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.
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 …
Being Prepared – Critical Points to an FDA Inspection
Tobacco Reporter https://www.tobaccoreporter.com/2018/06/being-prepared/ Karen Dixon June 1, 2018
The Supply Chain and Food Safety Culture: Distribution
Food Safety Magazine https://www.foodsafetymagazine.com/magazine-archive1/junejuly-2017/the-supply-chain-and-food-safety-culture-distribution/ Veny Gapud June/July 2017
Blomquist to Present on Rapid Testing Methods at the IAFP
Independent Consultant, David Blomquist, will speak on “Rapid Testing Methods for Safety and Spoilage in the Dairy Industry - What Is Needed, What Works and What Does Not” on July 9, 2018, at the International Association of Food Protection Conference. Says Blomquist, “The dairy industry has been...
Armstrong Authors Article on Mergers and Acquisitions for Natural Products Insider
Independent Advisor for Food Law and Regulation, Steve Armstrong, has authored an article for Natural Products Insider on buying a 21st-century food company and mergers and acquisitions. “A health and nutrition startup should resolve any potential issues with its quality control, labeling and...
Dietary Supplement GMP Online Short Course Available for Purchase
EAS Senior Director for Dietary Supplement and Tobacco Services, Tara Lin Couch, Ph.D., along with attorney Marc Ullman from Rivkin Radler, and EAS Independent Advisor for Quality and Compliance, Robert Fish, held a Dietary Supplement Short Course, consisting of four hours of regulatory content,...
May 2018 Drug and Device Corner
In the ongoing effort to make more affordable drugs available to the public, FDA Commissioner Scott Gottlieb, MD issued a statement on the FDA’s efforts to assist in this process. Of particular note is the FDA’s commitment to ensuring generic drug developers have access to brand drug samples for...
New Brewers Need to Know GMPs
By Charles Breen, Independent Advisor for FSMA The explosion in the numbers of new breweries is a blessing for beer drinkers and their communities. In FDA’s eye, beer is food, and while exempt from preventive control requirements, brewers must comply with good manufacturing practice regulations,...
EAS to Moderate Two Panels at IFT Annual Meeting, Exhibits at booth #S322
EAS will be well represented at the upcoming IFT Annual Meeting taking place in Chicago, July 15-18, 2018. EAS Chairman and CEO, Ed Steele, President and COO, Dean Cirotta and Senior Director for Food Consulting Services, Allen Sayler, will be manning the EAS booth (#S322) and taking questions...
EAS Authors Article in MedTech Intelligence on the New De Novo Pathway
EAS authored an article for MedTech Intelligence on FDA’s new approach to the regulatory pathway for De Novo medical device classification which simplifies the approval process for the class I or class II devices for which there is no one-to-one precedent or predicate. De Novo applications are...
Why is Codex Alimentarius Important to Me?
By Allen Sayler This month’s Ask the Expert is answered by Senior Director for Food Consulting Services, Allen Sayler, who recently returned from the 50th session of the Codex Committee on Food Additives held in Xiamen, China where 53 countries and 32 food industry observer organizations...
USDA Announces Members of NACMCF – Two EAS Independent Consultants are Included
The names of new and returning members of the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) have been announced and the committee now includes two EAS Independent Consultants. Returning member, Dr. Omar Oyarzabal who is a professor at the University of Vermont and...
FDA Expands Data Dashboard to Include FSMA
A new section of the FDA Data Dashboard has been launched to help importers and manufacturers/processors meet supply-chain requirements under the FDA Food Safety Modernization Act (FSMA) by helping them more easily find compliance and enforcement information related to specific firms. Three of the...
Medical Device Innovations and the Regulatory Landscape
By Dawn Wydner, Independent Consultant I’m amazed as I watch a Health Care System and then a Spectrum commercial to what our future holds with the sophisticated, interactive medical device and technology innovations and how they will enhance the capabilities of diagnosis and treatment. My...
EAS to Exhibit at Food Defense Conference
EAS will be exhibiting at the upcoming fourth annual Food Defense Conference to be held May 22-24, 2018 in Minneapolis. Senior Director for Food Consulting Services Allen Sayler will be in attendance along with experts from around the world to discuss and learn from each other about the current...
CTP Updates Provisional Substantial Equivalence Review Process
EAS Consulting Group would like to bring to your attention an FDA Center for Tobacco Products announcement regarding updates to the Provisional Substantial Equivalence review process. Substantial equivalence (SE) is the most commonly used pathway by which tobacco products may obtain premarket...
Tara Lin Couch, Ph.D. to Discuss Preparing for Cannabis GMPs
Tara Lin Couch Ph.D., Senior Director for Dietary Supplements and Tobacco Services, will present a webinar on August 6, 2018, at 1:00 pm Eastern to help cannabis firms prepare for cannabis Good Manufacturing Practices (GMPs). As states begin to regulate legalized cannabis, the concern of how GMPs...
Gabe Miller Discusses Necessity of Food Safety Programs for the Cannabis industry
Gabe Miller, an expert in Food Safety Programs has written an article for the Cannabis Industry Journal on how solid food safety programs can help make cannabis products safer and save businesses a lot of time and money. Gabe spoke at the upcoming University of Madison Cleaning and Sanitation...
Fairman Authors Articles on Workplace Safety and Golden Rules for Co-Packers
Independent Consultant, Heather Fairman has published two articles recently. One in Food Processing Magazine focuses on the positive impact of workplace safety programs on corporate culture. Next, she wrote about five “golden rules” for co-packers to stay competitive and profitable for Natural...
Steve Murphy to Present on Raw Materials at ADSA in Knoxville
Steve Murphy will present a session called “Time for Change; Indicators of Public Health Concern for Raw Milk and Processed Dairy Products” at the upcoming American Dairy Science Association Annual Meeting taking place June 24-27, 2018 in Knoxville. Says Murphy, “Regulatory standards used as...
EAS Independent Experts Offer Summer Webinar Compliance Series
EAS Consulting Group is offering a full line-up of educational opportunities through our informative webinar series. These 45-minute webinars are an opportunity to get up to the minute regulatory information on the latest topics pertaining to FDA regulated industries, with time for questions after...
FDA Confirms to Congressional Representatives that Safety is the Number One Priority for Dietary Supplements
FDA recently responded to a letter from congressional representatives regarding product safety in the dietary supplement industry. In the letter, dated April 12, 2018, the agency states that safety, product integrity, and informed decision-making are the prioritization factors used to determine...
April 2018 Drug and Device Corner
Reminder! 5 May 2018 is the date for DMF (Drug Master File) and IND (Investigational New Drug) applications to comply with eCTD format submission. There has been a delay for Type III DMF files to comply. The FDA announced in April via their Guidance Document Providing Regulatory Submissions in...