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< Back Podcast Monday Oct 24, 2022 Avoiding Marketing Risk and Remaining Compliant To Be Blunt with Shayda Toradi Asa Waldstein's best practices for avoiding marketing risk while staying compliant, herbalism, hemp regulations, and much more! Listen Here Previous Next

< Back FDA sends 7 Cardiovascular Disease Related Warning Letters Social media engagement is back in warning letters! It has been some time since FDA cited “Liking” a post as an endorsement of the “testimonial.” One of the companies was cited for this and also for commenting on a post. I suggest companies fight the urge to engage with disease-related comments. 👉 From warning letter. “Yes, it really works! my bad cholesterol drooped by 60 pts . . .” You endorsed this testimonial by responding, “That is amazing Jon! Thank you for sharing.” A key takeaway from this group of seven letters is talking about lowering blood pressure, lowering cholesterol, or even mentioning lowering LDL or “bad fats” can lead to a warning letter. Heart disease-related claims have always been top of mind for FDA, but I found some of the “mid-risk” diagnostic claims, such as “LDL reduction,” surprising. I encourage everyone to review their heart products to ensure there is no mention of these types of statements. This signals FDA’s concern that these claims may encourage consumers not to use cholesterol-lowering and other heart disease medication. 👉 FDA news release. “Given that cardiovascular disease is the leading cause of death in the U.S., it’s important that the FDA protect the public from products and companies that make unlawful claims to treat it. Dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease and related conditions could potentially harm consumers who use these products instead of seeking safe and effective FDA-approved treatments from qualified health care providers,” said Cara Welch, Ph.D., director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition. Claims made in a company’s Amazon storefront were cited in two of these letters, and statements made on platforms like Amazon and Walmart continue to be cited in warning letters. Now is an excellent time to review all marketing material, including the “forgotten” content on Amazon, to ensure there are no implied cardiovascular disease claims. Nine warning letters mention claims made on YouTube this year, demonstrating that videos are marketing claims and are, therefore, fair game for enforcement. In warning letters that mention videos or social media, there is always a statement like “this links to a website where customers can order products.” This is the link to commerce and establishes the “commercial bridge.” Read more about YouTube claims enforcement . 👉 From warning letter. (2:57-3:08) “Now next is Hawthorn Berry [an ingredient in your BPS-5 product]. Used in traditional Chinese medicine for thousands of years, Hawthorn Berry is a popular ingredient used to fight back against blood pressure, blood disorders, and heart disease.” 🔹 Product names are considered claims, as seen in this recent warning letter. I agree “Cholesterol” is regarded as a claim, but it is not as blatant as other product names, such as “Anxiety support.” 👉 From warning letter. “The product’s name (iwi Cholesterol) is an implied claim that it reduces cholesterol.” 🔹 Discussing ingredient benefits is considered marketing in the eyes of FDA. Here is a video about this. 👉 From warning letter. “Garlic powder [an ingredient in CholestAid] has been found to help your body reduce high cholesterol.” DATE ORIGINALLY POSTED: 11/30/22 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!

Ingredient research can be considered a marketing claim < Back Product “Tags” With Disease Claims Elevate Risk Ingredient research can be considered a marketing claim Ingredient research on a commercial website can be considered a marketing claim, which continues to be cited in warning letters. The key point that turns “research” into a marketing claim is when the ingredient is in a product sold on the site. This is when “education” crosses the line into marketing. Here is a post about seven CBD companies that were cited for this earlier in the year. Today’s #WarningLetterWednesday is another example of this, but it also has some new learning opportunities. Products or category “tags” help Google and customers find specific posts, but they are also considered marketing. These tags demonstrate the content’s intended marketing use and should be used carefully. I suggest against using disease “tags” on any supplement marketing, and this warning letter cites a very high-risk category tag. From warning letter: Your website ….. also includes various “Category” tags, including “COVID-19,” that link to the blog post “How Does CBD Help to Fight Against COVID-19?.” The blog post has links to CannaAid products available for purchase. I write more about product tags and meta tags here . This letter also references a call to action where the blog post links to a shopping cart. Although blogs with implied disease claims are cited in warning letters, this “commercial bridge” likely elevates the risk of scrutiny. This company would have received the warning letter without the “Covid” tags and without linking to a shopping cart, but this shows how authorities may consider these factors when deciding to issue a warning letter. Here is a post about discussing ingredient benefits. This joint FDA/FTC letter includes a cease and desist. Learn more about these here . Read the full letter here . DATE ORIGINALLY POSTED: 11/16/22 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!

