Maximizing sales by reducing risk in web and social media marketing for supplement and hemp industries. About Asa Waldstein Principal of Supplement Advisory Group , dedicated to providing regulatory and marketing risk analysis for the supplement industry. I love educating and supporting a community approach to compliance best practice development and lower-risk marketing strategies, which often change based on FDA/FTC enforcement trends. 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 . I'm a Certified Clinical Herbalist (CCH) with 20+ years of experience developing and deploying organizational strategies across divisions in the dietary supplement industry. I've developed, manufactured, and marketed hundreds of dietary supplement products and have helped oversee three FDA GMP audits with no 483s. Former C-level executive integral in retooling operations, manufacturing, and QA to greatly improve order efficiency, fulfillment time, out of stocks, and excessive labor KPIs while supporting the company during the brisk revenue growth stage. Current Chair of American Herbal Products Association's (AHPA) dynamic Cannabis Committee and former board member. These affiliations allow me to continue to help drive hemp and dietary supplement regulations and compliance forward during this important time in the industry. Founder and host of Asa's Regulatory Hints YouTube channel . My herbalism research focuses on herbal therapeutics and identifying and ethically wildcrafting medicinal plants, skills now used when formulating, ordering, and approving ingredients. AboutVideo Free Introductory Regulatory Consult Available Online 15 Minute Consultation with Asa Waldstein 15 min Book Now

Increase in claims cited in blogs and social media < Back Anxiety Claims Enforcement Review Increase in claims cited in blogs and social media Anxiety claims enforcement continues to be top of mind for the FDA. In this #WarningLetterWednesday I compare 2022 anxiety claims enforcement with the same time last year. I found some interesting data points that help us understand where the FDA is finding risky items. These learning tools can alert companies where to look for risky keywords that may be lurking on company websites and social media. Here are some key takeaways: 27% of this year’s warning letters mention claims made in hashtags compared with 20% in the same period last year. This shows that hashtags are indeed marketing claims and can tip the scale into the warning letter category if they are non-compliant. Here is my “Hashtags Are Marketing Claims” video . Warning letters citing blogs and anxiety claims more than doubled (63%) over the same period last year (30%). It is now common to see a several-year-old blog mentioned in a warning letter; a good reminder to ensure all blogs, including the old ones, are compliant. Here is my “Best Practices for Reducing Risk in Blogs” post . Social media enforcement continues to be a trend to watch. This is exemplified by the 63% anxiety claims number this year compared to 40% in the same period last year. The two most drastic changes this year were with CBD and animal anxiety claims. 72% of this year’s letters mention CBD, up from just 16% in the same period last year. This shows the FDA’s increasing intolerance of companies marketing CBD with disease claims. There has never been a riskier time to market CBD products; I go into detail about this here . This year, animal and anxiety warning letters increased from 10% to 45%. I write about this enforcement trend here . The one-two punch of both “anxiety” and “depression” is mentioned in about ¾ all of the 2021/22 anxiety warning letters. There have been 22 anxiety-related FDA warning letters this year compared to 30 in the same period last year. I was a little surprised by the low number this year. It is worth noting that “occasional anxiety” was mentioned zero times in these warning letters. The key takeaway is that focusing on life occurrences such as “occasional anxiety” or “occasional inflammation” may be a lower-risk marketing strategy. 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!

Citing studies leads to increased scrutiny < Back Citing Clinical Studies & Labeling Errors Lead To Warning Letter Citing studies leads to increased scrutiny Citing clinical studies, labeling, and formulation errors lead to a beverage warning letter. #WarningLetterWednesday I'm sometimes asked if supplements can make disease claims with competent and reliable scientific evidence. Unfortunately not; even if a Randomized Controlled Clinical Study (RCT) was conducted on a supplement, the FDA does not allow disease claims in supplements or foods. Citing studies with disease claims on a commercial website is a common error that increases the chance of scrutiny, in my opinion. From warning letter: “Green tea has been shown in studies to naturally lower blood pressure” Nutrient content claims are cited in this warning letter. The company labeled their product “nitrogen enriched,” but because there is no DV% for nitrogen, it can’t comply with this regulation. Read more amount other nutrient content claims like “good source of” and “high potency” here . This warning letter mentions the word “stevia,” which is an incomplete ingredient description, and this is a friendly reminder to add the plant part or other information to ingredient listings. From warning letter: “stevia” does not meet the ingredient declaration requirements of 21 CFR 101.4 because it is not specific or descriptive enough to be a common or usual name. Simply declaring “stevia” does not identify whether the ingredient is stevia leaf, crude stevia extract, or purified steviol glycosides.” Here is another interesting example of an inaccurate ingredient listing. From warning letter: “hydrogen enriched RO water” are not common or usual names as required by 21 CFR 101.4 because “RO” is not a widely used abbreviation established by common usage. In addition, as explained above, hydrogen must be declared as a separate ingredient of these beverages, rather than as part of the name of the water ingredient.” The FDA cites a different Nutritional Facts Panel listing on the website “label” and the product label. This is the first time I have seen this mentioned in a letter, and it is a great reminder to have continuity in marketing and labeling. From warning letter: On your website, the product page … includes an image of its Nutrition Facts panel showing that the product contains 9 grams of sugar per serving. However, the physical label collected for this product during our inspection declares 0 grams of sugar per serving” There are even more interesting aspects, and I suggest reading 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!

