Recall was UNFOUNDED and is now LIFTED
No Evidence to Support Raw Cheese Recall
RAW FARM Immediate WITHDRAWAL of Voluntary Cheese Recall
*This process also revealed damaging and unusual treatment with severe bias from FDA/CDC against RAW FARM and all its products
February 26, 2024
After an investigation and thorough review of hundreds of product samples and testing, no pathogens were found by FDA, multiple state health agencies or private laboratory testing.
RAW FARM was urgently pressured into issuing a Voluntary Recall with no evidence of adulterated product connecting to any consumer illness. On Thursday February 15th, 2024, RAW FARM was provided 30 minutes notice before a urgent conference call demanded by the FDA and CDC. In an preemptive preliminary abundance of caution, RAW FARM issued the Voluntary Recall on February 16, 2024. During this last 10-day Voluntary Recall period, RAW FARM acted in complete cooperation with the FDA and CDC and yet was treated with biased, brand-defaming, and inappropriate actions taken by the FDA and CDC.
Included in those actions:
1) FDA notified media, consumers, and retailers (Consignees) 3 hours before the deadline they gave to RAW FARM for issuing the Voluntary Recall, thereby issuing a de-facto mandatory recall outside of the FSMA administrative process requirements of section 402 of the FD&C Act.
2) FDA failed to comply with FSMA (Food Safety Modernization Act) guidelines for following a Voluntary Recall (including not following the Firms’ guidance) under section 423 (d) of the FD&C.
3) FDA exposed bias against raw cheese in using “forever directives” in their guidance which stated: “do not eat, sell, or serve RAW FARM-brand Raw Cheddar Cheese”. This guidance failed to limit the recommendation to specific date codes which would have set time sensitive limits to the recall. Standard procedure for pasteurized brands or product brands would have set date code limits to start and stop recall guidance. FDA failed to respond to multiple pleadings from RAW FARM to update their guidance to comply with standard procedures for all Voluntary Recalls.
4) FDA posted links on their cheese recall guidance that show biased and misleading information on raw milk, a product not implicated in the recall.
5) Dr. Stic Harris, Director at FDA, posted a biased and brand defaming image along with a statement on his FDA LinkedIn account showing anti-raw milk agendas unassociated with the ongoing investigation.
6) FDA has exposed its strong bias against raw cheese in its failure to respond to multiple requests for information and failure cooperate during the ongoing investigation.
Raw Farm is now publicly announcing that the Voluntary recall was UNFOUNDED and has been RETRACTED. All raw cheese product date codes are CONFIRMED safe to consume. We now direct all stores, consignees, and consumers to freely consume our products with confidence. This includes any product inventories which have been quarantined as subject to Voluntary Recall. Please release all product quarantines and resume all normal product sales and consumption.
Background:
On February 15, 2024 RAW FARM was contacted by the FDA and CDC regarding the “epidemiological possibility” (via PULSENET) that RAW FARM raw cheddar cheese might have caused some illnesses within a date range of October 18th 2023 and January 31st 2024. This included the verbal statements that about half of the ill people denied consuming any RAW FARM products. RAW FARM received no evidence of adulterated products on February 15, 2024 but reluctantly issued the Voluntary Recall on February 16, 2024 in full cooperation with the FDA/CDC and CDPH in a preemptive preliminary abundance of caution.
Investigation Findings:
1) RAW FARM assumed that the FDA/CDC would issue guidance that corresponded and supported RAW FARM’s Voluntary Recall, as per FSMA 423 (d) of the FD&C.
a. Instead of the FDA and CDC issuing guidance that followed the Voluntary Recall issued by RAW FARM, the FDA and CDC issued guidance that did not have a specific BATCH LOT ID or specific cheese product to be recalled and therefore did not correlate to RAW FARM Voluntary Recall.
2) The FDA recall guidance was a “forever directive” to throw away and never eat or consume RAW FARM cheese products.
a. This same FDA guidance overreached and advised consumers to never consume raw milk. Raw Milk was not and is not subject to recall.
b. The FDA does not regulate raw milk (state laws do) yet it directed consumers to never consume legally produced, inspected, and compliant raw milk.
3) In addition to this over-reaching and unfounded guidance, the FDA and CDC has failed to provide any evidence of an adulterated cheese product or any presence of a pathogen, required for a recall under the FSMA.
4) RAW FARM subsequent and thorough internal investigation of cheese subject to the Voluntary Recall confirms:
a. No root cause can be found.
b. No adulterated products leaving the facility, as confirmed by Food Safety Net Services AOAC PCR testing.
i. COA from 168 batches ranging from make date 2023-9-12 to 2023-12-19 (current cheese being cut) confirmed all negative pathogen results from FSNS PCR testing.
ii. CDFA testing of all products, including raw cheese, have revealed zero E coli 0157:H7 during the same date range.
c. No breaches in food safety protocols.
d. No violations of Critical Control Points.
e. No violations of Process Preventative Controls or FSMA (unrelated 9-day FDA inspection in January 2024 showed full compliance)
f. No violations of the Hazard Analysis.
g. No illnesses have been directly reported to RAW FARM.
h. No product testing has resulted in positive pathogen findings.
i. No environmental monitoring testing has resulted in a positive pathogen.
j. CDPH and UDPH have confirmed 24 total (15 CA, 9 UT) product samples taken from random “multiple state retail” consignees have tested negative by their State independent labs.
