Asa and other industry leaders interviewed < Back Stay in your lane: Novel delivery systems must comply with supplement regulations Judy Blatman Interview Asa and other industry leaders interviewed Read More Previous Next

< Back Interview Thursday Apr 29, 2021 Compliance, Herbalism, and the FDA view on CBD LuvNCann I enjoy speaking about my opinion of the FDA's view on CBD, warning letters, herbalism, and so much more on this great podcast! This is a unique podcast started to support hosts Osiris and Nina in their quest for health and happiness while raising a son with epilepsy. They have curated some important discussions! Learn more Previous Next

Called Apex Compliance, the software detects risky marketing terms and phrases and suggests lower-risk alternatives. < Back Regulatory compliance software helps supplement, nutrition, functional food, and cannabis brands vet their marketing claims Jennifer Grebow Interview Called Apex Compliance, the software detects risky marketing terms and phrases and suggests lower-risk alternatives. Read More Previous Next

< Back Presentation, Online Friday Nov 18, 2022 Naturally Informed: Living Longer, Stronger & Healthier Virtual Conference Registration Naturally Informed powdered by Wholefoods Magazine and Trust Transparency Center Asa Waldstein presents a regulatory and enforcement update on notable action happening in emerging categories such as brain health; bone, muscle, and joint health; libido; immunity; heart health; eye health; and more! On Demand Access Previous Next

Product reviews must be honest and truthful < Back Online company fined $4.2M for blocking negative product reviews Product reviews must be honest and truthful #WarningLetterWednesday Online company fined $4.2 million for blocking negative product reviews. The FTC alleges the company blocked product reviews with less than four stars. This is considered deceptive marketing and clearly warns companies that product reviews should be accurate. Here is what we can learn. 🔷Best practices for soliciting and posting reviews. From FTC letter ➡️Examples may include asking for reviews only from those likely to leave positive ones, preventing or discouraging submission of negative reviews, subjecting negative reviews to greater scrutiny, refusing to publish negative reviews, or otherwise not treating positive and negative reviews equally. 🔷Here are some FTC rules for possible exceptions to the "post all" rule. From FTC press release➡️(the company) must post on its website all customer reviews of products currently being sold—with the exception of reviews that contain obscene, sexually explicit, racist, or unlawful content and reviews that are unrelated to the product or customer services like shipping or returns. Here is a video about product reviews . Read the FTC press release . This is a different Warning Letter Wednesday because it is an FTC action (not FDA), and it involves a fine (not a warning letter) and doesn't include a supplement company. This is a good reminder that we can learn from other agency actions such as this one. 👉Join my Warning Letter Wednesday group 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!

< Back Interview Thursday Mar 25, 2021 Herbalism, Compliance, & GMP's The Natural Nurse I speak with The Natural Nurse about herbalism, GMP's, and marketing compliance Listen Previous Next

Everything used to market products must be compliant < Back Product Tags & Metatags Attract FDA Attention Everything used to market products must be compliant Website product tags and metatags continue to attract FDA attention in warning letters. #WarningLetterWednesday This year three warning letters mention product tags or “category” tags. These tags help people find products when they search for things on Google or a website, and they are considered marketing in the eyes of the FDA and FTC. Although these tags are an “extension of the label,” they are not likely to attract a warning letter on their own. However, they signal intended use, which can lead authorities to a commercial website to keep digging for claims once there. Here are some examples involving product tags and metatags with disease claims. It's worth noting that additional high-risk website and social media claims are also present in each warning letter. This is an important reminder that compliance is not done in a vacuum, and all online content must be free of high-risk claims to avoid warning letters. From Warning Letter: “From the product webpage at …. Tags: anxiety, . . . memory, mental performance, natural depression remedy” Read this warning letter From Warning Letter: “Tags: anti-viral, COVID, COVID-19, Cure ” Read this warning letter From Warning Letter: “The above noted website claims are supplemented by metatags used to bring consumers to your website ….. through Internet searches. The metatags are: • “Take Altitude RX for altitude sickness prevention…” Read this warning letter here: Here is my “All Marketing is Labeling ” video. 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!

