ECRM的动态

Dietary Supplements: A 2024 Update - Key Insights for Industry Stakeholders We're excited to share highlights from a recent presentation at our conference: Presentation: Dietary Supplements: A 2024 Update Presenter: - Name: Daniel Fabricant, Ph.D. - Position: President and CEO - Organization: Natural Products Association (NPA) Key Topics: 1. 30th anniversary of DSHEA and its impact on the industry 2. NPA's role as the industry's leading advocate and watchdog 3. Recent regulatory victories and ongoing challenges 4. State-level threats to sports and active nutrition products 5. Emerging issues: GLP-1 coverage, Amazon's new testing requirements. Why This Matters: This presentation provides crucial updates on the dietary supplement industry's regulatory landscape, which directly impacts: - Compliance with federal and state regulations - Market access and product innovation - Industry growth and consumer protection Dr. Fabricant highlights the important role that industry involvement plays in regulatory matters, warning that?"if you aren't at the table, you're on the menu." With the industry facing its greatest challenges since DSHEA, understanding and engaging with these issues is vital for the continued growth and protection of the $60 billion dietary supplement market. #DietarySupplements #RegulatoryUpdates #NaturalProducts #IndustryAdvocacy #ConsumerHealth #SoCalDSC

This is how you can save money if you sell supplements on Amazon Do you guys remember when I highlighted Amazon's tightened compliance for dietary supplements due to an FDA warning? Well, catch the wind. I have something that could save you some serious cash and hassle. Here is what you should know: Amazon has specifically targeted dietary supplements in three categories for stringent third-party testing: Sexual enhancement Weight management Sports nutrition and bodybuilding So, if your product information and copy refer to any of these benefits, you could be on the hook for unnecessary compliance costs, even when your supplements are not specifically designed to treat or enhance those areas. More frustratingly, Amazon demands retesting even if you've previously verified your products outside the new flow. Previously, product testing with a third-party lab could cost around $300 to $1,000. Now, with the new changes and requirements on using the TIC organizations approved by Amazon, that cost has gone up fourfold ($$$$). What's the solution? Appeal the misclassification. Remove any information or keywords that could incorrectly classify your products under the three targeted categories. Then, appeal the classification to the compliance team. Otherwise, you will have to pay for tests you don't really need, plus having listings that have been wrongfully categorized (definitely not a win) So what's your next move?

Exploring the Complex Landscape of FDA Regulations for Food and Dietary Supplements The US FDA's food and nutritional supplements regulations present an intricate panorama. While both classes' purpose is to beautify nicely-being, their pathways to market, prison necessities, and advertising strategies vary substantially. **Dietary Supplements: Flexible however Stringent** Dietary supplements provide quicker access to the market and freedom in selecting ingredients. They could make shape/function claims that assist bodily systems, catering to fitness-aware purchasers. However, they cannot make ailment remedy claims. Nonetheless, nutritional supplements face stringent labelling and safety requirements, which include exact element lists, complement data panels, and clear caution labels. **Food Products: Broader Appeal however Stricter Regulations** Food products enchantment to a much wider target market and enjoy extra consumer trust. They provide possibilities for innovative branding but are issued stricter meal protection policies, consisting of inspections, excellent control, and factor approval approaches. Certain components accredited in dietary supplements might not be allowed in food products, restricting manufacturers' alternatives. **Choosing the Right Path: Considerations** Selecting among those categories requires cautious consideration of: * Product components and meant use * Target target audience demographics and preferences * Regulatory compliance implications * Pros and cons of every pathway Dietary dietary supplements offer a spot marketplace with perceived fitness advantages, while food merchandise offers broader attraction and familiarity. **Legal and Regulatory Guidance: Essential** To make certain compliance and make knowledgeable marketing selections, manufacturers should be seeking criminal and regulatory steerage. This expertise helps align product improvement advertising and marketing with FDA standards, ensuring safety and efficacy whilst turning in fitness blessings to purchasers. By knowing these distinctions, manufacturers can optimize their marketplace strategy and deliver secure and effective products that meet FDA requirements. #FDACompliance #DietarySupplements #FoodSafety #MarketingStrategy #RegulatoryGuidance

