Some of our favorite resources for helping to mitigate the risks associated with Made in the USA and All-natural claims. Home / Made in USA & All Natural / Made in the USA and All Natural These are common areas of enforcement and lawsuits.Here are some resources to help understand these regulations. Made in the USA Anchor 1 "Made in the USA" Claims Demystified video FTC guidance Great podcast on this topic Lawsuit updates (Truth in Advertising) All Natural Anchor 2 Video: What can you say and what are the risks Article on natural claims Back

Mouth pouches have emerged as one of the fastest growing CPG categories, signaling a major trend in nootropics as consumers seek functional ways to boost performance—sans nicotine. < Back A new generation of energy: Are pouches the next ‘big thing’ in active nutrition? Danielle Masterson Interview Mouth pouches have emerged as one of the fastest growing CPG categories, signaling a major trend in nootropics as consumers seek functional ways to boost performance—sans nicotine. Performance pouches are gaining popularity among consumers, including at the gym. "Some pouches are more likely to be considered supplements if they are consistent with ingestion (e.g. swallow) and they avoid sublingual/oromucosal drug-type positioning. Others appear to "borrow" nicotine pouch marketing (e.g., 'niccotine-free'), which can create classification and consumer-perception issues even though it may be labeled as a supplement." - Asa Waldstein Read More Previous Next

Asa and other industry experts weigh in < Back Is your age verification process in place? Everything you need to know about selling in NY Danielle Masterson Interview Asa and other industry experts weigh in Read More Previous Next

Suprimo Imports still lists for sale products targeted by FDA in a warning letter, raising the question whether the company will face any legal or criminal action. < Back FDA targets AK Forte distributor for selling drugs, not supplements Kelly Teal Interview Suprimo Imports still lists for sale products targeted by FDA in a warning letter, raising the question whether the company will face any legal or criminal action. Read More Previous Next

Asa Waldstein's content is mentioned in this newsletter. < Back White Whale Creations Newsletter Lex Pelger, White Whale Creations Press Mention Asa Waldstein's content is mentioned in this newsletter. Read More Previous Next

< Back Beauty-From-Within Marketing: Best Practices and Pitfalls to Avoid Asa Waldstein Guest Article Read More Previous Next

Asa and other industry leaders interviewed in the New Hope article. < Back FDA rejects two new dietary ingredient submissions for CBD, leaving hemp industry with legislation as only route to clarity Rick Polito Interview Asa and other industry leaders interviewed in the New Hope article. Read More Previous Next

< Back Virtual Fireside Chat Friday Jan 19, 2024 Radicle Perspectives: Elevating the supplement industry Radicle Science There was no shortage of dietary supplement regulation and compliance talk in 2023. From FTC guidance and FDA’s response to NAC and NMN, to the Dietary Supplements Access Act, continued market disruption due to supply chains and inflation, not to mention authenticity issues continuing to plague major online retailers, what can we anticipate in 2024? Tune in to another insightful episode of Radicle Perspectives as we welcome our esteemed guest, Asa Waldstein, as we prognosticate about what 2024 has in store for dietary supplement regulations and compliance. Key Topics: Recap major industry news from 2023. Anticipate how these headlines from 2023 will impact regulations and compliance in 2024. Learn about other dietary supplement regulations and compliance issues beginning to percolate already. Register Previous Next

< Back Panel Discussion Wednesday Sep 21, 2022 Building Brands in Cannabis Naturally Boulder Boulder, CO CBD, THC, and Cannabis are all over the news. Consumers see the products in stores, are starting to see limited advertising, and are hearing anecdotes from their friends. Everyone is talking about it, but people have very little information about it. And, the information they do have varies by the state or community they live in. This creates an interesting business opportunity for entrepreneurs! For current brands looking to incorporate cannabinoid-based benefits of sleep, pain relief or calm there is obvious opportunity, but also, complexity and risk. For new brands launching into the space, there is a steep and unique learning curve in navigating formulation, branding, and distribution that is like no other industry. If you’ve wanted to learn more about this continually emerging, high-growth industry, Naturally Boulder has assembled a panel of experts to discuss the state of the industry, what’s hot and new, and how you can develop and build a powerhouse brand in the space. Learn More Previous Next

Regulatory compliance and marketing education on important issues in the dietary supplement industry. Helpful hints videos, blogs, and resources. Asa's public speaking schedule and webinar links. Consulting services for supplement marketing compliance. About Asa Waldstein Community, Compliance, Natural Health Principal of Supplement Advisory Group , specializing in practical regulatory support for dietary supplement marketers. We focus on finding marketing risks and providing practical marketing solutions on the web, social media, and product labels. I love educating about compliance best practices and lower-risk marketing strategies, which often change based on FDA/FTC enforcement trends. Building in-house expertise through education is part of my unique approach to regulatory consulting. I routinely speak at conferences on enforcement trends, industry compliance, and the nuances of effectively marketing products in the digital era. Check out my weekly Warning Letter Wednesday post . Learn More Email Me LinkedIn Home: About Home: Testimonials Testimonials Vardan Ter-Antonyan Chief Science Officer at Green Compass Global, Ltd Asa is one of the best experts and specialists of Regulatory Affairs in the dietary supplement and hemp space. If you are in need of any regulatory services when it comes to your labels, your operation, or anything else, contact Asa and he’ll make sure you are well equipped to face any regulatory inspection including the notorious FDA. Free Introductory Regulatory Consult Available Online 15 Minute Consultation with Asa Waldstein 15 min Book Now Home: Video Player Regulatory Hints Videos Educational Tools: Free for the community Play Video Share Whole Channel This Video Facebook Twitter Pinterest Tumblr Copy Link Link Copied Now Playing MLM Company Cited For Claims Made By Their Affiliates 02:39 Play Video Now Playing FDA Crackdown on Anxiety Claims 03:19 Play Video Now Playing Art of Wordsmithing: Replace High-Risk Marketing "Buzzwords" 01:12 Play Video Now Playing Supplement Advisory Group: About Us 01:02 Play Video Watch with captions on What I Do For A Living Get in Touch Newsletter signup, ask regulatory questions, public speaking inquiries Submit Thanks for submitting! Home: Contact

In this interview, Professor Ted Dinan, Medical Director at Atlantia Clinical Trials, and Asa Waldstein, Principal at Supplement Advisory Group, discuss Atlantia’s expertise in clinical trials for CBD < Back The Future of CBD research, marketing, and regulation Mychealla Rice Interview In this interview, Professor Ted Dinan, Medical Director at Atlantia Clinical Trials, and Asa Waldstein, Principal at Supplement Advisory Group, discuss Atlantia’s expertise in clinical trials for CBD Read More Previous Next

When will FDA go after “Nature’s Ozempic” claims < Back Biomarker Claims Enforcement When will FDA go after “Nature’s Ozempic” claims Making biomarker claims about dietary supplements has some risks, and here I explore enforcement trends to be aware of. In recent years, the FDA has increased scrutiny of biomarker-related claims, especially those linked to serious health conditions like heart disease and diabetes. A significant shift occurred in 2022 when the FDA began issuing warning letters for claims that were previously considered risky but not ultra-high risk. These include statements such as "lowers LDLs," "lowers cholesterol," and even "lowers bad fats" without the use of higher-risk terminology like "hypertension." Other biomarker claims that have been cited include "lowering A1C levels and blood sugar," which implies an effect on diabetes management, and "reducing arterial plaque," which suggests an influence on preventing cardiovascular disease. Interestingly, while FDA has cited heart health-related biomarker claims, there have not been notable warning letters related to C-reactive protein (CRP) or other inflammatory biomarkers. FDA seems to generally take a "hands-off" approach regarding discussions of inflammatory biomarkers, as long as no explicit disease claims are made. This suggests that while some biomarker claims may fall into the grey area, companies should use caution and keep up to date on enforcement trends to avoid crossing into disease claim territory. One hot area to watch is GLP-1 claims, which, when combined with claims such as "Nature's Ozempic," may be enough for a warning letter. DATE ORIGINALLY POSTED: 9/25/24 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!