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< Back Interview Friday Feb 26, 2021 The Surprising Risks of Marketing CBD Products Hemp Startup Journey In this engaging conversation with FDA compliance expert Asa Waldstein, we discuss how to avoid an FDA warning letter which surprisingly goes way beyond what businesses state on a product label. We cover best practices for CBD company social media managers, effective marketing messages with lower risk language, dos and don'ts of reposting and hashtags, mitigating compliance risk, avoiding making CBD health claims, and how to market your products instead. You will find out what it means for Asa to Create Authentic Excitement in your differentiation strategy and the peace of mind you may get from it. We also discuss cGMP compliance and Asa's recommendations for Spectrum Labs' GMP accreditation journey. Watch or Listen Previous Next

Old posts are "active" marketing < Back "Forgotten" Old Social Media Posts Old posts are "active" marketing “Forgotten” social media posts from years ago are active marketing and are fair game for enforcement. Today, I’ll explore old social media warning letter citations that include retweeting, images, videos, LinkedIn, hashtags, and more. Retweeting: Retweeting (or is it called ReXing (smiles)) and reposting are considered endorsing the testimonial claim. For example, if a consumer wrote something nice about your product and you retweeted it, the information in the consumer tweet would now be your marketing. The risk increases if you add commentary such as “This is why we made the product.” → From warning letter. “You retweeted another user’s September 26, 2014 tweet, which said, “#lipoicacid [an ingredient in your …R-Lipoic Acid Vegcaps 100 mg] model treats autonomic neuropathy.” → Read this warning letter . LinkedIn: Warning letters that mention claims on LinkedIn are rare, and they usually cite issues on a company’s company page rather than individual posts or claims made in easily searchable disease hashtags like # Covid. In the past, it seemed like LinkedIn did not allow posts to be indexed for Google searches, but in the past couple of months this has seemed to change, meaning that old posts are more discoverable. Because of this, I expect more LinkedIn-related warning letters this year. Images and videos: FDA also cited claims made in images and videos. Here are some examples of 4.5-year-old Facebook and Twitter posts. ● IMAGES: This post shows that imagery, especially when added to the disease-word-containing text, can be considered marketing. Here’s a recent LinkedIn post about this. → From warning letter. February 9, 2019 Twitter post: An image of the “Vision Clarity Eye Drops” with the text, “Carnosine, a cataracts worst nightmare.” ● VIDEOS: This Facebook video also shows that even making implied claims can lead to a warning letter. → From warning letter. “July 11, 2019 Facebook video post. “We do not make any medical claims nor guarantees on any specific health issue, but we are very thankful that for over 10 years, people have been able to avoid having cataract surgery because they’ve used these drops.” → Read this letter . Hashtags: Here’s a 2019 post that includes hashtags. Hashtags are easily searchable and are easy targets for agencies looking for disease-containing posts. → From warning letter. “On your April 26, 2019 tweet: “Make Nutrovape Recover your best friend and say adios to a #hangover!” I am writing this from a beautiful beach overlook in Whangarei, New Zealand, where the birdsongs and water make an excellent place for concentration and relaxation. 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!

What hemp leaders have learned about compensation and recruitment strategies in a young industry < Back Hiring and Recruiting Practices Hemp Industry Daily staff Interview What hemp leaders have learned about compensation and recruitment strategies in a young industry Read More Previous Next

How we work together Free Introduction $ 0 0$ 15 Minute Meeting (one time) Valid for one month Select Review socials, web, marketing materials, business strategy or just chat. Silver $ 250 250$ Services provided on a per hour basis Select All services available (3 hour minimum) $250 per hour Gold $ 0 0$ Hire me on retainer Free Plan Select On call regulatory consultant: GMP's & more Plans starting at just 5 hours per month Discounted rate applies for 3/6/9 month contracts Platinum $ 0 0$ Hire me on a project basis Free Plan Select This can include soup to nuts go to market services Full website and marketing review Content writing services

