An Ohio food manufacturing facility making low-acid Sweet Potato Butter and Pumpkin Butter is risking the growth of pathogenic microorganisms that could lead to deadly botulism, the U.S. Food and Drug Administration said in an Aug. 13 warning letter to the company.
FDA said inspectors found “serious deviations from low-acid food regulations” at the manufacturing facility owned by Amish Wedding Foods Inc. located in Millersburg.
The warning letter followed inspections at Amish Foods conducted last April and May.
Amish Wedding Foods was at the center of a recall last May 13 for pumpkin and sweet potato butters sold nationally under a long list of brands because the company’s low-acid manufacturing practices carried the threat of Clostridium botulism growth, which can lead to botulism.
FDA said “low-acid foods are identified as having a pH greater that 4.6 and a water activity greater than 0.85.”
“Hermetically sealed low-acid foods must achieve and maintain a finished, equilibrium pH value of 4.6 or lower and a water activity rate of 0.85 or lower in order to prevent the growth of pathogenic microorganisms, as required by 21 CFR 110.80 (b) (4),” the warning letter said.
FDA said the Sweet Potato and Pumpkin butters made by Amish Foods did now achieve and maintain those levels over the shelf life of the products. Inspectors took samples of the two products during the inspections and subjected them to tests, which showed they exceeded both pH and water activity safe levels.
“As a commercial processor engaged in thermal processing of low-acid foods packaged in hermetically sealed containers, you must, not later than 60 days after registration and prior to the packing of new product, provide the FDA information as to the scheduled processes including but not limited to the processing method, type of retort or other thermal processing equipment employed, minimal initial temperatures, times and critical control factors affecting heat penetration, and source and date of the establishment of the process for each low-acid food in each container size, to comply of 21 CFR 108.35 [c] , the warning letter said.
“However, your firm has not filed scheduled processes with FDA for low-acid food products you manufacturer, namely Pumpkin Butter and Sweet Potato Butter,” it added.
FDA also found the product labels for the two butter products “misbranded” because they fail to disclose a complete list of ingredients. Amish Wedding Old Fashioned Sweet Potato Butter contains salt but does not list it as an ingredient.
Amish Old Fashioned Pumpkin Butter contains water, salt and brown sugar, but those are not listed. FDA says the product does not contain lemon juice, which is listed as an ingredient.
Amish Cheese House Pumpkin Butter lists “lemon juice or citric acid” as an ingredient. FDA does not allow the use of “or” in an ingredient statement and neither lemon juice nor citric acid are used in the butter.
Finally, the products are “further misbranded” because they do not disclose the net quantity of contents and do not have proper nutrition statements on the products.