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Challenges of Implementing FSMA Import Provisions Take Shape
March 30, 2011By Ricardo Carvajal –
At FDA’s public meeting on the food import safety provisions of the Food Safety Modernization Act ("FSMA") (see our prior blog posting here), the challenges posed by implementation of those provisions started to take shape. Presentations by agency personnel, industry representatives, and consumer advocates highlighted the following issues (among many more):
◦ limited agency funding and personnel
◦ tight statutory deadlines
◦ ambiguous statutory terms
◦ integration of, or harmonization with, existing standards
◦ addressing reliability of third-party audits
◦ potential adverse effects on small and medium size businesses
◦ impact on competitiveness and efficiency
There was genuine enthusiasm for the possibility that certain aspects of the law, such as the Voluntary Qualified Importer Program, could help smooth the importation process for some importers. However, there was also concern that the Foreign Supplier Verification Program requirements could prove unduly burdensome for others. Much will depend on how the agency resolves perhaps the most fundamental issue of all – who qualifies as an importer?
You can read the Deputy Commissioner for Foods' take on the new paradigm for importers here.
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- Clear that Cabinet Tour ‘24 April 18, 2024
- The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation” April 17, 2024
- Does the Drug Shortage White Paper Fall Short? April 9, 2024
- OPQ’s 2023 Annual Report: an Upbeat Review of CDER’s Quality Efforts April 8, 2024
- FDA Tells Congress What It Wants, What it Really Really Wants (it really really really wants a zigazig-ah) April 3, 2024
- Big Molecule Watch Blog
- Bloomberg BNA Health Care Blog
- Drug and Device Law Blog
- Eye on FDA
- FDA Matters
- Harvard Law Bill of Health
- IN VIVO Blog
- Internet Drug News.com
- Lachman Consultants Blog
- Medical Devices Today
- Orange Book Blog
- The Orange Book Insights Blog
- Pharma IQ
- Pharmalot
- SCOTUS Blog
- The Volokh Conspiracy
- WLF Legal Pulse
- Advertising and Promotion (Federal Trade Commission)
- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
- Biosimilars
- Cannabis
- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
- Dietary Supplements
- Drug Development
- Drug Enforcement Administration
- Enforcement
- FDA News
- Foods
- Foods and Dietary Supplements
- Fraud and Abuse
- Government Pricing
- Hatch-Waxman
- Health Care
- Health Privacy
- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized