< Back GMP Pitfalls: Marketing, Manufacturing, & Labeling #WarningLetterWednesday 👉I got carried away writing this WLW post. Check out my blog for the detailed discussion. We can learn a lot from warning letters. Following FDA enforcement trends is a valuable tool for any savvy marketer, regulatory affairs professional, quality manager, or dietary supplement executive. We can adjust practices before they elevate to warning letters by learning how to read warning letters and act accordingly. This is the most detailed Warning Letter Wednesday I have written. ➡️ Read the full post here . 👉FDA Inspections Trigger Website Reviews The company was inspected by FDA in March 2021 and was issued several 483s. The company's website was recently reviewed in February 2022, which led to a letter. Learn about the difference between a 483 and a warning letter here . Usually the FDA investigator reviews a company's website for disease claims before an inspection. That is likely still happening but this is the third recent warning letter where FDA inspections led to a website review at a later date. These website reviews were then elevated to a warning letter. This is an enforcement trend and a reminder for those who have been inspected to clean up website claims. 👉I write about these letters here . 👉This warning letter is a great teaching case. Here are the learning targets. 🔷FDA Inspections Trigger Website Reviews 🔷Marketing Claims 🔷Distributors Responsibilities 🔷Common GMP errors 🔷*Writing and Following Specifications 🔷*Writing Procedures 🔷*Product Returns 🔷*Product Complaints 🔷Certain Herbs Are Not Allowed 🔷Common Allergen Labeling 🔷Domestic Street Address or Phone Number 🔷Languages Must Contain The Same Information 🔷Serving Size and Suggested Use 🔷Plant Parts Must Be Disclosed 🔷Correct Plant Listing 🔷Supplement Fact Panel: Line Thickness 🔷Percent Daily Values Label Requirement 🔷Expiration Dating 👉👉Join my Warning Letter Wednesday group . 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 In-Person, Presentation Friday Sep 5, 2025 Marketing Compliance & Best Practices For Natural Product Marketers: An exploration into enforcement trends and technology solutions SENPA Natural Industry Alliance SOHO Expo Orlando, FL SOHO EXPO is a Natural Products Industry Trade Show and Convention produced since 1971 by SENPA a non-profit Trade Association with proceeds from the show staying within the industry. SOHO EXPO offers the right mix of the natural products industry, and is located at the beautiful Gaylord Palms Resort and Convention Center in Orlando, FL. Join Asa Waldstein for an interactive deep dive into the evolving world of marketing compliance for natural product marketers. This session explores enforcement trends, such as FDA warning letters and litigation, to help inform compliant and effective marketing. This presentation provides actionable insights and pitfalls to avoid for independent retailers or brands of all sizes. Attendees are encouraged to bring their questions to this discussion. Learn more and register Previous Next

< Back Online Tuesday Dec 10, 2024 Navigating GLP-1 Regulatory Compliance: Marketing Best Practices in the Supplement Industry Naturally Informed Active Aging Event This presentation will delve into the current marketing landscape surrounding GLP-1 in the U.S. supplement industry. Asa will look at biomarker enforcement, such as LDLs, to gain insights into marketing best practices, focusing on compliant strategies and pitfalls to avoid when promoting GLP-1-related products. Learn More and Register Previous Next

Before marketing products check with a supplement expert < Back Learning Targets: definition of supplements, safety claims, disease statements Before marketing products check with a supplement expert Today's #WarningLetterWednesday is cringeworthy but also contains learning lessons for product marketers and developers. The product is a vape that contains caffeine, is labeled as a supplement, makes overt safety claims, and uses high risk marketing disease claims. There are a lot of learning lessons here. Vapes by definition are very high risk. Adding caffeine into a smokable product with other herbal ingredients may seem like a good idea to an untrained development team, but it is actually exceptionally dangerous. Supplements are defined as products taken by mouth that contain a "dietary ingredient" intended to supplement the diet. Smokable products by definition cannot be supplements because they are not ingested. As a side comment this is also why "sublingual" delivery is not suitable for supplements, as it's a drug delivery term. I ask, what regulatory category does a vape with herbal ingredients belong to? Making safety claims on any product must be substantiated. When statements like this are made it seems more like optimistic and potentially deceptive marketing than hard science: (from warning letter) “Is it safe to inhale caffeine?.....Yes" There are also high risk marketing disease claims mentioned in this warning letter. These include references to "inflammation" which I discussed in last week's Warning Letter Wednesday here . Lots of claims here discuss ingredient benefits such as: (from warning letter) "Vitamin B12 has even more science-based health benefits including:....Supporting bone health and preventing osteoporosis...Uplifting mood and symptoms of depression" I review ingredient benefit claims in another Warning Letter Wednesday here . Read full warning letter here . DATE ORIGINALLY POSTED: 12/15/21 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!

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!

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!