Clinical study parameters must match claims < Back Lessons From NAD Decision Clinical study parameters must match claims Most of the claims here are not high-risk, but this demonstrates that even lower-risk statements, especially when combined with "clinically proven" types of claims, can lead to increased scrutiny and potentially increased substantiation requirements. I usually write about FDA supplement warning letters, but they've been relatively quiet this year, so today's Warning Letter Wednesday discusses an interesting National Advertising Division (NAD) decision. NAD is a self-regulatory body under Better Business Bureau (BBB) programs, and I enjoy reading NAD cases to look for clues about claims substantiation and enforcement. After reviewing the substantiation, NAD recommended that the company discontinue the following claims. All "clinically tested," "scientifically tested," "mood support," "calmPM S symptoms," "ease cramps, bloat and moodiness" and help consumers "experience a better period" claims and Express and implied ingredient claims for ashwagandha, magnesium, vitamin B6, turmeric, and chasteberry. Natural claims It seems the company had conducted a clinical study on its OTC product and its dietary supplement botanicals product together, but NAD found tissues with the study. Unfortunately, there is no specific information on the study, such as if it was blinded or placebo-controlled. From NAD. "NAD found that the study did not meet the standard for competent and reliable scientific evidence." "several significant flaws, which rendered it insufficiently reliable to provide a reasonable basis for Pamprin Botanical's establishment and health-related claims." I've noticed that some companies use additional "creativity" in their Amazon descriptions, and this NAD case shows that even claims on Amazon are fair game for scrutiny. This is obvious, but it is uncommon for claims on Amazon pages to be cited unless they are high-risk disease statements. From NAD statement. "The National Advertising Division (NAD) determined that, in context, the "tried and trusted" claim that appeared on the Amazon product tile refers to Pamprin's history and that no modification was necessary." I find the company's approach to marketing the OTC and supplement products together to be an interesting strategy, and I wonder what FDA's position is on marketing drugs and supplements together in an instance like this. A little more about NAD. NAD reviews advertising disputes between competitors and other claims it becomes aware of. It is where companies can challenge each other's claims they feel are affecting their sales. NAD evaluates the truthfulness and accuracy of advertising and offers a streamlined resolution process to address advertising disputes. However, unlike a regulatory court, NAD cannot enforce its decisions, but if a company doesn't comply with NAD's recommendations, NAD can refer the case to the appropriate governmental regulatory authority, such as the Federal Trade Commission (FTC). This can also alert plaintiff attorneys. Read the NAD case here . It's really interesting and definitely worth checking out. 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 Discussing Ingredient Science Discussing ingredient benefits is "marketing" Helping you understand the fine line between education and product marketing is one of the reasons I love writing Warning Letter Wednesday. We continue to see well intentioned companies perhaps unknowingly cross the line from “education” to “disease claims.” Here I explore how discussing science easily become disease claim marketing. From warning letter. These lessons teach us what not to do. “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.” "CBD has been studied for its possible uses for children, and while the science is still preliminary, there are some promising opportunities. One of the best is the use of CBD for children with autism. One study of 188 children with autism, ages 5 to 18, found that some symptoms, such as seizures, restlessness and rage attacks, were lessened.” How can you use science in marketing? Here’s what the FDA’s Small Entity Compliance Guide on Structure-Function Claims says. This basically means that some citations are permitted but ensuring the context does not imply your product treats or help diseases is essential to compliance. As with many things we “know it when we see it.” Examples of cross the compliance boundaries include social media posts which mention the ingredient and the disease name, social posts with where the meta description mentions the ingredient and disease, company or ingredient hashtags on carefully worded scientific literature posts. Also, science that is showcased on product or ingredient pages often may be considered non-compliant. From FDA (Question and Answer). “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 implies 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.” DATE ORIGINALLY POSTED: 10/30/24 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!