Re-review online marketing if inspected by FDA < Back TCM Company Cited for Claims & GMP Violations Re-review online marketing if inspected by FDA This Traditional Chinese Medicine (TCM) product company was cited for GMP violations and disease claims. This warning letter contains critical GMP and marketing lessons such as labeling, testing, and marketing essentials. Here, we unpack some critical takeaways as a learning opportunity to help keep you out of trouble. This company was inspected by FDA and received some 483s, which led to their website being reviewed for disease claims months after the inspection. As we've spoken about many times here on Warning Letter Wednesday, it is imperative for companies that are inspected by FDA to ensure their websites are "clear" of risky claims. This is one of the reasons I developed Apex Compliance . To learn more about Apex Compliance, contact me. Here are some key labeling takeaways. The botanical ingredients are not in the standardized common name as noted in AHPA's Herbs of Commerce. They appear to be the TCM names, which is fine, but the common or Latin names are also required. If a label lists information in another language than English, all required information must also be listed in that secondary language. Admittedly, I've never thought about this, but it makes sense from a consumer protection standpoint. The plant parts were missing from a label. Many of the GMP violations cited here have to do with specifications. Specifications are integral to GMPs, and each raw material and finished product must have specifications for identity, purity, strength, and composition. I suggest reading through the warning letter to review FDA's comments. Master Manufacturing Records (MMRs) are the recipe telling the staff how to make a product. Here are several missing items that were cited in this letter. Description of packaging and a representative label. A complete list of components. The weight or measure of each component. Any intentional overage amount. This is to accommodate for shelf life testing and manufacturing variance. A statement of theoretical yield. This is so the company can find problems before the product gets to the next stage of production. For example, if too much of an ingredient was added, the weight should potentially be over the theoretical yield. In the past, my team accidentally added one kilo rather than 0.1 kilo, and calculating the yield caught the error. Specifications are needed for each point, step, or stage in the manufacturing process where control is necessary One person weighs or measures a component, and another person verifies the weight or measure. This is known as the doer/checker system to ensure weighing issues are prevented. This can be difficult to achieve in small companies. And many more items. Unqualified reference standards continue to be called out in warning letters. This company was cited for not using a validated reference standard for FT-IR identity tests. This essentially means if you are testing for something like chamomile powder, you must purchase a qualified sample and test against this standard. Yes, I know GMPs can be burdensome. There has never been a more challenging time than now to be a supplement manufacturer. I feel your pain. From warning letter. "You do not have an adequate identity specification because you are not conducting identity testing against a qualified reference standard." An Out Of Specification (OOS) was cited in this letter. An ingredient or product was OOS for zinc, but the company retested using a different method. FDA took issue with this, which is a learning lesson to ensure retests use the same method. This seems obvious, but in the heat of the pressure to release products, these items can sometimes be inadvertently overlooked. From warning letter. "The investigation testing was performed using a different methodology and by a different laboratory than the laboratory which conducted the original analysis, thus making it difficult to compare the results and to verify accuracy." The website states that products can only be purchased by a practitioner and that no retail sale is available. This is very interesting from a "material connection" point of view. If there is a material connection (e.g., commerce on the website), this is what FDA uses to connect marketing disease claims to commerce. If there is no commerce on the website or linked websites, FDA seems to rarely call out disease claims, which makes this example a rarity. Full disclosure: I have no way to verify if this was a recent change since the warning letter. If anyone knows, please let me know. There are so many GMP learning opportunities 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!

