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What do FDA’s Preventive Controls Rules Actually Mean?

St. Louis Partner Brandon Neuschafer authored an article Nov. 10 in Refrigerated & Frozen Foods magazine concerning the FDA’s Preventive Controls Rules. Released on Sept. 10, the rules aim to shift the focus of U.S. food safety away from incident response and toward prevention. “FDA expects that many large facilities are already doing a vast majority of what is now being required,” Neuschafer wrote. “Those facilities may still need to develop additional documentation or tweak procedures. Interesting and complicated issues swirl around companies who are not themselves food facilities, but are technology and equipment providers to such facilities.” Click here to read his full article.

FDA Proposes Draft Guidance on Mandatory Recall Authority

One key element of the 2011 Food Safety Modernization Act was the Act’s grant to FDA of powers to force a product recall.  Prior to FSMA, FDA had no such authority, and was required to use other authorities to “lean” on companies to conduct a recall.  Now, FDA may force a recall where it finds that there is a reasonable probability that food is adulterated or misbranded and the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals.  In addition to satisfying this fairly substantial threshold, the responsible party must refuse to voluntarily conduct a recall.  The result is that FDA has initiated its mandatory recall authority only a couple of times, notably with respect to Kasel Associates Industries, Inc.’s pet treats and dietary supplements manufactured by USPLabs.

FDA recently issued draft nonbinding guidance regarding its mandatory recall authority.  The draft

New FDA Guidance on “Gluten Free” Claims

Following up on last year’s “gluten-free” labeling rule, the FDA has now published guidance to help industry interpret and apply the rule.  All food products claiming to be “gluten-free” must comply with the rule by August 5, 2014.  At its essence, according to the FDA, “gluten-free” means that the food does not contain an ingredient made from a gluten-containing grain unless that grain has been processed to remove the gluten and the remaining gluten in he ingredient does not exceed 20 parts per million.  Food containing unavoidable amounts of gluten, such as from cross-contact, must still be below the 20 ppm threshold to use the “gluten-free” claim.  The rule does not require testing of gluten levels, but a company using the claim is responsible for ensuring that its product meets the established threshold to avoid product being adulterated and/or misbranded.

Interestingly, FDA has specifically stated that the “gluten-free” claim can

FDA Publishes Draft Rule to Address Intentional Adulteration of Food

FDA published a draft rule today designed to require the largest food businesses in the United States to take steps to address vulnerabilities in their operations to prevent the intentional adulteration of food – “food terrorism,” in other words.  The proposed rule will generally apply to both domestic and foreign facilities that manufacture, process, pack, or hold food and are required to register as a food facility.  Exempted from the rule are small businesses (less than $10 million in annual food sales), farms, food for animals, certain food holding facilities, and certain packing or labeling facilities.  As explained by FDA:

Under the proposed rule, a food facility would be required to have a written food defense plan that addresses significant vulnerabilities in its food production process. Facilities then would have to identify and implement strategies to address these vulnerabilities, establish monitoring procedures and corrective actions, verify that the system is working,

FDA Reports That 12% of Spice Imports Are Contaminated

What is in all of those little spice containers in the your kitchen?  According to the FDA, as recently reported by the New York  Times, about 12% of spice imports are contaminated with “insect parts, whole insects, rodent hairs, and other things.”  Nearly 7% of spices imported contained salmonella.   Under the Food Safety Modernization Act, FDA is looking at new rules to address food imported into the United States, including modifications to the foreign supplier verification program.  Recent changes to those proposed rules, however, are seen by many to weaken the program.  Those changes, which include eliminating the requirement for onsite audits and exemptions for importers doing less than $500,000 in business, would surely impact spice importers (as well as other food importers).

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