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!

Unsafe products marketed to children are deceptive < Back FDA/FTC Delta 8 Warning Letters Unsafe products marketed to children are deceptive Products like Doweedos Delta-8 Edible Chips were cited in yesterday's joint FDA/FTC warning letters. There were actually six warning letters sent in this enforcement action group, but for some reason, only five were joint FDA/FTC letters, and one was just an FDA letter. The FTC has more "teeth" than FDA, and these joint letters should send warning shots to sellers of THC and delta 8 products that are packaged favorably to children. Unfortunately, since this is not the first of these actions , I am unsure if the delta 8 market has gotten (or cares) about the message. One of the most interesting parts of this action is the use of Section 5 of the FTC Act, which prohibits unfair or deceptive acts. This prohibition includes practices that present unwarranted health or safety risks. Delta 8 poses dangers, especially to children, in favorable formats like cookies and bright-colored candy that looks like store-bought food. This is considered deceptive marketing. From warning letter. "Preventing practices that present unwarranted health and safety risks, particularly to children, is one of the Commission's highest priorities." Distributors are responsible: The companies in this enforcement action appear to be distributors of other products, showing that marketplace websites can be on the hook for what they sell. In the past FDA has primarily focused on large distributors like Amazon or websites selling dangerous products like delta 8. FDA does not like delta 8 for good reason, as shown in this consumer update . Delta 8 can be dangerous, and according to data from National poison control centers, 2,362 delta 8 exposure cases had been reported, including "One pediatric case was coded with a medical outcome of death." This report warns consumers that delta 8 products are widely available in forms favorable to children, such as chocolates and candies. This should have given the delta 8 industry pause, but these products have unfortunately continued to increase. The warning letters go into great detail about how the products mimic candy and other typical children's junk food. Here are some of the more appalling (and humorous) examples. Trips Ahoy Chocolate Chip Cookies: Flaming Hot Weedos Double Stuff Stoneo cookies This FTC quote sums it up nicely. "Companies that market and sell edible THC products that are easily mistaken for snacks and candy are not only acting illegally, but they are also putting the health of young children at risk," said Samuel Levine, Director of the FTC's Bureau of Consumer Protection. "Those that prioritize profits in front of children's safety are at serious risk of legal action." FDA reviewed many of these websites starting earlier this year and, according to the warning letters, re-reviewed the websites over the past few months. I ask, "What can we do to support the agency in removing these products from the market quickly, rather than having to go through the several months-long process they did here?" I think we can all agree taking these products out of the potential hands of kids is a good thing. In some instances, the online sellers removed only the products mentioned in the warning letters but continued to sell dangerous products. I ask, "Will they continue to sell these products, or will they face additional enforcement action?" After writing Warning Letter Wednesday for three years, I am still amazed by some of the bold claims and adulterated products sold, but this company won my "most OTT" prize. In addition to the delta 8 products cited in this warning letter , they are also selling pounds of psilocybin mushrooms from their website. The last I checked, these were Schedule 1 drugs, which means the potential for big legal issues. Oy vey! Here's the FTC press release on this action. DATE ORIGINALLY POSTED: 7/17/24 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!

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!

Brands should monitor influencer posts for compliance < Back Influencers Must Disclose Free Product Brands should monitor influencer posts for compliance Everyone loves free products, but influencers who receive free products and post about them must disclose this material connection. In a recent National Advertising Division monitoring case, a large publicly traded apparel and beauty brand was called out for its influencers not disclosing that they received free products. 👉From NAD case: “In exchange for receiving a clothing credit applicable towards … products, the influencers agree to publish a certain number of social media posts featuring (the brand). Here is what we can learn. 🔹Tagging a brand on a social media post is not disclosure. 🔹If an endorsement is made verbally, then the disclosure should also be made verbally. If the endorsement is not made verbally, then a # BrandAmbassador or “Thanks for the free product” is typically sufficient as long as it’s not buried below the “More” section. I made this video to show a possible way to disclose a free sample that can be fun and authentic. Providing influencers with examples like this can help maintain their compliance and authenticity. Read the NAD case here . DATE ORIGINALLY POSTED: 3/26/25 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!

