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Re-review marketing if FDA has inspected you < Back Online Marketing & GMP Lessons Re-review marketing if FDA has inspected you Learning about compliance is fun, and today’s Warning Letter Wednesday has critical teaching opportunities for marketing and GMP compliance. This is yet another example of a company being inspected by FDA; then, many months later, around the time of the inspection close out, FDA looked at the company’s online marketing and found a lot of no-nos. This is an enforcement trend that I write about in more detail here . First, the marketing issues : YouTube videos : Claims made in YouTube videos have been mentioned in three warning letters this year and I expect this trend to continue. Reviewing hours of YouTube videos for compliance concerns is painful, so I developed and patented a technology to help with this . In this warning letter FDA clearly shows the “material connection” or “commercial bridge” by referencing that the company placed its website on the screen. From warning letter. “the URL for your website … appears onscreen during the video and you state: “Very powerful anti-cancer properties…used in conjunction with chemotherapy and other cancer treatments, but not only does it have anti-cancer properties it also has a lot of other properties as well…the way that Taxane works in the body to fight cancer is it causes cell apoptosis in cancer cells.” Biomarker claims continue to be mentioned in warning letters. I go into more detail about this here . From warning letter. “Lowers LDL and Triglyceride Levels” Words with “anti” are disease claims , except for antioxidant and perhaps anti-aging. Words like anti-inflammatory have a risk rating of three out of five (Asa risk scale) which means they are not likely to attract a warning letter on their own, but words like anti-viral are very risky. From warning letter. Dr. Bob’s Parasite Killer is formulated with parasiticidal, anti-fungal, anti-viral, and antibacterial ingredients with the intention of killing everything in the digestive tract. Claims on product labels : We know that all marketing is an extension of the label, but I am still surprised by some of the “on-pack” claims companies put on the product label. No knowledgeable manufacturer would apply labels with these statements. From warning letter. “Dr. Bob’s Parasite Killer is formulated with parasiticidal, anti-fungal, anti-viral, and anti-bacterial ingredients with the intention of killing everything in the digestive tract.” Now the GMP learning opportunities : Component specifications are integral to GMPs, and each raw material must have written specifications. This is to ensure ingredients do not make it into inventory unless they’ve been checked. For example, suppose an ingredient’s visual specification was green and the product came in yellow, or the ingredient did not pass identity testing. In that case, the specification sheet should help catch and document this. From warning letter. “Yuan Zhi is an ingredient in your … but you did not establish such component specifications for Yuan Zhi.” Incomplete 483 responses are too common, and I write more about this here . From warning letter. “you did not provide any supporting documentation, such as copies of your specifications. We are unable to evaluate the adequacy of your corrective action, because you did not provide documentation to support that you have established component and finished product specifications.” Batch Production Records (BPRs) are the “recipe” and should have all adequate information, including copies of labels and cleaning records. Here are some of the items cited in this letter. The description and name of equipment used in producing the batch. This is important so cleaning can be documented. 🔷 The date and time of maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch or a cross-reference to records where this information is retained. 🔷 The unique identifier, such as a lot number and item number for each component, packaging, and label used. 🔷 The identity and weight or measure of each component used [21 CFR 111.260(e)]. A statement of the actual yield or theoretical yield at appropriate phases of processing. This is important to ensure the weight is correct. For example, a high yield could signify an ingredient may have been incorrectly weighed, and this may pose a safety concern. Documentation that the finished dietary supplement meets specifications. Documentation at the time of manufacturing, such as real-time quality checks. This includes bottle weight and label verification. Documentation that quality control personnel reviewed the batch production record and approved and released, or rejected, the batch for distribution. The job of quality is to review and release ingredients, in-process work, and finished products once it has been verified against its specification. Labeling issues were also cited. 🔷 Not listing the capsule in the label’s ingredients 🔷 Not listing the plant part such as ginkgo leaf. 🔷 Not using the standardized common name as described in AHPA’s Herbs of Commerce. Thanks, AHPA, for this resource! 🔷 Incorrect serving size. If the label states, “take 5-8 capsules,” the supplement fact panel must reflect the higher number. 🔷 Listing nutrients with zero amounts, like cholesterol, is not allowed on supplements but is standard for conventional food labels. 🔷 The company was cited for not listing black walnut as a major allergen. I ask, is black walnut a tree nut allergen? 🔷 DSHEA disclaimer: I don’t remember seeing this in a warning letter. The company was cited for apparently not having the DSHEA disclaimer on the label. From Warning Letter. Your … are each misbranded within the meaning of section 403(r)(6) [21 U.S.C. § 343(r)(6)] in that the products make structure-function claims but fail to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b). There are many more labeling items cited. 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!

< 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