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Guest article in Marijuana Business Daily < Back Staying on the Right Side of Regulators Asa Waldstein Guest Article Guest article in Marijuana Business Daily Read More Previous Next

Supplement should contain safe ingredients < Back 10 Companies Cited for NDIs and Impermissible Ingredients Supplement should contain safe ingredients The FDA issued ten warning letters to companies selling products with New Dietary Ingredients (NDIs) and other impermissible ingredients such as hordenine HCl. I see these ingredients in two categories. *NDIs: Higenamine, hordenine, octopamine *Impermissible dietary ingredients: 5-alpha-hydroxy-laxogenin, higenamine HCL, and hordenine HCL The FDA differentiates NDIs such as higenamine from impermissible dietary ingredients (higenamine HCl). You will notice that "HCL" (hydrochloride) here is the difference between an NDI and an impermissible ingredient. Here is how the FDA helps to define a dietary ingredient. From Warning Letter: Higenamine is a "dietary ingredient" under section 201(ff)(1)(F) of the FD&C Act [21 USC § 321(ff)(1)(F)] because it is a constituent of aconite, asarum, lotus, and other botanicals. Most of these warning letters include impermissible ingredients and NDIs with disease claims. There is one notable exception. This is the first time I've seen the FDA issue a warning letter solely for using a New Dietary Ingredient (NDI) without a disease claim. This is surprising! Read this letter . So what can we learn? 1) Companies should ensure they are not selling products containing any of these ingredients. I spoke about this "warning to industry" in a Warning Letter Wednesday post six months ago. 2) As I say each week, removing disease words helps to reduce risk. Here is a video about tips for understanding if a claim is made. 3) Most of these ingredients were removed from FDA's Dietary Supplement Ingredient Advisory List. Just because ingredients are removed from this list, this action shows FDA. is still serious about removing them from the food supply. Find the list here . Here is the FDA's constituent update . #WarningLetterWednesday 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!

Ensure substantiation is suitable for each claim < Back Learning Lessons From NAD Ensure substantiation is suitable for each claim I usually write about FDA warning letters, but today I will highlight a recent National Advertising Division (NAD) decision. NAD is a self-regulatory body under Better Business Bureau (BBB) programs, and I enjoy reading NAD cases to look for clues about claims substantiation and enforcement. Here are some marketing pieces NAD took issue with in this case. 👉From NAD complaint. "posts referenced the … Health Start Study, communicating that children taking …. visited the doctor less, missed fewer days of school, took fewer over-the-counter or prescription drugs and consumed less fast food/prescription drugs. DSSRC determined that the … Health Start Study was not the type of competent, reliable scientific evidence required for such claims and recommended that the claims be discontinued in the context in which they were communicated." Asa commentary: This shows that statements like "missing fewer days of school" are considered marketing claims and that these types of studies are insufficient substantiation. 👉From NAD complaint. "For the long-form videos shared on …., which include doctors making broad health claims related to use of the product, DSSRC determined that they may conflate certain health-related messages and that claims communicated in the videos are not supported by evidence in the record. DSSRC recommended that …. remove these videos or redact the portions of the video that make reference to the unsupported claims." Asa commentary: This shows that long-form videos will be scrutinized for marketing claims. These can be difficult to control because conversational discussions about product claims can easily cross the line. 🔷A little more about NAD. 🔹NAD reviews advertising disputes between competitors and other claims it becomes aware of. It is where companies can challenge each other's claims they feel are affecting their sales. NAD evaluates the truthfulness and accuracy of advertising and offers a streamlined resolution process to address advertising disputes. However, unlike a regulatory court, NAD cannot enforce its decisions, but if a company doesn't comply with NAD's recommendations, NAD can refer the case to the appropriate governmental regulatory authority, such as the Federal Trade Commission (FTC). This can also alert plaintiff attorneys. 🔹Interestingly, this complaint was not brought by a competitor but by a non-governmental advocacy group (NGO). The company in this complaint is an MLM which seems to attract more NAD scrutiny than other traditional supplement marketing channels. Read more about the case 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!

Jennifer Adam and Asa Waldstein provide commentary in this article by Cassandra Stern. < Back Olly and BrainPack NAD decisions highlight challenges in supplement advertising Cassandra Stern Interview Jennifer Adam and Asa Waldstein provide commentary in this article by Cassandra Stern. "Small words can impact the amount of substantiation needed, which is why it is important to build a company culture of compliance and help the marketing, sales, regulatory, and social teams understand the guardrails or substantiation and what can go wrong if they are not followed." - Asa Waldstein Read More Previous Next

Review old videos for compliance < Back Seven YouTube Warning Letters This Year Review old videos for compliance There have been seven YouTube-related FDA warning letters this year, and I expect the trend to continue. This demonstrates that videos are marketing claims and are, therefore, fair game for enforcement. In YouTube warning letters, there is always a statement such as “This links to a website where you take orders for the products.” This is the link to commerce and establishes the “commercial bridge.” If there was no link to a shopping cart in the videos or elsewhere in the YouTube channel, I wonder if they would be cited in the warning letters. One of the features of Apex Compliance ™ is scanning YouTube videos for compliance concerns. What used to take several minutes or longer can now be done in seconds. I love this feature! Warning letters this year also include YouTube videos embedded on websites, not just videos hosted on a YouTube channel. This shows that claims made in any format, including those in embedded videos, are being scrutinized. Now is a good time to review your videos, especially the old and potentially forgotten ones, for compliance before they turn into warning letters or lawsuits. 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!

