On Sept. 26 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

The Food and Drug Administration issued its weekly Enforcement Report for Sept. 26 that lists the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.

The Food and Drug Administration seeks comments by Nov. 27 on the labeling of plant-based products that include the names of dairy foods such as “milk,” “cultured milk,” “yogurt” and “cheese,” it said in a notice. The agency is interested in input regarding the current market for such products, including the extent they are sold and the costs of any labeling changes, as well as on consumer perceptions of plant-based foods that include the names of dairy foods. “We are taking this action to inform our development of an approach to the labeling of plant-based products that consumers may substitute for dairy foods,” which may include a labeling standard that deems misbranded any plant-based products that include dairy names. The effort is intended to address the increasing availability of foods such as almond milk, coconut kefir, soy yogurt and vegan mozzarella cheese that bear the names of dairy foods despite not including any dairy products.

The Food and Drug Administration is withdrawing a proposal to require labeling of imported food that was refused entry into the United States. Issued in 2008, the proposed rule would have required the labeling of the shipping container and entry documentation for such shipments with “UNITED STATES: REFUSED ENTRY,” in an attempt to prevent port shopping. But since that proposal was issued, many of these documents have been made electronic and prior notice requirements have been changed to require notification of any country to which imported food has been refused entry, including the United States. “FDA may reassess how to effectively implement the labeling of documentation accompanying refused food and consider whether to issue a revised proposed rule in the future,” it said.

On Sept. 25 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

The Food and Drug Administration seeks volunteers with multiple food processing facilities to participate in a test of a “two-tiered” inspection program for companies subject to supply chain program requirements under human food preventive controls regulations. Under the approach, FDA would first conduct a pre-arranged tier 1 inspection that would examine the company’s written supply chain programs and recall plans, as well as a facility near the company’s corporate headquarters. A second, unannounced tier 2 inspection would then assess compliance with all applicable preventive controls requirements except the written plans reviewed during the tier 1 inspection. Potential benefits of the scheme include decreased inspection time, improved public health protection and greater opportunities for education, outreach and communication between FDA and industry, the agency said. To participate, a company should have two or more domestic registered food facilities that are currently subject to preventive controls requirements and have a centrally developed supply-chain program and recall plan. Participation will be limited to five companies. Requests to participate are due Oct. 31. The Ohio AgriBusiness Association has posted a copy of FDA’s emailed notice to its website.

The Food and Drug Administration will allow a grace period for product identifier labeling requirements under the Drug Supply Chain Security Act, it said. Under a guidance finalized Sept. 20, the agency will not enforce labeling requirements on manufacturers that do not affix or imprint a product identifier to each package and homogenous case of product before Nov. 27, 2018. Similarly, the agency will “grandfather” products in packaging or homogenous cases not labeled with a product identifier, as long as there is documentation that the product was manufactured or imported before Nov. 27, 2018, it said in a separate guidance.

On Sept. 21 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

The Food and Drug Administration will allow for the expanded use of D&C Yellow No. 8 as a color additive in contact lens solution, it said in a final rule. The amendment to the color additive regulations was requested by Glo Eyes. The change takes effect Oct. 26, 2018.

On Sept. 20 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: