews page is an example of what not to do, and avoiding this can help keep you out of trouble. From FDA letter. "On the webpage https://lnkd.in/gemFTh54 . Customer review from 05/17/2024: "I've had brown eyes for years, and they were blue when I was born! Now, after 5 months, I bought it hoping for green eyes, and it works well. It has changed my eyes, and now having green eyes is what I'm most excited about." This company appears to continue to sell the product, which means we can likely expect more decisive FDA action soon. What do you think? Read the full letter here . DATE ORIGINALLY POSTED: 11/13/24 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!