The FDA courting 'Mexican stand-off'

Official's statement upends the concept of proprietary blends

United States Kentucky Fried Chicken's Colonel Sanders has never been forced to reveal his famous secret 11 herbs and spices, but supplements manufacturers and ingredients suppliers have been warned they may have to give up proprietary blend formulations under US Food and Drug Administration (FDA) GMP regulations.

It's a situation that may lead to an information boycott, according to one key industry spokesperson — 'may' being the operative word, as this aspect of the legislation is mud-like in its clarity. But a high-ranking FDA official has warned companies must prepare itemising paperwork to validate each proprietary offering.

"You must know what you are buying as a proprietary blend in order to use it in a product, and in order to identify it, you must know what the proprietary blend is,"?said Vasilos Frankos, director of the FDA's CFSAN Division of Dietary Supplement Programs.

He suggested this information should appear on-label, a proposition that surely razes the very concept of a proprietary blend. A blend cannot be proprietary and public at the same time, and suppliers and manufacturers will be concerned about the economic ramifications of Francos' suggestion.

Concern is justified, according to Loren Israelsen, the executive director of the United Natural Products Alliance, but he sees problems arising at the FDA-inspection level rather than on-label. "The Dietary Supplements and Health Education Act only requires declaration of the total amount of the proprietary blend, with the ingredients listed in descending order of predominance on finished-product labels," he told Functional Ingredients magazine.?"This protects the actual formulation at that level."

This is not the case at the supply-chain level, where an FDA inspector may insist on correlating raw-materials inputs with a manufacturer's records. "If said inspector insists on full disclosure of the proprietary blend in order to assure that GMP compliance is confirmed, then we have a problem," Israelsen warned. "FDA inspection records are matters of public record, so everyone will be reluctant to give the FDA such information. This is widely referred to as a 'Mexican stand-off.' My hope is that the FDA will be wise enough to provide field guidance to its inspectors on how to deal with this situation to prevent an unfortunate confrontation that need not happen."

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