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< Back Symposium Friday Oct 16, 2020 4 Hour cGMP & Marketing Workshop with Steven Yeager & Asa Waldstein American Herbalist Guild (AHG) Annual Symposium Herbal supplement manufacturers and marketers need to have a solid understanding of current Good Manufacturing Practices (cGMP). In this interactive presentation, you'll learn about the intricacies of cGMP, including all CFR 111 subparts. We'll give you examples about how to comply with each section, practical steps for implementing them in your facility, and common mistakes to avoid. We also provide real-world examples of how to prepare for and conduct oneself should you have to undergo an FDA inspection. We review common marketing mistakes made by herbal manufacturers and marketers. Only $30 and supports this important organization Purchase Previous Next

Ensure ingredients are GRAS for the marketed population < Back Printed Brochures Are Labeling Ensure ingredients are GRAS for the marketed population FDA has been paying close attention to probiotic products marketed to preterm infants recently, and this letter shows the continuing trend. There are ~100 searchable Warning Letter Wednesday posts here! You can search old posts for keywords. I've developed this as a resource for your regulatory, marketing, and executive teams. You can also sign up there to have Warning Letter Wednesday delivered to your inbox. 🔷An interesting part of this warning letter is that printed brochures are cited. Of course, all marketing is an extension of the label, but in this digital era, this is rare. FDA references claims made in a printed brochure that was given to hospital staff. Other than tradeshows and items gathered during GMP inspections, I can’t remember seeing printed brochures cited in the recent past. The lesson here is that even printed literature can elevate the risk of a warning letter. 👉From warning letter. Your “Probiotics and Preterm Infants: Clinical Evidence” handout provided by your sales representative to hospital staff has a section with the heading “Probiotics in the NICU: Clinical Evidence” that states, “Probiotics have shown to significantly improve outcomes” for “All-cause mortality,” “Necrotizing enterocolitis (NEC),” “Late-onset sepsis,” and “Feeding tolerance,” and that represents “Benefits of probiotics on NEC,” as “significantly reduc[ing] incidence of NEC in clinical studies.” The other marketing handout with the heading “The Promise of Similac Another Innovation Only From Similac” states that Similac® Probiotic Supplement undergoes safety testing to “ensure the probiotic is ready for hospital use” 🔷FDA took issue with a few of the probiotic ingredients in the product. For example, this probiotic is considered a new dietary ingredient (NDI), and the FDA states there is insufficient safety data to back up its use in preterm infants. According to a well-known supplier’s website, this ingredient is GRAS, but I wonder if the safety data applies to preterm infants. If the product was not marketed to preterm infants, it probably wouldn’t have been mentioned in this letter, in my humble opinion. 👉 From warning letter. “S. thermophilus (TH-4®), a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury, when used in preterm infants.” 🔷There is a lot more to this warning letter, such as FDA’s comments regarding the safety of B. infantis in preterm infants. Please share your thoughts on this. Here’s the FDA press announcement . Read the full 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!

