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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!

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

< Back Presentation, Online Friday Mar 18, 2022 Preparing for FDA Inspections Emblossum Herbal Conference “Knock knock.” “Who’s there?” “The FDA.” FDA inspections are no joke and inspectors can drop by any time. Knowing in advance what to do during an inspection can help ease the stress and make you more prepared. Steven Yeager and Asa Waldstein provide examples of how to prepare for the FDA, and they also review the dos and don’ts of working with an FDA inspector in your facility. Steven and Asa will share their FDA inspection experiences to help you be ready for the FDA. Learn More Previous Next

Asa Waldstein quoted < Back FDA, FTC slap CBD industry with seven warning letters related to COVID claims Hemp Industry Daily Relevant Article Asa Waldstein quoted Read More Previous Next

Disease claims trigger deeper FDA review < Back Drug Spiked Warning Letters Disease claims trigger deeper FDA review FDA sent three warning letters this week to companies selling drug-spiked ingredients like diclofenac and methocarbamol. This is a short Warning Letter Wednesday as I am writing this from holiday on the Sea of Corinth in Greece. Follow previous WLWs here . This continues the trend of FDA testing products for drugs like these. I thought it would be interesting to explore what we can learn from these types of products. Disease claims, especially in the joint health category, can trigger FDA to examine the product and company more closely. From warning letter: “Artritis” (English translation: Arthritis)” Recalls signal manufacturing and quality issues and allow the FDA to look deeper at the company’s QA/QC processes. Here is FDA’s Health Fraud Database , which links to drug-spiked product notifications and recalls. This is a good resource to help you identify what potential contaminants to test for in your products. FDA follows the “breadcrumbs” of non-compliance. When FDA inspects a facility, issues a public notification, investigates a recall, or finds a brand with issues, it will “follow the trail” to see what other similar violations it can find. For example, when a recall is reported for a drug-spiked ingredient, the FDA will look to other places where this brand may be sold, such as marketplace sites. Many of the previous diclofenac spiked products included Spanish language supplement labels. This set of letters included both Chinese and Spanish language labels. This may be because, in some cases, there may be less quality control for products manufactured for the Spanish language community. DATE ORIGINALLY POSTED: 9/4/24 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!

< Back Virtual Course Friday May 19, 2023 Ethics in Marketing Dietary Supplements: Common Practitioner Pitfalls to Avoid AcuHealth Academy • Understand what the FDA considers a disease claim. • Understand the repercussions of not complying. • Review common practitioner marketing mistakes. • Understand enforcement trends to protect your business. • Strategies for ethical and effective marketing. Register Previous Next

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 Sunday Feb 21, 2021 Know Your Legal GMP's Herbally Yours I talk about my herbalism journey, the American Herbalist Guild, dietary supplement safety, AHPA, GMP's, and more! Listen Here 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!

Companies are responsible for co-manufactured products < Back Eye Care (Ophthalmic) Products Under Increased Scrutiny Companies are responsible for co-manufactured products This warning letter is interesting. This is an ophthalmic drug warning letter, but the supplement and cosmetic industries can glean helpful information here. Here, I review these learning opportunities. Claims on website and videos. Timeline: Could the company have avoided a warning letter? Ophthalmic (eye) drug products are under increased scrutiny. Manufacturer and distributor responsibilities Are you interested in a free discussion about high-risk claims on your website? I’ll run my compliance software and share the findings. Book your free session . ● Claims on website and videos. FDA has cited seven companies for claims in YouTube videos this year. What makes this interesting is the videos mentioned in this warning letter were embedded on the webpage rather than just on YouTube. This shows me that FDA is going the extra mile to review videos. Also, some of these videos are old, like this one from 2018. From warning letter. “From your March 16, 2018, YouTube video titled, “MSM Eye Massage (Eye Exercise)” on your… where you demonstrate an eye massage with one of your MSM eye drop products: “This MSM eye massage is great for inflammatory eye conditions, blepharitis, dry-eye, improving the lymph system, and stimulation of tears.” As a side note, Apex Compliance, my monthly compliance software, scans YouTube video transcripts for compliance issues in seconds. Learn more . ● Timeline . FDA tested one of the company’s products and found that it contained microbial contamination, which is very serious for products applied to the eyes. On August 21stof this year, FDA and the company had a virtual meeting, presumably to talk about the contaminated product. A few days later, the company issued a voluntary recall for this and some of their other products. At some point in August FDA reviewed the company’s website and found many drug claims. At some point in August FDA reviewed their website. If the company would have conducted a website compliance check when contacted by FDA, I wonder if they could have avoided a warning letter. ● Manufacturer and distributor responsibilities. This company was using contract manufacturers but apparently did not check their work. Here FDA reminds companies that they are responsible for the products they get made by co-manufacturers. If the company had conducted quality checks, they probably would have caught the microbial contamination before it led to a recall and subsequent warning letter. →From warning letter. “You are responsible for the quality of your drugs regardless of agreements in place with your contract facilities.” FDA also provides a link to this useful guidance document, Contract Manufacturing Arrangements for Drugs: Quality Agreements . ● Ophthalmic drug products are under increased scrutiny. There have been 21 ophthalmic FDA warning letters this year, compared with seven last year. This continued enforcement trend has involved some of the largest companies, such as Amazon. I write more about this . It sounds like the company did not follow the path of an OTC or other drugs. Anything added to the eyes has a high level of danger and should go through proper regulatory channels. →From warning letter. “new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect…. No FDA-approved application pursuant to section 505 of the FD&C Act, 21 USC 355, is in effect for these products.” 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!

