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< 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

< Back Interview Tuesday Jun 1, 2021 U.S. Dietary Supplement Market Entry Regulatory Considerations Health Products Association China In this video, host Jeff Crowther and special guest Asa Waldstein discuss market entry considerations such as manufacturing, labeling, marketing, advertising, and some specific U.S. regulations that might be looked over by global players entering the market for the first time. Learn More Previous Next

CBD enforcement is top of mind for FDA < Back FDA Issues Five CBD-Related Warning Letters CBD enforcement is top of mind for FDA CBD-related FDA warning letters are up over 420% this year, and this recent batch of five warning letters has some excellent learning opportunities. The biggest news is one of these letters does not include disease claims. There may have been one or two CBD letters ever that did not include risky claims. The products cited are beverages that contain some caffeine and hemp extract. FDA's concern is related to CBD posing delayed caffeine metabolism. If you sell CBD and caffeine products, I would remove them from the market asap. This warning letter confirms that the labeled "hemp extract" is CBD by testing, citing a COA on the website, and citing blogs on the website. It's interesting to see how FDA "ties it all together." I ask, "If there was no caffeine in the product, would the company have been issued a warning letter?" Here is the letter . Many of these letters include CBD in food products such as lollipops, cookies, and infused sugar. This is a problem for FDA because these food formats are favorable to children who may consume too much CBD resulting in a possible health concern. These are not form factors used in the supplement industry; they seem unnecessary and poor formats for delivering CBD. FDA purchased and tested products from all five companies that received warning letters. I have not seen a reference to the FDA purchasing and testing products in any 2022 warning letters. What are your thoughts on this? Two of these warning letters reference five-year-old social media posts. Here's a post about this. One warning letter mentions Delta-8. Here's a video about Delta-8 enforcement. More YouTube claims are cited, including a 3-year-old video in this letter . When social media and YouTube claims are mentioned in letters, FDA demonstrates the commercial bridge with statements like this "which direct consumers to your website to purchase your products." Here is a post about this. From one of the warning letters. "From your YouTube social media" "July 16, 2019 video – "CBD has been shown to help with a lot of different things like anxiety, stress, pain, and inflammation, and even help with seizures." 40% of this year's CBD warning letters involve CBD and animal products, which continue to attract increased scrutiny. The FDA seems to have a lower "allowance" for claims about CBD and animal products. For example, "anxious feelings" for pets may be enough to attract a warning letter, whereas it's unlikely this statement would trigger a human product warning letter on its own. Here's a post and video about animal and CBD claims enforcement. Two of the letters include references to OTC drugs, including one involving sunscreen and CBD. This letter cites CBD as an active ingredient in the sunscreen product, a huge error. Anyone who has been paying attention knows FDA takes an unfavorable stance on CBD as an active or an inactive ingredient in OTCs. I write more about this here . Here's the warning letter that mentions sunscreen. Here's FDA's constituent update on these warning letters. 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!