Texas Company Pleads Guilty to Distributing Misbranded Dietary Supplements and Agrees to $4.5 Million Forfeiture Defyned Brands, an Austin, Texas, company also known as 5 Star Nutrition LLC, pleaded guilty today to a three-count information charging it with distributing misbranded dietary supplements. Pursuant to the plea agreement, the company admitted that from September 2018 to July 2020, it delivered into interstate commerce misbranded dietary supplements, which are considered a type of food under the federal Food, Drug and Cosmetic Act (FDCA). The company specifically admitted that shipments of products known as Epivar, Alpha Shredded and Laxobolic were misbranded. According to the plea agreement, the products contained ingredients mislabeled as dietary ingredients or not listed on the product label. The products at issue were marketed as workout supplements and sold at 5 Star Nutrition retail locations. As part of the plea, the company agreed to forfeit $4.5 million and comply with the terms of a compliance program and certain compliance reporting requirements. Magistrate Judge Susan Hightower of the U.S. District Court for the Western District of Texas presided over the plea. __________________________________ Not much information as to what the actual violation was. #dietarysupplements #sportsnutrition #Criminal

FDA Labeling Requirements for Dietary Supplements ?? Ensuring FDA compliance in labeling dietary supplements is crucial yet challenging. Proper labeling provides consumers with essential information while avoiding enforcement actions that can damage your company's reputation. Understanding Dietary Supplements Dietary supplements are defined under the FD&C Act and include vitamins, minerals, herbs, amino acids, and more. They must be labeled as such and comply with various preventive controls and labeling regulations. Principal Display Panel (PDP) Requirements The PDP must include: - Statement of Identity (e.g., "Vitamin C Supplement") - Net Quantity of Contents (e.g., "60 capsules") - Nutrition Labeling - Ingredient List - Manufacturer's or Distributor's Information Key Labeling Elements: - The Statement of Identity should be prominent and clear. - The Net Quantity of Contents must be accurate and specified in appropriate units. - The Supplement Facts Panel should list serving size, ingredients, and daily values. - The Ingredient List must detail components in descending order by weight. - Warning statements must be clearly displayed if applicable. Compliance is Key Labeling errors can result in FDA enforcement actions. Ensure your dietary supplement labeling meets all requirements to provide consumers with the necessary information and avoid penalties. Ready to get your product labels compliant? ?? Check out our comprehensive development services for supplement facts panels here: https://lnkd.in/da4x9_u4 #nutrition #fdacompliance #labeling #dietarysupplements #health #wellness #fmcg #food #supplements #fsvp #fssc22000 #supplementfacts #nutritionfacts #labelreview #fda

?? Exploring the New Dietary Ingredient (NDI) Notification Process: A Key Step for Product Compliance ?? Are you involved in the dietary supplement industry? Then you know the importance of staying compliant with regulations set forth by the U.S. Food and Drug Administration (USFDA). One critical aspect is the New Dietary Ingredient (NDI) Notification Process. Let's delve into what this entails and why it's crucial for businesses. ?? What are New Dietary Ingredients (NDIs)? NDIs are ingredients not commonly found in the food supply that manufacturers intend to use in dietary supplements. These could be new botanicals, extracts, or substances with potential health benefits. ?? NDI Notification Process: 1?? Identification: Firms must determine if their ingredient meets the criteria for an NDI. 2?? Notification: Submitting a pre-market notification to the USFDA, providing safety data and other relevant information. 3?? Evaluation: The FDA evaluates the notification to ensure safety for consumers. 4?? Compliance: Upon FDA review, companies can market the NDI if deemed safe, or make necessary adjustments to meet safety standards. ?? Why is it important? Compliance: Ensures products meet regulatory standards, reducing legal risks. Consumer Safety: Upholds consumer trust by guaranteeing the safety of dietary supplements. Market Access: Proper compliance facilitates entry into the market, expanding business opportunities. ?? USFDA Data Insights: According to USFDA records: X% of NDI notifications were accepted in the past year, highlighting the importance of thorough submissions. Y% of rejections were due to insufficient safety data, emphasizing the need for comprehensive documentation. Z% of notifications pertained to botanical ingredients, showcasing the growing interest in natural supplements. ?? Key Takeaways: Prioritize Compliance: Stay informed about NDI regulations to avoid legal ramifications. Invest in Research: Thoroughly gather safety data to increase the likelihood of notification acceptance. Embrace Transparency: Communicate openly with regulatory authorities to ensure compliance. Navigating the NDI Notification Process can be complex, but with the right understanding and preparation, businesses can ensure regulatory compliance while bringing innovative products to market. Stay informed, stay compliant, and pave the way for safer, more diverse dietary supplements! #NDINotification #USFDA #RegulatoryCompliance #DietarySupplements #ConsumerSafety #InnovationInHealthcare

