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Asa and other industry leaders weigh in < Back Regulators mostly silent on GLP-1 supplement claims Rachel French Interview Asa and other industry leaders weigh in The number of dietary supplement brands that make GLP-1-related claims is spiking. Yet, the emerging category of supplements has been largely met with silence from regulators, creating ambiguity for brands. Ozempic and similar drugs, classified as GLP-1 (glucagon-like peptide-1) agonists, were initially designed for the treatment of type 2 diabetes, but now are commonly used for weight loss. The drugs have seen immense popularity in recent years. One study published in the Annals of Internal Medicine identified a 700% increase in prescriptions for GLP-1 drugs in patients with overweight or obesity diagnoses over a four-year period. The study — which tapped 45 million de-identified medical records — found about 21,000 patients in the U.S. were using GLP-1 drugs to treat overweight or obesity in 2019, compared to 174,000 in 2023. Read More Previous Next

< Back In-Person, Panel Discussion Thursday Jan 23, 2025 Our Commitment to Product Integrity Organic & Natural Health Association Fort Lauderdale, FL 12:15 – 1:30 pm Our Commitment to Product Integrity Amy Summers Founder & President Pitch Publicity & INICIVOX- Moderator Deleo de Leonardis, CEO Co- Founder, Purity IQ Erin Taraborrelli, Program Manager, Labeling & Training Services, SGS nutrasource Ray Martinez, President, Florida Supplement Sandra Baek Lee , CEO, NJ Labs Asa Waldstein, Founder and Principal, Apex Compliance Learn More Previous Next

Companies that compensate influencers or affiliates may be responsible for claims they make < Back MLM Company Cited For Claims Made By Their Affiliates Companies that compensate influencers or affiliates may be responsible for claims they make This is the one-year anniversary of #WarningLetterWednesday. I have written this post every week, even when having Covid, on a tropical vacation, or under a massive work deadline. I love writing this post and hope you find as much joy in it as I do. Today’s post is unique. It involves an MLM company that was cited for claims made by company “consultants,” which is very similar to influencers or affiliates that receive compensation for referral sales to a company website. This is the first time I have seen a company cited for claims made by its affiliates, and this is a trend to watch. From warning letter: “Consumers interested in your products are then redirected by your consultants to your websites www.youngliving.com and www.naturesultra.com to purchase your products.” One of the affiliate Instagram pages mentioned in this letter only has 627 followers, a good reminder there is no such thing as being too small to attract FDA scrutiny. Most claims cited in the warning letters are from the “consultants,” with a few exceptions such as this. From warning letter: “On your website, https://naturesultra.com ....Some studies suggest [t]he most common illnesses caused by an improperly functioning ECS are depression, Alzheimer[’]s, IBS, fibromyalgia, and even migraines” The Denver office issued this warning letter, which seems to be more rigid with online claims enforcement than other divisions or the national offices. Key takeaways are companies should remove risky words from company websites and train and monitor affiliates and influencers to ensure no disease claims are present. I look forward to hearing your comments on this very fascinating warning letter! Full warning letter DATE ORIGINALLY POSTED: 7/20/22 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!

Here are tips on using FDA’s ingredient directory < Back Unallowable Ingredient Results in Warning Letter Here are tips on using FDA’s ingredient directory FDA cited a company for marketing sulbutiamine, an unallowable ingredient in their dietary supplement. This is different than the standard “drug-spiked” warning letter, where companies were hiding sildenafil and diclofenac in supplements. This company actually labeled their product as Sulbutiamine Plus Brain Support. I find this warning letter interesting for several reasons. First, I do not see Sulbutiamine listed in FDA’s “Information on Select Dietary Supplement Ingredients and Other Substances” link or in previous warning letters. This link can provide some helpful information to show FDA’s thinking on why certain ingredients may be allowable. Ingredients are listed by category. Here is the breakdown (from FDA). 🔹Category 2: Ingredient is the subject of a safety communication 🔹Category 3: Ingredient is not a “dietary ingredient” under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 🔹Category 4: Ingredient is excluded from the dietary supplement definition under section 201(ff)(3) of the FD&C Act 🔹Category 5: Dietary ingredient has not met the safety standard in section 402(f)(1)(A) of the FD&C Act 🔹Category 6: New dietary ingredient has not met the safety standard in section 402(f)(1)(B) of the FD&C Act 🔹Category 7: New dietary ingredient requiring a premarket safety notification under section 413(a)(2) of the FD&C Act, but for which no notification has been submitted This warning letter does not appear to mention that any commerce or testing occurred. It simply states that the company is selling a product with sulbutiamine, which is not a legal dietary ingredient or food additive. There is no statement such as “we reviewed your website over the past few months and see that you sell a product into interstate commerce.” FDA’s budget has been slashed, and we may see more of these low-lift letters in the future. I also ran the company’s website through Apex Compliance and found that the company is making disease claims on many other products but no disease claims are mentioned in this warning letter. I Googled sulbutiamine and found many well-known companies selling this ingredient. I expect more enforcement and private litigation around this ingredient in the near future. Read the warning letter . DATE ORIGINALLY POSTED: 5/21/25 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!

