The Food and Drug Administration is amending its food additive regulations to change requirements for vitamin D3 and calcium in fruit juices, in a final rule issued Sept. 20. In response to a petition filed by the Juice Products Association, FDA is replacing the current Reference Daily Intake percentage values of calcium in 100 percent fruit juice and fruit juice drinks with absolute values, and also updating the reference for vitamin D3 specifications. The final rule took effect Sept. 20, though objections may be submitted until Oct. 22.

The Food and Drug Administration recently issued a new guidance document on partial exemptions for “qualified facilities” from regulations on preventive controls for human and animal food. The guidance explains the definition of a qualified facility under the two rules, and how to calculate whether a company qualifies for qualified facility status, which is generally limited to small businesses. Under the preventive controls regulations, qualified facilities are exempt from complying with the full range of requirements, and must instead notify FDA that they are addressing hazards through preventive controls and monitoring.

On Sept. 19 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On Sept. 18 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 open the Voluntary Qualified Importer Program portal on Oct. 1, some three months earlier than planned, the agency said in an email. Importers can use the portal to submit notices of intent to participate and VQIP applications "for the Fiscal Year 2020 benefit period," it said.

On Sept. 14 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On Sept. 13 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. 12 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.

On Sept. 11 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 is proposing to eliminate drug approval requirements for pharmaceuticals sterilized by irradiation. Currently, any irradiated drug is considered a new drug by the agency. But under the proposal, over-the-counter drugs that are marketed pursuant to the OTC Drug Review and that are generally recognized as safe and effective could be marketed legally without an FDA-approved new drug application or abbreviated new drug application, even if they are sterilized by irradiation, FDA said. Now that the technology of controlled nuclear radiation for sterilization of drugs is well understood, “repealing the irradiation regulation would eliminate a requirement that is no longer necessary, and will not diminish public health protections,” FDA said.