< Back Symposium Thursday Jun 10, 2021 cGMP's and Marketing Compliance for herbal product manufacturers International Herb Symposium cGMP's and Marketing Compliance for herbal product manufacturers, Learn More Previous Next

Ensure weight loss products are tested for drugs < Back Weight Loss Claims Trigger FDA Product Testing Ensure weight loss products are tested for drugs This company was making weight loss claims, leading to FDA purchasing and testing their product. Sibutramine was found, but surprisingly, the company is still selling the product. I find this confusing and look to FDA to help remove these dangerous products from the market. Sign up and search all old Warning Letter Wednesday posts here. 🔷FDA reviewed the company’s website last December, and sometime after that, purchased and tested a product, which ended up containing the drug sibutramine. On February 8th of this year, FDA issued a public notification that this product contained a hidden drug ingredient. 🔹According to the warning letter, the company refused to recall the product. After finding the drug-spiked ingredient and issuing the public notification, I find it strange that the company didn’t comply with this request. At this point, do you think the FDA could/should have elevated this to a seizure or injunction? I don’t believe many drug-spiked products are in the market, but when the FDA finds them, I would like them removed in haste. 🔷Aside from the presence of the drug-spiked ingredient FDA also cited several “disease-type” claims. The claims in this letter, such as “burns fat,” “weight loss,” and “Lose 20 pounds in 20 days,” are not normally seen in warning letters unless ingredients like sibutramine are mentioned. This leads me to think FDA is scanning for these trigger words before testing the ingredients. Also, statements like these are more common in FTC and plaintiff attorney complaints. FTC’s “gut check” document on weight loss claims is worth a read. 🔷This company is lucky FDA didn’t dig any deeper into its website. I ran Apex Compliance on their site and found numerous “Alzheimer’s” and “virus and flu infection” statements. 🔷The moral of the story here is that if you are selling weight loss (or sexual health) products, ensure you are testing for undisclosed drug-spiked ingredients. Amazon already requires an annual test for this, but testing each product lot is not a bad idea. Read the full letter 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!

Remove COVID claims including on YouTube < Back The First 2023 Warning Letter Belongs to a CBD Company Remove COVID claims including on YouTube The first "supplement" warning letter of 2023 belongs to a CBD company. 2022 was the year of the CBD warning letter, and FDA enforcement in this area appears to be continuing. This warning letter is another reminder that no company is "too small to be off FDA's radar." A video cited in this letter only had 19 views at the time I wrote this post! This is the most unpopular video I have ever seen cited in a warning letter demonstrating that any online marketing is fair game for enforcement. I write more about this here . This company was marketing a cannabinoid product for COVID protection on its website, socials, and YouTube. There were several similar warning letters last year involving companies citing research about cannabinoids and COVID. I usually take a "maybe they didn't know any better” attitude when looking at enforcement and compliance, but in this case, the company should have known better because of the well-publicized action against other CBD companies for this same type of statements. Here are some critical posts about CBD enforcement in 2022. CBD enforcement is top of mind for FDA. This includes animal warning letters . CBD and anxiety claims . Citing clinical studies . Natural Products Insider Q4 Update . This letter mentions several claims made in YouTube videos. Last year nine warning letters cited claims made on YouTube, and I expect this enforcement trend to continue. I write more about this here . This letter cites claims made on the company's social media from early in the pandemic. As we've discussed many times on Warning Letter Wednesday several times before, companies are responsible for all social media posts, even if they are several years old. From warning letter. "COVID prevention with CBD? Canada study shows it's possible. Might be time to start a daily dose of…… all-natural pharmaceutical grade CBD products…. USE CODE: COV19" [from a May 15, 2020, post on your Facebook social media webpage" This letter also cites the product code "COV19" which is a bold claim and further shows the intended marketing use of the product. This is a reminder that items like meta tags, product tags, search tags, and coupon codes are considered marketing. This is a joint FDA and FTC warning letter, which is common when COVID claims are cited. This is serious, and it also involves a cease and desist barring the company from making COVID-related claims or face injunction, a civil penalty of up to $46,517 per violation requirements to refund customers. Read the full warning letter 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!

Webinars are “fair game” for enforcement < Back MLM Distributors Cited in FTC Lawsuits Webinars are “fair game” for enforcement Warning Letter Wednesday primarily focuses on FDA-related enforcement, but occasionally I review interesting FTC actions. Today's #WarningLetterWednesday highlights three FTC cases against distributors of doTerra essential oils and supplements. doTerra is a network marketing company. This differs from last year's Young Living FDA warning letter, where the MLM parent company received the letter for claims largely made by its distributors (affiliates). Read more about this letter here . The claims in these three complaints were made in webinars in early 2022. FTC states they are "former healthcare practitioners who touted their expertise in recommending the products." Interestingly, FTC points out that the distributors named in these lawsuits use their medical background to market supplements. I'm sometimes asked if doctors can make statements about supplements they sell that non-doctors can't make. The answer is, of course, no, but in these cases, the distributor's medical background seems to be mentioned as another way they potentially misled consumers. Some of the cited claims imply products can support the immune system, and they dance around the idea they can protect or help with COVID. Since COVID claims are very high risk, even lightly implying protection is enough to attract agency action like a warning letter, administrative complaint, or lawsuit. Here is one example. From Lauren Busch FTC lawsuit. "LLV should be part of your daily routine, DDR Prime should be a nonnegotiable, especially with all the exposures we have in this world beyond just what's going on with COVID." A key takeaway is that all secondary marketing will be heavily scrutinized if any COVID claims are present. doTerra, the parent company from today's Warning Letter Wednesday, seems to do a good job at compliance. I ran my Apex Compliance program on their website and found just a few concerns. I'm happy to run a sample keyword check on your website; just let me know. The FTC complaint includes a permanent injunction against each defendant, stopping them from making unsubstantiated claims and also pay a $15,000 fine each. In my opinion, this monetary amount seems low, but it does send a cautionary tale that MLM distributors can be liable for the claims they make. COVID claims are likely why these distributors were targeted. "Brain fog" is also cited in one of the complaints. Do you consider this to be a disease claim? According to HHS, brain fog can be a symptom of long-haul COVID, a recognized disability under the Americans for Disabilities Act (ADA). My take is brain fog related to COVID symptoms is undoubtedly a disease claim, but brain fog not related to Covid isn't high risk. I feel "occasional brain fog" from time to time. I write about brain fog claims here . From FTC complaints: "The webinar was organized and promoted by doTERRA distributors …. and the registration link for the webinar was distributed on publicly accessible social media accounts." Interestingly, FTC references that access to the webinar is publicly available. If the webinar was closed to the public or invite-only, do you think it would have been cited in this complaint? Also, it seems the webinar recording may have been posted on YouTube, which, if true, maybe how the FTC found it. Companies and company representatives frequently record webinars and podcasts. Claims enforcement made in these formats are rare unless they are posted on YouTube, or the transcripts are hosted on a commercial website. My SaaS Apex Compliance program scans YouTube videos as well as websites and documents for risky keywords. Learn more here . Citing research is also mentioned in one of the complaints. From FTC lawsuit "slide displayed the abstract from an article titled "Computational evaluation of major components from plant essential oils as potent inhibitors of SARS-CoV-2 spike protein." We have previously discussed how citing COVID research to sell products can lead to warning letters. Read my comments on last year's FTC's 4.2 million dollar fine against Fashion Nova for allegedly hiding unfavorable product reviews here . Read about the FTC action 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 Podcast Wednesday Oct 22, 2025 Honest Health with Jeffrey Burke S02 E60 - Asa Waldstein Honest Health with Jeffrey Burke Podcast Honest and relevant answers for better health and well being with the best minds in the Natural Products Industry. Also, one on one chats with entertainers, athletes and public figures we all know and love. Host Jeffrey Burke welcomes Asa Waldstein, a regulatory expert in the natural products industry. They discuss the importance of marketing compliance, the risks associated with misleading claims, and the evolving landscape of regulations in the health sector. Asa shares insights on how to navigate marketing-language effectively, the role of social media in compliance, and the significance of consumer safety. The pair also discuss the challenges faced during the CBD boom and the importance of awareness in the industry. "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." - Asa Waldstein Learn more and Listen Previous Next

< Back Webinar, Panel Discussion Thursday Jun 9, 2022 CBD Panel Discussion: Bridging the gap between science and regulation Atlantia Clinical Trials Asa Waldstein joins the Atlantia team to discuss how to use clinical data for marketing purposes to overcome regulatory hurdles that many CBD companies are encountering when commercializing their innovations. To many, CBD offers a variety of benefits when ingested, inhaled, or applied topically – with product marketing and advertising claims similarly ranging from calming effects to pain relief. Patient use fuels the research drive, which is rapidly increasing, and recent changes in the United States have paved the way for exciting new work. Both the safety and the potential therapeutic uses of these products need to be assessed for a range of indications. With the rapid expansion of new products, novel methods of use, and growing populations using these products for medical indications or for nonmedical use, regulatory restrictions are a major contributing factor to the limited data published addressing the most urgent questions on the potential effectiveness of products on the market for certain indications. Don't miss your opportunity to submit your CBD regulatory questions to our experts. Learn More & Register Previous Next

Carefully review all marketing materials < Back When Nutrient Claims Become Disease Statements Carefully review all marketing materials This warning letter involves a nut butter company that was making implied and express cancer claims on its website and product labels. This is an extreme example of what not to do and there are some good learning opportunities. Ingredient claims are product claims. Here, FDA references ingredient claims being used to help with cancer. These claims appear on the product page but even if they were separated from a shopping cart, such as in an ingredient blog, they would have likely attracted a warning letter. From warning letter. “[R]ecent studies have highlighted the potential of Brazil nuts, almonds, and cashews (ingredients in your Inspiration Butter) in fighting against cancer, thanks to their antioxidant properties and beneficial nutrients.” Claims about nutrients are product claims. This is interesting, as the statement references omegas and polyphenols, which the product contains, as fighting diseases. This is an possible example of what can go wrong when your marketing team is also your compliance team. Also, this was written on the product label! Oye vey! From warning letter. “(From the image of your product label) “THE POWER OF NUTRIENTS: Our uniquely tasty multi-nut butter blend contains Omega 3-6-9 fats with powerful antioxidant polyphenols, which studies have shown may . . . assist in the fight against certain diseases*.” Mission statements are marketing claims. This is pretty obvious as the company states they make products for people fighting cancer. In the past FDA has also cited mission statement related claims when they tie in product such as ‘I had cancer, and this inspired me to make these products.’ From warning letter. “OUR MISSION: We craft calorie-dense and nutrient-intense foods for people fighting cancer . . .. Organic BRAVEZIL BUTTER supports our mission of bringing naturally nutritious foods to market which ‘Fuel the Fight’.” If you market products online, you are on FDA’s radar. This company appears to be a small food manufacturer but since they advertise products on their website, it makes it easy for anyone with a computer, including FDA to find them. Here’s a post about this. Expect more “lower effort” warning letters. FDA’s budget unfortunately has suffered budgetary cutbacks. Web-surfing warning letters like this don’t require resource intensive in-person visits or product testing and we will see more of these in the future. To be fair this company seems to be well intentioned but they just have no idea about marketing compliance. This is one of the reasons why I enjoy writing Warning Letter Wednesday; to help get the world out about the basics, the nuances, the complexities and the best practices when marketing natural products. I really aim to help demystify the sometimes-confusing world of supplement and food marketing and I hope you enjoy it! Read the full warning letter here . DATE ORIGINALLY POSTED: 7/23/25 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!

< Back Presentation Tuesday Nov 15, 2022 Decoding the Regulations Around Cannabinoid Enforcement & Marketing Claims MJBizCon, Las Vegas, NV The FDA has not been shy about sending enforcement letters even with a lack of regulation and guidance. Operators in the hemp-CBD/cannabinoid marketplace can limit their risk, while still being truthful and not misleading. But what exactly is that magical line businesses cannot cross before getting a Dear John from the FDA? This session will identify high-risk marketing strategies and how to adapt accordingly. You will learn: - Recent enforcement trends across the industry - How to identify high-risk verbiage and example of lower-risk verbiage to communicate the same message - What is top of mind and what the FDA is looking for when reviewing claims in testimonials, hashtags influences and Tik Tok. - How to read enforcement actions (i.e. warning letters) and your next steps - Q&A at the end Session Date: Tuesday, November 15th, 2022 See the agenda here . Learn More Previous Next

Small issues signify deeper noncompliance < Back GMP Labeling Lessons Small issues signify deeper noncompliance Dietary supplement labeling can be confusing, but ensuring that the "small things" like line thickness are compliant is important. When FDA looks at a label that is not quite right, it can signify greater compliance concerns and trigger them to look deeper, as the adage "Where there's smoke, there's fire" is often true. Let's look at this warning letter to see what we can learn. 🔹Address or phone number: This is an important part of GMPs and safety and is considered a major violation if missing. This is how consumers report adverse events to the company, which can help the company identify quality issues and, if necessary, serious adverse events that must be reported to the FDA. Learn more here . Also, if the company named is not the manufacturer, the label must clearly disclose this fact using a statement like "Manufactured for" or "Distributed by." 👉From warning letter: "The labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1] may receive a report of a serious adverse event with such dietary supplement." 🔹The correct order of ingredients is important. Learn more here . 🔹"Supplement Facts" should be set at full width of the nutrition label, in accordance with 21 CFR 101.36(b)(1)(i) 🔹The correct nomenclature should be used for items with a percent daily value. 👉From warning letter. "The source ingredient that supplies a dietary ingredient may be identified within the nutrition label in parentheses immediately following or indented beneath the name of a dietary ingredient and preceded by the words "as" or "from", e.g., "Calcium (as calcium pyruvate)". When a source ingredient is not identified within the nutrition label, it shall be listed in an ingredient statement." 🔹Formatting is important. 👉From warning letter. "The Supplement Facts label format requirements including the use of bolded text, hairlines, and/or light and heavy bars are not in accordance with 21 CFR 101.36(e)." 👉From warning letter. "The statement "**Daily Value not Established" must be within the Supplements Facts label." 🔹Common ingredient name must be listed. 👉From warning letter. ""Aquamin™" is not the common or usual name for Lithothamnion spp." There are lots of GMP violations in this letter, which is likely the primary reason for this letter. Read the full warning letter here . DATE ORIGINALLY POSTED: 2/5/25 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!

< Back Podcast Thursday Jan 13, 2022 Compliance and Marketing Claims Canna Advocate Podcast A warning letter is a FTC notice to crack down on false claims. Why is this a problem? It can threaten your business! A warning letter requires legal resources to answer, which takes away your mental bandwidth. Warning letters are a public notice and can scare away investors. Also, warning letters are used for future class action lawsuits. Avoid the warning letter before it's an issue. Influencer marketing is an enforcement trend to pay attention to. People can make reviews and say whatever they want. But the seller must be careful to use reviews in a marketing campaign. Other terms to take seriously include, THC free or pesticide free. They maybe troublesome terms unless it's 100% true. Dietary supplement marketing examples that work include gaiaherbs.com . Future of Cannabis Marketing Future of the hemp and cannabis industry will be technologies that promote bio-availability products for efficiently absorbing cannabinoids and other nutraceuticals. Listen Previous Next

Product names are marketing < Back Small Herbal Company Cited For Marketing Claims Product names are marketing Even very small companies that market online can attract an FDA warning letter. I am still surprised when I hear companies saying they are not big enough to be on “FDA’s radar.” This warning letter shows that anyone, even a tiny company, is “fair game” for enforcement. Today’s Warning Letter Wednesday is a story of a small herb company cited for making serious disease claims, and I’m guessing they didn’t know the rules of dietary supplement marketing. This is one reason why I write Warning Letter Wednesday: to help raise awareness about enforcement trends and marketing rules in the digital era. 🔷Unfortunately, many schools do not teach the basics of DSHEA and marketing compliance. One of my missions is to educate these communities about the dos and don’ts of supplement marketing. Here is my speaking schedule , which includes three days of classes at next month’s International Herb Symposium at Wheaton College. Please let me know if I can extend free education to your school. I also offer customized marketing compliance company training called the “Regulatory Expert Package.” 🔷This warning letter contains numerous disease statements and is a cautionary tale of what not to do. This is one of the most glaring examples of a disease statement. Wow! 👉From warning letter. “[Echinacea Tonic] should be used for EVERY disease and illness.” 🔷The product names “Insomnia Formula” and “High Blood Pressure II” were cited in this warning letter. 👉From warning letter. “Insomnia Formula • Product name: The product name implies that the product is intended to cure, mitigate, treat, or prevent insomnia.” Read the full warning letter 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!

Asa Waldstein & other leaders interviewed < Back USDA Final Hemp Rule draws mixed reactions from industry stakeholders Danielle Masterson Interview Asa Waldstein & other leaders interviewed Read More Previous Next