Product reviews must be honest and truthful < Back Online company fined $4.2M for blocking negative product reviews Product reviews must be honest and truthful #WarningLetterWednesday Online company fined $4.2 million for blocking negative product reviews. The FTC alleges the company blocked product reviews with less than four stars. This is considered deceptive marketing and clearly warns companies that product reviews should be accurate. Here is what we can learn. 🔷Best practices for soliciting and posting reviews. From FTC letter ➡️Examples may include asking for reviews only from those likely to leave positive ones, preventing or discouraging submission of negative reviews, subjecting negative reviews to greater scrutiny, refusing to publish negative reviews, or otherwise not treating positive and negative reviews equally. 🔷Here are some FTC rules for possible exceptions to the "post all" rule. From FTC press release➡️(the company) must post on its website all customer reviews of products currently being sold—with the exception of reviews that contain obscene, sexually explicit, racist, or unlawful content and reviews that are unrelated to the product or customer services like shipping or returns. Here is a video about product reviews . Read the FTC press release . This is a different Warning Letter Wednesday because it is an FTC action (not FDA), and it involves a fine (not a warning letter) and doesn't include a supplement company. This is a good reminder that we can learn from other agency actions such as this one. 👉Join my Warning Letter Wednesday group 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!

Remove COVID claims including on YouTube < Back The First 2023 Warning Letter Belongs to a CBD Company Remove COVID claims including on YouTube The first "supplement" warning letter of 2023 belongs to a CBD company. 2022 was the year of the CBD warning letter, and FDA enforcement in this area appears to be continuing. This warning letter is another reminder that no company is "too small to be off FDA's radar." A video cited in this letter only had 19 views at the time I wrote this post! This is the most unpopular video I have ever seen cited in a warning letter demonstrating that any online marketing is fair game for enforcement. I write more about this here . This company was marketing a cannabinoid product for COVID protection on its website, socials, and YouTube. There were several similar warning letters last year involving companies citing research about cannabinoids and COVID. I usually take a "maybe they didn't know any better” attitude when looking at enforcement and compliance, but in this case, the company should have known better because of the well-publicized action against other CBD companies for this same type of statements. Here are some critical posts about CBD enforcement in 2022. CBD enforcement is top of mind for FDA. This includes animal warning letters . CBD and anxiety claims . Citing clinical studies . Natural Products Insider Q4 Update . This letter mentions several claims made in YouTube videos. Last year nine warning letters cited claims made on YouTube, and I expect this enforcement trend to continue. I write more about this here . This letter cites claims made on the company's social media from early in the pandemic. As we've discussed many times on Warning Letter Wednesday several times before, companies are responsible for all social media posts, even if they are several years old. From warning letter. "COVID prevention with CBD? Canada study shows it's possible. Might be time to start a daily dose of…… all-natural pharmaceutical grade CBD products…. USE CODE: COV19" [from a May 15, 2020, post on your Facebook social media webpage" This letter also cites the product code "COV19" which is a bold claim and further shows the intended marketing use of the product. This is a reminder that items like meta tags, product tags, search tags, and coupon codes are considered marketing. This is a joint FDA and FTC warning letter, which is common when COVID claims are cited. This is serious, and it also involves a cease and desist barring the company from making COVID-related claims or face injunction, a civil penalty of up to $46,517 per violation requirements to refund customers. 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!

