The U.S. Food and Drug Administration (FDA) issued a Final Rule last August establishing a federal standard for “gluten-free” labeling of foods. That standard went into effect on August 5, 2014, except for fermented and hydrolyzed foods (such as beers made from gluten-containing grains, malt vinegars, and soy sauce). FDA said it would address a gluten-free standard for those products in a separate rulemaking commencing later this year because the agency at that time was not aware of a scientifically valid test method that could accurately quantify the gluten content of fermented foods. FDA issued a notice earlier this summer indicating a Proposed Rule is forthcoming and awaiting internal agency clearance, followed by HHS intra-departmental review, and (potentially) review by OMB, before publication.

Breweries that bottle beer with “gluten-free” labeling are key stakeholders for this rulemaking, which is expected to address complex testing issues, based on FDA’s review of newly gathered scientific studies. Time is of the essence for any company that will be affected by this Proposed Rule, because once published, FDA will not meet with any stakeholders (citing “ex-parte” prohibitions). Instead, a company’s only meaningful recourse will be to prepare detailed written comments and persuade others to do so as well during a brief public comment period. As such, it is critical that companies get ahead of this rulemaking to help shape FDA’s approach to regulating gluten-free fermented foods and understand the potential commercial impacts of the direction FDA takes.

Learn more about the gluten-free standard for non-fermented or hydrolyzed foods that FDA began enforcing earlier this month by reading our advisory on FDA’s gluten-free compliance requirements.