Apex Compliance entered the dietary supplement space to simplify regulatory compliance by helping companies identify the words and phrases across marketing materials that trigger oversight agencies. < Back Q&A: Apex Compliance founder talks streamlining supplement regulatory marketing compliance Asia Sherman Interview Apex Compliance entered the dietary supplement space to simplify regulatory compliance by helping companies identify the words and phrases across marketing materials that trigger oversight agencies. Read More Previous Next

< Back Panel Discussion, Online Tuesday May 16, 2023 The Label: Getting to the truth on natural product claims AHPA Botanical Congress Consumer preference for better business practices has expanded the already complex regulatory landscape for natural product claims. In this session, Asa Waldstein (Supplement Advisory Group) will provide an overview of key considerations for label claims, with Amber Littlejohn (Ice Miller) and Jake Hebert (One Step Closer) expanding on health-related claims and environmental claims, respectively. Speakers: Asa Waldstein (Supplement Advisory Group) – Moderator Amber Littlejohn (Ice Miller) Jake Hebert (One Step Closer) Learn More Previous Next

Websites are considered “labeling” < Back OTC Drug Website Claims Websites are considered “labeling” I am far from an expert in OTC products, but this warning letter also includes herbal extracts, which I find interesting. OTC drugs follow strict monographs that describe the type of claims that can be made and the active ingredient recipe that must be followed. 🔷Here is the active ingredient definition from FDA, which essentially means that inactive ingredients cannot have a therapeutic effect: “Active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans.” 🔷 Website claims: This company added herbs as inactive ingredients but makes disease claims about them on their website. Aside from the directions, much of the actual label seems to be compliant, but statements made on websites are still considered labeling in the eyes of the FDA. This is a great example of how marketing statements can elevate the risk of scrutiny. Using software like my compliance program, Apex Compliance™ , can help prevent companies from receiving these preventable actions. 👉 From warning letter. “Hops adds a bitter flavor and is a stability agent. In herbal medicine, this plant is known to benefit conditions such as anxiety and insomnia…Passion Flower Is a climbing vine with beautiful flowers, and is recommended as a sedative and antispasmodic agent.” 🔷FDA also references that if the product is used as directed, it exceeds the maximum suggested daily amount in the OTC monograph. I am far from a safety expert, but this probably pushed FDA to issue the warning letter. Read the full warning letter . DATE ORIGINALLY POSTED: 1/31/24 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!

Plan for inspections with an “FDA Inspection” SOP < Back Ingredient Company Cited For Refusing An FDA Inspection Plan for inspections with an “FDA Inspection” SOP International ingredient company cited for refusing an FDA GMP inspection, a serious prohibited act. #WarningLetterWednesday What are the repercussions of denying inspections? 🔷All products from the facility are deemed adulterated, and it is a prohibited act to introduce products that are misbranded into interstate commerce. This is a serious offense! 🔷This company is located out of the country, and all products from their facility have been placed on an import alert, which means they will be rejected from entering the US. 🔷This will likely make future GMP inspections more rigid. FDA is authorized to conduct unannounced inspections of ingredient or product companies that hold and sell in the United States at any reasonable time. The FDA is not required to give advance notice. In my experience, the FDA commonly shows up without warning on Monday morning, and dietary supplement GMP inspections usually last 3-5 days. Although it’s not required FDA typically does schedule inspections for international companies. Refusing entrance to a facility or an area of the facility is considered inspection refusal. An unknowing front desk staff member may inadvertently turn away the FDA. This is one reason I suggest having a “What to do when the FDA arrives” SOP ready. Steven Yeager and I talk about this here . A side note on glycerin which is a common dietary supplement ingredient. As noted in this warning letter, in the past, glycerin has been adulterated with diethylene glycol (DEG), which can lead to fatalities. I suggest testing glycerin for DEG at least once annually. If you are interested in good bedtime reading, here is the FDA document “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.” 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!