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!

Amazon compliance still needs improving < Back FDA Crackdown on Animal Product Seizure Claims Amazon compliance still needs improving Six animal product companies received warning letters for making seizure, cancer, and other serious disease claims on Amazon, social media, and websites. You may be saying, “These companies should have known better,” and I agree, but what was bewildering is that three of these companies were cited for seizure-type claims on Amazon. This is surprising because these types of statements on a human supplement lead to delisting, but these letters have highlighted Amazon’s lack of enforcement in the nuanced animal “supplement” arena. I expect animal products making unallowable disease claims on Amazon to be delisted soon, as Amazon tends to be reactive when FDA warning letters are issued. For companies in the animal supplement space, working with the National Animal Supplement Council is a great path towards product compliance, and Apex Compliance , my marketing claims and compliance software product, is proud to be an NASC preferred supplier. From one of the warning letters. Yes, the name of the product is Epilepsy & Seizure Formula. “From your product webpage …” on Amazon… • “Epilepsy & Seizure Formula… Remedies for Dogs and Cats” Homeopathics : One of the warning letters included claims made about homepathics. This is an important reminder that FDA does not tolerate extreme disease claims made about homeopathic products. Here is my previous post about this. YouTube : One of the letters includes claims on YouTube. A new Apex Compliance feature allows you to scan entire YouTube channels for keywords and disease claims. This helps find issues before they lead to regulatory trouble. I love it! For those who are confused about what claims can be made about animal “supplements,” the answer is “not much.” This is because FDA takes a stricter approach against animal supplements compared to human supplements. Here are some differences in human and animal product claims enforcement with the caveat that all claims must be substantiated. Lower-risk structure-function claims like “joint support” are unlikely to attract warning letters in animal or human product marketing. Claims that push the compliance boundaries, like “reduces anxious feelings,” may attract an animal product warning letter but are unlikely to be the sole reason for a human product letter. This is because the FDA has a lower “tolerance” for these types of statements in animal products. I write about this here and here . Here are the six FDA warning letters. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/evolution-pets-llc-696281-11122024 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nutrition-strength-ltd-696350-11122024 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/energetic-essences-llc-dba-pet-essences-696395-11122024 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/veterinary-select-formula-dba-allergic-pet-696354-11122024 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intermarket-industries-inc-dba-doc-ackerman-pet-products-696352-11122024 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hdfrenchies-llc-dba-bully-baum-696351-11122024 DATE ORIGINALLY POSTED: 1/8/25 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!

Distributors are responsible for the products they sell < Back Walmart & Amazon Issued Warning Letters for Adulterated Products & Disease Claims Distributors are responsible for the products they sell Amazon and Walmart were cited for selling a product with disease claims and adulterated with NSAIDs. The product is a nutraceutical and omega-3 product that contains undeclared diclofenac, a non-steroidal anti-inflammatory drug (NSAID). Both warning letters include comments where FDA highlights that the company (Amazon or Walmart) is the party that fulfills and distributes the product. According to supplement regulations, companies that distribute products have a level of GMP and regulatory responsibility. Essentially if a company markets, distributes, and sells a product, they are responsible, even on a marketplace site. This webinar with Nathalie Bougenies and Steven Yeager shows many items companies need to comply with these regulations. From Amazon warning letter. “These products were introduced or delivered for introduction into interstate commerce by Amazon via your Fulfillment by Amazon service.” There were also examples of claims on both the Amazon and Walmart sites, such as “arthritis.” This is the most common “itis” referenced in warning letters and is an important reminder to scan for higher-risk words like “arthritis.” I expect this action to possibly lead to these companies asking for more adulterant testing and a deeper look at disease claims. For example, if the word “arthritis” is on your Amazon page, I expect it to be flagged. This product was recalled in June 2022. It is unclear if the products in these warning letters are from the same recalled lot or a different batch. From warning letter. “Combate la artritis.”” (English translation: Fights arthritis.)” Interestingly, the disease claims were in Spanish, a good reminder that the FDA also pays attention to claims made in other languages. I welcome your thoughts on these notable warning letters. Read the Amazon warning letter . Read the Walmart 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!

Replace “insomnia” with lower-risk alternatives < Back Insomnia claims continue to attract FDA attention Replace “insomnia” with lower-risk alternatives #WarningLetterWednesday highlights insomnia claims that continue to attract FDA's attention. There were 22 FDA warning letters in 2021 with insomnia claims, dramatically up from 14 in 2020, 2019 (13), and 2018 (7). This is a clear indication of an FDA enforcement trend and a good reminder for marketers to remove the high-risk buzzword "insomnia" from their marketing. As many of you know I have an "Asa Risk Scale" where certain claims are rated on a 1-5 risk scale, with anything 3+ likely to attract a warning letter. Insomnia is rated as a solid 3.5+, which means it should never be used. If truthful and not misleading here are some possible alternatives for insomnia. *feeling refreshed in the morning *a restful night's sleep *healthy slumber support *sleep support *supports a healthy night's sleep *support rest 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!

