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Asa and other industry leaders interviewed < Back Hemp and CBD Industry Responds to FDA’s Announcement on CBD Steven Hoffman Interview Asa and other industry leaders interviewed Read More Previous Next

Some of our favorite resources for helping to mitigate the risks associated with Made in the USA and All-natural claims. Home / Made in USA & All Natural / Made in the USA and All Natural These are common areas of enforcement and lawsuits.Here are some resources to help understand these regulations. Made in the USA Anchor 1 "Made in the USA" Claims Demystified video FTC guidance Great podcast on this topic Lawsuit updates (Truth in Advertising) All Natural Anchor 2 Video: What can you say and what are the risks Article on natural claims Back

Cosmetics are not "FDA-approved" < Back Marketing Claims Turn Cosmetics Into Drugs Cosmetics are not "FDA-approved" This warning letter shows us where the line is between allowable cosmetic claims, the "not really okay structure-function claims, and disease claims. In this letter, the disease claims tipped the scale to regulatory action. Cosmetics have a narrow definition of what types of marketing claims are allowed. First, let's start with FDA's cosmetic definition. "Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance." This is very narrow and leaves little room for bold marketing statements. Structure-function claims. Although not permitted for cosmetics FDA tends not to cite cosmetic companies for making lighter "supplement" structure-function claims such as "joint comfort" or "promotes skin elasticity." In this example, the company was making supplement-style claims about an ingredient in the formula. These types of statements, while not ultra-high risk, should still be avoided. From warning letter. "Magnesium Chloride helps with the normal functioning of cells, nerves, bones, and the heart." Disease claims. Here are some examples that cross the compliance line. From warning letter. "5 Benefits of Natural Progesterone Cream: Treats Fibroid Tumors . . . Helps Endometriosis" "Lower the risk of urinary tract infections (UTIs)" "May help relieve skin flares caused by Psoriasis & Eczema" GMP violations . This warning letter also includes GMP violations, such as the very common "you didn't test your glycerin for DEG" citation. I write more about this here . Cosmetics and supplements are not FDA-approved. I typically don't take pleasure in other company's misfortunes, but I rather enjoy seeing "FDA-approved" statements called out in warning letters. This serves as a reminder that cosmetics and supplements are not "FDA approved," which differs from "FDA registered." Interestingly, the website's "FDA approved" statement and the ambiguous website "FDA inspected and certified facility" claim were cited. I doubt the label claims would have been called out in this letter without the blatant "FDA-approved" website claims. I will add this to my Apex Compliance keyword lists, which helps companies find and replace risky statements before they lead to lawsuits or letters. ·From warning letter. "the website for Magnesium 50 mg Body Cream includes the image of a blue circle with the claim, "FDA * APPROVED * FACILITY." Further, the product labels and/or websites for the other seven before-listed products include statements that these products are made or manufactured in an "FDA inspected and Certified Facility," a "Certified FDA registered facility," I ran Apex Compliance on this company's website and found lots more very high-risk claims that can lead to additional warning letters or lawsuits. For example, "may help with depression" when promoting vitamin D ingredients. For just $500, I can provide a line-by-line report showing where risky phrases occur, a risk rating, notes, and more. Let me know if interested. There is a lot more to this letter. Read the full warning letter here . DATE ORIGINALLY POSTED: 8/28/24 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 are marketing statements < Back Blog Claims Result in Warning Letter Blogs are marketing statements This warning letter cites a kratom company for making disease claims related to opioid withdrawal, cancer, and depression in blogs. The learning targets in this Warning Letter Wednesday are: 1) Blogs are marketing claims 2) Comparing products to drugs is high risk 3) Scan websites for high-risk statements ✔ Blogs are marketing claims. Blogs continue to be cited in warning letters as they are "active" pieces of marketing, even if they are several years old. In this warning letter, the company talks about kava, an ingredient in its products being used for ADHD. If their products did not contain kava, this is low risk, but since this blog promotes its ingredients, this is essentially the same as putting "Our products help ADHD" right on the label. 👉 From warning letter (blog). "Here are ten amazing kava benefits you should be aware of . . . May Alleviate ADHD Symptoms[,] kava may be beneficial to people who suffer from attention deficit hyperactivity disorder (ADHD). ✔ Comparing product benefits to drugs is a great way to attract FDA attention. The example below is ultra-high risk because FDA is likely concerned that if people think the product works the same as cancer drugs, the consumer may forego lifesaving treatments for the natural (unproven) options. I am a fan of natural products, but it's important to market them in a compliant manner that does not inadvertently give people false hope about their uses. 👉 From warning letter. "Two of Kava's constituents …. have similar potency to the Alzheimer's disease treatment Memantine." 👉 I write more about the risks of comparing products to drugs . ✔ Most of the claims referenced in this letter have been removed, but there still are many claims on their website. I ran Apex Compliance and found dozens of very high-risk statements, especially when discussing their ingredient's benefits. There are also statements about helping COVID symptoms on their "forgotten" blog posts. I developed Apex Compliance to help companies identify and remove marketing risks on their websites and content before publishing. Learn more and schedule a demo . Also, DM me to schedule an Apex Compliance meeting at SupplySide West! 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!

