Turns Out, You CAN Fight FDA

Jan. 4, 2016

One week before Christmas, FDA director William A. Correll Jr. issued a close-out letter to Tetrick, concluding Tetrick had satisfactorily addressed four “significant violations” of section 403 of the Federal Food, Drug and Cosmetic Act cited in an Aug. 12 warning letter.

The axiom, “You can’t fight city hall,” may have been true in a simple, less contentious time in America, but litigation, picket signs and other citizen actions suggest no one is buying it anymore. And as Josh Tetrick, CEO of the San Francisco-based food company Hampton Creek, recently demonstrated, it’s not only possible to fight the U.S. Food and Drug Administration, you can win.

One week before Christmas, FDA director William A. Correll Jr. issued a close-out letter to Tetrick, concluding Tetrick had satisfactorily addressed four “significant violations” of section 403 of the Federal Food, Drug and Cosmetic Act cited in an Aug. 12 warning letter. Two of the violations involved the names Just Mayo, Hampton Creek’s flagship product, and Just Mayo Sriracha. Instead of eggs, Just Mayo substitutes pea protein and modified starches that do not meet the standard of identity for mayonnaise, FDA contended. The agency also took issue with the product’s cholesterol-free claim and what it characterized as an implied health claim on the company’s website.

“The use of the term ‘mayo’ in the product names and the image of an egg may be misleading to consumers because it may lead them to believe that the products are the standardized food, mayonnaise, which must contain eggs,” according to the warning letter. “’Mayo’ has long been used and understood as shorthand or slang for mayonnaise.”

Within days of receiving the warning, Tetrick confidently predicted he would prevail in retaining the names. “We’re solid on keeping our name,” he told Food Processing at the time. “We had a good call with FDA. They get the import of what we’re doing—and why it matters to our food system.

“This is larger than a conversation about mayo, as innovation—especially when it has a positive impact—is important to them. We'll sit down with the FDA shortly and are excited to talk with them about our approach. They understand our mission more than folks realize and want to find a way forward.”

The way forward includes some label tweaks, such as a larger callout of the product’s egg-free content and adding the words “spread and dressing” to distinguish it from traditional mayonnaise. But regarding the key contention that the name was misleading and confusing to consumers, FDA waved a white flag and came around to Tetrick’s point of view.

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