There are no FDA approved supplement facilities or supplement products < Back Supplement company’s brochures and online marketing lead to a warning letter There are no FDA approved supplement facilities or supplement products The FDA inspected a facility, then six months later they reviewed the company website. This is a continuing trend and a reminder to screen for disease words online, especially after a GMP inspection. Here the FDA refers to a product brochure as labeling. This is an important reminder that all marketing is an extension of the label. Here is a video about this. From warning letter: “On your product labeling (brochure) for “Kidz DHA,” which directs consumers to your website …. where the product is available for purchase: “DHA supplements are purported to treat certain health problems in children, such as allergies, asthma, and attention deficit-hyperactivity disorder (ADHD).” Several other disease words are mentioned in this letter, such as anti-bacterial and anti-inflammatory. As a rule, words containing “anti” should be avoided. The one exception here is antioxidant. Also interesting in this letter is the mention by FDA that they do not approve facilities or supplement products. If a company claims to have FDA approval of their supplements, this is a marker they do not understand the basics of dietary supplement regulations. From warning letter: "We note that your website includes the statement that …. are made . . . in an FDA approved facility.” Although certain facilities must register with FDA, FDA does not approve facilities. Read 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 Virtual Fireside Chat Friday Jun 16, 2023 Substantiation Dossiers: Building Trust in Label Claims for Retailers, Influencers, and Consumers Radicle Science June 16, 2023 (10:00 am PT / 1:00 pm ET) The dietary supplement industry has no shortage of attention lately when it comes to the Federal Trade Commission and the recent notices of penalty offenses on label claims. Brands are reaching for substantiation dossiers as a means to provide their retailer partners, influencers, and customers assurance that their label claims are factually accurate. Join Radicle Perspectives with Asa Waldstein , Principal of Supplement Advisory Group , as we discuss how to mitigate label claim risk, the impact recent headlines have had on dietary supplement consumers, and what Asa sees is next when it comes to the FTC drama. Key Topics: Understanding label claim risks in the dietary supplement industry Strategies to mitigate label claim risk through substantiation dossiers Insights into the future of FTC regulations and its implications for the industry Watch On Demand Previous Next

Called Apex Compliance, the software detects risky marketing terms and phrases and suggests lower-risk alternatives. < Back Regulatory compliance software helps supplement, nutrition, functional food, and cannabis brands vet their marketing claims Jennifer Grebow Interview Called Apex Compliance, the software detects risky marketing terms and phrases and suggests lower-risk alternatives. Read More Previous Next

< Back Presentation, Online Thursday Feb 29, 2024 The Regulatory Universe & AI Naturally Informed Asa is excited to participate in "The Regulatory Universe & AI" discussion with technology genus Akash Shah at this Naturally Informed event. Asa will be talking about how technology and AI can make regulatory marketing compliance better, and will also share his "recipe" for how to best use AI and algorithms together. Your questions will be answered in a Q&A format. Learn More & Register Previous Next

Ensure vendors are properly qualified < Back 7 Homeopathic Eye Product Warning Letters Ensure vendors are properly qualified Eight companies received warning letters for selling homeopathic and other eye-lubricating products. This signals the continued shift in FDA’s enforcement priorities towards homeopathics. Most of these companies were selling ophthalmic homeopathic products with some disease claims. I assume that if there were no GMP concerns, the products were not for use in the eyes, the target audience was adults, and there were no serious disease claims, many of these companies would not have received warning letters. FDA probably cited this group of products because they are (ophthalmic) added to the eyes, which may potentially endanger eye health. There are allowable OTC monographs for these types of products, but it seems the products were homeopathics, not labeled as OTCs (Drug Facts Panel), or in at least one instance, the product was labeled as an OTC but was not submitted to the required National Drug Code Registry . Products added to the eyes can be dangerous, and eye two lubricant products contain NAC, which I don’t think is approved for ophthalmic delivery. When I was a supplement manufacturer, I always said NO to making these types of products. From warning letter, “Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.” Here are some other highlights: 🔷 This company was cited for making disease claims in testimonials. It is worth noting that testimonials were showcased and promoted in a banner. If the testimonials were part of a 3rd party review widget, such as those uncurated reviews that come in through a service like Trustpilot, they probably would not have been cited. 🔷 My “day job” is running a regulatory consulting company. Contact me to discuss reviews, labels, or online marketing compliance questions. This helps support my WLW writing passion (smiles). 🔷 Normally, there has to be commerce for a company to receive a warning letter. This company does not appear to conduct commerce on its website and only offers a practitioner login option. The company was selling ophthalmic products with disease claims, which led to the warning letter even though there does not seem to be public commerce on the site. This is VERY INTERESTING and should be a wake-up to companies using this strategy to push the compliance boundaries. 🔷 This well-known homeopathic company was cited for not only making ophthalmic homeopathic products and disease claims, but this warning letter also includes numerous GMP violations. Products from this company were placed on import alert, which speaks to the severity of the alleged GMP issues. I assume that FDA “followed the breadcrumbs” for other products made at this facility, which led to the Walgreens and CVS warning letters. This highlights the need for supplier qualification, something consultant Nate Call is an expert at. 🔷 A four-year-old social post was cited, which is another reminder to remove language from all social media, no matter how old. 🔷 From warning letter. “February 9, 2019 Twitter post: An image of the “Vision Clarity Eye Drops” with the text, “Carnosine, a cataracts worst nightmare.” Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