Today I want to talk about Transparency and why Transparency Matters ??The Vital Role of Fact Panels in Sports Nutrition Supplements?? In the dynamic world of sports nutrition, where every gram counts and performance hinges on optimal fueling. Transparency stands as a cornerstone of trust and integrity. Especially when it comes to brands and why you should chose a brands products! I want to delve into the huge role transparent fact panels play in empowering athletes and fitness enthusiasts to make informed decisions about their supplement choices. Fact panels are more than just a list of ingredients; they are a window into the soul of a product, revealing its composition, potency, and ultimately, its potential impact on performance and health. As consumers, we rely on these panels to navigate the vast landscape of supplements, seeking formulations that align with our goals, values, and dietary preferences. But transparency extends beyond mere ingredient disclosure. It encompasses the clarity and accuracy with which information is presented, the absence of hidden fillers or undisclosed additives, and the integrity of the manufacturing process from start to finish. It's about providing athletes with the confidence that what they see on the label is precisely what they're putting into their bodies. To add, transparency creates accountability among supplement manufacturers, encouraging them to uphold the highest standards of quality, purity, and efficacy. By embracing transparency as a guiding principle, companies not only build trust with their customers but also contribute to the overall integrity of the sports nutrition industry. In a landscape filled with flashy marketing claims and exaggerated promises, transparency serves as a beacon of authenticity, guiding athletes toward products that deliver real results without compromising their health or integrity. It empowers consumers to ask the right questions, demand the highest standards, and hold brands accountable for their commitments. As professionals in the sports nutrition industry, it is on us to champion transparency at every turn, advocating for clear and comprehensive fact panels that empower athletes to make educated choices about their supplementation regimen. By elevating transparency as a non-negotiable standard, we not only safeguard the well-being of athletes but also elevate the credibility and integrity of our industry as a whole. Let us continue to prioritize transparency, both in our own practices and in the products we endorse, ensuring that athletes have access to the information they need to thrive and excel in their pursuits. #TransparencyMatters #SportsNutrition #Supplements #FactPanels #Integrity #Trust #Empowerment

Dietary Supplement Contract Manufacturing Market Size, Share & Trends Analysis Report by Product Type (Proteins and Amino Acid Supplements, Multivitamin, Multi-Mineral, and Antioxidant Supplements, Weight Management and Meal Replacer Supplements, Other Supplements), by Dosage Form(Tablets, Capsules, Liquid Oral, Powder In Sachet / Jar, Gummies), Forecast Period (2024-2031) Get Sample of Report at:https://lnkd.in/dJrzKkWG sample/dietary-supplement-contract-manufacturing-market Dietary supplement contract manufacturing market is anticipated to grow at a significant CAGR of 12.4% during the forecast period (2024-2031). Dietary Supplement Contract Manufacturing (DSCM) is a business model in the dietary supplement industry, involving a partnership between a brand and a contract manufacturer. The brand develops, markets, and sells the supplement, while the contract manufacturer handles manufacturing, packaging, and labeling. The market growth is driven by convergence of technology, genomics, and nutrition enables a more personalized approach to dietary plans. Key Players:Biovencer Healthcare Private Limited, Biotrex Nutraceuticals, CAPTEK? Softgel International, Catalent Pharma Solutions, MENADIONA, NutraScience Labs, Nutrivo, LLC, Rain Nutrience Ltd, Vantage Nutrition, among others. #DietarySupplements #ContractManufacturing #SupplementManufacturers #HealthSupplements #Nutraceuticals #SupplementIndustry #CustomSupplements #SupplementFormulation #SupplementsMarket #HealthAndWellness #NutritionIndustry

https://lnkd.in/eUeVbYKA Nutrivigilance is a term used to describe the monitoring of adverse effects related to the use of dietary supplements, functional foods, and other nutraceuticals. In the absence of regulations regarding ostensibly nutritional products, however, consumers are forced to rely on a sponsoring company’s evaluation and presentation of their product, or outside groups acting in watchdog roles, in order to make informed decisions about which products are safe and, perhaps more importantly, even useful (Malve and Bhalerao, 2023) #nutrivigilance #Safety #Nutraceuticals #DietarySupplements