“Extra” claims are often non-compliant < Back OTC Topical “Inactive” Ingredient Marketing Claims “Extra” claims are often non-compliant This warning letter involves claims made about a topical OTC menthol product. OTC products must follow monographs. These are essentially recipe books that guide the ingredients, dosages, labeling, and claims that products are allowed to be made. This is how OTC products are permitted to make claims like “Arthritis Pain Relief” that are out of bounds for cosmetic and personal care products. To check if a product is an OTC topical product or not, check the label. If it lists “Drug Facts” and lists “Inactive Ingredients” it is labeled as an OTC drug. This is another reason why cosmetic product labels should not list ingredients in “active” or “inactive” sections, as this implies the product is a drug. The product label has several violations cited in the warning letter. This shows that the product name is non-compliant and that therapeutic claims made about inactive ingredients are also not complaint. For all my regulatory nerds out there, here is a copy of the label I found online. 👉 From warning letter. “Temporarily relieves minor pain associated with cramps” [from the product label] 👉 From warning letter. “Menstrual Cramp RELIEF CREAM” 👉 From warning letter. “We believe in the power of plants and their therapeutic properties to offer solutions for menstrual discomforts.” The moral of the story is that OTC topicals provide a gateway to making otherwise risky and forbidden claims, but the rules are narrow and don’t allow for extra marketing statements, which can increase the likelihood of regulatory action. There are also drug-related GMP violations in this warning letter, which is worth reading. DATE ORIGINALLY POSTED: 4/16/25 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!

AI-powered proprietary technology could help the nutraceutical industry navigate the complexities of the regulatory world by finding – and replacing – risky marketing phrases on company websites. < Back AI-powered tech makes customised regulatory compliance possible Anthony Fletcher Interview AI-powered proprietary technology could help the nutraceutical industry navigate the complexities of the regulatory world by finding – and replacing – risky marketing phrases on company websites. Read More Previous Next

Hemp Industry 2023 Opportunities Report < Back FDA Warning Letters, activity and actions in 2022 and what that means for 2023 Let's Talk Hemp Contributing Author Hemp Industry 2023 Opportunities Report Read More Previous Next

< Back Webinar Friday Feb 12, 2021 Preparing For FDA Inspections: Fireside Chat Asa's Regulatory Education Series Asa and Steven Yeager discuss tools on how to prepare for and execute a successful FDA inspection. This includes an "Ask Me Anything" session where you can ask anything from us. How To Prepare: (Examples include): No Claims on Web & Social Media Outside of Building Clean Back Doors locked (GMP prerequisite) SOP Ready: What to do during an FDA inspection And more! Company Conduct: Quickly Turn Around Requests Make Copies of Everything Correct Observations Immediately Work with the investigator And more! Steven Yeager is Director of Quality and Regulatory Affairs for Mountain Rose Herbs and has overseen several FDA GMP inspections. Learn more here . Watch Previous Next

In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. < Back Q3 2024 warning letter roundup with Asa Waldstein Asa Waldstein Guest Article In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. At a Glance Minor label violations, such as fact panel line thickness, continue to be cited in warning letters. A NAD case involving a popular children's YouTube channel highlighted the complexities and need for material disclosure. FDA warning letters underscore that elaborating on studies or posting about them on social media can be problematic. Read More Previous Next

Labeling disputes over protein content and daily values continue to attract legal attention, particularly in California < Back Three recently filed lawsuits highlight legal risk in protein labeling compliance Cassandra Stern Interview Labeling disputes over protein content and daily values continue to attract legal attention, particularly in California Three newly filed class action lawsuits against supplement brands Pescience, Huel and OWYN reflect an ongoing trent of litigation over protein content claims and labeling compliance. At issue in each case are alleged violations of FDA rules regarding how protein content and daily values must be calculated and displayed on product labels. Read More Previous Next