Use FDA’s helpful resource (Criterion 2) < Back Best Practices When Making Biomarker and Implied Claims Use FDA’s helpful resource (Criterion 2) I often talk about disease claims attracting warning letters, but it can be difficult to know where the line is between allowable structure-function claims and off-limits health claims. Thankfully, the FDA has published the "Small Entity Compliance Guide on Structure Function Claims," which provides a Q&A with 10 criteria to help determine if a statement is a disease claim or a structure-function claim. It's really helpful! In today's Warning Letter Wednesday, I am exploring Criterion #2, "Claims an effect on characteristic signs or symptoms of disease using scientific or lay terminology." This criterion shows the FDA's thinking on why biomarker claims like "lowers cholesterol" are disease claims. 👉From FDA Guide. "Some claims imply disease treatment or prevention because they are so intimately tied to a disease. For example, "inhibits platelet aggregation" or "reduces cholesterol" are such characteristic signs or symptoms associated with stroke and cardiovascular disease and interventions to treat those diseases that any claim about them would be an implied disease claim." 🔹 Asa Comments: This is where FDA shares insight on why biomarker claims like "lower LDLs" are disease claims. They also use heart disease examples, which highlight why most of the biomarker warning letters involve cardiovascular-related claims. I write more about this here in a post from 2022, and the enforcement trends have continued. 👉From FDA Guide: "Other signs or symptoms are associated with a wide range of disease and non-disease states and do not necessarily imply an effect on a specific disease. For example, although "improves absentmindedness" might imply treatment of Alzheimer's disease and "relieves stress and frustration" might imply treatment of anxiety disorders, both of these signs also are characteristic of non-disease states. So, if there is no context linking them to a disease, they would be appropriate structure/function claims." 🔹 Asa Comments: This shows how context matters and how structure-function claims can cross the line into disease claims. For example, in the FDA's "improved absentmindedness" example, if there was an image of a confused elderly person, this would elevate the likelihood of it being an Alzheimer's claim. 🔹 🔹 We've all seen the "maintain cholesterol levels already within a normal range statement, and this is where it comes from. The key takeaway here is being "absolutely clear" when making disease-adjacent is a safer strategy. Of course, I am just talking about FDA guidance here and this doesn't stop retailers like Amazon from unnecessarily flagging keywords like "cholesterol levels" which can lead to delisting. Retailers are increasingly tuning into "another regulatory group" to be aware of. 👉From FDA Guide. "There are many conditions that are "normal," but under certain circumstances are also disease claims. The rule states that such claims (for example, maintaining normal cholesterol levels) may be appropriate structure/function claims and would not imply disease if the claim made absolutely clear that the claim is referring to structure/function claims that are already normal. This context would remove the inference to an effect on a structure/function that was abnormal (for example, "maintain cholesterol levels that are already in the normal range")." 👉From FDA Guide. "The standard focuses on whether the labeling suggests that the product will produce a change in a set of one or more signs or symptoms that are characteristic of the disease. You can meet this standard using technical or layman's language and it isn't necessary that every possible sign or symptom is used." 🔹 Asa Comments: This section focuses on implied claims such as an EKG symbol, "lowers bad fats," or statements like "I never had to see my cardiologist again." Before-and-after pictures of an older person who no longer has mobility issues also apply here. In practicality, implied claims are somewhat less likely to attract regulatory issues because they may not contain "trigger words," but avoiding them is a good idea. Read FDA's Small Entity Compliance Guide on Structure Function Claims here . This is a great resource! DATE ORIGINALLY POSTED: 4/9/25 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!