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“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!

Free products should also be disclosed < Back Influencers Must Disclose Material Connection Free products should also be disclosed Disclosing material connections is an important part of influencer and ambassador marketing, including when customers receive free products and post about them. Drunk Elephant, a well-known skincare brand, was recently targeted by the National Advertising Division (NAD) for alleged violations of their influencers and ambassadors not disclosing material connection. Here’s what we can learn. 👉 From NAD case: "A company influencer states “@Drunk Elephant you did it again – you guys know I’m obsessed with the bronzing drops… hashtag#drunkelephantpartner .” NAD goes on to state “The hashtag is on the fifth line and only visible if the viewer clicks on the hyperlink “more.” 🔹Takeaway: Hiding material connection below the “more” section is not considered conspicuous and is therefore not compliant. Adding disclosures at the beginning of the post is always best. Also since this is a video post where the endorsement is made verbally the disclosure should be made verbally as well. 🔹Unpaid product is compensation: In this example the unpaid consumer who receives free product does not disclose material connection. If they would have said “Thanks for the free product” or “I love this free sample” that would be sufficient disclosure. 👉 From NAD case: “The other TikTok video post was created by … an unpaid influencer who received free product from the company. (The) video post did not feature a material connection disclosure. The text accompanying her post states “b-goldi illuminating drops are 10/10.” NAD noted that receiving free product constitutes a material connection that requires disclosure.” Generally speaking, there are two main types of NAD cases. 1) Challenge cases: This is when a competitor challenges the validity of another company’s claims. There is a cost associated with this and typically only larger companies participate in this. This is important to keep in mind if you are “poking the bear” of a large company. For example, saying a product works better than an incumbent product is a quick way to attract a challenge case. 2) Monitoring cases: NAD looks at different categories of claims and then finds claims to challenge. This Drunk Elephant example is a challenge case and since there is little enforcement of TikTok, I expect more NAD scrutiny of this platform. Read the full case here . DATE ORIGINALLY POSTED: 11/20/24 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!

Asa Waldstein and two top advertising attorneys share their tips and best practices for marketing stress supplements. 🔷Stress-free rules Ivan Wasserman, Amin Talati Wasserman, LLP 🔷Pooja's do's and don'ts Pooja Nair 🔷Asa's helpful hints Supplement Advisory Group < Back Stress: What can you claim on a product label? Danielle Masterson Interview Asa Waldstein and two top advertising attorneys share their tips and best practices for marketing stress supplements. 🔷Stress-free rules Ivan Wasserman, Amin Talati Wasserman, LLP 🔷Pooja's do's and don'ts Pooja Nair 🔷Asa's helpful hints Supplement Advisory Group Read More 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!

Websites are considered “labeling” < Back OTC Drug Website Claims Websites are considered “labeling” I am far from an expert in OTC products, but this warning letter also includes herbal extracts, which I find interesting. OTC drugs follow strict monographs that describe the type of claims that can be made and the active ingredient recipe that must be followed. 🔷Here is the active ingredient definition from FDA, which essentially means that inactive ingredients cannot have a therapeutic effect: “Active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans.” 🔷 Website claims: This company added herbs as inactive ingredients but makes disease claims about them on their website. Aside from the directions, much of the actual label seems to be compliant, but statements made on websites are still considered labeling in the eyes of the FDA. This is a great example of how marketing statements can elevate the risk of scrutiny. Using software like my compliance program, Apex Compliance™ , can help prevent companies from receiving these preventable actions. 👉 From warning letter. “Hops adds a bitter flavor and is a stability agent. In herbal medicine, this plant is known to benefit conditions such as anxiety and insomnia…Passion Flower Is a climbing vine with beautiful flowers, and is recommended as a sedative and antispasmodic agent.” 🔷FDA also references that if the product is used as directed, it exceeds the maximum suggested daily amount in the OTC monograph. I am far from a safety expert, but this probably pushed FDA to issue the warning letter. Read the full warning letter . DATE ORIGINALLY POSTED: 1/31/24 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 Interview Tuesday Jun 15, 2021 Compliance Pitfalls to Avoid CBD Association Have a cannabinoid company and worried about falling victim to easily avoidable compliance pitfalls? If so, watch the CBD Association's vlog and learn from dietary supplement expert Asa Waldstein about the best business practices your company should be following. We also discuss the cannabinoid regulatory, marketing, and enforcement trend landscape. Learn More Previous Next

