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.
When is a Cosmetic Also a Drug?
Did you know that products designed to clean and beautify that ALSO affect the structure or function of the human body must bear special labeling? Per FDA’s 21 USC 359, these combination cosmetic – OTC Drug products must comply with OTC drug monographs and...
Sunscreen Quality, Safety and Efficacy
New Initiatives by FDA FDA has proposed revisions and updates to OTC-drug sunscreen requirements related to maximum sun protection factor (SPF) values, active ingredients, broad-spectrum requirements, and product labeling, among other provisions. This effort aims to ensure adequate ultraviolet A...
FDA Finalizes Two Foundational PMTA Rules
U.S. Food and Drug Administration has issued two final rules for the premarket review of new tobacco products, providing additional information on the requirements for the content, format and review of Premarket Tobacco Product Applications (PMTAs) and Substantial Equivalence (SE) Reports – two of...
Dietary Supplement Virtual GMP Refresher
Presented by EAS Independent Consultant Presented by Tamika CatheyJanuary 18-19, 2022 from 11am-3pm eastern The Good Manufacturing Practices (GMP) dictated in FDA’s 21 CFR 111 require that “Each person engaged in manufacturing, packaging, labeling, or holding, or in performing any quality control...
Why You Should Outsource Your Food Safety Testing
As a member of the Certified Group and Food Safety Net Services, EAS clients have access to world-renowned testing laboratories that meet your organization’s sophisticated needs. In this column, you’ll hear about their capabilities, environmental challenges and more. We hope you’ll enjoy a look...
Social Media Considerations for FDA-Regulated Products
By Susan Crane, Independent Advisor, OTC Drugs and LabelingHistorically, it has been straightforward for the FDA to review and monitor labeling and advertising for products under their jurisdiction, particularly drugs and medical devices. However, the widespread use of the internet and social...
Tim Lombardo Discusses Food Safety for CBD Infused Edibles in NCIA Podcast
Senior Director for Food Consulting Services, Tim Lombardo, recently joined NCIA for a podcast covering food safety of CBD-infused edibles. Listen here.
USDA FSIS Revised Guidelines for Labeling Kit Food Products
Those producing nonretail-exempt, multicomponent food kits (such as stir fry and pizza) have a newly revised resource from FSIS: An eight-page booklet with criteria that helps to determine whether the kit product needs to be prepared under FSIS inspection and if so, how to label a kit product that...
Drug and Device Corner September 2021
As part of the 2020 CARES Act, section 506J has been added to the FD&C Act. This section requires manufacturers of certain medical devices to report any interruption or permanent discontinuance in manufacturing to the CDRH. The list of relevant devices can be found on this FDA website. A...
Food Safety – Of the Package By the Package and For the Package
Presented by EAS Independent Consultant, Thomas Dunn. Did you know the safety of your product begins and ends with packaging? Packaging is considered the “forgotten food ingredient” and has a myriad of US regulatory requirements including food contact substances, minimizing or preventing food...
Brad Douglass Blogs for NCIA on GRAS for Cannabinoids
EAS dietary supplement, hemp, and CBD expert, Brad Douglass, Ph.D. published a blog for the National Cannabis Industry Association (NCIA) on GRAS as an option for cannabinoid food additive submissions to FDA. There are numerous benefits to choosing GRAS including market expansion, safety...
Drug OTC GMPs and Labeling
A Five-Part Virtual Series Presented by Bryan Coleman, Senior Director of Pharmaceuticals and Medical Devices; Victoria Pankovich, EAS Regulatory Specialist; Norma Skolnik, EAS Independent Consultant; and Bruce Elsner, EAS Independent Consultant. February 2, 9, 16, 23, and March 2, 2022If you...
Food Labeling Modernization Act of 2021 Introduced
‘The Food Labeling Modernization Act’ (FLMA) was introduced this month in both houses of Congress by Representative Frank Pallone (D-NJ) and Senator Richard Blumenthal (D-CT), along with Representative Rosa DeLauro (D-CT) and Senators Ed Markey (D-MA) and Senator Sheldon Whitehouse (D-RI). The...
What’s Hot in the Regulatory World
By Richard D’Alosio, EAS Independent Consultant I have always described working in regulatory as an iceberg, with the obvious black and white answers to inquiries akin to the visible iceberg floating in the water. However, underneath the water is the unknown or unregulated areas, and that is where...
Did you know? Color Additives Must Have FDA Approval and (Sometimes) Batch Certification
Color additives for most FDA-regulated products (tobacco and some medical device products are exceptions) must be approved by FDA and listed in the Code of Federal Regulations. If a color additive isn’t listed, its approval must be petitioned and approved by FDA prior to its use in products...
Environmental Monitoring and Mapping Application (emma®)
By Food Safety Net Services Environmental monitoring programs (EMPs) are critical in food processing environments to ensure the prevention and detection of pathogens. Many of these programs have evolved to mitigate risk of contamination and can serve as an early warning sign of risk to food...
Do you Make Good, Clean and Healthy Claims on Your Product Labels?
You may be misrepresenting your products by making claims such as good, clean and healthy. FDA has clearly defined definitions for some claims and deciding which to make to market your products can be tricky. Read the EAS authored article in Snack Food and Wholesale Bakery and learn how you can...
Drug and Device Corner August 2021
FDA has announced most FY2022 user fee rates this month, conspicuously missing are the OMUFA 2022 user fee rates. We will continue to monitor Federal Register notices and share information as soon as it becomes available. Federal Register Vol. 86, No. 142 announcing FDA 2022 GDUFA user fee rates...
Foreign Supplier Verification Program Failures – FDA’s Number One FSMA Citation
Presented by EAS Independent Consultant, Carlos Ortiz. Did you know that FSMA requires an established FSVP that places the onus of compliance verification for all aspects of FSMA on the importers? Failure to meet FSVP requirements can jeopardize any food or food ingredient being imported into the...
Is it a Drug or Cosmetic? EAS Podcast hosted by CPhI
As more and more companies operating in the pharmaceutical space are moving into cosmetics, the temptation is to think that life will be much easier from a regulatory and compliance perspective. However, while it is true that pharmaceuticals are more heavily regulated, this does not mean that...