FDA Releases Draft Guidance on Acidified Food

By Ricardo Carvajal –

FDA announced the availability of a draft guidance on acidified food intended to help processors determine whether their products are subject to the current good manufacturing practice ("CGMP") requirements in 21 CFR part 114 and the “Specific Requirements and Conditions for Exemption From or Compliance With an Emergency Permit” in 21 CFR 108.25.  Those regulations impose significant pre- and post-market requirements on processors who manufacture foods that meet the definition of an “acidified food,” and grant FDA comprehensive authority to take corrective action against processors that fail to meet the requirements.  The regulations governing acidified and low acid canned foods were adopted by FDA more than 30 years ago in part under the emergency permit control authority of section 404 of the Federal Food, Drug, and Cosmetic Act, after a New York banker was killed by botulism in a can of Bon Vivant vichyssoise – an event that pushed Bon Vivant into bankruptcy. 

The guidance discusses the differences between acid foods and acidified foods, the applicability of FDA’s requirements to fermented foods, the obligations of repackers and reprocessors of acidified foods, and the agency’s recommendations with respect to acid foods and fermented foods that contain small amounts of low-acid foods.  The guidance also provides the agency’s definition of certain terms that are not defined by regulation (e.g., “equilibrium pH”).  Comments on the guidance are due December 27.

Of late, FDA has shown increased interest in exercising its authority under section 404 and its implementing regulations.  Thus, the guidance should be of interest to both domestic and foreign manufacturers.

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