Product reviews are marketing claims < Back Warning Letter Issued for Eye Color Changing Drops Product reviews are marketing claims Do you ever see products and think to yourself, "This can't be safe" or "What regulatory category does that fall into?" After reading this recent warning letter that was issued to a company making ophthalmic (eyedrop) products designed to change people's eye color, I thought to myself, "Is this actually a product that people are putting in their eyes?" Sign up for this weekly newsletter and search three years of previous weekly posts here . According to FDA, making claims such as "Lighten & Brighten Dark Your Eye Color, Speed Up the Eye Color Changing Process" are unapproved drug claims. This is the 13th ophthalmic-related warning letter this year, which shows that if you make a product that goes into the eyes, use extreme caution in product marketing and cleanliness. Also, there's been a group of ophthalmic letters that involve MSM and other ingredients that generally should not be placed in the eyes. I write about this here . Also explore other homeopathic-related ophthalmic warning letters here . Product reviews are cited in this warning letter. This is a reminder that when reviews are curated on a "Reviews" page, FDA looks at them as being showcased, which means they are marketing and fair game for enforcement. There seems to be a fine line between third-party, non-curated reviews on a website and "marketing" reviews curated on a reviews page. I rarely call out companies by name on Warning Letter Wednesday, but looking at how the company formatted their reviews page is an example of what not to do, and avoiding this can help keep you out of trouble. From FDA letter. "On the webpage https://lnkd.in/gemFTh54 . Customer review from 05/17/2024: "I've had brown eyes for years, and they were blue when I was born! Now, after 5 months, I bought it hoping for green eyes, and it works well. It has changed my eyes, and now having green eyes is what I'm most excited about." This company appears to continue to sell the product, which means we can likely expect more decisive FDA action soon. What do you think? Read the full letter here . DATE ORIGINALLY POSTED: 11/13/24 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!

< Back In-Person, Presentation Tuesday May 14, 2024 Vitafoods Europe Startup Innovation Challenge 2024 Vitafoods Europe Geneva, Switzerland Apex Compliance has been invited as a start up finalist. Asa Waldstein will be on stage as a "top 6" finalist in the most innovative digital solution for the nutraceutical industry. Apex Compliance and five other companies have been selected in this category. Most Innovative Service, Technology, or Digital Solution Supporting the Nutraceutical Industry This is a "shark tank" style pitch where Asa will present our technology to an expert panel behind closed doors and also present on stage to the Vitafoods Europe audience. See Asa's LinkedIn post about this event here . Learn more Previous Next

< Back Webinar Wednesday Dec 3, 2025 Regulatory Reality Check: What Supplement Brands Need to Know About the Healthspan Category Naturally Informed Webinar Consumers aren’t just living longer... they want to live better. Consumers are demanding more than just longer lifespans—they’re seeking healthspan . This shift is transforming the supplement and functional foods markets. With global sales for older adult supplements projected to hit $265 billion by 2032, now is the time to understand where the market is headed—and how your brand or business can lead. At this three-day virtual event, you’ll hear from world-class experts covering: - The latest research in aging, longevity, and performance - Nutrition, lifestyle, and formulation insights driving product success - Opportunities in women’s health, mobility, cognition, and beauty-from-within - Marketing and regulatory perspectives shaping this high-growth sector Learn more and register Previous Next

Sponsored children’s content has increased disclosure requirements < Back Sponsored Video Disclosures: Found Incomplete Sponsored children’s content has increased disclosure requirements Videos must disclose material connections when making sponsored content. Here, we learn more about when material connection is needed and what constitutes disclosure, especially when children’s advertising is involved. In this NAD case, the very popular children’s YouTube channel Vlad and Nikki (405 million subscribers, 220 billion views) was cited for not properly disclosing material connections when marketing their own Vlad-and-Niki-branded products. One would think that the material connection is obvious, but here’s NAD’s thinking on the topic. From NAD. “CARU determined that not only does the relationship between Vlad and Niki’s videos and the advertiser, who is the party of the licensing and merchandising agreements, constitute a material connection, but because CMG is required to produce the videos under the terms of the agreement and shares in the revenue generated by sales of the Vlad-and-Niki branded products, CMG is also considered an endorser of the products.” Read more about influencer disclosure and best practices here . In some cases, these types of disclosures are appropriate, but as NAD states, they are not sufficient when children are involved. From NAD. “Other Sponsored Videos used language that CARU and the Federal Trade Commission (FTC) do not consider to be clear to children, such as “sponsored by” or “paid promotion” or the “#ad” disclosure in the description box of the video.” From NAD. “CARU recommends that … include language, in both text and audio in the video itself that is clear for children to understand, to clearly and conspicuously disclose the material connection to the video’s sponsor at standardized times (beginning and end and, for longer videos, after each ad break).” We can expect more of these “material connection disclosure” cases as the creator economy grows. The moral of the story is “When in doubt, disclose,” which can mean verbal and written disclosures. For support with influencer marketing compliance and guidance on how to market your products truthfully and effectively, contact me for a free consult. I love this stuff! Read the NAD case comments 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!