Influencers must disclose material connection < Back FTC Letters To Sugar-Promoting Influencers Influencers must disclose material connection FTC sent warning letters to two trade associations and 12 influencers for not disclosing material connection in their posts promoting the safety of aspartame and sugar. This shows that FTC is serious about enforcing its endorsement guidelines. There were some interesting FDA warning letters to write about this week, but this FDA action was too sweet to pass up. Many of the actions included posts on TikTok. Amazingly, TikTok posts are rarely cited in agency action compared to other platforms such as Instagram. Why is this? Also, claims on TikTok have never been cited in an FDA warning letter, but I expect this to change in 2024. Read about the FTC action . FTC provides guidance on what conspicuous disclosure means. Learn more . #Ad may not be enough. In the past, adding #Ad may have been sufficient, but now, a disclosure must be made in the format it was delivered. This means that "if the representation is made through audible means, the disclosure should be made in at least the communication's audible portion." From FTC warning letter. "The video itself did not include any disclosures. Viewers can easily watch a video without reading disclosures in a post's text description. There should be clear and conspicuous disclosures in the videos themselves, for example, by superimposing much larger text over the videos. In your video, you made endorsements through both visual and audible means, so the disclosures should have been made in both the visual and audible portions." Reels must also have disclosures; adding a hashtag in the description is not enough. I understand most influencer rules, but this one is tough to comply with. From FTC warning letter. "Videos have many competing elements. We therefore do not think that a disclosure in a Reels post's text description is clear and conspicuous." Paid partnership is not adequate disclosure. Many platforms like Instagram require influencers to use their "Paid Partnership" heading. Unfortunately, this is not sufficient for disclosing the material connection. In the future, I'd like to see these platforms harmonize their requirements with FTC regulations. This FTC quote sums it up, and I applaud FTC for this action. "It's irresponsible for any trade group to hire influencers to tout its members' products and fail to ensure that the influencers come clean about that relationship," said Samuel Levine, Director of the FTC's Bureau of Consumer Protection. "That's certainly true for health and safety claims about sugar and aspartame, especially when made by registered dieticians and others upon whom people rely for advice about what to eat and drink." The moral of the story is to disclose material connection in all formats when necessary, audio, video, and clearly in text. Yikes, being an influencer is more difficult than it used to be. DATE ORIGINALLY POSTED: 11/22/23 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!

Guest article in Yes Weekly < Back Tips for Lower Risk Marketing Supplements & CBD Products in the Coronavirus Era Asa Waldstein Guest Article Guest article in Yes Weekly Read More Previous Next

Free speech protections go away when there is marketing material connection < Back Affiliate Marketing Content Must Be Compliant Free speech protections go away when there is marketing material connection Affiliate marketers continue to be scrutinized for making claims. #WarningLetterWednesday A few years ago, affiliate warning letters were nearly nonexistent. Now regulators are savvy and are no longer tolerating claims where there is material connection. Affiliates develop content in hopes of bringing consumers to their site which then hyperlinks to a shopping cart for purchasing the mentioned product. Affiliates get a cut of sales which can be 30%, so you can see the incentive for sensationalized content. Affiliate relationships should also be disclosed clearly and conspicuously. Affiliates are responsible for the accuracy and compliance of their statements. The difference between "Average Jane" and affiliates is the material connection. If there is no material connection, including free product and employee/family relationships, consumers can say pretty much anything about products they like. Original Q&A published 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!

