FDA Modifies FSMA Enforcement

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Washington, D.C. — The U.S. Food and Drug Administration (FDA) has issued a constituent update announcing it will use enforcement “discretion” in specific provisions in four regulations of the Food Safety Modernization Act (FSMA).
They include:
  • Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food (AKA PC Rule or 21 CFR Part 117)
  • Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Animal Food
  • Foreign Supplier Verification Programs (FSVP)
  • Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (AKA Produce Safety)

According to Larisa Pavlick, VP, global regulatory and compliance for the United Natural Products Alliance, several of the areas addressed in the Fact Sheet accompanying the update affect the natural products industry.

  • Farm-related regulatory discretion applies because some of the botanicals used as raw materials are covered under the Produce Safety rule. Farm-related activities for industry might include drying of herbs used in dietary supplements as raw materials or dietary ingredients. 
  • Regulatory discretion in the area of written assurances in the “customer provision” in the PC Human Food rule applies in that written documentation (disclosures) can be provided disclosing a hazard has been identified, and it has not yet been controlled; however, it will be controlled by another processor before it reaches the consumer. FDA has acknowledged in the Facts Sheet that this responsibility may take additional time and it states in the Facts Sheet that it recognizes the difficulty with the resources to comply with this provision and the complexity of the supply chain relationships.
  • Human food by-products for use as animal food includes botanical tinctures and tea manufacturers, who may be using the excess or spent biomass for use as animal feed to local ranchers. Regulatory discretion will be used for the by-product dependent on if the by-product is further processed as an animal food. The Facts Sheets clarify the expectations for GMPs for the handling of human food by-product for use as an animal food.

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