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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!

Food safety plans should be comprehensive < Back Pepsi Cited For Salmonella Contamination Food safety plans should be comprehensive This is a cautionary tale of how quality control, food safety oversight, and sanitation, even at one of the world's largest companies, can go wrong. Salmonella was discovered at one of Pepsi's granola bar manufacturing facilities. Here's the timeline. 11/25/23: Sample confirmed to have Salmonella. 12/12/23: Testing reconfirmed Salmonella after a suspected lab error investigation. The sample matched the same form of Salmonella that was previously found in the facility a few months before. ➡ Asa comments: Finding Salmonella in a facility is not uncommon, but not taking the proper steps to remove it from the facility with hazard analysis, cleaning, and testing is a concern. 12/14/23: Company notified FDA of the recall of some lots of granola products. In this warning letter, FDA reminds the company of its obligation to file with the Reportable Food Registry within 24 hours of determining the food should be reported. ➡ Asa comments: Not following FDA's reporting timeline is a good way to irritate the inspector. 12/19/23: FDA sent the "swab patrol," which usually does not happen so quickly after a recall. One of the samples was positive for Salmonella in a crack in the floor. ➡ Asa comments: Floor cracks are common hiding places for these pathogens, which shows the importance of not only cleaning but also facility maintenance. 1/3/24: From FDA: "We advised you of the whole genome sequencing (WGS) results via a conference call on January 3, 2024. You acknowledged that you had identified historical isolates of Salmonella Cubana in your facility since at least 2020. These findings may indicate that the same strain of Salmonella Cubana has survived since 2020." ➡ Asa comments: This unfortunately shows that this strain of Salmonella has been living in the facility for years. This likely could have been avoided. 1/11/24: Company testing shows the Salmonella had migrated to an area of a production line without a kill step, and they issued a recall for all products made at that facility. ➡ Asa Comments: Issuing a recall of this level is costly, and from my inference of the information in this letter, it could have been avoided. Who is to blame? Usually, the plant manager or the head of quality makes the call to "keep going" rather than stopping production and conducting a comprehensive cycle of repairing, cleaning, and swabbing until the pathogen has been eradicated, but it is impossible to know what the culture of compliance broke down. 4/3/24: The company decided to close manufacturing operations at this facility. FDA goes on to share that the hazard analysis conducted at the facility after finding Salmonella in 2022 and 2023 was insufficient. From FDA. "Furthermore, your corporate PEM program states that "repeat positive results typically indicate further deep dive," but you did not have any records indicating corrective actions beyond normal cleaning/sanitizing and maintenance (e.g., "deep dive" corrective actions) were taken at your facility." There is more to this warning letter , and I suggest all executives, food safety, and quality teams read the letter as a case study of what can go wrong. At my consulting company Supplement Advisory Group , we do not focus on these matters, but if you need food safety support or GMP auditing, I would be happy to share my preferred contacts. DATE ORIGINALLY POSTED: 7/10/24 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!

Review old social posts < Back Social Media Disease Claims Earn Warning Letter Review old social posts Claims on social media can tip the scale to a warning letter. This warning letter is interesting. It includes topical products marketed as drugs, animal “drug” claims, and more, but today, I will be focusing on the social media claims. Please also forgive the brevity of this Warning Letter Wednesday as I am on a road trip visiting graduate schools with my daughter. FDA looks at the 10,000-foot view of a company’s online persona. One claim in isolation is probably not enough to trigger a warning letter unless it is very egregious (e.g., COVID). The agency chooses claims from all marketing, such as socials, websites, and YouTube, and pieces them together for one big picture of non-compliance. Most of the highest-risk claims in this warning letter are on social media. From warning letter. “On your Facebook account. June 27, 2022: • Under the heading “Benefits of Spirulina” [an ingredient in Fulvic Green]: − “[C]an reduce risk of cancer.” This shows how discussing ingredient benefits is a marketing claim. Since the post cited in the warning letter is almost two years old, it shows that even old social posts are active marketing in the eyes of FDA. The moral here is to review your old social post to ensure no “forgotten” high-risk disease claims are there. From warning letter. “On your Facebook account post, dated June 20, 2022:CAN PREVENT SEI-ZURES…used in traditional ayurvedic medi-cines as a cure for sei-zures and convulsions.” Discussing traditional use claims in this content is a disease claim and is therefore considered labeling. Read the full 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 ESG claims are substantiated < Back Environmental Claims Increase Scrutiny Ensure ESG claims are substantiated We love the environment, but companies making broad sustainability claims are asking for increased scrutiny. This is because statements like “environmentally friendly” and “sustainably sourced” can be interpreted in many ways, and providing the required substantiation is very difficult. A leading meat stick brand faced a challenge at the National Advertising Division (NAD) over its environmental and sourcing claims. In NAD cases, companies typically provide substantiating data to support their claims for review. However, rather than defending its claims, the company chose to remove the challenged environmental statements, including references to the product being “carbon neutral” and “sustainable.” 👉 From NAD. “(NAD) will treat the claims, for compliance purposes, as though NAD recommended they be discontinued.” Here are a few comments and best practices when making “eco” type claims. Provide measurable outcomes: For example, “Our packaging uses 30% post-consumer recycled content” is less likely to be challenged than “Our packaging is recyclable and sustainable.” Stay Away from Broad Claims: Statements like “No carbon footprint” are well-intentioned but are difficult to support without an offset program or verified calculation on all products. Specific vs. Broad Claims Example 🔹Broad Claim (Risky): “Our protein powder is eco-friendly and helps save the planet.” 🔹Specific Claim (Less Risky): “Our protein powder uses 25% less plastic per container compared to our 2021 packaging, reducing material waste.” Read the NAD decision here . DATE ORIGINALLY POSTED: 2/12/25 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!

