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Arthritis claims attract scrutiny < Back Tips For Understanding What A Claim Is Arthritis claims attract scrutiny Arthritis claims continue to be cited in warning letters. As many of you know, I love teaching about regulatory compliance to help you adjust your marketing and stay ahead of the regulatory curve. We hear about not “making claims,” but it can be challenging to know what a claim is. Here are a few general rules for avoiding high-risk claims that can lead to a warning letter. What other tips can you share? Anything ending in “itis,” such as “arthritis”. “Itis” means “inflammation of,” which helps me remember it should be avoided. Fun fact, “arthritis” is the most commonly referenced of all the words ending in “itis.” Other than “antioxidant” and perhaps “anti-aging,” words with “anti” should be avoided. Immune-related words like “antiviral” or “antitumor” are higher risk than “anti-inflammatory.” Words with an International Classification of Diseases (ICD) code. The name of any illness or syndrome, such as Alzheimer’s or IBS. Some are obvious, but some of the syndromes, like Leaky Gut Syndrome, may not be as obvious. Here is a post about this. Searching past FDA warning letters can help you learn what they’ve previously cited. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters “Better than drugs” statements attract FDA attention. Here’s a WLW post about this. FDA sent out 12 arthritis-related warning letters last year, so please avoid making these types of claims. This includes: Hashtags Showcased testimonials Citing clinical studies Product tags and meta tags Social share meta description FDA has been quiet with supplement warning letters, and I am in New Zealand, so this is a shorter post than normal. I am writing this WLW for the beautiful Coromandel. Yes, I love compliance and writing this post (smiles)! 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 Friday Sep 3, 2021 Marketing Compliance: Effective Strategies Open Discussion Southern Hemp Expo, Raleigh, NC The Southern Hemp Expo brings together unsurpassed education and networking with the Let’s Talk Hemp Speaker Series . Industry experts, speakers and exhibitors across the supply chain will show you how to RETHINK Hemp . A powerhouse line-up of industry leaders will be on stage to discuss hemp agriculture, business and investing, technology and innovation, wellness, textiles, fiber, food and beverage, composites and building materials — the whole supply chain of opportunity in hemp. Learn More Previous Next

< Back Panel Discussion Thursday Feb 25, 2021 Compliance and the Customer Experience Hemp Tours Live Learn about (AHPA) American Herbal Products Association and its mission. Importance for CBD brands to understand the supplement industry and its relationship to the FDA? High-risk marketing mistakes made by supplement and hemp product marketers. How we can market proucts without making claims. Watch 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

Asa and other industry experts interviewed < Back Ten experts reflect on state of U.S. hemp industry Interview Asa and other industry experts interviewed Read More Previous Next

< Back Presentation, Online Tuesday Sep 20, 2022 Naturally Informed: Stress & Mental Wellness: Mastering the Market Naturally Informed powdered by Wholefoods Magazine and Trust Transparency Center Regulatory Snapshot: Asa provides a review of enforcement trends, risks, and best practices for manufacturers and marketers in the stress and mental wellness space. Watch Now Previous Next

Emerging enforcement trends include FDA focus on documentation and identity testing, and increased scrutiny of online claims < Back Compliance in the Digital Age: Navigating Enforcement, Marketing Risks, and the Rise of AI | State of the Supplement Industry Asa Waldstein Guest Article Emerging enforcement trends include FDA focus on documentation and identity testing, and increased scrutiny of online claims Although the pace of FDA warning letters to dietary supplement companies appears to have slowed over the past 12 months, several important enforcement themes continue. GMP compliance remains a central focus, particularly regarding incomplete identity and finished product composition testing. The FDA’s long-standing mantra still applies: If it’s not written down, it didn’t happen. Read More Previous Next

