< 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!

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!

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!

Use caution with Made in USA claims < Back FTC Letters to Amazon, Walmart & Other Sellers Use caution with Made in USA claims Four years of Warning Letter Wednesday posts! I am so grateful for your support! When I started writing this post, I had no idea it would turn into this! I’ve made so many friends, colleagues, and business connections because of this. I’ve also learned so much, as it allows me the time each week to dig into the nuances of enforcement trends, which I love! Made in the USA (MUSA) claims are top of mind for FTC. They recently sent four warning letters to companies alleging noncompliant MUSA product claims. Amazon and Walmart also received notification letters (not warning letters) that companies on their platform are making unqualified MUSA statements. In the letter, they reference products making claims like “Made in the USA” or “100% USA Made, “even though the third-party seller is based outside the United States or the product listing describes the item as “imported.” Key takeaways: If you sell on Amazon or Walmart, it is a good time to review your listings to ensure there are no unqualified MUSA claims in text, images, or videos, as they will likely be flagged and delisted. In the past, it seems these platforms didn’t worry too much about this, but now, with the FTC’s attention, I expect tighter scrutiny. An upcoming Apex Compliance feature will scan all of a company’s Amazon storefront product pages in one click for any specific words, such as “Made in the USA,” and then surface issues. I am so excited about this new feature! FTC also references claims made on company websites and social media, and Apex Compliance is already great at finding issues on many of these platforms! “Manufactured in USA” may be considered the same as “Made in the USA.” One warning letter references “high quality America [sic] manufactured products.” FTC also referenced “We use only the highest American-made construction,” “handcrafted in USA,” and “American Made.” Hashtags count. One warning letter referenced the hashtag # MadeinUSA. Noncompliance can be expensive. Here are some of the enforcement “teeth” FTC can use. “Issuance of civil investigative demands (administrative subpoenas), the filing of a federal lawsuit, a permanent injunction, and the imposition of civil penalties of up to $53,088 per violation.” Read the FTC’s press release , which links to the warning letters. This also includes information on how to meet the “all or virtually all” MUSA standard. DATE ORIGINALLY POSTED: 7/30/25 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 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