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Ensure 483 responses are complete < Back Incomplete Batch Records & Ingredient Specifications Ensure 483 responses are complete This letter is a great reminder of the basics of Good Manufacturing Practices, starting with developing specifications to ensure the ingredients and products are correct and not contaminated with microbials or heavy metals. FDA inspected this company in January and February last year, and they provided 483 responses over the next couple of months. The findings during the inspection and the incomplete 483 responses led to this warning letter. Ingredient Heavy Metal Specifications: 🔹From warning letter. “You did not provide any heavy metal or microbial test specifications for your Acetyl-glutathione component.” Batch Production Record (BPR) Issues: 🔹From warning letter “A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing (21 CFR 111.260(f)).” 👉 Asa comments: This is important to identify whether ingredients were added correctly. For example, a lower-than-expected yield could signify missing ingredients or low capsule fill weight. 🔹From warning letter. “Documentation, at the date and time of performance, of labeling operations (21 CFR 111.260(k))” 👉 Asa comments: This is essential to verifying when processes were conducted, which can help identify issues before the product is released to the public. 🔹From warning letter. “An actual or representative label, or a cross-reference to the physical location of the actual or representative label used in production (21 CFR 111.260(k)(2))” 👉 Asa comments: Batch production records are recipes built in conjunction with the product label. Cross-referencing the label is a key part of ensuring the formula and label match. Master Manufacturing Record (MMR) Size: Each formula size should be its own MMR. 🔹From warning letter. “The MMR you provided in your April 8, 2024, response….not specific to a unique formulation of a dietary supplement and is not specific to batch size. Incomplete 483 Responses: The bizarre thing about the warning letter is that it could have been prevented. 🔹From warning letter. “Your response dated April 8, 2024, includes a document titled Returned Product Procedure. However, the procedure does not address the requirement for quality control to conduct a material review and make a disposition decision, as required by 21 CFR 111.510. The procedure states that the food safety officer will perform these activities.” 🔹Here is another reference to an incomplete 483 response. “Your current finished product specification sheet for your Acetyl-glutathione product lists the test method as N/A.” Quality Must Investigate To Prevent Bigger Potential Issues: The following section of the warning letter speaks to a core principle of GMPs: if there is a safety issue due to a product return, the company is required to ensure the return is not related to a problem that affects other batches. This does not need to be complicated, but it should be part of a product complaint or product return SOP. 🔹From warning letter related to the Returned Products Procedure. “Furthermore, the procedure also does not address the requirement that if the reason for a dietary supplement being returned implicates other batches, you must conduct an investigation of the manufacturing processes and each of those other batches to determine compliance with specifications.” There’s a lot more in this warning letter . DATE ORIGINALLY POSTED: 1/22/25 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 Presentation, Online Tuesday Sep 20, 2022 Naturally Informed: Stress & Mental Wellness: Mastering the Market Naturally Informed powdered by Wholefoods Magazine and Trust Transparency Center Regulatory Snapshot: Asa provides a review of enforcement trends, risks, and best practices for manufacturers and marketers in the stress and mental wellness space. Watch Now Previous Next

< Back Panel Discussion, Webinar Thursday Jun 27, 2024 Microbiome: Mastering the Market 2024 Naturally Informed Join industry experts Miguel Freitas, PhD, Vice President of Scientific Affairs for Danone North America; Kristina Campbell, Science and Medical writer; and Asa Waldstein, Principal of Supplement Advisory Group, for a look at ‘biotic supplement consumers. Learn how you can capitalize on the latest trends and insights in the space to reach your target audience in a compelling and compliant way. The experts will: Explore consumer data on 'biotics. Set the record straight on common myths and misperceptions. Reveal some of the big ideas and shifts in mindset occurring among consumers. Get updated on the latest need-to-know regulatory issues to ensure compliance. Learn more and register Previous Next