NAD challenge cases explored < Back Fruit Snack Wars NAD challenge cases explored The fruit snack wars are on! A few months ago, I wrote about General Mills challenging television commercials by Welch's Fruit Snacks (PIM's). In the commercials, chef Gordon Ramsay throws away "Fruit Flavored Snacks" by tossing them out of a window. That post includes information on "ash canning," an advertising term that describes the practice of portraying competing products as so inferior that they might as well be discarded like ashes. Read that post here . In this case, Welch's Fruit Snacks (PIM's), who was previously on the defense, challenged several claims made by the Mott's brand of General Mills. This shows that bringing NAD cases can have the added ramification of reciprocal action. 👉From NAD. Although these seem minor, they will likely lead to plaintiff lawsuits and demand letters, which are the biggest"impacts" of NAD decisions. "NAD found that General Mills failed to support these implied claims through challenged social media posts and by reviews reposted by General Mills, including: 🔹"These are great. Way [sic] to get my kids to eat fruits and vegetables. They have [had] a package each night after dinner for years and years." 🔹"My kids love eating these and I love the fact that it's made with real fruits and vegetables and no artificial colors. It helps with trying to show them how to eat mindfully and healthy." You may be asking yourself what the big deal is with fruit snacks. I looked this up. Apparently, this is a $4 billion industry in the US. Also, as a complete aside, every time I hear the name Mott's, I think about this 1987 commercial . Read the NAD case here . DATE ORIGINALLY POSTED: 12/4/24 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!

Asa Waldstein quoted < Back FDA, FTC slap CBD industry with seven warning letters related to COVID claims Hemp Industry Daily Relevant Article Asa Waldstein quoted Read More Previous Next

Use caution copy & pasting “ingredient benefits” onto commercial website < Back Learning targets: Children, risky words, intranasal, ingredient benefits Use caution copy & pasting “ingredient benefits” onto commercial website #WarningLetterWednesday is a cautionary tale for companies new to the space that are looking to market products. This company looks like a groovy crystal shop that started making topical products and products delivered to the eyes and nose. So what can we learn? 🔷Of course, there are high risks words referenced in the warning letter, Notably, the use of viruses, cancer, and so many more! 🔷Products delivered through the nose (intranasal) or as an eye drop are drugs and have a justifiable higher level of scrutiny. 🔷Products marketed for use by children are high-risk. 🔷This warning letter is a good teaching tool. Copying and pasting a product's "therapeutic uses" from a textbook or website is a great way to get into trouble. This appears to be the case here. ➡️From warning letter Colloidal silver is used to treat infections due to yeast; bacteria (tuberculosis, Lyme disease, bubonic plague, pneumonia, leprosy, gonorrhea, syphilis, scarlet fever, stomach ulcers, cholera); parasites (ringworm, malaria); and viruses (HIV/AIDS, pneumonia, herpes, shingles, warts). 🔷I understand these are obvious high-risk claims, but in some ways, this could have happened to any entrepreneur that doesn't understand the rules of marketing products. I have seen this happen several times with practitioners, herbalists, and even doctors that "cross the line" into marketing claims by using common therapeutic language such as anti-inflammatory and even "clears heat and resolves toxins." We talk about this here . ➡️From warning letter .... to heal skin irritations and scarring. 🔷Interestingly, there are a couple of references to helping skin irritations and scarring. I do not consider these to be high risk. They are likely a "pig pile" or a common secondary claim in warning letters. What are your thoughts on the risk level here? Read warning letter here . 👉In closing, I think the FDA would have left this company alone if there were not talking about viruses, selling products that go into the nose and eyes, are marketed as safe for children, and had just too many disease words to be avoided. I started a LinkedIn group just for warning letter discussion. Join 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, Workshop Monday Oct 28, 2024 Education session – Ingredient claims and legal flames: An interactive workshop to dodge regulatory heat SupplySide West Las Vegas, NV Noncompliant dietary supplement ingredient claims can be one of the reasons the Food and Drug Administration comes knocking. In this education session and interactive workshop, experts will dissect the U.S. regulations, laws and guidance that govern ingredient claims, as well as applicable court cases. The audience will apply these learnings in live polling, and then discuss and debate the results. If you’re a professional in marketing, science or regulatory affairs, don’t miss this practical, hands-on workshop. Katie Bond of Keller and Heckman LLP Stephanie-Anne Girard of SGS Nutrasource Corey Hilmas of KGK Science Josh Long of SupplySide Supplement Journal Theodora ("Teddy") McCormick of Epstein Becker & Green, P.C. Asa Waldstein of Supplement Advisory Group and Apex Compliance View Event Schedule Previous Next