FDA’s many new regulations to further strengthen the safety of the U.S. food supply under FSMA include the mandatory requirement for food facilities to register bi-annually. Those that do not register risk being “de-listed,” and thus unable to legally sell or import products in the U.S. Under FSMA, FDA also has the authority to audit… Read More
EAS Consulting Group, LLC (EAS) specializes in Food and Drug Administration (FDA) regulatory matters. Our prime focus is to assist domestic and foreign pharmaceutical, medical device, tobacco, food, dietary supplement, and cosmetic firms comply with applicable laws and regulations. EAS is staffed with former FDA compliance and inspection officials and industry executives, and is assisted by an extensive network of consultants with many years of FDA and industry experience.
Headquartered in Alexandria, VA with consultants and auditors located strategically throughout the U.S., EAS Consulting Group was established as an independent company in October 2006. Prior to that, it was a division of Kendle Regulatory Affairs (formerly known as AAC Consulting Group).
Recent Blog posts
Food Facility Bi-annual Registration on-going!
DQSA and a Myriad of New Regulations
With the enactment of the Drug Quality and Security Act, pharmacy compounders find themselves in a myriad of regulations that are not well understood within the practice of compounding pharmacy. Its difficult to establish processes and revise procedures to comply with GMPs. Outsourcing pharmacies will require many changes organizationally, training and a comprehensive mind set… Read More
Food Nutrition Facts Panel Webinar Wrap-Up
EAS Senior Advisor for Labeling and Claims Elizabeth Campbell instructed a fantastic webinar along with DeAnn Liska, PhD, Sr. Director, Nutrition & Scientific Affairs at BioFortis and John Szpylka, PhD, Director of Chemistry NA at Silliker in a co-sponsored EAS-Silliker production on September 23rd. It should come as no surprise that there are plenty of… Read More
Recent Issue of the Month Articles
Eight new sunscreen active ingredients have been awaiting approval—or any sort of decision—from the FDA for at least 12 years, with the last over-the-counter sunscreen ingredient approved by the agency in the 1990s. Meanwhile, some of these sunscreen ingredients have been available in Europe, Asia, or Latin America for more than 15 years. However, the… Read More
An estimated one million infants (roughly one-third) in the United States are fed infant formula from birth, and by the time they are three months old, about 2.7 million (roughly two-thirds) rely on formula for at least part of their nutrition. US-produced and packaged infant formula is in high demand internationally because of its excellent… Read More
Historically, 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 media has added increasing complexity to the issue for the agency as well as for FDA-regulated industries. As a result, the… Read More
Our July Issue of the Month article titled “Why Submit a GRAS Notification for a Dietary Ingredient?” drew a lot of attention from readers. In this follow-up note, Jim Hoadley responds to one significant question. Is an NDI exempt from the NDI notification requirement when the same substance is the subject of a food ingredient… Read More
A new dietary ingredient (NDI) is a dietary ingredient that was not sold in the United States as a dietary supplement ingredient before October 15, 1994. Manufacturers of NDI-containing dietary supplements must notify FDA of their intent to market a NDI-containing supplement at least 75 days before the supplement is marketed in the U.S. The… Read More