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!

Advisory labeling is not a replacement for allergen control program < Back Undeclared Allergens Lead To Recalls Advisory labeling is not a replacement for allergen control program Is major allergen labeling complicated? The answer is maybe sometimes, but it doesn’t have to be. Here, I review recent allergen labeling-related recalls and provide some helpful resource links. It seems like recall alerts for undeclared allergens happen every week, but even though recalls for undeclared allergens are common, allergen-related warning letters are uncommon, which makes this week’s Warning Letter Wednesday interesting (to me at least). One company has had four recalls related to undeclared major allergens since 2019, and here’s how the recent mix-up happened. This is, unfortunately, a common mistake and is the reason why GMPs and process control exist. · From warning letter. “You indicated that you were scheduled to run “Hamburger Cheeseburger Macaroni Skillet Meal”; however, the line supplier mistakenly brought the incorrect cartons to the production line, and the lab tech failed to verify that the correct cartons were used.” Read this warning letter here . Another company received a warning letter because of an inadequate FDA communications request response. They are also a conventional food company that had an undeclared allergen recall, which was apparently due to a formulation change without changing the label. The purpose of Warning Letter Wednesday is to educate, and this is a perfect example of a half-hearted response and no follow-through that led to an avoidable warning letter. Yikes! · From warning letter. “Your proposed action to prevent reoccurrence indicated that there would be no formulation changes without the signatures of the buyers and the owners.” ….” FDA sent you an email giving you an opportunity to provide FDA additional corrective actions to address the root cause of the undeclared major food allergen involved in your recall; however, you did not respond.” Read this warning letter here . Here are FDA’s comments on major allergen disclosure (from warning letters). The word “Contains” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act [21 USC § 343(w)(1)(A)]; or The common or usual name of the major food allergen in the list of ingredients is followed in parenthesis by the name of the food source from which the major food allergen is derived (e.g., “Whey (Milk)”), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 USC § 343(w)(1)(B)].” So how about allergen advisory statements like “This product was manufactured in a facility that handles peanuts, soy, and milk?” According to this FDA guidance document, “Advisory labeling, such as “may contain [allergen],” is not a substitute for adherence to current good manufacturing practices and, when used by a facility, food allergen preventive controls.” Read this FDA’s “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry” document here . Here’s how you sign up for FDA recall alerts . DATE ORIGINALLY POSTED: 3/13/24 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 Panel Discussion, In-Person Thursday Oct 30, 2025 The dietary supplement/food and beverage pipeline: Bridging the gap with science-backed ingredients SupplySide Global Mandalay Bay, Las Vegas As demand for convenient, wellness-driven products grows and pill fatigue sets in, today’s hottest supplement ingredients are breaking out of capsules and showing up in functional foods and beverages. Many of these science-backed ingredients currently claim self-affirmed GRAS (generally recognized as safe) status, opening the door for innovative formats that align with consumer expectations for efficacy, taste and accessibility. In this session, a panel of experts in regulatory affairs, product development and consumer insights will explore how manufacturers can navigate formulation, taste and compliance challenges while tapping into trends. Learn how supplement, food and beverage categories are converging, and what it means for ingredient positioning, innovation and future growth. Learn more and register Previous Next

Blogs are “labeling” < Back Product Reviews Become Marketing Claims Blogs are “labeling” Do you have product reviews on your website? In general, FDA is "hands off" with true 3rd party, non-curated, non-compensated honest reviews unless they have been endorsed. Here are some examples of how companies endorse testimonials, which turns them into marketing claims. Showcasing reviews: This is when reviews are in a banner or highlighted in some way. This includes using them in social media posts. Engaging with reviews: In this warning letter, the company has dozens of customer reviews with disease words relating to things like neuralgia and arthritis. This company's product reviews appear to come through a third-party widget like TrustPilot, and these types of "third-party" reviews are typically not cited in warning letters unless the company has commented on them. This engagement endorses the review and converts it to a marketing claim in the eyes of the agencies. This includes companies "Liking" or "Saying Thanks" to customer reviews on their social media wall. Of all the disease-containing reviews on the website FDA only mentions the ones that the company responded to, which is why I suggest "fighting the urge" to engage with reviews that contain disease or outlandish claims. Here is an example from this warning letter. From warning letter. "January 25, 2023 customer review states, "Best place for CBD oil. Really helps my older dog's arthritis pain" (company) replied, "Thank you… We are grateful to provide great service and products that help to our community. Glad to hear that it's helping ease your dog's pain." Blogs are "labeling" At Supplement Advisory Group , I am often asked if blogs are marketing claims. If the blog discusses ingredients that are in products sold on the website, these are marketing claims that can lead to regulatory issues, even if there is no cross-linking or hyperlinking to product pages or a shopping cart. From a blog cited in the warning letter. "CBD may protect nerve cells from deteriorating, and a study from Frontiers in Pharmacology found that CBD can significantly decrease the negative effects of Alzheimer[']s and also improve cognitive ability." This warning letter includes claims made about animal "supplements." I have written about FDA's enforcement view of pet product claims here . This is also a CBD warning letter, which is uncommon these days. Hey, supplement and CBD companies, FDA is watching, and this warning letter could have been easily avoided. Let's set up some time to meet for free, and I would be happy to help point you in the right direction. I've dedicated my life to understanding the nuances of truthful marketing compliance. I would be glad to donate some time to help support your compliance. I also run a consulting company that can help with all levels of support, such as website reviews, listing support, and more. Read the full letter here . DATE ORIGINALLY POSTED: 9/11/24 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!