The supplements labeled as weight loss products appear to be mislabeled as testing revealed the tejocote root was substituted with a potentially deadly plant. < Back New year, same problem: FDA issues tejocote root warning, finding the supplements adulterated with poisonous plant Danielle Masterson Interview The supplements labeled as weight loss products appear to be mislabeled as testing revealed the tejocote root was substituted with a potentially deadly plant. Read More Previous Next

Expect arterial health claims to be cited in the future < Back Biomarker Claims Lead to Warning Letter Expect arterial health claims to be cited in the future Blood sugar support claims continue to be cited in warning letters. This letter includes biomarker claims such as “improved blood sugar sensitivity and lower A1C.” Based on recent warning letters, listing these types of statements is now enough to attract a letter. I write more about this here . There are other biomarker claims cited in this letter, such as “increased levels of TT3 and TT4," "reduced mean fasting serum glucose," and "promotes arterial elasticity." Keep an eye on your marketing statements relating to arterial plaque and elasticity, as I predict we will see these cited in 2023. This is a warning to companies making similar biomarker claims, and now is the time to review marketing and find and replace these statements. In the past, biomarker claims were not typically enough for a warning letter, but the “Big 7” cardiovascular letters from November signal a change in FDA’s thinking. There are other commonly cited higher-risk claims, such as “diabetes” and “depression,” in this letter. The more of these words used in marketing, the higher the likelihood of receiving a warning letter. You may be saying, “these companies should know better,” and in many ways, I agree. However, they may not have understood that mentioning ingredients in blogs or citing ingredient research is considered marketing. These mistakes are all too common and are a sign of companies who don’t understand the nuanced rules of dietary supplement marketing. Educating on these topics is one of the reasons I write Warning Letter Wednesday. Blogs are mentioned in this warning letter. We are seeing blog titles like this mentioned in recent letters. They help bring traffic to the website but are also clear indications of intended marketing use. In this example, turmeric is in a product sold on the website, which is an implied claim. From warning letter. “Pain Support - Can Turmeric Relieve Arthritis, Joint Pain & Inflammation?” To round this letter out, there are statements such as “Reduce Chance of Catching A Cold.” Talking about reducing the duration of a cold, flu, or respiratory infection is off-limits and should be avoided. Read the 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!

< Back Interview Wednesday Nov 2, 2022 ‘Warning letter geek’ decodes marketing compliance SupplySide West Asa Waldstein is principal of the Supplement Advisory Group and the man behind 'Warning Letter Wednesdays.' His bread and butter is educating companies about the dos and don'ts of marketing. Watch Previous Next

Use qualified reference samples < Back Noncompliant Testing Methods Lead to Warning Letter Use qualified reference samples This company received 483s for GMP violations relating to testing methods and specifications. They were inspected in late 2021 and early 2022 and sent FDA five 483 responses last year. It seems these responses were not satisfactory, which led to this warning letter. There are numerous learning opportunities here. 🔷One of the violations was not having a strength test on a softgel product. It seems the company once had this, but it was removed 👉“at the request of the customer, as documented in your change control document.” A key learning lesson here is contract manufacturers should be flexible with their customers to a limit. Obviously, completely removing this test from the softgel specifications was a bad idea. Who knows, perhaps they could have found a more suitable strength test to satisfy GMP requirements and the customer. 🔷Unqualified reference standards are cited in this warning letter. The company was testing samples using FTIR, but the reference samples were not verified, which means they were likely from previous batches and not a purchased verified material. I will admit this is how I used to test identity circa 2010-ish. 👉From warning letter. “Identity testing using FTIR to compare the sample spectrum to an unverified reference sample is not an appropriate scientifically valid method” 🔷Identity testing in the finished product was brought up again, and this is a trend to watch. FDA requires the identity of each ingredient to be tested before blending and in the finished product. This is straightforward for some items but is costly and challenging if there are numerous botanical ingredients, as this requires developing expensive testing methods. I am unsure if this is the case in today’s #WarningLetterWednesday, but this is not the last time we will hear about this rigid pharmaceutical interpretation of supplement GMPs. I write about this here . 🔷Proving test method suitability is starting to appear in 483s and now in warning letters. This means that the FDA is asking why specific test methods are used. In the past, relying on a third-party lab for this was sufficient, but now, having suitability documentation on file for each method your lab uses is a good idea. 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!

“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!