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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!

All marketing is “labeling” < Back Topical Product Claims Turn Magnesium Oil Into Drug All marketing is “labeling” FDA cited this company for selling a topical magnesium product that also contains ingredients like fulvic acid, vitamin B6, and MSM. Based on website claims FDA concluded the product was an analgesic drug. Here are some of the cited claims from the warning letter. “For muscle cramps or pains, spray directly on problem area.” “Designed to provide relief from body tension and soreness.” “Leg cramps and muscle soreness,” along with “migraines, insomnia, [and] fatigue.” FDA classified this as a “topical external analgesic (OTC) drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h,” which is allowed if the product is made using a specific OTC monograph (recipe) under applicable GMPs. Since the product did not follow the monograph, primarily because other “active” ingredients like MSM are not on the monograph, FDA deemed this product an unapproved new drug. To be fair, the other sections of the warning letter contain very serious disease claims like “cancer” and “depression,” which are likely the primary reason reasons for the letter. Some warning letters like this are very comprehensive and may cite “secondary” claims, which may not be enough to trigger a letter on its own. In the case of the magnesium oil, I doubt making claims about pain or soreness is enough for agency action, but listing diseases related to magnesium deficiency, such as insomnia, and then suggesting the product can address these deficiencies is high risk. I have seen some companies use the nutrient deficiency and disease claim strategy on dietary supplements, which is out of my risk tolerance, but when used on topical products that do not provide absorbable nutrients, it goes too far. As a friendly reminder, topical non-drug products are not allowed to “affect the structure or any function of the body,” which supplements are permitted to do. So would a topical product with a “relieve and soothe” claim attract a warning letter? This is unlikely unless there were adjacent claims like “helps with arthritis,” which turned the product into a drug. 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 tags are marketing claims < Back FSMA Compliance Lessons Product tags are marketing claims For those still learning about FSMA, food labeling, nutrient content claims, and website marketing claims, reading this post and the entire warning letter is suggested. This letter is a lesson in what not to do when operating a conventional food company, but the supplement industry can also learn from the website disease claims and some of the FSMA requirements referenced here. Wow, this was a fun post to write, and I could have written a small novel with the learning opportunities. For now, here are the high points. 🔷First, let’s talk about the marketing claims (my favorite topic). 🔹 Product tags are mentioned in this warning letter. The company was using product tags to market the intended use of the product, such as “depression” and “anxiety.” I haven’t seen product tags cited in a warning letter for a while, but this is a good reminder that product tags are marketing. I write more about product tags and meta tags here . 🔹 The product descriptions also include numerous disease claims such as “Helps Fight Infections Like Cold & Flu.” Even though the company was inspected in April 2023, FDA did not start reviewing its website until three months later. This trend reminds companies that have been inspected to review their online marketing. Removing these serious claims would have helped the company avoid this scathing warning letter. I write more about this here . 🔷Several of the herbal products had a bizarre DSHEA-like disclaimer on the labels. The products were labeled with Nutrition Fact Panels but had the following warning. This is so weird I had to add it to this post. 👉From warning letter. “Statements regarding dietary supplement have not been evaluated by the FDA and are not intended to diagnose, treat, cure, or prevent and [sic] disease or health condition.” 👉FDA then adds these comments. “To the extent you intend these products to be conventional foods, you should not refer to them as dietary supplements. We note that, under section 201(ff)(2)(B) of the Act, a dietary supplement “means a product that . . . is not represented for use as a conventional food or as a sole item of a meal or the diet.” 🔷The term antioxidant has an FDA definition, but it’s not commonly cited in warning letters. In this letter, the company was labeling some of its herbal products with the term “powerful antioxidants,” but since the product doesn’t contain ingredients with a %DV like vitamin A, this is not a compliant claim. 🔷The warning letter also references that the cleaning products used for food contact surfaces are not for commercial food contact use. The lesson here is ensuring that the cleaning products used are suitable for food contact use and that they do not leave a residue. When I was overseeing supplement manufacturing facilities, we used food-grade hydrogen peroxide to clean food surfaces, which was also compliant with organic processor/handler regulations. 👉From warning letter. “You stated that you use Mrs. Meyer’s Clean Day Multi-Surface Concentrate as the main cleaning solution for cleaning all areas of the facility, including food-contact surfaces. This is labeled as a household cleaner, not for use on food-contact equipment in a food manufacturing facility.” 🔷The company provided a 483 response that seemed to be incomplete. As we’ve discussed many times, most 483s can be avoided with comprehensive responses. 483 responses must provide proof that the corrective action has been taken. Here, the company did not follow through on providing evidence of this. 👉The 483 responses stated in the warning letter that “all FDA-compliant Food Safety Program documentation to be completed within 3 weeks of receiving back a signed proposal, a deposit payment and a completed client intake questionnaire.” 👉FDA then responded: “We cannot fully evaluate your response because you did not submit the completed food safety program or how you will assure that your facility is compliant with all FDA requirements.” 🔷There are so many great CFR 117 learning opportunities in this letter, such as incomplete hazard analysis and labeling for major allergens and the identification and evaluation of pathogens like Salmonella in the supply chain. Determining if hazards exist and if they need preventative controls is a core principle of FSMA (CFR 117). 🔷This FDA document shows what CFR 117 regulations supplement companies must comply with. It’s also a good resource for FSMA in general. 🔷Advisory statement labeling: We’ve all seen statements like “May be packaged in a facility that also packs nuts.” Here’s FDA clarifies this is not a substitute for GMPs. 👉 From warning letter. Advisory labeling is not a substitute for adherence to current good manufacturing practices and, when used by a facility, food allergen preventive controls. 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!

