Labeling disputes over protein content and daily values continue to attract legal attention, particularly in California < Back Three recently filed lawsuits highlight legal risk in protein labeling compliance Cassandra Stern Interview Labeling disputes over protein content and daily values continue to attract legal attention, particularly in California Three newly filed class action lawsuits against supplement brands Pescience, Huel and OWYN reflect an ongoing trent of litigation over protein content claims and labeling compliance. At issue in each case are alleged violations of FDA rules regarding how protein content and daily values must be calculated and displayed on product labels. Read More Previous Next

Distributors are responsible for products they sell < Back Amazon Receives 3rd Warning Letter This Year Distributors are responsible for products they sell Amazon just received its third warning letter this year and the fifth in the last 15 months! All of these letters are for selling adulterated or unallowable products. What makes this warning letter interesting is that it’s for a sexual enhancement product that was adulterated with sildenafil (Viagra). Amazon requires some mandatory third-party tests for products in this high-risk category, but I wonder why the drug-spiked ingredients were not found here. Perhaps after the initial batch tests, a subsequent non-tested batch contained the drug-spiked ingredients? ❗️Warning Letter Wednesday is available as a free weekly email. Sign up here . 🔷When we look at other Amazon warning letters, FDA seems to “follow the breadcrumbs” from other warning letters, recalls, or issues to Amazon. For example, this warning letter references products that were part of a drug-spiked recall in August. I would think that Amazon has the technological capability to find and remove recalled products from its platform. These types of warning letters come in groups so if companies were selling any of the adulterated brands cited in this warning letter, removing them from commerce now can help to avoid a letter. 🔷Amazon warning letters state that Amazon handles the products as opposed to them being dropped-shipped by the vendors. In my opinion, this “handling” is important to designate Amazon’s responsibility. I wonder if this means that marketplace sites that don’t actually touch the products have a lower risk of distributor scrutiny. 👉From warning letter. “Amazon distributed each of the products directly to individual U.S. consumers on behalf of third parties. Each of the products was “fulfilled” by Amazon; your website states, “Fulfillment by Amazon (FBA) is a service that allows you to outsource order fulfillment to Amazon. Sign up for Amazon FBA to send products to Amazon’s global network of fulfillment centers and offer customers free, two-day shipping through Prime. When a customer makes a purchase, Amazon fulfillment specialists can pick, pack, and ship the order. We can also provide customer service and process returns for those orders.” 🔷Other recent Amazon warning letters were for ophthalmic (eye), homeopathic products for molluscum contagiosum, Diclofenac spiked products and disease claims, and skin tag removal products. Read the full warning letter . DATE ORIGINALLY POSTED: 12/27/23 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, Principal, Supplement Advisory Group, discussed the most recent info on FDA and FTC’s thinking regarding immune support in Communicating in-store and online—where are we now? “FDA is going back many years and citing multi-year-old social media posts in warning letters,” he shared. “One cited a social media post from 2014, and they treat those the same way as new posts. Hashtags are also claims. ‘Liking’ a post is a claim. Replying to or reposting a customer comment on social media, that’s a claim. All marketing is considered ‘labeling’.” That includes, he said, product reviews and testimonials; infographics; citing studies; blogs; and more. < Back #NaturallyInformed Event Looks at Immune Health from All Angles Julia Peterman Press Mention Asa Waldstein, Principal, Supplement Advisory Group, discussed the most recent info on FDA and FTC’s thinking regarding immune support in Communicating in-store and online—where are we now? “FDA is going back many years and citing multi-year-old social media posts in warning letters,” he shared. “One cited a social media post from 2014, and they treat those the same way as new posts. Hashtags are also claims. ‘Liking’ a post is a claim. Replying to or reposting a customer comment on social media, that’s a claim. All marketing is considered ‘labeling’.” That includes, he said, product reviews and testimonials; infographics; citing studies; blogs; and more. Read More Previous Next

Asa Waldstein is principal of Supplement Advisory Group, chair of the AHPA Cannabis Committee, and undisputed AHPA superfan – championing the association and contributing to AHPA initiatives every chance he gets. With a background in herbalism, Asa has 20 years of experience developing and implementing compliant marketing and cGMP manufacturing processes, and he is widely respected for his dietary supplement and hemp regulatory expertise and creative outreach. His dedication to supporting the market for safe, high quality dietary supplements and herbal products is outstanding and his commitment to advancing AHPA's efforts is inspiring. Asa Waldstein is the recipient of the 2023 AHPA Herbal Hero Award. “When I started studying clinical herbalism in the late 90s and followed my passion for herbs into the supplement industry, I had no idea how much fun and opportunity it would bring me. This award signifies that anything is possible if you follow your passions, work hard, and find a supportive community like AHPA. I have been an AHPA member for almost half of my life, and I attribute much of my professional success to the connections and education from being an active AHPA member. I thank the AHPA community for this prestigious award. It's genuinely one of the pinnacles of my professional career, and I am so thankful!” -Asa Waldstein < Back Asa Waldstein wins AHPA Herbal Hero Award AHPA Press Mention Asa Waldstein is principal of Supplement Advisory Group, chair of the AHPA Cannabis Committee, and undisputed AHPA superfan – championing the association and contributing to AHPA initiatives every chance he gets. With a background in herbalism, Asa has 20 years of experience developing and implementing compliant marketing and cGMP manufacturing processes, and he is widely respected for his dietary supplement and hemp regulatory expertise and creative outreach. His dedication to supporting the market for safe, high quality dietary supplements and herbal products is outstanding and his commitment to advancing AHPA's efforts is inspiring. Asa Waldstein is the recipient of the 2023 AHPA Herbal Hero Award. “When I started studying clinical herbalism in the late 90s and followed my passion for herbs into the supplement industry, I had no idea how much fun and opportunity it would bring me. This award signifies that anything is possible if you follow your passions, work hard, and find a supportive community like AHPA. I have been an AHPA member for almost half of my life, and I attribute much of my professional success to the connections and education from being an active AHPA member. I thank the AHPA community for this prestigious award. It's genuinely one of the pinnacles of my professional career, and I am so thankful!” -Asa Waldstein Read More Previous Next

This edition talks about labeling essentials and best practices. < Back Compliance Essentials for Hemp-CBD Companies Part 2 of 3 Asa Waldstein Guest Article This edition talks about labeling essentials and best practices. Read More Previous Next

Remove high-risk claims in all marketing materials < Back Product catalogs are considered extensions of the label Remove high-risk claims in all marketing materials #WarningLetterWednesday Claims made in product catalogs are considered marketing. This warning letter includes claims made on product labels, catalogs, newsletters, and brochures. This is a good reminder that anything used to sell a product is considered an extension of the label and, therefore, should be compliant. Here is a video about this . 🔷This timeline is interesting here. The company was inspected in June 2021, before, during, and after a recall for undeclared soy allergens. FDA then reviewed this company's website in February 2022, which is the basis for most of the items in this warning letter. This is a trend, as last week's WLW also talks about an FDA inspection that leads to a website review and a warning letter . 👉This is a good reminder for companies to clean up their websites before/during/after GMP inspections, as a complete website compliance clean-up may have prevented this letter. From the warning letter. ➡️From the product catalog on your website, On page 13: “Enzymes Plus: … This formula uses specialized enzymes that helps the body break down excess protein on scar tissue and fibrin in the blood vessels and internal organs. It also seems to help remove the protective protein coating on tumors, cancers, and parasites, helping the body render viruses and bacteria inert. This blend is combined with Magnesium (a natural blood thinner) and B-6 that the body uses to help lower Blood Pressure and dissolve blood clots.” 👉Read the full warning letter here . 👉👉Join my Warning Letter Wednesday group . 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!

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!

Do not over-explain clinical research < Back Best Practices For Using Clinical Study Citations Do not over-explain clinical research Using clinical study citations can be a crucial part of product marketing. If the study citations are from well-powered studies using competent and reliable scientific evidence, they can bolster the brand's scientifically supported position, which is important to many customers. I have heard this also helps boost Google's SEO rankings. There is, however, a fine line between compliantly using clinical study stations and making high-risk disease claims. When can clinical study citations be used? FDA addresses this question in the Small Entity Compliance Guide On Structure-Function Claims . From FDA. "Can I use citations of publications that relate to my product's intended use in labeling if the publication title or the journal name mentions a disease name? Yes, but some limitations apply. If the citation implies treatment or prevention of a disease, it is a disease claim. Thus, if in the context of the labeling as a whole, its presence suggests treatment or prevention of disease (for example, by placement on the immediate product label or packaging, inappropriate prominence, or lack of relationship to the product's express claims), the citation is a disease claim. If the citation is used in labeling, its context determines if it is a disease claim. A citation that is used in the bibliography section of labeling, is included in a balanced discussion of the scientific literature, is not excessively prominent relative to other citations, and provides legitimate support for a structure/function claim made for the product would not be a disease claim." Asa comments. Adding citations at the bottom of a scientific blog is not likely to attract a warning letter, but the keywords do attract attention. For example, words like Alzheimer's will be picked up by web crawlers and invite attention. This means if you are using clinical citations in product marketing, ensure these are not construed as marketing by showcasing them. Also, double-checking the rest of your web and social marketing is crucial, as extra attention will be paid to ALL marketing. Elaborating on the studies does cross the line into marketing, as we see with this recent warning letter . From warning letter. "In another recent study, correlations between CBD and blood pressure were examined. Two groups were evaluated, one being test subjects who were given CBD and the other being a control group with a placebo. All subjects were exposed to stressors that would induce a higher blood pressure. The study concluded that a dose of CBD was helpful to reducing blood pressure." FDA has also cited companies for posting about clinical studies on social media. This includes sharing clinical studies that have ingredient and disease containing meta descriptions such as "X ingredient studied for depression. The moral here is when including citations in your marketing materials, ensure they are appropriately placed—ideally within a bibliography or as part of a balanced discussion of scientific literature. They should not be excessively prominent or showcased. The Small Entity Compliance Guide is also an excellent resource for helping us understand the nuances of dietary supplement marketing such as this. From FDA, "Examples of acceptable structure/function claims are "mild memory loss associated with aging," "noncystic acne," or "mild mood changes, cramps, and edema associated with the menstrual cycle." From FDA, "Examples of disease claims are "Alzheimer's disease or senile dementias in the elderly," "cystic acne," or "severe depression associated with the menstrual cycle." DATE ORIGINALLY POSTED: 9/18/24 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!

In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. < Back Q2 warning letter roundup with Asa Waldstein Asa Waldstein Guest Article In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. Read More Previous Next