Product claims must be compliant < Back Tea Product Cited for Blood Sugar, Cholesterol & Cancer Claims Product claims must be compliant This is a story of a small tea company that was cited for making risky disease claims on its website. The company probably didn’t realize they were breaking the rules, demonstrating a considerable opportunity for education in the herbal products market. This is one of the reasons I started Warning Letter Wednesday, to help educate companies on enforcement trends and marketing compliance. This is a reminder that even very small companies are “on FDA’s radar” if they market products online. I write about this here . There are many risky claims in this warning letter. These include blood pressure and cholesterol, which I wrote about last week . There are also claims about insomnia. There have been 20 insomnia-related warning letters this year, and this continues to be an FDA enforcement priority. There is even a cancer claim which is a justifiable automatic warning letter. From this FDA warning letter. “Keeps blood pressure under check.”- “Lowers cholesterol.”- “Controls blood sugar level.”- “Lowers the risk of cancer.” The company removed the items cited in the warning letter from its website. However, very risky posts mentioning claims such as “fights bacteria and viruses” are still on its social media. This again shows that company needs compliance support to understand what constitutes a claim. Here is a “What is a Claim” video . 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!

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!

Test glycerin for contaminants < Back When Topical OTC Manufacturing Goes Wrong Test glycerin for contaminants This may be the oddest response to an FDA batch product record request. 👉From warning letter. “recipes and procedures have been followed for decades. Though not in writing, they have been committed to memory.” This company is an Amish topical OTC manufacturer that specializes in pain relief products. OTC products are permitted to make specified monograph claims like “pain reliever,” whereas topical cosmetic products are not. The OTC tradeoff is that they must follow the monograph (recipe) and specific labeling requirements. For example, a topical OTC product cannot make claims about its inactive ingredients and cannot make product claims that are not listed in the monograph. 🔹How to tell if a product is an OTC topical product? Usually the “Drug Facts” label is a giveaway but in this warning letter the company appeared to be using a Drug Facts label but did not submit all their products to FDA for a National Drug Code (NDC) number. Companies are not required to add an NDC number to labels, but it is common practice. Here is where you can search the NDC database . Key Takeaways: 🔺FDA expects OTC companies to test their glycerin for the contaminants diethylene glycol (DEG) and ethylene glycol (EG). There have been dozens of warning letters about this, and the trend continues. Testing for these contaminants in glycerin is also a good idea for those using it in cosmetics or supplements. 👉Here is FDA’s “Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol” document . 🔺Off-label claims are still “labeling.” If a company markets its product’s benefits that are outside the scope of approved monograph claims, expect the FDA to pay attention. This is also true for making benefit claims about inactive ingredients. Here’s a WLW post about this. 👉From warning letter. “Includes claims to relieves minor aches and pains associated sore throat, sinus trouble, and restless leg syndrome…... These indications described above go beyond the general intended uses for an external analgesic drug product.” 🔺GMP processes are required. This warning letter mentions batch records, identity testing, proper labeling, and finished product testing, among other oversights. 🔺Improper 483 responses lead to a warning letter. Many 483 responses can be handled before they lead to a warning letter, but in this warning letter, the company said they were going to take corrective actions, but did not “show their work.” This is a common but preventable error. Lots more juicy manufacturing violations . DATE ORIGINALLY POSTED: 6/18/25 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!