Uncompliant hashtags attract FDA attention < Back 6-Year-Old Social Media Posts & Hashtags in Warning Letter Uncompliant hashtags attract FDA attention Today's #WarningLetterWednesday reminds us that the FDA considers old social media posts and hashtags marketing claims. Six-year-old social media posts, uncompliant hashtags, and product tags are mentioned in this warning letter. We have spoken about the importance of cleaning old non-compliant social media posts many times. Today's WLW is another reminder. Here is a post and video about this from a few months back. From FDA warning letter On your June 2, (Facebook) 2016 post: “Phenibut is known as a GABA analogue. Outside the US many countries around the world use phenibut clinically for symptoms of PTSD, anxiety, depression and insomnia.” Hashtags on a social media page that link to a product shopping cart are considered marketing claims. It is important to remember the “linking to a shopping cart” portion is the material connection that turns a general statement into a marketing statement. Here is a “Hashtags Are Claims ” video you may enjoy. From FDA warning letter On your February 27, 2017(Instagram) post: “#anxietyrelief” Here is a post and video about identifying and replacing high-risk “buzzwords. ” This is the first step in making online marketing compliant. Interestingly, product tags are mentioned in this letter. Product tags, like metatags, are not likely to attract warning letters on their own. They do, however, signal intended use to the FDA/FTC, showing the authorities. From FDA warning letter “Tags: anxiety, . . natural depression remedy” “Medical studies indicate that L-theanine is neuroprotective and can improve symptoms of depression, anxiety, insomnia, and cognitive impairment. . . . Here is a WLW post from July 2021 where metatags are mentioned . 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 Webinar Wednesday Sep 30, 2020 Intersection of Dietary Supplements & Hemp-CBD Asa's Regulatory Education Series Reviewing the intersection of the dietary supplement and hemp-CBD industries from a legal, regulatory, ethical, marketing, operational, and brand perspective. A discussion about considerations supplement companies face when adding hemp/CBD into products or when opening up new hemp product lines. We also explore this from the perspective of hemp companies adding supplements into their products and open ing up new non-hemp product lines. I am joined by two wonderful guests: Rend Al-Mondhiry is Partner at Amin Talati Wasserman, LLP. Dr. Jeremy Stewart is Chief Scientist and VP of Scientific Affairs for Gaia Herbs. Watch Previous Next

Guest article in Marijuana Business Daily < Back Staying on the Right Side of Regulators Asa Waldstein Guest Article Guest article in Marijuana Business Daily Read More Previous Next

In the latest episode of The Hoban Minute, straight from the NOCO 9 trade show in Colorado Springs, Xavier interviews Asa Waldstein, founder of Apex Compliance and principal at Supplement Advisory Group. Xavier gets a first look at Asa’s new compliance tool, Apex, and the two discuss the dire need for marketing claim reviews in the hemp cannabinoid product space and how Apex Compliance is a tool designed specifically to help brands, marketers, consultants, and more navigate the ever-changing regulations around marketing their products. < Back Cutting-Edge Solutions For Hemp Marketing Benzinga Cannabis Podcast Interview In the latest episode of The Hoban Minute, straight from the NOCO 9 trade show in Colorado Springs, Xavier interviews Asa Waldstein, founder of Apex Compliance and principal at Supplement Advisory Group. Xavier gets a first look at Asa’s new compliance tool, Apex, and the two discuss the dire need for marketing claim reviews in the hemp cannabinoid product space and how Apex Compliance is a tool designed specifically to help brands, marketers, consultants, and more navigate the ever-changing regulations around marketing their products. Read More Previous Next

The Sports & Active Nutrition Summit also celebrated its three new Start-Up Stars, innovative early-stage companies that are disrupting the sector. < Back Celebrating innovation Stephen Daniells Press Mention The Sports & Active Nutrition Summit also celebrated its three new Start-Up Stars, innovative early-stage companies that are disrupting the sector. Read More Previous Next

