< Back Podcast Wednesday Feb 1, 2023 Asa Waldstein - Principal @ Supplement Advisory Group | FDA Enforcement Trends + Social Media Ingredients for Success Podcast On this episode, @AsaWaldstein Principal @ Supplement Advisory Group, joined the show to discuss FDA Enforcement Trends for 2023, Social Media Compliance, and his weekly newsletter, Warning Letter Wednesday. Asa is a Certified Clinical Herbalist and a 20-year dietary supplement executive. Asa's consulting company, Supplement Advisory Group, is a boutique group focusing on marketing risk analysis and practical marketing solutions for the web and social media. He chairs the American Herbal Products Association's (AHPA) Cannabis Committee. Watch Previous Next

According to a Federal Trade Commission official, settlements in a law enforcement sweep against CBD marketers send a "clear message" to the growing sector: "Don’t make spurious health claims that are unsupported by medical science." < Back FTC targets CBD marketers in law enforcement sweep Josh Long Interview According to a Federal Trade Commission official, settlements in a law enforcement sweep against CBD marketers send a "clear message" to the growing sector: "Don’t make spurious health claims that are unsupported by medical science." Read More Previous Next

Formats that are favorable to children should be avoided < Back Another Delta 8 Warning Letter Formats that are favorable to children should be avoided This is the tenth FDA delta 8 warning letter this year, which is an important reminder that delta 8 THC is still on FDA’s mind, especially when it’s sold in formats that are favorable to children, like candy ropes. Distributors are responsible: This website distributes products from several different companies, demonstrating that even companies that sell other’s products are responsible. I think of this as a mini-Amazon, and I expect more distributors selling high-risk items to be called out in the near future. Favorable to children: FDA takes dangerous products in forms that appeal to children very seriously. Products such as delta 8 infused snacks with names like “Not Ya Son’s Weed Bakedies Delta 8 THC 600MG Crispy Bites” were cited in this letter. The takeaway here is that companies selling delta 8 are a high risk for FDA enforcement, especially if they sell products in forms favorable to children, such as candy. Past delta 8 warning letters were jointly issued by FTC and FDA, which usually come with more “teeth,” such as a cease and desist. This company was “lucky” this is “only” an FDA warning letter. Since there are no marketing claims cited in this and many previous letters, you may be asking what the FTC has to do with this. Interestingly, marketing unsafe products, especially to children, is considered deceptive marketing. Go FTC! From the previous warning letter. “Section 5 of the FTC Act prohibits unfair or deceptive acts or practices in or affecting commerce. This prohibition includes practices that present unwarranted health or safety risks….. preventing practices that present unwarranted health and safety risks, particularly to children, is one of the Commission’s highest priorities.” Also, I ran Apex Compliance on the company’s website and found a motherlode of high-risk claims such as cancer and opioid support statements. I wonder why FDA did not cite these. I’d love to show you what Apex Compliance finds on your site. Schedule a demo . I write more about FDA’s position on delta 8 and the previous warning letters here . 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!

< 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

Don’t engage with risky reviews < Back Product Reviews Become Marketing Don’t engage with risky reviews In this warning letter, the company engaged with "third-party" reviews on its website, which turned them into marketing. If product reviews are collected and displayed on a website, the agencies are generally "hands-off" as long as they are: Third-party Honest: The honest experience with the product. Here's an FTC case concerning Google and I Heart Radio from a couple of years ago. Not solicited: Such as "a free product for a favorable review." Non-curated: Don't favor positive reviews. Also, conglomerating reviews on a "Reviews" page can be considered curation. Non-compensated: No paid influencers or free products unless disclosed. Not showcased: Such as those highlighted in a banner or a social media image. Not engaged with: These reviews become marketing when a company showcases them in a banner or social media post or engages with them on their website or social media. When in doubt, don't engage is a good rule for product reviews and testimonials. Not hidden negative reviews: FTC pays attention to companies hiding negative reviews, and, in some cases, hands down big fines, such as this $4.2 million case against Fashion Nova . Some companies go the extra mile and delete any reviews or testimonials that contain disease words. This is fine as long as you have a documented policy that treats positive and negative reviews the same. Here's an example from the warning letter. From warning letter. "January 24, 2023 customer review states, "I have been using this CBD for my pup who has seizures for some time, since starting CBD she has not had one. I like that there are no unnecessary ingredients, and she takes it with no problems." (company) replied, "Thank you for the review, (b)(6) That is amazing news - we are so glad to hear that your pup's seizures stopped!!!" There is so much more to this warning letter. Read it here . DATE ORIGINALLY POSTED: 10/23/24 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 Interview Thursday Jun 4, 2020 Cannabis, CBD, Regulations, & AHPA CannabisRadio.com Concierge For a Better Living Cannabis, CBD, Regulations, and AHPA are what Asa Waldstein, a veteran of the dietary supplement industry, sit down and talk about in today’s episode of Concierge For Better Living with Doc Rob. During these tough times, it gets harder and harder to find the light at the end of the tunnel. Asa helps do this by diving deep into the dietary faction of cannabis. He also explains how old practices such as canning, can and are making a comeback in today’s cannabis industry. Listen Previous Next