Be nice to FDA investigators & follow inspection SOPs < Back Refusing FDA Inspection Access Be nice to FDA investigators & follow inspection SOPs GMP inspection preparedness is an essential part of business and compliance. This includes ensuring team members know how to conduct themselves during an inspection, what types of information FDA is allowed to request, and understanding what can go wrong if staff do not allow access to the specific areas of the facility. This warning letter is an extreme example of what not to do during an inspection. The company, a cosmetic and topical OTC manufacturer, was issued a letter for not allowing FDA to enter certain areas of their facility, but it doesn't stop there. Apparently, the quality manager shoved and shouted at FDA investigators? As my daughter would say, "WTF." From warning letter. "Quality Manager entered the laboratory and exhibited hostility by shoving and shouting at our investigators for conducting the inspection without their presence. Additionally, laboratory staff refused to open a drug stability chamber based on his hostile behavior. FDA inspectors are real people, and common courtesy goes a long way, such as offering them water (do not offer anything else as it is considered inappropriate), suggesting a good restaurant for lunch, and just being nice. It goes without saying that shouting and shoving anyone, especially FDA, is bad, and it would set up the rest of the inspection to go much worse than it could have. Employee training and mock FDA inspections are a critical part of a smooth "real" GMP inspection. It is standard practice for FDA to request a list of complaints to ensure they are being investigated properly. A customer complaint related to mold and its associated investigations was not disclosed in the list of complaints provided to the FDA. The section of the warning letter is sad and potentially speaks to an unfriendly and potentially fishy work environment. From warning letter. "While interviewing an employee regarding the undisclosed positive mold results for your …. your Quality Manager entered the room and began berating the employee, who then left the room, impeding FDA's review of your contamination investigation required under CGMP." There are several other GMP citations listed in the warning letter. Failure to Test Finished Products (21 CFR 211.165(a)). Failure to Test Components for Identity and Purity (21 CFR 211.84(d)). Testing glycerin for diethylene glycol (DEG) or ethylene glycol (EG) is mentioned here. FDA is very serious about this and has been mentioned in 40+ warning letters this year. Inadequate Facility and Storage Conditions (21 CFR 211.42(b)). Inadequate Quality Unit Oversight (21 CFR 211.22). Lack of Process Validation and Cleaning Validation (21 CFR 211.100(a) and 211.67(b)). This warning letter reads like a bad movie and makes the company look unprepared and non-compliant. Read the full letter here . DATE ORIGINALLY POSTED: 12/25/24 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 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

< Back Presentation Tuesday May 23, 2023 Regulatory compliance and reducing class action risk Naturally Informed - Microbiome: Mastering the Market 2023 A blurry concept only 5 years ago, the microbiome has become understood as perhaps the most critical environment impacting human health – and consumers know this. What they know less about is exactly how it works and what they can do to impact it. And the more things come into focus, the more we have yet to learn about these complex systems so fundamental to life – the science is evolving literally daily. This three-day intensive virtual conference will examine not only probiotics, prebiotics, synbiotics and postbiotics, but also numerous other microbiome- modulated interactions including the impact of stress and diet. Experts will examine leading-edge science, and deliver practical tools to leverage this science to competitive advantage and truly mastering the market. Register Previous Next

< Back Podcast Wednesday Dec 4, 2024 Unveiling Supplement Regulations: Asa’s Insights on Compliance and Ethical Marketing Natural Products Marketer Podcast Unlock the secrets of dietary supplement regulations with our esteemed guest, Asa, a seasoned regulatory consultant with a background in clinical herbalism. Discover the intricacies of FDA oversight in the supplement industry and learn why the notion that dietary supplements are unregulated is a myth. Asa’s journey from herbal studies in Boulder to advising companies on maintaining compliance provides unique perspectives and invaluable lessons for anyone navigating this complex field. Gain a deeper understanding of the transformative impact of the Dietary Supplement Health and Education Act (DSHEA) and its role in shaping the herbal and dietary supplement industry. We explore the distinction between structure/function claims and disease claims, and how these affect marketing strategies. Delve into the evolution of labeling and marketing regulations, and consider potential legislative updates that could further refine the guidelines set by DSHEA over the past three decades. Lastly, we tackle the challenges retailers face in complying with regulatory guidelines, particularly in the context of influencer marketing and digital platforms. Learn about the risks associated with unsubstantiated claims and how innovative tools like Apex Compliance software are helping companies stay in line with regulations. Through practical advice and expert insights, this episode equips businesses with the knowledge to market their health products ethically and legally. Listen to the Podcast Previous Next

