Search Results

Key GMP learning opportunities explored < Back Incomplete 483 Responses Lead to Warning Letter Key GMP learning opportunities explored We can learn a lot from warning letters. This manufacturer was inspected in April 2022, where they received some 483s. The company subsequently responded to some 483s, but according to the warning letter, “Not all of the items on the issued Form 483 were addressed in your response.” In my experience, most 483s can be addressed before they become warning letters. I talk about improper 483 responses here. Here is an example from the warning letter. From warning letter. “We have reviewed your June 23, 2022 response to the form FDA 483. We are unable to evaluate the adequacy of your response because you did not provide documentation demonstrating you have established specifications… You provide documents you describe as revised finished product specifications for the … product. We note that these documents do not demonstrate that you have established specifications that provide standards to confirm the identity, purity, strength, and composition of the finished batch of your dietary supplements. For example, the finished product specification for … product lists an “identification” specification of “Conforms to Standard” with a test method of “Eurofins or eq.” and a frequency of “Rotational.” “Conforms to standard” does not specify the extent to which the component must conform. “Eurofins or eq.” is not a test method, and “Rotational” does not describe the frequency of when testing is to occur. Let’s break this down. 🔹Identification: The company lists the type of identification as “conforms to standard” but does not provide information on what that standard is. The company is close but, unfortunately, falls short of GMP requirements. Here is howI think about GMP documents, such as this specification sheet. Will someone unfamiliar with your process be able to step in and understand how to test the product if there is no “institutional knowledge?” It is the "recipe" for staff to follow. 🔹Test method: The company lists “Eurofins or eq” which is the name of the laboratory, not the name of the method, such as “AOAC 121804.” 🔹Frequency of testing is listed as “Rotational,” which is not sufficient. It should state “Test all” or refer to an SOP on skip lot testing. Incorrect reference samples are also cited. 👉From warning letter. "You failed to establish and follow laboratory control processes that are reviewed and approved by quality control personnel to use criteria for selecting standard reference materials used in performing tests and examinations… Specifically, the FTIR analysis performed by your third-party laboratory uses previous shipments of components as the reference for testing and they do not own a reference library for the FTIR tests. Testing components against previous shipments of the component may confirm receipt of the same component but this does not ensure the identity, purity, quality, and strength of the component is thoroughly characterized.” I admit this is how I tested identity around 2010 until I realized that having a qualified reference sample was essential. In this example, the third-party lab should have handled this rather than just depending on previously provided reference samples, and the quality personnel should not have allowed this. One more learning opportunity. 🔹Theoretical yield calculation helps “error-proof” manufacturing. Let’s use the example of a capsule product. First, the powder needs to be blended. If the theoretical yield is off, this will signify too much or too little of an ingredient was added and, therefore, should not “pass” to the encapsulation process. 🔹The same Is true for encapsulation. If a company has substantially more capsules than the theoretical yield, this signifies the capsules are underweight and not at label claim. The production should be stopped for evaluation here. 🔹If the yield is too high in bottling, this shows there are likely not enough capsules in each bottle. This lily-pad approach to quality is designed to stop problems before they happen. From warning letter: "A statement of the theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process and the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary." Interested in learning more about GMPs? Here are a few webinars you may enjoy. 🔹Distributor requirements for supplements . 🔹Getting ready for FDA inspections . There are so many learning lessons. 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!

Replace “insomnia” with lower-risk alternatives < Back Insomnia claims continue to attract FDA attention Replace “insomnia” with lower-risk alternatives #WarningLetterWednesday highlights insomnia claims that continue to attract FDA's attention. There were 22 FDA warning letters in 2021 with insomnia claims, dramatically up from 14 in 2020, 2019 (13), and 2018 (7). This is a clear indication of an FDA enforcement trend and a good reminder for marketers to remove the high-risk buzzword "insomnia" from their marketing. As many of you know I have an "Asa Risk Scale" where certain claims are rated on a 1-5 risk scale, with anything 3+ likely to attract a warning letter. Insomnia is rated as a solid 3.5+, which means it should never be used. If truthful and not misleading here are some possible alternatives for insomnia. *feeling refreshed in the morning *a restful night's sleep *healthy slumber support *sleep support *supports a healthy night's sleep *support rest 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!

