The Food and Drug Administration said it will hold another two meetings during the comment period of its proposed rule on intentional adulteration of food to explain the proposal and get feedback from the public. The meetings will be held in Chicago on Feb. 27, and on March 13 in Anaheim, Calif. The proposed rule on intentional adulteration of food, required under the Food Safety Modernization Act, would require food facilities that are required to register with FDA to address hazards that may be intentionally introduced by acts of terrorism (see 13122017). FDA already said one public meeting on the rule will be held on Feb. 20 in College Park, Md.
On Jan. 29 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Jan. 28 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 recently sent warning letters to seafood companies in India and China, threatening refusal of their products at the border unless violations of the seafood hazard analysis and critical control point (HACCP) regulations are corrected. In a letter dated Jan. 16 (here), FDA warned Gadre Marine Export Pvt. Ltd. that deficient HACCP procedures at the company’s Gujarat, India facility rendered the company’s frozen imitation crab sticks adulterated under FDA regulations. In a letter dated Jan. 15 (here), FDA told Yuet Heung Yuen Sauce Food (Zhuhai) Ltd. that it considered oyster sauce produced at the company’s Zhuhai City, China facility to be adulterated, also because of HACCP violations.
During the week of Jan. 20-26, 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:
The Food and Drug Administration said it is taking steps to refuse entry to several devices made by Lucky Beauty Equipment Co., Ltd. in China, because the company is marketing them in the U.S. for unapproved uses. According to FDA’s Jan. 15 warning letter, Lucky Beauty markets in the U.S. its Panda-B RF Beauty Device, the Lipolaser Machine, the LBS11 RF Skin Lift, the LBS54 Lipo Laser Fat Burner, the LBS56 Lipolaser, and LBS12 Vertical RF. The company’s website lists uses including cellulite removal, face lifting, removing wrinkles, removal of fat, and body shaping as uses for the various devices. Because these uses would affect the structure or function of the body, FDA considers the products to be medical devices that require approval, which Lucky Beauty hasn’t obtained. FDA said it will detain the devices at the border without physical examination until the violations are corrected.
The Food and Drug Administration on Jan. 28 released its report to Congress on its use of Food Safety Modernization Act mandatory recall authority. The agency is required by FSMA to report every two years on its mandatory recall authority, which allows FDA to order the recall of dangerous food if the distributor does not voluntarily cease distribution. This year’s report is the first since FSMA was passed in 2011. According to the report, FDA has only had to issue one mandatory recall order in the past two years. The agency ordered a recall of pet treats made in Colorado by Kasel Associates Industries, after the company didn’t recall all batches of pet treats that FDA had found to be contaminated with salmonella.
On Jan. 27 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Jan. 24 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 Jan. 22 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.