Ensure vendors are properly qualified < Back 7 Homeopathic Eye Product Warning Letters Ensure vendors are properly qualified Eight companies received warning letters for selling homeopathic and other eye-lubricating products. This signals the continued shift in FDA’s enforcement priorities towards homeopathics. Most of these companies were selling ophthalmic homeopathic products with some disease claims. I assume that if there were no GMP concerns, the products were not for use in the eyes, the target audience was adults, and there were no serious disease claims, many of these companies would not have received warning letters. FDA probably cited this group of products because they are (ophthalmic) added to the eyes, which may potentially endanger eye health. There are allowable OTC monographs for these types of products, but it seems the products were homeopathics, not labeled as OTCs (Drug Facts Panel), or in at least one instance, the product was labeled as an OTC but was not submitted to the required National Drug Code Registry . Products added to the eyes can be dangerous, and eye two lubricant products contain NAC, which I don’t think is approved for ophthalmic delivery. When I was a supplement manufacturer, I always said NO to making these types of products. From warning letter, “Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.” Here are some other highlights: 🔷 This company was cited for making disease claims in testimonials. It is worth noting that testimonials were showcased and promoted in a banner. If the testimonials were part of a 3rd party review widget, such as those uncurated reviews that come in through a service like Trustpilot, they probably would not have been cited. 🔷 My “day job” is running a regulatory consulting company. Contact me to discuss reviews, labels, or online marketing compliance questions. This helps support my WLW writing passion (smiles). 🔷 Normally, there has to be commerce for a company to receive a warning letter. This company does not appear to conduct commerce on its website and only offers a practitioner login option. The company was selling ophthalmic products with disease claims, which led to the warning letter even though there does not seem to be public commerce on the site. This is VERY INTERESTING and should be a wake-up to companies using this strategy to push the compliance boundaries. 🔷 This well-known homeopathic company was cited for not only making ophthalmic homeopathic products and disease claims, but this warning letter also includes numerous GMP violations. Products from this company were placed on import alert, which speaks to the severity of the alleged GMP issues. I assume that FDA “followed the breadcrumbs” for other products made at this facility, which led to the Walgreens and CVS warning letters. This highlights the need for supplier qualification, something consultant Nate Call is an expert at. 🔷 A four-year-old social post was cited, which is another reminder to remove language from all social media, no matter how old. 🔷 From warning letter. “February 9, 2019 Twitter post: An image of the “Vision Clarity Eye Drops” with the text, “Carnosine, a cataracts worst nightmare.” 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!

