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.
December 2017 Drug and Device Corner
We would like to highlight one of the Draft Guidance issued by the FDA this month.**The U.S. Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. This proposed new approach would update the FDA’s existing policy to better address...
Why Audits Are Part of the Food Safety System
Unraveling The Impact of FSMA On Acidified Food Regulations
This webinar hosted by EAS Consulting Group will provide you with these answers. The webinar will be presented by EAS Independent Consultant Omar A. Oyarzabal, Ph.D., a microbiologist processing authority, and FDA Consumer Safety Officer Priya Rathnam with the Office of Compliance …
GMP and Other Requirements for Dietary Supplement Contract Manufacturers
Natural Products INSIDER https://www.naturalproductsinsider.com/manufacturing/gmp-and-other-requirements-dietary-supplement-contract-manufacturers Robert Fish December 14, 2017
FDA Allows Co-Manufacturers More Time to Comply With Supply-Chain Program Requirements
In a nod to one of the more complex aspects of current food manufacturing and FSMA compliance, FDA recently published guidance that it will exercise enforcement discretion for two years over supply-chain requirements for domestic co-manufacturers of human and animal foods, and also under the...
Validating a Contract Laboratory – Infographic
Natural Products INSIDER https://www.naturalproductsinsider.com/labstesting/infographic-validating-contract-laboratory Tara Lin Couch, Ph.D. November 20, 2017
The Role of Regulatory Affairs in Product Development
Regulatory Affairs touches each and every product within a company, ensuring compliance with local regulations and internal policies and the creation of sound guidelines related to labeling, safety, and nutrition. Through the strategic links to trade associations, Government …
FDA Issues Guidance on Facilities Exempt from CGMP and Preventive Controls
One of the first steps for assessing a facility’s compliance status under the rules implementing the Food Safety Modernization Act is to consider whether the facility is required to comply or if it may qualify for an exemption, however narrow it may be. As a simple rule of thumb, if a food...
What to Expect from SQF Modifications
FDA Proposes Four-Year Compliance Delay for Produce Rule’s Water Standard
FDA issued a proposed rule September 13, 2017, that would extend the compliance dates for agricultural water requirements in the Produce Safety Rule, giving the agency four years to reconsider the water standards to ensure that they are feasible. FDA Commissioner Scott Gottlieb hinted at a...
U.S. Dairy Industry Challenge – How Many Food Safety Plans Are Enough?
By Allen Sayler, Senior Director for Food and Cosmetic Consulting Services The U.S. dairy processing industry is facing a significant challenge as it moves toward compliance with the FDA Food Safety Modernization Act (FSMA). This is best captured by a conversation I had with a corporate quality...
Getting Your Medical Device Into the US Market
The White Paper provides real-world and practical information directed to the manufacturer of Class II and Class III devices in navigating the Premarket Notification 510(k) clearance with insight into the various documentation required by FDA for submitting a 501(k)…
FDA Issues New Food Defense Guide, Food Safety Software
FDA released two useful tools last month to advise and assist companies in complying with new FSMA rules. The agency issued a Small Entity Compliance Guide(SECG) to help small food businesses comply with the FSMA final rule on Mitigation Strategies to Protect Food Against Intentional Adulteration....
Tips for Auditing a Contract Laboratory
By Tara Lin Couch, Ph.D., EAS Senior Director, Dietary Supplements and Tobacco Contract laboratories provide an extremely valuable and necessary service to the dietary supplement industry. The own-label distributor or manufacturer rarely has an in-house laboratory equipped with the appropriate...
FDA Funds States’ Efforts to Implement FSMA Produce Rule
FDA awarded almost $31 million in funding last month to help states implement FSMA produce safety programs -- on top of the almost $22 million the agency awarded last fall for that purpose. The year-two funding underscores the importance of state partnerships as the agency moves forward with...