The FDA/FTC look at old posts the same as current ones < Back Clean up old social media posts The FDA/FTC look at old posts the same as current ones #WarningLetterWednesday highlights very old social media posts called out in this warning letter. It is common for the FDA to look back a couple of years on social media posts, but this warning letter mentions a 2014 re-tweet and several three-year-old Facebook posts. This is an excellent reminder to clean up old social media posts, as the FDA/FTC looks at old posts similarly to current ones. I even made a video about this. Re-tweeting and re-posting can be seen as marketing claims, especially if a company adds commentary to the original post. This is the first time I have seen a re-tweet without company commentary called out in a warning letter. This is surprising and shows the viewpoint of the FDA's West Division 5 office, which has rarely issued marketing-only warning letters. It is interesting to see what online marketing claims each FDA division focuses on, and I will dig deeper into this fascinating aspect of enforcement at a later date. There are several high-risk disease words mentioned in this warning letter, such as Parkinson's, antidepressant, anti-tumor, and hashtag diabetes, which likely was why this company received a letter. Here's a video I made about removing and replacing high-risk "buzzwords" being the most crucial first step to becoming compliant. Claims made on Amazon are also referenced in the warning letter. It is no longer considered the "unholy grail" of disease claims, and I expect to see more Amazon warning letters in the future. Read the warning letter here . I've been writing about these enforcement trends for a while now. You may enjoy reading my regulatory blogs here . It can be challenging to find content on LinkedIn, so I started this Warning Letter Wednesday Group . Please check it out. DATE ORIGINALLY POSTED: 1/19/22 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!

Some of my favorite regulatory resources. If there are other resources I should list here please let me know. Helpful Resources Here are some of my favorite regulatory resources. If there are other resources I should list here please let me know. Marketing Guidance This section covers helpful marketing resources, View Resources Prop 65 Guidance Prop 65 can be confusing. Here are some of my favorite resources. View Resources cGMP Guidance This section covers helpful GMP resources, View Resources Made in the USA and All Natural These are common plaintiff lawsuit targets. View Resources Labeling Guidance This section covers helpful labeling resources, View Resources NDI and GRAS Guidance This section covers helpful NDI and GRAS resources, View Resources Influencer Marketing & Product Reviews This section covers helpful influencer marketing resources. View Resources Home About Warning Letter Wednesday Work With Me Testimonials Appearances Press Regulatory Blog Resources More

< Back Meet-Up Group Wednesday Jan 15, 2020 FDA and Class Action Enforcement Trends & Updates: Fireside Chat Asa's Regulatory Education Series Boulder Hemp-CBD Group Meet-Up hosted by Asa (In-person) In any rapidly emerging industry building a community to help support each other in education, compliance, and in developing best practices is always a good idea. This is a fireside chat format to discuss FDA and class action enforcement and trends. We expect an update from the FDA soon and we can likely guess there will be more lawsuits and perhaps more warning letters as well. I am joined by special guests: Garrett Graff , Managing Attorney of Hoban Law Group Dave Rodman , Founder of the Rodman Law Group Read more Previous Next

All dietary ingredients must be tested for identity < Back Company Cited For Not Testing Known Contaminants All dietary ingredients must be tested for identity Testing for known contaminants is an essential part of GMPs. This company was cited for not conducting proper identification and known contaminant testing on glycerin, an ingredient used in its manufacturing. The known contaminant in glycerin is diethylene glycol (DEG). During one GMP inspection I helped oversee, FDA was happy to see we had tested for DEG in glycerin. This showed we were aware of the potential safety issue with glycerin and were taking steps to ensure the finished product was safe. Learn more with the FDA’s guidance document , Testing of Glycerin for Diethylene Glycol. Other known contaminants are melamine in milk and methanol in ethanol. What other known contaminants does your company test for? The company that received this letter is an OTC and homeopathic drug manufacturer, but supplement folks can learn from this. Also, FDA cited the company for not proving their method was sufficient to test for DEG. As I discussed last week , proving test method suitability is top of mind for FDA investigators. 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!

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!

Asa and other industry leaders weigh in. < Back 30 supplement industry voices suggest changes to DSHEA NBJ Interview Asa and other industry leaders weigh in. Asa Waldstein, Supplement Advisory Group: "Since DSHEA was enacted before the internet boom, I would like to see some clarification on what constitutes allowable marketing in the digital sphere. For instance, if the FDA would define the marketing compliance boundaries of reposting and social engagement and help explain why they consider a social media post from years past as active marketing, it could help companies better navigate compliance. There are also antiquated regulations that should be updated, such as 21 CFR 101.93(d), which states that the DSHEA disclaimer should be “on the same panel or page that bears the (structure/function) statement” on labels. This means that if there’s a structure/function claim on the principal display panel, then the DSHEA disclaimer should also be on the same panel. While the FDA does not seem to enforce this, plaintiff attorneys continue to cite this regulation in lawsuits, which creates unnecessary expense (and ugly labels) for supplement companies." Read More Previous Next

