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FDA Releases Small Business Compliance Guides for FSMA Human, Animal Food Safety Rules

November 2, 2016 |FDA

The Food and Drug Administration recently published two small entity compliance guides to help small businesses comply with new Food Safety Modernization Act regulations on preventive controls for human food (here) and animal food (here). Foreign and domestic human food facilities have been required to comply with certain provisions of the human food rule since Sept. 19, and must comply with the animal food rule beginning in September 2017, though small businesses have an additional one to two years to comply, depending on size. Importers must generally begin verifying their suppliers' compliance with these rules about six months after a supplier is required to comply, though no earlier than May 2017.

New and Revised FDA Import Alerts for Oct. 31

November 1, 2016 |FDA

On Oct. 31 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

New and Revised FDA Import Alerts for Oct. 28-29

October 31, 2016 |FDA

On Oct. 28-29 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Issues Draft Guidance on FSMA Downstream Customer Disclosure Statements

October 31, 2016 |FDA

The Food and Drug Administration issued draft guidance (here) on how to comply with Food Safety Modernization Act regulations that allow food facilities and importers to rely on downstream customers to control food safety hazards. Included under FSMA regulations on produce safety, preventive controls for human and animal food and the Foreign Supplier Verification Program, the regulations require a disclosure statement, in documents accompanying food, that certain hazards have not been controlled by the food facility or importer. According to the draft guidance, the statement may be provided using a “wide variety of types of documents that accompany the food, such as labels, labeling, bill of lading, shipment-specific certificates of analysis, and other documents or papers associated with the shipment that a food safety manager for the customer is likely to read,” though it is “not sufficient to reference a website in a document of the trade without including the disclosure statement, itself, in the document of the trade,” FDA said. In FSVP disclosure statements, importers may identify biological hazards using general terms (i.e., not describing the specific microbe), but chemical and physical hazards must be described specifically, the draft guidance said. Comments on the draft are due May 1, FDA said (here).

New and Revised FDA Import Alerts for Oct. 27

October 28, 2016 |FDA

On Oct. 27 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Enforcement Report on Recalls & Field Corrections for Oct. 26

October 28, 2016 |FDA

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

New and Revised FDA Import Alerts for Oct. 26

October 27, 2016 |FDA

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

New and Revised FDA Import Alerts for Oct. 25

October 26, 2016 |FDA

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

FDA Proposes to End Exemptions for Use of Ozone Depleting Substances in Medical Devices

October 25, 2016 |FDA

The Food and Drug Administration is eliminating an exemption to the ban on the use of chlorofluorocarbons (CFCs) and other ozone depleting substances (ODSs) in sterile aerosol talc administered intrapleurally by thoracoscopy for human use and metered-dose atropine sulfate aerosol human drugs administered by oral inhalation, it said in an interim final rule (here). The end of the “essential use” exemption will take effect Feb. 23, unless comments opposing the final rule are received by Dec. 27. If that happens, FDA may withdraw its interim rule and consider the changes under an identical proposed rule (here), with comments also due Dec. 27. Separately, FDA is also proposing to eliminate the “essential use” exemption for use of CFCs and other ODSs in anesthetic drugs for topical use on accessible mucous membranes of humans where a cannula is used for application. Comments on that proposed rule (here) are due Dec. 27.

New and Revised FDA Import Alerts for Oct. 21

October 24, 2016 |FDA

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