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< 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

A look at the manufacturing and quality process < Back In-Process Quality Testing A look at the manufacturing and quality process GMP is basically a series of quality processes, such as holding, verifying, and then releasing. This is true for incoming raw materials and all in-process materials. This shows where some companies could make noncompliant decisions in the manufacturing process. Let's look into the manufacturing and quality-checking process and use a capsule product as an example. First, all of the ingredients, bulk capsules, and packaging need to be QC-checked and cleared. This is typically done by reviewing the raw material specification sheet, which shows what types of tests are needed. The samples are sent to a qualified lab and if everything passes, a member of Quality then releases the raw material. Next is blending: All ingredients are weighed by one employee and verified by another (called the doer-checker system). They are then blended, and then a member of Quality verifies that the weight matches the projected yield and verifies organoleptics such as color and smell. If the projected yield is too low, then an ingredient may have been forgotten, and if it's too high, then there is likely some other issue like a duplicate or mis-weighed ingredient. If all looks good, then the blend is released to the next step in the process. Next is encapsulation: A lot of variances can happen in the encapsulation process, so conducting R&D testing to ensure flowability and density is integral to a properly filled capsule. Quality typically checks the capsule weights consistently at the beginning of encapsulation, then about every 15-30 minutes to ensure they are weighing and looking good. After the encapsulation run is completed, Quality then verifies the projected yield of capsules to ensure they are within the predetermined range and releases them to the next step in the manufacturing process. If it is too high, then the capsules are underfilled, and the finished product will be below the label claim. If it is too low, then the capsules are overfilled, which may create a safety issue if there are ingredients that are unsafe at higher amounts. Packaging: The projected yield is calculated from the number of capsules, and bottles are typically weighed consistently when the runs starts, then every 15-30 minutes to ensure the correct number of capsules is in each bottle. Then, the final calculation is reviewed to verify the number of bottles is within the projected range. If it is too high, then the bottle may be underfilled, which is non-compliant. However, if it is too low, that is not necessarily a compliance issue, but it can indicate a money-losing project. Quality then takes a few finished products for sample retention (a GMP requirement) and sends a bottle or two for finished product testing. Once the test results come back, they are written on the finished product specification sheet, and if everything passes, it is released for sale. Celebration time! This lilypad approach to quality is designed to keep non-compliant materials out of the product facility and catch errors during the manufacturing process long before they reach the finished product. Of course, I am simplifying this, as a lot more goes into making a compliant product, but I thought you might enjoy this "behind-the-scenes" look at what goes into making a compliant dietary supplement product. DATE ORIGINALLY POSTED: 4/2/25 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 Symposium Friday Oct 16, 2020 4 Hour cGMP & Marketing Workshop with Steven Yeager & Asa Waldstein American Herbalist Guild (AHG) Annual Symposium Herbal supplement manufacturers and marketers need to have a solid understanding of current Good Manufacturing Practices (cGMP). In this interactive presentation, you'll learn about the intricacies of cGMP, including all CFR 111 subparts. We'll give you examples about how to comply with each section, practical steps for implementing them in your facility, and common mistakes to avoid. We also provide real-world examples of how to prepare for and conduct oneself should you have to undergo an FDA inspection. We review common marketing mistakes made by herbal manufacturers and marketers. Only $30 and supports this important organization Purchase Previous Next

All claims should be substantiated < Back Key Takeaways From FTC “Warning” to ~670 Companies All claims should be substantiated Most of us have heard about the recent FTC notice of penalty offense sent to ~670 companies. To those not on the list, mazel tov. This FTC action puts these companies on notice that claims must be substantiated, and endorsement guidelines must be followed, or the companies can face fines of $50,120 per violation. Here is FTC’s press release , which includes links to the list of companies that received the warning and the letter to the recipients. This is worth reading, but I share some key points below. So why did “these” companies get cited? My Magic 8 ball did not tell me the answer, but I am guessing that search terms like “proven safety,” “scientifically proven,” and “clinically proven” were trigger words. Most of the companies on the list have exquisite compliance, and I verified this using my Apex Compliance program, but there are a few that certainly need a lot of regulatory help to be compliant. I wonder if these blanket “you haven’t done anything wrong, but you are warned” statements are fair. FTC could have found egregious violators with a quick Google search. The action warns companies about two sections of advertising basics: Substantiation & Endorsements Substantiation : We all know that claims should be substantiated, but here are the notable items from FTC’s Substantiation Notice. Product safety : FDA’s supplement regulations require products to be safe, and FTC reminds us that companies should have data to back to this. Discussing “proven safety” likely elevates the risk of FTC scrutiny. Supplements have parameters to ensure these are used safely. They have warnings about potential risks such as “not for use in pregnancy,” “may elevate blood pressure when used long term,” or “may interfere with medications,” and they also have serving suggestions to ensure they are used within safe constraints. I ask, “Is there any reason to claim safe supplements?” Health benefits : This is a broad statement. So, what is a “health benefit?” I think of structure-function statements such as “joint support” or “helps with sleep” as health benefit statements. FTC says all health benefits need to be substantiated, which is common knowledge, but I don’t think FTC will start asking companies for their structure-function dossiers anytime soon. I see this more as a gentle reminder about the basics of advertising and substantiation. However, implying there is clinical proof to support a structure-function claim will attract attention. Mitigates or treats disease : This is obvious, and I expect this to be where much of the FTC’s substantiation enforcement will be. This is even more reason to ensure marketing does not have disease claims. Apex Compliance, my patent pending SaaS compliance program, scan websites, YouTube, and uploaded content for compliance concerns like disease words. Learn more here . Clinically proven statements : This is also where FTC will likely focus its enforcement action. Stating that ingredients have “proven efficacy” or that products are “clinically proven” or “scientifically proven” is a high substantiation standard that will certainly attract FTC and plaintiff attorney scrutiny. Apex Compliance can scan for any phrase, such as “clinically proven.” Set up some time to learn about it here . The Substantiation Notice is not all about health claims. It also applies to claims about efficacy statements such as “phospholipids added for increased absorption” or “helps with weight loss” and performance claims like “fast-acting.” I don’t expect FTC action solely for these lower-risk statements, but the mantra is that everything should have substantiation. From FTC press release: “the notice is not limited to health claims and applies to any marketer making claims about the efficacy or performance of its products.” Endorsements : The other part of the FTC “warning” concerns endorsements. Here are some key points, but most are obvious. Our purchasing behavior is affected by influencers and product reviews, so steps to keep this part of marketing ethical are a good thing. Thanks, FTC! Falsely claiming a 3rd party endorsement of a product when they don’t, such as stating, “Tom Hanks loves my product.” Misrepresenting that an endorsement represents the experience or opinions of product users. Of course, someone shouldn’t say I take this product every day when they’ve never tried it. This FTC lawsuit against Google and iHeartMedia is a great example. Using an endorsement to make deceptive claims (like disease claims). If you can’t say it on a product label, an endorsement shouldn’t either. I write about how a customer social media post becomes an endorsed testimonial here . Failing to disclose material connection: This is so basic, but many influencers skip over this, especially on TikTok. Here are some tips for disclosing material connection. Fake reviews: Right on FTC! Yes, fake reviews are bad. How about withholding unfavorable reviews; this led to this 4.2 million dollar fine . 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 Panel Discussion Wednesday Feb 19, 2025 Key Takeaways for Dietary Supplement Marketers NutraIngredients: Weight Management Summit San Diego The Weight Management Summit , hosted by NutraIngredients-USA and in association with Iovate Health Sciences . This dynamic half-day summit that dives deep into the rapidly transforming weight management landscape. Gain valuable insights into the latest market trends, evolving regulatory frameworks, and groundbreaking science behind dietary ingredients as natural alternatives to GLP-1 drugs, along with solutions to manage their side effects. Discover actionable strategies to effectively engage and inspire today’s informed consumer, equipping your brand to thrive in this competitive space. Learn More & Book Your Ticket Previous Next

Learn from others’ mistakes < Back Dietary Supplement Manufacturing & Marketing Lessons Learn from others’ mistakes Dietary supplement manufacturing and marketing issues are all cited in this warning letter. This feels like a trip way back in time when GMP regulations and compliance for “supplements” were likely not top of mind. Here’s what we can learn. GMP compliance: One of the many violations in this letter involves the Batch Production Record (BPR). Although these are fundamental aspects of GMP compliance, re-reviewing these glaring oversights is always a good reminder. Here are some of the issues FDA pointed out. 🔺Missing batch, lot, or control number. This is how the product is categorized and tracked. 🔺Missing the date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch or a cross-reference to records, such as individual equipment logs, where this information is retained. This proves that cleaning has occurred and is especially important when reviewing product quality investigations, such as verifying whether major allergen cleaning was conducted. 🔺Missing identity and weight or measure of each component used. 🔺Missing statement of the actual yield and a statement of the percentage of theoretical yield at appropriate processing phases. This is one way the formulations are verified to ensure ingredients were not missed or double-counted and that bottles have the correct weight. 🔺Missing initials of the person responsible for verifying the weight or measure of each component used in the batch. This is the doer and checker system to ensure weights are added correctly and then verified by another party. 🔺 Missing actual or representative label or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record. This is important to prevent labeling mix-ups, which can be very dangerous. 🔺Missing documentation at the time of performance that quality control personnel approved and released, or rejected, the batch for distribution. Quality must review and release/reject the batch without exception. Marketing claims: This warning letter contains some of the most sever disease claims I’ve read in a long time. The claims appear on website product pages and actual labels. 👉From warning letter. “Recommended Package: Cancer . . . This package contains the following products. . Calcium 2 OZ Bottle . . . Magnesium 2 OZ Bottle . . . Silver 2 OZ Bottle” 👉From warning letter, “On the product label for Silver, 8oz: - “Silver is a potent natural antibacterial, antiviral, and antifungal.” Sadly, the website remains filled with disease claims and non-compliant product labels. Read the full letter here . DATE ORIGINALLY POSTED: 7/2/25 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 Meet-Up Group Wednesday Jan 15, 2020 FDA and Class Action Enforcement Trends & Updates: Fireside Chat Asa's Regulatory Education Series Boulder Hemp-CBD Group Meet-Up hosted by Asa (In-person) In any rapidly emerging industry building a community to help support each other in education, compliance, and in developing best practices is always a good idea. This is a fireside chat format to discuss FDA and class action enforcement and trends. We expect an update from the FDA soon and we can likely guess there will be more lawsuits and perhaps more warning letters as well. I am joined by special guests: Garrett Graff , Managing Attorney of Hoban Law Group Dave Rodman , Founder of the Rodman Law Group Read more Previous Next

Some of my favorite regulatory resources. If there are other resources I should list here please let me know. Helpful Resources Here are some of my favorite regulatory resources. If there are other resources I should list here please let me know. Marketing Guidance This section covers helpful marketing resources, View Resources Prop 65 Guidance Prop 65 can be confusing. Here are some of my favorite resources. View Resources cGMP Guidance This section covers helpful GMP resources, View Resources Made in the USA and All Natural These are common plaintiff lawsuit targets. View Resources Labeling Guidance This section covers helpful labeling resources, View Resources NDI and GRAS Guidance This section covers helpful NDI and GRAS resources, View Resources Influencer Marketing & Product Reviews This section covers helpful influencer marketing resources. View Resources Home About Warning Letter Wednesday Work With Me Testimonials Appearances Press Regulatory Blog Resources More

Ensure material connection is disclosed properly < Back NAD Case: Influencer Material Disclosure Ensure material connection is disclosed properly This NAD case is a good reminder of the importance of influencers properly disclosing material connections in the same manner that endorsement is made. For example, suppose there is an image and no video/audio. In that case, then simply using hashtag#Ad or #(Company)Ambassador is sufficient, as long as these disclosures are not buried in a string of hashtags or below the “Read More” button. Now, according to the updated FTC guidelines, if an endorsement is made verbally, then the disclosure must also be made verbally. This kind of makes sense to me, but it becomes complicated when endorsements are made in Reels and Stories. Last year, FTC sent warning letters to several influencers and some sugar trade groups for not disclosing material connections in videos. I write about this here . Aside from that group of FTC letters, there hasn’t been much action with this new guidance, which is why this NAD case is so interesting. From NAD case stating what the company has agreed to do. "Requiring its influencers to include a verbal notice of their partnership with ... in any video influencer material." These rules ensure that consumers are not misled, which is important as we count on the honesty of reviews to make purchasing decisions. These disclosure requirements also apply to ambassadors, investors, and family members of companies. In this case, actor Demi Moore seemed to cross this line. From NAC case. "... challenged a social media post by Demi Moore in which she stated that her promotion of ... was "not an ad" and failed to disclose that she is an investor in the brand. The Demi Moore example is pretty over the top, but the likelihood that the other claims would have been cited in warning letter or agency action seems relatively low. This shows that “poking the bear,” which in this case is a very large company in the antacid space, can lead to increased challenger scrutiny. When in doubt, be very careful when disrupting category leader incumbents. Wondering what the National Advertising Division (NAD) is? Check out this post . There are some more interesting items in this case. Please read it 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!

“Brain Fog” claims related to Covid will attract scrutiny < Back Small Herbal Company in Big Trouble for Disease Claims “Brain Fog” claims related to Covid will attract scrutiny This is yet another example of a well-intentioned herbalist-owned, very small company being cited for disease claims. I write about how no company is “too small to be off FDA radar” here . This company is a farm that makes small-batch products, but unfortunately, they don’t seem to know the rules of dietary supplement marketing. All the claims cited in the FDA warning letter have been removed, but there is still a cancer treatment herbal kit for sale on their website. Unfortunately, the basics of DSHEA and marketing compliance are not taught in herb and acupuncture schools. One of my missions is to educate these communities about the basics of the dos and don’ts of supplement marketing. Here is my speaking schedule ; please let me know if I can extend free education to your school. Also interesting in this warning letter is the second mention of “brain fog” in FDA letters. 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. Due to the hashtags in this post, the correlation to Covid is undeniable. This is a good reminder that hashtags can be considered disease claims and tip the scale into the warning letter category. Here’s a video about this. From warning letter. “Plants geared towards cardiac and mental health, brain fog, respiratory issues, and fatigue . . . # postcovid, # postcovidsyndrome, # longcovidrecovery, # longcovidsymptoms This is a joint FDA and FTC warning letter, which is common when Covid claims are cited. This is very 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. Full warning 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!