Blogs can easily cross the line from “education” to “disease claims” < Back Best Practices For Reducing Risk in Blogs Blogs can easily cross the line from “education” to “disease claims” This year, there have been five warning letters that include claims made in blogs, and the line between what is allowable and what is a claim continues to shrink. #WarningLetterWednesday It is easy for a well-intentioned content writer to cross the line from education into the disease claim category, which I wrote this post. I break blogs into two categories. Both are considered marketing and must be compliant, but dividing them into two categories helps clients understand how rigid they want their compliance to be. Ideally, there would be no "educational" or "science" blogs on a commercial website, but few companies follow this path. The life of a consultant is helping companies understand risk while also supporting their real-world, compliant and effective marketing. This is fun! Informational & Product Blogs Informational blogs: These are not intended to sell a product but are used to educate about ingredients and science. Crossing the line from informational into a product blog is very easy, so extreme care should be used. Removing all calls to action, such as linking to a shopping cart, can help lessen the implication that a blog is being used to sell a product. I discussed "educational" blogs and compliance with a top FTC official who said something similar to this. 'Why is a company using blogs on their commercial website if not to sell products.' This is the lens the FTC and FDA look at when reviewing marketing statements. I often use this example when educating about how "informational" blogs can easily cross the line into claims. Here's a post from last year about this. I also suggest removing any high-risk "buzzwords" from the blog, including pictures and clinical study URLs. Here is a post and video about finding and placing these high-risk disease words . Product blogs: These are considered "extensions of a product label" and, therefore, must be ultra compliant. If a company wouldn't write "pain" on the label, this word should not be used in a product blog. The same rules about "buzzwords" apply here. Here is a video about reducing risks when using blogs . Here is a detailed post where I discuss blogs and much more! "Warning Letter Review: What Went Wrong & How to Avoid " 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!

Cognition and memory products are big business, and the Food and Drug Administration (FDA), National Advertising Division (NAD), Federal Trade Commission (FTC) and plaintiff attorneys are paying attention. < Back Cognitive and memory warning letters and litigation trends: Best practices for reducing risk Asa Waldstein Guest Article Cognition and memory products are big business, and the Food and Drug Administration (FDA), National Advertising Division (NAD), Federal Trade Commission (FTC) and plaintiff attorneys are paying attention. Cognition and memory products are big business, and the Food and Drug Administration (FDA), National Advertising Division (NAD), Federal Trade Commission (FTC) and plaintiff attorneys are paying attention. This leads to warning letters, competitor challenges and lawsuits, but it can be confusing to know how to discuss ingredients and products without crossing the compliance line or becoming an easy lawsuit target. In this article, I’ll review enforcement trends and best practices to help keep you out of trouble while continuing to educate your consumers and grow your business. Read More Previous Next

Blogs can be considered marketing < Back When “Educational” Blogs Become “Labeling” Blogs can be considered marketing I love educating about enforcement trends and regulatory marketing compliance, and I've been writing this weekly post for almost three years. I have two small companies in the dietary supplement marketing compliance space. Supplement Advisory Group is my consulting company that focuses on dietary supplement labeling and online marketing compliance support. Apex Compliance ™ is my subscription software product that helps find and replace risky marketing phrases on websites, videos, and content before publishing. I've dedicated my life to understanding enforcement trends as a way to inform compliant marketing. Today's post sums up common compliance oversights I commonly see in both of my companies. There have been no dietary supplement warning letters this week and I am attending a conference in NYC, so today's post will be brief. I'm writing this from beautiful Bryant Park, my NYC "office." I often see companies with compliant labels and product pages but have blogs on their websites filled with disease claims. In this post, we'll help demystify when "educational" blogs become marketing. If a supplement company writes about practices such as meditation or exercise being useful for diseases like anxiety, this is generally low risk. If the company mentions the benefits of ingredients they don't sell, again, this is low risk. Now, if there are blogs that talk about ingredients in products they sell, this crosses the line from education to product marketing, even if there are no hyperlinks or cross-linking. Just mentioning ingredients and then suggesting that they can help with diseases is enough to attract a warning letter. Here is an example of what I call the "common blog writer trap." Let's say a company writes a blog such as "5 Tips For Beating The Winter Blues." Typically, it would discuss winter blues and references disease names such as "depression." The blog would then talk about health-giving activities like meditation, snowboarding, working out, and journaling. The company may even talk about how there are studies suggesting that vitamin D supplementation can help. If the company doesn't sell vitamin D, then this blog is likely to be considered educational. However, if vitamin D is in any of their products, this crosses the line for product marketing. The more explicit the statement is, the more likely it is to be cited in a warning letter. For example, "Recent studies show that vitamin D supplementation can help alleviate many of the symptoms associated with depression." When in doubt, resist the urge to overexplain ingredient benefits, as this can result in a 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!

< Back Solo presentation, Panel Discussion Wednesday Feb 14, 2024 Sports & Active Nutrition Summit USA Sports & Active Nutrition Summit USA San Diego The 2024 Sports & Active Nutrition Summit USA will return to San Diego for its sixth year on February 12, 13 & 14 at the Hyatt Regency Mission Bay. Produced by NutraIngredients-USA.com , this summit serves as a pivotal gathering for professionals in the sports and active nutrition sector, facilitating connections between cutting-edge science, business strategy, and key regulatory developments. This must attend three-day summit will showcase expert presentations, dynamic panel discussions, various networking opportunities, and a wellness program. It provides a comprehensive platform, serving as a one-stop shop for the latest indispensable insights in the realms of sports and active nutrition. See our most recent newsletter which highlighted this event. Learn More Previous Next