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A worst-case scenario under Section 912?

Laurie Budgar

December 19, 2008

2 Min Read
A worst-case scenario under Section 912?

Ingredients manufacturers are sounding the alarm that broad interpretation of Section 912 of the U.S. Food and Drug Administration Amendments Act could discourage innovation to such a degree that new ingredient investigations are halted altogether.

Passed in 2007, Section 912 creates a new section of the Federal Food, Drug and Cosmetic Act: Section 301, which prevents the interstate shipment of foods containing a substance that has undergone publicly disclosed substantial clinical testing. If the definition of "food" is stretched to include dietary supplements, then Section 912 could prohibit the marketing of a product as a dietary supplement if it contains any ingredient that has undergone testing for therapeutic uses.

Comments filed with the FDA by attorneys Ullman, Shapiro and Ullman on behalf of a Japanese ingredient manufacturer illustrate the sticky issue of new ingredient testing under a broadly interpreted Section 912. Tokyo-based Mitsubishi Gas Chemical Co. manufactures a new ingredient called VitaPQQ, a brand of pyrroloquinoline quinone that the company claims offers significant health benefits due to "vitamin-like activity, cognitive function benefits and antioxidant effects." Because MGC is unable to point to a history of human consumption to prove the PQQ's safety, the company submitted scientific evidence to the FDA, including a number of published clinical studies.

The comments filed with the FDA said that, under a broadly interpreted 912, "MGC might be prevented from marketing PQQ in dietary supplements and conventional foods due to the existence of the very studies that were utilized to satisfy the standards required of New Dietary Ingredients. Such an outcome would be unconscionable and could likely cause other companies to cautiously refrain from conducting investigations that might benefit the public health. This result is entirely incompatible with the public interest in encouraging dietary supplement companies to invest resources in ensuring the safety and efficacy of their products."

The comment period for Section 912 ended Nov. 25. Now the FDA will review those comments before issuing any clarification on the intent of the provision. Marc Ullman, one of the attorneys representing MGC, said the two most important points for the FDA to clarify are that this new section does not apply to dietary supplements and that it applies with a very narrow scope to conventional foods.

When asked how worried he and his clients are about the worst case scenario under Section 912, Ullman said, "We think it's a legitimate concern and you can see that in the quantity and the quality of the comments that were submitted to the FDA. Everyone is urging a very narrow application of this new section."

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