Flu & virus claims are enough for regulatory action < Back Website & Social Claims Lead To Warning Letter Flu & virus claims are enough for regulatory action This company was making claims about virus and flu prevention on its website and social media accounts, which led to a warning letter. Here are some of the high-risk claims from the warning letter. 🔹“Support the immune system against virus and germs” 🔹“Vitamin C stimulates antibody production to aid the immune system in reducing the severity and duration of colds” Many may not know that I have a certified clinical herbalist background, and I love plant medicine. Some botanicals do have antiviral properties, such as the wonderful osha plant here in the Rocky Mountains, and herbal texts and people talk about the benefits of plants. This is OK, but it crosses the compliance line when companies use these descriptors to market their products. It seems this is what happened here: a potentially unaware company copying and pasting product benefits from herbal texts, scientific journals, or ChatGPT. Here are a few basic rules for avoiding this issue. 🔹Avoid words ending in “itis,” which means “inflammation of.” 🔹Avoid most words with “anti” such as “antiviral.” 🔹Avoid comparing products to drugs, especially those in the mental health, blood sugar, or heart health categories. 🔹Use caution in the immune category. For example, “immune support” may be allowed with substantiation, but “use when sick” is going too far. 🔹Search Warning Letter Wednesday for what others have been cited for. I’ve written this for ~3 years, and old posts are searchable by keyword. There are also several mid-risk claims in this warning letter. Even though they should be avoided in dietary supplement marketing, they are not typically enough for a warning letter. Here are some examples of mid-risk claims. From warning letter. 🔹“Helps…and pain of the throat” 🔹“DIMINISHES PHLEGM: …. contains a generous dose of ginger, which has been used for centuries as a natural decongestant and antihistamine." 🔹“ALLEVIATES SORE THROATS: …. has a generous amount of honey which will quickly reduce inflammation and soothe your respiratory system.” Read the full warning letter . DATE ORIGINALLY POSTED: 8/7/24 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!

Hashtags elevate marketing risk < Back Discussing Ingredient Benefits Leads To Warning Letter Hashtags elevate marketing risk In the eyes of FDA, discussing product ingredients is a marketing claim, even if there is no direct cross-linking to a product page or shopping cart. This is a common mistake and a good reminder for companies to re-review their websites. Do you want Warning Letter Wednesday delivered to your inbox each week? Sign up here . 👉From warning letter. "On the … Health & Wellness page in the linked article titled: "WHAT IS CALCIUM? | CALCIUM BENEFITS” “[C]alcium supplements are tied to several health benefits including…lowering the risk of colon cancer…” 🔷This is obviously high risk, but it shows how an inexperienced and probably well-intentioned marketer can attract serious agency action. This is one of the reasons I write Warning Letter Wednesday, to help companies get into compliance before they get into trouble. 👉From warning letter. (Facebook) "What happens if a child doesn't get enough calcium?...Kids who don't get enough calcium will have increased risk of bone fractures, not able to reach potential height, and osteoporosis later in life….#dcal #dcalkids" 🔷Adding a product name in a hashtag significantly elevated the likelihood of scrutiny as it correlates the product to the claims in the post. 🔷Here is an example of when hair loss statements cross the line into disease claim category. By removing "alopecia," this would reduce the likelihood of FDA action. This is only the third FDA warning letter to mention "hair loss" claims in the past three years, and all letters included high-risk words. Even though "hair loss" statements are not top of mind for FDA, they are likely to be scrutinized by FDA, NAD, or plaintiff attorneys. Read more about NAD here . 👉From warning letter. "Do I need calcium for hair growth?... Low levels of vitamin D are associated with alopecia or hair loss. Adding vitamin D and calcium supplements may help create new hair follicles, which can play a role in hair growth." 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!

Nutrient content claims must be compliant < Back Labeling Errors Lead to Warning Letter Nutrient content claims must be compliant This warning letter resulted from a GMP inspection and label review. Several labeling errors are cited in this letter, which are excellent learning lessons. FDA has clear requirements for nutrient content claims such as “good source,” “high in,” and “high potency.” From warning letter. Your …product label displays the following claim “Canary Seed … is high in protein content.” In the context of this label, FDA considers the claim “Canary Seed . . . is high in protein content.” Botanicals must be listed in the supplement fact panel according to AHPA’s Herbs of Commerce. Learn more about this book here . From warning letter. “the Supplement Facts label lists “guanabana” which is not a standardized common name listed in the reference Herbs of Commerce; soursop is the standardized common name for guanabana.” The words “Dietary Supplement” are not in bold and prominent font size. This is rarely cited in warning letters but is a friendly reminder of this regulation. From warning letter. “Your …. product label’s dietary supplement statement of identity is not presented in bold type on the principal display panel and in a size reasonably related to the most prominent printed matter on the principal display panel. (see 21 CFR 101.3(d))” There are so many lessons; read 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!