Learning from other’s mistakes is a good strategy < Back FDA Crackdown on Monkeypox Claims Learning from other’s mistakes is a good strategy FDA sent five warning letters this week to companies selling products for Monkeypox. This is a clear violation, but there are some critical learning lessons here. Sign up for this weekly Warning Letter Wednesday post here . 🔹One company is a wallpaper website with a few herbal tinctures containing uncompliant product descriptions. They probably just posted whatever content the tincture company provided, which shows that companies distributing supplements are on the hook for claims made on their platforms. Find my video and post about the distributors Amazon and Walmart here . 🔹Implied claims are marketing claims. In this blog post titled “What is Monkeypox,” the company says the product may help Monkeypox and then states, “we don’t know enough to be sure.” Suggestive words and phrases do not protect companies from implying their product will help diseases. 👉From warning letter: “What Can I Do To Protect My Family From Monkeypox?... products like Vitamin A, Vitamin D, Zinc, Mother’s Immunity, and Immunity Boost [each of these product names links to your page selling the product] . . . help to prevent viral infections in general and *MAY* help prevent Monkeypox (we simply do not know enough to say for sure if they will offer protection).” This company needs a lot of compliance help. I found 161 occurrences of “depression” and 2930 references to “infection” on their website. I offer website and social compliance cleanup services. Let’s talk about how I can help you avoid a warning letter. 🔹Another company has DSHEA disclaimers all over their disease-containing posts. This is not a “get out of warning letter jail free” card that allows companies to say whatever they want. The dietary supplement industry is nuanced and requires knowledge and care when marketing supplements. This is why I always suggest hiring dietary supplement experts to help grow your company. I write in detail 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!

Maximizing sales by reducing risk in web and social media marketing for supplement and hemp industries. About Asa Waldstein Principal of Supplement Advisory Group , dedicated to providing regulatory and marketing risk analysis for the supplement industry. I love educating and supporting a community approach to compliance best practice development and lower-risk marketing strategies, which often change based on FDA/FTC enforcement trends. I routinely speak at conferences on enforcement trends, industry compliance, and the nuances of effectively marketing products in the digital era. Check out my weekly Warning Letter Wednesday post . I'm a Certified Clinical Herbalist (CCH) with 20+ years of experience developing and deploying organizational strategies across divisions in the dietary supplement industry. I've developed, manufactured, and marketed hundreds of dietary supplement products and have helped oversee three FDA GMP audits with no 483s. Former C-level executive integral in retooling operations, manufacturing, and QA to greatly improve order efficiency, fulfillment time, out of stocks, and excessive labor KPIs while supporting the company during the brisk revenue growth stage. Current Chair of American Herbal Products Association's (AHPA) dynamic Cannabis Committee and former board member. These affiliations allow me to continue to help drive hemp and dietary supplement regulations and compliance forward during this important time in the industry. Founder and host of Asa's Regulatory Hints YouTube channel . My herbalism research focuses on herbal therapeutics and identifying and ethically wildcrafting medicinal plants, skills now used when formulating, ordering, and approving ingredients. AboutVideo Free Introductory Regulatory Consult Available Online 15 Minute Consultation with Asa Waldstein 15 min Book 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!

Citing studies leads to increased scrutiny < Back Citing Clinical Studies & Labeling Errors Lead To Warning Letter Citing studies leads to increased scrutiny Citing clinical studies, labeling, and formulation errors lead to a beverage warning letter. #WarningLetterWednesday I'm sometimes asked if supplements can make disease claims with competent and reliable scientific evidence. Unfortunately not; even if a Randomized Controlled Clinical Study (RCT) was conducted on a supplement, the FDA does not allow disease claims in supplements or foods. Citing studies with disease claims on a commercial website is a common error that increases the chance of scrutiny, in my opinion. From warning letter: “Green tea has been shown in studies to naturally lower blood pressure” Nutrient content claims are cited in this warning letter. The company labeled their product “nitrogen enriched,” but because there is no DV% for nitrogen, it can’t comply with this regulation. Read more amount other nutrient content claims like “good source of” and “high potency” here . This warning letter mentions the word “stevia,” which is an incomplete ingredient description, and this is a friendly reminder to add the plant part or other information to ingredient listings. From warning letter: “stevia” does not meet the ingredient declaration requirements of 21 CFR 101.4 because it is not specific or descriptive enough to be a common or usual name. Simply declaring “stevia” does not identify whether the ingredient is stevia leaf, crude stevia extract, or purified steviol glycosides.” Here is another interesting example of an inaccurate ingredient listing. From warning letter: “hydrogen enriched RO water” are not common or usual names as required by 21 CFR 101.4 because “RO” is not a widely used abbreviation established by common usage. In addition, as explained above, hydrogen must be declared as a separate ingredient of these beverages, rather than as part of the name of the water ingredient.” The FDA cites a different Nutritional Facts Panel listing on the website “label” and the product label. This is the first time I have seen this mentioned in a letter, and it is a great reminder to have continuity in marketing and labeling. From warning letter: On your website, the product page … includes an image of its Nutrition Facts panel showing that the product contains 9 grams of sugar per serving. However, the physical label collected for this product during our inspection declares 0 grams of sugar per serving” There are even more interesting aspects, and I suggest reading 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!