< Back Webinar Wednesday Jan 20, 2021 Label & Marketing Claims: Fireside Chat Asa's Regulatory Education Series We discuss label and marketing claims which impact the dietary supplement and hemp industries. This is reviewed from a legal, regulatory, and marketing viewpoint. Made in the USA & All Natural: What can you say and what is the risk? Type of claims: structure-function, qualified, etc. What defines clinically proven? Review nutrient content claims: Free Of, Good Source, High-In A quick primer on Prop 65 including labeling Risks associated with making claims And more! I am joined by two expert guests. Douglas Kalman Ph.D., RD, FACN, FISSN , is the Vice President of Scientific Affairs for Nutrasource, a nutrition-centric Contract Research & Service Organization. Erica W. Stump is the owner and founder of the Erica W. Stump, P.A. law firm. Watch Previous Next

< Back Podcast Monday Apr 17, 2023 The Hoban Minute - Episode 170 with Asa Waldstein of Supplement Advisory Group The Hoban Minute In this short, special episode straight from the NOCO 9 trade show in Colorado Springs, Xavier interviews Asa Waldstein, founder of Apex Compliance and principal at Supplement Advisory Group. Xavier gets a first look at Asa’s new compliance tool, Apex, and the two discuss the dire need for marketing claim reviews in the hemp cannabinoid product space and how Apex Compliance is a tool designed specifically to help brands, marketers, consultants, and more navigate the ever-changing regulations around marketing their products. Listen Previous Next

< Back Webinar Wednesday Sep 30, 2020 Intersection of Dietary Supplements & Hemp-CBD Asa's Regulatory Education Series Reviewing the intersection of the dietary supplement and hemp-CBD industries from a legal, regulatory, ethical, marketing, operational, and brand perspective. A discussion about considerations supplement companies face when adding hemp/CBD into products or when opening up new hemp product lines. We also explore this from the perspective of hemp companies adding supplements into their products and open ing up new non-hemp product lines. I am joined by two wonderful guests: Rend Al-Mondhiry is Partner at Amin Talati Wasserman, LLP. Dr. Jeremy Stewart is Chief Scientist and VP of Scientific Affairs for Gaia Herbs. Watch Previous Next

Specifications continue to be cited < Back GMP Manufacturing Lessons Specifications continue to be cited Manufacturing supplements is not easy. I was a supplement manufacturing & marketing executive for 15 years before starting my regulatory marketing compliance company , and implementing continuous improvement into our Quality Management System required several full-time jobs. Step one in GMP compliance is setting and following specifications, and this Warning Letter Wednesday highlights several GMP lessons, especially the importance of specifications. Heavy metal specifications. Here, FDA cites the company for not establishing heavy metal specifications for botanical ingredients, which are especially at risk of heavy metal contamination. FDA notes that a lack of ingredient specifications may lead to issues in the finished product. I like this example because it demonstrates that stopping potential problems before they get to the production line is best. From warning letter. “The investigator noted that you failed to establish limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch of the dietary supplement.” Interestingly, the company did have finished product heavy metals specifications, but it seems FDA pushed back on their arsenic limits, asking for clarification on why they were set so high. This reminds us that specifications must have a scientific rationale. As a good reference point, the American Herbal Products Association (AHPA ) is an excellent resource for this. From warning letter. We note that the (b)(4) finished product specification for Lead is < (b)(4) ppm and for Arsenic is < (b)(4) ppm. Your batch record for (b)(4) batch (b)(4) reports lead results of (b)(4) ppm. Under 21 CFR 111.70(e), you must establish specifications for limits on those types of contamination that may adulterate, or may lead to adulteration of, the finished batch of dietary supplement to ensure the quality of the dietary supplement. We request that your response address the scientific basis for setting a specification for Lead at < (b)(4) ppm as a level that will not adulterate the dietary supplement. Testing by input. Over the past two years, FDA has increasingly been citing companies for testing finished products by input rather than using qualified analytical methods. The company’s 483 response seems to show that instead of providing a specification sheet example with valid testing methods, they apparently listed “input” as the test method. This part of the warning letter could have been avoided with a proper 483 response. FDA’s response, “measuring input may be a useful process control, but it is not an appropriate test method for determining the strength specification,” should be an essential mantra written on the wall of every QA/QC department. From warning letter. We received and reviewed your December 5, 2023, written response and determined it inadequate. Your finished product specification sheet for your (b)(4) product is lacking adequate strength specifications. The method listed on the finished product specification sheet for determining the strength of (b)(4) and (b)(4) in the finished product is by “input.” While measuring input may be a useful process control, it is not an appropriate test method for determining the strength specification of these ingredients in the finished batch of dietary supplement. Also, the company was cited for selling a product with a disease claim in the product’s title. This name was redacted in the warning letter, so I reached out to the company that received the letter to ask what the product’s name was, but I have not heard back from them. I’m always intrigued when I see product names cited in warning letters, and I’ve previously written about this here . From warning letter. “Product name, (b)(4) : The product name implies the product is intended to cure, mitigate, treat, or prevent migraines.” Labeling issues are also mentioned in this letter. Check out last week’s post for best practices for labeling dietary supplements. Read the full warning letter here . DATE ORIGINALLY POSTED: 7/31/24 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!