Small words can drastically increase claim risk < Back "Promotes Brain Health” Claim Challenged Small words can drastically increase claim risk A children’s brain health applesauce product received a National Advertising Division inquiry for cognitive and immune-related claims. This is an important reminder that claims, even if not high-risk, should always be substantiated. Learn more about my weekly post, and sign up here . Here’s what we can learn. Action words like “promote” can increase the type of substantiation needed. Here, it seems that NAD implies a difference between “promotes brain health” and making statements about supporting brain health. For statements related to the brain or immunity, I suggest replacing action words like “enhance” and “increase” with “support.” 👉From NAD. “NAD found that in context, the “promotes brain health” claim conveyed a message that the applesauce provided important cognitive benefits beyond simply supporting brain health. Given the gap between the strength of the DHA in the applesauce and that tested in the underlying studies, NAD concluded that the cognitive benefits message was not supported.” NAD also recommended that the company remove the “clean ingredients” claim, which was likely due to unnatural ingredients such as citric acid and ascorbic acid. This may have done the company a favor, as any type of “clean” or “pure” are easy lawsuit targets. Also, this product appears to have a Clean Label Project Certified seal, which shows that certifications should be used with caution. Read the NAD case decision . DATE ORIGINALLY POSTED: 1/29/25 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 Webinar Wednesday Mar 12, 2025 Beyond the Aisle: Navigating Marketing Compliance in the Supplement Industry SENPA Staying compliant with marketing claims is one of the biggest challenges retailers face in the natural products industry. With regulatory scrutiny increasing, understanding the nuances of the Dietary Supplement Health and Education Act (DSHEA) is more important than ever. Join us for the next session of Beyond the Aisle: Navigating Natural Products Retail, where we welcome Asa Waldstein, a seasoned regulatory consultant and clinical herbalist and founder of Apex Compliance, to break down what retailers need to know about compliance. During this insightful session, Asa will provide: ✅ A clear understanding of DSHEA and its impact on the herbal and dietary supplement industry. ✅ The difference between structure/function claims and disease claims—and how they affect marketing. ✅ Practical strategies to ensure your store’s marketing remains compliant, from product signage to digital advertising. - Date: Wednesday, March 12, 2025 ⏰ Time: 2:00 PM EST Don't risk compliance missteps that could put your business at risk. Register now to gain expert insights from Asa and learn how to navigate marketing claims with confidence. Register Previous Next

< Back Presentation, Online Wednesday May 18, 2022 Microbiome: Mastering the Market Naturally Informed powdered by Wholefoods Magazine and Trust Transparency Center Asa Waldstein presents a regulatory and enforcement update on notable action happening in the microbiome space. Watch Previous Next

Citing ingredient research is a marketing claim < Back Uncompliant Product Name Leads To Warning Letter Citing ingredient research is a marketing claim #WarningLetterWednesday This company received a warning letter for claims made in a product name. The product “Covid-19 Immune Support” is a bold Covid prevention and treatment claim. This is a basic but important reminder that product names are marketing claims. The company was also cited for referencing Covid studies for an ingredient in their products. This “implied claim” enforcement is a continuing trend, and I caution companies to remove ingredient study references that contain disease words from their website. I talk more about this here . This is a joint FDA and FTC warning letter and includes a cease and desist demand. I talk more about what this means here . 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!