< Back Interview Tuesday Jun 15, 2021 Compliance Pitfalls to Avoid CBD Association Have a cannabinoid company and worried about falling victim to easily avoidable compliance pitfalls? If so, watch the CBD Association's vlog and learn from dietary supplement expert Asa Waldstein about the best business practices your company should be following. We also discuss the cannabinoid regulatory, marketing, and enforcement trend landscape. Learn More Previous Next

Following specifications prevents greater issues < Back Heavy Metal Contamination Leads to Recall Following specifications prevents greater issues High lead recall alert! A dietary supplement company in New York issued a recall for its finished product, Shatavari, due to high lead levels. Greetings from Expo West! Today's Warning Letter Wednesday reviews the importance of making and following specifications. Sign up for my weekly blog here , which allows you to search 150+ previous posts. The batch of high-lead products has been in circulation since 2022 and was recently tested by the Connecticut Department of Consumer Protection's Food & Standards Division, which resulted in the recall. Thank you for finding this CDCP! Botanicals contain "naturally occurring" amounts of heavy metals, especially in the roots, which is why ingredients and finished product specifications are required to test these items. The American Herbal Products Association (AHPA) is a good resource for understanding specifications, but keep in mind that retailers and states like California (Prop 65) may have their own requirements. The most common warning letter violations involve specifications being incorrectly written or followed. Here are a couple of Warning Letter Wednesday posts about this. 🔹 1/22/25: Incomplete Batch Records & Ingredient Specifications 🔹 7/31/24: GMP Manufacturing Lessons As Warning Letter Wednesday readers know, I am not a company or product basher, which is why I typically don't call out company names in my newsletter. I, however, always provide a link to the warning letter or case so inquisitive subscribers can explore publicly available documents. When I look at the recall notice in more detail, I also see labeling issues such as the Statement of Identity "Herbal Supplement" or Dietary Supplement" missing from the Principal Display Panel (PDP). This is considered a major labeling violation, and it signals deeper compliance issues to anyone who is a label reader. The adage "Where there's smoke, there's fire" is often true with labeling violations. I then ran Apex Compliance® on the company's website and found several over-the-top disease claims. Since recalls often lead to warning letters, now is the time for this company to remove these risky marketing phrases. Also, to anyone who sells Shatavari, expect the FDA to ask about your specifications and testing during your next inspection. 👉 I write about the joys of being a label reader while traveling here (280k impressions). 👉 Read about the recall here . DATE ORIGINALLY POSTED: 3/5/25 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!

Find and remove high-risk “buzzwords” < Back PTSD Claims Enforcement Increasing Find and remove high-risk “buzzwords” FDA enforcement of PTSD claims is increasing. This year there have been five PTSD-related warning letters, up from just three PTSD-related letters in all of 2021. This is an example of a high-risk “buzzword” to watch out for, and a great opportunity for companies to ensure this word is not lurking in any marketing. Look for high-risk words in: 🔷 Old social media posts. 🔷 Blogs: Here is a post about best practices for reducing risks when writing blogs. 🔷 Hashtags: Here is a video about this. Here's a post about removing high-risk "buzzwords". Most PTSD letters also mention CBD, meaning any company selling cannabinoids should especially ensure they are not using high-risk words. 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!

