The Food and Drug Administration on Nov. 7 announced it intends to restrict sale of partially hydrogenated oils because of health concerns associated with trans fats (here). Although trans fats occur naturally in meat and dairy products and refined edible oils, partially hydrogenated oils have trans fats intentionally added as an integral component, explained FDA. A Center for Disease Control study showed elimination of partially hydrogenated oil from the food supply could prevent thousands of deaths from heart attacks annually, it said. Given that partially hydrogenated oils are no longer generally recognized as safe by scientists, FDA intends to reclassify them as food additives. If FDA finalizes the reclassification, food manufacturers would no longer be permitted to sell partially hydrogenated oils, either directly or as ingredients in another food product, without prior FDA approval for use as a food additive. FDA requested comments by Jan. 7 in a concurrent Federal Register notice (here).
The Food and Drug Administration issued its weekly Enforcement Report for Nov. 6 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration issued the Interstate Certified Shellfish Shippers List (ICSSL) for November. The ICSSL is published monthly for the information and use by food control officers, the seafood industry and other interested persons. The shippers listed have been certified by regulatory authorities in the U.S., Canada, Chile, South Korea, Mexico and New Zealand under the uniform sanitation requirements of the National Shellfish Program.
On Nov. 6 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The Food and Drug Administration posted a draft guidance on hearing aid devices and personal sound amplification products (here). Once finalized, the guidance will clarify for industry and staff the differences between hearing aids and personal sound amplification products, as well as the regulatory controls that apply to each, FDA said. Hearing aids are defined as medical devices, and are more heavily regulated by FDA than personal sound amplification products, it said. Comments on FDA’s draft guidance are due by Feb. 5.
On Nov. 5 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 posted a list of upcoming guidance documents on medical devices that it intends to publish in fiscal year 2014, as required by the Medical Device User Fee Amendments of 2012. The list is divided into an “A” list of priority guidances, and a “B” list that FDA will get to if it has enough remaining resources. According to FDA’s website, guidances the agency plans to issue in fiscal year 2014 include one on the Global Unique Device Identification Database, one on the evaluation of automatic Class III designation, and several detailing premarket notification requirements.
During the week of Oct. 29 - Nov. 4, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of:
On Nov. 4 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 on Oct. 31 announced two actions aimed at preventing and resolving drug shortages. An FDA proposed rule (here) would set requirements for manufacturers of drugs or biological products to notify FDA of any permanent discontinuance or interruption in production if the lapse is likely to lead to a “meaningful disruption in supply.” A concurrently released strategic plan (here) outlines steps FDA can take in preventing or mitigating shortages, including the exercise of temporary enforcement discretion and cooperation with foreign governments to bring in temporary imports.