Use FDA's helpful resource (Criterion 7) < Back Navigating the Risks of Therapy-Adjacent Health Claims Use FDA's helpful resource (Criterion 7) Navigating allowable and off-limits claims can be confusing. Fortunately, the FDA offers a helpful resource, The “Small Entity Compliance Guide on Structure/Function Claims” which includes a Q&A format outlining 10 key criteria to help distinguish between disease claims and structure-function claims. In today's Warning Letter Wednesday, I am exploring Criterion #7, "Claims to augment a therapy or drug intended to diagnose, mitigate, treat, cure, or prevent a disease." This criterion shows the FDA's thinking on why statements like “useful on your chemotherapy journey” or “take with antibiotics” are disease claims. 👉From FDA Guide. “A claim that a dietary supplement will augment a particular therapy or drug action that is intended to diagnose, mitigate, treat, cure, or prevent disease is a disease claim.” 🔹 Asa Comments: The best example of what not to do is from this 2021 warning letter where the company stated “ Vitamin C May Combat Cancer & Ease Cancer Treatment.” This is an issue because it claims to support or ease an oncology treatment and the vitamin C is positioned as an adjunct to drug therapy. 👉From FDA Guide. “A dietary supplement may state that it is useful in providing nutritional support, as long as that claim doesn't imply disease.” 🔹 Asa Comments: This is an interesting one as there is a fine line between making statements like “Omega 3’s are helpful at supporting mood” and making a “People with depression are often low in Omega 3’s, which is why we made this fish oil product” which would be crossing the compliance line. 👉From FDA Guide. In general, mentioning the name of a specific therapy, drug, or drug action will associate the claim with the intended use of the therapy, drug, or drug action and be a disease claim. 🔹 Asa Comments: Another 2021 warning letter shows us that FDA will flag supplements claiming to reduce the side effects of drugs. This is an area of the regulation that can be improved in my opinion as it’s well known that prescription drugs have side effects such as hurting the microbiome that can be lessened by taking probiotics. Addressing drug induced nutrient deficiencies is vital to health such as with statins which are known to deplete CoQ10 which is crucial to heart health. While a statement like “Replenishes CoQ10 lost when you’re on a statin ” may attract regulatory scrutiny, sticking with “Take CoQ10 as part of your heart wellness protocol” are lower risk, if substantiated. 👉 From warning letter. “Helps to reduce the risk of antibiotic-associated diarrhea…” When supplements are marketed to be taken with drugs this can also lead to litigation as we saw with the Culterelle case . This involves a probiotic product being labeled to be taken with antibiotics. Read FDA's Small Entity Compliance Guide on Structure Function Claims here . This is a great resource! DATE ORIGINALLY POSTED: 4/23/25 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!

“Arthritis” claims elevate risk < Back Testimonials & Video Claims Lead To Warning Letter “Arthritis” claims elevate risk The timeline of the FDA interaction is notable. The company was inspected last August, then FDA reviewed their website in October and November, then reviewed it again in March 2023. If the company had cleaned up its website before the last FDA website review, it probably could have avoided this warning letter. Do your teammates ever ask you what happens if you receive a warning letter? I made a one-minute video about this. Testimonials are cited in the letter. Third-party non-curated, non-compensated, honest reviews are unlikely to be scrutinized, but they become marketing when used to sell products. This includes: ●“Liking” or “saying thanks” on a social post ●Interacting with a product review ●Showcasing a product review This company has a page specifically for testimonials which makes them curated, which is marketing. →From warning letter. On your Testimonials page: “I prefer … over chronic use of Rx or OTC NSAIDS for arthritis due to the potential renal and gastric side effects of chronic NSAID use.” As we have discussed before, claiming a supplement is better than drugs is a quick way to irritate FDA and attract a warning letter. No GMP manufacturing claims are cited in this letter, which means they are probably doing a good job making the product, but they have crossed the compliance line with their marketing claims. If interested in talking about the nuances of marketing compliance, I would be happy to meet for 30 minutes at no charge. I am here to (try to) help! YouTube claims are cited again in this warning letter. This is the third FDA warning letter that mentions YouTube videos this year. Are you interested in seeing the others? You can search old Warning Letter Wednesday posts by keyword here . This is intended to be an ongoing resource for your regulatory and marketing teams. Claims about “pain” are cited in this warning letter. While it is unlikely a company would receive a warning letter without higher-risk words like “arthritis,” occurrences of “pain” do elevate the overall likelihood of agency action. Did you know that “arthritis” is the most common “itis” in warning letters? If accurate, replacing “arthritis” with “joint discomfort” can help to lower risk. →From warning letter. “… is made of 12 key ingredients - each chosen for its specific ability to address the complex causes of pain.” I’m writing this #WarningLetterWednesday post as I fly to Vitafoods in Geneva, where I am speaking about US supplement regulations and marketing best practices . Let’s meet if you are in Geneva! 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!

< 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