Specializing in FDA Regulatory Matters

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).

Expediting FDA Approval of Sunscreen Ingredients

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

FDA to Enforce New Infant Formula Rules Immediately

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

The Impact of Social Media on FDA-Regulated Products

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

Follow-Up to the July Issue of the Month

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

Why Submit a GRAS Notification for a Dietary Ingredient?

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