FSMA Gives FDA Fee Collection Authority for Certain Violations

Instructor: Ralph A Simmons
Product ID: 704787
  • Duration: 90 Min

recorded version

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Read Frequently Asked Questions

FSMA has modified the traditional position that FDA would not collect fees from food companies to allow collection of the agency’s costs of remedying certain violations of food law. This training program will offer a background on FDA imposition of fees on food producers, the fee amount, and how it applies to small businesses.

Why Should You Attend:

  • Understand when and how FDA will apply fees.
  • What legal violations will trigger the imposition of fees?
  • When will fees begin to be imposed?
  • What will be the amount of the fees?

Historically, FDA has not had authority to collect fees from the food industry for any reason (except in the case of a court-ordered seizure of product which violates the Federal Food, Drug, and Cosmetic Act. FSMA does not authorize fees for food additive petitions or other applications for FDA approval for food additives.

The authorization is to offset FDA costs of facility re-inspections after violations; costs to FDA of a recall if the responsible company refuses an FDA recall order; and the costs of re-inspection of food offered for import which appears to violate the Act.

Areas Covered in the Webinar:

  • Background on FDA imposition of fees on food producers
  • Circumstances under which FSMA authorizes FDA to collect fees with respect to food products
  • When will the fees be imposed?
  • Amount of the fees
  • Application to small business

Who Will Benefit:

  • Quality and compliance personnel
  • Regulatory personnel
  • Small to mid-size food producers and importers

Instructor Profile:

Ralph A. Simmons has over 35 years of experience in FDA regulation of food, and related products such as direct food additives, and food-contact substances. This experience has included the representation of companies with FDA-regulated products and experience as a senior policy advisor within FDA. The experience in FDA included work on regulations to implement FSMA.

Mr. Simmons has extensive experience in working with FDA on FSMA regulations and regulations in related areas, such as direct food additives and food-contact substances. This experience has included representing industry in negotiations with FDA, which avoided having food-contact material suppliers being registered under FDA’s program of registration of food facilities, located domestically and internationally.

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