Ensure ingredients are not on FDA’s “naughty list” < Back FDA cracks down on unsubmitted NDI ingredient hordenine Ensure ingredients are not on FDA’s “naughty list” The FDA is starting to crack down on unsubmitted NDI's. Today's #WarningLetterWednesday reviews a recent hordenine warning letter. Hordenine and higenamine warning letters also include high risk disease claim language. This is a good opportunity for companies selling these high risk ingredients to stop sales immediately and also to clean up their uncompliant marketing. From warning letter: On your product webpage for “OPTIMUM-CLA”: “Conjugated linoleum Acid (CLA): is a potent . . . anti-carcinogen, and anti-catabolic . . . Some of the common accolades of CLA are . . . is a cancer fighter. From warning letter: On your product webpage for “ADIPROPEN ULTRA”: “ADIPROPEN ULTRA is our new and improved version of Adipropen with added Vinpocetine, commonly referred to as ‘Viagra for the Brain.’ [I]t is more effective than Clenbuterol.” 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!

Ensure GMPs are developed and followed. CBD is risky when added to OTC topicals. < Back Marketing CBD in OTC drugs is risky Ensure GMPs are developed and followed. CBD is risky when added to OTC topicals. #WarningLetterWednesday involves CBD in an OTC topical (hand sanitizer) and further defines FDA’s position regarding CBD as an active or inactive ingredient in OTC drugs. There are also numerous GMP violations that paint an overall picture of noncompliance. The references to CBD in this letter are worth reading. It is hard to defend adding CBD as an inactive ingredient if the amount of CBD is listed on the label or is marketed for CBD content. From warning letter: “Specifically, your product label for MEDICALLY MINDED 100% THC FREE Hand Sanitizer Gel prominently features on the Principal Display Panel (PDP) the statement, “200 MG CANNABINOIDS 100 MG CBD + 100MG CBG.” The product label also lists,.....a website that markets and sells CBD products for various therapeutic benefits. As noted above, CBD and CBG are not an active ingredient in any applicable final monograph”. Although is letter is only one of seven CBD-related warning letters in 2021 (down from 21 last year) it is essentially a teaching case about the importance of GMPs. The FDA sent two records requests which the company did not answer. Not answering these FDA requests is a prohibited act and is serious. The FDA then inspected the company and found serious violations including hand sanitizer that contained 0% ethanol and 58% methanol. This is dangerous! This then led to a national recall of the adulterated lot numbers of hand sanitizer. If the company had a proper Quality Management System (QMS) they would have responded to the FDA’s information request and may have prevented an inspection. They would have also identified the adulterated hand sanitizer before it shipped to the public and caused the subsequent recall. The company was issued a 483 which they didn’t respond to. Learn more about the differences between warning letters and 483’s here . Properly responding to a 483 is an important part of avoiding warning letters. Most 483’s can be addressed with the FDA before they are elevated into a warning letter. Learn more about reasons to avoid a warning letter here . The GMP violations include not setting specifications, quality not approving production procedures, and quality not controlling incoming components. Although these violations cite OTC drug manufacturing regulations, they are the basics all dietary supplement companies should be complying with. Not writing and following specifications is one of the most common supplement GMP citations. Read 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!