Getting Your Medical Device Into the U.S. Market
By EAS Independent Consultant, Joe Ouellette If you are a manufacturer whose medical device is either a Class I, or a 510(k) exempt device Class II device, consider yourself and your company lucky that you do not have to try to “thread the needle” of the litigious and arduous process known as...
FDA Draft Guidance on New Dietary Ingredients: Do you Need to File?
Tablets and Capsules July 1, 2017 https://tabletscapsules.com/wp-content/uploads/pdf/tc_20170701_0032.pdf Amy Scanlin
Changes in What Constitutes ‘Dietary Fiber’ for Nutrition Facts Labeling May be in the Works
By Bruce Silverglade, EAS Product Development and Labeling Consultant One of the more controversial aspects of the FDA’s final rule on revising the Nutrition Facts Panel (NFP), 81 Fed. Reg. 33742(May 27, 2016), changes the definition of “Dietary Fiber” as it is disclosed on the NFP. The new rule...
FDA Unveils Accredited Third-Party Certification Site
In one more step toward improved oversight of imported foods, FDA unveiled a new section of the FDA Industry Systems (FIS) websiteon June 21, 2017, to allow organizations – including foreign governments and agencies or private third-parties – to apply for recognition as third-party accreditation...
Foreign Supplier Verification Program – What Does It Mean For Your Business
If you export food, food ingredients, food packaging, dietary supplements or food additives to the United States, your U.S. Importer will soon require that you provide documentation verifying that your company is compliant with the Food Safety Modernization Act (FSMA) regulations from the U.S. Food and Drug …
Process Labeling – Pathway to Transparency?
By Steve Armstrong, EAS Independent Advisor, Food Law & Regulation A thirty-year old federal court opinion that is well known to students of food and drug law holds that in the absence of a detailed, Congressionally mandated definition, courts and regulators should follow the common...
First FSVP Compliance Deadline Arrives
In a significant FSMA milestone, May 30, 2017 was the initial deadline for U.S. food importers to implement a foreign supplier verification program (FSVP). Beginning May 30, the U.S. Customs and Border Patrol (CBP) Automated Commercial Environment (ACE) system is requiring filers to enter at least...
EAS Offers U.S. Agent Services for Foreign Companies
By Bryan Coleman, EAS Senior Director Pharmaceutical & Device Consulting Services, and Victoria Pankovich, EAS Regulatory Specialist The FDA’s regulatory requirement for foreign firms to have a U.S. Agent can be confusing, to say the least. There are very specific requirements for foreign...
Book Chapter: Food Products in the Fundamentals in US Regulatory Affairs, 10th Edition
FDA Combines Old and New Inspection Tools for Imported Foods
The Food and Drug Administration is using a combination of old and new tools to improve the safety of imports and a quick look at the numbers explains why. We’ve seen the familiar statistics: Almost 50 percent of fresh fruit, 20 percent of fresh vegetables, and 80 percent of seafood is imported....
Safe Quality Food – Mitigation Strategies for Food Safety Fundamentals
The Facts About Supplement Facts
Wholefoods Magazine https://wholefoodsmagazine.com/blog/facts-supplement-facts/ Susan Crane April 19, 2017
The Food Processing Industry’s Newest Challenge: Safe Quality Food’s Edition 8.0
By Allen Sayler, EAS Senior Director for Food and Cosmetic Consulting Services The Safe Quality Food Institute (SQFI) is coming close to releasing its long-anticipated Edition 8.0. While many things could change during the final review and “sign-off” by the SQFI Technical Advisory Committee and...
Interview: Monitoring ingredient suppliers is imperative
Compliance With EU Food Regulation: What if Traceability and Food Recall are Not Enough?
EAS Consulting Group, LLC, leaders in FDA regulatory consulting is pleased to release a joint White Paper prepared by Italian business associate, Almater Food Technologists and Consultants srl (Italy) and LEXMA, who provide consulting services to food firms wish to …