Even lower risk statements can trigger NAD scrutiny < Back “Reduce Bloating” Claims Lead To NAD Case Even lower risk statements can trigger NAD scrutiny Even lower-risk statements can lead to scrutiny, as we see in this National Advertising Division (NAD) case. I do not consider any of the claims NAD cited to be high risk, but this shows that even low to mid-risk structure-function claims may attract NAD scrutiny. This, of course, reminds us that all marketing should be substantiated. Here are some of the claims mentioned in the NAD case. “Relieves symptoms of Menopause” “Relieves hot flashes” “Improve sleep quality” “Reduces bloating and gas” I am unable to determine if these were on-pack or off-pack claims. This matters (to me) because NAD’s position is that the company did not provide substantiation for these claims partially because there was “no testing on the product itself,” so I am hoping to understand how the company was positioning these claims. If they were on-label, then perhaps a reasonable consumer would think the entire product rather than the ingredients have been tested, but does this also apply to product pages or website statements? Interestingly, NAD reinforces its position that generally attributing benefits to ingredients may be okay, as we see in these wordy examples. From NAD case. “NAD noted that nothing in its decision would prevent (the company) from: Making claims regarding the ability of fennel and chaste berry to positively affect menopausal symptoms that are supported by the limited findings of the research in evidence. Making supported claims that describe the traditional or historic use of ashwagandha to support sleep or are carefully qualified to avoid any misleading implication about the product’s efficacy or health benefits. Describing the traditional or historic use of chamomile in reducing bloating and gas.” There are two main types of NAD cases. 1) Competitor challenges: This is where the competitor publicly challenges certain claims a company makes. This is a public process and does require a cost. 2) Monitoring cases: These are when NAD monitors different types of marketing and brings the cases themselves without a company challenger. This case was a monitoring case, which means they just happened to come across this company’s marketing. Read the full case here . DATE ORIGINALLY POSTED: 8/21/24 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!

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!

Marketing in all languages should be compliant < Back Disease Claims Lead To Warning Letter Marketing in all languages should be compliant FDA issued a warning letter yesterday for Spanish language disease claims made on product labels and the company’s website. Examples of these claims include “cancer,” “antiviral,” and “arthritis.” Surprisingly, there have only been a small number of warning letters for dietary supplements issued by the FDA this year, which is why I was so excited to read this letter today. In April of this year, FDA purchased supplements from this company by calling the phone number listed on the website. Typically, FDA issues warning letters by simply flagging the online claims without purchasing products. I wonder if this is part of the continued adulterant testing of Spanish-language joint health products that are also making over-the-top disease claims such as thes e . This warning letter is a great example of claims to avoid, such as “diabetes,” “hypertension,” “antiviral,” and “prevent infections.” Read the full letter here . This letter shows that all products, even those in other languages, are fair game for scrutiny. This company’s website appears to be shut down, which seems to happen frequently when small companies get warning letters. Do you think this is enough to dissuade companies from making serious disease claims about their products? 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!

Screen all blogs and social media for disease claims < Back Disease Claims Turn Supplements Into Unapproved New Drugs Screen all blogs and social media for disease claims This #WarningLetterWednesday is an excellent lesson about turning a supplement into an “unapproved new drug” by making disease claims. Other lessons here are: ● LinkedIn claims cited again! ● Eight-year-old social media post! ● Claims made on social media are top of mind for the FDA. From Warning Letter: “Ayurveda has solutions for managing high blood pressure. . . . THREE PRODUCTS TO HELP HIGH BLOOD PRESSURE . . . Arjuna Arishtam supports healthy heart function and reduces high blood pressure.” Social media is mentioned in this warning letter. The citation below is boilerplate in warning letters, and it is a good reminder that directing consumers to a website to purchase the product is the “material connection.” If these social media sites did not link to a commercial website or shopping cart, they likely would not be cited in this letter. From Warning Letter: “these social media websites direct consumers to your website at https://lnkd.in/g-vvBiJH to purchase your products. An eight-year-old Facebook post is mentioned here, and this may be a record for the oldest post mentioned in a warning letter! As I’ve spoken about several times, the FDA looks at old social media posts in the same manner as current ones, and we talk about this here . From Warning Letter: “On an April 3, 2014, post from your Facebook social media website” Check out the citations at the bottom of the warning letter! They reference claims made on LinkedIn. I wrote about this just a couple of weeks ago, and it is a good reminder to clean up old social media pages, including LinkedIn. Join the discussion here : Pro tip: This post includes a high-risk hashtag, which makes it easy for the FDA to find claims in the cluttered world of LinkedIn. From Warning Letter “This webpage is also linked from a post on your LinkedIn social media website, which states “# Highbloodpressure does not have to be permanent: # Ayurveda has solutions for managing high blood pressure. When turning the light of Ayurveda onto HBP, there is a priority toward each person’s imbalance and recommendations are made based on the best diet and activities for each person.” Read the 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!

< Back Panel Discussion, Online Wednesday Mar 2, 2022 Immunity: Mastering the Market Naturally Informed powdered by Wholefoods Magazine and Trust Transparency Center It’s nearly universally agreed that the impact of the pandemic has changed the way consumers purchase health foods and nutritional supplements, with a huge amount of attention being placed on immunity. However, as we all begin to live in a “new normal,” the way shoppers and the industry think about immunity is shifting. Join the Naturally Informed team for a two-day event exploring the science, trends, supply-chain and business strategy of the immunity trend as it evolves again in 2022. Learn from a line-up of world-class speakers as we explore how to master the immunity market in the post-pandemic era, with cutting-edge insights on emerging research, consumer trends, product positioning, marketing messaging, and more. Learn More and Register Previous Next

< Back Interview Saturday Jun 20, 2020 Why Hemp-CBD Companies Need a Supplement Executive NutraCast Maximizing sales by decreasing the time to get to operational efficiency is important. Learning on the job when it comes to best interpreting GMP's, knowing what machinery companies to purchase from, how to market products effectively and compliantly can slow the time to get to maximum peak performance. Focus on sales rather than being bogged down in the "learning curve"stages of growth by hiring an industry expert. We discuss this and more during our fun discussion. Listen Previous Next