< Back Interview, Online Tuesday Nov 23, 2021 Practitioner v Product Claims NuHerbs Asa Waldstein and Wilson Lau explore the differences between claims that practitioners can make within their scope of practice versus ones they can make as herbal product marketers. How to be mindful of where you are making claims and in what capacity you are making such claims. Asa shares tips on how to create compliant claims and how to turn high-risk claims into low-risk claims. Asa brings a unique viewpoint being both a clinical herbalist and a seasoned veteran of the dietary supplement industry. Asa writes a weekly #WarningLetterWednesday post where recent enforcement trends are reviewed. Here is a post where practitioner education crosses the line into marketing claims. Watch Previous Next

< Back Podcast, Interview Wednesday Jan 19, 2022 Thought Leadership and Compliance Move The Stairs Podcast Here's what we discuss: FDA's position of Hemp CBD. Why following enforcement trends is important for marketers. Reasons to clean up old social media posts. Step by step process in becoming a thought leader such as "What problem am I having and how can I be extremely helpful to others in helping to solve this?" Why being a thought leader can help companies react appropriately in a crisis or with important news. One great example is how to talk about the recent CBD study without making a product COVID claim. Press release benefits and best practices. Listen Previous Next

< Back Webinar Wednesday Oct 12, 2022 10 Herbal Product Marketing Tips & Pitfalls to Avoid with Asa Waldstein Herb Rally LIVE WEBINAR HOSTED ON ZOOM Asa Waldstein reviews common marketing pitfalls to avoid, such as social media engagement, hashtags, reposting, product reviews, citing studies, and blogs. He will provide practical information on implementing lower-risk marketing strategies without impacting sales. This is a town hall and presentation format so please bring your questions. This online event is LIVE and FREE. Register Previous Next

Hire experts to help with 483 responses < Back GMP Violations Continue to be Cited in Warning Letters Hire experts to help with 483 responses FDA continues to issue more warning letters to companies that do not adequately respond to 483 violations. The violations and 483 responses provide excellent learning opportunities. Here are some key takeaways. ● Documentation. This is a rather embarrassing reminder that FDA can look at any controlled document. “If it’s not written down, it didn’t happen” is a vital part of GMPs. → From warning letter. “The tablet run sheet for … includes out of specification fill weights… The tablet run sheet has weights throughout in the range and notes “tablet won’t hit the weight so running.” A corrective action approved by the firm’s quality unit was not documented.” ● Common (major) allergen disclosure . When disclosing the major allergens fish, crustaceans, or tree nuts (most cases), the specific type should be disclosed, such as “Contains fish (tuna).” I remember when the FALCPA was enacted in 2004, my third year as a supplement manufacturer. → From warning letter. “the finished product labels fail to declare the major food allergen, shrimp and crab, as required by section 403(w)(1) of the Act. Specifically, as you have chosen to use a “Contains” statement, you must declare the specific type of Crustacean shellfish.” ● Herb common names . The American Herbal Products Association (AHPA) Herbs of Commerce book is the FDA-recognized way to list the common names of herbs. This book is essential for supplement companies and consultants. → From warning letter. “Your … Facts label declares the … but fails to state the standardized common name “(b)(4) ” as listed in the reference Herbs of Commerce, as incorporated by 21 CFR 101.4(h).” ● Finished product composition. This has been showing up in more warning letters and 483s and is a rigid interpretation of the finished product composition requirements. Let’s say there is a blend of herbal ingredients that have been tested for identity and purity. If they are blended with a validated procedure and encapsulated, FDA requires a company to prove composition in the finished product even if there are no specific constituents, such as curcuminoid content, to test. It is my understanding FDA has been encouraging companies to develop expensive finished product composition tests to verify this. This is a new and burdensome enforcement trend to watch. → From warning letter. “The input of the various dietary ingredients during production and subsequent analysis of a single dietary ingredient alone in the finished product is not sufficient to verify specifications for identity, purity, strength, and composition in a finished product because inputting specific amounts of various ingredients during manufacturing does not ensure that specifications are met in the finished product, nor does later testing for a single dietary ingredient assess any other components within the finished product.” Adverse event reporting address on labels. A domestic street address or phone number is required on labels which is an essential aspect of dietary supplement safety. An email, website, or QR code is not sufficient. → From warning letter. “Your product label is misbranded within the meaning of section 403(y) of the Act [21 USC § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement.” Read the full warning letter here . The 483 responses are humorous. 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!

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!