On Jan. 30 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 extending until March 31 the comment period on its Food Safety Modernization Act proposed rule on animal food. The proposal would set current good manufacturing practices and hazard analysis and risk-based preventative controls requirements for animal feed and pet food (see 13102519). Comments were originally due Feb. 26, but FDA is giving commenters more time to consider new CGMP requirements, as well as the relationship between the animal food rule proposal and the Foreign Supplier Verification Program, it said.
The Food and Drug Administration is increasing civil monetary penalty amounts for violations of the Food, Drug and Cosmetic Act to adjust for inflation. Instead of going through the normal notice-and-comment process, FDA is implementing the across-the-board increase through a direct final rule here). The rule also allows FDA staff other than the Office of Chief Counsel to authorize civil monetary penalty complaints against tobacco retailers. The new provisions are set to take effect June 18, unless FDA gets adverse comment in response to a concurrent proposed rule by April 17 (here), in which case it will withdraw the direct final rule and follow normal notice-and-comment procedures.
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:
The Food and Drug Administration issued its weekly Enforcement Report for Jan. 29 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 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. 28 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
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 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.