Reduce litigation by following labeling rules < Back Nutrient Content Claims Guidance Reduce litigation by following labeling rules Nutrient content claims can lead to litigation and are often cited in warning letters, although they are not typically the primary reason for a letter. Following all the rules can be confusing, so here's some guidance on how to be compliant. Thank you to the thousands of wonderful weekly Warning Letter Wednesday readers. I hope this helps (smiles). "Good Source" Claims 10-19% DV: Terms like "good source," "contains," or "provides." Example: "Good source of magnesium" must have at least 10% DV magnesium per serving. "High" & "Rich In" Claims 20%: Terms like "high," "rich in," or "excellent source of." Example: "Rich in magnesium" must have at least 20% DV magnesium per serving. "High Potency" Claims: 100% DV: Example: "High potency magnesium" must have at least 100% DV magnesium per serving. For multi-ingredient foods, at least two-thirds of the vitamins and minerals must meet these criteria. I actually did not know this until I researched for this post. Fiber Claims: When claiming high fiber content, the total fat content must also be disclosed if the food is not low in fat. Antioxidant Claims: The nutrients have recognized antioxidant activity like vitamins A, C, and E meet % DV requirements. This means that items without a %DV, like botanicals, cannot be listed as antioxidants. Mentioning the effect on the antioxidant system, however, is not high risk. These rules are nuanced. Learn more here . Include the names of the antioxidant nutrients in the claim, such as "high in antioxidants vitamins A and C." "More" & "Enriched" Claims 10% DV: Terms like "more," "fortified," "enriched," "added," "extra," "plus," and" compared to a reference food.Must comply with fortification policies, and comparisons with the reference food must be clearly stated. Sugar Content Claims: Terms such as "sugar-free" and "no added sugar" can be used in some instances, but they can lead to lawsuits. Here is an excellent article by Todd Harrison, Kristen Klesh, and others. It has a VERY helpful table that can help avoid the common litigation surrounding "not a low-calorie food" requirements. Cholesterol and Fat Claims: This continues to be mentioned in warning letters as a secondary (not the primary reason for a letter) citation. "Cholesterol Free" and "No Trans Fat" claims must be made in accordance with specific FDA guidelines. Declarations for mono- and polyunsaturated fats must be made under 21 CFR 101.9(c)(2)(ii) and (iv) if such claims are made unless the food qualifies as "fat-free" under 21 CFR 101.62(b)(1). Calorie Content Claims "Calorie Free" Claims: If the food contains less than 5 calories per serving, terms like "calorie-free" or "zero calories" can be used. "Low Calorie" Claims: For foods that provide 40 calories or less per serving for larger servings and smaller servings, if not more than 40 calories per 50 grams. "Reduced Calorie" Claims: "Reduced calorie" claims are permissible if the food contains at least 25% fewer calories per serving than a reference food. Here are some helpful resources. Specific Requirements for Nutrient Content Claims Nutrient content claims for "good source," "high," "more," and "high potency" Warning: This is for informational purposes only. Please check labels and marketing content with your competent legal or regulatory counsel. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

“Arthritis” claims elevate risk < Back Testimonials & Video Claims Lead To Warning Letter “Arthritis” claims elevate risk The timeline of the FDA interaction is notable. The company was inspected last August, then FDA reviewed their website in October and November, then reviewed it again in March 2023. If the company had cleaned up its website before the last FDA website review, it probably could have avoided this warning letter. Do your teammates ever ask you what happens if you receive a warning letter? I made a one-minute video about this. Testimonials are cited in the letter. Third-party non-curated, non-compensated, honest reviews are unlikely to be scrutinized, but they become marketing when used to sell products. This includes: ●“Liking” or “saying thanks” on a social post ●Interacting with a product review ●Showcasing a product review This company has a page specifically for testimonials which makes them curated, which is marketing. →From warning letter. On your Testimonials page: “I prefer … over chronic use of Rx or OTC NSAIDS for arthritis due to the potential renal and gastric side effects of chronic NSAID use.” As we have discussed before, claiming a supplement is better than drugs is a quick way to irritate FDA and attract a warning letter. No GMP manufacturing claims are cited in this letter, which means they are probably doing a good job making the product, but they have crossed the compliance line with their marketing claims. If interested in talking about the nuances of marketing compliance, I would be happy to meet for 30 minutes at no charge. I am here to (try to) help! YouTube claims are cited again in this warning letter. This is the third FDA warning letter that mentions YouTube videos this year. Are you interested in seeing the others? You can search old Warning Letter Wednesday posts by keyword here . This is intended to be an ongoing resource for your regulatory and marketing teams. Claims about “pain” are cited in this warning letter. While it is unlikely a company would receive a warning letter without higher-risk words like “arthritis,” occurrences of “pain” do elevate the overall likelihood of agency action. Did you know that “arthritis” is the most common “itis” in warning letters? If accurate, replacing “arthritis” with “joint discomfort” can help to lower risk. →From warning letter. “… is made of 12 key ingredients - each chosen for its specific ability to address the complex causes of pain.” I’m writing this #WarningLetterWednesday post as I fly to Vitafoods in Geneva, where I am speaking about US supplement regulations and marketing best practices . Let’s meet if you are in Geneva! 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!

Plan for inspections with an “FDA Inspection” SOP < Back Ingredient Company Cited For Refusing An FDA Inspection Plan for inspections with an “FDA Inspection” SOP International ingredient company cited for refusing an FDA GMP inspection, a serious prohibited act. #WarningLetterWednesday What are the repercussions of denying inspections? 🔷All products from the facility are deemed adulterated, and it is a prohibited act to introduce products that are misbranded into interstate commerce. This is a serious offense! 🔷This company is located out of the country, and all products from their facility have been placed on an import alert, which means they will be rejected from entering the US. 🔷This will likely make future GMP inspections more rigid. FDA is authorized to conduct unannounced inspections of ingredient or product companies that hold and sell in the United States at any reasonable time. The FDA is not required to give advance notice. In my experience, the FDA commonly shows up without warning on Monday morning, and dietary supplement GMP inspections usually last 3-5 days. Although it’s not required FDA typically does schedule inspections for international companies. Refusing entrance to a facility or an area of the facility is considered inspection refusal. An unknowing front desk staff member may inadvertently turn away the FDA. This is one reason I suggest having a “What to do when the FDA arrives” SOP ready. Steven Yeager and I talk about this here . A side note on glycerin which is a common dietary supplement ingredient. As noted in this warning letter, in the past, glycerin has been adulterated with diethylene glycol (DEG), which can lead to fatalities. I suggest testing glycerin for DEG at least once annually. If you are interested in good bedtime reading, here is the FDA document “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.” 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!

Blogs are marketing statements < Back Blog Claims Result in Warning Letter Blogs are marketing statements This warning letter cites a kratom company for making disease claims related to opioid withdrawal, cancer, and depression in blogs. The learning targets in this Warning Letter Wednesday are: 1) Blogs are marketing claims 2) Comparing products to drugs is high risk 3) Scan websites for high-risk statements ✔ Blogs are marketing claims. Blogs continue to be cited in warning letters as they are "active" pieces of marketing, even if they are several years old. In this warning letter, the company talks about kava, an ingredient in its products being used for ADHD. If their products did not contain kava, this is low risk, but since this blog promotes its ingredients, this is essentially the same as putting "Our products help ADHD" right on the label. 👉 From warning letter (blog). "Here are ten amazing kava benefits you should be aware of . . . May Alleviate ADHD Symptoms[,] kava may be beneficial to people who suffer from attention deficit hyperactivity disorder (ADHD). ✔ Comparing product benefits to drugs is a great way to attract FDA attention. The example below is ultra-high risk because FDA is likely concerned that if people think the product works the same as cancer drugs, the consumer may forego lifesaving treatments for the natural (unproven) options. I am a fan of natural products, but it's important to market them in a compliant manner that does not inadvertently give people false hope about their uses. 👉 From warning letter. "Two of Kava's constituents …. have similar potency to the Alzheimer's disease treatment Memantine." 👉 I write more about the risks of comparing products to drugs . ✔ Most of the claims referenced in this letter have been removed, but there still are many claims on their website. I ran Apex Compliance and found dozens of very high-risk statements, especially when discussing their ingredient's benefits. There are also statements about helping COVID symptoms on their "forgotten" blog posts. I developed Apex Compliance to help companies identify and remove marketing risks on their websites and content before publishing. Learn more and schedule a demo . Also, DM me to schedule an Apex Compliance meeting at SupplySide West! 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!

No such thing as “too small to be on FDA’s radar” < Back Discussing Ingredient Benefits Leads to a Warning Letter No such thing as “too small to be on FDA’s radar” Small herb company cited for elderberry-oriented disease claims. This is a good reminder there is no such thing as “too small to be on the FDA’s radar.” Claims in the letter provide some good learning opportunities. Discussing ingredient benefits on a commercial website where those ingredients are sold is a marketing claim, even if there is no cross-linking to a product page. In this letter, the company made statements about elderberry in their “Elderberry 101” FAQs. Here is another post about this. From warning letter: “In 2004, a study on elderberry extract in flu patients revealed that symptoms were relieved 4 days sooner than patients who didn’t receive elderberry.” Claims made on social media are also cited. It seems like the majority of warning letters involve social media claims. The front and last line of defense is the company’s social media manager. Unfortunately, it’s common for these team members not to understand the nuances of supplement marketing. This is one of the reasons I make helpful hints regulatory videos such as this. From warning letter: “Benefits of Elderberry .. From Facebook “Another 2020 review of five elderberry studies concluded that, when taken within 48 hours of initial symptoms, elderberry supplements may reduce the length and severity of fever, headache, runny nose, and congestion associated with cold and flu.” Copying literature or “research” about an ingredient onto a commercial website or social media post is a common trap new supplement marketers fall into. I talk about this here . This is another example of a well-intentioned cottage herb company that didn’t understand the rules of marketing supplements, thus resulting in a warning letter. Once product marketing is posted online or on socials the risks of FDA/FTC scrutiny increase. Unfortunately, marketing compliance is not commonly taught at herb or natural medicine schools. Helping to educate this community is one of my missions, so please help me spread the good word of compliance. 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!