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Brands need to ensure regulatory responsibilities are accounted for at the start of a contract manufacturing partnership. < Back Compliance responsibilities when using a contract manufacturer Rachel Adams Press Mention Brands need to ensure regulatory responsibilities are accounted for at the start of a contract manufacturing partnership. Read More Previous Next

Curated testimonials are marketing claims < Back Injectable CBD Warning Letter Curated testimonials are marketing claims Injectable CBD? The first CBD warning letter of the year is an odd one. The company was cited for selling injectable CBD products and making disease claims on its website and social media. Here are some key takeaways. 🔹Where is the commerce (sales) taking place? The company's website is designed for practitioners, and it looks like no actual commerce takes place on the website or social media. I even looked at archived website versions of the Wayback Machine. I didn't see anywhere to actually purchase the product unless I set up an appointment with a licensed therapy professional or provided professional credentials. Typically, these "gated" or "commerce-removed" websites do not attract FDA warning letter attention since no public commerce takes place. This type of situation is rare and is really interesting. 🔹Curated testimonials: The agencies are generally "hands off" with third-party, non-curated, non-compensated product reviews or testimonials. These become "marketing" when the company engages with them or curates them, such as adding them to a banner, product page, or social post. Also, FDA sometimes considers separate "testimonial" or "product review" pages as being curated, meaning they are fair game for enforcement. In this letter, the "testimonials" web page had many disease claims. This testimonial shows that making a "better than drugs" statement will increase the chance of a warning letter. 👉From warning letter. "I have now completed two PICO CBD infusions (each 14 days apart) and have had no need to take any Xanax. It's been years since I have been able to go 30+ days without an anti-anxiety pill." 🔹Products marketed as a dietary supplement. Even though the product image label does not appear to list a "supplement" statement of identity or fact panel, the FDA did some investigation work. 👉From warning letter. "You appear to be marketing your "Pico IV" as a dietary supplement. For example, marketing material found on your website states that "CBD, and other cannabinoids, are considered dietary supplements by the FDA . . . even if they're administered intravenously." 🔹Social media disease claims. FDA cited several disease claims in this letter. What's fascinating about this example is the company's use of "potentially." The softening words do not allow a company to make disease claims. 👉From warning letter. "CBD [p]otentially reduce anxiety and inflammation. CBG [c]an support bone health and neuroprotection" This letter came in a group of other injectable-related warning letters which shows that FDA wanted to make a statement about the dangers of IV therapeutics. Read the full letter here . DATE ORIGINALLY POSTED: 3/19/25 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!

Dietary supplement consultant Asa Waldstein reviews regulatory trends over the last quarter in his FDA warning letter roundup column. < Back Q1 2024 warning letter roundup with Asa Waldstein Asa Waldstein Guest Article Dietary supplement consultant Asa Waldstein reviews regulatory trends over the last quarter in his FDA warning letter roundup column. Read More Previous Next

< Back Panel Discussion, Online Tuesday Nov 14, 2023 The claims they are a-changin’ AHPA Botanical Congress In the first update to dietary supplement advertising guidance since 1998, the Federal Trade Commission (FTC) issued its Health Products Compliance Guidance in December 2022. Then, in April 2023, FTC sent out a mass notice of penalty offenses to almost 700 companies that market dietary supplements, OTC drugs, homeopathic products, and functional foods, referring to the guidance and warning that the agency could pursue civil penalties for companies that did not substantiate their claims. Moderated by Asa Waldstein (Supplement Advisory Group), this session will feature discussion of the new guidance, the notices, and the impact of both, as well as adequate claim substantiation. Attorney Ricardo Carvajal (Hyman, Phelps & McNamara) will also review current trends in litigation. Learn More & Register Previous Next

< Back Panel Discussion Wednesday Mar 29, 2023 Claims, Compliance, COA panel NoCo Hemp Expo Colorado Springs, CO For nearly a decade, NoCo Hemp Expo — the world’s most comprehensive industrial hemp exposition and conference — has brought together international business and government leaders, academia, nonprofits, media and the public to collaborate on important initiatives, opportunities and solutions for the future of a crop and an industry that can have significant positive impact on human, animal and planetary health. Claims, Compliance, COA panelists include: Asa Waldstein Marielle Weintraub, Ph.D. Christopher Hudalla Holly Bell Jackie Bowen Learn More Previous Next