Do's and don'ts of puffery < Back Puffery Claims Explored Do's and don'ts of puffery Puffery is one of my favorite advertising compliance discussions. Last week, I attended the ACI Substantiation Conference in NYC, where puffery was widely discussed. A recent National Advertising Division (NAD) case determined that a beef jerky company’s “the best” and “Clearly the best” statements were puffery. OK, I know I write about supplements, but we can learn from the beef jerky NAD case. Also, I go into more detail about what constitutes puffery below. According to NAD, puffery is “an exaggerated, blustering, or boastful statement or general claim that could only be understood to be an expression of opinion, not a statement of fact.” From NAD case. “Old Trapper’s “Clearly the Best Beef Jerky” slogan, when used on its product packaging and website, conveys a message of corporate pride, and the use of “best” is not comparative as no specific competitor or ingredient is identified. In these contexts, the challenged claims are unquantifiable and, therefore, puffery.” “The claim “The Best Ingredients Create the Best Beef Jerky” which appears prominently on the Old Trapper website landing page, did not convey a specific comparative superiority message.” “Old Trapper’s 15-second YouTube video that depicted a single bag of Old Trapper jerky while “Old Trapper is Clearly the Best Beef Jerky. Clearly More. Clearly Nothing to Hide. Clearly Fresh. Clearly the Best”, did not convey a comparative superiority message because the video only featured Old Trapper, did not tout attributes other than a single reference to “clearly fresh,” and did not refer to or depict any competitors or competitors’ products.” NAD did however find that the company’s “We use only the highest quality ingredients” is an objective claim that requires support. If they had stayed with the “Only the best ingredients make the best products” claim, this would have likely been considered puffery. NAD looks at whether a claim is provable, measurable, or is an opinion. Here are three parameters of puffery (with examples). Thanks for this, NAD! 1) Puffery as exaggeration: We all remember the movie Elf, where Will Ferrell declares the crummy coffee was, in fact, the “World’s best of coffee.” This statement is so exaggerated that no reasonable consumer would believe this to be accurate. If a company advertised “Best cup of coffee in Boulder,” then perhaps it would no longer be puffery. Adding quantifiable comments such as “#1 coffee choice in Boulder” would require substantiation. 2) Puffery as an opinion: “The best almonds make the best almond milk.” was considered to be proof of corporate pride in its product and was not a comparative claim. This would require substantiation if it could be quantified, such as “We only use the best California almonds.” 3) Puffery from depictions and imagery: This example shows how context matters and that even if a claim is puffery, the corresponding imagery can make it a claim requiring substantiation. a. A statement that may have been puffery in isolation but was presented in the context of other claims that made it NOT puffery. Many of us may remember the “Hefty, hefty, hefty. Wimpy, wimpy, wimpy.” advertisements. NAD found that in a radio advertisement, this line was puffery, but when used in a television commercial featuring John Cena, who is very large, and Rob Schneider (much smaller), the visual commercial made Glad Bags seem wimpy. NAD has a podcast about puffery. Learn more here . Read the beef jerky NAD case here . DATE ORIGINALLY POSTED: 2/14/24 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 Webinar Tuesday Sep 24, 2024 Technology solutions for marketing and manufacturing supplements in the US FoodChain ID Asa Waldstein of Apex Compliance and Jérôme Le Bloch and Amélie Denis of FoodChain ID partner in this educational webinar. They review technology solutions for ingredient suitability, marketing compliance, and more. Ingredient Suitability & Claims: FoodChain ID’s experts will guide you through determining ingredient suitability and navigating claims regulations in the U.S. Regulatory Compliance: Discover how FoodChain ID’s Supplements R&D Insight tool offers comprehensive regulatory data and scientific analysis to simplify compliance. Content & Enforcement Trends: Apex will demonstrate how their Compliance tools help avoid costly FDA warning letters and litigation through efficient content review and risk management. Learn More and Register Previous Next

< Back Panel Discussion, Webinar Tuesday Apr 9, 2024 New Technology: Opportunities and challenges in the dietary supplement industry AHPA Webinar Technology is evolving rapidly, with new tools emerging that impact our daily lives both personally and professionally. In the dietary supplement industry, innovations like A.I., blockchain, and zero knowledge proof are being applied in novel ways to improve the safety, quality, and efficacy of herbal and natural products. In this webinar, expert speakers will bring awareness to some of these new technologies and discuss: How new technologies can be used to support regulatory compliance, product integrity, and new ingredient discovery Potential advantages and disadvantages Associated risks and trends in litigation Speakers: Asa Waldstein (Supplement Advisory Group) Derek Lurth (HealthLoq) Dr. Swati Kalgaonkar (Brightseed) Carolyn Riggs (Ice Miller) Kristina Dahmann (Ice Miller) Moderator: Robert Marriott (AHPA) Registration: AHPA member: $199 Non-member: $399 Can't attend live? Registration includes on-demand access to the webinar recording and materials following the event. Don't miss out! Register Previous Next

A roundup of thought-provoking posts we saw on social media! < Back The Buzz in Natural: December 2024 WholeFoods Magazine Staff Press Mention A roundup of thought-provoking posts we saw on social media! Asa Waldstein , Principal of Supplement Advisory Group, got the industry digging out their dusty old photo albums when he posted: “I'm kicking off a new trend to celebrate the 30th anniversary of the Dietary Supplement Health and Education Act (DSHEA) of 1994, which paved the way for the supplements industry as we know it today. Withou t #DSHEA , there wouldn't be a lawful pathway for us to sell and enjoy supplements…Let the fun begin!” Waldstein’s challenge: Post a picture of yourself from 1994,, and share a short sentence about what you like about the supplement industry. Include the hashtag #DSHEA94Pic in the post. The industry accepted the challenge–check out #DSHEA94Pic on LinkedIn to see throwback pics from industry members throughout the supply chain. And join the fun! Post your 1994 photo (or as close as you can get) and let us know what you like about this industry! Read More Previous Next