Homeopathic products under increased scrutiny < Back Amazon and Walmart Cited For Distributing Homeopathic “Drug” Products Homeopathic products under increased scrutiny Amazon, Walmart, and four other companies were issued warning letters for distributing homeopathic products used to treat molluscum contagiosum, a viral skin condition most commonly occurring in children. This is the second warning letter Amazon and Walmart have received in the past year. The other letters were for distributing drug-spiked products with disease claims. Sign up for Warning Letter Wednesday. 🔷 Why did FDA choose to select products marketed for the skin ailment molluscum contagiosum? It seems FDA is concerned about the self-diagnosis of this skin infection when it could potentially be skin cancer. They also are concerned about products marketed as being “child safe.” 👉From warning letter. “A healthcare professional is needed to rule out the possibility of a more serious condition, such as, skin cancer…… FDA is concerned that people are forgoing or delaying proper diagnosis and treatment of a potentially serious, undiagnosed health condition by purchasing and using an unapproved drug product claiming to treat molluscum contagiosum.” 🔷We all know that Amazon dislikes this type of attention, and I wonder if this means the end of homeopathic sales on their platform. 🔷I am always interested when distributors actually get in trouble for selling products on their marketplace. We recently saw delta 8 distributors cited for this as well. According to regulations, companies are responsible for the products they distribute. 🔷The footnotes in the warning letter are worth reading and show that both Walmart and Amazon touched the products. If they did not physically handle the products, would they have been cited? 👉 From warning letter. “Each of the products was “fulfilled” by Amazon; your website states, “Fulfillment by Amazon (FBA) is a service that allows businesses to outsource order fulfillment to Amazon. .....when a customer makes a purchase, we pick, pack, and ship the order.” 🔷The warning letter footnotes also include FDA’s position on homeopathics. Several recent FDA letters have cited homeopathic claims, and I expect more in the future. Here is the Homeopathic Drug Products: Guidance . Reading this guidance and the warning letter footnotes shed light on where FDA’s thinking lies when it comes to homeopathic enforcement priorities and “discretion.” 👉Read the full Walmart letter 👉Amazon warning letter DATE ORIGINALLY POSTED: 8/23/23 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!

Packaging procedures prevent labeling issues < Back Major Allergen Labeling Issues Lead To Warning Letter Packaging procedures prevent labeling issues There are three lessons in this Warning Letter Wednesday post. Labeling major allergens, avoiding label mix-ups, and hazard analyses are required for conventional food. The specific type of allergen is needed for tree nuts, crustacean shellfish, and fish. This is still a common error that I see when reviewing dietary supplement labels. The specific species of fish (e.g., bass, flounder, tilapia, salmon or cod) The specific species of Crustacean shellfish (e.g., crab, lobster, or shrimp) The specific type of tree nut (e.g., almond, pecans, or walnuts) I review 10+ dietary supplement labels each month at my consulting company, Supplement Advisory Group . Contact me to learn more about this and my website/content compliance review services. I love this stuff. Proper labeling and packaging control can prevent dangerous and expensive mix-ups. This company put the wrong labels on which resulted in recalls and the warning letter. Proper packaging process control and documentation are critical in manufacturing, and up-front organization can prevent expensive issues. I use consultants like Nate Call & Blake Ebersole for Quality Management System development and implementation. If you want an introduction, please let me know. Conventional food companies must comply with all subparts of 21 CFR 117 , which include a risk-based hazard analysis. There are so many warning letters about this essential aspect of food safety. As a side point, dietary supplements need to only comply with some of the 21 CFR 117 subparts. Here is a good FDA resource that includes directions on listing major allergens and common seafood names. If you know of a better allergen resource, please do share. 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!

< Back Panel Discussion, Online Wednesday Mar 2, 2022 Immunity: Mastering the Market Naturally Informed powdered by Wholefoods Magazine and Trust Transparency Center It’s nearly universally agreed that the impact of the pandemic has changed the way consumers purchase health foods and nutritional supplements, with a huge amount of attention being placed on immunity. However, as we all begin to live in a “new normal,” the way shoppers and the industry think about immunity is shifting. Join the Naturally Informed team for a two-day event exploring the science, trends, supply-chain and business strategy of the immunity trend as it evolves again in 2022. Learn from a line-up of world-class speakers as we explore how to master the immunity market in the post-pandemic era, with cutting-edge insights on emerging research, consumer trends, product positioning, marketing messaging, and more. Learn More and Register Previous Next

< Back Podcast Monday Jan 3, 2022 The Supplement and CBD Advisor: Bridging the Regulatory and Marketing Gap Getting Transparent Podcast In this episode of Getting Transparent , Asa Waldstein, Founder and Principal of Supplement Advisory Group joins host Joe Witte to discuss the intersection of FDA regulations and marketing claims in the supplement and CBD industries. In addition to running his own advisory firm, Asa serves at the Cannabis Committee Chair, and on the Sustainability Committee for the American Herbal Products Association. Asa also founded the Supplement and Hemp Education Series and has extensive education in botany and is a certified clinical herbalist. And just as important, Asa is an avid hiker, skier and Grateful Dead fan! In this podcast episode, Asa shares wisdom on some of the following topics: How making certain marketing claims for your supplements and CBD can put your company at risk The unforeseen risks of FDA warning letters Managing claims on social media and blogs (and how to avoid FDA issues) Preparing for FDA audits “Regulatory compliance does not have to be scary…by reading enforcement trends, we’re then able to change our marketing approach in a way that can authentically connect with consumers, but can also keep us out of trouble.” - Asa Waldstein. Listen Previous Next

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!

< Back Presentation Tuesday Aug 30, 2022 Common Mistakes and Best Practices for Online Supplement Sales Positively Natural Marketplace Las Vegas, NV In this interactive discussion, Asa Waldstein reviews common and preventable mistakes companies make when selling supplements online. This includes the nuances of discussing ingredient benefits, social media, and blogs. Asa will also review enforcement trends and share best practices to sell products without inadvertently crossing the line into high-risk marketing. Please bring your questions to this session. Learn More Previous Next

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!