Implied marketing statements should be compliant < Back Suggestive Words Like “May Help” Do Not Allow Risky Marketing Claims Implied marketing statements should be compliant I like to think of suggestive words like “may” and “could” as the compliance version of “with all due respect.” If I say “with all due respect” to someone, it doesn’t allow me to say whatever I want. The same is true with marketing statements. In this warning letter, the company was cited for making many suggestive disease claims. Marketers can learn what not to do from these examples. From warning letter. “Maca may also help…lower blood pressure ….” “It is known for aiding in…constipation, diarrhea, and diabetes!” It’s thought to be particularly effective against allergies and sinus infections.” “It’s often used as a folk remedy for…the common cold and flu.” This is a shorter Warning Letter Wednesday than normal as I’m attending the Organic and Natural Health Association conference in Florida, where I’m presenting Apex Compliance and participating in an "Amazon: Opportunities and Threats" panel. 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 Webinar Wednesday Jun 15, 2022 cGMP Facility Inspections Conducted by FDA: How Inspection Ready are You? AHPA Webinar This webinar is designed to help businesses in the dietary supplement industry understand the elements of current Good Manufacturing Practice (cGMP) regulations (21 CFR 111) that are the primary focus during U.S. Food and Drug Administration (FDA) facility inspections. FDA inspects facilities to ensure their compliance with regulations and laws surrounding the manufacturing, labeling, and handling of food, drugs, medical devices, and cosmetics that are commercially distributed in the U.S. Attend this webinar to gain insight on how FDA approaches GMP facility inspections, with the goal of understanding how to always be inspection ready as an organization, and how best to prepare for inspection by FDA. This knowledge will assist businesses in better allocating and directing their compliance resources. Prior to the COVID-19 pandemic, an inspector could drop by your facility at any time without advance warning. In light of the pandemic, FDA will now pre-announce domestic onsite inspections of regulated businesses, excluding tobacco inspections. Having a plan in place that includes inspection best practices will go a long way in eliminating the stress that undoubtedly comes when you’re put on notice that an inspection is imminent. Join us on June 15, 2022 (10am-12pm PT / 1-3pm ET), when our expert presenters will: Provide an overview of the current cGMP enforcement landscape – who, what, where and why FDA can inspect Provide examples of how to prepare for an FDA inspection Review the dos and don’ts of working with an FDA inspector in your facility Share first account FDA inspection experiences Presenters Asa Waldstein , CEO, Supplement Advisory Group Will Woodlee, Esq., , Partner, Kleinfeld, Kaplan & Becker, LLP / AHPA General Counsel Steven Yeager , Director of Quality and Regulatory Affairs, Mountain Rose Herbs Cost AHPA Members: $199 Non-Members: $399 Register Previous Next

All social media is “fair game” for enforcement < Back LinkedIn Posts Mentioned in Warning Letter All social media is “fair game” for enforcement It is no surprise that company social media posts are considered marketing claims, as they are commonly mentioned in warning letters. Interestingly, this letter references posts made on LinkedIn. This is a new aspect of enforcement, as previously, I have only seen claims made on a company's LinkedIn page mentioned in warning letters. I find it interesting the FDA is looking at actual posts on LinkedIn, which is an important reminder that all marketing must be compliant and is "fair game" for regulatory scrutiny. This warning letter is Covid-related, which, of course, is a very high risk; however, it is a reminder that hashtags and reposting content elevate risk. In this example, a "Covid study" is shared, and the material connection is solidified with a covid hashtag and a hashtag containing the product's name. From Warning Letter "More evidence that respiratory diseases should be treated in the nose and throat! .... # biovanta # science # covid" [from a post on your social media webpage at...." Read the full warning letter here. This joint FDA and FTC warning letter includes an FTC cease and desist prohibiting the company from making future Covid claims. This sets the FTC up to potentially impose financial penalties and has more "teeth" than a standard 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!

Find high-risk words lurking in old blogs, testimonials, and socials < Back FDA & FTC Crackdown on Products Marketed For Opioid Withdrawal Find high-risk words lurking in old blogs, testimonials, and socials FDA and FTC crackdown on products marketed for opioid withdrawal. The FDA and FTC recently sent five joint warning letters to companies marketing products for opioid withdrawal. Joint FDA/FTC warning letters are rare and a good signal for the industry to pay attention. These are not just warning letters but also include cease and desist demands requiring the companies to stop making unsubstantiated claims or face injunction, civil penalties of up to $46,517 per violation, and requirements to refund customers. This is very serious! Here are some key takeaways. 🔷Products marketed for opioid and substance withdrawals remain high risk. Those suffering from addiction are considered a “vulnerable population” and are top of mind for the FDA/FTC. Other vulnerable populations are the elderly, children, and those with mental illness. This is not a new trend, as opioid-related warning letters go back several years. Now is a great time to ensure these high-risk statements are not inadvertently lurking on a company website or social. The FDA is looking at several-year-old blogs and social media posts in the same manner as current ones. I developed a program to find any website keyword. Please get in touch with me for a free keyword compliance check. 🔷Other high-risk words such as depression and diabetes are mentioned in some of the letters. This should come as no surprise. Here is my blog from last year about depression claims . Here is my post about blood sugar claims enforcement . 🔷Claims made in blogs are prevalent in these letters. Here are my “best practices for reducing risks in blogs” post. 🔷Product reviews are also called out. From a warning letter: “From a review on your webpage …“Its [sic] been great to give up the opioids and feel good.” Four of the warning letters are directed toward kratom companies, and one is to an essential oil company. It is interesting to see what keywords and themes are common in these letters. Contact me for a deeper discussion on this. From a warning letter: “EUCALYPTUS OIL . . . The oil produces a stimulating effect on the body and mind. This aids in reducing the lethargy that may be experienced during opiate withdrawal.” Read the FDA roundup about this 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!