Playful ads can attract scrutiny < Back Bashing Competitors Can Lead to Challenges Playful ads can attract scrutiny Bashing competitors, even unnamed ones, can lead to competitor challenges. In this post, I review this National Advertising Division case where General Mills challenges television commercials by Welch's Fruit Snacks. In the commercials, celebrity chef Gordon Ramsay throws away generically labeled "Fruit Flavored Snacks" by tossing them out of a window and even spitting them out. In my opinion, the commercial is actually pretty good. It can be watched here . 🔹From NAD. "NAD determined that one reasonable takeaway from the commercials is that the whole fruit content of Welch's Fruit Snacks makes it a superior product for consumers." NAD also determined that the dramatic throwing away of the generic products was considered "ash canning," which depicts "competing products like General Mills' fruit snacks as lacking any positive value." The term "ash canning" in advertising refers to a practice of depicting competing products as having little or no value and implies that the competing product is so inferior that it might as well be discarded like ashes. Here's another NAD case involving "ash canning," where a beer company was asked to discontinue a commercial with imagery and a "Light beer shouldn't talk like water. It should taste like beer. "statement. In the beer case, NAD offers this information regarding the needed substantiation. 🔹 "NAD determined that tasting "like water" is a measurable attribute. Reliable sensory testing could demonstrate whether consumers detect a watery taste or the complete absence of taste. Consumers may also reasonably expect that the statement is supported by such evidence. Good resource here; I came across the ABC Television: Advertising Standards & Guidelines document , which has some helpful high level information on things like puffery, ash canning, and substantiation of performance and efficacy claims. The moral of this story is to use caution when bashing even anonymous products, especially the litigious ones with deep pockets, to initiate challenges. Read the case summary here . DATE ORIGINALLY POSTED: 10/16/24 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!

Key GMP learning opportunities explored < Back Incomplete 483 Responses Lead to Warning Letter Key GMP learning opportunities explored We can learn a lot from warning letters. This manufacturer was inspected in April 2022, where they received some 483s. The company subsequently responded to some 483s, but according to the warning letter, “Not all of the items on the issued Form 483 were addressed in your response.” In my experience, most 483s can be addressed before they become warning letters. I talk about improper 483 responses here. Here is an example from the warning letter. From warning letter. “We have reviewed your June 23, 2022 response to the form FDA 483. We are unable to evaluate the adequacy of your response because you did not provide documentation demonstrating you have established specifications… You provide documents you describe as revised finished product specifications for the … product. We note that these documents do not demonstrate that you have established specifications that provide standards to confirm the identity, purity, strength, and composition of the finished batch of your dietary supplements. For example, the finished product specification for … product lists an “identification” specification of “Conforms to Standard” with a test method of “Eurofins or eq.” and a frequency of “Rotational.” “Conforms to standard” does not specify the extent to which the component must conform. “Eurofins or eq.” is not a test method, and “Rotational” does not describe the frequency of when testing is to occur. Let’s break this down. 🔹Identification: The company lists the type of identification as “conforms to standard” but does not provide information on what that standard is. The company is close but, unfortunately, falls short of GMP requirements. Here is howI think about GMP documents, such as this specification sheet. Will someone unfamiliar with your process be able to step in and understand how to test the product if there is no “institutional knowledge?” It is the "recipe" for staff to follow. 🔹Test method: The company lists “Eurofins or eq” which is the name of the laboratory, not the name of the method, such as “AOAC 121804.” 🔹Frequency of testing is listed as “Rotational,” which is not sufficient. It should state “Test all” or refer to an SOP on skip lot testing. Incorrect reference samples are also cited. 👉From warning letter. "You failed to establish and follow laboratory control processes that are reviewed and approved by quality control personnel to use criteria for selecting standard reference materials used in performing tests and examinations… Specifically, the FTIR analysis performed by your third-party laboratory uses previous shipments of components as the reference for testing and they do not own a reference library for the FTIR tests. Testing components against previous shipments of the component may confirm receipt of the same component but this does not ensure the identity, purity, quality, and strength of the component is thoroughly characterized.” I admit this is how I tested identity around 2010 until I realized that having a qualified reference sample was essential. In this example, the third-party lab should have handled this rather than just depending on previously provided reference samples, and the quality personnel should not have allowed this. One more learning opportunity. 🔹Theoretical yield calculation helps “error-proof” manufacturing. Let’s use the example of a capsule product. First, the powder needs to be blended. If the theoretical yield is off, this will signify too much or too little of an ingredient was added and, therefore, should not “pass” to the encapsulation process. 🔹The same Is true for encapsulation. If a company has substantially more capsules than the theoretical yield, this signifies the capsules are underweight and not at label claim. The production should be stopped for evaluation here. 🔹If the yield is too high in bottling, this shows there are likely not enough capsules in each bottle. This lily-pad approach to quality is designed to stop problems before they happen. From warning letter: "A statement of the theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process and the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary." Interested in learning more about GMPs? Here are a few webinars you may enjoy. 🔹Distributor requirements for supplements . 🔹Getting ready for FDA inspections . There are so many learning lessons. Read the full letter here. Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

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!