Review of NAD case < Back Finished Product: Clinical Study Required Review of NAD case Are clinical studies really needed on finished dietary supplements? Here, I review a recent National Advertising Division (NAD) case on the topic. Full disclosure: I like NAD, and their cases are a wealth of learning opportunities, but the interesting and somewhat mind-boggling portion of this case has to do with performance claims. Based on the information provided, it seems that NAD requires a finished product study to substantiate the “helps maintain healthy eyesight and visual performance” statement. 🔹 NAD states this is “because the studies and meta-analysis relied on by the advertiser were not conducted on the (product).” 🔹 NAD goes on to say, “NAD recommended the claim be discontinued but noted that nothing in its decision prevents (product) from tailoring its claims to the benefits specific ingredients in (product).” A takeaway here is attributing substantiated structure-function claims to ingredients like “vitamin C for skin health” rather than simply stating the product is used for skin health is a risk-lowering strategy. I still feel like I am missing something here because I can’t imagine agencies or courts requiring finished product studies for low-risk structure-function claims that do not state the product is clinically proven. I write more about these important points from the FTC’s Notice of Penalty Offence letters here . There’s more to this case , including bioavailability claims, and I suggest everyone read it. Please let me know your thoughts. 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!

Nutrition fact panels must be in a compliant format < Back Lack of Allergen Labeling Leads to Potential Death Nutrition fact panels must be in a compliant format Allergen labeling regulations are important. They help people with severe allergies avoid products that can make them sick or worse. In this example, the company allegedly did not disclose peanuts and eggs, which led to an anaphylactic death. 👉From warning letter. “On January 23, 2024, after being notified of a consumer complaint received by the FDA regarding an anaphylactic death associated with …. your firm recalled the cookies. The products contained peanuts and eggs but your printed label on the package did not contain an allergen statement or ingredient declaration for peanuts or eggs.” The warning letter goes on to state that there are missing and extra ingredients on the label, which shows that the company’s quality control procedures need a serious review. Disclosing major allergens is easy. Here are the two options. I always prefer the “Contains” option as it’s more apparent to the consumer. 👉The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]; or 👉The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., “Whey (Milk)”), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)]. The Nutrition Facts Panel (NFP) is also not in the correct format. There are differences between a Supplement Fact Panel and an NFP. This FDA reference is pretty good. 👉From warning letter. “The calorie declaration is not shown bolded and in larger print size, as required by 21 CFR 101.9(d)(1)(iii). b. It lacks the declaration for added sugars, as required by 21 CFR 101.9(c)(6)(iii) c. It lacks the declaration for the required vitamins and minerals, vitamin D and potassium, as required by 21 CFR 101.9(c)(8)(ii)” Here are some examples of compliant NFPs . Read the warning letter here . DATE ORIGINALLY POSTED: 11/27/24 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!

< Back Interview Thursday Jul 15, 2021 Effective and practical marketing compliance Insider in the Afternoon We speak about structure-function claims, disease claims, marketing risk versus reward, and clever product names. Watch Previous Next

< Back Workshop Tuesday Apr 19, 2022 Marketing and Regulatory Compliance for 5th Year PharmD Students (2022) Massachusetts College of Pharmacy and Health Sciences This course reviews common product online and social media marketing pitfalls to avoid. We also discuss strategies to give graduates a leg up in nuanced and competitive world or product marketing Learn More Previous Next

Guest article in Let's Talk Hemp < Back FTC’s Operation CBDeceit Brings Action Against CBD Companies Asa Waldstein Guest Article Guest article in Let's Talk Hemp Read More Previous Next

