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

AsaWaldstein.com Terms of Service Please read these terms of service ("terms of service", "terms") carefully before using www.AsaWaldstein.com operated by Regulatory Education Events LLC dba Supplement Advisory Group LLC (AsaWaldstein.com). Conditions of use By using this website, you certify that you have read and reviewed this Agreement and that you agree to comply with its terms. If you do not want to be bound by the terms of this Agreement, you are advised to leave the website accordingly. Regulatory Education Events LLC dba Supplement Advisory Group LLC (AsaWaldstein.com) only grants use and access of this website, its products, and its services to those who have accepted its terms. Privacy policy Before you continue using our website, we advise you to read our privacy policy regarding our user data collection. It will help you better understand our practices. Age restriction You must be at least 18 (eighteen) years of age before you can use this website. By using this website, you warrant that you are at least 18 years of age and you may legally adhere to this Agreement. Regulatory Education Events LLC dba Supplement Advisory Group LLC (AsaWaldstein.com) assumes no responsibility for liabilities related to age misrepresentation. Intellectual property You agree that all materials, products, and services provided on this website are the property of [name], its affiliates, directors, officers, employees, agents, suppliers, or licensors including all copyrights, trade secrets, trademarks, patents, and other intellectual property. You also agree that you will not reproduce or redistribute the [name]’s intellectual property in any way, including electronic, digital, or new trademark registrations. You grant Regulatory Education Events LLC dba Supplement Advisory Group LLC (AsaWaldstein.com) a royalty-free and non-exclusive license to display, use, copy, transmit, and broadcast the content you upload and publish. For issues regarding intellectual property claims, you should contact the company in order to come to an agreement. User accounts As a user of this website, you may be asked to register with us and provide private information. You are responsible for ensuring the accuracy of this information, and you are responsible for maintaining the safety and security of your identifying information. You are also responsible for all activities that occur under your account or password. If you think there are any possible issues regarding the security of your account on the website, inform us immediately so we may address it accordingly. We reserve all rights to terminate accounts, edit or remove content and cancel orders in their sole discretion. Applicable law By visiting this website, you agree that the laws of the [location], without regard to principles of conflict laws, will govern these terms and conditions, or any dispute of any sort that might come between Regulatory Education Events LLC dba Supplement Advisory Group LLC (AsaWaldstein.com) and you, or its business partners and associates. Disputes Any dispute related in any way to your visit to this website or to products you purchase from us shall be arbitrated by state or federal court [location] and you consent to exclusive jurisdiction and venue of such courts. Indemnification You agree to indemnify Regulatory Education Events LLC dba Supplement Advisory Group LLC (AsaWaldstein.com) and its affiliates and hold Regulatory Education Events LLC dba Supplement Advisory Group LLC (AsaWaldstein.com) harmless against legal claims and demands that may arise from your use or misuse of our services. We reserve the right to select our own legal counsel. Limitation on liability Regulatory Education Events LLC dba Supplement Advisory Group LLC (AsaWaldstein.com) is not liable for any damages that may occur to you as a result of your misuse of our website. Regulatory Education Events LLC dba Supplement Advisory Group LLC (AsaWaldstein.com) reserves the right to edit, modify, and change this Agreement any time. We shall let our users know of these changes through electronic mail. This Agreement is an understanding between Regulatory Education Events LLC dba Supplement Advisory Group LLC dba (AsaWaldstein.com) and the user, and this supersedes and replaces all prior agreements regarding the use of this website.

Asa and other industry leaders interviewed < Back Product Reviews & Marketing Claims Kate Robertson Interview Asa and other industry leaders interviewed Read More Previous Next

Asa and other industry leaders interviewed < Back House Oversight chair to FDA: Enough is enough Danielle Masterson Interview Asa and other industry leaders interviewed Read More Previous Next

Small labeling issues increase warning letter risk < Back Labeling Violations & Web Claims Small labeling issues increase warning letter risk This company received several observations for minor labeling issues, but the GMP-related observations and the website disease claims likely tipped the scale into a warning letter. This warning letter is filled with important reminders about labeling format, and I review some key points here. Do you want Warning Letter Wednesday delivered to your inbox each week? 🔷Structure-function claims and the DSHEA disclaimer are required to link to each other with a symbol. This is rarely referenced in warning letters but may be a more common plaintiff lawsuit. 👉From warning letter. “Your … product labels each fail to bear a symbol next to all structure/function claims linking the claim to the disclaimer, in accordance with 21 CFR 101.93 and (d). For example, we note use of the term “wellness” is a structure function claim.” 🔷“Supplement Facts” should stretch the top length of the supplement fact panel. This is a minor but common label oversight. 👉From warning letter. “Your… products fail to set the “Supplement Facts” full width of the nutrition label.” 🔷Vitamins or minerals with less than 2% daily value must be listed in “Other Ingredients.” Admittedly, this is a new one for me. 👉From warning letter. “Any dietary … that is present in an amount that can be declared as zero in section 21 CFR 101.9(c), must not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals). The source of the ingredient, i.e., potassium citrate must be listed in the Other Ingredients list. “ 🔷Items without a percent daily values must be disclosed in grams rather than milligrams if over 1000mg. Again, this is a minor but common oversight. 👉From warning letter. “Your … products fail to declare the quantitative amount by weight of each dietary ingredient per serving using metric measures in appropriate units (i.e., 1000 units must be declared in the next higher set of units, e.g., 1,100mg must be expressed as 1.1 g)” 🔷“Dietary Supplement” should be in bold and in a large font size. 👉From warning letter. “The statement of identity “dietary supplement” on your … products must be presented in bold type on the principal display panel, in a size reasonably related to the most prominent printed matter on the panel” 🔷This warning letter is another example of an FDA inspection that led to a website review six months after the initial inspection. This is an important reminder that a compliance re-review of online marketing is essential if the FDA has recently visited your facility. I ran ApexCompliance on their website and found many risky statements. Learn more about this compliance program . There are many more learning lessons in this letter . 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!