The FDA Globalization Act's Impact on Flavor

As previously discussed, the drafted Food and Drug Administration Globalization Act of 2008 will impact the fragrance industry. According to the Flavor Extract Manufacturers Assocation (FEMA), it will also affect the flavor industry. FEMA believes that "should the bill be enacted as currently drafted it would overly burden the food industry with unjustified new regulations, costly fees for registration and importation and restrict imports to only those ports of entry with certified FDA laboratories."

Of particular note are the provisions for registration of all food facilities on an annual basis at a cost of $2,000 per registration. Before a facility introduces or delivers for introduction into interstate commerce any shipment of food, the owner, operator or agent in charge of the facility would be required to develop and implement a written food safety plan. The Secretary of Health and Human Services would also be allowed to establish by regulation and enforce performance standards that define, with respect to specific foods and comtaminants in food, the level of food safety performance that a facility shall meet.

Prescriptive new regulatory requirements will stifle the development and adoption of innovative technologies, divert resources from proven food safety systems and dramatically increase the cost of producing food without improving safety. Food and flavor manufacturers already have powerful incentives to ensure the safety of their products and ingredients.

Click here (pdf, 182 kb) to view the draft bill (69 pages). (Source: FEMA)

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