Replace “high risk” words with lower risk alternatives < Back Using words such as “inflammation” increase warning letter chances Replace “high risk” words with lower risk alternatives #WarningLetterWednesday High risk words should be avoided in all forms of marketing. The words "inflammation" or "anti-inflammatory" is being referenced in many warning letters. Read full warning letter here . If truthful and not misleading replacing "inflammation" with words such as discomfort, soothe, support-comfort, body-resilience can help convey a marketing message in a lower risk manner. 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!

Informational blogs on a commercial website are considered “labeling” < Back Learning targets: Blogs, risky words, testimonials, ingredient benefits Informational blogs on a commercial website are considered “labeling” Today's #WarningLetterWednesday is an important reminder that blogs, testimonials, and discussing ingredient benefits can easily cross the line into claims, especially when filled with high-risk buzzwords! 🔷The FDA and FTC look for a material connection. The material connection was evident in this warning letter, as there's a hyperlink (Call To Action) to a shopping cart, as noted here. ➡️From warning letter: On the "Prevent MRSA Infection" blog post ... which hyperlinks to the product webpage for B Complex. 🔷I discuss best practices for reducing risks on blogs here . 👓 🔷Ingredient descriptions on a commercial website may be implied product claims. I discuss this here . 🔷A good strategy is to ensure ingredient education is free of high-risk "buzzwords" or disease claims. Some examples are anti-inflammatory, insomnia, or anything ending in "itis" (arthritis). Here is a WLW post and video about this from a few months back. 🔷Product testimonials can be marketing claims, especially as they're highlighted in this company's "Customer Stories" section. ➡️From warning letter: "'I have been taking CellRenew since May of 2003. . . . This product has kept my arthritis at bay. . . .'" This company talks about viruses that are top of mind for the FDA, and I am unsurprised by this warning letter. Good job, Denver office! We've seen the Denver office focus on claims made in blogs before, a cautionary tale for companies in their district. Read the full warning letter here . Follow 👉My Warning Letter Wednesday LinkedIn Group for early WLW access. 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!

Review old social posts for regulatory “landmines” < Back Seven-Year-Old Facebook Post Leads To Warning Letter Review old social posts for regulatory “landmines” This company received a warning letter for claims made on its website and old social media posts. The oldest post cited in this letter is from 2016, which shows that even old and potentially “forgotten” social posts are active marketing in the eyes of the authorities. Many companies now have “clean” marketing, but they may have inadvertently overlooked the regulatory landmines in their old socials. Now is the time to review and update these old posts (and old blogs). Sign up for this weekly email ! 🔷 Some very high-risk language on Facebook is cited in the letter. 👉 From warning letter.” In a July 29, 2017 post: “Can Plaquex® help prevent cancer?...When I linked the facts of these three independent information sources, the thought came to me, that Plaquex® – Phosphatidylcholine – may be able to prevent cancer.” 🔷 Following the “breadcrumbs” in warning letters is always fun. For example, in this letter, FDA notes that the Facebook page links to a website (book-selling site) that links to another website where customers can order supplements. FDA rarely references anything over “two clicks,” which is what makes this so interesting. FYI, the two-click rule is an urban legend and, as demonstrated in this letter, does not protect from disease claim enforcement. This “commercial bridge” is important, as it’s often cited in warning letters. 🔷 Unfortunately, this warning letter has not stopped the company from continuing to make very high-risk claims, such as statements about ingredients being antidepressant and antiarthritic. Read the full 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!

< Back Panel Discussion Thursday Mar 24, 2022 2022 Regulatory and Compliance Update NoCo Hemp Expo, Denver, CO Speakers: Josh Hendrix , Jonathan Miller , Asa Waldstein , Samantha Walsh , Marielle Weintraub Today, there are a number of congressional bills and legislative and regulatory activity that can have an impact the hemp industry. Join this expert panel for an overview and analysis of key political, policy and regulatory activity that require the hemp industry’s attention, and how producers and marketers of CBD and other cannabinoids, in particular, can remain compliant in the face of USDA, FDA, EPA and other regulatory oversight. Learn More Previous Next