EAS Blog
EAS Independent Consultants and staff provide in-depth regulatory expertise and authoritative reporting on a variety of compliance requirements for industries that EAS serves. Our experts break down complicated topics into easily understandable summaries and analysis. Subscribe to our newsletter and receive these monthly updates directly in your in-box.
Podcast Interview: Quality Systems in a Contract Manufacturing Partnership
Natural Products Insider https://www.naturalproductsinsider.com/contract-manufacturing/supplyside-west-podcast-quality-systems-contract-manufacturing-partnership Tara Lin Couch, Ph.D. August 8, 2018
Science Direct – Food Regulations & Enforcement
Color Coding: Adding Discipline to a Food Processor’s Preventive Control Program
Food Defense Training and the New “Focused Mitigation Strategies to Protect Food against Intentional Adulteration” Rule
Video Interview: The Potential Delay to Nutrition Facts labels should not slow compliance efforts
Updated Food Safety Training, Solution for Upcoming FSMA Challenges
Food Safety Magazine https://www.foodsafetymagazine.com/enewsletter/updated-food-safety-training-solution-for-upcoming-fsma-challenges/ Mehrdad Tajkarimi August 7, 2018
Botanical Submissions: NDI Versus GRAS in a Post-DSHEA World
AHPA Report http://ahpa.org/News/AHPAReports/TabId/136/ArtMID/607/ArticleID/1013/In-Florida-the-berries-have-hit-the-fan-in-the-August-2018-AHPA-Report.aspx Amy Scanlin August 7, 2018
Quality Systems for the Cannabis Industry – Preparing for State GMP Regulations
As states begin to regulate legalized cannabis, the concern of how Good Manufacturing Practices (GMPs) apply to this unique industry cannot be understated. While regulations vary from state to state the quality systems under which cannabis products are grown and manufactured have similarities that can begin to pave the way for …
FDA 483 Responses – Missing the Mark?
By Cindy Beehner, Independent Consultant In recent months, it appears more companies are having difficulties meeting the requirements of FDA Form 483, List of Observations, response. The inspection situation is very stressful and if it ends with the dreaded “483”, it can be positively...
Are Plant-Based Proteins Milking Dairy?
By Allen Sayler, Senior Director for Food Consulting Services When FDA announced recently that the agency is seeking public comment for standards of identity overhaul that will focus in part on plant-based products that are marketed as “milk” substitutes, manufacturers of those products as well as...
EAS Co-Authors Article for FDLI Update on the Benefits of Consultants as Part of a Legal Team
EAS joined forces with Ronald J. Levine, co-chair on Herrick, Feinstein LLP’s Litigation Department to author an article published in the Food Drug Law Institute Update Magazine on how the use of consultants can benefit a legal team. Consultants provide unique insights, given their detailed...
EAS Consultants Invited Speakers at Two FDLI Conferences
EAS is pleased to be invited speakers at two upcoming Food Drug Law Institute (FDLI) Events. Andrea Yablunosky will speak at an in-house event held at FDA CFSAN on Food Labeling: Nutrient Content, Health, and Other Claims on August 7th. Bruce Silverglade will speak on the same subject as part of...
EAS Offers Complimentary Webinars on Cannabis, Foreign FDA Inspections, Temporary Marketing Permits and More
Quality Systems for the Cannabis Industry – Preparing for State GMPs August 6, 2018, 1:00pm Eastern Tara Lin Couch Ph.D., Senior Director for Dietary Supplements and Tobacco Services, will help cannabis firms prepare for cannabis Good Manufacturing Practices (GMPs). While regulations vary from...
New Webinar on Environmental Monitoring Added to EAS’ Summer Compliance Line-Up
Are Industry-Initiated Environmental Swab-a-Thons a Benefit? September 17, 2018, 1:00pm Eastern The emphasis on proactive management of issues that could cause a food safety hazard, per FDA’s Food Safety Modernization Act, requires firms to improve controls for a variety of issues at all levels....