Re-review online marketing after FDA inspection < Back Improper 483 responses Re-review online marketing after FDA inspection This company was inspected by FDA and received several common 483 violations, such as improper specifications and not having written procedures for cleaning and product returns. 🔷 From my reading of this warning letter, they could have probably avoided the GMP-related letter if they had responded correctly. People like Marian Boardley and Tara Couch can help with 483 responses. Here is FDA’s response to a poor 483 response. 👉 From warning letter. “we are unable to evaluate your corrective action because you have not provided revised “Raw Materials Spec Sheet” for the components used in the manufacture of the …. dietary supplements, nor have you provided finished product specifications for each of the products.” 🔷As with all warning letters, looking at the timing is important. The company was inspected in March and April this year and provided 483 responses in May. One month later, in June of this year, FDA reviewed the company’s website and found some violations, such as “anti-cancer” statements. They also cited the product name “Edema NatRelief” as a disease claim. Usually, product names must really push compliance boundaries to be cited, such as this warning letter from September, where the product “Full Body Antibiotic” was called out. As I’ve spoken about in previous posts, FDA has been reviewing websites 2-8 months after inspection, which is a friendly reminder to double-check online marketing if you’ve recently been visited by FDA. This is one of the reasons I developed Apex Compliance, which helps companies find the high-risk “forgotten landmines” before they become issues. In fact, I ran Apex Compliance on their website and found even riskier claims that were not mentioned here. Removing them now can help this company avoid repeat warning letters or lawsuits. Learn more about Apex Compliance . 🔷Some of the violations are scary. For example, identity testing for the Rauwolfia root ingredient was done by organoleptics rather than analytical testing. This ingredient is amazing at helping to lower blood pressure, but if the company received a Rauwolfia extract rather than the root powder, for example, this could have potentially led to a hypotensive (low blood pressure) crisis. 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!

Learning from other’s mistakes is a good strategy < Back FDA Crackdown on Monkeypox Claims Learning from other’s mistakes is a good strategy FDA sent five warning letters this week to companies selling products for Monkeypox. This is a clear violation, but there are some critical learning lessons here. Sign up for this weekly Warning Letter Wednesday post here . 🔹One company is a wallpaper website with a few herbal tinctures containing uncompliant product descriptions. They probably just posted whatever content the tincture company provided, which shows that companies distributing supplements are on the hook for claims made on their platforms. Find my video and post about the distributors Amazon and Walmart here . 🔹Implied claims are marketing claims. In this blog post titled “What is Monkeypox,” the company says the product may help Monkeypox and then states, “we don’t know enough to be sure.” Suggestive words and phrases do not protect companies from implying their product will help diseases. 👉From warning letter: “What Can I Do To Protect My Family From Monkeypox?... products like Vitamin A, Vitamin D, Zinc, Mother’s Immunity, and Immunity Boost [each of these product names links to your page selling the product] . . . help to prevent viral infections in general and *MAY* help prevent Monkeypox (we simply do not know enough to say for sure if they will offer protection).” This company needs a lot of compliance help. I found 161 occurrences of “depression” and 2930 references to “infection” on their website. I offer website and social compliance cleanup services. Let’s talk about how I can help you avoid a warning letter. 🔹Another company has DSHEA disclaimers all over their disease-containing posts. This is not a “get out of warning letter jail free” card that allows companies to say whatever they want. The dietary supplement industry is nuanced and requires knowledge and care when marketing supplements. This is why I always suggest hiring dietary supplement experts to help grow your company. I write in detail about this 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!

All marketing is “labeling” < Back Topical Product Claims Turn Magnesium Oil Into Drug All marketing is “labeling” FDA cited this company for selling a topical magnesium product that also contains ingredients like fulvic acid, vitamin B6, and MSM. Based on website claims FDA concluded the product was an analgesic drug. Here are some of the cited claims from the warning letter. “For muscle cramps or pains, spray directly on problem area.” “Designed to provide relief from body tension and soreness.” “Leg cramps and muscle soreness,” along with “migraines, insomnia, [and] fatigue.” FDA classified this as a “topical external analgesic (OTC) drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h,” which is allowed if the product is made using a specific OTC monograph (recipe) under applicable GMPs. Since the product did not follow the monograph, primarily because other “active” ingredients like MSM are not on the monograph, FDA deemed this product an unapproved new drug. To be fair, the other sections of the warning letter contain very serious disease claims like “cancer” and “depression,” which are likely the primary reason reasons for the letter. Some warning letters like this are very comprehensive and may cite “secondary” claims, which may not be enough to trigger a letter on its own. In the case of the magnesium oil, I doubt making claims about pain or soreness is enough for agency action, but listing diseases related to magnesium deficiency, such as insomnia, and then suggesting the product can address these deficiencies is high risk. I have seen some companies use the nutrient deficiency and disease claim strategy on dietary supplements, which is out of my risk tolerance, but when used on topical products that do not provide absorbable nutrients, it goes too far. As a friendly reminder, topical non-drug products are not allowed to “affect the structure or any function of the body,” which supplements are permitted to do. So would a topical product with a “relieve and soothe” claim attract a warning letter? This is unlikely unless there were adjacent claims like “helps with arthritis,” which turned the product into a drug. 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!