Re-review online marketing if inspected by FDA < Back TCM Company Cited for Claims & GMP Violations Re-review online marketing if inspected by FDA This Traditional Chinese Medicine (TCM) product company was cited for GMP violations and disease claims. This warning letter contains critical GMP and marketing lessons such as labeling, testing, and marketing essentials. Here, we unpack some critical takeaways as a learning opportunity to help keep you out of trouble. This company was inspected by FDA and received some 483s, which led to their website being reviewed for disease claims months after the inspection. As we've spoken about many times here on Warning Letter Wednesday, it is imperative for companies that are inspected by FDA to ensure their websites are "clear" of risky claims. This is one of the reasons I developed Apex Compliance . To learn more about Apex Compliance, contact me. Here are some key labeling takeaways. The botanical ingredients are not in the standardized common name as noted in AHPA's Herbs of Commerce. They appear to be the TCM names, which is fine, but the common or Latin names are also required. If a label lists information in another language than English, all required information must also be listed in that secondary language. Admittedly, I've never thought about this, but it makes sense from a consumer protection standpoint. The plant parts were missing from a label. Many of the GMP violations cited here have to do with specifications. Specifications are integral to GMPs, and each raw material and finished product must have specifications for identity, purity, strength, and composition. I suggest reading through the warning letter to review FDA's comments. Master Manufacturing Records (MMRs) are the recipe telling the staff how to make a product. Here are several missing items that were cited in this letter. Description of packaging and a representative label. A complete list of components. The weight or measure of each component. Any intentional overage amount. This is to accommodate for shelf life testing and manufacturing variance. A statement of theoretical yield. This is so the company can find problems before the product gets to the next stage of production. For example, if too much of an ingredient was added, the weight should potentially be over the theoretical yield. In the past, my team accidentally added one kilo rather than 0.1 kilo, and calculating the yield caught the error. Specifications are needed for each point, step, or stage in the manufacturing process where control is necessary One person weighs or measures a component, and another person verifies the weight or measure. This is known as the doer/checker system to ensure weighing issues are prevented. This can be difficult to achieve in small companies. And many more items. Unqualified reference standards continue to be called out in warning letters. This company was cited for not using a validated reference standard for FT-IR identity tests. This essentially means if you are testing for something like chamomile powder, you must purchase a qualified sample and test against this standard. Yes, I know GMPs can be burdensome. There has never been a more challenging time than now to be a supplement manufacturer. I feel your pain. From warning letter. "You do not have an adequate identity specification because you are not conducting identity testing against a qualified reference standard." An Out Of Specification (OOS) was cited in this letter. An ingredient or product was OOS for zinc, but the company retested using a different method. FDA took issue with this, which is a learning lesson to ensure retests use the same method. This seems obvious, but in the heat of the pressure to release products, these items can sometimes be inadvertently overlooked. From warning letter. "The investigation testing was performed using a different methodology and by a different laboratory than the laboratory which conducted the original analysis, thus making it difficult to compare the results and to verify accuracy." The website states that products can only be purchased by a practitioner and that no retail sale is available. This is very interesting from a "material connection" point of view. If there is a material connection (e.g., commerce on the website), this is what FDA uses to connect marketing disease claims to commerce. If there is no commerce on the website or linked websites, FDA seems to rarely call out disease claims, which makes this example a rarity. Full disclosure: I have no way to verify if this was a recent change since the warning letter. If anyone knows, please let me know. There are so many GMP learning opportunities 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!

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!

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!