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.
Expediting FDA Approval of Sunscreen Ingredients
By EAS Senior Consultant, Norma Skolnik 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...
FDA Officials Discuss Phase Two of FSMA Implementation
Although still in the phase 1 rulemaking stage of implementing the Food Safety Modernization Act (FSMA), the Food and Drug Administration is planning for moving forward with “phase 2” which will involve training and compliance activities. FDA Deputy Director for Regulatory Affairs, Roberta...
FDA to Enforce New Infant Formula Rules Immediately
By EAS Senior Consultant Allen Sayler 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...
FDA Announces FSMA Fees for Fiscal Year 2015
FDA announced the Food Safety Modernization Act (FSMA) domestic and foreign facility reinspection, recall and importer reinspection fee rates for Fiscal Year (FY) 2015, in an August 1, 2014 Federal Register notice. Section 107 of FSMA added section 743 to the FD&C Act giving FDA the...
FDA Sends Revised FSVP Rule to OMB
The Food and Drug Administration recently sent a revised rule to the White House Office of Management and Budget (OMB) that will be an important tool in FDA’s future oversight of foods and ingredients imported into the United States. Under FSMA, FDA has increased regulatory authority over...
Follow-Up to the July Issue of the Month
By EAS Senior Consultant James Hoadley Ph. D. 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...
FDA Reopens Comment Period on Reportable Food Registry ANPR
On June 18, FDA reopened the comment period on an advance notice of a proposed rule that would introduce certain changes to the Reportable Food Registry (RFR), implementing provisions in Section 211 of the Food Safety Modernization Act (FSMA). The RFR reporting requirements apply to all...
Why Submit GRAS Notification for a Dietary Ingredient?
By James Hoadley, Ph.D., EAS Senior Consultant 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...
FDA Extends Comment Deadline on Sanitary Transportation Rule
In 1990, Congress enacted the Sanitary Food Transportation Act that directed the Department of Transportation to promulgate regulations for the transportation of food to ensure its safety. DOT issued a proposed rule in 1993, but later determined that it lacked the expertise to implement the...
FDA’s Strategy for Implementing Next Phase of FSMA
FDA offers some insights into its strategy for implementing the next phase of the Food Safety Modernization Act (FSMA) in a guidance document posted on the agency’s website May 2. A key element of the agency’s operational strategy will be to rely heavily on the industry to implement preventive...
FDA Has Higher Expectations for Generic Drug Applications
By Charles “Chris” Celeste, Director of Regulatory Information and Submissions FDA expects industry to begin submitting higher-quality applications to facilitate expedited reviews and approvals of generic drugs, agency officials explained at the Generic Drug User Fee Amendment (GDUFA) and...
FDA Issues Revised Draft Guidance on Prior Notice of Imported Foods
FDA announced the release of new draft guidance on requirements for prior notice of imported food, in a March 31 Federal Register notice. Some of the draft guidance responds to provisions in section 304 of the Food Safety Modernization Act (FSMA). The new draft includes several new...
The Top Ten Reasons for FDA Warning Letters to Medical Device Firms
By EAS Director of Regulatory Affairs and Submissions, Chris Celeste Since December 1978, medical device manufacturers have been subject to FDA regulations and inspections based on the Good Manufacturing Practices (GMP) requirements. On June 1, 1997 FDA amended the 1978 regulations to include...
FDA Issues Proposed Rule on Sanitary Transportation of Food
On January 31, 2014, FDA issued a proposed rule on sanitary transportation of human and animal foods -- the seventh of seven regulations mandated by the FDA Food Safety Modernization Act. So we now have all the proposed rules that would implement key elements of FSMA. The other six rules...
On FDA’s Proposed Rule on Intentional Adulteration
FDA released its proposed rule on intentional adulteration of food in a December 24 Federal Register notice. The proposed rule, Focused Mitigation Strategies To Protect Food Against Intentional AdulterationFocused Mitigation Strategies To Protect Food Against Intentional Adulteration, would apply...
FDA’s Proposed Rule on Antibacterial Soaps
By EAS Senior Consultant Norma Skolnik In 2010 the Natural Resources Defense Council (NRDC) sued FDA to force the agency to issue a final rule on antibacterial soaps. As part of a settlement signed last month, the agency issued a proposed rule Dec. 16, 2013 and committed to taking final action by...
FDA Needs Input on Proposed Animal Food Rule
In last month’s FSMA Perspective, I focused on FDA’s release of its proposed rule on Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. I would like to follow up here with issues raised November 21 at a public meeting in College...
On FDA’s Proposed Rule on Preventive Controls for Animal Food Facilities
FDA unveiled its proposed rule on Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals on October 25 after more than a year and half of waiting for the proposal to emerge from the White House Office of Management and Budget. This proposed...
Reporting from Proposed FSMA-related Audits Raises Concerns
Reporting requirements from third-party audits drew many questions from stakeholders at the agency’s public meeting on proposed rules on Foreign Supplier Verification Programs (FSVP) and the Accreditation of Third-Party Auditors/Certification Bodies, held in Washington D.C., September 19-20. As...
Distinguishing Medical Device Recalls
By EAS Senior Consultant Paul F. Tilton Do you know when a product enhancement is considered to be a recall in the eyes of the Food and Drug Administration? If not, I draw your attention to the draft guidance from FDA entitled Distinguishing Medical Device Recalls from Product Enhancements and...
Regulatory Options for Food Ingredients in the U.S.
By EAS Senior Advisor for Food & Color Additive Safety Robert Martin Before releasing any food ingredient into the market, it is incumbent upon the manufacturer/supplier to ensure that the product is safe for its intended use. Oftentimes, deciding how to approach this can be confusing. Under...
On the Proposed Rules for the Safety of Imported Food
One of FDA's biggest challenges as it rolls out new regulations to implement the Food Safety Modernization Act will be outreach and education so every impacted business will know what's expected under the new, prevention-based regulatory approach. As part of its outreach efforts, FDA posted a...
ISO/IEC 17025:2005 and the Benefits of Accreditation
By EAS Senior Consultant Bob Mehta There is immense value for medical device manufacturers in having their calibration and testing laboratory suppliers comply with the General Requirements for the Competence of Testing and Calibration Laboratories in ISO/IEC 17025:2005. From initial design and...
FSMA’s Registration Mandate is the Key
The focus of media attention is currently on FDA's proposed rules for a Foreign Supplier Verification Program and for Accreditation of Third-Party Auditors. But I would draw your attention to a FSMA provision that is already in force, which, from the agency's viewpoint, is the most significant new...