Extra attention is paid to animal CBD products < Back 3 Animal Product Companies Receive Warning Letters Extra attention is paid to animal CBD products FDA has a low tolerance for animal product disease claims, especially when they include CBD. FDA recently issued three warning letters to companies marketing their CBD products as safe solutions for animal ailments such as anxiety and cancer. Many of these lessons also apply to human products as well. I will focus on one of the more egregious letters. FDA is looking at blogs. This is nothing new, but a friendly reminder that blogs, including those old “forgotten” posts, are considered active marketing. For example, when I run Apex Compliance on a website and see a lot of blogs from 2020, there is almost a guarantee that they will be filled with disease words. When I bring these up to clients, most of them don’t even know they were on their site. The key takeaway here is to review old marketing and social posts for compliance issues. 👉 From warning letter. “On your blog post titled “Benefits of Mushrooms for Cats. Medicinal mushrooms are used for many purposes, to name a few: Fight viruses and bacterial infections.” FDA is looking at YouTube. In this example, the FDA cited disease claims made on the company’s About section. I ran Apex Compliance , my marketing compliance software, on their YouTube channel. It conducted a full audio scan of the entire channel in one minute and found many more compliance concerns. Let me know if you are interested in learning more. 👉From warning letter. “On your CBD Dog Health YouTube page within the “About” section: Did you know that animals can benefit from CBD oil even more than humans can? Whether your dog is suffering from: Seizures.” FDA is looking at socials. Here FDA cites the company for posting a picture of their product with disease claims in the image. 👉From warning letter. “On your November 15, 2024, Instagram post with a photograph of your Heal (product): CBD Oil for Dogs, Remedy: Tumors, Cysts, and Infections for Dogs.” Curated testimonials are claims. On the Success Stories page, several testimonials were cited. FDA often considers grouping testimonials on its own page the same thing as curating. Engaging with reviews or curating them turns them into marketing. After a lull in CBD-related warning letters , these are the first three in a while. The FDA has only issued two other CBD letters in the past six months, and these were for potentially risky injectable and CBD-infused tampon products. I am still surprised at the limited number of CBD warning letters, and perhaps this will signal an enforcement ramp-up. FDA does not like CBD in animal products. In addition to disease claims, one of FDA’s concerns is with the apparent lack of safety data about when humans consume food that has been fed CBD. 👉From warning letter. “CBD products for food-producing animals raise concerns regarding the safety of the human food (meat, milk, and eggs) derived from those animals. There is currently a lack of data about the formation of residues in edible products of food-producing animals in association with the consumption of CBD products by those animals and about safe levels of any potential residues for the human consumer.” Read the warning letter. DATE ORIGINALLY POSTED: 5/14/25 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!

Test ingredients for common adulterants < Back OTC Companies Cited For Refusing Records Request Test ingredients for common adulterants When FDA asks for records, companies should generally comply or they can face warning letters. This year FDA has sent eight warning letters to OTC companies refusing to respond to FDA’s request for records requests. This is a steep jump from only two similar letters in all of 2022. 🔷Yes, I know these are OTC-related and not supplement warning letters , but we can still learn a few things and also be amused by some of the responses, such as a company saying they were “not prepared to allow the FDA to audit and inspect.” Here is the timeline: 🔹March 17, 2023, the FDA sent an electronic request for records and other to the contact email address provided in your registration file. This request went unanswered. 🔹Second and third requests were sent via email on April 6 and April 18, 2023. 🔹On April 19, 2023, you responded stating that you were “not prepared to allow the FDA to audit and inspect” your firm. 🔹The Agency sent a follow-up written request for such records and other information on April 28, 2023, to your registered address on file; however, we received a delivery failure notification. 🔷Testing for contaminants: These “refusal to comply” letters were issued to OTC companies, four of whom were selling products with ingredients like glycerin. FDA pays extra attention to these types of ingredients as they may be susceptible to Diethylene Glycol (DEG) and Ethylene Glycol (EG) contamination. Dietary supplement companies can learn from this and test glycerin and ethanol for these common adulterants. This is good business, and FDA will want to see these tests when inspecting your or your comanufacturer’s facility. I write more about this here . 🔷This is not to be confused with the FDA’s Remote Regulatory Assessment (RRA) program, which is voluntary. Complying with this can help deprioritize FDA from visiting your facility and seems like a good idea if documents are in order. What are your thoughts on RRAs? 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!