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< Back Interview Thursday May 6, 2021 The Rigorous Road to Compliance The Hoban Minute Asa sits down with The Hoban Minute to talk about his roots in herbalism, his career in the herbal products and supplement industry, the importance of regulatory compliance, and why creativity is the best tool for marketing cannabinoid products, and more! Learn more Previous Next

< Back Webinar Thursday May 21, 2020 Regulatory Hurdles Associated with Cannabis & Its Concentrates Burdock Group Consultants Interesting topics for the CBD and hemp industries. FDA/FTC enforcement trends Truth in labeling cGMP Compliance Animal products Epidiolex desceduling And more... Tatiane Berdum: Host, Burdock Group Elan Sudberg: CEO, Alkemist Labs Dr. Marielle Weintraub: President, US Hemp Authority Brett Goldman: Industry Regulatory Expert Asa Waldstein: AHPA Cannabis Commitee Chair Watch Previous Next

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!

Only use permitted dietary ingredients or face regulatory issues < Back Unauthorized NDI Leads To Warning Letter Only use permitted dietary ingredients or face regulatory issues Warm greetings from 35,000 feet, as I am flying back from a 3-day whirlwind trip to participate in the Vitafoods Startup Award finals in Geneva. This company received a warning letter for using N-Methyltyramine, an unauthorized New Dietary Ingredient (NDI), in its products. This shows that FDA is getting serious about enforcing the unauthorized NDI requirement. FDA has sent warning letters for Hordenine (a similar molecule to N-Methyltyramine) in the past, but using these types of ingredients typically isn’t enough to attract a letter unless disease claims or GMP violations are present. In this instance, there were no disease claims or GMP violations present which should give companies pause before using certain NDI ingredients. Read this WLW post about hordenine warning letters. I predict this may be paving the way for more CBD and kratom letters, even if there are no disease claims present. A similar ingredient to N-Methyltyramine is listed in FDA’s Information on Select Dietary Supplement Ingredients and Other Substances document . This includes some “off limits” products such as DMAA but also includes commonly used dietary ingredients like biotin. I would like to see this list clarified to show what FDA considers lawful dietary ingredients, unauthorized new dietary ingredients, and unallowed ingredients such as DMAA. Read the letter here . DATE ORIGINALLY POSTED: 5/15/24 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 Webinar Thursday Apr 23, 2020 Ethical Product Marketing in the Coronavirus Era: Town Hall Asa's Regulatory Education Series Discussing the do's and don'ts of marketing products during the Coronavirus era. I will be joined by two special guests which cover the expert legal, regulatory, and marketing sides of the industry. Linda Nielander is VP of Sales and Marketing for Quicksilver Scientific. Erica W. Stump is the owner and founder the Erica W. Stump, P.A. law firm. Watch Previous Next

Marketing in all languages should be compliant < Back Disease Claims Lead To Warning Letter Marketing in all languages should be compliant FDA issued a warning letter yesterday for Spanish language disease claims made on product labels and the company’s website. Examples of these claims include “cancer,” “antiviral,” and “arthritis.” Surprisingly, there have only been a small number of warning letters for dietary supplements issued by the FDA this year, which is why I was so excited to read this letter today. In April of this year, FDA purchased supplements from this company by calling the phone number listed on the website. Typically, FDA issues warning letters by simply flagging the online claims without purchasing products. I wonder if this is part of the continued adulterant testing of Spanish-language joint health products that are also making over-the-top disease claims such as thes e . This warning letter is a great example of claims to avoid, such as “diabetes,” “hypertension,” “antiviral,” and “prevent infections.” Read the full letter here . This letter shows that all products, even those in other languages, are fair game for scrutiny. This company’s website appears to be shut down, which seems to happen frequently when small companies get warning letters. Do you think this is enough to dissuade companies from making serious disease claims about their products? 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!