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< 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

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

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!

< 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!

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!

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!

< 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

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!

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!