Marketing strategies should consider “reasonable consumer expectations” to avoid issues < Back GLP-1 Product Receives Warning Letter Marketing strategies should consider “reasonable consumer expectations” to avoid issues This is one of the cringiest Warning Letter Wednesday posts I've ever written. Wow! This company received a warning letter for making claims that it is better than Ozempic, has FDA approval, does not require a prescription, has no side effects, and is clinically proven in "clinical trials and was approved by the Food and Drug Administration last year." This is the first GLP-1-related "supplement" FDA warning letter. Interestingly, it came in a group of five letters; the other four were companies selling semaglutide (generic Ozempic) labeled as "RESEARCH USE ONLY," but FDA cites their secondary marketing claims as proof of the intended weight loss use. Good detective work FDA! This warning letter is a great study of how implied and express claims cross the compliance limits, such as with the before and after pictures, statements like "Only active GLP-1 is effective GLP-1," and "FDA approved" statements. Here is my opinion on some of the information I've gathered. It is unclear what the ingredients in the product are, but they are marketed as natural and side-effect-free. The product is not labeled as a supplement, but it lists "Clinically Proven" and "Metabolism boost drops for weight management" on the label. The before and after pictures are super cringy and likely violate FTC regulations against deceptive marketing. The product reviews feel doctored, and the entire vibe of the website seems like an AI-generated experiment. It gave me the heebie-jeebies, and I expect the FTC would have a field day with this site. There are other "supplements" for sale on the website, such as THC gummies and weight loss gummies, that are making claims related to anxiety reduction (thanks to Apex Compliance for helping me find these). And much more FDA also cites this company for making "FDA-approved" claims. As we know, supplements are FDA-regulated but not "approved." From warning letter. "webpage for ...includes the image of a blue circle with the claim, "FDA APPROVED" along with the statement,. . . was approved by the Food and Drug Administration last year." Implied GLP-1 statements are cited but they’re probably not the primary reason for this warning letter. From warning letter. “The Science of GLP-1 . . . The effectiveness of … lies in its dual-action approach, addressing intake and expenditure. On one hand, it suppresses appetite, aiding in reduced food consumption and subsequent weight loss. It also slows gastric emptying, prolonging the feeling of fullness over an extended period.” Bashing companies is not my style, as I believe in a "rising tide" and educational approach, as many companies who receive warning letters may not know any better, but this company's marketing feels calculated and intentional. Read the full warning letter here . DATE ORIGINALLY POSTED: 12/18/24 Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading. Previous Next Get Warning Letter Wednesday in your Inbox Sign-Up Now!

< Back Interview Thursday Nov 23, 2023 Managing Dietary Supplement Marketing Risks, with Asa Waldstein of the Supplement Advisory Group NutraPreneur Episode Overview Episode Topic : Join us in this episode of NutraPreneur as we delve into the intricate world of compliance and best practices in the dietary supplement industry with Asa Waldstein, principal of the Supplement Advisory Group and founder of Apex Compliance . Discover the strategies and insights that have shaped Asa’s approach to regulatory adherence and how the Supplement Advisory Group navigates the dynamic landscape of dietary supplement regulations. Lessons You’ll Learn : In this episode, you’ll gain insights into key strategies for mitigating marketing risks, ensuring compliance, and fostering a community approach within the industry. Learn about practical lower-risk solutions and essential elements in marketing and product labeling that not only meet regulatory standards but also enhance consumer trust. Understand the challenges and success stories encountered in implementing compliance best practices and discover the critical regulatory challenges on the horizon. About Our Guest : Our esteemed guest, Asa Waldstein, is the principal of the Supplement Advisory Group and the founder of Apex Compliance. With a wealth of experience in the dietary supplement industry, Asa has been instrumental in guiding marketers toward lower-risk strategies, ensuring compliance with regulatory standards, and fostering a culture of regulatory adherence within the industry. Take a firsthand look at Warning Letter Wednesday and unlock the secrets of FDA scrutiny and industry pitfalls. Topics Covered : In this episode, Asa shares key strategies for crafting foolproof compliance in marketing and product labelling. Beyond the challenges, he champions a community-driven approach and spills industry collaboration secrets. A sneak peek into the Supplement Advisory Group’s regulatory game plan adds a practical touch, making compliance not just informative but an enjoyable ride for marketers. Watch Previous Next