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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?

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...

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Sunscreen Quality, Safety and Efficacy

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...

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FDA Finalizes Two Foundational PMTA Rules

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...

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Dietary Supplement Virtual GMP Refresher

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...

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USDA FSIS Revised Guidelines for Labeling Kit Food Products

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...

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Drug OTC GMPs and Labeling

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...

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Food Labeling Modernization Act of 2021 Introduced

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...

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What’s Hot in the Regulatory World

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...

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Is it a Drug or Cosmetic? EAS Podcast hosted by CPhI

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...

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