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New and Revised FDA Import Alerts for Sept. 11

September 12, 2018 |FDA

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:

FDA Proposes to End Drug Approval Requirement for Irradiated OTC Drugs

September 11, 2018 |FDA

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.

New and Revised FDA Import Alerts for Sept. 7

September 10, 2018 |FDA

On Sept. 7 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 Sept. 6

September 7, 2018 |FDA

On Sept. 6 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 Sept. 5

September 7, 2018 |FDA

The Food and Drug Administration issued its weekly Enforcement Report for Sept. 5 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.

New and Revised FDA Import Alerts for Sept. 5

September 6, 2018 |FDA

On Sept. 5 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Intends to Allow Alternate Live Microbe Quantity Listing on Supplement Facts Labels

September 6, 2018 |FDA

The Food and Drug Administration issued a new draft guidance document announcing the agency’s intent to let dietary supplement manufacturers with live microbial ingredients to list the quantity of those ingredients in “colony forming units” (CFUs) on revised supplement facts labels soon set to take effect. For supplements containing live microbials, such as probiotics, labels may include a declaration of live microbial quantity in CFUs alongside the quantitative amount by weight already required on the labels, provided the weight is listed first, the CFU quantity is listed separately, in clear terms and accurately, and the CFU amount online includes live microbes and not dead or inactive organisms, among other conditions, FDA said. New supplement facts labels are required beginning in 2020 for most manufacturers, and in 2021 for small businesses (see 1805030053). Comments on the draft are due Nov. 6.

New and Revised FDA Filer Evaluation Outcomes

September 5, 2018 |FDA

The Food and Drug Administration posted its updated list of filer evaluation outcomes dated Sept. 4, 2018. The frequency of filer evaluations depends on the number of lines filed by the company. An outcome of "paperless" means FDA has determined that electronic filing is appropriate, while "corrective action plan" means FDA has found an elevated error rate and has directed the filer to fix the issue, and "dual-mode filer" means the company has failed to implement corrective action plans and has been returned to dual-mode (paper and electronic) filing. The following filer evaluation outcomes were updated in FDA's latest list:

FDA Announces First Approved Third-Party Certification Body for Food Safety Rules, VQIP

September 5, 2018 |FDA

The first third-party certification body under the Food Safety Modernization Act has been accredited and is available to perform food safety audits and issue food and facility certifications, the Food and Drug Administration announced Sept. 5. Approved by the American National Standards Institute, Perry Johnson Registrars Food Safety, Inc. of Troy, Michigan, will be able to certify under FDA’s produce safety regulations, human food preventive controls regulations, and juice and seafood hazard analysis and critical control point (HACCP) rules, FDA said. Certifications issued by certification bodies accredited through FDA’s Accredited Third Party Certification Program can also be used by importers to establish eligibility for participation in the Voluntary Qualified Importer Program, the agency said.

New and Revised FDA Import Alerts for Aug. 30

August 31, 2018 |FDA

On Aug. 30 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: