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Safety related product claims attract scrutiny < Back “Non-Toxic” Claims Require Extensive Substantiation Safety related product claims attract scrutiny Making a “Certified Non-Toxic” claim on a mouthwash triggered a competitor challenge. According to the National Advertising Division (NAD) comments, the substantiation provided by the company was not sufficient to support the claim. 👉From NAD. “In support of the “Certified Non-Toxic” claim, Oral Essentials submitted two cytotoxicity studies (one for its sensitivity mouthwash and one for its whitening mouthwash) and a certification statement from MADE SAFE, a third-party certification program that verifies ingredient safety and non-toxicity. Oral Essentials mouthwashes were certified by MADE SAFE at the time of manufacture.” 👉From NAD. “Strong evidence is needed for non-toxic claims due to potential health and environmental risks as well as the potential for consumers to misuse the product or take away a broader message about the product’s safety that is not supported by the claim.” 👉Apparently, the cytotoxicity studies did not exactly match the and did not address the “real-world” effects. From NAD. “NAD found Oral Essentials’ cytotoxicity studies did not support the challenged claims such studies do not reflect the real-world effects on humans and only address one form of toxicity. Additionally, the study formulations contained one less ingredient and differed from the current product ingredients.” It seems the position is that making a “Certified Non-Toxic” claim on a mouthwash label may give some consumers the idea that they can drink the whole bottle or put it in their eyes with no safety issues. I expect people to have more common sense than this, but I guess it is possible for a consumer to think that “Non-Toxic” means they can go nuts with it. I assume the same rationale would apply to toothpaste or any other product that is sparingly used internally. 🔹Don’t rely on certifications: The company also relied on a “MADE SAFE” certification, but this did not substantiate the claim because it was unclear to NAD which real-world factors were evaluated in the certification process, and the company's certification had expired in October 2024. At Supplement Advisory Group , my regulatory consulting company, I often share the “less-is-more” principle with clients. This means that every aspect of packaging will be scrutinized, and if it’s not necessary for marketing, removing it is a good idea. This is not always a popular opinion, but it is important to measure risk and reward while keeping substantiation in mind. Read more about the case here . DATE ORIGINALLY POSTED: 1/15/25 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!

Practitioners who sell supplements need to be aware that health and medical claims made in nutritional marketing can attract unwanted attention from the US Food and Drug Administration. < Back Common Practitioner Pitfalls to Avoid When Marketing Dietary Supplements Asa Waldstein Guest Article Practitioners who sell supplements need to be aware that health and medical claims made in nutritional marketing can attract unwanted attention from the US Food and Drug Administration. Read More Previous Next

Arthritis claims attract scrutiny < Back Tips For Understanding What A Claim Is Arthritis claims attract scrutiny Arthritis claims continue to be cited in warning letters. As many of you know, I love teaching about regulatory compliance to help you adjust your marketing and stay ahead of the regulatory curve. We hear about not “making claims,” but it can be challenging to know what a claim is. Here are a few general rules for avoiding high-risk claims that can lead to a warning letter. What other tips can you share? Anything ending in “itis,” such as “arthritis”. “Itis” means “inflammation of,” which helps me remember it should be avoided. Fun fact, “arthritis” is the most commonly referenced of all the words ending in “itis.” Other than “antioxidant” and perhaps “anti-aging,” words with “anti” should be avoided. Immune-related words like “antiviral” or “antitumor” are higher risk than “anti-inflammatory.” Words with an International Classification of Diseases (ICD) code. The name of any illness or syndrome, such as Alzheimer’s or IBS. Some are obvious, but some of the syndromes, like Leaky Gut Syndrome, may not be as obvious. Here is a post about this. Searching past FDA warning letters can help you learn what they’ve previously cited. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters “Better than drugs” statements attract FDA attention. Here’s a WLW post about this. FDA sent out 12 arthritis-related warning letters last year, so please avoid making these types of claims. This includes: Hashtags Showcased testimonials Citing clinical studies Product tags and meta tags Social share meta description FDA has been quiet with supplement warning letters, and I am in New Zealand, so this is a shorter post than normal. I am writing this WLW for the beautiful Coromandel. Yes, I love compliance and writing this post (smiles)! 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!

< Back Webinar Thursday Jul 23, 2020 Enforcement Trend Analysis CBDIA Webinar: FDA/FTC Asa Waldstein reviews warning letters and gives examples of how to lower marketing risk for the cannabinoid and dietary supplement industries Here are some other lower-risk ways to communicate how your product can help: Balanced state of mind Happy mood support A good night’s sleep supports the body’s health Support resilience Slumber support for optimal health Mental equilibrium Be kind to your body with hemp oil, your body systems will thank you! Watch Previous Next

< Back Panel Discussion, Online Tuesday May 16, 2023 The Label: Getting to the truth on natural product claims AHPA Botanical Congress Consumer preference for better business practices has expanded the already complex regulatory landscape for natural product claims. In this session, Asa Waldstein (Supplement Advisory Group) will provide an overview of key considerations for label claims, with Amber Littlejohn (Ice Miller) and Jake Hebert (One Step Closer) expanding on health-related claims and environmental claims, respectively. Speakers: Asa Waldstein (Supplement Advisory Group) – Moderator Amber Littlejohn (Ice Miller) Jake Hebert (One Step Closer) Learn More Previous Next

Product review engagement leads to a warning letter < Back FDA Crackdown on CBD in Animal Products Product review engagement leads to a warning letter FDA crackdown on CBD in animal products. This month, we saw the fourth warning letter that mentions CBD in animal products. This is the 20th CBD-related FDA warning letter this year, up dramatically from only seven in all of 2021. This is an enforcement trend to watch! These warning letters involve companies marketing CBD products for farm animals and humans, but there are also some great learning opportunities for the broader dietary supplement market. The most interesting point is a company was cited for engaging with product reviews on their website. The product reviews look like third-party-generated content, such as from TrustPilot, of which the authorities have been “hands-off.” The company then comments on the product review, which contains disease claims, and this is similar to how a company may comment on social media. If the company had not engaged in commenting on the review, I doubt this would have been cited in this letter. This is an essential lesson for content writers and social media managers: fight the urge to engage when customers write product reviews with disease claims. The more attention is paid to them, the higher their chance of being scrutinized. From the warning letter “Customer review: “I wanted to ask if these pellets would help my goat, has a bad front leg, he holds it up a lot, the vet says it arthritis …Do you have anything that would ease the pain…” o Response from ….Hope Botanicals: “Yes, I think the pellets would be beneficial for your goat. We have lots of goat customers” Read the letter here . The critical point here is that true third-party product reviews seem to be safer from scrutiny, but they cross the line into a marketing claim when a company comments on them. This is considered substantiation of the customer statement, and the engagement changes into “an extension of the label.”. This lesson can be applied to social media engagement as well. “All Marketing is Labeling” video . These letters are also the “greatest hits” of what not to. · Old social media posts · Claims made in blogs, videos, hashtags · Testimonials are claims The FDA is concerned about CBD getting into the food supply. From Warning Letters: “The Agency is particularly concerned that you market one of your CBD products for food-producing animals”. Hashtags are also mentioned. From Haniel warning letter: “On a May 12, 2019 post on Instagram states, “What can # CBD do for #animals and # anxiety # inflammation # arthritis # pain # seizures # cancer # cbdoil Blogs are also mentioned in this letter. Remember, old blog posts are now commonly mentioned in warning letters. Here is my “Best Practices for Reducing Risk in Blogs” post . From warning letter: On your …. November 5, 2019 blog posting titled “Is CBD Safe for Dogs with Anxiety”: • “One of the most popular uses of CBD is to treat anxiety. In my opinion, the claims cited in this video are not considered high risk. This is a good reminder that even mid-level risk claims can attract a warning letter (see below). From Plantacea, LLC dba Kahm warning letter: “In a Product Display training video dated December 7, 2020 at https://www.youtube.com/watch?v=8BwdqTedTa0 , during the discussion of your “CBD Hemp Pellets” (from the 4:52 to 4:55 mark) the presenter states: “It’s also amazing for the anti-inflammatory effects that CBD has.” Here is an example of a high-risk claim that likely “tipped the scale” into the warning letter category. Note these social media post is four years old! From Plantacea, LLC dba Kahmwarning letter: On your Instagram social media website ….from posts on July 24, 2018: • “An article published in the February 2013 issue of The British Journal of Clinical Pharmacology states, ‘CBD. . . inhibits cancer cell migration, adhesion, and invasion.’” 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 names are marketing < Back Small Herbal Company Cited For Marketing Claims Product names are marketing Even very small companies that market online can attract an FDA warning letter. I am still surprised when I hear companies saying they are not big enough to be on “FDA’s radar.” This warning letter shows that anyone, even a tiny company, is “fair game” for enforcement. Today’s Warning Letter Wednesday is a story of a small herb company cited for making serious disease claims, and I’m guessing they didn’t know the rules of dietary supplement marketing. This is one reason why I write Warning Letter Wednesday: to help raise awareness about enforcement trends and marketing rules in the digital era. 🔷Unfortunately, many schools do not teach the basics of DSHEA and marketing compliance. One of my missions is to educate these communities about the dos and don’ts of supplement marketing. Here is my speaking schedule , which includes three days of classes at next month’s International Herb Symposium at Wheaton College. Please let me know if I can extend free education to your school. I also offer customized marketing compliance company training called the “Regulatory Expert Package.” 🔷This warning letter contains numerous disease statements and is a cautionary tale of what not to do. This is one of the most glaring examples of a disease statement. Wow! 👉From warning letter. “[Echinacea Tonic] should be used for EVERY disease and illness.” 🔷The product names “Insomnia Formula” and “High Blood Pressure II” were cited in this warning letter. 👉From warning letter. “Insomnia Formula • Product name: The product name implies that the product is intended to cure, mitigate, treat, or prevent insomnia.” 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!

Increase in claims cited in blogs and social media < Back Anxiety Claims Enforcement Review Increase in claims cited in blogs and social media Anxiety claims enforcement continues to be top of mind for the FDA. In this #WarningLetterWednesday I compare 2022 anxiety claims enforcement with the same time last year. I found some interesting data points that help us understand where the FDA is finding risky items. These learning tools can alert companies where to look for risky keywords that may be lurking on company websites and social media. Here are some key takeaways: 27% of this year’s warning letters mention claims made in hashtags compared with 20% in the same period last year. This shows that hashtags are indeed marketing claims and can tip the scale into the warning letter category if they are non-compliant. Here is my “Hashtags Are Marketing Claims” video . Warning letters citing blogs and anxiety claims more than doubled (63%) over the same period last year (30%). It is now common to see a several-year-old blog mentioned in a warning letter; a good reminder to ensure all blogs, including the old ones, are compliant. Here is my “Best Practices for Reducing Risk in Blogs” post . Social media enforcement continues to be a trend to watch. This is exemplified by the 63% anxiety claims number this year compared to 40% in the same period last year. The two most drastic changes this year were with CBD and animal anxiety claims. 72% of this year’s letters mention CBD, up from just 16% in the same period last year. This shows the FDA’s increasing intolerance of companies marketing CBD with disease claims. There has never been a riskier time to market CBD products; I go into detail about this here . This year, animal and anxiety warning letters increased from 10% to 45%. I write about this enforcement trend here . The one-two punch of both “anxiety” and “depression” is mentioned in about ¾ all of the 2021/22 anxiety warning letters. There have been 22 anxiety-related FDA warning letters this year compared to 30 in the same period last year. I was a little surprised by the low number this year. It is worth noting that “occasional anxiety” was mentioned zero times in these warning letters. The key takeaway is that focusing on life occurrences such as “occasional anxiety” or “occasional inflammation” may be a lower-risk marketing strategy. 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!

We can learn a lot from NAD cases < Back NAD Case: Sustainability & Clean Ingredient Substantiation We can learn a lot from NAD cases This company was making claims related to sustainability, “clean ingredients,” and efficacy. This is a really interesting case that we can learn a lot from! The National Advertising Division (NAD) is a great place to look for case law regarding substantiation requirements. Here, I review a recent NAD monitoring case against a cosmetic and flavor ingredient company. Clean Ingredients Here is the claim challenged by NAD. “Clean ingredients and clean formulas – we ban over 2000 ingredients that are known to be toxic to you and the environment.” NAD’s finding: “NAD found that it is not clear whether the over 2,000 ingredients … does not use in its products are associated with cosmetic products. Therefore, NAD recommended modifying the claim specifying banned ingredients typically used in cosmetic products.” Asa comments: This shows that if a product does not typically contain an ingredient, stating that the product is free of an unlikely ingredient may be misleading. Do you think this applies to labeling a product “no soy” if it’s very unlikely to contain soy? Sustainability Claims Here is the claim challenged by NAD. “Keeping 2 million sharks every year safe from liver harvesting.” To substantiate this claim, the company provided data regarding an estimated number of sharks killed and an estimate of the global demand for shark liver oil; however, this was insufficient to provide a reliable number. NAD’s finding: “NAD recommended that the claim be discontinued or modified to avoid referring to a numerical figure. NAD noted that nothing in its decision prevents …. from making a more general claim that sharks are not harvested for squalane found in (its) products.” Asa comments: Numerical claims require increased substantiation and should be avoided unless there is firm supporting data. Here is another numerical claim example. Challenged claim and NAD’s findings: “All of our ingredients are also ethically and sustainably sourced,” NAD determined that while … Supplier Code of Conduct might demonstrate its commitment to ensuring that ingredients are ethically and sustainably sourced, it does not demonstrate that all ingredients are, in fact, ethically and sustainably sourced. Asa comments: I wonder if the code of conduct would have substantiated a “some of our ingredients” statement. Efficacy Claim NAD challenged this efficacy claim: “(ingredient) locks in weightless moisture, calms and protects, and improves elasticity.” NAD’s findings: “(The company) relied on three studies that assessed the impact of squalane, in the form and range of the amount found in the … products, on these objectively measurable attributes.” Asa comments: This shows how important it is to have comparable studies. For example, if the studies were conducted using different forms and dosages, they may not have been sufficient for substantiation. This is a slightly shorter WLW than normal as I am celebrating my wife’s birthday Tuesday night, so no staying up late for me. Read the NAD case 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!

“Extra” claims are often non-compliant < Back OTC Topical “Inactive” Ingredient Marketing Claims “Extra” claims are often non-compliant This warning letter involves claims made about a topical OTC menthol product. OTC products must follow monographs. These are essentially recipe books that guide the ingredients, dosages, labeling, and claims that products are allowed to be made. This is how OTC products are permitted to make claims like “Arthritis Pain Relief” that are out of bounds for cosmetic and personal care products. To check if a product is an OTC topical product or not, check the label. If it lists “Drug Facts” and lists “Inactive Ingredients” it is labeled as an OTC drug. This is another reason why cosmetic product labels should not list ingredients in “active” or “inactive” sections, as this implies the product is a drug. The product label has several violations cited in the warning letter. This shows that the product name is non-compliant and that therapeutic claims made about inactive ingredients are also not complaint. For all my regulatory nerds out there, here is a copy of the label I found online. 👉 From warning letter. “Temporarily relieves minor pain associated with cramps” [from the product label] 👉 From warning letter. “Menstrual Cramp RELIEF CREAM” 👉 From warning letter. “We believe in the power of plants and their therapeutic properties to offer solutions for menstrual discomforts.” The moral of the story is that OTC topicals provide a gateway to making otherwise risky and forbidden claims, but the rules are narrow and don’t allow for extra marketing statements, which can increase the likelihood of regulatory action. There are also drug-related GMP violations in this warning letter, which is worth reading. DATE ORIGINALLY POSTED: 4/16/25 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!

Do not over-explain clinical research < Back Best Practices For Using Clinical Study Citations Do not over-explain clinical research Using clinical study citations can be a crucial part of product marketing. If the study citations are from well-powered studies using competent and reliable scientific evidence, they can bolster the brand's scientifically supported position, which is important to many customers. I have heard this also helps boost Google's SEO rankings. There is, however, a fine line between compliantly using clinical study stations and making high-risk disease claims. When can clinical study citations be used? FDA addresses this question in the Small Entity Compliance Guide On Structure-Function Claims . From FDA. "Can I use citations of publications that relate to my product's intended use in labeling if the publication title or the journal name mentions a disease name? Yes, but some limitations apply. If the citation implies treatment or prevention of a disease, it is a disease claim. Thus, if in the context of the labeling as a whole, its presence suggests treatment or prevention of disease (for example, by placement on the immediate product label or packaging, inappropriate prominence, or lack of relationship to the product's express claims), the citation is a disease claim. If the citation is used in labeling, its context determines if it is a disease claim. A citation that is used in the bibliography section of labeling, is included in a balanced discussion of the scientific literature, is not excessively prominent relative to other citations, and provides legitimate support for a structure/function claim made for the product would not be a disease claim." Asa comments. Adding citations at the bottom of a scientific blog is not likely to attract a warning letter, but the keywords do attract attention. For example, words like Alzheimer's will be picked up by web crawlers and invite attention. This means if you are using clinical citations in product marketing, ensure these are not construed as marketing by showcasing them. Also, double-checking the rest of your web and social marketing is crucial, as extra attention will be paid to ALL marketing. Elaborating on the studies does cross the line into marketing, as we see with this recent warning letter . From warning letter. "In another recent study, correlations between CBD and blood pressure were examined. Two groups were evaluated, one being test subjects who were given CBD and the other being a control group with a placebo. All subjects were exposed to stressors that would induce a higher blood pressure. The study concluded that a dose of CBD was helpful to reducing blood pressure." FDA has also cited companies for posting about clinical studies on social media. This includes sharing clinical studies that have ingredient and disease containing meta descriptions such as "X ingredient studied for depression. The moral here is when including citations in your marketing materials, ensure they are appropriately placed—ideally within a bibliography or as part of a balanced discussion of scientific literature. They should not be excessively prominent or showcased. The Small Entity Compliance Guide is also an excellent resource for helping us understand the nuances of dietary supplement marketing such as this. From FDA, "Examples of acceptable structure/function claims are "mild memory loss associated with aging," "noncystic acne," or "mild mood changes, cramps, and edema associated with the menstrual cycle." From FDA, "Examples of disease claims are "Alzheimer's disease or senile dementias in the elderly," "cystic acne," or "severe depression associated with the menstrual cycle." DATE ORIGINALLY POSTED: 9/18/24 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!

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!