Distributors are responsible for the products they sell < Back Walmart & Amazon Issued Warning Letters for Adulterated Products & Disease Claims Distributors are responsible for the products they sell Amazon and Walmart were cited for selling a product with disease claims and adulterated with NSAIDs. The product is a nutraceutical and omega-3 product that contains undeclared diclofenac, a non-steroidal anti-inflammatory drug (NSAID). Both warning letters include comments where FDA highlights that the company (Amazon or Walmart) is the party that fulfills and distributes the product. According to supplement regulations, companies that distribute products have a level of GMP and regulatory responsibility. Essentially if a company markets, distributes, and sells a product, they are responsible, even on a marketplace site. This webinar with Nathalie Bougenies and Steven Yeager shows many items companies need to comply with these regulations. From Amazon warning letter. “These products were introduced or delivered for introduction into interstate commerce by Amazon via your Fulfillment by Amazon service.” There were also examples of claims on both the Amazon and Walmart sites, such as “arthritis.” This is the most common “itis” referenced in warning letters and is an important reminder to scan for higher-risk words like “arthritis.” I expect this action to possibly lead to these companies asking for more adulterant testing and a deeper look at disease claims. For example, if the word “arthritis” is on your Amazon page, I expect it to be flagged. This product was recalled in June 2022. It is unclear if the products in these warning letters are from the same recalled lot or a different batch. From warning letter. “Combate la artritis.”” (English translation: Fights arthritis.)” Interestingly, the disease claims were in Spanish, a good reminder that the FDA also pays attention to claims made in other languages. I welcome your thoughts on these notable warning letters. Read the Amazon warning letter . Read the Walmart 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!

Trustpilot reviews can be “marketing” < Back Product Review Engagement Trustpilot reviews can be “marketing” CBD in tampons? During a GMP inspection at this company’s facility in Bulgaria, FDA determined that CBD is a drug product that deems the tampons adulterated. This, along with some disease claims and other violations related to vaginal microbiome screening kit claims, led to a warning letter. This is the ninth CBD (or delta 8) related warning letter in 2024 which is 47% less than last year, showing that CBD enforcement continued to plummet. As we know FDA is not a fan of CBD, especially when they feel it can be harmful. From warning letter. “FDA evaluated the regulatory decision form that you provided the investigator to support not needing a 510(k) for the CBD Coated … Tampons and found the assessment was inadequate because the CBD coating raises significant concerns regarding safety and effectiveness of the devices due to the potential for local and systemic exposure of CBD, potential adverse events (e.g., reproductive/developmental toxicity) associated with CBD, and potential effects due to the uncertainty of the potency and quality of the CBD (e.g., psychoactive effects from possible contaminants like Delta-9-tetrahydrocannabinol).” Product reviews: Agencies like FDA are typically “hands off” with third party product reviews if they are non-curated, non-compensated, are truthful, and are not showcased. The exception is when a company engages with third party reviews that contain disease claims, as this is considered an endorsement and turns a product review into a marketing claim. Here’s an example from the warning letter where the company engaged with reviewed on its Trustpilot site. Claims in product reviews typically appear in warning letters when they appear on a company website, but I’ve not seen this cited when hosted on platforms like Trustpilot, which reinforces the “Don’t engage with product reviews when they are risky words” rule. From warning letter showing how the company engaged with a review. “Trustpilot Web Site: “We're really sorry to hear that the CBD tampons didn’t work for you. Research shows that different bodies have different responses to CBD, and just as other forms of pain relief, annoyingly it won’t work for everyone.” Complaints on Trustpilot not investigated. Product complaints and safety issues need to be adequately investigated. Typically, customer complaints are emailed or called into the company, and once the company is aware of potential issues, it is its obligation to investigate. Interestingly, in the example, FDA requires the company to investigate third-party reviews on the Trustpilot site since they engaged with these reviews. As I discussed above, engaging with third-party reviews is an endorsement and makes them marketing. In this example, it also shows FDA that the company is aware of the issues and triggers the investigation requirement. This is the first time I’ve seen FDA mention this for third party reviews and companies should take note. We can also extrapolate that the FDA will want companies engaging with customer complaints on social media to properly investigate the issues as well. From warning letter. “Complaints related to the addition of CBD to … Tampons that were listed in Trustpilot or third party systems were given responses by your firm, but not logged and evaluated appropriately in your complaint handling system. The complaints indicate CBD … Tampons may have an impact on the patients’ health (e.g. CBD drug interactions) that exceed the expected risks associated with regular (non-CBD) tampons.” The company was also cited for selling a vaginal microbiome screening kit which FDA does not consider a general wellness kit. They determined this by reviewing the product’s claims like “Detect bacteria that cause vaginal infections like yeast infections” from their Amazon store, Trustpilot page, and website. I had never read the “General Wellness: Policy for Low Risk Devices” document before and it worth knowing about. From warning letter. “Your firm markets the device with diagnostic claims that are outside the scope of a general wellness device as described in the FDA guidance document “General Wellness: Policy for Low Risk Devices” at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices; and therefore, your device would need to be submitted for premarket review by the FDA.” Read the full warning letter here . This Warning Letter Wednesday post marks 52 weekly posts this year and over 150 since I started writing WLW. Thank you for all of your support! You are appreciated! DATE ORIGINALLY POSTED: 1/1/25 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!

Some of our favorite resources to help educate about influencer marketing and product review compliance. Influencer Marketing & Reviews / Influencer Marketing & Product Reviews These are common areas of enforcement and lawsuits.Here are some resources to help understand these regulations. Product reviews and testimonials podcast: Justin Prochnow How influencers can comply with FTC disclosure guidelines video FTC's Disclosures 101 for social media influencers FTC's featuring online customer reviews: A guide for platforms Influencers and CBD: Interview with Asa and a popular influencer Back

Consulting and advisory services for the dietary supplment and hemp industries. Formulation, GMP review, FDA/FTC enforcement trend analysis, company marketing risk training. COMPLIANT MARKETING STRATEGY REVIEW HELP AVOID WARNING LETTERS Review marketing and social media campaigns with a risk level-based analysis. Develop training and best practice documents. (social media interactions, biogs, hashtags, infographics, videos). SOCIAL MEDIA Effective marketing messaging with lower risk language. Best practices for social media managers. Do's and don'ts of reposting and hashtags. BUSINESS STRATEGY INCLUDING NEW SECTOR EXPANSION Industry expert review before expanding into supplement or hemp product categories. M&A compliance due diligence review before new acquisitions. EXPERT LABEL COMPLIANCE & COMPANY TRAININGS Product label reviews Company compliance trainings to help develop in-house expertise. Founded by Asa Waldstein , a dietary supplement and hemp expert with 20 years of experience developing and implementing compliant marketing and cGMP manufacturing processes. Asa has formulated, manufactured, and marketed hundreds of products in a compliant manner and has helped oversee three FDA CFR 111 audits without any 483s. Asa decided after years as an executive for other companies the best use of his skills was to open Supplement Advisory Group to serve the greater supplement and hemp marketplace. About Supplement Advisory Group Specializing in marketing risk analysis and practical marketing solutions on the web, social media, and product labels. We focus on finding marketing risks and providing practical lower-risk solutions on the web, social media, and product labels. This includes compliant marketing strategy review and claims risk analysis. We take a preventative approach to regulatory risk in the dietary supplement and hemp industries. Learn More Free Introductory Regulatory Consult Available Online 15 Minute Consultation with Asa Waldstein 15 min Book Now

Some of our favorite resources to help educate about cGMP manufacturing compliance. cGMP Guidance / cGMP Guidance These are common areas of enforcement and lawsuits.Here are some resources to help understand these regulations. New Cosmetic Regulations Webinar: cGMP Basics for Hemp-CBD Companies. This is an excellent training tool for your supplement or hemp company! Webinar: Preparing for FDA cGMP Facility Inspections Preparing for FDA Inspections: Fireside Chat Webinar Back

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