Helpful Resources See Appearances for Asa's Events and Podcasts See Asa's Regulatory Hints Videos which can be used as additional training tools Marketing Guidance Asa's weekly #WarningLetterWednesday post FTC Document: How to Make Effective Disclosures in Digital Advertising FTC Document: Social Media Disclosures FTC's Dietary Supplement Advertising Guide For Industry Made in the USA lawsuit reference (TINA) Natural Claims article Made in the USA (Great Podcast!) Made in the USA FTC Guidance AHPA Hemp CBD Supplement Congress videos! 9th Circuit Ruling S/F Josh Long article FDA Label Claim Guidance Regulatory: Blog, Events, Resources AHPA Labeling Guidance Document FTC Guidance: Claim Substantiation FTC Guides Concerning the Use of Endorsements and Testimonials in Advertising AHPA Alerts: Stay up to date (AHPA members only) Other AHPA Guidance Documents June 10th GMP & Marketing Claims Demystified Workshop: Resources Steven Yeager LinkedIn Asa Waldstein LinkedIn FDA Supplements Q&A 21 CFR 111 Subparts & descriptions 21 CFR 111 Reference guide Adverse Event Reporting guidance FDA Alerts (allergens, recalls, warning letters Common allergen labeling guidance AHPA Herbs of Commerce Labeling and Allergens Guidance Webinar: CGMP Basics for Hemp-CBD Companies: This is applicable to herbal supplement manufacturers. Regulatory hints YouTube channel AHPA Prop 65 Guidance Preparing for FDA GMP Facility Inspections Webinar Asa’s Regulatory Education Series Why avoid warning letter video Video about the risks of "THC Free" or "THC Free" labeling: Made in the USA Claims Demystified video All Natural: What can you say and what is the risk video Prop 65 webinar AHPA Prop 65 Resources May 4th Webinar Resources Burdock: Food Safety & Regulatory Compliance Consultants for FDA AHPA Hemp CBD Supplement Congress videos! Why join AHPA's Cannabis Committee? Regulatory: Blog, Events, Resources AHPA Labeling Guidance Document AHPA NDI Workshop cGMP Basics for Hemp-CBD Companies Free Webinar AHPA Prop 65 Guidance Regulatory Hints YouTube Channel and Prop 65 Webinar AHPA’s Cannabis Committee AHPA’s Hemp Lexicon AHPA’s NDI Database AHPA’s Botanical Congress: May 24th Asa’s Regulatory Consulting Company Burdock Associates Webinar: GRAS & NDI Certification: Ask the expert Asa’s Next Event: Distributor Pitfalls to Avoid: Hemp and Supplement Products: cGMP Guidance Other AHPA Guidance Documents Webinar: cGMP Basics for Hemp-CBD Companies. This is an excellent training tool for your supplement or hemp company! Webinar: Preparing for FDA cGMP Facility Inspections Preparing for FDA Inspections: Fireside Chat Webinar Regulatory: Blog, Events, Resources Labeling Guidance FDA Label Claim Guidance AHPA Labeling Guidance Document June 3rd Webinar Resources Harris Bricken Canna Law Blog cGMP Basics for Hemp-CBD Companies Free Webinar AHPA Hemp CBD Supplement Congress videos ! Regulatory: Blog, Events, Resources AHPA Labeling Guidance Document Getting Ready for FDA Inspections Webinar AHPA Prop 65 Guidance Regulatory Hints YouTube Channel and Prop 65 Webinar AHPA SOP Templates (members only) Asa’s Regulatory Education Series video channel AHPA’s Guidance Documents HerbalGram Cannabis Resources Asa’s Regulatory Consulting Company Prop 65 Guidance AHPA Expert Prop 65 Webinar Regulatory Videos AHPA Prop 65 Herbal Products Guidance AHPA Prop 65 Cannabis Guidance NDI and GRAS Guidance Burdock Associates Webinar : GRAS & NDI Certification: Ask the expert

Asa and other industry leaders weigh in < Back 2025 State of the Industry Sean Moloughney Interview Asa and other industry leaders weigh in Asa Waldstein, Principal, Supplement Advisory Group : "Looking at the past can help predict future regulatory enforcement. There has been no FDA enforcement of claims made on TikTok, and FTC’s enforcement has been limited to a few cases in which notable influencers did not disclose material connections. I expect this minimal enforcement to ramp up over the next year. Also, I predict more FDA biomarker enforcement, which up until this point has only involved heart disease-related statements like “reduces LDL.” This big question is “Will FDA also target GLP-1 statements?” I suspect we will see this appear in some supplement warning letters, but only when higher-risk statements like “prevents obesity” and cringeworthy “nature’s Ozempic” phrases are present." Read the full article here . Read More Previous Next

Asa writes the FDA and Hemp section of this prestigious annual paid publication. < Back Hemp Industry 2022 Opportunities Report Let's Talk Hemp Media Guest Article Asa writes the FDA and Hemp section of this prestigious annual paid publication. Read More Previous Next