Distributors are responsible for the products they distribute < Back Amazon & Others Cited for Selling Injectables Distributors are responsible for the products they distribute Another Amazon warning letter, this time for distributing products apparently intended for injection, such as the “L-Carnitine Body Serum Ampoule.” This is part of a group of at least six warning letters issued to companies selling similar products. FDA did some good detective work here to determine whether the products were drugs masquerading as body care products. 👉From warning letter. “The QR code sticker on the product package directs to the URL website xxxx, which includes a link to the website xxxx, which redirects consumers to the website xxxx.” This final website then links to social media accounts where they cite claims like “Discover a non-surgical alternative to liposuction that effectively targets and eliminates unwanted fat, giving you the body confidence you’ve been striving for.” Although it does not seem the companies are explicitly marketing their products as injectables, the packaging and corresponding claims imply the intended use. As more GLP-1 injectable products receive warning letters, this appears to be part of a second wave targeting any type of injectable for fat loss. We should expect more warning letters like this, especially since other major retailers like Walmart seem to continue to offer some of these products. As we’ve discussed before, since Amazon handles (fulfills) the product, they have a responsibility to ensure the products they are distributing are compliant. I suggest everyone read the warning letter footnote that cited Amazon’s product handling. This is a good reminder that product distributors have responsibility and liability. I write more about this here . According to FDA, Amazon is “responsible for introducing or delivering for introduction into interstate commerce these products, which are unapproved new drugs.” FDA is rightfully concerned about injectable products being sold on the open market, as they refer to potential safety issues. 👉From warning letter. “These products are especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.” Read the warning letter here . DATE ORIGINALLY POSTED: 3/12/25 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 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

Kratom 7-OH products are highly scrutinized < Back Product Reviews Are Marketing Claims Kratom 7-OH products are highly scrutinized This is one of the only occurrences I’ve seen where “third-party” website product reviews were cited in a warning letter. There are, however, a few caveats and key takeaways. Let’s review in more detail. This was part of a group of five warning letters recently sent to companies selling 7-hydroxymitragynine (7-OH) kratom products. FDA is not a fan of these kratom products, especially those containing the highly purified 7-OH. This elevated the level of scrutiny, in my opinion. This warning letter primarily cited customer website reviews containing disease claims. When I looked at the website (and the Wayback Machine site), I expected to see showcased testimonials in a banner or image, and I was wrong. The reviews appeared in a format similar to many website product review widgets, lacking engagement and showcasing. Check it out . Sure, product reviews have been cited in many letters, but these were curated, showcased, or engaged with. If product reviews are displayed on a website, agencies typically take a "hands-off" approach if they meet the following criteria: Third-party: They come from independent sources. Honest: Reflect genuine user experiences. (Example: The FTC’s case involving Google and iHeartRadio.) Not solicited: Avoid exchanges like “free product for a positive review.” Do not selectively highlight only positive feedback. Even gathering reviews on a dedicated "Reviews" page may be viewed as curation. Uncompensated: No payments or free products unless clearly disclosed. Not showcased: Avoid featuring reviews in banners, ads, or social media images. No engagement: Don’t respond to or amplify reviews on your site or social platforms. Engaging turns reviews into marketing, which changes the compliance landscape. No suppression of negatives: Don’t hide unfavorable reviews. The FTC has issued major fines for this practice, like the $4.2 million case against Fashion Nova. There were other claims cited in the letter from the website and social, but they were not high-risk. From warning letter : “On your Instagram social media account. “Hydroxie strips are ultra-concentrated – powerful by design . . . they’re a simple way to empower your calm, focus, and clarity.”” I don’t think that if this weren’t a 7-OH product, these items and the “third-party” product reviews would have been mentioned. What are your thoughts? Also, AHPA has some new kratom labeling guidance that is helpful. DATE ORIGINALLY POSTED: 8/6/25 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!

Asa and other industry leaders interviewed < Back EU’s new THC limits for hemp-based products will ‘level the playing field’ for food producers Interview Asa and other industry leaders interviewed Read More Previous Next

Asa and other industry leaders weigh in < Back Formulating For Quality Mike Straus Interview Asa and other industry leaders weigh in Creating a new product is fraught with challenges. From determining which market you want to target, to formulating the product for maximum safety and efficacy, to determining ingredient ratios and more, bringing new products to market is a resource-intensive process. However, if you’ve done your research, you’ve likely identified a profitable gap in the market for your product, which, ultimately, will justify all of the R&D investment spent on this new product. But how can you ensure that you end up with a high-quality product that consumers will love? How can you ensure product-market fit, product efficacy and a timely production process—all without being overwhelmed by your many choices, and all while ensuring regulatory compliance? Nutrition Industry Executive (NIE) has convened a panel of experts to give their insights into creating new products and bringing them to market. Read More Previous Next