< Back GMP Pitfalls: Marketing, Manufacturing, & Labeling #WarningLetterWednesday 👉I got carried away writing this WLW post. Check out my blog for the detailed discussion. We can learn a lot from warning letters. Following FDA enforcement trends is a valuable tool for any savvy marketer, regulatory affairs professional, quality manager, or dietary supplement executive. We can adjust practices before they elevate to warning letters by learning how to read warning letters and act accordingly. This is the most detailed Warning Letter Wednesday I have written. ➡️ Read the full post here . 👉FDA Inspections Trigger Website Reviews The company was inspected by FDA in March 2021 and was issued several 483s. The company's website was recently reviewed in February 2022, which led to a letter. Learn about the difference between a 483 and a warning letter here . Usually the FDA investigator reviews a company's website for disease claims before an inspection. That is likely still happening but this is the third recent warning letter where FDA inspections led to a website review at a later date. These website reviews were then elevated to a warning letter. This is an enforcement trend and a reminder for those who have been inspected to clean up website claims. 👉I write about these letters here . 👉This warning letter is a great teaching case. Here are the learning targets. 🔷FDA Inspections Trigger Website Reviews 🔷Marketing Claims 🔷Distributors Responsibilities 🔷Common GMP errors 🔷*Writing and Following Specifications 🔷*Writing Procedures 🔷*Product Returns 🔷*Product Complaints 🔷Certain Herbs Are Not Allowed 🔷Common Allergen Labeling 🔷Domestic Street Address or Phone Number 🔷Languages Must Contain The Same Information 🔷Serving Size and Suggested Use 🔷Plant Parts Must Be Disclosed 🔷Correct Plant Listing 🔷Supplement Fact Panel: Line Thickness 🔷Percent Daily Values Label Requirement 🔷Expiration Dating 👉👉Join my Warning Letter Wednesday group . 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 head of FDA's Office of Dietary Supplement Programs and a dozen others offered their perspective on the recent DSHEA at 30 Summit in Salt Lake City. < Back FDA, industry experts reflect on DSHEA at 30 Summit Josh Long Interview The head of FDA's Office of Dietary Supplement Programs and a dozen others offered their perspective on the recent DSHEA at 30 Summit in Salt Lake City. Asa Waldstein, principal, Supplement Advisory Group: “The DSHEA Summit was a well-structured and moderated event that provided a wonderful opportunity for stakeholders in the natural wellness space to come together, appreciate and contextualize the origins and initial purposes of DSHEA, align concerning the current status of regulation in the space, and exchange ideas about what adjustments or improvements are needed. We need to use this opportunity to move forward in achieving our shared goals together. DSHEA is a remarkable statute that accomplished both expected and unexpected results. We should work to improve upon DSHEA and not simply abandon it or rush into new legislation that betrays its underlying principle of empowering consumers to make informed decisions about managing their own health and wellness.” Read More Previous Next

< Back Presentation, Online Thursday Dec 7, 2023 Making Your (Compliant) Message Shine: Best Practices for Reaching & Engaging Consumers Naturally Informed The goal for 2023: to live stronger, longer. Consumers today are focused on extending health span, defined as the period of one’s life that one is healthy. Emphasis on the healthy, because we want to stay active and energized into our golden years. And more than ever before, younger generations are recognizing that to stay vibrant, one must be proactive. That realization has opened this market up to consumers of all ages who are seeking out nutritional supplements and functional foods and beverages to help them achieve their goals. During this three-day virtual conference, leading experts will discuss the active aging market and trending subcategories. Cognitive health, bone and joint support, libido, and more will be covered, with a look at the latest science on ingredients, consumer market trends, and business strategies. Join us for A+ education that can help you succeed in this space and master this market. Zoom Registration Register Previous Next

< Back Panel Discussion Thursday Feb 25, 2021 Compliance and the Customer Experience Hemp Tours Live Learn about (AHPA) American Herbal Products Association and its mission. Importance for CBD brands to understand the supplement industry and its relationship to the FDA? High-risk marketing mistakes made by supplement and hemp product marketers. How we can market proucts without making claims. Watch Previous Next