Distributors are responsible for products they sell < Back Amazon Receives 3rd Warning Letter This Year Distributors are responsible for products they sell Amazon just received its third warning letter this year and the fifth in the last 15 months! All of these letters are for selling adulterated or unallowable products. What makes this warning letter interesting is that it’s for a sexual enhancement product that was adulterated with sildenafil (Viagra). Amazon requires some mandatory third-party tests for products in this high-risk category, but I wonder why the drug-spiked ingredients were not found here. Perhaps after the initial batch tests, a subsequent non-tested batch contained the drug-spiked ingredients? ❗️Warning Letter Wednesday is available as a free weekly email. Sign up here . 🔷When we look at other Amazon warning letters, FDA seems to “follow the breadcrumbs” from other warning letters, recalls, or issues to Amazon. For example, this warning letter references products that were part of a drug-spiked recall in August. I would think that Amazon has the technological capability to find and remove recalled products from its platform. These types of warning letters come in groups so if companies were selling any of the adulterated brands cited in this warning letter, removing them from commerce now can help to avoid a letter. 🔷Amazon warning letters state that Amazon handles the products as opposed to them being dropped-shipped by the vendors. In my opinion, this “handling” is important to designate Amazon’s responsibility. I wonder if this means that marketplace sites that don’t actually touch the products have a lower risk of distributor scrutiny. 👉From warning letter. “Amazon distributed each of the products directly to individual U.S. consumers on behalf of third parties. Each of the products was “fulfilled” by Amazon; your website states, “Fulfillment by Amazon (FBA) is a service that allows you to outsource order fulfillment to Amazon. Sign up for Amazon FBA to send products to Amazon’s global network of fulfillment centers and offer customers free, two-day shipping through Prime. When a customer makes a purchase, Amazon fulfillment specialists can pick, pack, and ship the order. We can also provide customer service and process returns for those orders.” 🔷Other recent Amazon warning letters were for ophthalmic (eye), homeopathic products for molluscum contagiosum, Diclofenac spiked products and disease claims, and skin tag removal products. Read the full warning letter . DATE ORIGINALLY POSTED: 12/27/23 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 FDA's helpful resource (Criterion 7) < Back Navigating the Risks of Therapy-Adjacent Health Claims Use FDA's helpful resource (Criterion 7) Navigating allowable and off-limits claims can be confusing. Fortunately, the FDA offers a helpful resource, The “Small Entity Compliance Guide on Structure/Function Claims” which includes a Q&A format outlining 10 key criteria to help distinguish between disease claims and structure-function claims. In today's Warning Letter Wednesday, I am exploring Criterion #7, "Claims to augment a therapy or drug intended to diagnose, mitigate, treat, cure, or prevent a disease." This criterion shows the FDA's thinking on why statements like “useful on your chemotherapy journey” or “take with antibiotics” are disease claims. 👉From FDA Guide. “A claim that a dietary supplement will augment a particular therapy or drug action that is intended to diagnose, mitigate, treat, cure, or prevent disease is a disease claim.” 🔹 Asa Comments: The best example of what not to do is from this 2021 warning letter where the company stated “ Vitamin C May Combat Cancer & Ease Cancer Treatment.” This is an issue because it claims to support or ease an oncology treatment and the vitamin C is positioned as an adjunct to drug therapy. 👉From FDA Guide. “A dietary supplement may state that it is useful in providing nutritional support, as long as that claim doesn't imply disease.” 🔹 Asa Comments: This is an interesting one as there is a fine line between making statements like “Omega 3’s are helpful at supporting mood” and making a “People with depression are often low in Omega 3’s, which is why we made this fish oil product” which would be crossing the compliance line. 👉From FDA Guide. In general, mentioning the name of a specific therapy, drug, or drug action will associate the claim with the intended use of the therapy, drug, or drug action and be a disease claim. 🔹 Asa Comments: Another 2021 warning letter shows us that FDA will flag supplements claiming to reduce the side effects of drugs. This is an area of the regulation that can be improved in my opinion as it’s well known that prescription drugs have side effects such as hurting the microbiome that can be lessened by taking probiotics. Addressing drug induced nutrient deficiencies is vital to health such as with statins which are known to deplete CoQ10 which is crucial to heart health. While a statement like “Replenishes CoQ10 lost when you’re on a statin ” may attract regulatory scrutiny, sticking with “Take CoQ10 as part of your heart wellness protocol” are lower risk, if substantiated. 👉 From warning letter. “Helps to reduce the risk of antibiotic-associated diarrhea…” When supplements are marketed to be taken with drugs this can also lead to litigation as we saw with the Culterelle case . This involves a probiotic product being labeled to be taken with antibiotics. Read FDA's Small Entity Compliance Guide on Structure Function Claims here . This is a great resource! DATE ORIGINALLY POSTED: 4/23/25 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!