Clinical study parameters must match claims < Back Lessons From NAD Decision Clinical study parameters must match claims Most of the claims here are not high-risk, but this demonstrates that even lower-risk statements, especially when combined with "clinically proven" types of claims, can lead to increased scrutiny and potentially increased substantiation requirements. I usually write about FDA supplement warning letters, but they've been relatively quiet this year, so today's Warning Letter Wednesday discusses an interesting National Advertising Division (NAD) decision. NAD is a self-regulatory body under Better Business Bureau (BBB) programs, and I enjoy reading NAD cases to look for clues about claims substantiation and enforcement. After reviewing the substantiation, NAD recommended that the company discontinue the following claims. All "clinically tested," "scientifically tested," "mood support," "calmPM S symptoms," "ease cramps, bloat and moodiness" and help consumers "experience a better period" claims and Express and implied ingredient claims for ashwagandha, magnesium, vitamin B6, turmeric, and chasteberry. Natural claims It seems the company had conducted a clinical study on its OTC product and its dietary supplement botanicals product together, but NAD found tissues with the study. Unfortunately, there is no specific information on the study, such as if it was blinded or placebo-controlled. From NAD. "NAD found that the study did not meet the standard for competent and reliable scientific evidence." "several significant flaws, which rendered it insufficiently reliable to provide a reasonable basis for Pamprin Botanical's establishment and health-related claims." I've noticed that some companies use additional "creativity" in their Amazon descriptions, and this NAD case shows that even claims on Amazon are fair game for scrutiny. This is obvious, but it is uncommon for claims on Amazon pages to be cited unless they are high-risk disease statements. From NAD statement. "The National Advertising Division (NAD) determined that, in context, the "tried and trusted" claim that appeared on the Amazon product tile refers to Pamprin's history and that no modification was necessary." I find the company's approach to marketing the OTC and supplement products together to be an interesting strategy, and I wonder what FDA's position is on marketing drugs and supplements together in an instance like this. A little more about NAD. NAD reviews advertising disputes between competitors and other claims it becomes aware of. It is where companies can challenge each other's claims they feel are affecting their sales. NAD evaluates the truthfulness and accuracy of advertising and offers a streamlined resolution process to address advertising disputes. However, unlike a regulatory court, NAD cannot enforce its decisions, but if a company doesn't comply with NAD's recommendations, NAD can refer the case to the appropriate governmental regulatory authority, such as the Federal Trade Commission (FTC). This can also alert plaintiff attorneys. Read the NAD case here . It's really interesting and definitely worth checking out. 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!

Batch records should be complete < Back Improper Written Specifications Lead To Warning Letter Batch records should be complete This warning letter is interesting as it details some of FDA's thinking on test methods. Upon my initial reading of this letter, it seemed like FDA had an issue with HPTLC, but the problem was actually how the specification was written. HPTLC is mentioned in this letter. Here FDA states that HPTLC is not a parameter that can be tested to. More information is needed, such as the plant’s genus, species, and the plant part. From warning letter. “HPTLC” is not a qualitative or quantitative parameter to which a test result can be compared to verify the identity of the component.” Thanks to my friends at Alkemist Labs for talking this through with me. Your expertise is very appreciated! This is a shortened version of Warning Letter Wednesday as I’m currently attending Supplyside West. If you are here and want to discuss consulting or Apex Compliance™ Compliance, let me know. There are also other GMP violations in the letter, such as incomplete batch records. This example FDA cites the company for not having cleaning records. When I was a manufacturer, we would attach cleaning records to each batch record. As FDA notes below, this is not needed, but cross-referencing this information is required. 👉 From warning letter. “Your batch production record fails to include the date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch or a cross-reference to records, such as individual equipment logs, where this information is retained.” I recommend reading the full warning letter , as there are other labeling and testing citations that provide good learning opportunities. 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!

Asa and other industry leaders interviewed < Back Hemp and CBD Industry Responds to FDA’s Announcement on CBD Steven Hoffman Interview Asa and other industry leaders interviewed Read More Previous Next

Some of our favorite resources for helping to mitigate the risks associated with Made in the USA and All-natural claims. Home / Made in USA & All Natural / Made in the USA and All Natural These are common areas of enforcement and lawsuits.Here are some resources to help understand these regulations. Made in the USA Anchor 1 "Made in the USA" Claims Demystified video FTC guidance Great podcast on this topic Lawsuit updates (Truth in Advertising) All Natural Anchor 2 Video: What can you say and what are the risks Article on natural claims Back