Ensure 483 responses are complete < Back GMP Violations & Unanswered 483s Lead to a Warning Letter Ensure 483 responses are complete #WarningLetterWednesday involves a company inspected by the FDA last year that received several 483s for common violations like not having proper component and product specifications. The company submitted 483 responses, but these responses were incomplete which led to a warning letter. From Warning Letter: “We acknowledge your response, received December 30, 2021, which acknowledged that specific elements needed to be updated and asserted that “[b]y March 31, 2022, MCACO will update and complete component specifications.” However, we are unable to evaluate the adequacy of your corrective action because you did not provide updated finished product specifications for review.” Here is a Warning Letter Wednesday post about this common GMP violation. The lesson here is to ensure that 483 violations are adequately addressed and that all grievances are met. Most 483s can be “walked back” and addressed before they become warning letters. Warning letters should be avoided. Learn more about the ramifications here . Here is a video about the differences between 483s and warning letters. Other violations cited in this warning letter include: * Not verifying a raw material supplier’s Certificate of Analysis (COA). Depending on the supplier’s Certificate of Analysis (COA), without validating the results with a third-party lab landed this company a 483. The FDA requires that manufacturers verify COAs, including microbial and heavy metals. From Warning Letter: “you have never conducted heavy metal and microbiological tests to confirm results provided by the supplier’s COA.” * Incomplete Master Manufacturing Records (MMR). From Warning Letter: “A description of the packaging and a representative label.” GMPs work backward from the label to ensure there is a 100% label claim at expiration. From Warning Letter: “Written instructions, including specific actions necessary to perform and verify points, steps or stages in the manufacturing process where control is necessary.” The MMR is essentially an easily replicated recipe that includes what goes into the blend, how to verify the numbers are correct, and the instructions for mixing and testing. Here is a very detailed WLW post about GMP violations and best practices. 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!

In his quarterly update, consultant Asa Waldstein identifies trends in FDA warning letters impacting manufacturers and marketers of dietary supplements. < Back Q2 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. Read More Previous Next

Review old social posts for regulatory “landmines” < Back Seven-Year-Old Facebook Post Leads To Warning Letter Review old social posts for regulatory “landmines” This company received a warning letter for claims made on its website and old social media posts. The oldest post cited in this letter is from 2016, which shows that even old and potentially “forgotten” social posts are active marketing in the eyes of the authorities. Many companies now have “clean” marketing, but they may have inadvertently overlooked the regulatory landmines in their old socials. Now is the time to review and update these old posts (and old blogs). Sign up for this weekly email ! 🔷 Some very high-risk language on Facebook is cited in the letter. 👉 From warning letter.” In a July 29, 2017 post: “Can Plaquex® help prevent cancer?...When I linked the facts of these three independent information sources, the thought came to me, that Plaquex® – Phosphatidylcholine – may be able to prevent cancer.” 🔷 Following the “breadcrumbs” in warning letters is always fun. For example, in this letter, FDA notes that the Facebook page links to a website (book-selling site) that links to another website where customers can order supplements. FDA rarely references anything over “two clicks,” which is what makes this so interesting. FYI, the two-click rule is an urban legend and, as demonstrated in this letter, does not protect from disease claim enforcement. This “commercial bridge” is important, as it’s often cited in warning letters. 🔷 Unfortunately, this warning letter has not stopped the company from continuing to make very high-risk claims, such as statements about ingredients being antidepressant and antiarthritic. Read the full 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!