Cause, Effect and Impact of RTE Operations on Complying With FDA’s Draft Listeria Guidance
Natural Products Insider https://www.naturalproductsinsider.com/supply-chain/cause-effect-and-impact-rte-operations-complying-fdas-draft-listeria-guidance Mehrdad Tajkarimi July 31, 2018
Factoring in the Human Element in Food Safety Programs
Food Safety News https://www.foodsafetynews.com/2018/07/factoring-in-the-human-element-in-food-safety-programs/ Robert Lavieri July 28, 2018
Produce Safety Rule’s July Compliance Dates
By Charles Breen, Independent Advisor for FSMA Those closely watching FSMA compliance dates will note that July 26, 2018 marks a significant date for FSVP and the Produce Safety Rule. Specifically, importers with Small Business Foreign Suppliers will now be required to comply with sprout...
EAS Consultants to Present in Two Technical Sessions at the IFT 2018 Annual Meeting
EAS Independent Advisor Charles Breen is the panel moderator for two technical sessions at IFT – one on the Preventive Controls for Human Foods and another on the Foreign Supplier Verification Program. Esteemed panelists include for PCHF, Joann Givens, Director of the Office of Human and Animal...
EAS Short Videos Describe Services to the Food Industry
EAS offers a wealth of regulatory consulting capabilities in all FDA commodity areas, as well as USDA and some state regulatory services as they pertain to food and dietary supplement products. EAS is creating short clips that discuss our capabilities and is posting them on our website. We invite...
Probiotics Here to Stay Says DeMuri in Natural Products Insider
EAS Independent Consultant Steve DeMuri authored an article in Natural Products Insider on Probiotic health benefits of natural foods and supplements. With many reported health benefits currently being studied, “Probiotics are here to stay and now is the time for companies to conduct new product...
Elizabeth Campbell and April Kates Discuss Clean Labels in Natural Products Insider
EAS Independent Advisor Elizabeth “Betty” Campbell and Independent Consultant, April Kates have co-written an article on how to keep “clean label” claims legal for Natural Products Insider. “Marketing a clean label can be a great way to for brands to connect to consumers,” they say, “but they need...
Kristen Steel
Kristen Steel is a regulatory professional with a strong background in healthcare marketing, compliance and strategic partnerships within healthcare, CPG, and foodservice environments. She works with project and database management, organizational management, FDA/USDA/DSHEA regulatory and labeling...
Food Safety Plan Builder Updates Released
FDA has released an updated version of the downloadable Food Safety Plan Builder tool designed to help owners and operators of food establishments with the development of a food safety plan that identified hazards requiring preventive controls to prevent foodborne illnesses specific to their...
FDA Food Code 12th Edition – What’s New?
By Charles S. Otto, III, Independent Consultant The FDA Food Code is used as the basis for food safety regulation of more than a million restaurants, retail food stores, institutional and other food operations in the US and around the world. It is updated every two years through a collaborative...
OTC Monograph System Gets an Update
By Susan Crane This month’s Ask the Expert is answered by EAS Independent Advisor for OTC Drugs and Labeling, Susan Crane. Susan specializes in quality and regulatory compliance for over-the-counter (OTC) and dietary supplement products. She has a thorough knowledge of federal regulations...
Schebella Offers Tips for Designing Cannabis Food Edibles in the State of California in Cannabis Industry Journal
Independent Consultant Celia Schebella discusses tips for designing a cannabis edible in the state of California that meets customer expectations and regulatory requirements in Cannabis Industry Journal. Designing a cannabis food product with GMPs, local regulations, ingredient sourcing and...
Updated Guidance for Declaration of Dietary Fiber in Nutrition Labels
Before 2016, FDA regulations for nutrition labeling did not define the term “dietary fiber” but in 2016, FDA issued regulation defining dietary fiber as two types of fiber: [1] non-digestible soluble and insoluble carbohydrates and lignin that are intrinsic and intact in plants; and [2] isolated...
June 2018 Drug and Device Corner
Federal Register Notice Vol 83, No. 108 FDA is publishing an order to exempt a list of class II devices from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for the listed class II...
Designing the Perfect Cannabis Edible in California
Cannabis Industry Journal https://www.cannabisindustryjournal.com/feature_article/designing-the-perfect-cannabis-edible-in-california/ Celia Schebella June 28, 2018
Conferencia web de EAS: Programa de verificación de proveedores extranjeros – ¿qué significa para usted?
Si usted exporta alimentos, ingredientes, empaques, suplementos o aditivos alimenticios hacia los Estados Unidos, su agente aduanal en los Estados Unidos, importador y clientes le pedirán proporcionar documentación para verificar que su empresa cumple con la Ley de Modernización de la …